Sittings · Document

Draft report (COM(2025)0102 – 2025/0102(COD)) 2025-09-26

Laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795

Committee on Public Health

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AM_Com_LegReport

Amendment 170

Christine Anderson

Proposal for a regulation

–

Proposal for rejection

The European Parliament rejects [the Commission proposal].

Or. en

Justification

This Regulation’s reliance on Article 114 TFEU as its legal basis is open to challenge. The primary objective of the proposal appears to be public health planning, strategic investment, and industrial policy rather than the harmonisation of national laws essential for internal market functioning. Accordingly, the principle of subsidiarity is not respected, and the proposal risks encroaching on Member States’ exclusive competence for health service organisation under Article 168(7) TFEU.Moreover, the Critical Medicines Act (CMA) reflects a flawed centralised approach; market failures in medicines supply are more likely to be the result of prior EU and MS intervention. Red tape, not lack of EU involvement, is the primary cause of underinvestment and rigidity in supply chains. The Act is unlikely to deliver on its objectives and may do more harm than good.

Amendment 171

Christophe Clergeau

Proposal for a regulation

Title 1

Text proposed by the Commission

Amendment

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795 (Text with EEA relevance)

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products and critical medical countermeasures as well as the availability of, and accessibility of, medicinal products of common interest and medical countermeasures of common interest, and amending Regulation (EU) 2024/795 (Text with EEA relevance)

Or. en

Justification

Shortages of medical countermeasures have demonstrated to be a salient issue during the Covid-19 crisis, showing that the Union was not sufficiently prepared to ensure the efficient development, manufacturing, procurement and distribution of crisis-relevant medical countermeasures in the case of crises and preparedness situation. Complementary to the possibility provided by the Emergency Framework Regulation to be activated in the event of a public health emergency to ensure the supply of crisis-relevant medical countermeasures, it is necessary to also strengthen the supply chain of critical medical countermeasures upstream of crises and preparedness situations. Amendments throughout the text aim to expand the scope of this Regulation also to critical medical countermeasures.

Amendment 172

Aleksandar Nikolic, Mathilde Androuët, Marie-Luce Brasier-Clain

Proposal for a regulation

Citation 1

Text proposed by the Commission

Amendment

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to Article 168 of the Treaty on the Functioning of the European Union, and in particular paragraph 7 thereof,

Or. fr

Amendment 173

Radan Kanev

Proposal for a regulation

Citation 1

Text proposed by the Commission

Amendment

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(5) thereof,

Or. en

Amendment 174

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Ton Diepeveen, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Citation 1

Text proposed by the Commission

Amendment

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168 thereof,

Or. en

Amendment 175

Kristian Vigenin

Proposal for a regulation

Citation 1

Text proposed by the Commission

Amendment

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168 thereof,

Or. en

Amendment 176

Christine Anderson

Proposal for a regulation

Citation 1

Text proposed by the Commission

Amendment

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(5) thereof,

Or. en

Justification

The use of Article 114 is legally flawed because the proposal goes beyond internal market harmonisation and introduces measures that amount to direct interference in national health systems and procurement policy — which is explicitly excluded under Article 168(7) TFEU. If the proposal is to proceed at all, it must be restructured to fit within Article 168(5) — which prohibits harmonisation and limits the EU to incentive-based, non-binding coordination measures.

Amendment 177

Oliver Schenk

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1) Pursuant to Article 9 of the Treaty on the Functioning of the European Union (‘TFEU’) and Article 35 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), the Union is to ensure a high level of human health protection in all Union policies and activities. The availability of safe, efficacious and high-quality medicinal products, underpinned by a resilient and competitive pharmaceutical industry and secure, reliable supply chains forming the backbone of the supply of medicine, is vital to achieving this objective and to safeguarding public health across the Union and improving the preparedness and the Union’s overall security.

Or. en

Amendment 178

Radan Kanev

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

Or. en

Justification

For a medicinal product, being efficacious means that the product can produce the desired beneficial effect in a controlled setting, such as during clinical trials. “Effective” is related to the intended therapeutic actions after the medicinal product has received MA.

Amendment 179

Kristian Vigenin

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

Or. en

Amendment 180

Kristian Vigenin

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission

Amendment

(1 a) The security of supply and availability of critical medicinal products for patients is a strategic objective of the Union. The Member States and the Commission should work together to strengthen the security of supply and continuous availability of critical medicinal products in the Union through measures that take full advantage of the potential of the internal market. The Commission should support the coordinated efforts of the Members States.

Or. en

Justification

Language moved from art. 4 here

Amendment 181

Aleksandar Nikolic, Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission

Amendment

(1a) Between January 2023 and January 2024, 46 % of Portuguese citizens, 42 % of Spanish citizens, 34 % of Italian citizens and 33 % of Belgian citizens already experienced medicines shortages. More recently, in 2024, 39 % of French citizens faced the same supply difficulties, and 35 % of them said they were unable to obtain alternative treatments.

Or. fr

Amendment 182

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Gerald Hauser, Ton Diepeveen, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission

Amendment

(1 a) This Regulation that concerns the availability and security of supply of critical medicinal products directly affects public health and health systems across the Union. Pursuant to Article 168 of the Treaty on the Functioning of the European Union (TFEU), public health is primarily a competence of the Member States.

Or. en

Amendment 183

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission

Amendment

(1 a) The Critical Medicines Act should contribute to the achievement of the Union’s commitments on gender equality, as set out in the EU Gender Equality Strategy 2020–2025 and Article 8 TFEU requiring gender mainstreaming in all Union policies

Or. en

Amendment 184

Aleksandar Nikolic, Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a regulation

Recital 1 b (new)

Text proposed by the Commission

Amendment

(1b) A stock shortage reported by a laboratory leads to an average 11 % drop in deliveries to pharmacies for the entire duration of the shortage1 a.

_________________

1 a https://www.polytechnique-insights.com/tribunes/sante-et-biotech/penurie-de-medicaments-39-des-francais-exposes-en-2024/

Or. fr

Amendment 185

Marie-Luce Brasier-Clain, Aleksandar Nikolic, Ondřej Knotek, Tomáš Kubín, Ton Diepeveen

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) In recent years, the Union has experienced an increasing number of shortages of medicinal products, including shortages of medicinal products for which insufficient supply results in serious harm or risk of serious harm to patients. It should be emphasised that 60 % to 80 % of the active ingredients used in the manufacture of medicinal products marketed in the Union come from third countries, mainly the People’s Republic of China and the Republic of India, which are also major suppliers of generic medicinal products, and that 90 % of the reported shortages of critical medicinal products are precisely in relation to generic medicinal products.

Or. fr

Amendment 186

Oliver Schenk

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) In recent years, the Union has experienced an increasing number of shortages of medicinal products, including shortages which have resulted in serious harm or risk of serious harm to patients’ health and safety. Beyond their impact on healthcare systems, such shortages could also undermine national security, disrupt critical supply chains, and have detrimental effects on the broader economy.

Or. en

Amendment 187

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

Or. en

Amendment 188

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

Or. en

Amendment 189

Tilly Metz

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

Or. en

Amendment 190

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Gerald Hauser, Ton Diepeveen, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) In recent years, Member States have experienced an increasing number of shortages of medicinal products, including shortages of medicinal products for which insufficient supply results in serious harm or risk of serious harm to patients.

Or. en

Amendment 191

Radan Kanev

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) In recent years, the Union has experienced an increasing number of shortages of critical medicinal products, including shortages of medicinal products for which insufficient supply results in serious harm or risk of serious harm to patients.

Or. en

Amendment 192

Leire Pajín

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2 a) The COVID-19 pandemic demonstrated that access to medicines and health security is a global challenge requiring collective solutions, and therefore that the Union's health security is closely tied to that of its partners. The Union therefore has a responsibility to ensure that its measures to strengthen security of supply also contribute to improving availability of critical medicines in partner countries, in particular in the Global South. Union action should support local manufacturing and equitable access to medical products worldwide, in a manner that supports resilient health systems.

Or. en

Amendment 193

Tilly Metz

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2 a) Sustainable and resilient supply chains of medicinal products are essential to protect people's health and prevent medicine shortages that can lead to deterioration of patients' health, increased costs and extensive burden on healthcare professionals, including pharmacists.

Or. en

Amendment 194

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2 a) A stable and resilient supply of medicines critical to the health of patients in the Union is essential, as shortages can lead to deterioration of patients’ health, increased healthcare costs, and significant burdens on healthcare systems and public authorities.

Or. en

Amendment 195

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 2 b (new)

Text proposed by the Commission

Amendment

(2 b) To monitor and mitigate potential shortages of critical medicines, Regulation [reference to be added after adoption cf. COM(2023) 193 final] sets up a Unon list of critical medicinal products. The MSSG should be able to provide recommendations on measures to be taken by marketing authorisation holders, Member States, the Commission and other entities to resolve any critical shortage or to ensure the security of supply of those critical medicinal products to the market. The inclusion of medicinal products in the list does not necessarily indicate an imminent shortage, rather it prioritises prevention efforts by the Union and Member States for those critical medicinal products.

Or. en

Amendment 196

Nikos Papandreou

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) Shortages of medicinal products can have very different and complex root causes, with challenges identified along the entire pharmaceutical value chain. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. These include existing dependencies on a limited number of suppliers globally and lack of Union capacities to produce certain medicinal products, their active substances or key raw pharmaceutical materials. Through diversification of supply sources and investment in local production, the Union can reduce its risk of exposure to shortages of medicinal products.

(3) Shortages of medicinal products can have very different and complex root causes, with challenges identified along the entire pharmaceutical value chain. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components, including starting materials, intermediates and other raw pharmaceutical materials. These include existing dependencies on a limited number of suppliers globally and lack of Union capacities to produce certain medicinal products, their active substances or key raw pharmaceutical materials. Through diversification of supply sources and investment in local production, as well as meaningful involvement of patient organisations from an early stage, the Union can reduce its risk of exposure to shortages of medicinal products.

Or. en

Amendment 197

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) Shortages of medicinal products can have very different and complex root causes, with challenges identified along the entire pharmaceutical value chain. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components, including starting materials, intermediates and other raw pharmaceutical materials. These include existing dependencies on a limited number of suppliers globally and lack of Union capacities to produce certain medicinal products, their active substances or key raw pharmaceutical materials. Through diversification of supply sources and investment in local production, the Union can reduce its risk of exposure to shortages of medicinal products.

Or. en

Amendment 198

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Gerald Hauser, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) Shortages of medicinal products can have very different and complex root causes, with challenges identified along the entire pharmaceutical value chain. In particular, shortages of medicinal products can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. These include existing dependencies on a limited number of suppliers globally and lack of Member States' capacities to produce certain medicinal products, their active substances or key raw pharmaceutical materials. Through diversification of supply sources and investment in local production, the Union and its Member States can reduce its risk of exposure to shortages of medicinal products.

Or. en

Amendment 199

Laurence Trochu

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

(3a) The implementation of national initiatives to recycle unused medicinal products cannot be considered a valid source of critical medicinal products for reuse. There is currently no precise data on the nature of medicinal products collected in this way and the storage conditions, in particular humidity and temperature, cannot be assured.

Or. fr

Amendment 200

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

(3 a) Shortages of medicines disproportionately affect women, particularly in areas such as reproductive health, maternal health, menopause treatment, and female cancers. This Regulation should take into account the gender impact and provide for specific measures to address gender inequalities and safeguard equitable access to medicines.

Or. en

Amendment 201

Alessandra Moretti

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. Setting up new, or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages and the need for specialised skills in pharmaceutical manufacturing further add to the industrial challenges to manufacturing in the Union. Targeted financial incentives, simplified administrative processes, and better Union-level coordination can contribute to supporting efforts to increase manufacturing capacities in the Union and strengthen the supply chains for critical medicines.

Or. en

Amendment 202

Sirpa Pietikäinen

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. The Union’s heavy dependency on third countries for critical ingredients, such as active pharmaceutical ingredients (APIs), has become evident, with up to 80% of APIs used in Europe and around 40% of finished medicines sold in Europe originating from China or India1a, threatening strategic autonomy, resilience, and people’s wellbeing and health. Setting up new, or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages and the need for specialised skills in pharmaceutical manufacturing further add to the industrial challenges to pharmaceutical manufacturing and development in the Union. Targeted financial incentives, simplified administrative processes, and better Union-level coordination can contribute to supporting efforts to increase manufacturing capacities in the Union and strengthen the supply chains for critical medicines.

_________________

1a https://www.eesc.europa.eu/en/our-work/opinions-information-reports/opinions/securing-europes-medicine-supply-envisioning-critical-medicines-act

Or. en

Amendment 203

Aurelijus Veryga

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

Or. en

Amendment 204

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. Setting up new, or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages and the need for specialised skills in pharmaceutical manufacturing further add to the industrial challenges to manufacturing in the Union. Targeted financial incentives, simplified administrative processes, whilst upholding the highest social, health and environmental standards, and better Union-level coordination can contribute to supporting efforts to increase manufacturing capacities in the Union and strengthen the supply chains for critical medicines.

Or. en

Amendment 205

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Gerald Hauser, Ton Diepeveen, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. Setting up new, or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages and the need for specialised skills in pharmaceutical manufacturing further add to the industrial challenges to manufacturing in the Union along with high energy prices caused mainly by the EU Green Deal policies. Targeted financial incentives, simplified administrative processes, and better Union-level coordination can contribute to supporting efforts to increase manufacturing capacities in the Union and strengthen the supply chains for critical medicines.

Or. en

Amendment 206

Tilly Metz

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. Setting up new, or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages and the need for specialised skills in pharmaceutical manufacturing further add to the industrial challenges to manufacturing in the Union. Targeted financial incentives, simplified administrative processes, safeguarding social and environmental standards and better Union-level coordination can contribute to supporting efforts to increase manufacturing capacities in the Union and strengthen the supply chains for critical medicines.

Or. en

Amendment 207

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

(4 a) While medicine shortages can occur for any type of product, they disproportionately affect older, off-patent, and generic medicines, primarily due to their low profit margins, which reduce incentives for investment in robust manufacturing capacity. Older, off-patent, and generic medicines make up the majority of the medicinal products placed on the Union List of Critical Medicinal Products, due to low profit margins that limit investment in manufacturing. Many off-patent and generic medicines suppliers have outsourced manufacturing or relocated production of finished products outside the Union, and frequently source their APIs from third countries. Consequently, the Union relies on a limited number of API suppliers and manufacturers, many located outside its borders. Understanding and addressing shortages of critical medicines requires distinguishing the market dynamics of generic and off-patent products from those of innovative medicinal products.

Or. en

Amendment 208

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Gerald Hauser, Ton Diepeveen, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

(4 a) Due to the Green Deal, the EU pursues one of the most ambitious environmental policies in the world, which has too often resulted in overregulation and increased production costs, ultimately leading to the relocation of manufacturing capacities outside the Union. This Regulation seeks to reinforce the Members States manufacturing base and to reduce the dependency on third countries. In this context, it is necessary to streamline and accelerate the permitting procedures in order to facilitate investment and industrial capacity within the Union. Environmental assessments carried out under this Regulation should not impose unnecessary burdens on pharmaceutical manufacturers that could undermine their competitiveness, while safeguarding patients’ access to critical medicinal products.

Or. en

Amendment 209

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

(4 a) While environmental legislation plays a vital role in protecting public health and the environment, it can also create unintended challenges for the continuous supply of critical medicinal products and medicinal products of common interest, like adding regulatory burdens or limiting production capacity. To safeguard the uninterrupted availability of these products, it is important to assess the combined effects of relevant environmental rules on manufacturing and supply. This Regulation should therefore promote a coordinated assessment of such impacts to minimise disruptions and uphold the availability of critical medicinal products for Union citizens.

Or. en

Amendment 210

Aurelijus Veryga

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

(4 a) Environmental and chemical legislation, while essential to public and environmental health, may inadvertently impact the continuity of supply of critical medicinal products or medicinal products of common interest through increased regulatory burden or production constraints. To ensure the uninterrupted availability of such medicines, it is necessary to assess the cumulative impacts of relevant environmental and chemical legislative frameworks on manufacturing and supply capacities. This Regulation should therefore support a coordinated assessment of such impacts to ensure minimal disruption to critical medicine availability

Or. en

Amendment 211

András Tivadar Kulja

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

This Regulation should promote a coordinated approach to recent and forthcoming environmental and chemical legislation, assessing their aggregate impact on the security of supply of critical medicinal products or products of common interest, to avoid undue regulatory burdens or production constraints.

Or. en

Amendment 212

Marie-Luce Brasier-Clain, Aleksandar Nikolic, Ondřej Knotek, Tomáš Kubín, Ton Diepeveen

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

(4a) In order to strengthen the strategic autonomy of the Union, production capacities for critical and commonly used medicines need to be developed within its own territory. In this case, the lack of strategic autonomy makes the Member States dependent on third countries which may be required to reduce their exports, particularly in the event of exceptional health crises or periods of diplomatic tension.

Or. fr

Amendment 213

Letizia Moratti, Adam Jarubas

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

(4 a) The availability of critical medicines may be affected by Union legislation in other sectors, in particular environmental legislation such as Directive (EU) 2024/3019 on Urban Waste Water Treatment Directive. In order to ensure coherence and avoid unintended consequences leading to shortages, it is important to assess the impact of such measures on the supply of medicines.

Or. en

Amendment 214

Galato Alexandraki, Emmanouil Fragkos

Proposal for a regulation

Recital 5 a (new)

Text proposed by the Commission

Amendment

(5a) It is essential to prioritise strengthening the domestic and European production of active substances and medicines in order to reduce dependency on third countries and ensure the Union’s strategic autonomy.

Or. el

Amendment 215

Nikos Papandreou

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) However, despite regulatory obligations on marketing authorisation holders to ensure the continuous supply of medicinal products to meet patients’ demand and the additional regulatory mechanism introduced by Regulation of the European Parliament and of the Council (EU) 2022/123 and Regulation (EU) …/… [reference to be added after adoption cf. COM(2023)193 final] to mitigate and respond to shortages, the functioning of markets alone does not always guarantee the availability of medicinal products. This risk is particularly evident in cases of supply chain disruptions, especially when the supply of a given medicinal product relies on a limited number of global suppliers and production facilities or where there is a high dependency on a single or a limited number of third countries.

(7) However, despite regulatory obligations on marketing authorisation holders to ensure the continuous supply of medicinal products to meet patients’ needs and the additional regulatory mechanism introduced by Regulation of the European Parliament and of the Council (EU) 2022/123 and Regulation (EU) …/… [reference to be added after adoption cf. COM(2023)193 final] to mitigate and respond to shortages, the functioning of markets alone does not always guarantee the availability of medicinal products. This risk is particularly evident in cases of supply chain disruptions, especially when the supply of a given medicinal product relies on a limited number of global suppliers and production facilities or where there is a high dependency on a single or a limited number of third countries.

Or. en

Amendment 216

Tilly Metz

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

Or. en

Amendment 217

Nicolás González Casares, Pierre Jouvet, Romana Jerković, Leire Pajín

Proposal for a regulation

Recital 7 a (new)

Text proposed by the Commission

Amendment

(7 a) The COVID-19 pandemic and other recent shortages of essential medicinal products have demonstrated the Union’s vulnerability to disruptions in global supply chains. The Strategic Report of the Critical Medicines Alliance highlighted that insufficient visibility over the origin of active pharmaceutical ingredients, intermediates, and raw materials, combined with a high reliance on a limited number of third-country suppliers, creates significant risks for the continuity of supply of critical medicines in the Union. In order to reduce these dependencies and strengthen the Union’s strategic autonomy, it is necessary to establish a framework for systematic monitoring and mapping of supply chains for critical medicines. For such a monitoring system to succeed, both governments and industry must see clear value in their participation. The European Medicines Agency and the Commission, through Directorate-General for Health and Food Safety or the Health Emergency Preparedness and Response Authority, should therefore build on existing regulatory data to avoid duplication and minimise burdens, especially for small and medium-sized enterprises, while guaranteeing strict protection of commercially sensitive information.

Or. en

Amendment 218

Christine Anderson

Proposal for a regulation

Recital 7 a (new)

Text proposed by the Commission

Amendment

(7 a) Market failures in the pharmaceutical sector are often the result of existing regulatory burdens, price controls, and procurement rules that discourage investment and production. Efforts to address availability must begin by removing excessive red tape and restoring the conditions for competitive, decentralised supply chains to function effectively.

Or. en

Amendment 219

Nicolás González Casares, Pierre Jouvet, Leire Pajín

Proposal for a regulation

Recital 7 b (new)

Text proposed by the Commission

Amendment

(7 b) The Commission, the Agency, and national competent authorities should be able to exchange relevant data under strict confidentiality arrangements, so as to ensure coherent action across the Union without undermining trust with industry. In return, participating companies should benefit from reciprocal advantages, such as access to aggregate market intelligence, consideration for regulatory flexibilities where early reporting prevents shortages, and coordinated support in addressing supply disruptions. By embedding reciprocity and trust, the system can become a win–win mechanism: governments gain situational awareness and preparedness in the face of health crises, while industry benefits from a more stable, predictable, and resilient market environment. This cooperative approach will foster solidarity across Member States, reduce harmful national measures such as export bans or hoarding, and reinforce the Union’s preparedness and response capacities under the European Health Union.

Or. en

Amendment 220

Oliver Schenk

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8) As the Union market for medicinal products remains fragmented, there is a need for better coordination between Member States to leverage in full the Union’s potential to strengthen the security of supply of medicinal products, without calling into question Member States’ responsibilities for the organisation and delivery of health services and medical care. Uncoordinated national measures risk disrupting the internal market, fail to address broader supply chain issues, and are insufficient to resolve cross-border issues, including the Union's dependency on third countries. The regulatory framework for medicinal products therefore needs to be complemented by targeted actions providing for further harmonisation, while avoiding duplication or overlap of existing structures. That principle should also apply to existing Union law, including the ongoing revision of the general pharmaceutical legislative acts, the European Health Data Space (Regulation (EU) 2025/327 of the European Parliament and of the Council1a), the Clinical Trials Regulation (Regulation (EU) No 536/2014 of the European Parliament and of the Council 1b), and other relevant legal frameworks, with a view to ensuring consistency. Furthermore, existing data infrastructures and databases, such as epidemiological data from the European Centre for Disease Prevention and Control (ECDC), should be fully leveraged in order to reduce reporting burdens, streamline the monitoring of medicinal product supply chains, and improve the efficiency of data exchange between competent authorities and stakeholders. The use of existing structures would also help ensure more stable and predictable data flows.

Or. en

Amendment 221

Ton Diepeveen, Aleksandar Nikolic, Tomáš Kubín, Valérie Deloge

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

Or. en

Amendment 222

Tilly Metz

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

Or. en

Amendment 223

Aurelijus Veryga

Proposal for a regulation

Recital 8 a (new)

Text proposed by the Commission

Amendment

(8 a) The ongoing revision of the Union’s general pharmaceutical legislation introduces important measures to improve access to medicines, including incentives for timely market entry, enhanced availability and reduced inequalities between Member States. This Regulation complements that framework by focusing specifically on strengthening the resilience of supply chains and addressing concrete security-of-supply vulnerabilities, thereby contributing to the objectives of the Union’s pharmaceutical strategy.

Or. en

Amendment 224

Radan Kanev

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 225

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Some medicinal products of common interest, which can include, among others, orphan medicinal products, innovative or high-cost treatments or antimicrobials, are key for the provision of adapted care to patients, while not affected by supply security issues, may still not be available to patients in some Member States. This may be caused by a variety of factors, including product or geographical demand market size, which can impact the timely availability of medicinal products in certain Member States, increasing inequalities between patients in the Union and undermining the Union's commitment to achieving universal access to essential medicine by 2030 in line with the United Nations sustainable development goal 3.8.

Or. en

Amendment 226

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Some medicinal products of common interest which are key for the provision of adapted care to patients, while not affected by supply security issues, may still not be available to patients in some Member States. This may be caused by a variety of factors, including product or geographical demand market size, which can impact the timely availability of medicinal products in certain Member States. This Regulation aims at reducing such inequalities among Member States, ensuring more equitable access to medicinal products across the Union, so that patients enjoy the same level of access regardless of their country of residence.

Or. en

Amendment 227

Nikos Papandreou, Romana Jerković

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Some medicinal products of common interest which are key for the provision of adapted care to patients, while not affected by supply security issues, may still not be available to patients in some Member States increasing inequalities between patients in the Union and undermining the Union's commitment to achieving universal access to essential medicine by 2030 in line with the United Nations sustainable development goal 3.8. This may be caused by a variety of factors, including product or geographical demand market size, which can impact the timely availability of medicinal products in certain Member States.

Or. en

Amendment 228

Tilly Metz

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Some medicinal products of common interest which are key for the provision of adapted care to patients, while not affected by supply security issues, may still not be available to patients in some Member States, increasing inequalities between patients in the Union and undermining the Union’s commitment to achieving universal access to essential medicinal products by 2030, in line with the United Nations Sustainable Development Goal 3.8. This may be caused by a variety of factors, including product or geographical demand market size, which can impact the timely availability of medicinal products in certain Member States.

Or. en

Amendment 229

Oliver Schenk

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Some medicinal products of common interest which are key for the provision of adapted care to patients, while not affected by supply security issues, may still not be available to patients in some Member States. This may be caused by a variety of factors, including product geographical demand market size or characteristics of broader national healthcare systems, which can impact the timely availability of medicinal products in certain Member States.

Or. en

Amendment 230

Aurelijus Veryga

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Some medicinal products of common interest which are key for the provision of adapted care to patients, while not affected by supply security issues, may still not be accessible to patients in some Member States. This may be caused by a variety of factors, including national healthcare priorities and budgets, product or geographical demand market size, which can impact the timely availability of medicinal products in certain Member States.

Or. en

Amendment 231

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

Or. en

Amendment 232

Adam Jarubas, Ewa Kopacz, Letizia Moratti

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

Or. en

Amendment 233

András Tivadar Kulja

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) Some medicinal products of common interest which are key for the provision of adapted care to patients, while not affected by supply security issues, may still not be accessible to patients in some Member States. This may be caused by a variety of factors, including product or geographical demand market size, which can impact the timely availability of medicinal products in certain Member States.

Or. en

Amendment 234

Margarita de la Pisa Carrión

Proposal for a regulation

Recital 9 a (new)

Text proposed by the Commission

Amendment

(9 a) The network of community pharmacies across the Union plays a crucial role in ensuring the timely and equitable distribution of critical medicinal products to patients, and guaranteeing that such products are dispensed by qualified health professionals to ensure correct administration.

Or. en

Amendment 235

Ton Diepeveen, Aleksandar Nikolic, Tomáš Kubín, Gerald Hauser, Valérie Deloge

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) The smooth functioning of the internal market and a high level of protection of human health should be ensured as regards medicinal products and it should be aimed to complementing other Union pharmaceutical legislation by providing for a harmonised framework supporting Member States’ coordinated efforts to encourage investments in new and existing manufacturing capacities for critical medicinal products, encouraging the strategic use of public procurement instruments by the Member States as well as the coordination of the Member States’ approaches, including through leveraging aggregated demand through Commission facilitated collaborative procurement procedures of critical medicinal products and medicinal products of common interest. Due to the international dimension of the security of supply, in particular taking into account that diversification of supply chains and an overall increase of supply are elements of a solution for ensuring the security of supply, international cooperation should be encouraged.

(10) The smooth functioning of the internal market and a high level of protection of human health should be ensured. In addition, international cooperation should be encouraged.

Or. en

Amendment 236

Radan Kanev

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) The smooth functioning of the internal market and a high level of protection of human health should be ensured as regards medicinal products and it should be aimed to complementing other Union pharmaceutical legislation by providing for a harmonised framework supporting Member States’ coordinated efforts to encourage investments in new and existing manufacturing capacities for critical medicinal products, encouraging the strategic use of public procurement instruments by the Member States as well as the coordination of the Member States’ approaches, including through leveraging aggregated demand through Commission facilitated collaborative procurement procedures of critical medicinal products and medicinal products of common interest. In accordance with Union Treaties and existing legislation, the use of such public procurement instruments should remain strictly voluntary, both for Member States entering procurement procedures, as well as market actors eligible for participation in procurement procedures, in order to avoid market disruptions. Due to the international dimension of the security of supply, in particular taking into account that diversification of supply chains and an overall increase of supply are elements of a solution for ensuring the security of supply, international cooperation should be encouraged.

Or. en

Justification

Justification:In accordance with EU legal basis, and the principle of subsidiarity, the use of procurement procedures should remain entirely voluntary for Member States. Similarly, participation by commercial actors to bids should remain voluntary and driven by adequate market considerations and procurement requirements – and not become a coercive instrument that would further degrade the attractiveness of the European market to commercial actors, with potential adverse effects on availability and access to medicines across Member States.

Amendment 237

Adam Jarubas, Ewa Kopacz, Letizia Moratti

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) The smooth functioning of the internal market and a high level of protection of human health should be ensured as regards medicinal products and it should be aimed to complementing other Union pharmaceutical legislation by providing for a harmonised framework supporting Member States’ coordinated efforts to encourage investments in new and existing manufacturing capacities for critical medicinal products, simplifying the procedure for authorising a critical medicinal product for marketing, encouraging the strategic use of public procurement instruments by the Member States as well as the coordination of the Member States’ approaches, including through leveraging aggregated demand through Commission facilitated collaborative procurement procedures of critical medicinal products and medicinal products of common interest. Due to the international dimension of the security of supply, in particular taking into account that diversification of supply chains and an overall increase of supply are elements of a solution for ensuring the security of supply, international cooperation should be encouraged.

Or. en

Amendment 238

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) The smooth functioning of the internal market and a high level of protection of human health should be ensured as regards medicinal products and it should be aimed to complementing other Union pharmaceutical legislation by providing for a harmonised framework supporting Member States’ coordinated efforts to encourage investments in new and existing manufacturing capacities for critical medicinal products, simplifying the procedure for authorizing a critical medicinal product for marketing, encouraging the strategic use of public procurement instruments by the Member States as well as the coordination of the Member States’ approaches, including through leveraging aggregated demand through Commission facilitated collaborative procurement procedures of critical medicinal products and medicinal products of common interest. Due to the international dimension of the security of supply, in particular taking into account that diversification of supply chains and an overall increase of supply are elements of a solution for ensuring the security of supply, international cooperation should be encouraged.

Or. en

Amendment 239

Sirpa Pietikäinen

Proposal for a regulation

Recital 10 a (new)

Text proposed by the Commission

Amendment

(10 a) In order to ensure equal availability to all Europeans, regardless of national wealth, with predictable and fair pricing, possibilities of a long-term EU-level procurement and negotiated agreements with industry are needed. Guaranteed procurement volumes and long-term agreements provide certainty for companies to plan production, while the EU counties together entail stronger purchasing power than individual Member States on their own. At least 20% of critical medicines and active pharmaceutical ingredients (API) should be produced within the EU. Local production allows rapid scaling in case of shortages and reduces dependency on external suppliers. Public procurement should guarantee that hospitals in Member States purchase their fair share of locally produced medicines. This may include the establishment of an EU Critical Medicines Fund, financed by Member States, to support research, procurement, and distribution. Pilot projects could focus initially on rare diseases or other small-scale medicines.

Or. en

Amendment 240

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 11 a (new)

Text proposed by the Commission

Amendment

(11 a) The implementation of this Regulation should be coherent with Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space (EHDS) to enhance the interoperability, secure exchange, and real-time monitoring of health data relevant to the availability and supply of medicinal products. Improved integration between this Regulation and the EHDS will contribute to early detection of shortages, cross-border distribution, and streamlined access to critical medicines.

Or. en

Amendment 241

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 11 a (new)

Text proposed by the Commission

Amendment

(11 a) Ensuring the continuous availability of medicinal products for all patients in the Union is a key strategic objective. This Regulation should be closely aligned with the Union general pharmaceutical legislation to avoid any potential fragmentation and duplication, and to ensure coherence of legislative initiatives affecting the pharmaceutical sector.

Or. en

Amendment 242

Michele Picaro, Ruggero Razza

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) While the primary objective of this Regulation should be to strengthen the security of supply and ensure the availability of critical medicinal products and of medicinal products of common interest, given a lack of critical medicinal products can affect the functioning of the economy as a whole, this Regulation should also support the Union’s competitiveness by fostering a more stable and predictable market environment, encouraging investment and supporting innovation in the pharmaceutical sector. Ensuring the security of supply and availability of critical medicinal products and the availability and accessibility of other medicinal products of common interest should moreover contribute to the Union’s preparedness, resilience, and economic and overall security, including when cross-border supply chains risk being disrupted. The past health emergencies and crises, like COVID-19, have demonstrated how the presence of critical infrastructures, including hospitals and community pharmacies, has been fundamental in achieving these objectives. Furthermore, in order to strengthen the functioning of the internal market and to ensure the uninterrupted availability of critical medicinal products and medicinal products of common interest across the Union, it is necessary to establish a Union coordination mechanism for critical medicinal products and medicinal products of common interest notwithstanding Member States competencies and what is provided by the current legislation. Such a mechanism would enhance the Union capacity to address shortages, strengthen supply chain resilience, and enable coordinated approaches to national stockpiling and contingency stocks.

Or. en

Justification

COVID-19 exposed that uninterrupted operation of hospitals and community pharmacies was indispensable for maintaining treatment continuity and safeguarding public trust. Explicitly acknowledging this experience aligns the Regulation with the EU’s “lessons learnt” approach promoted by the DG HERA, the Council’s conclusions on pandemic preparedness, and the European Parliament´s report on the Covid-19 pandemic. It is as well crucial not to overstep on national competencies by ensuring that the subsidiarity principle is respected by this provision. It is crucial to ensure that what is provided by the already existing legislation, on cross country cooperation in shortages, on EMA role and on the use of IT systems, is respected

Amendment 243

Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

Or. en

Amendment 244

Aurelijus Veryga

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

Or. en

Amendment 245

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

Or. en

Amendment 246

Sirpa Pietikäinen

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

Or. en

Amendment 247

Kristian Vigenin

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) Тhe primary objective of this Regulation should be to strengthen the security of supply and ensure the availability of critical medicinal products and of medicinal products of common interest, given a lack of critical medicinal products can affect the functioning of the economy as a whole. Ensuring the security of supply and availability of critical medicinal products and the availability and accessibility of other medicinal products of common interest should moreover contribute to the Union’s preparedness, resilience, and economic and overall security, including when cross-border supply chains risk being disrupted.

Or. en

Justification

Support for the industry is out of the scope of this regulation, there are other tools for it.

Amendment 248

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

Or. en

Amendment 249

Aleksandar Nikolic, Ondřej Knotek, Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

Or. fr

Amendment 250

Radan Kanev

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) While the primary objective of this Regulation should be to strengthen the security of supply and ensure the availability of critical medicinal products, given a lack of critical medicinal products can affect the functioning of the economy as a whole, this Regulation should also support the Union’s competitiveness by fostering a more stable and predictable market environment, encouraging investment and supporting innovation in the pharmaceutical sector, whilst securing faster patient access across the Union. Ensuring the security of supply and availability of critical medicinal products should moreover contribute to the Union’s preparedness, resilience, and economic and overall security, including when cross-border supply chains risk being disrupted.

Or. en

Amendment 251

Adam Jarubas, Ewa Kopacz, Letizia Moratti

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

Or. en

Amendment 252

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

Or. en

Amendment 253

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

Or. en

Amendment 254

Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 12 a (new)

Text proposed by the Commission

Amendment

(12 a) Novel antimicrobials (e.g., reserve antibiotics or certain antifungals), often used as last-resort treatments for serious or life-threatening infections, represent a distinct subset of medicinal products of common interest. Their use is guided by antimicrobial stewardship principles and varies significantly across the Member States due to the differing epidemiological landscape of antimicrobial resistant pathogens, clinical practices, and national guidelines. To ensure effective healthcare and policy responses, it is essential to distinguish novel antimicrobials, including reserve antibiotics, from other antimicrobials in the Union list of critical medicinal products. This differentiation enables the prioritisation of development of tailored incentive measures for novel antimicrobials. Such measures must reflect their significant public health contribution, restricted market uptake, and their strategic importance in efficiently combating antimicrobial resistance, by securing appropriate patient access and evaluation of their value-contribution.

Or. en

Justification

This is a necessary clarification in the CMA framework by identifying novel antimicrobials (including reserve antibiotics and certain antifungal) as a specific subset of medicinal products of common interest (MPCI), rather than critical medicinal products. Unlike critical medicines, which are typically defined by immediate supply risks, novel antimicrobials are not generally subject to shortages. Instead, they face sustainability challenges due to low and unpredictable demand. Their categorization under MPCI reflects their strategic importance and public health relevance, especially in the context of AMR. This distinction allows for more targeted interventions, such as financial incentives, while avoiding misapplication of supply-side tools, and aligns with EU and WHO guidance on stewardship of last-resort antimicrobials.

Amendment 255

Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 12 b (new)

Text proposed by the Commission

Amendment

(12 b) Due to their limited and variable use across Member States, novel antimicrobials are not well-suited to volume-based pricing and reimbursement mechanisms and therefore face economic disincentives due to market failure. In order to improve the availability and access to these life-saving treatments, including as part of Union emergency preparedness, incentives mechanisms, such as revenue guarantees, compensatory remuneration for maintaining stockpiles, or other forms of EU financial support should be considered. This would help advance the goals of the EU Medical Countermeasures Strategy, presented by the European Commission on 9 July 2025, to advance the development and availability of medical countermeasures and high-value technologies.

Or. en

Justification

Novel antimicrobials face a unique market failure: they are essential for public health but economically unattractive to innovate and manufacture due to low demand and governance and stewardship-driven restrictions. Traditional procurement tools, such as joint procurement or volume-based contracts, are therefore ill-suited to stimulate the manufacturing of these products. Without tailored incentives that are specific to novel antimicrobials, manufacturers may exit the market, leaving the EU vulnerable to AMR-related health threats. This recital supports the development of fit-for-purpose and right-sized financial instruments – such as those proposed by HERA or through strategic projects under the CMA – to ensure that novel antimicrobials will be available when needed, even if they will not be routinely used.

Amendment 256

Viktória Ferenc

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) Taking into account the different root causes of the availability issues affecting critical medicinal products and medicinal products of common interest, some measures should apply to critical medicinal products only. However, this does not dispense with the need to address also the issue of access to the medicinal products necessary for treating rare diseases.

Or. hu

Amendment 257

Oliver Schenk

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) Taking into account the different root causes of the availability issues affecting critical medicinal products medicinal products of common interest, some measures to address shortages or their underlying causes should apply to critical medicinal products only.

Or. en

Amendment 258

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) The availability and the security of supply of critical medicinal products are essential to safeguard public health and the economic and overall security of the Union and therefore should be considered strategic objectives of the Union. The Commission should carefully consider the potential impact on the security of supply and the availability of critical medicinal products when preparing any legislative proposal, delegated acts, or implementing acts, including under horizontal Union legislation.

Or. en

Amendment 259

Tilly Metz

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) The availability and the security of supply of critical medicinal products are essential to safeguard public health and the economic and overall security of the Union and therefore should be considered strategic objectives of the Union. Different models of production, including public not-for-profit infrastructure can contribute to strengthening the availability and security of supply of medicinal products in the Union.

Or. en

Amendment 260

Oliver Schenk

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) The availability and the security of supply of critical medicinal products are essential to safeguard public health and the economic and overall security of the Union and therefore should be considered strategic objectives of the Union. Existing data on supply chain vulnerabilities should be fully used to strengthen the Union’s capacity to anticipate disruptions in critical medicines and to shape effective early warning measures.

Or. en

Amendment 261

Sirpa Pietikäinen

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) The availability and the security of supply of critical medicinal products are essential to safeguard public health and the economic and overall security of the Union and therefore should be considered strategic objectives of the Union and pursued with measures that take full advantage of the potential of the internal market and safeguard the free movement of goods.

Or. en

Amendment 262

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) The availability and the security of supply of critical medicinal products are essential to safeguard public health, patients’ safety and to maintain the best possible quality of life and the economic and overall security of the Union and therefore should be considered strategic objectives of the Union.

Or. en

Amendment 263

Aleksandar Nikolic, Ondřej Knotek, Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) The availability and the security of supply of critical medicinal products are essential to safeguard public health and the strategic autonomy and economic and overall security of the Union and therefore should be considered strategic objectives of the Union and its Member States.

Or. fr

Amendment 264

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) The availability and the security of supply of critical medicinal products are essential to safeguard public health, patient safety and the economic and overall security of the Union and therefore should be considered strategic objectives of the Union.

Or. en

Amendment 265

Michalis Hadjipantela

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

Or. en

Amendment 266

Tilly Metz

Proposal for a regulation

Recital 14 a (new)

Text proposed by the Commission

Amendment

(14 a) The European Parliament called on the Commission and the Member States, in its resolution of 2020, to examine the possibility of creating one or more European non-profit pharmaceutical undertakings which operate in the public interest to manufacture medicinal products of health and strategic importance for healthcare, in the absence of existing industrial production, in order to complete and guarantee security of supply and prevent possible shortages of medicines in cases of emergency. The European Council, in its conclusions of November 2021, underlined the importance of that resolution in order to secure the supply of medicines affected by market failures.

Or. en

Amendment 267

Radan Kanev

Proposal for a regulation

Recital 14 a (new)

Text proposed by the Commission

Amendment

(14 a) In order to protect the public health and to strengthen the security of the Union, no means or consequences under this Regulation should lead to supply limitations or pressure on prices for medicines in any Member State, should not negatively impact affordability and result in less access for the patients even in case of increased supply, especially in Member States with lower GDP and should not limit the competition by driving out of the market smaller manufacturers.

Or. en

Amendment 268

Tilly Metz

Proposal for a regulation

Recital 14 b (new)

Text proposed by the Commission

Amendment

(14 b) Novel antimicrobials are essential for protecting public health and addressing the threat of antimicrobial resistance, which poses a growing threat to human and animal health in the Union. Their appropriate use requires limiting sales volumes to preserve their effectiveness and prevent resistance, creating a specific market failure. This could result in low and unpredictable revenues, particularly in smaller markets, and can undermine the ability of manufacturers, including SMEs, to supply these products sustainably. Consequently, the availability of newer antimicrobials has been limited, and some products have been withdrawn from the market. Ensuring a sustainable supply of low-volume, high-value antimicrobials, including through financial mechanisms such as revenue guarantees, is therefore necessary.

Or. en

Amendment 269

Tilly Metz

Proposal for a regulation

Recital 14 c (new)

Text proposed by the Commission

Amendment

(14 c) Pack sizes of medicinal products should be evaluated in light of current therapeutic use, with products posing particular risks to the environment or public health (e.g. antimicrobial resistance) meeting unit-dose or flexible pack-size requirements to dispense the exact prescribed quantity. Packaging rules could also be reviewed to minimise environmental impact, reduce waste and avoid loss of medicines, and encourage Union-level harmonisation.

Or. en

Amendment 270

András Tivadar Kulja

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15) A well-defined list of critical medicinal products is essential to ensure that the measures are targeted, effective, and proportionate. The critical medicinal products covered by this Regulation should be those for which insufficient supply results in serious harm or risk of serious harm to patients. For this reason this Regulation should apply to critical medicinal products on the Union list of critical medicinal products, as established by Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final]. That list builds upon the experiences of the European Medicines Agency and Member States’ Agencies that in 2024, in anticipation of the reform of pharmaceutical legislation, identified a list of 276 critical medicinal products. A criticality assessment aimed at complementing the list should be conducted on a regular basis. The criticality assessment process should involve representatives of healthcare professionals responsible of selecting, storing, prescribing, managing, dispensing and monitoring medication. The Union list of critical medicinal products should take into consideration all therapeutic categories. A comprehensive list of available therapeutic alternatives should be published by the European Medicines Agency.

Or. en

Amendment 271

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15) A well-defined list of critical medicinal products is essential to ensure that the measures are targeted, effective, and proportionate. The critical medicinal products covered by this Regulation should be those for which insufficient supply results in serious harm or risk of serious harm to patients. For this reason this Regulation should apply to critical medicinal products on the Union list of critical medicinal products, as established by Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final]. That list builds upon the experiences of the European Medicines Agency and Member States’ Agencies that in 2024, in anticipation of the reform of pharmaceutical legislation, identified a list of 276 critical medicinal products. A criticality assessment aimed at complementing the list should be conducted on a regular basis. The criticality assessment process should involve representatives of patient organisations, including women's health organisations, as well as healthcare professionals. The Union list of critical medicinal products should cover all therapeutic categories and be published by the European Medicines Agency.

Or. en

Amendment 272

Sirpa Pietikäinen

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15) A well-defined list of critical medicinal products is essential to ensure that the measures are targeted, effective, and proportionate, to cover medicines that are critical for immediate survival, such as oncology drugs, those essential for public health, for example influenza vaccines, medicines where supply chain shortages create uncertainties, as well as widely used medicines such as painkillers and antibiotics, where any disruption in availability would have significant effects on overall health and wellbeing. The critical medicinal products covered by this Regulation should be those for which insufficient supply results in serious harm or risk of serious harm to patients. For this reason this Regulation should apply to critical medicinal products on the Union list of critical medicinal products, as established by Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final]. That list builds upon the experiences of the European Medicines Agency and Member States’ Agencies that in 2024, in anticipation of the reform of pharmaceutical legislation, identified a list of 276 critical medicinal products.

Or. en

Amendment 273

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

Or. en

Amendment 274

Adam Jarubas, Ewa Kopacz, Letizia Moratti

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

Or. en

Amendment 275

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Recital 15 a (new)

Text proposed by the Commission

Amendment

(15 a) In order to ensure unimpeded access to critical medicinal products, it is necessary to eliminate regulatory barriers to their marketing, particularly when these products contain active substances with well-established medicinal uses and a proven efficacy profile and level of safety. Under the centralised procedure, it should be possible for an applicant to submit an application based on so-called well-established medicinal use. Such a solution significantly accelerates the release of a critical medicinal product, eliminating the need to conduct costly and time-consuming studies when their results are de facto known and confirmed in clinical practice and provides unified access to this product throughout the Union on the basis of a single decision issued by the Commission. It should be noted that the possibility of presenting independent and reliable scientific publications in the application does not lead to a lowering of standards for verification of the safety and efficacy of the medicinal product, being a solution already known to Directive 2001/83/EC on the Community code relating to medicinal products for human use1a. The above solution will benefit the monitoring of the availability of critical medicines and the conduct of joint procurement proceedings by contracting authorities from different Member States. Furthermore, this solution provides additional motivation for investment and the development of strategic projects. It also implements the principle of solidarity by ensuring equal access to treatment throughout the Union and strengthens its strategic autonomy in the area of healthcare, enabling a rapid response to shortages of critical medicines.

_________________

1a Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal L 136 , 30/04/2004 P. 0034 - 0057) https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32004L0027

Or. en

Amendment 276

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16) To ensure that the measures are applied where justified and proportionate, it is necessary to demonstrate that some measures address a vulnerability in the supply chains of a given critical medicinal product. This Regulation should rely on the vulnerability evaluation performed for the purpose of the application of the general pharmaceutical legislation as per Regulation (EU) No …/… [reference to be added after adoption cf. COM(2023) 193 final]. To detect a vulnerability in the supply chains it is necessary to look at aggregated data across all medicinal products authorised in the Union and containing the same active substance, route of administration and formulation. Such an approach allows for the determination whether, for a critical medicinal product with a given active substance, the Union is highly dependent on a single or a limited number of third countries, or a limited number of sites, for active substances, key inputs, or finished dosage forms. A biannual vulnerability evaluation should be conducted to prevent shortages of medicines for which a potential vulnerability has emerged. The vulnerability assessment should be transparent and performed adopting a multi-stakeholder information sharing approach involving all supply chain actors. These include representatives of national competent authorities, of the Commission and the European Medicines Agency, wholesalers, manufacturers, pharmacists, healthcare professionals and patient organisations.

Or. en

Amendment 277

Michele Picaro, Ruggero Razza

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16) To ensure that the measures are applied where justified and proportionate, it is necessary to demonstrate that some measures address a vulnerability in the supply chains of a given critical medicinal product. This Regulation should rely on the vulnerability evaluation performed for the purpose of the application of the general pharmaceutical legislation as per Regulation (EU) No …/… [reference to be added after adoption cf. COM(2023) 193 final]. To detect a vulnerability in the supply chains it is necessary to look at aggregated data across all medicinal products authorised in the Union and containing the same active substance, route of administration and formulation. A vulnerability evaluation should be conducted to prevent shortages of medicines for which a potential vulnerability has emerged. The vulnerability evaluation should be performed involving all supply chain actors. Such an approach allows for the determination whether, for a critical medicinal product with a given active substance, the Union is highly dependent on a single or a limited number of third countries, or a limited number of sites, for active substances, key inputs, or finished dosage forms.

Or. en

Justification

Vulnerability assessments or evaluations are required to detect and track possible threats that could interrupt the manufacture or distribution of a medicinal product or any of its key inputs. These assessments make it possible to single out medicines that demand immediate action to anticipate, avert, or remedy a shortage. These vulnerability evaluations would ensure a product-by-product approach, that is needed to really understand which products require specific measures.

Amendment 278

Sirpa Pietikäinen

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16) To ensure that the measures are applied where justified and proportionate, it is necessary to demonstrate that some measures address a vulnerability in the supply chains of a given critical medicinal product. This Regulation should rely on the vulnerability evaluation performed for the purpose of the application of the general pharmaceutical legislation as per Regulation (EU) No …/… [reference to be added after adoption cf. COM(2023) 193 final]. To detect a vulnerability in the supply chains it is necessary to look at aggregated data across all medicinal products authorised in the Union and containing the same active substance, route of administration and formulation, taking into consideration the existence of therapeutical alternatives. Such an approach allows for the determination whether, for a critical medicinal product with a given active substance, the Union is highly dependent on a single or a limited number of third countries, or a limited number of sites, for active substances, key inputs, or finished dosage forms.

Or. en

Amendment 279

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Recital 16 a (new)

Text proposed by the Commission

Amendment

(16 a) In order to ensure unimpeded access to critical medicinal products, it is necessary to eliminate regulatory barriers to their marketing, particularly when these products contain active substances with well-established medicinal uses and a proven efficacy profile and level of safety. Under the centralised procedure, it should be possible for an applicant to submit an application based on so-called well-established medicinal use. Such a solution significantly accelerates the release of a critical medicinal product, eliminating the need to conduct costly and time-consuming studies when their results are de facto known and confirmed in clinical practice and provides unified access to this product throughout the Union on the basis of a single decision issued by the Commission. It should be noted that the possibility of presenting independent and reliable scientific publications in the application does not lead to a lowering of standards for verification of the safety and efficacy of the medicinal product, being a solution already known to Directive 2001/83/EC on the Community code relating to medicinal products for human use. The above solution will benefit the monitoring of the availability of critical medicines and the conduct of joint procurement proceedings by contracting authorities from different member states. Furthermore, this solution provides additional motivation for investment and the development of strategic projects. It also implements the principle of solidarity by ensuring equal access to treatment throughout the Union and strengthens its strategic autonomy in the area of healthcare, enabling a rapid response to shortages of critical medicines.

Or. en

Amendment 280

Ingeborg Ter Laak

Proposal for a regulation

Recital 16 a (new)

Text proposed by the Commission

Amendment

(16 a) In the context of contingency stocks and national stockpiles, Member States should be encouraged to explore sustainable measures that contribute to reducing waste and improving the efficient use of available medicinal products.

Or. en

Amendment 281

Aurelijus Veryga

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) Certain projects can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for critical medicinal products and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects should be introduced. Given their role in ensuring the Union’s security of supply for critical medicinal products, the relevant permitting authority should consider strategic projects to be in the public interest. To ensure their expedient implementation, national authorities should ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law. National authorities should consider, when possible, their streamlining as well as enable digital submission of required information.

(17) Certain projects and technologies can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for and improve efficiencies in the production of critical medicinal products and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects should be introduced. Given their role in ensuring the Union’s security of supply for critical medicinal products, the relevant permitting authority should consider strategic projects to be in the public interest. The European Medicines Agency should have a clear mandate and framework to expedite the review of new technologies that can improve the efficiency of production of critical medicines. To ensure their expedient implementation, national authorities should ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law. National authorities should consider, when possible, their streamlining as well as enable digital submission of required information.

Or. en

Amendment 282

András Tivadar Kulja

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) Certain projects can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for critical medicinal products and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects should be introduced. Given their role in ensuring the Union’s security of supply for critical medicinal products, the relevant permitting authority should consider strategic projects to be in the public interest. The European Medicines Agency should have a clear mandate and framework to expedite the review of new technologies that can improve the efficiency of production of critical medicines. To ensure their expedient implementation, national authorities should ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law. National authorities should consider, when possible, their streamlining as well as enable digital submission of required information.

Or. en

Amendment 283

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) Certain projects can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for critical medicinal products, improve efficiencies in the production of those products, and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects should be introduced. Given their role in ensuring the Union’s security of supply for critical medicinal products, the relevant permitting authority should consider strategic projects to be in the public interest. To ensure their expedient implementation, national authorities should ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law, whilst upholding the highest social, health and environmental standards. National authorities should consider, when possible, their streamlining, introducing a single point of contact as well as enabling digital submission of required information.

Or. en

Amendment 284

Alessandra Moretti

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) Certain projects can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for critical medicinal products and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects should be introduced. Given their role in ensuring the Union’s security of supply for critical medicinal products, the relevant permitting authority should consider strategic projects to be in the public interest if they meet conditionalities related to transparency, accessibility and affordability. To ensure their expedient implementation, national authorities should ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law. National authorities should consider, when possible, their streamlining as well as enable digital submission of required information.

Or. en

Amendment 285

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) Certain projects can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for critical medicinal products and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects and cross-border strategic projects should be introduced. Given their role in ensuring the Union’s security of supply for critical medicinal products, the relevant permitting authority should consider strategic projects to be in the public interest. To ensure their expedient implementation, national authorities should ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law. National authorities should consider, when possible, their streamlining as well as enable digital submission of required information.

Or. en

Amendment 286

Oliver Schenk

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) Certain projects can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for critical medicinal products and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects should be introduced. Given their role in ensuring the Union’s security of supply for critical medicinal products, the relevant permitting authority should consider strategic projects to be in the public interest. To ensure their expedient implementation, national authorities should ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law. National authorities should consider their streamlining as well as enable digital submission of required information.

Or. en

Amendment 287

Aurelijus Veryga

Proposal for a regulation

Recital 17 a (new)

Text proposed by the Commission

Amendment

(17 a) In order to safeguard the Union’s strategic interests and the resilience of its industrial base, strategic projects for manufacturing critical medicines must operate without interruption, including during crises or supply chain disruptions. Member States should take all necessary measures to prevent or mitigate unplanned disruptions to essential supplies and to ensure the continued availability of key personnel. During national emergencies or periods of mobilisation, such personnel should be exempted from active military service or, where appropriate, assigned mobilisation duties within the project to preserve operations and meet Union health objectives.

Or. en

Amendment 288

Alessandra Moretti

Proposal for a regulation

Recital 17 a (new)

Text proposed by the Commission

Amendment

(17 a) The provision of financial support for strategic projects must be accompanied by measures that guarantee public return on public investment, together with clear conditionalities to protect public interest, such as for example in terms of accessibility and affordability of the interested medicinal products, and in terms of transparency in the use of these public funds, also with reference to actual costs of R&D;

Or. en

Amendment 289

Tilly Metz

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) To avoid unnecessary delays and the creation of additional administrative layers, the verification of whether a project fulfils the strategic project criteria should be performed by any Member State authority requested to provide advantages offered in this Regulation. A designated authority should, when solicited, verify whether a given project is a strategic project. In order to accelerate and facilitate their deployment, strategic projects should benefit from streamlined administrative processes, priority status in the context of permit granting procedures and related dispute resolution procedures, as well as, be offered targeted regulatory support. In this context, the Member States should give particular attention to small and medium sized enterprises (SMEs) which should have a fair chance to initiate strategic projects.

(18) To avoid unnecessary delays and the creation of additional administrative layers, the verification of whether a project fulfills the strategic project criteria should be performed by any Member State authority requested to provide advantages offered in this Regulation. A designated authority should, when solicited, verifies whether a given project is a strategic project. In order to accelerate and facilitate their deployment, strategic projects should benefit from streamlined administrative processes, priority status in the context of permit granting procedures and related dispute resolution procedures, as well as, be offered targeted regulatory support. In this context, the Member States should give particular attention to small and medium sized enterprises (SMEs) which should have a fair chance to initiate strategic projects.

Or. en

Amendment 290

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 18 a (new)

Text proposed by the Commission

Amendment

(18 a) The absence of or insufficient enforcement of environmental regulations in certain regions producing pharmaceuticals has resulted in environmental pollution by manufacturing waste. Significant amounts of active pharmaceutical ingredients are consequently being released into rivers, groundwater, natural ecosystems and soils. This form of pollution poses serious risks to public health, spreads antimicrobial resistance, harms ecosystems and biodiversity, and can disrupt the balance of food chains.

Or. en

Amendment 291

Sirpa Pietikäinen

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) The production of medicinal products has environmental implications and may negatively impact not only the environment itself but also human health. The environmental assessments and authorisations required under Union law are an integral part of the permit-granting process for strategic projects and an essential safeguard to ensure negative environmental impacts are prevented or minimised. However, to ensure that permit-granting processes for strategic projects are predictable and timely, it should be possible to streamline the required assessments and authorisations by the relevant authority, while not lowering the level of environmental protection. Piloting for the safe reuse of certain unused medicines dispensed for home use must continue to reduce negative environmental impacts, allowing products not consumed by one patient to be reallocated to another, e.g. cytotoxic drugs in the Netherlands. Special attention should also be given to antimicrobial resistance (AMR), as pharmaceutical discharges into water and soil contribute to its spread, creating both environmental and public health risks.

Or. en

Amendment 292

Ingeborg Ter Laak

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) The production of medicinal products has environmental implications and may negatively impact not only the environment itself but also human health. The environmental assessments and authorisations required under Union law are an integral part of the permit-granting process for strategic projects and an essential safeguard to ensure negative environmental impacts are prevented or minimised. However, to ensure that permit-granting processes for strategic projects are predictable and timely, it should be possible to streamline the required assessments and authorisations by the relevant authority, while not lowering the level of environmental protection. These standards should apply equally to producers within the Union and in third countries to ensure fair competition and safeguard health and the environment.

Or. en

Amendment 293

Tilly Metz

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) The production of medicinal products has environmental implications and may negatively impact not only the environment itself but also human and animal health. The environmental assessments and authorisations required under Union law are an integral part of the permit-granting process for strategic projects and an essential safeguard to ensure negative environmental impacts are prevented or minimised. However, to ensure that permit-granting processes for strategic projects are predictable and timely, it should be possible to streamline the required assessments and authorisations by the relevant authority, without undermining the quality and robustness of assessments, while not lowering the level of environmental protection.

Or. en

Amendment 294

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

Or. en

Amendment 295

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Ton Diepeveen, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 19 a (new)

Text proposed by the Commission

Amendment

(19 a) A series of environmental laws have been adopted in recent years with the objective of protecting the environment and public health, however, certain sector-specific considerations, in particular those concerning the pharmaceutical industry, have not been fully taken into account, particularly the compliance costs. Another example is the Urban Wastewater Treatment Directive, which requires the pharmaceutical and cosmetics sectors to contribute to the cost of removing micropollutants from wastewater. This requirement undermines the spirit of competitiveness for major medicine suppliers, goes against the objectives set out in the Competitiveness Compass, and contradicts the polluter-pays, proportionality, and non-discrimination principles. In order to create a well-functioning public health system, while maintaining high environmental standards, it is indispensable to boost the competitiveness of the industry.

Or. en

Amendment 296

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Estelle Ceulemans, Pierre Jouvet, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 19 a (new)

Text proposed by the Commission

Amendment

(19 a) This Regulation should grant Member States' authorities the possibility to streamline required assessments and authorisations for strategic projects while upholding the Union's high environmental standards. This Regulation should apply therefore without prejudice to obligations under the United Nations Economic Commission for Europe (UNECE) Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters, signed at Aarhus on 25 June 1998, and under the UNECE Convention on environmental impact assessment in a transboundary context, signed at Espoo on 25 February 1991 and its Protocol on Strategic Environmental Assessment, signed in Kyiv on 21 May 2003.

Or. en

Amendment 297

Tilly Metz

Proposal for a regulation

Recital 19 a (new)

Text proposed by the Commission

Amendment

(19 a) In line with the Union’s commitment to the One Health approach, which recognises the interdependence of human, animal and environmental health, pharmaceutical production within Europe should be developed and safeguarded in a manner that supports public health, prevents antimicrobial resistance, and protects ecosystems. Strengthening the Union’s strategic autonomy in the pharmaceutical sector should therefore go hand in hand with the integration of One Health principles, ensuring that measures to boost manufacturing capacity and supply resilience are fully aligned with the protection of health, biodiversity and the environment.

Or. en

Amendment 298

Tilly Metz

Proposal for a regulation

Recital 19 b (new)

Text proposed by the Commission

Amendment

(19 b) The Union’s environmental and labour policies, in line with the objectives of the European Green Deal, lay down essential sustainability requirements which guarantee that production within the Union is conducted in a safe, responsible and sustainable manner over the long term. Obligations such as emission limit values, requirements on wastewater treatment, and restrictions on the use of certain substances are indispensable to preventing hidden costs resulting from environmental degradation, adverse public health impacts, remediation measures, or long-term societal liabilities.

Or. en

Amendment 299

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Ton Diepeveen, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 19 b (new)

Text proposed by the Commission

Amendment

(19 b) The cumulative impact of environmental and chemical legislation poses significant challenges for the pharmaceutical sector, which is already subject to extensive regulation, it is essential to ensure that future measures are developed and applied in a coordinated manner. In this regard, the one-in, one-out principle should be respected so as to prevent duplication and the creation of disproportionate barriers to the sector’s functioning.

Or. en

Amendment 300

Tilly Metz

Proposal for a regulation

Recital 19 c (new)

Text proposed by the Commission

Amendment

(19 c) Weak enforcement of environmental standards in certain major pharmaceutical-producing regions has led to the improper management of waste from manufacturing plants, resulting in the leakage of active pharmaceutical ingredients into rivers, groundwater and soil. Such pollution not only endangers public health, but also disrupts ecosystems, threatening biodiversity and destabilising food chains.

Or. en

Amendment 301

Tilly Metz

Proposal for a regulation

Recital 19 d (new)

Text proposed by the Commission

Amendment

(19 d) The release of antibiotics and resistant bacteria into the environment from manufacturing facilities is a significant, yet under-regulated, driver of antimicrobial resistance. Wastewater containing high concentrations of antibiotics creates conditions for resistant strains to emerge and spread through water, food systems and direct human contact, thereby posing a serious cross-border public health risk. The Union should align the reshoring of the pharmaceutical production with the Union’s objectives of safeguarding public health, protecting the environment and combating AMR.

Or. en

Amendment 302

Tilly Metz

Proposal for a regulation

Recital 19 e (new)

Text proposed by the Commission

Amendment

(19 e) Acknowledging the importance of international cooperation in environmental matters, this Regulation respects the obligations arising from the United Nations Economic Commission for Europe (UNECE) Conventions. Specifically, it does not affect the UNECE Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (the Aarhus Convention, 1998), as well as the UNECE Convention on Environmental Impact Assessment in a Transboundary Context (the Espoo Convention, 1991) and its Protocol on Strategic Environmental Assessment (the Kyiv Protocol, 2003).

Or. en

Amendment 303

Tilly Metz

Proposal for a regulation

Recital 19 f (new)

Text proposed by the Commission

Amendment

(19 f) The 2019 Commission Strategic Approach to Pharmaceuticals in the Environment recognised that pharmaceuticals pose risks to both the environment and human health, requiring a comprehensive strategy to address them. It outlined several areas for action, including gathering and analysing monitoring data on pharmaceutical residues, incentivising the 'green design' of medicines, reducing emissions from manufacturing processes, and improving wastewater treatment to eliminate pharmaceutical residues and waste management.

Or. en

Amendment 304

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) Given the capital-intensive nature of pharmaceutical production, including the establishment or expansion of manufacturing sites for critical medicinal products, active substances, and key inputs, targeted financial support can play a crucial role in incentivising production within the Union. To strengthen the security of supply of critical medicinal products, and where private investment alone is not sufficient, financial support of investments in manufacturing capacity within the Union may be justified. Member States should be able to prioritise financial support for strategic projects that address specific vulnerabilities in the supply chains, while ensuring that such support complies with the Union’s State aid rules. For this purpose, specific guidance to clarify the application of EU State aid rules to assist the Member States has been provided by the Commission services and will be updated as necessary.

Or. en

Amendment 305

Tilly Metz

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

Or. en

Amendment 306

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) Given the capital-intensive nature of pharmaceutical production, including the establishment or expansion of manufacturing sites for critical medicinal products, active substances, and key inputs, targeted financial support can play a crucial role in incentivising production within the Union. To strengthen the security of supply of critical medicinal products, and where private investment alone is not sufficient, financial support of investments in manufacturing capacity within the Union may be justified. Member States should be able to prioritise financial support for strategic projects that address specific vulnerabilities in the supply chains, while ensuring that such support complies with the Union’s State aid rules. A block exemption for pharmaceutical manufacturing should be introduced under the General Block Exemption Regulation (GBER), enabling support even in strong regions or for large companies. For this purpose, specific guidance to clarify the application of EU State aid rules to assist the Member States has been provided by the Commission services and will be updated as necessary.

Or. en

Amendment 307

Nikos Papandreou

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

Or. en

Amendment 308

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

Or. en

Amendment 309

Viktória Ferenc

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) Given the capital-intensive nature of pharmaceutical production, including the establishment or expansion of manufacturing sites for critical medicinal products, active substances, and key inputs, targeted financial support can play a crucial role in incentivising production within the Union. To strengthen the security of supply of critical medicinal products, in particular the critical medicinal products needed to treat the most common rare diseases in the Union, and where private investment alone is not sufficient, financial support of investments in manufacturing capacity within the Union may be justified. Member States should be able to prioritise financial support for strategic projects that address specific vulnerabilities in the supply chains, while ensuring that such support complies with the Union’s State aid rules. For this purpose, specific guidance to clarify the application of EU State aid rules to assist the Member States has been provided by the Commission services and will be updated as necessary.

Or. hu

Amendment 310

Radan Kanev

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) Given the capital-intensive nature of pharmaceutical production, including the establishment or expansion or modernisation of manufacturing sites for critical medicinal products, active substances, and key inputs, targeted financial support can play a crucial role in incentivising production within the Union. To strengthen the security of supply of critical medicinal products, and where private investment alone is not sufficient, financial support of investments in manufacturing capacity within the Union may be justified. Member States should be able to prioritise financial support for strategic projects that address specific vulnerabilities in the supply chains, while ensuring that such support complies with the Union’s State aid rules. For this purpose, specific guidance to clarify the application of EU State aid rules to assist the Member States has been provided by the Commission services and will be updated as necessary.

Or. en

Amendment 311

Dan-Ştefan Motreanu

Proposal for a regulation

Recital 21 a (new)

Text proposed by the Commission

Amendment

(21 a) In order to ensure that additional manufacturing capacity for critical medicines is realised without delay, it is necessary to make explicit that direct financial support for production infrastructure within the Union is possible. Such support, including capital expenditure subsidies for the construction, expansion or modernisation of production sites, is necessary given the long investment cycles and low margins of many critical medicines. To avoid subsidy races and market fragmentation, such support should be transparent, proportionate, and coordinated at Union level, fully respecting Union State aid rules.

Or. en

Amendment 312

Dan-Ştefan Motreanu

Proposal for a regulation

Recital 21 b (new)

Text proposed by the Commission

Amendment

(21 b) In order to enable Member States to provide timely and effective support for investments related to critical medicinal products, it is necessary to ensure that the applicable State aid framework is sufficiently flexible. The current procedures under Union law, including Regulation (EU) No 651/2014 declaring certain categories of aid compatible with the internal market and the Commission Decision of 20 December 2011 on the application of Article 106(2) TFEU to State aid in the form of public service compensation, may not always allow for rapid or targeted responses. Therefore, specific and simplified rules for State aid in the field of critical medicinal products should be considered, with a view to facilitating faster procedures and providing legal certainty for Member States and undertakings.

Or. en

Amendment 313

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(22) Union-level funding may be leveraged to facilitate investments in strategic projects. Strategic projects may benefit from access to existing EU funding instruments, such as the EU4Health Programme4 , Digital Europe Programme5 , the regional funds and Horizon Europe6 (relevant, for example, for active substances referred to in Article 5(d) of Regulation (EU)2021/695), the European Defence Fund (for dual-use manufacturing enablers where eligible), as well as the Strategic Technologies for Europe Platform (STEP), when they fulfil the criteria established in these instruments. Authorities in charge of the Union programmes covered by Regulation (EU) 2024/795 of the European Parliament and of the Council7 (STEP) should in particular consider supporting strategic projects addressing a vulnerability in the supply chains of critical medicinal products and therefore Regulation (EU) 2024/795 should be amended. Union funding should prioritise strategic projects that align with the public health goals of the Union and include transparency and supply obligations, as well as access requirements. Where limitations in Union funding arise, it is appropriate for the Commission to assess and, where necessary, propose complementary funding instruments or increased budgetary allocations to support the implementation of this Regulation.

_________________

4 Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of Health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014, (OJ L 107, 26.3.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/522/oj)

5 Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240( OJ L166, 11.5.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/694/2023-09-21)

6 Regulation (EU) 2021/695 of the European Parliament and of the council of 28 April 2021 establishing Horizon //Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 (OJ L170, 12.5.2021, p. 1, ELI: http://data.europa.eu/eli/reg/2021/695/oj)

7 Regulation (EU) 2024/795 of the European Parliament and of the Council of 29 February 2024 establishing the Strategic Technologies for Europe Platform (STEP), and amending Directive 2003/87/EC and Regulations (EU) 2021/1058, (EU) 2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 2021/695, (EU) 2021/697 and (EU) 2021/241, (OJL 2024/794, 29.2.2024, ELI: http://data.europa.eu/eli/reg/2024/795/oj)

Or. en

Amendment 314

Tilly Metz

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 315

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Recital 22 a (new)

Text proposed by the Commission

Amendment

(22 a) Given the capital-intensive nature of pharmaceutical production, including the establishment or expansion of manufacturing sites for critical medicinal products, active substances, and key inputs, targeted financial support can play a crucial role in incentivising production within the Union. To strengthen the security of supply of critical medicinal products, and where private investment alone is not sufficient, financial support of investments in manufacturing capacity within the Union may be justified. Member States should be able to prioritise financial support for strategic projects that address specific vulnerabilities in the supply chains. Given the critical importance of access to resilient supply chains for medicinal products that are essential to public health, the strategic autonomy of the Union, and the continuity of healthcare, this sector requires a specific regulatory and financial approach. In order to enable Member States to take swift and targeted action, State aid granted for the implementation of such projects should be considered compatible with Articles 107 and 108 TFEU, provided that it is necessary, proportionate and effectively contributes to increasing the security of supply of those products in the Union. This approach enables Member States to take swift and targeted action in areas of key importance for public health, while remaining consistent with the principles of the internal market and competition policy. In order to support Member States in designing legally compliant and effective support instruments, specific guidance to clarify the application of Union State aid rules to assist the Member States has been provided by the Commission services and will be updated as necessary.

Or. en

Amendment 316

Dan-Ştefan Motreanu

Proposal for a regulation

Recital 22 a (new)

Text proposed by the Commission

Amendment

(22 a) In order to provide a structural and sustainable response to the challenges of large-scale pharmaceutical manufacturing, it is necessary to look beyond the current Multiannual Financial Framework 2021–2027. While existing Union programmes can temporarily support critical projects, they are not specifically designed to cover the high capital requirements of establishing and expanding production facilities for critical medicines. The next Multiannual Financial Framework 2028–2034 should therefore include a dedicated Union financial instrument for the pharmaceutical sector within the Competitiveness Pillar, targeted at strengthening local production capacity for critical medicines and their key inputs. Such an instrument would provide long-term certainty for investors, complement national funding, and reduce disparities between Member States.

Or. en

Amendment 317

Catarina Martins, Sebastian Everding

Proposal for a regulation

Recital 22 a (new)

Text proposed by the Commission

Amendment

(22 a) In order to expand existing capacity, boost and reshore production of critical medicinal products, medicinal products of common interest, active ingredients and enhance the autonomy, sovereignty and security of supply in the Union, the 2028-2034 Multiannual Financial Framework should include a 'Health security and preparedness fund' with a budget allocation of at least 5 billion EUR.

Or. en

Amendment 318

Viktória Ferenc, Aleksandar Nikolic, Ondřej Knotek, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Recital 22 a (new)

Text proposed by the Commission

Amendment

(22 a) According to industry experts nearly 4 billion EUR will be required in the next Multiannual Financial Framework to sufficiently ensure the implementation of this Regulation, particularly in the current challenging geopolitical context.

Or. en

Amendment 319

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 22 a (new)

Text proposed by the Commission

Amendment

(22 a) For long term predictability and strategic planning, the Commission should establish a Critical Medicines Fund as part of the post-2027 Multiannual Financial Framework.

Or. en

Amendment 320

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 22 b (new)

Text proposed by the Commission

Amendment

(22 b) Where financial support has been granted at the national level, the project promoter should demonstrate that the funds have been used within the Member State providing such support; where Union financial support has been granted, the project promoter should demonstrate that the funds have been used within the territory of the Union.

Or. en

Amendment 321

Tilly Metz

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

(23) To allow for a more coordinated approach to financial support, it is appropriate that Member States and the Commission exchange the information on financial support to strategic projects. As regards the strategic projects that have benefitted from EU funding, the beneficiaries should follow the relevant communication and visibility rules8 .

(23) To allow for a more coordinated approach to financial support, it is appropriate that Member States and the Commission exchange the information on financial support to strategic projects. The financial support for strategic projects should be accompanied by measures that maximise the return on public investment and that include transparency standards, supply obligations and access requirements. Regarding the strategic projects that have received EU funding, the beneficiaries should follow the relevant communication and visibility rules8 .

_________________

8 Communication and visibility rules - Publications Office of the EU

Or. en

Amendment 322

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

(23) To allow for a more coordinated approach to financial support, it is appropriate that Member States and the Commission exchange the information on financial support to strategic projects. As regards the strategic projects that have benefitted from EU funding, the beneficiaries should follow the relevant communication and visibility rules8 .

_________________

8 Communication and visibility rules - Publications Office of the EU

Or. en

Amendment 323

Dan-Ştefan Motreanu

Proposal for a regulation

Recital 23 a (new)

Text proposed by the Commission

Amendment

(23 a) In order to strengthen the resilience of supply and distribution chains for critical medicines, it is necessary to promote public–private partnerships. Such partnerships can improve transparency, facilitate investment in logistics and storage infrastructure, and foster innovative approaches to distribution. When designed with clear governance rules, PPPs can reduce fragmentation across Member States, enhance coordination between public authorities and private operators, and ensure continuity of supply to patients, while fully respecting Union competition and State aid rules.

Or. en

Amendment 324

Aurelijus Veryga

Proposal for a regulation

Recital 23 a (new)

Text proposed by the Commission

Amendment

(23 a) To achieve the objective of contributing to the security of supply of critical medicinal products, Member States should ensure that any accelerated procedure or public funding granted under this Regulation for strategic projects requires enforceable undertakings by the beneficiary regarding security of supply, affordability of end-products, and transparency in the use of public funds, and that the resulting medicines are made available in all Member States.

Or. en

Amendment 325

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Procurement requirements based on such considerations should include stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery and measures in case of non-timely delivery.

(24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Due consideration should also be given to environmental sustainability, including the use of green manufacturing technologies and the minimisation of active substance emissions into the environment during production. Procurement requirements based on such considerations should include stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery and measures in case of non-timely delivery.

Or. en

Amendment 326

Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations as well as support the commercial viability of the procurement procedures in a way that actively encourages the participation of pharmaceutical manufacturers in procurement processes. Procurement requirements based on such considerations should include stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery and measures in case of non-timely delivery.

Or. en

Amendment 327

Tilly Metz

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Procurement requirements based on such considerations should include stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority, environmental sustainability, including the use of green manufacturing technologies and minimisation of pharmaceutical waste, as well as contract performance clauses on timely delivery and measures in case of non-timely delivery.

Or. en

Amendment 328

Aurelijus Veryga

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Procurement requirements based on such considerations should include value-based criteria, such as product quality measured by patient impact and clinical value, stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery and measures in case of non-timely delivery.

Or. en

Amendment 329

András Tivadar Kulja

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of critical medicines and other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Procurement requirements based on such considerations should include stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority, subject to compliance with trade secrets, and contract performance clauses on timely delivery and measures in case of non-timely delivery.

Or. en

Amendment 330

Kristian Vigenin

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products of common interest, it could be beneficial to establish rules that allow for the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Procurement requirements based on such considerations should include stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery and measures in case of non-timely delivery.

Or. en

Amendment 331

Radan Kanev

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of medicinal products, it is necessary to establish rules that allow for the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Procurement requirements based on such considerations may include stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery and measures in case of non-timely delivery.

Or. en

Amendment 332

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Recital 24 a (new)

Text proposed by the Commission

Amendment

(24 a) At the same time, ensuring the security of supply of critical medicinal products and increasing their availability and affordability is a priority of the Union public health policy, which requires certain exceptions to be made. Current Union state aid rules on regional aid limit the possibility of granting support in developed regions, but many potential pharmaceutical investments are located in such areas, where infrastructure, human capital, and research centres already exist. Given the strategic importance of investments in the Union supply chain for critical medicinal products, it is therefore necessary to allow regional aid to be granted at a level independent of the intensity specified in the regional aid map. The removal of geographical barriers aims to increase the investment attractiveness of strategic projects involving critical medicinal products in the pharmaceutical and biotechnology sectors throughout the Union, which will contribute to accelerating the resilience of the European drug supply chain to disruptions. Increasing drug safety is a priority that does not mean abandoning cohesion policy, but aims to strengthen it and ensure a stable supply of critical medicinal products through support without territorial discrimination.

Or. en

Amendment 333

Tilly Metz

Proposal for a regulation

Recital 24 a (new)

Text proposed by the Commission

Amendment

(24 a) In order to strengthen the resilience of supply chains for medicinal products and to mitigate the risk of supply disruptions, procurement procedures carried out under this Regulation should, where appropriate, allow for the award of contracts to multiple suppliers for the same product. Such multi-winner procurement approaches can promote diversification of supply, enhance security of supply, and ensure that production capacity is distributed across different manufacturers and geographical locations within the Union.

Or. en

Amendment 334

Marie-Luce Brasier-Clain, Aleksandar Nikolic, Ton Diepeveen

Proposal for a regulation

Recital 24 a (new)

Text proposed by the Commission

Amendment

(24a) It should be noted that Member States alone are responsible for building up their own national strategic stockpiles, in line with their respective legislative frameworks. Any agreement to pool or coordinate those stockpiles among EU Member States should take into account the specific characteristics of each market in order to ensure rapid and efficient mobilisation in the event of a shortage.

Or. fr

Amendment 335

Tilly Metz

Proposal for a regulation

Recital 24 b (new)

Text proposed by the Commission

Amendment

(24 b) To provide market predictability and support investment in the production of medicinal products, procurement procedures under this Regulation should, where justified, include minimum binding quantities. Those commitments can serve as an incentive for manufacturers to maintain or scale up production capacity, particularly for medicinal products that are essential for public health but may not be commercially attractive under standard market conditions.

Or. en

Amendment 336

Radan Kanev

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Use of MEAT criteria can not be mandatory. It should be possible also in future to use the price as the leading criteria.

Amendment 337

Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25) Inconsistent use of procurement requirements in public procurement procedures may have negative impact on the internal market as it creates obstacles to cross-border participation and a lack of predictability for bidders. In order to avoid such negative outcomes, the use of MEAT criteria should be mandatory. To minimise market fragmentation and create certainty and predictability for both public health system payers as well as for pharmaceutical manufacturers, the Commission should coordinate and maintain a catalogue of such MEAT criteria, as well as relevant best practices to using them in public procurement, for use by the Member States.

Or. en

Amendment 338

Galato Alexandraki, Emmanouil Fragkos

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

Or. el

Amendment 339

Kristian Vigenin

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

Or. en

Amendment 340

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26) To ensure a high level of health protection and security of supply, it is necessary to procure in a way that promotes diversification of suppliers where dependency on a single or a limited number of third countries, threatening the security of supply, has been established through a vulnerability evaluation. In such situations, contracting authorities in the Member States should introduce procurement requirements that favour suppliers of critical medicinal products that manufacture a significant portion of these products in the EU, provided that this is feasible having regard to the distinctive nature of the supply chains for specific medicines. Moreover, the contracting authorities in the Member States, when justified by market analysis and public health considerations, may apply procurement requirements that favour suppliers of medicinal products of common interest that manufacture a significant portion of these medicinal products in the EU. These measures should be designed and applied in line with the Union's international obligations including the principles of non-discrimination and proportionality. In order to provide legal certainty over the application of EU preference in public procurement for the suppliers that manufacture a significant proportion of the medicinal products in the Union, the Commission should publish guidelines by 6 months from the date of entry into force of this Regulation. In the guidelines, the Commission should set the minimum percentage of APIs produced in the Union, minimum percentage of the value of the final medicinal products or the minimum essential steps to be carried out in the Union to be defined as 'significant portion' of Union manufacturing.

Or. en

Amendment 341

Radan Kanev

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

Or. en

Amendment 342

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

Or. en

Amendment 343

Nikos Papandreou

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

Or. en

Amendment 344

Kristian Vigenin

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

Or. en

Amendment 345

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 26 a (new)

Text proposed by the Commission

Amendment

(26 a) In order to strengthen the security of supply of critical medicinal products and medicinal products of common interest in the Union, procurement procedures should, where justified and in full compliance with the Union’s international commitments, prioritise suppliers that manufacture a significant proportion of such products within the Union. Where such supply is not available, priority should be given to suppliers established in the United Kingdom, the European Economic Area or the Swiss Confederation, and, where necessary, to suppliers from a third country which is a Party to the WTO Agreement on Government Procurement or in a third country with which the Union has concluded a free trade agreement covering government procurement.

Or. en

Amendment 346

Sirpa Pietikäinen

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

(27) The application of procurement requirements should take into account the specific market conditions and public health needs of each procurement procedure, whilst bearing in mind the considerations related to affordability of medicinal products. Certain procurement requirements may not be justified if they result in disproportionate cost for procurers or discourage participation, leading to no bids.

Or. en

Amendment 347

Marie-Luce Brasier-Clain, Aleksandar Nikolic, Ondřej Knotek, Tomáš Kubín

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

(27) The application of procurement requirements should take into account the specific market conditions and public health needs of each procurement procedure, whilst bearing in mind the considerations related to affordability of medicinal products. Certain procurement requirements may not be justified in the event of a major health crisis, if they result in risks of shortages of critical medicinal products or disproportionate cost for procurers, or discourage participation, leading to no bids.

Or. fr

Amendment 348

Dan-Ştefan Motreanu

Proposal for a regulation

Recital 27 a (new)

Text proposed by the Commission

Amendment

(27 a) While the mandatory use of procurement requirements beyond price-only criteria can strengthen resilience and sustainability of supply chains, it may also raise concerns regarding the affordability of medicinal products for public health systems. Without careful analysis, such requirements could lead to higher procurement prices and additional budgetary pressures, especially in Member States with limited resources. A comprehensive assessment of the financial impact of mandatory MEAT criteria on affordability should therefore accompany their implementation. Contracting authorities should be able to apply such criteria in a proportionate and context-sensitive manner, taking into account competition conditions on the market and the availability of alternative suppliers.

Or. en

Amendment 349

Laurence Trochu

Proposal for a regulation

Recital 28

Text proposed by the Commission

Amendment

(28) In accordance with Article 168(7) TFEU Member States’ responsibilities for the definition of their health policy and for the organisation and delivery of health services and medical care, including the allocation of financial resources, are to be respected. The contracting authorities should therefore retain the ability, where justified by the considerations related to the market analysis or considerations related to financing of health services, to adopt procurement approaches that differ from those set out in this Regulation as long as they are in line with the Union’s international obligations.

Or. fr

Amendment 350

Ingeborg Ter Laak

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

(29) The Commission intends to issue guidelines designed to support Member States in implementing their obligations to use procurement requirements including award criteria beyond price considerations with a view to strengthening the security of supply, building on best practices identified in the context of the cooperation of national competent authorities on pricing and reimbursement and public health care payers and detailing procurement practices that support availability and security of supply is appropriate. In the context of public procurement of medicinal products, principal buyers, including public authorities and entities entrusted with public functions, should take into account not only price but also other relevant criteria. Particular attention should be given to ensuring a level playing field with third countries and their pharmaceutical producers, especially with regard to the environmental impact of production processes.

Or. en

Amendment 351

András Tivadar Kulja

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

(29) The Commission intends to issue guidelines, in consultation with patient organisations, healthcare professionals and marketing authorisation holders, designed to support Member States in implementing their obligations to use procurement requirements, including award criteria beyond price considerations, with a view to strengthening the security of supply. Building on best practices identified in the context of the cooperation of national competent authorities on pricing and reimbursement and public health care payers, detailing procurement practices that support availability and security of supply is appropriate.

Or. en

Amendment 352

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

(29) The Commission should issue guidelines designed to support Member States in implementing their obligations to use procurement requirements including award criteria beyond price considerations with a view to strengthening the security of supply, building on best practices identified in the context of the cooperation of national competent authorities on pricing and reimbursement and public health care payers. The publication of detailed procurement practices and guidelines that support availability, affordability, equitable access, resilience and security of supply, having into account the impact on the patient needs, healthcare systems, as well as compliance with the social and environment obligations should be made available.

Or. en

Amendment 353

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

(29) The Commission should, after consultation with relevant stakeholders such as patients and consumer organisations, healthcare professionals public healthcare payers and marketing authorisation holders, intends to issue guidelines designed to support Member States in implementing their obligations to use procurement requirements including award criteria beyond price considerations with a view to strengthening the security of supply, building on best practices identified in the context of the cooperation of national competent authorities on pricing and reimbursement and public health care payers and detailing procurement practices that support availability and security of supply is appropriate.

Or. en

Amendment 354

Tilly Metz

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

(29) The Commission intends to issue guidelines designed to support Member States in implementing their obligations to use procurement requirements including award criteria beyond price considerations with a view to strengthening the security of supply, building on best practices identified in the context of the cooperation of national competent authorities on pricing and reimbursement and public health care payers and detailing procurement practices that support availability and security of supply is appropriate. The Commission intends to consult relevant stakeholders, including patients and consumers, healthcare professionals, payers and marketing authorisation holders.

Or. en

Amendment 355

Aurelijus Veryga

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

(29) The Commission intends to issue guidelines, in consultation with patients, healthcare professionals and marketing authorisation holders, designed to support Member States in implementing their obligations to use procurement requirements including award criteria beyond price considerations with a view to strengthening the security of supply, building on best practices identified in the context of the cooperation of national competent authorities on pricing and reimbursement and public health care payers and detailing procurement practices that support availability and security of supply is appropriate.

Or. en

Amendment 356

Radan Kanev

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

(29) The Commission intends to issue guidelines designed to support Member States if they decide to use procurement requirements including award criteria beyond price considerations with a view to strengthening the security of supply, building on best practices identified in the context of the cooperation of national competent authorities on pricing and reimbursement and public health care payers and detailing procurement practices that support availability and security of supply is appropriate.

Or. en

Amendment 357

Kristian Vigenin

Proposal for a regulation

Recital 29

Text proposed by the Commission

Amendment

Or. en

Amendment 358

Michalis Hadjipantela

Proposal for a regulation

Recital 29 a (new)

Text proposed by the Commission

Amendment

(29 a) The Commission must develop specific guidance for Advanced Therapy Medicinal Products (ATMPs), taking into account their distinct characteristics, including on-demand, patient-specific manufacturing, limited treatment centres, fragile supply chains, long-term monitoring and cross-border patient access;

Or. en

Amendment 359

Sebastian Everding

Proposal for a regulation

Recital 29 a (new)

Text proposed by the Commission

Amendment

(29a) The European Union shall promote measures leading, in line with the 'One Health' approach, to a reduction in multidrug-resistant bacteria and animal testing in accordance with the '3R principle.' This should also have a measurable positive effect on security of supply of medicines.

Or. de

Amendment 360

Radan Kanev

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

(30) The procurement of medicinal products is organised differently across Member States, involving various actors. To strengthen the security of supply chains for critical medicinal products, Member States should establish national programmes that promote the consistent use of procurement criteria by contracting authorities within their territory, including the application of multi-winner approaches where beneficial, based on thorough market analysis. To ensure a comprehensive approach, and considering that critical medicinal products are also relevant for outpatient sector where they are often not purchased through public procurement, these programmes may also encompass measures to strengthen supply chain resilience and sustainability through measures related to pricing and reimbursement, where appropriate. The programmes should be shared with the Commission and the Critical Medicines Coordination Group, established by this Regulation, to facilitate the exchange of best practices and coordination between the Member States. This cooperation should enhance the overall effectiveness of the various measures put forward to secure the supply of critical medicinal products, while respecting the principles of subsidiarity and proportionality.

deleted

Or. en

Amendment 361

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

Or. en

Amendment 362

András Tivadar Kulja

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

(30) The procurement of medicinal products is organised differently across Member States, involving various actors. To strengthen the security of supply chains for critical medicinal products, Member States should establish national programmes that promote the consistent use of procurement criteria by contracting authorities within their territory, including the application of multi-winner approaches where beneficial, based on thorough market analysis. To ensure a comprehensive approach, and considering that critical medicinal products are also relevant for outpatient sector where they are often not purchased through public procurement, these programmes may also encompass measures to strengthen supply chain resilience and sustainability through measures related to pricing and reimbursement, where appropriate. Such programmes should take into account the economic viability of critical medicines, and recommend relevant measures, including exemptions of specific categories of critical medicines, such as products derived of substances of human origin (SoHO), from national cost-containment measures. The programmes should be shared with the Commission and the Critical Medicines Coordination Group, established by this Regulation, to facilitate the exchange of best practices and coordination between the Member States. This cooperation should enhance the overall effectiveness of the various measures put forward to secure the supply of critical medicinal products, while respecting the principles of subsidiarity and proportionality.

Or. en

Amendment 363

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Recital 30 a (new)

Text proposed by the Commission

Amendment

(30 a) In order to strengthen the resilience and security of supply of critical medicinal products across the wider European market, candidate countries should participate in the collaborative procurement procedures established under this Regulation. Their participation should foster coordinated action and enhance the accessibility of critical medicinal products, without prejudice to their accession negotiations or to the rights and obligations reserved exclusively to Member States under Union law.

Or. en

Amendment 364

Veronika Cifrová Ostrihoňová, Vlad Vasile-Voiculescu, Olivier Chastel, Stine Bosse

Proposal for a regulation

Recital 30 a (new)

Text proposed by the Commission

Amendment

(30 a) The Union should secure effective trade and international agreements by promoting and facilitating robust, resilient, and open global supply chains, so as to guarantee patient access to medicines and to sustain cooperation with key international partners essential to global pharmaceutical supply, as well as with accession candidates, in ensuring supply security and a solidarity-based response to crises.

Or. en

Amendment 365

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 30 a (new)

Text proposed by the Commission

Amendment

(30 a) To improve the functioning of the pharmaceutical market in the Union, Member States and the Commission should, when implementing pricing and public procurement practices, take action to achieve the objectives of the 2019 World Health Assembly Resolution on Improving the transparency of markets for medicines, vaccines, and other health products.

Or. en

Amendment 366

Tilly Metz

Proposal for a regulation

Recital 30 a (new)

Text proposed by the Commission

Amendment

(30 a) To improve the functioning of the pharmaceutical market in the Union, Member States and the Commission should, when implementing pricing and public procurement practices, take action to achieve the objectives of the 2019 World Health Assembly Resolution on Improving the Transparency of Markets for Medicines, Vaccines, and other Health Products.

Or. en

Amendment 367

Nikos Papandreou, Romana Jerković

Proposal for a regulation

Recital 30 a (new)

Text proposed by the Commission

Amendment

(30 a) Experience from COVID-19 and subsequent shortages shows that multi-winner procurement, increases resilience, reduces single-supplier risk and helps avoid market exits, while maintaining affordability;

Or. en

Amendment 368

Nikos Papandreou, Romana Jerković

Proposal for a regulation

Recital 30 b (new)

Text proposed by the Commission

Amendment

(30 b) The Union should ensure strong trade and international agreements by ensuring and facilitating robust, resilient and open global supply chains to safeguard patient access and continuing collaboration with key international partners playing crucial role in global medicinal supply chains, as well as accession candidates, on the security of supply and solidarity-based responses to crises, included accession countries.

Or. en

Amendment 369

Ton Diepeveen, Aleksandar Nikolic, Tomáš Kubín, Valérie Deloge

Proposal for a regulation

Recital 31

Text proposed by the Commission

Amendment

(31) Obligations imposed by the Member States on companies in the pharmaceutical supply chain to hold contingency stocks can have a serious negative impact on the internal market and other Member States. To avoid such an impact, these obligations should be designed taking into consideration the principles of proportionality, transparency and solidarity. The Member States should give due consideration to forthcoming Commission guidelines designed to facilitate the fulfilment of Member States’ obligations as regards the absence of any negative impact on the internal market when proposing and defining the scope and timing of any form of requirements for companies to hold such stocks.

deleted

Or. en

Amendment 370

Sirpa Pietikäinen

Proposal for a regulation

Recital 31

Text proposed by the Commission

Amendment

(31) Obligations imposed by the Member States on companies in the pharmaceutical supply chain to hold contingency stocks or restrictions they establish on the free movement of medicines can have a serious negative impact on the internal market and other Member States. To avoid such an impact, these measures should be designed taking into consideration the principles of proportionality, transparency and solidarity. The Member States should give due consideration to forthcoming Commission guidelines designed to facilitate the fulfilment of Member States’ obligations as regards the absence of any negative impact on the internal market when proposing and defining the scope and timing of any form of requirements for companies to hold such stocks. National measures on security of supply should be communicated to the Agency, which will assess their impact and inform the Commission where necessary. Where appropriate, the Commission may engage with the Member State concerned to identify coordinated solutions, fully leveraging the functioning of the internal market.

Or. en

Amendment 371

Aurelijus Veryga

Proposal for a regulation

Recital 31

Text proposed by the Commission

Amendment

Or. en

Amendment 372

Laurence Trochu

Proposal for a regulation

Recital 31

Text proposed by the Commission

Amendment

(31) Obligations imposed by the Member States on companies in the pharmaceutical supply chain to hold contingency stocks could have a serious negative impact on the internal market and other Member States, in particular if demand is incompatible with production capacity or if there is a sudden increase in market needs. To avoid such an impact, these possibilities for voluntary stock sharing should be designed taking into consideration the principles of proportionality, transparency and solidarity. The Member States could thus be supported in taking an approach based on solidarity, with due consideration given to forthcoming Commission guidelines designed to reduce any negative impacts on the internal market when proposing and defining the scope and timing of any form of requirements for companies to hold such stocks.

Or. fr

Amendment 373

Emmanouil Fragkos

Proposal for a regulation

Recital 31 a (new)

Text proposed by the Commission

Amendment

(31a) To prevent shortages, in particular where the vulnerability evaluation indicates a high dependence on third countries or a limited number of suppliers, Member States should ensure that minimum safety stocks of critical medicinal products are maintained.

These stocks should be planned and implemented in a way that is proportionate, transparent and based on solidarity, and they should be based on uniform methodologies for calculating ‘days of coverage’, subject to regular rotation and coordinated through the Critical Medicines Group, in order to avoid negative effects on the internal market.

Or. el

Justification

This introduces the principle of minimum safety stocks with guarantees of proportionality, transparency and EU coordination so as not to create distortions.

Amendment 374

Nikos Papandreou

Proposal for a regulation

Recital 31 a (new)

Text proposed by the Commission

Amendment

(31 a) Union stockpiling should be a measure of last resort and digital reporting should leverage existing infrastructures (e.g. EMVS) to avoid duplicative burdens;

Or. en

Amendment 375

Radan Kanev

Proposal for a regulation

Recital 32

Text proposed by the Commission

Amendment

(32) Availability and access disparities exist for critical medicinal products and medicinal products of common interest throughout the Union, disproportionately affecting some Member States. The collaborative procurement of critical medicinal products can be a powerful tool to improve their security of supply and accessibility when it provides an attractive framework for marketing authorisation holders, by ensuring reasonable commercial viability and predictability of single-product procurement processes. This should include the mobilisation of EU funds in relevant cases.

Or. en

Justification

There is a concern that by selective pooling of Member States with significant differences in GDP per capita ratios, procurement negotiations may lead to price levels that would make procurement processes commercially inviable. Targeted use of EU funds would help alleviate such differences and ensure all EU Member States can benefit equally from such procurement procedures.

Amendment 376

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Recital 32

Text proposed by the Commission

Amendment

(32) Availability and access disparities exist for critical medicinal products and medicinal products of common interest throughout the Union, disproportionately affecting some Member States. The collaborative procurement of critical medicinal products and of medicinal products of common interest can be a powerful tool to improve their security of supply and accessibility, including medicines for rare diseases, antimicrobials, and other innovative, high-cost, or specialised treatments across various therapeutic areas, such as oncology.

Or. en

Amendment 377

Oliver Schenk

Proposal for a regulation

Recital 32 a (new)

Text proposed by the Commission

Amendment

(32 a) Forming common principles may be a suitable measure to promote engagement in collaborative procurement procedures for critical medicinal products and medicines of common interest. Such principles could aim to enhance predictability, ensure equitable access among participating Member States, and strengthen the overall efficiency and legal certainty of joint purchasing arrangements, while fully respecting the confidentiality of negotiations and their outcomes.

Or. en

Amendment 378

Tilly Metz

Proposal for a regulation

Recital 32 a (new)

Text proposed by the Commission

Amendment

(32 a) Medicines of common interest can include, among other, medicines for rare diseases (orphan medicinal products), antimicrobials, vaccines, and novel or high-cost treatments for other therapeutic areas such as oncology, chronic diseases, and advanced therapies, especially where affordability and equitable access remain critical concerns.

Or. en

Amendment 379

András Tivadar Kulja

Proposal for a regulation

Recital 32 a (new)

Text proposed by the Commission

Amendment

(32 a) Whereas access is a national competence, Member States should prioritise engagement in bilateral negotiations with Marketing Authorisation Holders without compromising the security of the supply chain of other Member States;

Or. en

Amendment 380

Radan Kanev

Proposal for a regulation

Recital 34

Text proposed by the Commission

Amendment

(34) Taking into account experiences resulting from the implementation of joint procurement of medical countermeasures pursuant to Regulation (EU) 2022/2371 of the European Parliament and of the Council10 and of COVID-19 vaccines, pursuant to Council Regulation (EU) 2016/36911 in the context of the EU Vaccines Strategy and acknowledging potential benefits that leveraging of several Member States demand in one procurement procedure may have, Member States should be able to consider the use of joint procurement or to consider requesting the Commission to procure on their behalf, or in their name, where such procurement could contribute to the achievement of the objectives of this Regulation.

deleted

_________________

10 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26, ELI: http://data.europa.eu/eli/reg/2022/2371/oj).

11 Council Regulation (EU) 2016/296 of 15 March 2016 on the provision of the emergency support within the Union (OJ L 70, 13.3.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/369/oj)

Or. en

Amendment 381

Marie-Luce Brasier-Clain, Aleksandar Nikolic, Ondřej Knotek, Tomáš Kubín

Proposal for a regulation

Recital 34

Text proposed by the Commission

Amendment

(34) Taking into account experiences resulting from the implementation of joint procurement of medical countermeasures pursuant to Regulation (EU) 2022/2371 of the European Parliament and of the Council10and of COVID-19 vaccines, pursuant to Council Regulation (EU) 2016/36911in the context of the EU Vaccines Strategy and acknowledging potential benefits that leveraging of several Member States demand in one procurement procedure may have, Member States should be able to consider the use of joint procurement or to consider requesting the Commission to procure on their behalf, or in their name, where such procurement could contribute to the achievement of the objectives of this Regulation.

_________________

11 Council Regulation (EU) 2016/296 of 15 March 2016 on the provision of the emergency support within the Union (OJ L 70, 13.3.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/369/oj)

11 Council Regulation (EU) 2016/296 of 15 March 2016 on the provision of the emergency support within the Union (OJ L 70, 13.3.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/369/oj).

Or. fr

Amendment 382

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Gerald Hauser, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Recital 34

Text proposed by the Commission

Amendment

(34) Taking into account experiences resulting from the implementation of joint procurement of medical countermeasures pursuant to Regulation (EU) 2022/2371 of the European Parliament and of the Council10 and of COVID-19 vaccines, pursuant to Council Regulation (EU) 2016/36911 in the context of the EU Vaccines Strategy and acknowledging potential benefits that leveraging of several Member States demand in one procurement procedure may have, Member States should be able to consider the use of joint procurement or to consider requesting the Commission to procure on their behalf, or in their name, where such procurement on voluntary basis could contribute to the achievement of the objectives of this Regulation.

_________________

11 Council Regulation (EU) 2016/296 of 15 March 2016 on the provision of the emergency support within the Union (OJ L 70, 13.3.2016, p. 1, ELI: http://data.europa.eu/eli/reg/2016/369/oj)

Or. en

Amendment 383

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Recital 34 a (new)

Text proposed by the Commission

Amendment

(34 a) Taking into account the Union's simplification and competitiveness objectives, and the different root causes of the supply security or access issues affecting vulnerable critical medicines or medicinal products of common interest respectively, the collaborative procurement procedure provided for in Article 21, and the joint procurement procedures provided for in Article 22, should be subject to a preliminary assessment by the Commission in order to confirm that they constitute an objectively necessary and proportionate response to a specific market access failure or to a supply security concern, which cannot be adequately resolved by other, more appropriate means, while fully respecting the competences of the Member States and taking due account of the specific characteristics of the relevant medicinal products and the national circumstances concerned.

Or. en

Amendment 384

Kristoffer Storm

Proposal for a regulation

Recital 34 a (new)

Text proposed by the Commission

Amendment

(34 a) Joint and/or collaborative procurement procedures should aim to broaden patient access to medicines while also increasing the size of, and access to, the market for companies. To that end, joint and/or collaborative procurement should be voluntary for the biopharmaceutical and the Member states and confidential, and should not duplicate, or be duplicated by, national or sub-national pricing and reimbursement procedures for the same medicinal product. To facilitate the process of jointly negotiating confidential agreements, Member States wishing to participate in joint and/or collaborative procurement should take steps to remove price referencing mechanisms.

Or. en

Amendment 385

András Tivadar Kulja

Proposal for a regulation

Recital 34 a (new)

Text proposed by the Commission

Amendment

(34 a) Taking into account the Union's simplification and competitiveness objectives, and the different root causes of the supply security or patient access issues affecting vulnerable critical medicines or medicinal products of common interest respectively, the collaborative procurement procedure provided for in Article 21, and the joint procurement procedures provided for in Article 22, should be subject to a preliminary assessment by the Commission to confirm that they are an objectively necessary and proportionate response to a particular market access failure or supply security concern respectively, that cannot be resolved by other more appropriate means.

Or. en

Amendment 386

Christine Anderson

Proposal for a regulation

Recital 34 a (new)

Text proposed by the Commission

Amendment

(34 a) The joint procurement of vaccines during the COVID-19 pandemic highlighted the risks of over-centralisation: inflexible contracts, delivery delays, and lack of transparency. Future procurement initiatives should be assessed against decentralised alternatives and ensure accountability for cost and performance

Or. en

Amendment 387

Ruggero Razza, Michele Picaro

Proposal for a regulation

Recital 36

Text proposed by the Commission

Amendment

(36) To ensure transparency, legal clarity, and effective coordination, structured agreement between the Member States and the Commission should govern procurement procedures under this Regulation that rely on an active Commission involvement. Such agreement should set out the division of responsibilities, decision-making processes, the information to be shared as relevant to the procurement procedure, including information on Member States’ participation in parallel negotiations through different channels in relation to the same medicinal products or the same active substances as appropriate, and liability provisions, ensuring a fair and efficient framework for participating Member States while preventing market distortions and supply disruptions. This Regulation is without prejudice to and does not prevent the use of joint procurement procedures established under Regulation (EU) 2022/2371 of the European Parliament and of the Council for those critical medicinal products and other medicinal products that also fall within the definition of medical countermeasures as set out in that Regulation. For such medicinal products, the objective of the joint procurement initiative should determine the applicable framework. Where a joint procurement procedure is initiated with the aim of advance purchasing of these medicinal products as medical countermeasures to prepare for and respond to serious cross- border threats to health, such a procurement procedure should be carried out in accordance with Regulation (EU) 2022/2371. This Regulation is without prejudice to Council Regulation (EU) 2022/237213 setting the framework of measures for ensuring the supply of crisis- relevant medical countermeasures in the event of a public health emergency at Union level. In order to ensure the effectiveness of joint procurement procedures for critical medicinal products and medicinal products of common interest, certain conditions should apply. Those conditions should include the application of regulatory flexibilities, such as electronic packaging information together with the paper one, harmonised pack sizes, and labelling adjustments, to facilitate supply and distribution notwithstanding Member States competencies and what is provided from the current legislation. Participating Member States should commit to binding minimum quantities and take all necessary steps to ensure the timely availability of the procured products within their territories. To preserve the integrity of the joint procurement procedure and the negotiating power under such procedure, participating Member States should refrain from engaging in parallel procurement or separate negotiations for the same product during the joint procurement process.

_________________

13 Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level (OJ L 314, p. 64, ELI: http://data.europa.eu/eli/reg/2022/2372/oj)

Or. en

Amendment 388

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 36 a (new)

Text proposed by the Commission

Amendment

(36 a) In order to prevent or mitigate critical shortages of medicinal products within the Union, it is appropriate to activate the voluntary solidarity mechanism, agreed by the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) during its meeting held on June 19th 2023, whereby Member States, coordinated by the Critical Medicines Coordination Group and supported by the Commission, may provide assistance to one another. This mechanism should be activated only when national measures have been exhausted and should complement them, without prejudice to other Union instruments and measures in the field of medicinal products.

Or. en

Amendment 389

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Estelle Ceulemans, Pierre Jouvet, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 36 b (new)

Text proposed by the Commission

Amendment

(36 b) Where appropriate, the voluntary solidarity mechanism should allow for the mobilisation of logistical support and Union-level capacities under the Union Civil Protection Mechanism pursuant to Regulation (EU) 2016/369, including rescEU capacities, in order to ensure the swift and efficient delivery of critical medicinal products between Member States. The mechanism should operate in accordance with the principles of transparency, proportionality and solidarity, and should be subject to monitoring and evaluation by the Commission in cooperation with the Medicines Shortages Steering Group.

Or. en

Amendment 390

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Estelle Ceulemans, Pierre Jouvet, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 36 c (new)

Text proposed by the Commission

Amendment

(36 c) Where the Voluntary Solidarity Mechanism is activated by a Member State, and to foster the rapid reallocation of stocks across Member States, it is appropriate that Union and national law allow for flexibility regarding packaging and labelling requirements, including multi-country packs, and package leaflets, including the use of electronic package leaflets only, while ensuring that patients retain the right to request paper package leaflets.

Or. en

Amendment 391

Michele Picaro, Ruggero Razza

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Group should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States, the European Medicines Agency (‘the Agency), healthcare professionals and patient organisations with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. It should assess the vulnerability of medicines in line with Article 3 and identify options to address any vulnerabilities including through industrial policy measures, when relevant. It should also support the Member States and the Commission, where appropriate, in the establishment of mechanisms for transferring stock of medicinal products within national health systems and across Member States, ensuring that whenever a shortage arises no medicines are wasted and that national stockpiles and contingency stocks are used in the most efficient and equitable manner. The Critical Medicines Group should not replace but rather complement the work of the joint action steering group established by Article 4(1) of Regulation (EU) 2022/2372 of the European Parliament and of the Council and the vigilance monitoring and reporting of supply issues and shortages coordinated by EMA under Regulation (EU) 2022/123.

Or. en

Amendment 392

Tilly Metz

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States and the European Medicines Agency with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Critical Medicines Group should also include as full members representatives appointed by patient, consumers and healthcare professional organisations. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

Or. en

Amendment 393

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat. In addition, the Critical Medicines Coordination Group should ensure the structured involvement of patient representatives and advocates, and civil society stakeholders, such as pharmacists, doctors and nurses.

Or. en

Amendment 394

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Coordination Group should also include representatives of patient and consumer organisations, workers’ organisations and non-governmental civil society organisations, with the right to speak and to propose. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

Or. en

Amendment 395

Aurelijus Veryga

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States, European Medicines Agency (EMA), Health Emergency Preparedness and Response Authority (HERA) and representatives of patient and healthcare professional organisations with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

Or. en

Amendment 396

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States, European Medicines Agency, Patient, Women's Health and Consumer Organisations and Healthcare professionals with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

Or. en

Amendment 397

András Tivadar Kulja

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States, the European Medicines Agency and patient organisations with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

Or. en

Amendment 398

Marie-Luce Brasier-Clain, Aleksandar Nikolic, Ondřej Knotek, Tomáš Kubín, Ton Diepeveen

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should assist the chair of the Critical Medicines Group, which rotates among representatives of the Member States, and perform the functions of its secretariat.

Or. fr

Amendment 399

Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States, the European Medicines Agency and patient organisations with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

Or. en

Amendment 400

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 37 a (new)

Text proposed by the Commission

Amendment

(37 a) The Health Emergency Preparedness and Response Authority (DG HERA) of the European Commission plays a central role in strengthening the Union’s preparedness and response capacities, including the coordination of joint procurement of medical countermeasures and the management of Union-level strategic stockpiles. To maximise synergies, avoid duplication and ensure efficient use of resources, the Commission should be represented in the Critical Medicines Coordination Group by a representative of DG HERA, in close cooperation with other relevant Commission services. This arrangement should ensure consistency between joint procurement, stockpiling activities and the broader work of the Critical Medicines Coordination Group, including the prioritisation of joint procurement initiatives, planning of Union stockpiles, exchange of relevant data on supply chain vulnerabilities and coordination with other shortages-prevention platforms, while respecting the respective competences and confidentiality obligations of all actors involved.

Or. en

Amendment 401

Radan Kanev

Proposal for a regulation

Recital 38

Text proposed by the Commission

Amendment

(38) To ensure coordinated implementation of this Regulation, the Critical Medicines Group should enable exchanges of information related to funding of strategic projects and facilitate the strategic orientation of financial support for strategic projects. The Critical Medicines Group should also facilitate the exchange of information on national programmes, including on the approach to contingency stock requirements in public procurement contracts. When relevant, the Critical Medicines Group should facilitate the coordination of national programmes. The Critical Medicines Group should furthermore facilitate discussions on the need to launch a collaborative procurement initiative and the need to prioritise the vulnerability evaluation for specific critical medicinal products.

deleted

Or. en

Amendment 402

Sirpa Pietikäinen

Proposal for a regulation

Recital 38

Text proposed by the Commission

Amendment

Or. en

Amendment 403

Dan-Ştefan Motreanu

Proposal for a regulation

Recital 38 a (new)

Text proposed by the Commission

Amendment

(38 a) In the absence of a coordinated European approach, the implementation of this Regulation may risk accentuating disparities between Member States with well-developed industrial capacities and those without. To prevent fragmentation and to ensure a balanced distribution of manufacturing and supply security across the Union, the mandate of the Critical Medicines Coordination Group should include the ability to define minimum indicative production targets for classes of critical medicines, maintain a centralised mapping of production, storage and distribution capacities in the Union, and recommend targeted corrective interventions and investments where critical gaps are identified. In times of crisis or major disruptions, the Group should also facilitate mechanisms of solidarity between Member States, including the redistribution of stocks or temporary reallocation of production from surplus to deficit countries, in order to safeguard patient access across the Union.

Or. en

Amendment 404

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 38 a (new)

Text proposed by the Commission

Amendment

(38 a) The Critical Medicines Alliance provides an inclusive and transparent consultative platform bringing together Member States, industry, civil society and the scientific community to identify vulnerabilities and propose priority actions to strengthen the supply of critical medicines in the Union, particularly for those substances listed on the Union List of Critical Medicinal Products. The Critical Medicines Group and the Critical Medicines Alliance should exchange on a biannual basis to integrate the views of relevant stakeholders regarding vulnerabilities in supply chains and mitigation measures to address structural risks and reinforce supply.

Or. en

Amendment 405

Leire Pajín

Proposal for a regulation

Recital 38 a (new)

Text proposed by the Commission

Amendment

(38 a) The Group should ensure structured consultation with civil society and academia (including partner country stakeholders through the Global Health Policy Forum) when assessing international partnerships, and should be able to invite relevant partner-country institutions as observers when discussing cooperation affecting their regions.

Or. en

Amendment 406

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 38 b (new)

Text proposed by the Commission

Amendment

(38 b) In order to strengthen the Union’s preparedness and ensure an inclusive, needs-driven, transparent and coordinated approach to future challenges in the supply of critical medicinal products, the Critical medicines group, after consultation with the Commission, the European Medicines Agency and the Critical Medicines Alliance, should establish a strategic foresight process. This process should identify and assess potential strategic projects, taking into account long-term trends, vulnerabilities, and opportunities for enhancing the resilience and sustainability of supply chains within the Union, specifically based on unmet medical needs.

Or. en

Amendment 407

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 38 c (new)

Text proposed by the Commission

Amendment

(38 c) The development of antimicrobial resistance is a growing concern and the pipeline of effective antimicrobials is obstructed due to a market failure whereby antimicrobial research and development (R&D) is hampered by the low commercial value of the antimicrobial medicinal product market. It is therefore necessary to maintain the efficacy of existing antimicrobials for as long as possible and to consider a number of new measures to promote the development of priority antimicrobials that are effective against antimicrobial resistance and to support undertakings, often SMEs, and not-for-profit entities which choose to invest in this area. It is equally necessary to support research and development of novel antimicrobials through the different phases of antimicrobial development, in particular through market entry rewards and milestone reward payments. Additionally, the establishment of subscription models which delink the volume of antimicrobial sales from the reward received, in particular through voluntary joint procurement, can help overcome such market failures.

Or. en

Amendment 408

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Estelle Ceulemans, Pierre Jouvet, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 38 d (new)

Text proposed by the Commission

Amendment

(38 d) A subscription model consists of a series of financial payments to an antibiotic developer for successfully obtaining regulatory approval for an antibiotic that meets specific pre-defined criteria. A subscription model scheme through voluntary joint procurement agreements should alleviate concerns for developers by ensuring that there is a market for the antimicrobial when it is developed.

Or. en

Amendment 409

András Tivadar Kulja

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

(39) The Union could further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union could, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties. Representatives of healthcare professionals involved in the procurement processes at the national level should participate in the Critical Medicines Coordination Group to provide advice based on the practical experience of their respective communities. The Critical Medicines Coordination Group should act in close coordination with the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and other institutional actors.

Or. en

Amendment 410

Tilly Metz

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

(39) The Union could further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union could, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties. Any such partnership must comply with equivalent requirements regarding safety, quality, environmental protection, and labour standards. In addition, the promotion of domestic pharmaceutical production in low- and middle-income countries should primarily serve to meet local public health needs; only once these needs are sufficiently addressed should surplus production be directed towards mitigating shortages in the Union.

Or. en

Amendment 411

Marie-Luce Brasier-Clain, Aleksandar Nikolic

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

(39) The Union could further enhance the availability and security of supply of critical medicinal products by supporting and encouraging the public investments needed to establish new sectors within the Member States, or by helping to bring those production chains back to Europe. Although it is vital to diversify our supply sources to ensure that we are no longer dependent on others, the Commission must firstly consult the Member States’ representatives before entering into or revising any trade agreement.

Or. fr

Amendment 412

Laurence Trochu

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

(39) Public health is too sensitive to leave supplies of critical medicinal products dependent on third countries. If the Union could further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation, reshoring the production of medicinal products needed by the people of Europe should still be retained as a strategic objective.

Or. fr

Amendment 413

Ingeborg Ter Laak

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

(39) The Union could further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union could, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties. Given the urgency of addressing shortages, diversification through international partnerships should be prioritised as the most immediate and effective instrument to strengthen resilience; additionally, longer-term measures such as reshoring of production should be taken.

Or. en

Amendment 414

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

(39) The Union should further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union could, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties. The Commission should specifically consider the inclusion of access to API starting materials and active pharmaceutical ingredients in the scope of trade agreements and international partnership.

Or. en

Amendment 415

Oliver Schenk

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

(39) The Union could further enhance the availability and security of supply of critical medicinal products, as well as their active substances and key inputs needed for their manufacturing by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union could, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties.

Or. en

Amendment 416

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

(39) The Union should further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union should, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties.

Or. en

Amendment 417

Marie-Luce Brasier-Clain, Aleksandar Nikolic, Ondřej Knotek, Tomáš Kubín, Ton Diepeveen

Proposal for a regulation

Recital 41

Text proposed by the Commission

Amendment

(41) In order to ensure that this Regulation effectively meets its objectives, it is essential to assess its implementation and impact over time. The Commission should carry out an evaluation of this Regulation five years after its application and every five years thereafter. This evaluation should include an assessment of the extent to which the Regulation’s objectives, as set out in Article 1, have been achieved, including its impact on stakeholders, regulatory procedures, and market dynamics. In particular, the Commission’s evaluation should take into account the views of Member States, economic operators, and other relevant stakeholders, ensuring that their feedback contributes to the continuous improvement of the regulatory framework. The results of this evaluation should be presented to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. In order to facilitate this evaluation, national authorities and economic operators should provide relevant data and information upon request to support the Commission’s assessment.

(41) In order to ensure that this Regulation effectively meets its objectives, it is essential to assess its implementation and impact over time. To this end, the Commission should provide an impact assessment of the Regulation’s main provisions to monitor their effectiveness in the short, medium and long term. The Commission should carry out an evaluation of this Regulation five years after its application and every five years thereafter. This evaluation should include an assessment of the extent to which the Regulation’s objectives, as set out in Article 1, have been achieved, including its impact on stakeholders, regulatory procedures, and market dynamics. In particular, the Commission’s evaluation should take into account the views of Member States, economic operators, and other relevant stakeholders, ensuring that their feedback contributes to the continuous improvement of the regulatory framework. The results of this evaluation should be presented to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. In order to facilitate this evaluation, national authorities and economic operators should provide relevant data and information upon request to support the Commission’s assessment.

Or. fr

Amendment 418

Christophe Clergeau

Proposal for a regulation

Recital 41 a (new)

Text proposed by the Commission

Amendment

(41 a) Shortages of medical countermeasures represent a growing threat to public health, with potential serious risks to the health of patients and medical workers in the Union as demonstrated by the Covid-19 crisis. The root causes of shortages are multifactorial, with challenges identified along the entire medical countermeasures value chain, from quality and manufacturing problems. In particular, shortages of medical countermeasures can result from supply chain disruptions and vulnerabilities affecting the supply of key ingredients and components. The Commission should therefore establish in the short-term a strategy to address and reduce shortages of medical countermeasures upstream of crises and preparedness situations. In the long-term, the Commission should assess the appropriateness of expanding the scope of this Regulation to critical medical countermeasures to durably increase access to medical countermeasures, improving security of supply, and addressing shortages.

Or. en

Justification

As an alternative to expanding the scope of this Regulation to medical countermeasures in this procedure, the text should task the Commission to conduct a review of this Regulation to include critical medical countermeasures in the mid to long term.

Amendment 419

Radan Kanev

Proposal for a regulation

Recital 42

Text proposed by the Commission

Amendment

(42) Since the objectives of this Regulation to establish a framework to strengthen the availability and security of supply of critical medicinal products within the Union and to improve the availability and accessibility of medicinal products of common interest through coordinated and targeted action of Member States cannot be sufficiently achieved by the Member States acting alone, but can rather, by reason of its scale, be better achieved at Union level, the Union may adopt measures in accordance with the principle of subsidiarity, as set out in Article 5 of the TFEU. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve its objectives.

deleted

Or. en

Amendment 420

Dario Tamburrano, Valentina Palmisano, Catarina Martins

Proposal for a regulation

Recital 42 a (new)

Text proposed by the Commission

Amendment

(42 a) Considering that security of supply and accessibility to critical medicines is a key strategic objective of the Union that requires an ambitious EU-wide investment plan, with dedicated funding and not limited to State aid, to strengthen manufacturing capacities for active pharmaceutical ingredients (APIs) and finished medicines in Europe. This plan should include the redefinition of 'innovation' in State aid schemes and Important Projects of Common European Interest (IPCEIs) to cover production processes that support the green and digital transitions, as well as security of supply. The creation of European non-profit pharmaceutical companies operating in the public interest for the production of strategically important medicines, including vaccines, along the lines of public research infrastructures should also be explored.

Or. en

Amendment 421

Stine Bosse, Billy Kelleher

Proposal for a regulation

Recital 42 a (new)

Text proposed by the Commission

Amendment

(42 a) In order to ensure sustainable access to priority antimicrobials and to provide adequate incentives for their development, it is appropriate to establish a coordination framework at Union level. This framework should combine the coordination of national subscription contracts with a Union-level service contract, thereby ensuring both predictability of revenues for developers and timely availability of antimicrobials for the Member States. The framework should also define a fair distribution of financial contributions among Member States and the Union budget, in proportion to participation. To guarantee transparency and legal certainty, the detailed modalities of the framework should be laid down in a delegated act adopted by the Commission.

Or. en

Amendment 422

Christine Anderson

Proposal for a regulation

Recital 42 a (new)

Text proposed by the Commission

Amendment

(42 a) This Regulation should be implemented in a manner that respects the Member States’ primary competence in organising healthcare and avoids imposing uniform approaches that may not reflect national realities or policy priorities.

Or. en

Amendment 423

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Recital 42 b (new)

Text proposed by the Commission

Amendment

(42 b) In order to ensure the accessibility and competitiveness of medicinal products, the Union should promote greater transparency throughout the supply chain, including research and development costs, prices and insurance reimbursement policies, as well as stock availability.

Or. en

Amendment 424

Dario Tamburrano, Valentina Palmisano, Catarina Martins

Proposal for a regulation

Recital 42 c (new)

Text proposed by the Commission

Amendment

(42 c) In order to strengthen security of supply and reduce dependence on external suppliers, the creation of a European public infrastructure for the production and supply of critical medicines (‘European Medicines House’) should be considered, aimed at ensuring universal access at fair prices and correcting market failures.

Or. en

Amendment 425

Dario Tamburrano, Valentina Palmisano, Catarina Martins

Proposal for a regulation

Recital 42 d (new)

Text proposed by the Commission

Amendment

(42 d) Recognising the structural shortcomings of the current European system of research and development in the pharmaceutical sector, the European Parliament, in its 2020 resolution on shortages of medicines, called on the Commission and the Member States to examine the possibility of setting up one or more European non-profit pharmaceutical companies, operating in the public interest, for the production of public health medicines. The European Council, in its conclusions of November 2021, underlined the importance of that resolution in order to secure the supply of medicines affected by market failures.

Or. en

Amendment 426

Radan Kanev

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

It is also the objective of this Regulation to support the Union’s competitiveness and simplification objectives by fostering a more stable and predictable market environment supporting innovation in the research-based pharmaceutical sector as a strategic asset for the Union’s economy, and promoting targeted, evidence-based and proportionate measures that avoid unintended consequences on the security of supply and accessibility of critical medicinal products.

Or. en

Justification

This introduction of objectives goes beyond the strict provision of critical medicinal products, risking to compromise the usual supply chain of medicinal products delivery.

Amendment 427

Kristian Vigenin

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, while safeguarding the right to accessible and affordable healthcare for all Union citizens, thereby ensuring a high level of public health protection and supporting the security of the Union. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to patients, whilst giving due consideration to the appropriateness to ensure the affordability of medicinal products.

This Regulation is without prejudice to Member States' responsibilities in healthcare, including pricing and reimbursement, as well as the allocation of human and budgetary resources at national level.

Or. en

Amendment 428

Victor Negrescu

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby ensuring a high level of public health protection and supporting the security of the Union. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to patients, whilst giving due consideration to the appropriateness to ensure the affordability of medicinal products. Special attention shall be given to reducing East–West disparities in access to critical medicinal products, ensuring that patients in all Member States, including those in economically disadvantaged and remote regions, benefit from equitable and reliable availability.

Or. en

Amendment 429

Tilly Metz

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby ensuring a high level of public health protection and supporting the security of the Union. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to all patients in the EU, whilst giving due consideration to the appropriateness to ensure the accessibility and affordability of medicinal products, including both critical medicinal products and medicinal products of common interest.

Or. en

Amendment 430

Laurent Castillo

Proposal for a regulation

Article premier – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union and to reduce the critical dependency of the Union, thereby ensuring a high level of public health protection and supporting the security of the Union. The objective of this Regulation is also to improve the Union’s competitiveness in pharmaceuticals so as to attract manufacturing investments, while making the sector a strategic area. It also aims to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to patients, whilst giving due consideration to the appropriateness to ensure the affordability of medicinal products.

Or. fr

Amendment 431

Oliver Schenk

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby ensuring a high level of public health protection and supporting the security of the Union. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to patients, whilst giving due consideration to the appropriateness to ensure the affordability of medicinal products. Strengthening manufacturing capacities and the resilience of supply chains, as well as competitiveness and innovation in the Union’s pharmaceutical sector, is an integral part of the objectives of this Regulation.

Or. en

Amendment 432

Adam Jarubas, Ewa Kopacz, Letizia Moratti

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby ensuring a high level of public health protection and supporting the security of the Union, including Union's pharmaceutical supply, based on a thorough, evidence-based evaluation of current market dynamics, potential supply chain vulnerabilities, and their root causes. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to patients, whilst giving due consideration to the appropriateness to ensure the affordability of medicinal products

Or. en

Amendment 433

Christophe Clergeau

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products and critical medical countermeasures within the Union, thereby ensuring a high level of public health protection and supporting the security of the Union. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products and medical countermeasures, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products and medical countermeasures to patients and medical workers, whilst giving due consideration to the appropriateness to ensure the affordability of medicinal products and medical countermeasures.

Or. en

Amendment 434

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby reducing its dependency on third countries and thereby ensuring a high level of public health protection, maintaining patient safety and supporting the security of the Union. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to patients in the Union, whilst giving due consideration to the appropriateness to ensure the accessibility and affordability of medicinal products.

Or. en

Amendment 435

Alessandra Moretti

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

Both objectives shall be pursued while ensuring affordability and accessibility of those products in all Member States and while ensuring full transparency in the use of public funds.

Or. en

Amendment 436

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Gerald Hauser, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby ensuring a high level of public health protection, supporting the security of the Union and Member States, and increasing the competitiveness of Union’s pharmaceutical sector. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to patients, whilst giving due consideration to the appropriateness to ensure the affordability of medicinal products.

Or. en

Amendment 437

Christine Anderson

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 438

Marie-Luce Brasier-Clain, Aleksandar Nikolic, Ondřej Knotek, Tomáš Kubín, Ton Diepeveen

Proposal for a regulation

Article premier – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby ensuring a high level of public health protection and supporting the security and strategic autonomy of the Union. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to patients, whilst giving due consideration to the appropriateness to ensure the affordability of medicinal products.

Or. fr

Amendment 439

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply and the availability of critical medicinal products within the Union, thereby ensuring a high level of public health protection and supporting the security of the Union. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to all patients within the Union, whilst giving due consideration to the appropriateness to ensure the affordability of medicinal products.

Or. en

Amendment 440

András Tivadar Kulja

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply and the availability and accessibility of critical medicinal products within the Union, thereby ensuring a high level of public health protection and supporting the security of the Union. The objective of this Regulation is also to improve the availability and accessibility of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability and accessibility of those medicinal products to patients, whilst giving due consideration to the appropriateness to ensure the affordability of medicinal products.

Or. en

Amendment 441

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply, the availability, affordability and equitable access of critical medicinal products within the Union, thereby ensuring a high level of public health protection, patient safety and supporting the security of the Union. The objective of this Regulation is also to improve the availability, affordability and equitable access of other medicinal products, where the functioning of the market does not otherwise sufficiently ensure the availability, affordability and equitable access of those medicinal products to patients in all the Union Member States.

Or. en

Amendment 442

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. The objective of this Regulation is to strengthen the security of supply, the affordability and the availability of critical medicinal products within the Union, as well as the availability and accessibility of medicines of common interest, explicitly including medicines for rare diseases, women’s reproductive health and areas with unmet medical needs. To that end, the Regulation promotes public investment and non-profit-oriented production models, reduces dependence on external sources and ensures a high level of protection of public health and general safety in the Union.

Or. en

Amendment 443

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) facilitate investments in manufacturing capacity for critical medicinal products, their active substances and other key inputs in the Union;

(a) facilitate and support investments in new manufacturing capacity and strengthen existing manufacturing capacity for critical medicinal products, their active substances and other key inputs in the Union with a priority given to critical medicinal products that could become critical if affected by supply chain vulnerabilities in their supply chain;

Or. en

Amendment 444

Tilly Metz

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) facilitate investments in manufacturing capacity for critical medicinal products, their active substances and other key inputs in the Union;

(a) facilitate investments in manufacturing capacity for critical medicinal products, their active substances and other key inputs in the Union, while maximising the efficiency of public spending by ensuring a return on public investments and maintaining full transparency for public oversight;

Or. en

Amendment 445

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) facilitate investments in manufacturing capacity for critical medicinal products, their active substances and other key inputs in the Union;

(a) strengthen and increase the manufacturing capacity for critical medicinal products, their active substances and other key inputs within the EU;

Or. en

Amendment 446

Christophe Clergeau

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) facilitate investments in manufacturing capacity for critical medicinal products, their active substances and other key inputs in the Union;

(a) facilitate investments in manufacturing capacity for critical medicinal products, their active substances, critical medical countermeasures and other key inputs in the Union;

Or. en

Amendment 447

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 1 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(a a) Improve supply and production conditions within the Union by promoting local, social responsible and environmental sustainable production along the value chain.

Or. en

Amendment 448

Laurent Castillo

Proposal for a regulation

Article premier – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(aa) facilitate and support research and development projects in any innovation that can substitute for critical medicinal products;

Or. fr

Amendment 449

Alessandra Moretti

Proposal for a regulation

Article 1 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) lower the risk of supply disruptions and strengthen availability by incentivising supply chain diversification and resilience in the public procurement procedures of critical medicinal products and other medicinal products of common interest, whilst ensuring sufficient public return on public investment and full transparency in the use of public funds;

Or. en

Amendment 450

Christophe Clergeau

Proposal for a regulation

Article 1 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) lower the risk of supply disruptions and strengthen availability by incentivising supply chain diversification and resilience in the public procurement procedures of critical medicinal products, other medicinal products of common interest, and critical medical countermeasures, and other medicinal countermeasures of common interest;

Or. en

Amendment 451

Tilly Metz

Proposal for a regulation

Article 1 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) lower the risk of supply disruptions and strengthen availability by incentivising supply chain diversification and resilience, as well as their compliance with environmental and social standards in the public procurement procedures of critical medicinal products and other medicinal products of common interest;

Or. en

Amendment 452

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Article 1 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) lower the risk of supply disruptions and strengthen availability by incentivising supply chain diversification, resilience, and compliance with environmental and social standards in the public procurement procedures of critical medicinal products and other medicinal products of common interest;

Or. en

Amendment 453

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 1 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) lower the risk of supply disruptions and dependencies and strengthen availability by incentivising supply chain diversification and resilience through transparent and predictable public procurement procedures for critical medicinal products and other medicinal products of common interest;

Or. en

Amendment 454

Laurent Castillo

Proposal for a regulation

Article premier – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) lower the risk of supply disruptions and strengthen availability by reducing the Union’s dependency and incentivising supply chain diversification and resilience in the public procurement procedures of critical medicinal products and other medicinal products of common interest;

Or. fr

Amendment 455

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 1 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

(b a) enhance the availability of medicinal products by harmonising the principles governing contingency stocks, with a view to preventing shortages and ensuring transparency and coordination among Member States in this regard;

Or. en

Amendment 456

Ondřej Krutílek

Proposal for a regulation

Article 1 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

(b a) Strengthen the availability of medicinal products by harmonising the principles related to contingency stock of medicinal products in order to prevent shortages and ensure transparency among Member States in this area;

Or. en

Amendment 457

Laurent Castillo

Proposal for a regulation

Article premier – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

(ba) ensure harmonised and coordinated management of critical medicine stocks held by suppliers, the Member States and the Union;

Or. fr

Amendment 458

Laurent Castillo

Proposal for a regulation

Article premier – paragraph 2 – point b b (new)

Text proposed by the Commission

Amendment

(bb) prevent unintended restrictions on the manufacturing and availability of critical medicinal products as a result of environmental and chemical legislation;

Or. fr

Amendment 459

Peter Agius

Proposal for a regulation

Article 1 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) leverage the aggregated demand of participating Member States through collaborative and joint procurement procedures, and

Or. en

Justification

The addition is to align the provision with the text, since both collaborative and joint procurement aggregate demand for the participating Member State

Amendment 460

Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 1 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) leverage the aggregated demand of participating Member States through voluntary collaborative procurement procedures, and

Or. en

Amendment 461

Kristian Vigenin

Proposal for a regulation

Article 1 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) leverage the aggregated demand of participating Member States through voluntary collaborative procurement procedures, and

Or. en

Amendment 462

Aurelijus Veryga

Proposal for a regulation

Article 1 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) leverage the aggregated demand of voluntary participating Member States through collaborative procurement procedures,

Or. en

Amendment 463

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

Article 1 – paragraph 2 – point c a (new)

Text proposed by the Commission

Amendment

(c a) Lower the risk of supply disruptions and lower the waste of finished medicinal products of critical medicinal products through the adoption of adequate methods of establishing rolling contingency stocks;

Or. en

Amendment 464

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Romana Jerković, Raffaele Topo

Proposal for a regulation

Article 1 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) support the diversification of supply chains also by facilitating the conclusion of strategic partnerships.

(d) support the diversification of supply chains also by facilitating the conclusion of strategic partnerships with a priority given to critical medicinal products that could become critical if vulnerabilities affect their supply chain.

Or. en

Amendment 465

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 1 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) support the diversification of supply chains also by facilitating the conclusion of strategic partnerships.

(d) support the diversification of supply chains also by facilitating the conclusion of strategic partnerships, having into account the need to mitigate potential geopolitical risks;

Or. en

Amendment 466

Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 1 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(d a) facilitate investments in critical distribution infrastructure capacity for critical medicinal products ensuring security of supply, availability and accessibility in the Union;

Or. en

Justification

Including critical infrastructure in the Regulation’s objectives ensures the CMA strengthens both manufacturing capacity and the logistical backbone for secure distribution of critical medicines. This aligns with the EU Critical Entities Regulation and NATO’s 2025 guidance on defense-related infrastructure, supporting a comprehensive and resilient approach to pharmaceutical supply under this Regulation.

Amendment 467

Margarita de la Pisa Carrión

Proposal for a regulation

Article 1 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(d a) guarantee the critical distribution infrastructure capacity for critical medicinal products ensuring security of supply, availability and accessibility in the Union;

Or. en

Amendment 468

Tilly Metz

Proposal for a regulation

Article 1 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(d a) ensure coordinated stockpiling of critical medicines in the Union.

Or. en

Amendment 469

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. This Regulation applies to the critical medicinal products listed in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] and their active substances, API starting materials and other key inputs in the Union, provided that they are used for the purposes of critical medicinal products.

Or. en

Amendment 470

Oliver Schenk

Proposal for a regulation

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. This Regulation applies to the critical medicinal products listed in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final], taking into account the distinctive characteristics of each medicinal product’s supply chain covered by this Regulation.

Or. en

Amendment 471

Christophe Clergeau

Proposal for a regulation

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. This Regulation applies to the critical medicinal products listed in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final], and to medical countermeasures listed in the EU List of Medical Countermeasures for Priority Threats.

Or. en

Amendment 472

Aurelijus Veryga

Proposal for a regulation

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. This Regulation applies to the critical medicinal products listed in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final], taking into account the distinctive characteristics of each medicinal product's supply chain.

Or. en

Amendment 473

András Tivadar Kulja

Proposal for a regulation

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. This Regulation applies to the critical medicinal products listed in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final]. taking into account the distinctive characteristics of each medicinal product's supply chain.

Or. en

Amendment 474

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. This Regulation applies to the critical medicinal products listed in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final], taking into account the distinctive characteristics of each medicinal product’s supply chain.

Or. en

Amendment 475

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Gerald Hauser, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. This Regulation applies to the critical medicinal products listed in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] taking into account the distinctive characteristics of each medicinal product’s supply chain.

Or. en

Amendment 476

Laurent Castillo

Proposal for a regulation

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

Or. fr

Amendment 477

Michalis Hadjipantela

Proposal for a regulation

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. This Regulation applies to the critical medicinal products listed in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… and treatments for rare diseases. [reference to be added after adoption cf. COM(2023) 193 final].

Or. en

Amendment 478

Ondřej Krutílek

Proposal for a regulation

Article 2 – paragraph 2

Text proposed by the Commission

Amendment

2. Chapter IV and Article 26(2) point (c) also apply to medicinal products of common interest. Chapter III does not apply to medicinal products of common interest.

deleted

Or. en

Amendment 479

Radan Kanev

Proposal for a regulation

Article 2 – paragraph 2

Text proposed by the Commission

Amendment

2. Chapter IV and Article 26(2) point (c) also apply to medicinal products of common interest. Chapter III does not apply to medicinal products of common interest.

2. Chapter IV and Article 26(2) point (c) and 16.3 also apply to medicinal products of common interest. Chapter III does not apply to medicinal products of common interest with the exception of art 16.3.

Or. en

Justification

Amending the scope is necessary to ensure EU funds can be used beyond strategic projects to account for differences in willingness and availability to pay among Member States.

Amendment 480

Laurent Castillo

Proposal for a regulation

Article 2 – paragraph 2

Text proposed by the Commission

Amendment

2. Chapter IV and Article 26(2) point (c) also apply to medicinal products of common interest. Chapter III does not apply to medicinal products of common interest.

2. Chapter IV and Article 26(2) point (c) also apply to medicinal products of common interest. Chapter III, sections 1 and 2, applies to medicinal products of common interest.

Or. fr

Amendment 481

Christine Anderson

Proposal for a regulation

Article 2 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The measures in this Regulation shall not apply where Member States demonstrate that domestic decentralised or competitive market-based procurement systems have delivered equivalent or better outcomes in terms of supply resilience and access.

Or. en

Amendment 482

Christine Anderson

Proposal for a regulation

Article 2 a (new)

Text proposed by the Commission

Amendment

Article 2a

Voluntary Application Principle

Member States may opt out of the application of this Regulation, in whole or in part, where national measures achieve the same objectives more effectively or proportionately. Such opt-outs shall be notified to the Commission and recorded publicly.

Or. en

Amendment 483

Oliver Schenk

Proposal for a regulation

Article 3 – paragraph 1 – point 2

Text proposed by the Commission

Amendment

(2) ‘key input’ means input material other than an active substance required in the manufacturing process of a given medicinal product, including primary packaging materials, excipients, solvents and reagents;

(2) ‘key input’ means input material other than an active substance required in the manufacturing process of a given medicinal product, including raw materials, intermediates, starting materials, primary packaging materials, including those with safety-related features, excipients, solvents, reagents;

Or. en

Amendment 484

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 3 – paragraph 1 – point 2

Text proposed by the Commission

Amendment

(2) ‘key input’ means input material other than an active substance required in the manufacturing process of a given medicinal product, including intermediates, raw materials, feedstock and starting materials, primary packaging materials, excipients, solvents and reagents;

Or. en

Amendment 485

Marta Temido, Pierre Jouvet

Proposal for a regulation

Article 3 – paragraph 1 – point 2

Text proposed by the Commission

Amendment

(2) ‘key input’ means input material other than an active substance or active pharmaceutical ingredient required in the manufacturing process of a given medicinal product, including intermediate substances, primary packaging materials, excipients, solvents and reagents;

Or. en

Amendment 486

Laurent Castillo

Proposal for a regulation

Article 3 – paragraph 1 – point 2

Text proposed by the Commission

Amendment

Or. fr

Amendment 487

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic, Margarita de la Pisa Carrión

Proposal for a regulation

Article 3 – paragraph 1 – point 3 a (new)

Text proposed by the Commission

Amendment

(3 a) The Commission shall ensure that the implementation of this Regulation is consistent with other relevant EU legislative measures, including the EU Generic Pharmaceutical Legislation, in particular with regard to resilience of supply chains, regulatory obligations of marketing authorisation holders, and market availability of critical medicinal products.

Or. en

Amendment 488

Marta Temido, Pierre Jouvet

Proposal for a regulation

Article 3 – paragraph 1 – point 4

Text proposed by the Commission

Amendment

(4) ‘critical medicinal product’ means a medicinal product for which insufficient supply results in serious harm or risk of serious harm to patients as defined in Article 4 point (13) of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final];

(4) ‘critical medicinal product’ means a medicinal product for which insufficient supply results in serious harm or risk of serious harm to patients as defined in Article 2 point (13) of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final];

Or. en

Amendment 489

Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 3 – paragraph 1 – point 4 a (new)

Text proposed by the Commission

Amendment

(4 a) ‘Novel antimicrobial’ designates an antimicrobial (such as a reserve antibiotic or an antifungal) that is made of, or contains, a new class or new mechanism of treatment and is active against certain antimicrobial resistant pathogens. Novel antimicrobials are a subset of medicinal products of common interest used to treat serious, life-threatening infections, often used as last-resort treatments, and for which uptake varies significantly across Member States due to the differing epidemiological landscape of antimicrobial resistant pathogens, clinical practices, and national stewardship guidelines and policies.

Or. en

Amendment 490

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Article 3 – paragraph 1 – point 4 a (new)

Text proposed by the Commission

Amendment

(4 a) ‘substance of human origin’ or ‘SoHO’ means any substance collected from the human body, as defined in Article 3 of Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC;

Or. en

Amendment 491

Kristoffer Storm

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

(5) ‘medicinal product of common interest’ means a medicinal product, other than a critical medicinal product, for which in three or more Member States the functioning of the market does not sufficiently ensure the availability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member States;

deleted

Or. en

Amendment 492

Radan Kanev

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

The dual focus on access and supply chain risks dilutes the emphasis on the original objective of the proposed Act and undermines the considerable work by the Critical Medicines Alliance in shaping the security of supply for critical medicines. Moreover, besides adding complexity and diverting attention from the original intent, the proposals made under this Act for medicines of common interests will not deliver any improvements in patient access whilst risking widening Europe’s competitiveness gap and further undermining the pharmaceutical sector’s viability in the region. We refer to the additional arguments made under the below relevant sections of the proposed Act that pertain to medicines of common interest

Amendment 493

Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

(5) ‘medicinal product of common interest’ means a medicinal product, including investigational medicinal products, subject to strict conditions of necessity, effectiveness and safety, and the commitment to apply for a marketing authorisation, other than a critical medicinal product, for which in three or more Member States the functioning of the market does not sufficiently ensure the availability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member States or which meets at least one of the following criteria: (a) it is designated as orphan medicinal product pursuant to Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products; (b) it is a novel antimicrobial medicinal product which: (i) contains an active substance with a new chemical structure or a new mechanism of action not previously authorised within the Union for the treatment or prevention of infections; (ii) is intended for the treatment or prevention of infections caused by pathogens which are resistant to existing antimicrobial agents; (iii) addresses an unmet medical need in accordance with Directive (EU) …/… of the European Parliament and of the Council [reference to be added after adoption cf. COM(2023) 192 final] ; or (iv) benefited from the Priority Medicinal Products (‘PRIME’) scheme.

Or. en

Amendment 494

Tilly Metz

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

(5) ‘medicinal product of common interest’ means a medicinal product, other than a critical medicinal product, for which in at least one Member State the functioning of the market does not sufficiently ensure the availability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member State(s); including situations in which the marketing authorisation holder has not launched, or has discontinued the placing on the market of, the product in one or more of those Member State(s) and can include, among other, medicines for rare diseases (orphan medicinal products), antimicrobials, vaccines, and novel or high-cost treatments for other therapeutic areas including oncology, chronic diseases, and advanced therapies, particularly where affordability and equitable access remain critical concerns.

Or. en

Amendment 495

Catarina Martins, Sebastian Everding

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

(5) ‘medicinal product of common interest’ means a medicinal product, other than a critical medicinal product, for which in two or more Member States the functioning of the market does not sufficiently ensure the availability, affordability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member States; the category of medicinal product of common interest shall include any of the approved medicines in Europe, other than critical medicinal products, including newly authorised medicines at EU-level, including the ones benefiting from Priority Medicinal Products scheme (PRIME), orphan medicinal products, novel antimicrobial medicinal products, and others whenever the therapeutic could substantially improve the life quality of the patient;

Or. en

Amendment 496

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

Or. en

Amendment 497

Letizia Moratti

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

(5) ‘medicinal product of common interest’ means a medicinal product, other than a critical medicinal product, for which, four years after marketing authorisation, no reimbursement decision has been reached under national pricing and reimbursement procedures, or the product is not available to meet patient needs in at least three Member States, based on objective and verifiable criteria;

Or. en

Amendment 498

Aurelijus Veryga

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

(5) ‘medicinal product of common interest’ means a medicinal product, other than a critical medicinal product, for which in three or more Member States the functioning of the market does not sufficiently ensure the availability and accessibility and affordability to patients in the quantities and presentations necessary to cover the needs of patients in those Member States;

Or. en

Amendment 499

Sirpa Pietikäinen

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

Or. en

Amendment 500

Marie-Luce Brasier-Clain, Aleksandar Nikolic, Ondřej Knotek, Tomáš Kubín, Ton Diepeveen

Proposal for a regulation

Article 3 – paragraph 1 – point 5 a (new)

Text proposed by the Commission

Amendment

(5a) ‘national strategic stockpile’ means the reserves, covering at least two months, of a quantity of critical medicinal products or medicinal products of common interest established under national law by a Member State for a public health use, such as national strategic reserves.

Or. fr

Amendment 501

Christophe Clergeau

Proposal for a regulation

Article 3 – paragraph 1 – point 5 a (new)

Text proposed by the Commission

Amendment

(5 a) ‘medical countermeasures’ means medical countermeasures within the meaning of Article 3, point (10), of Regulation (EU) 2022/2371, including personal protective equipment and substances of human origin, with the exception of medicinal products already listed in the Union list of critical medicinal products;

Or. en

Amendment 502

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Romana Jerković, Raffaele Topo

Proposal for a regulation

Article 3 – paragraph 1 – point 5 a (new)

Text proposed by the Commission

Amendment

(5 a) 'API starting material’ means a raw material, an intermediate, or an active pharmaceutical ingredient that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API.

Or. en

Amendment 503

Christophe Clergeau

Proposal for a regulation

Article 3 – paragraph 1 – point 5 b (new)

Text proposed by the Commission

Amendment

(5 b) ‘critical medical countermeasures’ means a medicinal product for which insufficient supply results in serious harm or risk of serious harm to patients or medical personnel as listed on the EU List of Medical Countermeasures for Priority Threats;

Or. en

Amendment 504

Christophe Clergeau

Proposal for a regulation

Article 3 – paragraph 1 – point 5 c (new)

Text proposed by the Commission

Amendment

(5 c) ‘medical countermeasure of common interest’ means a medical countermeasure, other than a critical medical countermeasure, for which in three or more Member States the functioning of the market does not sufficiently ensure the availability and accessibility to patients or medical workers in the quantities and presentations necessary to cover the needs of patients or medical workers in those Member States;

Or. en

Amendment 505

Sirpa Pietikäinen

Proposal for a regulation

Article 3 – paragraph 1 – point 6

Text proposed by the Commission

Amendment

(6) ‘vulnerability in the supply chains’ means risks and weaknesses within the supply chains of critical medicinal products, identified at the aggregated level, taking into account all authorised medicinal products in the EU and grouped under a common name with the same route of administration and formulation, that compromise the continuous supply of such medicinal products to patients in the Union;

Or. en

Amendment 506

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 3 – paragraph 1 – point 6

Text proposed by the Commission

Amendment

(6) ‘vulnerability in the supply chains’ means risks and weaknesses within the supply chains of critical medicinal products, identified at the aggregated level, including dependence on a limited number of manufacturers of active pharmaceutical ingredients (APIs) or finished products, lack of transparency on R&D costs and prices, and barriers to entry of generics or biosimilars due to excessive or unjustified patent protection;

Or. en

Amendment 507

Nicolás González Casares, Tiemo Wölken, Vytenis Povilas Andriukaitis, Marta Temido, Pierre Jouvet, Romana Jerković, Leire Pajín

Proposal for a regulation

Article 3 – paragraph 1 – point 6

Text proposed by the Commission

Amendment

(6) ‘vulnerability in the supply chains’ means risks and weaknesses within the supply chains of critical medicinal products, identified at the aggregated level, taking into account all authorised medicinal products in the EU and grouped under a common name with the same route of administration and formulation, and the specific features of the supply chains of each product, that compromise the continuous supply of such medicinal products to patients in the Union;

Or. en

Amendment 508

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 3 – paragraph 1 – point 6

Text proposed by the Commission

Amendment

(6) ‘vulnerability in the supply chains’ means risks and weaknesses within the supply chains of critical medicinal products or medicinal products of common interest, identified at the aggregated level, taking into account all authorised medicinal products in the EU and grouped under a common name with the same route of administration and formulation, that compromise the continuous supply of such medicinal products to patients in the Union;

Or. en

Amendment 509

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

Article 3 – paragraph 1 – point 6

Text proposed by the Commission

Amendment

(6) ‘vulnerability in the supply chains’ means structural and non-structural risks and weaknesses within the supply chains of critical medicinal products, identified at the aggregated level, taking into account all authorised medicinal products in the EU and grouped under a common name with the same route of administration and formulation, that compromise the continuous supply of such medicinal products to patients in the Union;

Or. en

Amendment 510

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

(7) ‘vulnerability evaluation’ means the evaluation of the supply chains of critical medicinal products and medicinal products of common interest through the application of a clear methodology using quality and quantity indicators capable of identifying the complex and multifactorial vulnerabilities of each medicine taking into account its specificity. The evaluation shall be performed on a regular basis by the MSSG in consultation with all the relevant stakeholders, including market holders, patient organisations and healthcare professionals, in accordance with Regulation (EU) …/… of the European Parliament and of the Council14 [reference to be added after adoption cf. COM(2023) 193 final] and should be used as a guide for prioritising target actions and direct investments to secure the supply of critical and vulnerable medicines in the EU;

_________________

14 Regulation (EU) …. of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (OJ …) [D.G.: Title according to COM(2023) 193 final. Please check against latest version of this draft Regulation].

Or. en

Amendment 511

Laurent Castillo

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

(7) ‘vulnerability evaluation’ means the evaluation of the supply chains of critical medicinal products to identify their vulnerabilities, taking into consideration in particular the volume of shortages reported over the past two years, the complexity of the product and the reason for the vulnerabilities, the place of manufacture, production and origin of key inputs and active substances at each stage in the supply chain in connection with the marketing authorisation holders. It is performed by the MSSG in accordance with Regulation (EU) …/… of the European Parliament and of the Council14 [reference to be added after adoption cf. COM(2023) 193 final]. It may concern essential active substances and key inputs;

_________________

Or. fr

Amendment 512

Kristoffer Storm

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

(7) ‘vulnerability evaluation’ means the evaluation of the supply chains of critical medicinal products to identify their vulnerabilities taking in consideration shortages in the past 2 years, the products’ complexities, specific characteristics and respecting EU international commitments performed by the MSSG in consultation with the respective marketing authorisation holders and in accordance with Regulation (EU) …/… of the European Parliament and of the Council14 [reference to be added after adoption cf. COM(2023) 193 final];

_________________

Or. en

Amendment 513

Radan Kanev

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

(7) ‘vulnerability evaluation’ means the evaluation of the supply chains of critical medicinal products to identify their vulnerabilities taking in consideration the products’ complexities and specific characteristics as performed by the MSSG in consultation with the respective marketing authorisation holders and in accordance with Regulation (EU) …/… of the European Parliament and of the Council14 [reference to be added after adoption cf. COM(2023) 193 final];

_________________

Or. en

Amendment 514

Christophe Clergeau

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

(7) ‘vulnerability evaluation’ means the evaluation of the supply chains of critical medicinal products to identify their vulnerabilities performed by the MSSG in accordance with Regulation (EU) …/… of the European Parliament and of the Council14 [reference to be added after adoption cf. COM(2023) 193 final], or the evaluation of the supply chains of critical medical countermeasures to identify their vulnerabilities performed by the Critical Medicines and Medical Countermeasures Group in accordance with this Regulation;

_________________

Or. en

Amendment 515

András Tivadar Kulja

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

(7) ‘vulnerability evaluation’ means the evaluation of the supply chains of critical medicinal products to identify their vulnerabilities performed by the MSSG in accordance with Regulation (EU) …/… of the European Parliament and of the Council14 [reference to be added after adoption cf. COM(2023) 193 final], following the criteria developed within the Critical Medicines Alliance. Healthcare professionals should be involved in the vulnerability evaluation.

_________________

Or. en

Amendment 516

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

Article 3 – paragraph 1 – point 7

Text proposed by the Commission

Amendment

(7) ‘vulnerability evaluation’ means the methodological evaluation of the supply chains of critical medicinal products to identify their vulnerabilities performed by the Executive Steering Group on Shortages and Safety of Medicinal Products ("the MSSG") in accordance with Regulation (EU) …/… of the European Parliament and of the Council14 [reference to be added after adoption cf. COM(2023) 193 final] and Commission Decision (C(2021) 6712);

_________________

Or. en

Amendment 517

Radan Kanev

Proposal for a regulation

Article 3 – paragraph 1 – point 7 a (new)

Text proposed by the Commission

Amendment

(7 a) ‘contingency stock’ means an obligation imposed on supply chain actors to establish buffer stocks of certain medicines to mitigate the risk of supply disruption.

Or. en

Amendment 518

Radan Kanev

Proposal for a regulation

Article 3 – paragraph 1 – point 7 b (new)

Text proposed by the Commission

Amendment

(7 b) ‘stockpiling’ by a public health institution in order to anticipate and manage a specific crisis.

Or. en

Amendment 519

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

Article 3 – paragraph 1 – point 10

Text proposed by the Commission

Amendment

(10) ‘strategic project’ means an industrial project identified pursuant to the criteria set out in Article 5;

(10) ‘strategic project’ means an industrial project that has a positive impact on the supply chain and downstream sectors identified pursuant to the criteria set out in Article 5;

Or. en

Amendment 520

Margarita de la Pisa Carrión

Proposal for a regulation

Article 3 – paragraph 1 – point 10

Text proposed by the Commission

Amendment

(10) ‘strategic project’ means an industrial project identified pursuant to the criteria set out in Article 5;

(10) ‘strategic project’ means an industrial or infrastructure project identified pursuant to the criteria set out in Article 5;

Or. en

Amendment 521

Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 3 – paragraph 1 – point 10

Text proposed by the Commission

Amendment

(10) ‘strategic project’ means an industrial project identified pursuant to the criteria set out in Article 5;

(10) ‘strategic project’ means an industrial or infrastructure project identified pursuant to the criteria set out in Article 5;

Or. en

Amendment 522

Aurelijus Veryga

Proposal for a regulation

Article 3 – paragraph 1 – point 10

Text proposed by the Commission

Amendment

(10) ‘strategic project’ means an industrial project identified pursuant to the criteria set out in Article 5;

(10) ‘strategic project’ means an industrial project or technology identified pursuant to the criteria set out in Article 5;

Or. en

Amendment 523

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 3 – paragraph 1 – point 10

Text proposed by the Commission

Amendment

(10) ‘strategic project’ means an industrial project identified pursuant to the criteria set out in Article 5;

(10) ‘strategic project’ means a project identified pursuant to the criteria set out in Article 5;

Or. en

Amendment 524

Laurent Castillo

Proposal for a regulation

Article 3 – paragraph 1 – point 10 a (new)

Text proposed by the Commission

Amendment

(10a) ‘cross-border strategic project’ means an industrial project considered strategic in accordance with the criteria set out in Article 5 and taking place in at least two Member States;

Or. fr

Amendment 525

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 3 – paragraph 1 – point 10 a (new)

Text proposed by the Commission

Amendment

(10 a) ‘cross-border strategic project’ means an industrial project identified pursuant to the criteria set out in Article 5, which may be carried out by a minimum of two Member States;

Or. en

Amendment 526

Laurent Castillo

Proposal for a regulation

Article 3 – paragraph 1 – point 11

Text proposed by the Commission

Amendment

(11) ‘project promoter’ means any undertaking or consortium of undertakings developing a strategic project;

(11) ‘project promoter’ means any public institution, undertaking or consortium of undertakings developing a strategic project;

Or. fr

Amendment 527

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Romana Jerković, Raffaele Topo

Proposal for a regulation

Article 3 – paragraph 1 – point 11 a (new)

Text proposed by the Commission

Amendment

(11 a) ‘economic operator‘ means any natural or legal person or public entity or group of such persons and/or entities, including any temporary association of undertakings, which offers the execution of works and/or a work, the supply of products or the provision of services on the market as defined in Directive 2014/24/EU;

Or. en

Amendment 528

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Article 3 – paragraph 1 – point 13

Text proposed by the Commission

Amendment

(13) ‘innovative manufacturing process’ means a novel manufacturing process and technology or novel application of an existing technology, including, but not limited to, decentralised manufacturing, continuous manufacturing, automation, yield improvements or other chemistry or biotechnology processes that increase security of supply, energy efficiency and environmental performance, Artificial Intelligence, platform techniques, 3D manufacturing, environmentally superior manufacturing methods;

Or. en

Amendment 529

Dan-Ştefan Motreanu

Proposal for a regulation

Article 3 – paragraph 1 – point 13

Text proposed by the Commission

Amendment

(13) ‘innovative manufacturing process’ means a novel manufacturing process and technology or novel application of an existing technology, including, but not limited to, decentralised manufacturing, continuous manufacturing, automation, yield improvements or other chemistry or biotechnology process that contribute to increase level of security, energy and environmental performance of the production, Artificial Intelligence, platform techniques, 3D manufacturing;

Or. en

Amendment 530

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Article 3 – paragraph 1 – point 13 a (new)

Text proposed by the Commission

Amendment

(13 a) ‘contingency stock requirement’ means an obligation imposed by a Member State on marketing authorisation holders and/or other economic operators of the supply chain to establish buffer stocks of certain medicinal products to mitigate the risk of supply disruption and which obligation is imposed by law;

Or. en

Amendment 531

Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 3 – paragraph 1 – point 17 a (new)

Text proposed by the Commission

Amendment

(17 a) ‘systemic wholesaler’ means wholesalers of medicinal products that hold a wholesale distribution authorisation and fulfil all obligations laid down in Article 166 of Directive (EU) …/… [reference to be added to corresponding Article after adoption of cf. COM(2023)192 final] and wholesale and continuously distribute either; the full range of prescription medicines, meaning more than 80%; or above 20% of the total market share of prescription medicines, available for sale in the pharmacy market in a Member State;

Or. en

Justification

Defining “systemic wholesalers” ensures legal clarity on entities essential for secure distribution and stockpiling of critical medicines. By explicitly linking this definition to both the possession of a wholesale distribution authorization and a quantifiable market presence, the proposed regulation ensures that only those wholesalers with substantial operational capacity and systemic importance are designated as critical elements of the distribution infrastructure. This complement national obligations under the Critical Entities Regulation

Amendment 532

Michalis Hadjipantela

Proposal for a regulation

Article 3 – paragraph 1 – point 18

Text proposed by the Commission

Amendment

(18) ‘strategic partnership’ means a commitment between the Union and a third country, group of third countries or international organisations to increase cooperation related to one or more critical medicinal products that is established through a non-binding instrument and which facilitates beneficial outcomes for both the Union and the relevant third country, group of third countries or international organisation.

Or. en

Amendment 533

Ondřej Krutílek

Proposal for a regulation

Article 3 – paragraph 1 – point 18 a (new)

Text proposed by the Commission

Amendment

(18 a) contingency stock’ means the contingency stock of mandated supplier of critical medicinal products and medicinal products of common interest when there is a requirement imposed by an authority (such as a government or regulatory body), but the responsibility for maintaining and owning the stock remains with the supplier, and the contingency stock of critical medicinal products and medicinal products of common interest done, managed and controlled by the Member States related to supply chain disruptions and the prevention of shortages of medicinal products (strategic reserves of Member States or EU intended for use during emergencies, such as health threats, natural disasters, economic crises are excluded);

Or. en

Amendment 534

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 3 – paragraph 1 – point 18 a (new)

Text proposed by the Commission

Amendment

(18 a) ‘Most Economically Advantageous Tender (MEAT) criteria’ means the implementation of award criteria following the best price-quality ratio in accordance with the concept outlined by the Directive 2014/24/EC. This concept shall encompass a balanced assessment taking into account but not limited to: price; quality; safety; effectiveness; delivery times; contingency stock capacity; continuity and security of supply; transparency; compliance with the highest corporate, social and environmental standards in the supply chain and production process.

Or. en

Amendment 535

Margarita de la Pisa Carrión

Proposal for a regulation

Article 3 – paragraph 1 – point 18 a (new)

Text proposed by the Commission

Amendment

(18 a) ‘systemic wholesaler’ means wholesalers of medicinal products that hold a wholesale distribution authorisation and fulfil all obligations laid out in Article 166 of Directive (EU) …/… [reference to be added to corresponding Article after adoption of cf. COM(2023)192 final] and wholesale and continuously distribute either; the full range of prescription medicines, meaning more than 80%; or above 20% of the total market share of prescription medicines, available for sale in the pharmacy market in a Member State;

Or. en

Amendment 536

András Tivadar Kulja

Proposal for a regulation

Article 3 – paragraph 1 – point 18 a (new)

Text proposed by the Commission

Amendment

(18 a) 'substance of human origin’ or ‘SoHO’ means any substance collected from the human body, as defined in Article 3 of REGULATION (EU) 2024/1938 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC

Or. en

Amendment 537

Laurence Trochu

Proposal for a regulation

Article 3 – paragraph 1 – point 18 a (new)

Text proposed by the Commission

Amendment

(18 a) ‘significant proportion of manufacture of critical medicinal product in the Union’ means the medicinal product manufactured in the Union where at least 75 % of the final product is manufactured from materials from the Union.

Or. en

Amendment 538

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 3 – paragraph 1 – point 18 a (new)

Text proposed by the Commission

Amendment

(18 a) “economic accessibility”: the availability of medicines at sustainable prices for patients and public health systems, taking into account the real cost of research, development and production.

Or. en

Amendment 539

Ton Diepeveen, Aleksandar Nikolic, Tomáš Kubín, Valérie Deloge

Proposal for a regulation

Article 3 – paragraph 1 – point 18 a (new)

Text proposed by the Commission

Amendment

(18 a) “designated authority”: a national body established by national law that specialises in all policy areas referred to in Article 6.

Or. en

Justification

Certain quality requirements must be imposed on the designated authorities.

Amendment 540

Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 3 – paragraph 1 – point 18 a (new)

Text proposed by the Commission

Amendment

(18 a) ‘critical distribution infrastructure’ means warehouses and distribution capacity operated by systemic wholesalers of medicinal products;

Or. en

Justification

Including a definition of critical distribution infrastructure ensures legal clarity in identifying assets essential for secure storage and timely distribution of critical medicines. In crises or hybrid-warfare, entities equipped for such events are vital. Recognizing warehouses and distribution capacity of systemic wholesalers reflects their key role in supply chain resilience and aligns with national stockpiling practices.

Amendment 541

András Tivadar Kulja

Proposal for a regulation

Article 3 – paragraph 1 – point 18 b (new)

Text proposed by the Commission

Amendment

(18 b) 'Most Economically Advantageous Tender (MEAT) criteria’ means the implementation of award criteria following the best price-quality ratio in accordance with the concept outlined by Directive 2014/24/EC. This concept shall encompass a balanced assessment taking into account, but not limited to: price; quality; patient safety; effectiveness; delivery times; contingency stock capacity; continuity and security of supply; transparency; multi-winner approach; social and environmental standards in the manufacturing process

Or. en

Amendment 542

Ondřej Krutílek

Proposal for a regulation

Article 3 a (new)

Text proposed by the Commission

Amendment

Article 3a

Vulnerability evaluation

When Member State informs the Critical Medicines Group of the intention to provide financial support to a strategic project according to the Article 17 paragraph 1, the MSSG shall update the vulnerability evaluation based on the expected creation or increase of manufacturing capacity, including the quantity of manufactured critical medicinal product, and the expected date of creation or increase of manufacturing capacity of the strategic project financially supported by the Member State.

When the Commission informs the Critical Medicines Group of the strategic projects that benefited from financial support from the Union according to the Article 17 paragraph 2, the MSSG shall update the vulnerability evaluation based on the expected creation or increase of manufacturing capacity, including the quantity of manufactured critical medicinal product, and the expected date of creation or increase of manufacturing capacity of the strategic project financially supported by the Union.

The Agency shall publish the vulnerability evaluation and its updates on their website.

Or. en

Amendment 543

Ondřej Krutílek

Proposal for a regulation

Article 3 a (new)

Text proposed by the Commission

Amendment

Article 3a

Determining medicinal products of common interest

When a Member State decides that the functioning of the market does not sufficiently ensure the availability and accessibility of a medicinal products to patients in the quantities and presentations necessary to cover the needs of patients they shall inform the Commission.

When the Commission is informed according to paragraph 1 by three or more Member States in case of a certain medicinal product they shall communicate such information to the Member States. The Commission shall publish and update a list of medicinal products of common interest on its website.

Or. en

Amendment 544

Kristian Vigenin

Proposal for a regulation

Article 4

Text proposed by the Commission

Amendment

Article 4

deleted

Strategic objective of the Union

1. The security of supply and availability of critical medicinal products for patients is a strategic objective of the Union.

3. The Commission shall support the coordinated efforts of the Members States.

Or. en

Justification

This is too aspirational for the operative part, this is recital language, so we moved it to recital 1a.

Amendment 545

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 4 – paragraph 1

Text proposed by the Commission

Amendment

1. The security of supply and availability of critical medicinal products for patients is a strategic objective of the Union.

1. The security and resilience of supply, affordability, equitable access and availability of critical medicinal products and medicinal products of common interest for patients is a strategic objective of the Union.

Or. en

Amendment 546

Peter Agius

Proposal for a regulation

Article 4 – paragraph 1

Text proposed by the Commission

Amendment

1. The security of supply and availability of critical medicinal products for patients is a strategic objective of the Union.

1. Access, availability, affordability and the security of supply of critical medicinal products and of medicinal products of common interest for patients is a strategic objective of the Union.

Or. en

Justification

It is important that these principles are included in the text, which is legally binding.

Amendment 547

Christophe Clergeau

Proposal for a regulation

Article 4 – paragraph 1

Text proposed by the Commission

Amendment

1. The security of supply and availability of critical medicinal products for patients is a strategic objective of the Union.

1. The security of supply and availability of critical medicinal products for patients and critical medical countermeasures is a strategic objective of the Union.

Or. en

Amendment 548

Aleksandar Nikolic, Ondřej Knotek, Marie-Luce Brasier-Clain, Mathilde Androuët

Proposal for a regulation

Article 4 – paragraph 1

Text proposed by the Commission

Amendment

1. The security of supply and availability of critical medicinal products for patients is a strategic objective of the Union.

1. The security of supply and availability of critical medicinal products for patients are a vital strategic objective of the Union and its Member States.

Or. fr

Amendment 549

Ton Diepeveen, Ondřej Knotek, Aleksandar Nikolic, Tomáš Kubín, Gerald Hauser, Valérie Deloge

Proposal for a regulation

Article 4 – paragraph 1

Text proposed by the Commission

Amendment

1. The security of supply and availability of critical medicinal products for patients is a strategic objective of the Union.

1. The security of supply, safety and availability of critical medicinal products for patients is a strategic objective of the Union.

Or. en

Amendment 550

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 4 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The Union pursues the objective of ensuring that medicinal products are equally available in all Member States, in order to ensure equal and universal access for patients.

Or. en

Amendment 551

Aurelijus Veryga

Proposal for a regulation

Article 4 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The Union shall pursue the objective of ensuring that medicinal products are available in all Member States to ensure equitable access of patients.

Or. en

Amendment 552

Oliver Schenk

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. The Member States and the Commission shall work together to strengthen the security of supply and continuous availability of critical medicinal products in the Union through measures that take full advantage of the potential of the internal market. In doing so, they shall take into account the roles of relevant stakeholders, including the pharmaceutical industry, in particular manufacturers and marketing authorisation holders, as well as patient organisations and health insurance bodies, and shall involve them, where appropriate.

Or. en

Amendment 553

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. The Member States and the Commission shall work together to strengthen the security of supply and continuous availability of critical medicinal products, giving priority to those that could become critical if affected by supply chain vulnerabilities, in the Union through measures that take full advantage of the potential of the internal market and to reduce dependencies on third countries, while ensuring predictability for project promoter.

Or. en

Amendment 554

Galato Alexandraki, Emmanouil Fragkos

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. The Member States and the Commission shall work together to strengthen the security of supply, prioritising the production of critical medicinal products and active substances within the Union and respecting the competence of Member States to take national measures to protect public health.

Or. el

Amendment 555

Tilly Metz

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. The Member States and the Commission shall work together, in cooperation with civil society, particularly patient and healthcare professionals organisations, to strengthen the security of supply and continuous availability of critical medicinal products in the Union through measures that take full advantage of the potential of the internal market.

Or. en

Amendment 556

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 557

Aurelijus Veryga

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 558

Laurent Castillo

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

Or. fr

Amendment 559

Nikos Papandreou, Romana Jerković

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. The Member States and the Commission shall work together with patient organisations and other relevant stakeholders to strengthen the security of supply and continuous availability of critical medicinal products in the Union through measures that take full advantage of the potential of the internal market.

Or. en

Amendment 560

Sirpa Pietikäinen

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 561

Christophe Clergeau

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. The Member States and the Commission shall work together to strengthen the security of supply and continuous availability of critical medicinal products and critical medical countermeasures in the Union through measures that take full advantage of the potential of the internal market.

Or. en

Amendment 562

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. The Member States and the Commission shall work together to strengthen the security and resilience of supply, affordability, equitable access and continuous availability of critical medicinal products and medicinal products of common interest in the Union.

Or. en

Amendment 563

Laurent Castillo

Proposal for a regulation

Article 4 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. The Commission shall facilitate and support research and development projects in any innovation that can substitute for critical medicinal products.

Or. fr

Amendment 564

Tiemo Wölken, Nikos Papandreou, Günther Sidl, Vytenis Povilas Andriukaitis, Estelle Ceulemans, Pierre Jouvet, Marta Temido, Romana Jerković, Raffaele Topo

Proposal for a regulation

Article 4 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall support the coordinated efforts of the Members States.

3. The Commission shall support the coordinated efforts of the Members States and foster a secure cross-border exchange of relevant information and facilitate the distribution of critical medicinal products throughout the Union.

Or. en

Amendment 565

Tilly Metz

Proposal for a regulation

Article 4 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall support the coordinated efforts of the Members States.

3. The Commission shall support the coordinated efforts of the Member States.

Or. en

Amendment 566

Catarina Martins, Sebastian Everding

Proposal for a regulation

Article 4 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. A dysfunction of the market shall be declared when the medicinal product is not available under a general reimbursement scheme in a Member State, 12 months after the marketing authorization holder has been granted.

The European Commission shall adopt guidelines establishing further criteria to demonstrate that the functioning of the market does not sufficiently ensure the availability, affordability and equitable access of medicinal products of common interest to patients in the quantities and presentations necessary to cover the needs of patients in those Member States. Those criteria may include the following:

(a) the absence of clinical trials conducted in the relevant Member State;

(b) the unavailability of the medicinal product under compassionate use programmes;

The guidelines shall include a mechanism allowing representatives of patients and healthcare professionals to report a dysfunction of the market for a medicinal product of common interest for the purposes of requesting Member States or the Commission to use the collaborative procurements included in Chapter IV, Section II of this Regulation.

Or. en

Amendment 567

Laurent Castillo

Proposal for a regulation

Article 4 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. The Commission shall ensure that the potential impact on the security of supply and the availability of critical medicinal products is assessed and taken into account in the drafting of any legislative proposal, delegated act or implementing act, including under horizontal Union legislation, that may have an impact on that supply and availability.

Or. fr

Amendment 568

Aurelijus Veryga

Proposal for a regulation

Article 4 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Commission shall ensure that the potential impact on the security of supply and the availability of critical medicinal products is assessed and taken into account in the drafting of legislative proposals, delegated acts and implementing acts, including under horizontal Union legislation, where such measures may affect that supply and availability.

Or. en

Amendment 569

Dan-Ştefan Motreanu

Proposal for a regulation

Article 4 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Commission shall ensure that the potential impact on the security of supply and availability of critical medicinal products is assessed and taken into account when preparing any legislative proposals, delegated acts, or implementing acts, including under horizontal Union legislation, that may affect such supply and availability.

Or. en