Sittings · Document

Draft report (COM(2023)0192 – C9-0143/2023 – 2023/0132(COD)) 2023-11-21

Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC

Committee on the Environment, Public Health and Food Safety

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Amendment 143

Rosanna Conte, Annalisa Tardino

Proposal for a directive

Recital 2

Text proposed by the Commission

Amendment

(2) The most recent comprehensive revision took place between 2001 and 2004 while targeted revisions on post-authorisation monitoring (pharmacovigilance) and on falsified medicines were adopted subsequently. In the almost 20 years since the last comprehensive revision, the pharmaceutical sector has changed and has become more globalised, both in terms of development and manufacture. Moreover, science and technology have evolved at a rapid pace. However, there continues to be unmet medical needs, i.e. diseases without or only with suboptimal treatments. Moreover, some patients may not benefit from innovation because medicines may be unaffordable or not placed on the market in the Member State concerned. There is also a greater awareness of the environmental impact of medicines. More recently, the COVID-19 pandemic has stress tested the framework.

(2) The most recent comprehensive revision took place between 2001 and 2004 while targeted revisions on post-authorisation monitoring (pharmacovigilance) and on falsified medicines were adopted subsequently. In the almost 20 years since the last comprehensive revision, the pharmaceutical sector has changed and has become more globalised, both in terms of development and manufacture. Moreover, science and technology have evolved at a rapid pace. However, there continues to be unmet medical needs, i.e. diseases without or only with suboptimal or highly burdensome treatments, or with treatments targeting only sub-populations of a disease. Moreover, some patients may not benefit from innovation because medicines may be unaffordable or not placed on the market in the Member State concerned. There is also a greater awareness of the environmental impact of medicines. More recently, the COVID-19 pandemic has stress tested the framework.

Or. it

Amendment 144

Billy Kelleher, Catherine Amalric, Ondřej Knotek

Proposal for a directive

Recital 2

Text proposed by the Commission

Amendment

(2) The most recent comprehensive revision took place between 2001 and 2004 while targeted revisions on post-authorisation monitoring (pharmacovigilance) and on falsified medicines were adopted subsequently. In the almost 20 years since the last comprehensive revision, the pharmaceutical sector has changed and has become more globalised, both in terms of development and manufacture. Moreover, science and technology have evolved at a rapid pace. However, there continues to be unmet medical needs, i.e. diseases without or only with suboptimal, inappropriate or highly burdensome treatments or treatments addressing subpopulations of a disease only. Moreover, some patients may not benefit from innovation because medicines may be unaffordable or not placed on the market in the Member State concerned. There is also a greater awareness of the environmental impact of medicines. More recently, the COVID-19 pandemic has stress tested the framework.

Or. en

Amendment 145

Margrete Auken

Proposal for a directive

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2 a) This Directive should contribute to the implementation of the One Health Approach, stressing the well-established interconnectedness between human, animal, and ecosystem health and the need to include those three dimensions when addressing public health threats. The loss of biodiversity, changes in land use, deforestation, urbanisation, agricultural expansion and intensification, poor air quality, wildlife trafficking and consumption patterns and transmissions of diseases between humans and animals are all factors that have contributed to the increasing disease burden. In addition, pollution from active pharmaceutical ingredients negatively affects the quality of waters and ecosystems, posing risks to public health globally.

Or. en

Amendment 146

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 3

Text proposed by the Commission

Amendment

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines for patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to ensure access to innovative and established medicines for patients and improve affordability of these medicines, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; and create a balanced and competitive system that keeps medicines affordable for health systems and patients while particularly rewarding targeted innovation that improves access to medicinal products in all Member States, where they address unmet medical needs and where preclincial studies and development has taken place in the Union, reinforcing our industrial ecosystems.

Or. en

Amendment 147

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Recital 3

Text proposed by the Commission

Amendment

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, and establishes a conducive environment for the research, development, and manufacturing of pharmaceuticals within the Union while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines for patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.

Or. en

Amendment 148

Rosanna Conte, Annalisa Tardino

Proposal for a directive

Recital 3

Text proposed by the Commission

Amendment

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines under equal conditions for all patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.

Or. it

Amendment 149

Marian-Jean Marinescu

Proposal for a directive

Recital 3

Text proposed by the Commission

Amendment

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure equal access to innovative and established medicines for all patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.

Or. en

Amendment 150

Billy Kelleher, Catherine Amalric, Ondřej Knotek

Proposal for a directive

Recital 3

Text proposed by the Commission

Amendment

(3) This revision is part of the implementation of the Pharmaceutical strategy for Europe and aims to promote innovation, in particular for unmet medical needs, while reducing regulatory burden and the environmental impact of medicines; ensure access to innovative and established medicines for all patients, with special attention to enhancing security of supply and addressing risks of shortages, taking into account the challenges of the smaller markets of the Union; and create a balanced and competitive system that keeps medicines affordable for health systems while rewarding innovation.

Or. en

Amendment 151

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez

Proposal for a directive

Recital 3 a (new)

Text proposed by the Commission

Amendment

(3 a) In parallel of this revision, the Union should build a new European pharmaceutical ecosystem to accelerate research and development of a new medicinal product and support innovation through the establishment of public-private partnerships, the multiplication of University Hospital Institutes, centres of excellence and bioclusters.

Or. en

Amendment 152

Maria Angela Danzì

Proposal for a directive

Recital 3 a (new)

Text proposed by the Commission

Amendment

(3 a) In the interest of public health and for the wellfunctioning EU regulatory framework, the innovative medicinal product should be understood as one that meets a previously unmet or inadequately met, substantive health need and offers enhanced effectiveness or other incremental benefit relative to existing therapeutic alternatives.

Or. en

Justification

There is a clear need to better define what constitutes “innovation” for the benefit of patients and health systems. This definition is also needed for the optimisation of the incentive system and for the improved access to affordable medicinal products.

Amendment 153

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Ondřej Knotek

Proposal for a directive

Recital 3 b (new)

Text proposed by the Commission

Amendment

(3 b) With the financial support from the Horizon Europe programme, the Union should participate to the establishment of a sustainable network of centres of excellence complementing each other to enable transnational research in ATMPs or other related innovative therapeutic modalities relevant to the future treatment of any diseases. These scientific and technical centres are expected to provide access and advance translatable, quality-controled technologies, share data, and build capacity to assist industrial and academic developers of ATMPs. They are also expected to explore the establishment of connections with clinical networks.

Or. en

Amendment 154

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 4

Text proposed by the Commission

Amendment

(4) This revision focuses on provisions relevant to achieve its specific objectives; therefore it covers all but provisions concerning falsified medicines, homeopathic and traditional herbal medicines. Nevertheless, for the sake of clarity, it is necessary to replace Directive 2001/83/EC of the European Parliament and of the Council38 with a new Directive. The provisions on falsified medicines, homeopathic medicines and traditional herbal medicines are therefore maintained in this Directive without changing their substance compared to previous harmonisations. However, in view of the changes in the governance of the Agency, the Herbal Committee is replaced by a working group.

(4) This revision focuses on provisions relevant to achieve its specific objectives; therefore it covers all but provisions concerning falsified medicines and traditional herbal medicines. Nevertheless, for the sake of clarity, it is necessary to replace Directive 2001/83/EC of the European Parliament and of the Council[1] with a new Directive. The provisions on falsified medicines and traditional herbal medicines are therefore maintained in this Directive without changing their substance compared to previous harmonisations. However, in view of the changes in the governance of the Agency, the Herbal Committee is replaced by a working group.

_________________

38 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

Or. en

Amendment 155

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Recital 4 a (new)

Text proposed by the Commission

Amendment

(4 a) This revision should align with the EU's ambitions in industry, digitalization, and trade, acknowledging the critical role of the European life sciences sector, especially the pharmaceutical industry, in upholding the EU's competitive edge. Bolstering robust European research and development is crucial for European sovereignty within the ambit of a globally competitive geopolitical landscape. The pharmaceutical legislative framework should be attuned to the broader EU industrial strategy, echoing the Council's emphasis from 23 March 2023 on amplifying incentives for investment in innovation and the 2016 Council's guidance that any amendments, including those affecting the incentive system, should not hinder the creation of drugs for rare disease treatment. Advancements in innovation are pivotal for enhancing patient health outcomes and the wider public health sector.

Or. en

Amendment 156

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Recital 4 b (new)

Text proposed by the Commission

Amendment

(4 b) This Directive should acknowledge that fostering a competitive pharmaceutical industry within the EU, bolstering EU-based clinical trials, and localizing the manufacture of active pharmaceutical ingredients are complementary objectives that enhance the Union's strategic health autonomy while increasing the affordability, accessibility, and availability of medicinal products, thereby supporting a more resilient and sustainable European health ecosystem.

Or. en

Amendment 157

Marian-Jean Marinescu

Proposal for a directive

Recital 6

Text proposed by the Commission

Amendment

(6) The regulatory framework for medicinal products use should also take into account the needs of the undertakings in the pharmaceutical sector and trade in medicinal products within the Union, without jeopardising the quality, safety and efficacy of medicinal products.

Or. en

Amendment 158

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 6

Text proposed by the Commission

Amendment

(6) The regulatory framework for medicinal products for human use should also take into account the needs of the undertakings in the pharmaceutical sector and trade in medicinal products within the Union, without jeopardising the quality, safety and efficacy of medicinal products.

Or. en

Amendment 159

Sirpa Pietikäinen

Proposal for a directive

Recital 8

Text proposed by the Commission

Amendment

(8) This revision maintains the level of harmonisation that has been achieved. Where necessary and appropriate, it further reduces the remaining disparities, by laying down rules on the supervision and control of medicinal products and the rights and duties incumbent upon the competent authorities of the Member States with a view to ensuring compliance with legal requirements. In the light of experience gained on the application of the Union pharmaceutical legislation and the evaluation of its functioning, the regulatory framework need to be adapted to scientific and technological progress, the current market conditions and economic reality within the Union. Scientific and technological developments induce innovation and development of medicinal products, including for therapeutic areas where there is still unmet medical need. To harness these developments, the Union pharmaceutical framework should be adapted to meet scientific developments such as genomics, accommodate cutting edge medicinal products, e.g. personalised medicinal products and technological transformation such as data analytics, digital tools and the use of artificial intelligence. These adaptations also contribute to competitiveness of the Union pharmaceutical industry.

(8) This revision maintains the level of harmonisation that has been achieved. Where necessary and appropriate, it further reduces the remaining disparities, by laying down rules on the supervision and control of medicinal products and the rights and duties incumbent upon the competent authorities of the Member States with a view to ensuring compliance with legal requirements. In the light of experience gained on the application of the Union pharmaceutical legislation and the evaluation of its functioning, the regulatory framework need to be adapted to scientific and technological progress, the current market conditions and economic reality within the Union. Scientific and technological developments induce innovation and development of medicinal products, including for therapeutic areas where there is still unmet medical need and of medicinal products with less harmful impacts on environment. To harness these developments, the Union pharmaceutical framework should be adapted to meet scientific developments such as genomics, accommodate cutting edge medicinal products, e.g. personalised medicinal products and technological transformation such as data analytics, digital tools and the use of artificial intelligence. These adaptations also contribute to competitiveness of the Union pharmaceutical industry.

Or. en

Amendment 160

Cyrus Engerer

Proposal for a directive

Recital 8

Text proposed by the Commission

Amendment

(8) This revision maintains the level of harmonisation that has been achieved. Where necessary and appropriate, it further reduces the remaining disparities, by laying down rules on the supervision and control of medicinal products and the rights and duties incumbent upon the competent authorities of the Member States with a view to ensuring compliance with legal requirements. In the light of experience gained on the application of the Union pharmaceutical legislation and the evaluation of its functioning, the regulatory framework need to be adapted to scientific and technological progress, the current market conditions and economic reality within the Union. Scientific and technological developments induce innovation and development of medicinal products, including for therapeutic areas where there is still unmet medical need. To harness these developments, the Union pharmaceutical framework should be adapted to meet scientific developments such as genomics, accommodate cutting edge medicinal products, e.g. personalised medicinal products, novel health treatments and technological transformation such as data analytics, digital tools and the use of artificial intelligence. These adaptations also contribute to competitiveness of the Union pharmaceutical industry.

Or. en

Amendment 161

Sunčana Glavak, Tomislav Sokol

Proposal for a directive

Recital 9

Text proposed by the Commission

Amendment

(9) Medicinal products for rare diseases and for children, should be subject to the same conditions as any other medicinal product concerning their quality, safety and efficacy, for example for what concerns the marketing authorisation procedures, quality and the pharmacovigilance requirements. However, specific requirements also apply to them considering their unique characteristics. Such requirements, which are currently defined in separate legislations, should be integrated in general pharmaceutical legal framework in order to ensure clarity and coherency of all the measures applicable to these medicinal products. Furthermore, as some medicinal products authorised for use in children are authorised by the Member States, specific provisions should be integrated in this Directive.

(9) Medicinal products for rare diseases and for children, should be subject to the same conditions as any other medicinal product concerning their quality, safety and efficacy, for example for what concerns the marketing authorisation procedures, quality and the pharmacovigilance requirements. However, specific requirements also apply to them considering their unique characteristics, and encountered problems such as failure to timely accomplish the paediatric clinical studies and obtain data required for marketing authorization, which results in significant delay of approval in children compared to adults. Such requirements, which are currently defined in separate legislations, should be integrated in general pharmaceutical legal framework in order to ensure clarity and coherency of all the measures applicable to these medicinal products. Furthermore, as some medicinal products authorised for use in children are authorised by the Member States, specific provisions should be integrated in this Directive.

Or. en

Amendment 162

Margrete Auken

Proposal for a directive

Recital 9

Text proposed by the Commission

Amendment

(9) Medicinal products for rare diseases and for children, should be subject to the same conditions as any other medicinal product concerning their quality, safety, efficacy and environmental risk, for example for what concerns the marketing authorisation procedures, quality and the pharmacovigilance requirements. However, specific requirements also apply to them considering their unique characteristics. Such requirements, which are currently defined in separate legislations, should be integrated in general pharmaceutical legal framework in order to ensure clarity and coherency of all the measures applicable to these medicinal products. Furthermore, as some medicinal products authorised for use in children are authorised by the Member States, specific provisions should be integrated in this Directive.

Or. en

Amendment 163

Sirpa Pietikäinen

Proposal for a directive

Recital 9 a (new)

Text proposed by the Commission

Amendment

(9 a) Member States should form and take part to an EU-wide Rare Medicines Fund where each Member State should invest 5% of its average costs resulting from medicinal expenses that is the share of rare diseases. The Fund should negotiate, jointly for all Member States, the prices of medicines and medicinal products for rare diseases, and the Member States should commit to the purchase of these medicines by public procurement to respond to the needs of their citizens.

Or. en

Amendment 164

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Recital 11

Text proposed by the Commission

Amendment

(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular SMEs. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need and innovation that reaches patients and improves access across the Union. To make the regulatory system more efficient and innovation-friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.

(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the EU's pharmaceutical industry, in particular of SMEs. Furthermore, it should aim to prioritize the expansion of EU-based clinical trials and the local production of active pharmaceutical ingredients, thereby reinforcing the strategic autonomy of the European health ecosystem. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need, EU-based innovation and innovation that reaches patients and improves access across the Union. To make the regulatory system more efficient and innovation-friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.

Or. en

Amendment 165

Marian-Jean Marinescu

Proposal for a directive

Recital 11

Text proposed by the Commission

Amendment

(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular SMEs and to ensure an increased access to innovative, quality medicines. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need and innovation that reaches patients and improves access across the Union. To make the regulatory system more efficient and innovation-friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.

Or. en

Amendment 166

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 11

Text proposed by the Commission

Amendment

(11) The Directive should work in synergy with the Regulation to enable innovation and promote competitiveness of the Union pharmaceutical industry, in particular SMEs. In this respect a balanced system of incentives is proposed that rewards innovation especially in areas of unmet medical need, innovation that reaches patients and improves access across the Union and innovation that stems from preclinical studies developed in the Union. To make the regulatory system more efficient and innovation-friendly the Directive also aims at reducing administrative burden and simplifying procedures for undertakings.

Or. en

Amendment 167

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 11 a (new)

Text proposed by the Commission

Amendment

(11 a) It is however, difficult to establish a direct link between incentives offered nowadays at Union level and Union competitiveness in the pharmaceutical sphere vis-à-vis third country based companies. While incentives can make the EU a more attractive market for industry, they remain agnostic to medicines´ geographical origin. Medicines originating from third country based companies are eligible to all EU incentives. Equally, EU based innovative companies can benefit from incentives elsewhere if they sell their products in these markets. Therefore a reduction in the regulatory data protection period should not harm EU companies vis-à-vis non EU companies coming to the EU market in terms of competitiveness.

Or. en

Amendment 168

Dolors Montserrat, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Recital 11 a (new)

Text proposed by the Commission

Amendment

(11 a) This Directive should be in line with the EU’s industrial, digital and trade aspirations. The European life sciences sector, and the pharmaceutical industry in particular, are essential in ensuring EU’s competitiveness. Maintaining and strengthening robust R&D sectors are key pillars of the shared European sovereignty in an increasingly competitive geopolitical context.

Or. en

Amendment 169

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 11 b (new)

Text proposed by the Commission

Amendment

(11 b) However, to improve research and development in the pharmaceutical sphere stemming from the Union, as well as contributing to open EU strategic autonomy, it could be beneficial to establish a direct link between preclinical studies conducted in the Union and an incentive pronlonging data protection for a medicinal product. Therefore, an incentive to extend the data protection period is proposed where a company can demonstrate this.

Or. en

Amendment 170

Dolors Montserrat, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Recital 11 b (new)

Text proposed by the Commission

Amendment

(11 b) This Directive should recognize that there is no trade-off between maintaining a competitive pharmaceutical industry in the EU and ensuring the affordability, accessibility, and availability of medicinal products in the EU.

Or. en

Amendment 171

Pernille Weiss

Proposal for a directive

Recital 12

Text proposed by the Commission

Amendment

(12) The definitions and scope of Directive 2001/83/EC should be clarified in order to achieve high standards for the quality, safety and efficacy of medicinal products and to address potential regulatory gaps, without changing the overall scope, due to scientific and technological developments, e.g. low-volume products, bedside-manufacturing or personalised medicinal products that do not involve an industrial manufacturing process.

(12) The definitions and scope of Directive 2001/83/EC should be clarified in order to achieve high standards for the quality, safety and efficacy of medicinal products and to address potential regulatory gaps, without changing the overall scope or affecting national competences in this regard, such as for pricing and reimbursement procedures, due to scientific and technological developments, e.g. low-volume products, bedside-manufacturing or personalised medicinal products that do not involve an industrial manufacturing process.

Or. en

Amendment 172

Margrete Auken

Proposal for a directive

Recital 13

Text proposed by the Commission

Amendment

(13) To avoid the duplication of requirements for medicinal products in this Directive and in the Regulation, the general standards in regards to quality, safety and efficacy of medicinal products laid down in this Directive shall be applicable to medicinal products covered by national marketing authorisation and also to medicinal products covered by centralised marketing authorisation. Therefore, the requirements for an application for medicinal product are valid for both, also the rules on prescription status, product information, regulatory protection and rules on manufacturing, supply, advertising, supervision and other national requirements shall be applicable to medicinal products covered by centralised marketing authorisation.

(13) To avoid the duplication of requirements for medicinal products in this Directive and in the Regulation, the general standards in regards to quality, safety, efficacy and environmental risk of medicinal products laid down in this Directive shall be applicable to medicinal products covered by national marketing authorisation and also to medicinal products covered by centralised marketing authorisation. Therefore, the requirements for an application for medicinal product are valid for both, also the rules on prescription status, product information, regulatory protection and rules on manufacturing, supply, advertising, supervision and other national requirements shall be applicable to medicinal products covered by centralised marketing authorisation.

Or. en

Amendment 173

Sirpa Pietikäinen

Proposal for a directive

Recital 13 a (new)

Text proposed by the Commission

Amendment

(13 a) The Commission should create a process to prioritize less environmentally harmful medicines by enabling Member States to withdraw the marketing authorisation of medicines where a less environmentally harmful, equivalent alternative exists for the medicine. Life-saving medicines or medicines responding to unmet medical needs should be excluded from this process. Member States should equally fund capacities that facilitate the development of enviromentally less harmful medicines.

Or. en

Amendment 174

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 15

Text proposed by the Commission

Amendment

(15) In order to take account both of the emergence of new therapies and of the growing number of so-called ‘borderline’ products between the medicinal product sector and other sectors, certain definitions and derogations should be modified, so as to avoid any doubt as to the applicable legislation. With the same objective of clarifying situations when a product fully falls within the definition of a medicinal product and also meet the definition of other regulated products, the Agency and the advisory and regulatory bodies established in other Union legislation, as relevant, should engage in consultations, in order to find consensus on the regulatory status of the product or the application of Union law to the borderline product in question. Where necessary, the Commission should be empowered to take the decision on the regulatory status or applicability of legal rules to the borderline product,the assessment and conclusions of which should be made publicly available. Furthermore, for transparency purposes, the respective opinions and conclusions of the Agency and the other advisory and regulatory bodies established in other Union legislation should be made publicly available. Furthermore, to ensure the clarity of applicable rules, it is also appropriate to improve the consistency of the terminology of the pharmaceutical legislation and clearly indicate the products excluded from the scope of this Directive.

Or. en

Amendment 175

Joanna Kopcińska

Proposal for a directive

Recital 15 a (new)

Text proposed by the Commission

Amendment

(15 a) It would be valuable to map terms used in ICD 11 an MedDRA, to clearly identify indications and to harmonise terminology used in other healthcare systems.

Or. en

Amendment 176

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 16

Text proposed by the Commission

Amendment

(16) The new definition for a substance of human origin (SOHO) by the [SoHO Regulation] covers any substance collected from the human body in whatever manner, whether it contains cells or not and regardless of whether it meets the definition of ‘blood’, ‘tissue’ or ‘cell’, for example human breast milk, intestinal microbiota and any other SoHO that may be applied to humans in the future. Such substances of human origin, other than tissues and cells, may become SoHO derived medicinal products, other than ATMPs, when the SoHO is subject to an industrial process involving systematisation, reproducibility and operations performed on a routine basis or batch-wise resulting in a product of standardised consistency. When a process concerns extraction of an active ingredient from the SoHO, other than tissues and cells, or a transformation of a SoHO, other than tissues and cells, by changing its inherent properties, this should also be considered a SoHO derived medicinal product. When a process concerns concentrating, separating or isolating elements in the preparation of blood components, this should not be considered as changing their inherent properties.

(16) The new definition for a substance of human origin (SOHO) by the [SoHO Regulation] covers any substance collected from the human body in whatever manner, whether it contains cells or not and regardless of whether it meets the definition of ‘blood’, ‘tissue’ or ‘cell’, for example human breast milk, intestinal microbiota and any other SoHO that may be applied to humans in the future. Such substances of human origin, other than tissues and cells, may become SoHO derived medicinal products, other than ATMPs, when the SoHO is subject to an industrial process involving systematisation, reproducibility and operations performed on a routine basis or batch-wise resulting in a product of standardised consistency. When a process concerns extraction of an active ingredient from the SoHO, other than tissues and cells, or a transformation of a SoHO, other than tissues and cells, by changing its inherent properties, this should also be considered a SoHO derived medicinal product. When a process concerns pooling, separating or isolating elements in the preparation of SoHO, as well as methods to reduce, inactivate or eliminate microbes to enhance micro-biological quality, this should not be considered as changing their inherent properties.

Or. en

Amendment 177

Margrete Auken

Proposal for a directive

Recital 16

Text proposed by the Commission

Amendment

(16) The new definition for a substance of human origin (SOHO) by the [SoHO Regulation] covers any substance collected from the human body in whatever manner, whether it contains cells or not and regardless of whether it meets the definition of ‘blood’, ‘tissue’ or ‘cell’, for example human breast milk, intestinal microbiota and any other SoHO that may be applied to humans in the future. Such substances of human origin, other than tissues and cells, may become SoHO derived medicinal products, other than ATMPs, when the SoHO is subject to an industrial process involving systematisation, reproducibility and operations performed on a routine basis or batch-wise resulting in a product of standardised consistency. When a process concerns extraction of an active ingredient from the SoHO, other than tissues and cells, or a transformation of a SoHO, other than tissues and cells, by changing its inherent properties, this should also be considered a SoHO derived medicinal product. When a process concerns pooling, concentrating, separating or isolating elements in the preparation of SoHO, as well as methods that increase micro-biological quality, this should not be considered as changing their inherent properties.

Or. en

Justification

Many of these processes include pooling and they also do not change inherent properties of SoHO. Similarly, pathogen inactivation processes may change the substance’s inherit properties but this should not transform these SoHO into medicinal products, at the risk of causing severe disruption to the work of blood establishments in ensuring the safe and sufficient supply of blood components in Europe. The rationale applies to all SoHO and not just blood components.

Amendment 178

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 17 a (new)

Text proposed by the Commission

Amendment

(17 a) For SoHO derived medicinal products, each Member State shoud ensure through public service obligations that those manufacturers provide an appropriate and continuous supply of SoHO derived medicinal products to patients in their territory. Member States should negotiate fair and transparent prices for SoHO derived medicinal products that are derived from altruistic and unpaid donations. Member States should also ensure that affordable SoHO derived medicinal products are available to patients in their territory. In this regard, manufacturers of these products should report annually to authorities on the quantities prepared and the amount supplied for public use.

Or. en

Amendment 179

Pernille Weiss

Proposal for a directive

Recital 17 a (new)

Text proposed by the Commission

Amendment

(17 a) Member States should take measures to promote the availability of medicinal products derived from substances of human origin and together with the Commission strengthen EU open strategic autonomy with regard to plasma for fractionation intended for plasma-derived medicinal products.

Or. en

Amendment 180

Susana Solís Pérez

Proposal for a directive

Recital 18

Text proposed by the Commission

Amendment

(18) Advanced therapy medicinal products that are prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemption. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

(18) Advanced therapy medicinal products that are prepared incidentally and exceptionally on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). Hospital exemptions should be granted strictly when there is neither a certified medicinal alternative available, nor an appropriate clinical trial or compassionate use program that aligns with the therapeutic needs for an Advanced Therapy Medicinal Product (ATMP) for which the patient is qualified within the European jurisdiction, provided that the production of such therapy is a singular event and not part of a standard manufacturing cycle. The system for granting marketing authorizations is underpinned by the evidence from clinical trials, which is essential for confirming product safety and effectiveness. Therefore, it is crucial to ensure that the hospital exemption does not deplete the pool of clinical trial participants or jeopardize the reliability of the marketing authorization process for ATMPs. Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to assist in the overall surveillance of the products’ quality, safety, and effectiveness.. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

Or. en

Amendment 181

Pietro Fiocchi

Proposal for a directive

Recital 18

Text proposed by the Commission

Amendment

(18) Advanced therapy medicinal products that are prepared incidentally and exceptionally on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a product custom-made to meet the special needs of an individual patient should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). The use of hospital exemption should apply only where there is neither a centrally authorised medicinal product nor a relevant clinical trial or compassionate use program for the same indication with an advanced therapy medicinal product for which the patient is eligible in the Union. The manufacturing of such products should not result in any one of the following conditions over the course a year: (i) standardised process; (ii) repetitive process; (iii) process involving pre-planning other than that which is required for an urgent ad-hoc situation. Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from all stakeholders. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

Or. en

Amendment 182

István Ujhelyi

Proposal for a directive

Recital 18

Text proposed by the Commission

Amendment

(18) Advanced therapy medicinal products that are prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the general scope of this Directive (‘hospital exemption’). This should remain incidental and exceptional to meet the special needs of an individual patient and under conditions that avoid that the marketing authorisation system and relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). The marketing authorisation system also relies on the outcomes of clinical trials and provides the best guarantee for demonstrating the safety and efficacy of the products. In that light, it is important to avoid that hospital exemption may result in a shortage of patients for clinical trials or that it would undermine the predictability of securing a marketing authorisation for ATMPs. Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to help a general monitoring of the quality, safety and efficacy of the products used. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

Or. en

Amendment 183

Pietro Fiocchi

Proposal for a directive

Recital 18

Text proposed by the Commission

Amendment

(18) Advanced therapy medicinal products that are prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a product custom-made to meet the special needs of an individual patient where there is neither an authorised medicinal product available, a compassionate use programme nor a relevant clinical trial for the same indication with an advanced therapy medicinal product for which the patient is eligible in the Union, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from all stakeholders. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

Or. en

Amendment 184

Margrete Auken

Proposal for a directive

Recital 18

Text proposed by the Commission

Amendment

(18) Advanced therapy medicinal products that are prepared on a non-routine basis according to specific quality standards, and used within the same Member State in a hospital under the professional responsibility of a medical practitioner and hospital pharmacist, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemption. In case of unmet medical need, Member States may allow for mutual recognition and cross-border exchange of advanced therapy medicinal products prepared under hospital exemption. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

Or. en

Amendment 185

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 18

Text proposed by the Commission

Amendment

(18) Advanced therapy medicinal products that are prepared according to specific quality standards, and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Directive whilst at the same time ensuring that relevant Union rules related to quality and safety are not undermined (‘hospital exemption’). Experience has shown that there are great differences in the application of hospital exemption among Member States. To improve the application of hospital exemption this Directive introduces measures for collection, reporting of data as well as review of these data yearly by the competent authorities and their publication by the Agency in a repository. Furthermore, the Agency should provide a report on the implementation of hospital exemption on the basis of contributions from Member States in order to examine whether an adapted framework should be established for certain less complex ATMPs that have been developed and used under the hospital exemption. When an authorisation for the manufacturing and use of an ATMP under hospital exemption is revoked because of safety concerns, the relevant competent authorities shall inform the competent authorities of other Member States.

Or. en

Amendment 186

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 18 a (new)

Text proposed by the Commission

Amendment

(18 a) Hospital exemption pathway is a crucial way of providing patients with access to innovative and affordable treatments that may not be available through other channels. Any limitations to this pathway should avoided, but only based on efficacy, quality and safety criteria, without time restrictions or restrictions on quantities. Competent authorities should guarantee that the authorisation of other products through the centralized procedure does not adversely affect the activities and responsibilities of developers functioning under the hospital exemption. The Agency, as well as competent authorities at the national level, should support academic institutions and other non-profit entities through the requirements of the hospital exemption clause and, when adequate, should provide guidance through centralised marketing authorisation procedure.

Or. en

Amendment 187

István Ujhelyi

Proposal for a directive

Recital 18 a (new)

Text proposed by the Commission

Amendment

(18 a) The Agency should also establish support programmes to help guiding academic and other not-for-profit entities through the centralised marketing authorisation procedure. This could build on the EMA pilot program for enhanced support to academic and non-profit developers of advanced therapy medicinal products, started in September 2022 and take into account experience with hospital exemption uses.

Or. en

Amendment 188

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Recital 18 a (new)

Text proposed by the Commission

Amendment

(18 a) The Agency should create a program aimed at assisting academic institutions and non-profit organizations in navigating the centralized marketing authorization process. This initiative should be informed by insights from the EMA's pilot program that began in September 2022, which provided specialized support to academic and non-profit developers of advanced therapy medicinal products.

Or. en

Amendment 189

Margrete Auken

Proposal for a directive

Recital 20

Text proposed by the Commission

Amendment

(20) In the interest of public health, a medicinal product should only be allowed to be placed on the market in the Union when the marketing authorisation has been granted to the medicinal product, and its quality, safety and efficacy have been demonstrated. However, exemption should be provided from this requirement in situations characterised by an urgent need to administer a medicinal product to address the specific needs of a patient, or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation that could cause harm. In particular, to fulfil special needs, Member States should be allowed to exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility. Member States should be also allowed to temporarily authorise the distribution of an unauthorised medicinal product in response to a suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm.

(20) In the interest of public health, a medicinal product should only be allowed to be placed on the market in the Union when the marketing authorisation has been granted to the medicinal product, and its quality, safety, efficacy and environmental risk have been demonstrated. However, exemption should be provided from this requirement in situations characterised by an urgent need to administer a medicinal product to address the specific needs of a patient, or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation that could cause harm. In particular, to fulfil special needs, Member States should be allowed to exclude from the provisions of this Directive medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under their direct personal responsibility. Member States should be also allowed to temporarily authorise the distribution of an unauthorised medicinal product in response to a suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation any of which could cause harm.

Or. en

Amendment 190

Marian-Jean Marinescu

Proposal for a directive

Recital 21

Text proposed by the Commission

Amendment

(21) Marketing authorisation decisions should be taken on the basis of the objective scientific criteria of quality, safety and efficacy of the medicinal product concerned, to the exclusion of economic or any other considerations. However, Member States should be able exceptionally to prohibit the use in their territory of medicinal products.

(21) Marketing authorisation decisions should be taken on the basis of the objective scientific criteria of quality, safety and efficacy of the medicinal product concerned, to the exclusion of economic or any other considerations including the status of intellectual property rights. . However, Member States should be able exceptionally to prohibit the use in their territory of medicinal products.

Or. en

Justification

Scientific decisions should not be based on the status of patents or supplementary protection certificates.

Amendment 191

Margrete Auken

Proposal for a directive

Recital 22

Text proposed by the Commission

Amendment

(22) The particulars and documentations that are to accompany an application for marketing authorisation for a medicinal product demonstrate that the therapeutic efficacy of the product overweight potential risks. The benefit-risk balance of all medicinal products will be assessed when they are placed on the market, and at any other time the competent authority deems appropriate.

(22) The particulars and documentations that are to accompany an application for marketing authorisation for a medicinal product demonstrate that the therapeutic efficacy of the product overweight potential risks. The benefit-risk balance of all medicinal products will be assessed when they are placed on the market, five years after market approval, except for generics, and at any other time the competent authority deems appropriate.

Or. en

Amendment 192

Margrete Auken

Proposal for a directive

Recital 22 a (new)

Text proposed by the Commission

Amendment

(22 a) As a general rule, marketing authorisation should be granted based on comparative clinical trials on patients who are representative of the population to be treated with the product. To this end, placebo controlled trials should only be accepted where duly justified, necessary and ethical. In addition, patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) should be an integral part of clinical data submitted with the marketing authorisation application in order to assess the quality of care and the impact of the treatments on patients. Particular attention should be given to the gender balance of clinical trials so that women can fully and safely benefit from medicines throughout their life-course.

Or. en

Amendment 193

Nathalie Colin-Oesterlé

Proposal for a directive

Recital 23 a (new)

Text proposed by the Commission

Amendment

(23a) Patent protection creates a legal framework, which is important for pharmaceutical innovation as it provides companies with financial incentives to cover the research and development (R&D) costs of new medicinal products. The research-based pharmaceutical industry is an essential sector and contributor to ensuring quality manufacturing and supply of medicinal products, to ensuring future innovation to address outstanding, unmet needs, and to supporting the resilience, responsiveness and readiness of healthcare systems to address future challenges, including pandemics.

Or. fr

Amendment 194

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 24

Text proposed by the Commission

Amendment

(24) It is therefore necessary to introduce a requirement for new medicinal products or when developing paediatric indications of already authorised products covered by a patent or a supplementary protection certificate to present either the results of studies in the paediatric population in accordance with an agreed paediatric investigation plan or proof of having obtained a waiver or deferral, at the time of filing a marketing authorisation application or an application for a new therapeutic indication, new pharmaceutical form or new route of administration. However, in order to avoid exposing children to unnecessary clinical trials or due to the nature of the medicinal products, that requirement should not apply to generics or similar biological medicinal products and medicinal products authorised through the well-established medicinal use procedure, nor to homeopathic medicinal products and traditional herbal medicinal products authorised through the simplified registration procedures of this Directive.

(24) It is therefore necessary to introduce a requirement for new medicinal products or when developing paediatric indications of already authorised products covered by a patent or a supplementary protection certificate to present either the results of studies in the paediatric population in accordance with an agreed paediatric investigation plan or proof of having obtained a waiver or deferral, at the time of filing a marketing authorisation application or an application for a new therapeutic indication, new pharmaceutical form or new route of administration. However, in order to avoid exposing children to unnecessary clinical trials or due to the nature of the medicinal products, that requirement should not apply to generics or similar biological medicinal products and medicinal products authorised through the well-established medicinal use procedure, and traditional herbal medicinal products authorised through the simplified registration procedures of this Directive.

Or. en

Amendment 195

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 27

Text proposed by the Commission

Amendment

(27) Certain particulars and documentation that are normally to be submitted with an application for a marketing authorisation should not be required if a medicinal product is a generic medicinal product or a similar biological medicinal product (biosimilar) that is authorised or has been authorised in the Union. Both generic and biosimilar medicinal products are important to ensure access of medicinal products to a wider patient population and create a competitive internal market. In a joint statement authorities of the Member States confirmed that the experience with approved biosimilar medicinal products over the past 15 years has shown that in terms of efficacy, safety and immunogenicity they are comparable to their reference medicinal product and are therefore interchangeable and can be used instead of its reference product (or vice versa) or replaced by another biosimilar of the same reference product.

(27) Certain particulars and documentation that are normally to be submitted with an application for a marketing authorisation should not be required if a medicinal product is a generic medicinal product or a similar biological medicinal product (biosimilar) that is authorised or has been authorised in the Union. Both generic and biosimilar medicinal products are important to ensure access of medicinal products to a wider patient population at more affordable prices and create a competitive internal market . In a joint statement authorities of the Member States confirmed that the experience with approved biosimilar medicinal products over the past 15 years has shown that in terms of efficacy, safety and immunogenicity they are comparable to their reference medicinal product and are therefore interchangeable and can be used instead of its reference product (or vice versa) or replaced by another biosimilar of the same reference product.

Or. en

Amendment 196

Stelios Kympouropoulos

Proposal for a directive

Recital 30

Text proposed by the Commission

Amendment

(30) Regulatory decision-making on the development, authorisation and supervision of medicines may be supported by access and analysis of health data, including real world data i.e. health data generated outside of clinical studies where appropriate, and/or data generated via in silico methods, such as computational modelling and simulation, molecular modelling, mechanistic modelling, digital twin and artificial intelligence (AI). The competent authorities should be able to use such data, including via the European Health Data Space interoperable infrastructure.

Or. en

Amendment 197

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 31

Text proposed by the Commission

Amendment

(31) Directive 2010/63/EU of the European Parliament and of the Council43 lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or read-across models.

(31) Directive 2010/63/EU of the European Parliament and of the Council[1] lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be undertaken as a last resort and be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The marketing authorisation applicant should not carry out animal tests in case scientifically satisfactory non-animal testing methods are available. Where scientifically satisfactory non-animal testing methods are not available, applicants that use animal testing should ensure that the principle of replacement, reduction and refinement of animal testing for scientific purposes has been with regard to any animal study conducted for the purpose of supporting the application. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or read-across models. [1] Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

_________________

43 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

Or. en

Amendment 198

Stanislav Polčák

Proposal for a directive

Recital 31

Text proposed by the Commission

Amendment

(31) Directive 2010/63/EU of the European Parliament and of the Council43lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or read-across models.

(31) Directive 2010/63/EU of the European Parliament and of the Council[1] lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be designed to avoid causing pain, suffering, distress, lasting harm or death to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies in place of animal testing. These can include but are not limited to: These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models;in silico tools or read-across models. [1] Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

_________________

43 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

Or. cs

Amendment 199

Margrete Auken

Proposal for a directive

Recital 31

Text proposed by the Commission

Amendment

(31) Directive 2010/63/EU of the European Parliament and of the Council[1] lays down provisions on the protection of animals used for scientific purposes based on the principles of replacement, reduction and refinement. Ultimately, efforts should be made to fully replace procedures on live animals for scientific purposes. Any study involving the use of animals, which provides essential information on the quality, safety and efficacy of a medicinal product, should take into account those principles of replacement, reduction and refinement, where they concern the care and use of live animals for scientific purposes, and should be optimised in order to provide the most satisfactory results whilst using the minimum number of animals. The procedures of such testing should be designed to avoid causing pain, suffering, distress or lasting harm to animals and should follow the available EMA and ICH guidelines. In particular, the marketing authorisation applicant and the marketing authorisation holder should take into account the principles laid down in Directive 2010/63/EU, including, where possible, use new approach methodologies (NAMs) in place of animal testing. These can include but are not limited to: in vitro models, such as microphysiological systems including organ-on-chips, (2D and 3D-) cell culture models, organoids and human stem cells-based models; in silico tools or grouping and read-across, aquatic egg models as well as invertebrate species.

_________________

43 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

Or. en

Amendment 200

Stelios Kympouropoulos

Proposal for a directive

Recital 31

Text proposed by the Commission

Amendment

_________________

43 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

Or. en

Amendment 201

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 32

Text proposed by the Commission

Amendment

(32) Procedures should be in place to facilitate joint animal testing, wherever possible, in order to avoid unnecessary duplication of testing using live animals covered by Directive 2010/63/EU. Marketing authorisation applicants and marketing authorisation holders should make all efforts to reuse animal study results and make the results obtained from animal studies publicly available. For abridged applications marketing authorisation applicants should refer to the relevant studies conducted for the reference medicinal product.

(32) Procedures should be in place to facilitate joint animal testing, wherever possible, in order to avoid unnecessary testing using live animals covered by Directive 2010/63/EU. Marketing authorisation applicants and marketing authorisation holders should make all efforts to reuse animal study results and make the results obtained from animal studies publicly available. For abridged applications marketing authorisation applicants should refer to the relevant studies conducted for the reference medicinal product.

Or. en

Amendment 202

Margrete Auken

Proposal for a directive

Recital 34

Text proposed by the Commission

Amendment

(34) There is the possibility under certain circumstances for marketing authorisations to be granted, subject to specific obligations or conditions, on a conditional basis or under exceptional circumstances. The legislation should allow under similar circumstances for medicinal products with a standard marketing authorisation for new therapeutic indications to be authorised on a conditional basis or under exceptional circumstances. The products authorised on a conditional basis or under exceptional circumstances should in principle satisfy the requirements for a standard marketing authorisation with the exception of the specific derogations or conditions outlined in the relevant conditional or exceptional marketing authorisation and shall be subject to specific review of the fulfilment of the imposed specific conditions or obligations. The grounds for refusal of a marketing authorisation should apply mutatis mutandis for such cases.

(34) There is the possibility under certain duly justified circumstances for marketing authorisations to be granted, subject to specific obligations or conditions, on a conditional basis or under exceptional circumstances. The legislation should allow under similar circumstances for medicinal products with a standard marketing authorisation for new therapeutic indications to be authorised on a conditional basis or, in case of centrally-authorised products, under exceptional circumstances. The products authorised on a conditional basis or under exceptional circumstances should in principle satisfy the requirements for a standard marketing authorisation with the exception of the specific derogations or conditions outlined in the relevant conditional or exceptional marketing authorisation and shall be subject to specific review of the fulfilment of the imposed specific conditions or obligations. The grounds for refusal of a marketing authorisation should apply mutatis mutandis for such cases.

Or. en

Amendment 203

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 39

Text proposed by the Commission

Amendment

(39) In the interest of as broad as possible access to medicinal products, a Member State that has an interest in receiving access to a particular medicinal product undergoing authorisation through the decentralised and mutual recognition procedures should be able to opt-into that procedure. A Member State who did not join the initital application for the decentralised procedure within 30 days of the sumission of the application should still have a second opportunity to opt into the procedure at a later point, in this case they should immeditately inform the applicant and the competent authority of the reference Member State for the decentralised procedure.

Or. en

Amendment 204

Joanna Kopcińska

Proposal for a directive

Recital 39

Text proposed by the Commission

Amendment

Or. en

Amendment 205

Cristian-Silviu Buşoi

Proposal for a directive

Recital 41

Text proposed by the Commission

Amendment

(41) In the case of generic medicinal products of which the reference medicinal product has been granted a marketing authorisation under the centralised procedure, applicants seeking marketing authorisation should be able to choose either of the two procedures, on certain conditions. Similarly, the mutual-recognition or decentralised procedure should remain available as an option for certain medicinal products, even if they represent a therapeutic innovation or are of benefit to society or to patients. Since generic medicines account for a major part of the market in medicinal products, their access to the Union market should be facilitated in the light of the experience acquired, therefore, the procedures to include other Member States concerned to such procedure should be further simplified.

(41) In the case of products with well-known molecules, generic medicinal products of which the reference medicinal product has been granted a marketing authorisation under the centralised procedure, hybrid medicinal products, well established and products with fixed dose combinations of known molecules, applicants seeking marketing authorisation should be able to choose either of the two procedures, on certain conditions. Similarly, the mutual-recognition or decentralised procedure should remain available as an option for certain medicinal products, even if they represent a therapeutic innovation or are of benefit to society or to patients. Since generic medicines account for a major part of the market in medicinal products, their access to the Union market should be facilitated in the light of the experience acquired, therefore, the procedures to include other Member States concerned to such procedure should be further simplified.

Or. en

Amendment 206

Margrete Auken

Proposal for a directive

Recital 42

Text proposed by the Commission

Amendment

(42) The simplification of procedures should not have an impact on standards or the quality of scientific evaluation of medicinal products to guarantee the quality, safety and efficacy and therefore, the scientific evaluation period should remain. However, the reduction of overall period for marketing authorisation procedure from 210 days to 180 days is foreseen.

(42) The simplification of procedures should not have an impact on standards or the quality of scientific evaluation of medicinal products to guarantee the quality, safety, efficacy and environmetal risk and therefore, the scientific evaluation period should remain. However, the reduction of overall period for marketing authorisation procedure from 210 days to 180 days is foreseen.

Or. en

Amendment 207

Cyrus Engerer

Proposal for a directive

Recital 44

Text proposed by the Commission

Amendment

(44) As regards access to medicinal products, previous amendments to the Union pharmaceutical legislation have addressed this issue by providing for accelerated assessment of marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies, these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicinal products. Patient access to medicinal products depends on many factors. Marketing authorisation holders are not obliged to market a medicinal product in all Member States; they may decide not to market their medicinal products in, or withdraw them from, one or more Member States. National pricing and reimbursement policies, the size of the population, the organisation of health systems and national administrative procedures are other factors influencing market launch and patient access.

Or. en

Amendment 208

Margrete Auken

Proposal for a directive

Recital 44

Text proposed by the Commission

Amendment

(44) As regards access to medicinal products, previous amendments to the Union pharmaceutical legislation have addressed this issue by providing for accelerated assessment of marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies in some areas, there still exist many public health priorities unaddressed and these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicinal products. Patient access to medicinal products depends on many factors. Marketing authorisation holders are not obliged to market a medicinal product in all Member States; they may decide not to market their medicinal products in, or withdraw them from, one or more Member States. National pricing and reimbursement policies, the size of the population, the organisation of health systems and national administrative procedures and often high prices of innovative medicines are other factors influencing market launch and patient access.

Or. en

Amendment 209

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 44

Text proposed by the Commission

Amendment

(44) As regards access to medicinal products, previous amendments to the Union pharmaceutical legislation have addressed this issue by providing for accelerated assessment of marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies, these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicinal products. Patient access to medicinal products depends on many factors. Marketing authorisation holders are not obliged to market a medicinal product in all Member States; they may decide not to market their medicinal products in, or withdraw them from, one or more Member States, often due to profitability considerations. National pricing and reimbursement policies, the size of the population, the organisation of health systems, and national administrative procedures are other factors influencing market launch and patient access.

Or. en

Amendment 210

Margrete Auken

Proposal for a directive

Recital 44 a (new)

Text proposed by the Commission

Amendment

(44 a) In order to increase the availability of medicines and contribute to reducing of access inequalities within the Union, the marketing authorisation holders of medicinal products other than generics should submit an application for pricing and reimbursement in Member States upon request. In addition, the Agency should include in its medicine database information on the actual placing on the market and reimbursement status for all centrally authorised medicines.

Or. en

Amendment 211

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 45

Text proposed by the Commission

Amendment

(45) Addressing unequal patient access and affordability of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe, as also highlighted by Council conclusions45 and a resolution of the European Parliament46 . Member States called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring health system sustainability, patient access and availability of affordable medicinal products in all Member States.

(45) Addressing unequal patient access and affordability of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe, as also highlighted by Council conclusions[1] and a resolution of the European Parliament[2]. Member States called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring health system sustainability, patient access and availability of affordable medicinal products in all Member States. Putting in place tolls to evaluate access to medicines at a Union level is key to follow-up on the results achieved through incentives.

_________________

45 Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States, (OJ C, C/269, 23.07.2016, p. 31). Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU, (2021/C 269 I/02).

46 European Parliament resolution of 2 March 2017 on EU options for improving access to medicine (2016/2057(INI)) Shortages of medicines, 2020/2071(INI).

Or. en

Amendment 212

Cyrus Engerer

Proposal for a directive

Recital 45 a (new)

Text proposed by the Commission

Amendment

(45 a) Given the unmet needs in the area of mental health, the revision should also support early access to novel treatments for patients who need them most through means like compassionate use programmes and conditional marketing authorisation. These programs should play a pivotal role in providing treatment experience for providers and generating valuable real-world data to inform safety policies and future product labelling.

Or. en

Amendment 213

Cyrus Engerer

Proposal for a directive

Recital 45 b (new)

Text proposed by the Commission

Amendment

(45 b) Use of early access pilot programs to treat a diverse set of patients with complex comorbidities who are often excluded from clinical trials focused on novel mental health treatments should be supported. Allowing this would support gathering critical additional data on the safety and efficacy of these treatments in a broader population. Furthermore, these programs should explore different treatment protocols, such as group therapy and peer support specialists, to find the optimal balance of safety, efficacy, affordability, and equitable access.

Or. en

Amendment 214

Cyrus Engerer

Proposal for a directive

Recital 45 c (new)

Text proposed by the Commission

Amendment

(45 c) The revision should aim to support innovative mental health care treatments that combine pharmacological, and psychological aspects. Moreover, generation of empirical evidence for the quality and safety of novel mental health treatments should be further explored and supported. This includes understanding the interactions between the pharmacological substances and the psychotherapy as well as assistive technologies that can assist to patient preparation, monitoring or treatment integration.

Or. en

Amendment 215

Cyrus Engerer

Proposal for a directive

Recital 45 d (new)

Text proposed by the Commission

Amendment

(45 d) Mental health disorders also represent an area of unmet medical need, where only a moderate progress has been achieved during the past decades, especially in addressing the treatment resistant depression, treatment-resistant PTSD as well as regarding the neurodegenerative diseases. At the same time the mental health disorders pose a substantial burden on individuals, healthcare systems, caregivers, and economies.

Or. en

Amendment 216

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 46

Text proposed by the Commission

Amendment

(46) Access also comprise affordability. In this regard, the Union pharmaceutical legislation respects the competence of the Member States in terms of pricing and reimbursement. In a complementary manner, it aims to have a positive impact on affordability and sustainability of health systems with measures that support competition from generic and biosimilar medicinal products. The competition from generic and biosimilar medicinal products should also, in turn, increase patient access to medicinal products.

(46) Access also comprises affordability. In this regard, the Union pharmaceutical legislation respects the competence of the Member States in terms of pricing and reimbursement. In a complementary manner, it aims to have a positive impact on affordability and sustainability of health systems with measures that support competition from generic and biosimilar medicinal products. The competition from generic and biosimilar medicinal products should also, in turn, increase patient access to medicinal products.

Or. en

Amendment 217

Margrete Auken

Proposal for a directive

Recital 47

Text proposed by the Commission

Amendment

(47) To ensure dialogue among all actors in the medicines lifecycle, discussions on policy issues related to the application of the rules related to prolongation of regulatory data protection for market launch shall take place in the Pharmaceutical Committee. The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.

(47) To ensure dialogue among all actors in the medicines lifecycle, the Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.

Or. en

Amendment 218

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Recital 47

Text proposed by the Commission

Amendment

(47) To ensure dialogue among all actors in the medicines lifecycle, discussions on policy issues related to the application of the rules related to prolongation of regulatory data protection shall take place in the Pharmaceutical Committee. The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.

Or. en

Amendment 219

Joanna Kopcińska

Proposal for a directive

Recital 47

Text proposed by the Commission

Amendment

(47) To ensure dialogue among all actors in the medicines lifecycle, discussions on policy issues related to the application of the rules related to prolongation of regulatory market protection shall take place in the Pharmaceutical Committee. The Commission may invite bodies responsible for health technology assessment as referred to in Regulation (EU) 2021/2282 or national bodies responsible for pricing and reimbursement, as required, to participate in the deliberations of the Pharmaceutical Committee.

Or. en

Amendment 220

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen, Dacian Cioloş

Proposal for a directive

Recital 48

Text proposed by the Commission

Amendment

(48) While pricing and reimbursement decisions are a Member State competence, cooperation in this area is essential in order to avoid that decisions in one Member State create shortages in other Member States. For this reason, the Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. While the price paid within a given Member State reflects the preference of a national health system, more coordination on pricing and procurement could contribute to more equal and timely access to medicines, including for Member States with lower purchasing power. The Commission may support joint price negotiation with pharmaceutical companies, as per the Beneluxa Initiative on Pharmaceutical Policy and the Valletta Declaration. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad-hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost-effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on national pricing, reimbursment and public procurement of medicines, while fully respecting the competences of Member States in this area. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.

Or. en

Amendment 221

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 48

Text proposed by the Commission

Amendment

(48) While pricing and reimbursement decisions are a Member State competence, the Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad-hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost-effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on public procurement of medicines, while fully respecting the competences of Member States in this area. Such procurement efforts should be based on the principle of the ‘most economically advantageous tender’ (‘MEAT’ criteria), which aims to ensure the best value for money rather than most economically advantageous product. Such an approach could also help in defining adequate supply in relation to critical medicines and, thereby, compensate and incentivise industry, and support the application of these criteria in a coordinated way, at EU level. Predictability of supply would also be helped by medium-term contractual incentives to diversify and attract the next generation of manufacturing investments in Europe. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.

Or. en

Amendment 222

Erik Poulsen, Catherine Amalric, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Recital 48

Text proposed by the Commission

Amendment

(48) While pricing and reimbursement decisions are a Member State competence, cooperation and dialogue with all stakeholders in this areas could help to avoid that decisions in one Member State contribute to unavailability in other Member States. The Pharmaceutical Strategy for Europe announced actions to support cooperation of Member States to improve affordability. The Commission has transformed the group of National Competent Authorities on Pricing and Reimbursement and public healthcare payers (NCAPR) from an ad-hoc forum to a continuous voluntary cooperation with the aim to exchange information and best practices on pricing, payment and procurement policies to improve the affordability and cost-effectiveness of medicines and health system’s sustainability. The Commission is committed to stepping up this cooperation and further supporting information exchange among national authorities, including on public procurement of medicines, while fully respecting the competences of Member States in this area. The Commission may also invite NCAPR members to participate in deliberations of the Pharmaceutical Committee on topics that may have an impact on pricing or reimbursement policies, such as the market launch incentive.

Or. en

Amendment 223

Margrete Auken

Proposal for a directive

Recital 48

Text proposed by the Commission

Amendment

Or. en

Amendment 224

Joanna Kopcińska, Andrey Slabakov

Proposal for a directive

Recital 49

Text proposed by the Commission

Amendment

(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States interested in joint procurement of medicines can make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support interested Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases.

_________________

47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65).

48 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.

49 COM/2022/223 final.

Or. en

Amendment 225

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen, Ondřej Knotek

Proposal for a directive

Recital 49

Text proposed by the Commission

Amendment

_________________

47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65).

48 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.

49 COM/2022/223 final.

Or. en

Amendment 226

Margrete Auken

Proposal for a directive

Recital 49

Text proposed by the Commission

Amendment

_________________

47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65).

48 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.

49 COM/2022/223 final.

Or. en

Amendment 227

Sirpa Pietikäinen

Proposal for a directive

Recital 49

Text proposed by the Commission

Amendment

(49) Joint procurement, whether within a country or across countries, can improve access, affordability, and security of supply of medicines, in particular for smaller countries. Member States joint procurement of medicines should make use of Directive 2014/24/EU47 , which sets out purchasing procedures for public buyers, the Joint Procurement Agreement48 and the proposed revised Financial Regulation49 . Upon request from the Member States the Commission may support Member States by facilitating coordination to enable access to medicines for patients in the Union as well as information exchange, in particular for medicines for rare and chronic diseases.

_________________

47 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65).

48 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.

49 COM/2022/223 final.

Or. en

Amendment 228

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 49 a (new)

Text proposed by the Commission

Amendment

(49 a) Practices in procurement procedures for medicines differ between Member States and long-term availability is rarely a primary consideration. The 2014 Procurement Directive encourages a more strategic approach through award criteria, including criteria beyond price. Using the lowest price as the main selection criterion may reduce incentives for the industry to build for long-term supply in the EU. At the same time, vulnerability may be increased when public procurement procedures award contracts to a single company. Where challenges with access to a critical medicine and related affordability may be an issue, Member States can work together to increase buying power. Joint procurement between Member States can act as a powerful tool to improve access, affordability and security of supply, of particular benefit in smaller EU markets. This can improve the negotiating position of Member States to incentivise production capacities, as well as diversifying supply chains. In specific cases, those instruments could also support enhanced predictability through multi-annual contracts. The joint procurement of medicines or on Member States’ behalf in the case of the COVID-19 pandemic, for example, provided a powerful tool to improve access, affordability, and security of supply, was of particular benefit to smaller EU Member States with less economic power.

Or. en

Amendment 229

Sirpa Pietikäinen

Proposal for a directive

Recital 49 a (new)

Text proposed by the Commission

Amendment

(49 a) Member States should develop a Joint Pharmaceuticals Development Body that would consist of 15 members from research, industry, Member States and the Commission. The Body should come up with joint solutions in ensuring access to up-to-date and best available medicinal care for Europeans. The purpose of the Body shoudl be to guarantee competitiveness and innovational capacity of the Union regarding pharmaceutical innovation and manufacturing, as well as the strategic autonomy of the Union when it comes to medicines, drawing from the joint actions and cooperation within the Union and between Member States during the COVID-19 pandemic.

Or. en

Amendment 230

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 50

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Not in the Directive

Amendment 231

Susana Solís Pérez

Proposal for a directive

Recital 50

Text proposed by the Commission

Amendment

(50) The establishment of a criteria-based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that lack effective treatments or where only less-than-ideal therapies exist, with the aim of spurring pharmaceutical research and development that genuinely meets patient requirements.that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining morbidity or mortality’, ‘relevant patient population’, ‘quality of life’, ‘burden of administration’, ‘appropriate standard of care’, ‘significant added therapeutic value’, ‘patient experience data’ following scientific assessment by the Agency. The Agency should include patient representatives in its decision-making processes, will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. Given that chronic diseases account for 86% of all deaths in the EU, the assessment of disease burden should not be limited to mortality and morbidity metrics alone but ought to incorporate relevant data on patient experiences, including aspects related to quality of life. The inclusion of new therapeutic indications to an authorised medicinal products should contribute to the access of patients to additional therapies and therefore should be incentivised.

Or. en

Amendment 232

Rosanna Conte, Annalisa Tardino

Proposal for a directive

Recital 50

Text proposed by the Commission

Amendment

(50) The establishment of a criteria-based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, as well as the manifold aspects it encompasses, such as the potential of medicines to improve quality of life, ease the burden of care and take into account the scope (addressing only a sub-population of a disease) of therapies, where they exist, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, 'quality of life', relevant patient population', 'access and scope (e.g. addressing only a sub-population of a disease) and ease of use of existing treatments' and 'severity of illness', following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies – including relevant patient populations – active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, taking into account their complex nature and including all relevant aspects that determine the level of unmet medical need as listed above, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ should be holistic, inclusive and take into account the many complex factors involved, and can be subsequently used by Member States to identify specific therapeutic areas of interest.

Or. it

Amendment 233

Margrete Auken

Proposal for a directive

Recital 50

Text proposed by the Commission

Amendment

(50) The establishment of a criteria-based definition of ‘unmet medical need’ is necessary to ensure incentives for the development of medicinal products in therapeutic areas that are currently underserved are appropriately allocated and to prevent unintended extensions of data protection based on unclear interpretation of unmet medical need. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.

Or. en

Justification

There is no implementing act related to Article 83 which spells out what is meant by unmet medical need, clarified with Commission that this is a drafting mistake

Amendment 234

Billy Kelleher

Proposal for a directive

Recital 50

Text proposed by the Commission

Amendment

(50) The establishment of a criteria-based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments, current knowledge in underserved diseases, as well as the many aspects that it embodies – e.g. the potential of medicines to improve quality of life, ease the burden of treatment and take account of the scope (addressing a subpopulation of a disease only) of treatments where they exist - the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’ following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities and other relevant stakeholders such as relevant patient populations or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs – taking into account the impact, scope, ease of access and use as well as availability and appropiateness of treatments where they exist, and the potential of innovation to improve quality of life for patients and their families - burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ should be holistic, inclusive and take account of its many complex factors - can be subsequently used by Member States to identify specific therapeutic areas of interest.

Or. en

Amendment 235

Kateřina Konečná

Proposal for a directive

Recital 50

Text proposed by the Commission

Amendment

(50) The establishment of a criteria-based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas for which no or only suboptimal treatments are available and to encourage pharmaceutical research and development that truly addresses the needs of patients. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge, the Commission should specify and update using implementing acts, the criteria of ‘remaining high morbidity or mortality’, ‘relevant patient population or subpopulation’, ‘burden of disease’, ‘appropriate standard of care’, ‘significant added therapeutic value’, ‘patient experience data’ following scientific assessment by the Agency. The Agency shall involve patient representatives in its decision-making, seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004] and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. As chronic diseases represent 86% of all deaths in the EU, the burden of diseases cannot solely be assessed by measuring mortality and morbidity, but should include relevant patient experience data, including quality of life.

Or. en

Amendment 236

Ondřej Knotek, Billy Kelleher, Susana Solís Pérez

Proposal for a directive

Recital 50

Text proposed by the Commission

Amendment

(50) The establishment of a criteria-based definition of ‘unmet medical need’ is required to incentivise the development of medicinal products in therapeutic areas that are currently underserved. To ensure that the concept of unmet medical need reflects scientific and technological developments and current knowledge in underserved diseases, the Commission should specify and update using implementing acts, the criteria of satisfactory method of diagnosis, prevention or treatment, ‘remaining high morbidity or mortality’, ‘relevant patient population’ and 'quality of life' following scientific assessment by the Agency. The Agency will seek input from a broad range of authorities or bodies active along the lifecycle of medicinal products in the framework of the consultation process established under the [revised Regulation (EC) No 726/2004], consult relevant stakeholders including representatives from patient's organisations, healthcare professionals and industry and also take into account scientific initiatives at EU level or between Member States related to analysing unmet medical needs, burden of disease and priority setting for research and development. The criteria for ‘unmet medical need’ can be subsequently used by Member States to identify specific therapeutic areas of interest.

Or. en

Amendment 237

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Recital 50

Text proposed by the Commission

Amendment

Or. en

Amendment 238

Sunčana Glavak, Tomislav Sokol

Proposal for a directive

Recital 50

Text proposed by the Commission

Amendment

Or. en

Amendment 239

Cyrus Engerer

Proposal for a directive

Recital 50

Text proposed by the Commission

Amendment

Or. en

Amendment 240

Susana Solís Pérez

Proposal for a directive

Recital 50 a (new)

Text proposed by the Commission

Amendment

(50 a) Advancing treatments in neglected therapeutic areas can significantly enhance patient lives, particularly by considering the management of side effects, daily functioning, pain, and co-existing illnesses. Enhancements in patient quality of life should be able to lead to their re-engagement in work or education, benefiting both the individual and society by reducing economic burdens. Additionally, new treatments can lessen the load on caregivers, with wider social benefits. Defining these therapeutic areas and unmet needs should involve consultation with stakeholders like patients, healthcare providers, and industry experts.

Or. en

Amendment 241

Sunčana Glavak, Tomislav Sokol

Proposal for a directive

Recital 50 a (new)

Text proposed by the Commission

Amendment

(50 a) The development of medical products in underserved therapeutic areas can greatly increase the quality of life for patients. In that regard, elements such as acute or chronic side effects, in particular in relation to the toxicity of a product, as well as the ability of patients to perform regular life activities, the presence of pain and the management of co-morbidities should be considered in the assessment of improving quality of life. The importance of the long-term age appropriate development and maturation of paediatric patients, and of retaining their normal daily activities, can not be overemphasized.

Or. en

Amendment 242

Dolors Montserrat, Nathalie Colin-Oesterlé, Stelios Kympouropoulos

Proposal for a directive

Recital 51 a (new)

Text proposed by the Commission

Amendment

(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentivised as it can expand access in an affordable manner, providing significant benefits to patients;

Or. en

Amendment 243

Marian-Jean Marinescu

Proposal for a directive

Recital 51 a (new)

Text proposed by the Commission

Amendment

(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentivised as it can expand access in an affordable manner, providing significant benefits to patients.

Or. en

Justification

Repurposing off-patent molecules has emerged as an important strategy in developing more affordable types of innovation. Developing new therapeutic options, via the development of indications, reformulations or combinations can significantly expand access to treatment

Amendment 244

Tomislav Sokol

Proposal for a directive

Recital 51 a (new)

Text proposed by the Commission

Amendment

(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentivised as it can expand access in an affordable manner, providing significant benefits to patients.

Or. en

Amendment 245

Cristian-Silviu Buşoi

Proposal for a directive

Recital 51 a (new)

Text proposed by the Commission

Amendment

(51 a) Repurposing of off-patent medicines to develop new therapeutic options should also be incentived as it can expand access to patients and reduce health inequalities.

Or. en

Amendment 246

Margrete Auken

Proposal for a directive

Recital 52

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 247

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 52

Text proposed by the Commission

Amendment

(52) For the initial marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence-based existing treatment should be incentivised, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States. National competent authorities and the Agency should promote, when possible, the use of comparative studies when giving regulatory advice prior to marketing authorization for medicinal products.

Or. en

Amendment 248

Stelios Kympouropoulos

Proposal for a directive

Recital 52

Text proposed by the Commission

Amendment

(52) For the initial marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence-based existing treatment or an undertaking to generate real world evidence, including patient reported outcomes that compare the new active substance to the existing treatment, should be incentivised, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States.

Or. en

Amendment 249

Joanna Kopcińska

Proposal for a directive

Recital 52

Text proposed by the Commission

Amendment

(52) For the initial marketing authorisation application for medicinal products containing a new active substance, the submission of clinical trials that include as a comparator an evidence-based existing treatment should be recommended, especially in regards to medicines for non rare diseases, in order to foster the generation of comparative clinical evidence that is relevant and can accordingly support subsequent health technology assessments and decisions on pricing and reimbursement by Member States.

Or. en

Amendment 250

Susana Solís Pérez

Proposal for a directive

Recital 53

Text proposed by the Commission

Amendment

(53) A marketing authorisation holder should ensure the appropriate and continuous supply of a medicinal product throughout its lifetime irrespective of whether that medicinal product is covered by a supply incentive or not.

(53) A marketing authorisation holder should, within its responsibilities, ensure the appropriate and continuous supply of a medicinal product throughout its lifetime irrespective of whether that medicinal product is covered by a supply incentive or not.

Or. en

Amendment 251

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Recital 53 a (new)

Text proposed by the Commission

Amendment

(53 a) During negotiations, developers and Member States should imperatively respect and adhere to the timelines set out by Directive 89/105/EEC, to accelerate and widen the availability of innovative therapies to patients.

Or. en

Amendment 252

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Recital 54

Text proposed by the Commission

Amendment

(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to market a medicinal product in the Member States where the marketing authorisation is valid for the purposes of receiving additional regulatory data protection.

(54) Micro, small and medium-sized enterprises (‘SMEs’), not-for-profit entities or entities with limited experience in the Union system should benefit from additional time to submit an application for pricing and reimbursement for a medicinal product in the Member States where a Member State has requested it and the marketing authorisation is valid for the purposes of receiving additional regulatory data protection.

Or. en

Amendment 253

Margrete Auken

Proposal for a directive

Recital 54

Text proposed by the Commission

Amendment

Or. en

Amendment 254

Joanna Kopcińska

Proposal for a directive

Recital 54

Text proposed by the Commission

Amendment

Or. en

Amendment 255

Margrete Auken

Proposal for a directive

Recital 55

Text proposed by the Commission

Amendment

(55) When applying the provisions on market launch incentives, marketing authorisation holders and Member States should do their utmost to achieve a mutually agreed supply of medicinal products in accordance with the needs of the Member State concerned, without unduly delaying or hindering the other party from enjoying its rights under this Directive.

(55) Marketing authorisation holders and Member States should do their utmost to achieve a mutually agreed supply of medicinal products in accordance with the needs of the Member State concerned, without unduly delaying or hindering the other party from enjoying its rights under this Directive.

Or. en

Amendment 256

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Recital 55

Text proposed by the Commission

Amendment

Or. en

Amendment 257

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 56

Text proposed by the Commission

Amendment

(56) Member States have the possibility to waive the condition of launch in their territory for the purpose of the prolongation of data protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory data protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place later. In the case where a Member State does not react to the application by the marketing authorisation holder within the deadline provided, it should be considered that a statement of non objection has been provided and the condition in that Member State should be waived. The Commission should ensure that marketing authorisation holders are not unduly prevented from receiving the incentives for actions beyond their control.

Or. en

Amendment 258

Margrete Auken

Proposal for a directive

Recital 56

Text proposed by the Commission

Amendment

(56) Member States have the possibility to request a market launch of centrally or decentrally approved product at any time after the marketing authorisation is valid in the Member State. Subsequently, marketing authorisation holders have nine months to apply for a pricing and reimbursement in that Member State, 18 months where the marketing authorisation holder is an SME, an entity not engaged in economic activity or an entity with a limited experience in the Union system. Alternative timelines may be agreed between the Member State and the marketing authorisation holder. Marketing authorisation holders have the right to launch a product in a Member State before being proactively approached by that Member State.

Or. en

Amendment 259

Joanna Kopcińska

Proposal for a directive

Recital 56

Text proposed by the Commission

Amendment

(56) Member States have the possibility to waive the condition of launch in their territory for the purpose of the prolongation of market protection for market launch. This can be done through a statement of non-objection to prolong the period of regulatory market protection. This is expected to be the case particularly in situations where launch in a particular Member State is materially impossible or because there are special reasons why a Member State wishes that launch take place later.

Or. en

Amendment 260

Margrete Auken

Proposal for a directive

Recital 57

Text proposed by the Commission

Amendment

(57) The issuing of documentation from the Member States as regards the prolongation of data protection for the purpose of supply of medicinal products in all Member States where a marketing authorisation is valid, in particular the waiver to the conditions for such prolongation, does not affect at any time the powers of the Member States as regards the supply, setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes. Member States do not waive the possibility to request release or supply of the product concerned at any time before, during or after the prolongation of the data protection period.

(57) The application for pricing and reimbursement in the Member States does not affect at any time the powers of the Member States as regards the supply, setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes.

Or. en

Amendment 261

Joanna Kopcińska

Proposal for a directive

Recital 57

Text proposed by the Commission

Amendment

(57) The issuing of documentation from the Member States as regards the prolongation of market protection for the purpose of supply of medicinal products in all Member States where a marketing authorisation is valid, in particular the waiver to the conditions for such prolongation, does not affect at any time the powers of the Member States as regards the supply, setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes. Member States do not waive the possibility to request release or supply of the product concerned at any time before, during or after the prolongation of the market protection period.

Or. en

Amendment 262

Ondřej Knotek, Catherine Amalric, Billy Kelleher, Susana Solís Pérez

Proposal for a directive

Recital 58

Text proposed by the Commission

Amendment

(58) An alternative way of demonstrating supply relates to the inclusion of medicinal products in a positive list of medicinal products covered by the national health insurance system in accordance with Directive 89/105/EEC. The related negotiations between companies and the Member State should be conducted in good faith. In addition, the timelines set by Directive 89/105/EEC should be respected during the negotiations between Member States and marketing authoriation holder to ensure a fast and timely patient's access to medicines.

Or. en

Amendment 263

Margrete Auken

Proposal for a directive

Recital 58

Text proposed by the Commission

Amendment

Or. en

Amendment 264

Dolors Montserrat, Nathalie Colin-Oesterlé, Stelios Kympouropoulos, Tomislav Sokol

Proposal for a directive

Recital 58 a (new)

Text proposed by the Commission

Amendment

(58 a) Small patient populations, especially paediatric or rare disease ones, are often the most disadvantaged when it comes to access to medicines. In this regard, Directive 2011/24/EU should be considered as an alternative pathway of making available medicinal products to patients, who need paediatric, orphan medicinal products or advanced therapy medicinal products. The medicines can be administered via a center of excellence, early access or compassionate use programs, or other cross-border healthcare services.

Or. en

Amendment 265

István Ujhelyi

Proposal for a directive

Recital 58 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 266

Susana Solís Pérez, Catherine Amalric

Proposal for a directive

Recital 58 a (new)

Text proposed by the Commission

Amendment

(58 a) Supply assurance can also be achieved through national strategies that facilitate patient access, such as programs for named patients, tailored individual patient initiatives, and the uptake and optimization of cross-border healthcare options, as stipulated in Directive 2011/24/EU. It is crucial to bolster cross-border healthcare, especially for treatments that require specialized infrastructure or technical expertise that may be lacking in certain Member States.

Or. en

Amendment 267

Margrete Auken

Proposal for a directive

Recital 59

Text proposed by the Commission

Amendment

(59) A Member State that considers that the conditions of supply have not been met for its territory should provide a reasoned statement of non-compliance at the latest in the Standing Committee on Medicinal Products for Human Use procedure of the variation linked to the provision of the relevant incentive.

deleted

Or. en

Amendment 268

Susana Solís Pérez

Proposal for a directive

Recital 59 a (new)

Text proposed by the Commission

Amendment

(59 a) If negotiations between Member States and developers are conducted sincerely but fail to result in an agreement on the distribution and ongoing supply of a therapy, the introduction of a mediation process should be warranted. This mechanism, overseen by the Commission, should safeguard developers from unfairly missing out on incentives due to factors beyond their influence.

Or. en

Amendment 269

Margrete Auken

Proposal for a directive

Recital 60

Text proposed by the Commission

Amendment

(60) The Commission and Member States shall continuously monitor any data and learnings from the application of the incentives system in order to improve, including through implementing acts, how these provisions are applied. The Commission shall establish a list of national contact points in this regard.

(60) The Commission and Member States shall continuously monitor any data and learnings from the application of the incentives system in order to improve how these provisions are applied. The Commission shall establish a list of national contact points in this regard.

Or. en

Amendment 270

Jessica Polfjärd

Proposal for a directive

Recital 61

Text proposed by the Commission

Amendment

(61) When a compulsory licence has been granted by a relevant authority in the Union to tackle a public health emergency, regulatory data protection may, if still in force, prevent the effective use of the compulsory licence as they impede the authorisation of generic medicinal products, and thus access to the medicinal products needed to address the crisis. For this reason, data and market protection should be suspended when a compulsory licence has been issued to tackle a public health emergency. Such a suspension of the regulatory data protection should be allowed only in relation to the compulsory licence granted and its beneficiary. The suspension shall comply with the objective, the territorial scope, the duration and the subject matter of the granted compulsory licence.

deleted

Or. en

Justification

The criteria for a situation described as “emergency mode” or “crisis mode” that would activate the option for compulsory licensing are defined in such an ambiguous way as it currently is formulated, that the compulsory license could be subject to scenarios beyond public health emergency and threats. It is also not clear what the wording “suspension” would mean of data and market protection and its impacts on products marketed under a union compulsory license.

Amendment 271

Margrete Auken

Proposal for a directive

Recital 61

Text proposed by the Commission

Amendment

(61) When a compulsory licence has been granted by a relevant authority in the, regulatory data protection, market protection and market exclusivity may, if still in force, prevent the effective use of the compulsory licence as they impede the authorisation of generic medicinal products, and thus access to the medicinal products needed. For this reason, data and market protection and exclusivity should be suspended when a compulsory licence has been issued. Such a suspension of the regulatory data protection, market protection and market exclusivity should be allowed only in relation to the compulsory licence granted and its beneficiary. The suspension shall comply with the objective, the territorial scope, the duration and the subject matter of the granted compulsory licence. Where necessary to safeguard public health, national competent authorities should be able to also reduce the duration of market and data protection and market exclusivity for medicinal products that are not protected by a patent or a supplementary protection certificate.

Or. en

Amendment 272

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 61

Text proposed by the Commission

Amendment

(61) When a compulsory licence has been granted by a relevant authority in the Union to safeguard public health ,[A1] regulatory data protection may, if still in force, prevent the effective use of the compulsory licence as they impede the authorisation of generic medicinal products, and thus access to the medicinal products needed to address a crisis or safeguard public health interests as determined on a Member State level. For this reason, data and market protection should be suspended when a compulsory licence has been issued to safeguard public health.. Such a suspension of the regulatory data protection should be allowed only in relation to the compulsory licence granted and its beneficiary. The suspension shall comply with the objective, the territorial scope, the duration and the subject matter of the granted compulsory licence.

Or. en

Amendment 273

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 61 a (new)

Text proposed by the Commission

Amendment

(61 a) The WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) provides for a possibility, under conditions, to issue compulsory licences. This provides governments the authority to grant the use of a patented invention without the consent of the patent owner. The Doha Declaration on the TRIPS Agreement and Public Health provides that each WTO Member has not only the right to grant compulsory licences, but also the freedom to determine the grounds upon which such licences are granted.

Or. en

Amendment 274

Jessica Polfjärd

Proposal for a directive

Recital 62

Text proposed by the Commission

Amendment

(62) The suspension of the regulatory data protection should be granted only for the duration of the compulsory licence. A ‘suspension‘ of data and market protection in cases of public health emergency shall mean that data and market protection shall produce no effect in relation to the particular licensee of the compulsory licence while that compulsory licence is in effect. When the compulsory licence ends, the data and market protection shall resume their effect. The suspension should not result in an extension of the original duration.

deleted

Or. en

Justification

Amendment 275

Margrete Auken

Proposal for a directive

Recital 62

Text proposed by the Commission

Amendment

(62) The suspension of the regulatory data protection should be granted only for the duration of the compulsory licence. A ‘suspension‘ of data and market protection and market exclusivity shall mean that data and market protection and market exclusivity shall produce no effect in relation to the particular licensee of the compulsory licence while that compulsory licence is in effect. When the compulsory licence ends, the data and market protection shall resume their effect. The suspension should not result in an extension of the original duration.

Or. en

Amendment 276

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 62

Text proposed by the Commission

Amendment

(62) The suspension of the regulatory data protection should be granted only for the duration of the compulsory licence. A ‘suspension‘ of data and market protection to safeguard public health shall mean that data and market protection shall produce no effect in relation to the particular licensee of the compulsory licence while that compulsory licence is in effect. When the compulsory licence ends, the data and market protection shall resume their effect. The suspension should not result in an extension of the original duration.

Or. en

Amendment 277

Maria Angela Danzì

Proposal for a directive

Recital 63

Text proposed by the Commission

Amendment

(63) It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal relevant product, without this being considered patent or Supplementary Protection Certificate (SPC) infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products, on day one after loss of the patent or SPC protection to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessments, obtaining pricing and reimbursement, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member Stateof the patent or SPC, for the relevant product or process, there can be placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Or. en

Amendment 278

Pietro Fiocchi

Proposal for a directive

Recital 63

Text proposed by the Commission

Amendment

(63) It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products, without this being considered patent or Supplementary Protection Certificate ( SPC infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce pr ices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio hybrid medicinal products, on day one after loss of the patent or SPC protection , to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies, trials and other activities needed for the regulatory approval process or administrative purposes , health technology assessments, obtaining pricing and reimbursement, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member State of the patent or SPC , for the relevant product or process , there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Or. en

Amendment 279

Dolors Montserrat, Massimiliano Salini, Nathalie Colin-Oesterlé, Stelios Kympouropoulos, Tomislav Sokol

Proposal for a directive

Recital 63

Text proposed by the Commission

Amendment

(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products, on day one after loss of the patent or SPC protection, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessments, obtaining pricing and reimbursement, and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member State of the patent or SPC the reference medicinal relevant product or process, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Or. en

Amendment 280

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Recital 63

Text proposed by the Commission

Amendment

(63) It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products without this being considered patent or Supplementary Protection Certificate (SPC) infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal product on day one after loss of the patent or SPC protection, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment, obtaining pricing and reimbursement decisions, the public and private procurement of medicinal products to be supplied immediately after ex piry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member State of the patent or SPC for the relevant product or or process, there can be no placing on the market in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01).

Or. en

Amendment 281

Tomislav Sokol

Proposal for a directive

Recital 63

Text proposed by the Commission

Amendment

(63) It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products, without this being considered patent or Supplementary Protection Certificate (SPC) infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular of generic, biosimilar, hybrid and bio-hybrid medicinal products on day one after after the loss of the patent or SPC protection, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessments, pricing and reimbursement, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member Stat of the patent or SPC for the relevant product or process, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Or. en

Amendment 282

Sirpa Pietikäinen

Proposal for a directive

Recital 63

Text proposed by the Commission

Amendment

(63) It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products without this being considered patent or Supplementary Protection Certificate (SPC) infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products on day one after loss of the patent or SPC protection to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment, obtaining pricing and reimbursement, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a Member State of the patent or SPC, for the relevant product or process, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Or. en

Amendment 283

Cristian-Silviu Buşoi

Proposal for a directive

Recital 63

Text proposed by the Commission

Amendment

(63) It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products ,on day one after loss of the patent or SPC protection to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conducting studies, trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessments, obtaining pricing and reimbursement, the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC and complying with other regulatory or administrative requirements, including after a marketing authorisation has been granted, even though this may require substantial amounts of test production to demonstrate reliable manufacturing, both by the applicants and by third party suppliers or service providers. During the term of protection in a MS of the patent or SPC for therelevant medicinal product or process, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Or. en

Amendment 284

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 63

Text proposed by the Commission

Amendment

(63) The timely entry of generics and biosimilars onto the Union market is important, notably to increase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines by patients in the EU. The importance of such timely entry has been underlined by the Council in its conclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its Member States. It is currently possible for applicants for marketing authorisation of medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain regulatory approvals and variations thereof, without this being considered patent or Supplementary Protection Certificate (SPC) infringement.

Or. en

Amendment 285

Marian-Jean Marinescu

Proposal for a directive

Recital 63

Text proposed by the Commission

Amendment

(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain and vary regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal relevant product, without this being considered patent or Supplementary Protection Certificate (SPC) infringement. The application of this limited exemption is however fragmented across the Union and the objective of enabling a day-one entry of generic and biosimilar medicinal products has not been fully achieved. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. It is considered necessary, in order to facilitate the market entry of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products, on day one after loss of the patent or SPC protection , to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process, health technology assessment and pricing reimbursement request, even though this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Or. en

Justification

It is important to reiterate the scope of Bolar clause and it`s objective of allowing day-one launch after protections expire.

Amendment 286

Heléne Fritzon

Proposal for a directive

Recital 63

Text proposed by the Commission

Amendment

(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate the market entry of generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, on day one after loss of the patent and SPC protection of the said reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The timely entry of generic and biosimilar medicinal products into the Union market is important in order to increase competition, reduce prices, ensure that national healthcare systems are sustainable and improve patients’ access to affordable medicines. The exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process, health technology assessment and for obtaining pricing and reimbursement, even though this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no placing on the market of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Or. en

Justification

Support and clarify the expansion in scope of the exemption to the protection of intellectual property rights (so-called ‘Bolar’ exemption) for the purpose of bringing generics and biosimilars products to the market as soon as the relevant patent and SPC protection expire (‘day-one competition’), hence promoting affordability.

Amendment 287

Ondřej Knotek, Billy Kelleher

Proposal for a directive

Recital 63

Text proposed by the Commission

Amendment

(63) It is currently possible for applicants for marketing authorisation of generic, biosimilar, hybrid and bio-hybrid medicinal products to conduct studies, trials and the subsequent practical requirements necessary to obtain regulatory approvals for those medicinal products during the term of protection of the patent or Supplementary Protection Certificate (SPC) of the reference medicinal product, without this being considered patent or SPC infringement. The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate the market entry on day-one of medicinal products, in particular generic, biosimilar, hybrid and bio-hybrid medicinal products that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The entry of generic, biosimilar, hybrid and bio-hybrid into the Union market on day-one is necessary to increase competition, improve patient's access to affordable medicines and reduce the pressure on national healthcare systems. The exemption must be confined to conduct studies and trials and other activities needed for the regulatory approval process or administrative purposes, health technology assessment and to obtain pricing reimbursement request, even though this may require substantial amounts of test production to demonstrate reliable manufacturing. During the term of protection of the patent or SPC of the reference medicinal product, there can be no commercial use of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Or. en

Amendment 288

Margrete Auken

Proposal for a directive

Recital 63

Text proposed by the Commission

Amendment

Or. en

Amendment 289

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 63 a (new)

Text proposed by the Commission

Amendment

(63 a) The application of this limited exemption is however fragmented across the Union and it is considered necessary, in order to facilitate entering the market of any Member State of medicinal products and in particular generic, biosimilar, hybrid and bio-hybrid medicinal products, upon expiry of the corresponding patent or supplementary protection certificate (EU ‘Day-one’ entry) that rely on a reference medicinal product, to clarify its scope in order to ensure a harmonised application in all Member States, both in terms of beneficiaries and in terms of activities covered. The exemption must be confined to conduct studies, trials and other activities needed for the administrative or regulatory approval process, health technology assessment and and for obtaining pricing and reimbursement, as well as the public and private procurement of medicinal products to be supplied immediately after tbe expiry of the corresponding patent or supplementary protection certificate), even though this may require substantial amounts of test production to demonstrate reliable manufacturing both by the applicant or third party suppliers or service providers. During the term of protection of the patent or SPC of the medicinal product, there can be no placing on the market (within the meaning of the Commission Notice – The ‘Blue Guide’ on the implementation of EU product rules 2022 2022/C 247/01) in that Member State) of the resulting final medicinal products obtained for the purposes of the regulatory approval process.

Or. en

Amendment 290

Maria Angela Danzì

Proposal for a directive

Recital 64

Text proposed by the Commission

Amendment

(64) It will allow, inter alia, to conduct studies to support pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the purpose of seeking marketing authorisations during that period, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct activities to support to support regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of active substances for the aforementioned purposes, contributing to the timely market entry medicinal products, in particular the market entry of generics and biosimilars, on day one after loss of the patent or SPC protection, under fair competitive conditions.

Or. en

Amendment 291

Joanna Kopcińska, Andrey Slabakov

Proposal for a directive

Recital 64

Text proposed by the Commission

Amendment

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct studies activities to support regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the aforementioned purposes of seeking marketing authorisations during that period, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one after of loss of the patent or SPC protection under fair competitive conditions.

Or. en

Amendment 292

Dolors Montserrat, Massimiliano Salini, Nathalie Colin-Oesterlé, Stelios Kympouropoulos

Proposal for a directive

Recital 64

Text proposed by the Commission

Amendment

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct activities to support regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of patent protected active substances for the aforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars, on day one after loss of the patent or SPC protection, under fair competitive conditions.

Or. en

Amendment 293

Sirpa Pietikäinen

Proposal for a directive

Recital 64

Text proposed by the Commission

Amendment

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct activities to support regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of active substances for the aforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one after loss of the patent or SPC protection, under fair competitive conditions.

Or. en

Amendment 294

Tomislav Sokol

Proposal for a directive

Recital 64

Text proposed by the Commission

Amendment

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct activities to support regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of active substances for the aforementioned purpose, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one after loss of the patent or SPC protection, under fair competitive conditions.

Or. en

Amendment 295

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Recital 64

Text proposed by the Commission

Amendment

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct activities to support regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of active substances for the aforementioned purposes contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars on day one after loss of the patent or SPC protection, under fair competitive conditions.

Or. en

Amendment 296

Cristian-Silviu Buşoi

Proposal for a directive

Recital 64

Text proposed by the Commission

Amendment

(64) It will allow all steps required to effectively launch on day-one after patent or SPC protection, inter alia, to conduct activities to support regulatory approval, health technology assessments, pricing and reimbursement and other regulatory procedures and requirements in the Union or elsewhere, including after a marketing authorisation has been granted, as well as the manufacture or purchase of active substances for the aforementioned purposes, contributing to the timely market entry of medicinal products, in particular the market entry of generics and biosimilars, on day one after loss of the patent or SPC protection, under fair competitive conditions.

Or. en

Amendment 297

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 64

Text proposed by the Commission

Amendment

(64) It will allow all steps required to effectively launch on day-one after patent and SPC protection, inter alia, to conduct activities to support regulatory approval, health technology assessment, pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the aforementioned purposes, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.

Or. en

Amendment 298

Heléne Fritzon

Proposal for a directive

Recital 64

Text proposed by the Commission

Amendment

(64) It will allow all steps required to effectively launch on day-one after patent and SPC protection, inter alia, to conduct activities to support regulatory approval, health technology assessment, pricing and reimbursement as well as the manufacture or purchase of patent protected active substances for the aforementioned purpose, contributing to the market entry of generics and biosimilars on day one of loss of the patent or SPC protection.

Or. en

Justification

Amendment 299

Sirpa Pietikäinen

Proposal for a directive

Recital 65

Text proposed by the Commission

Amendment

(65) The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product.

(65) Avoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions and a resolution of the European Parliament. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement or for the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC.

Or. en

Amendment 300

Cristian-Silviu Buşoi

Proposal for a directive

Recital 65

Text proposed by the Commission

Amendment

Or. en

Amendment 301

Maria Angela Danzì

Proposal for a directive

Recital 65

Text proposed by the Commission

Amendment

Or. en

Amendment 302

Adam Jarubas, Ewa Kopacz, Elżbieta Katarzyna Łukacijewska

Proposal for a directive

Recital 65

Text proposed by the Commission

Amendment

(65) Avoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council1a and the European Parliament1b. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement or for the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC.

_________________

1a Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States, (OJ C, C/269, 23.07.2016, p. 31) Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU, (2021/C 269 I/02)

1b European Parliament resolution of 2 March 2017 on EU options for improving access to medicine (2016/2057(INI))

Or. en

Amendment 303

Dolors Montserrat, Massimiliano Salini, Nathalie Colin-Oesterlé, Stelios Kympouropoulos, Tomislav Sokol

Proposal for a directive

Recital 65

Text proposed by the Commission

Amendment

(65) Avoiding that circumstances may encourage inappropriate market behaviours hampering the emergence of generic and biosimilar medicinal products, ensuring timely availability of generic and biosimilar medicinal products and ending patent linkage were highlighted as priorities by Council conclusions1a and a resolution of the European Parliament2a. The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC.

_________________

1a Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States. Council Conclusions on Access to medicines and medical devices for a Stronger and Resilient EU

2a European Parliament resolution of 2 March 2017 on EU options for improving access to medicine

Or. en

Amendment 304

Marian-Jean Marinescu

Proposal for a directive

Recital 65

Text proposed by the Commission

Amendment

(65) The competent authorities should refuse the validation for an application for a marketing authorisation referring to data of a reference medicinal product or for an application for pricing and reimbursement or for the public and private procurement of medicinal products to be supplied immediately after expiry of the relevant patents or SPC only on the basis of the grounds set out in this Directive. The same applies to any decision to grant, vary, suspend, restrict or revoke the marketing authorisation or pricing and reimbursement. The competent authorities cannot base their decision on any other grounds. In particular, those decisions cannot be based on the patent or SPC status of the reference medicinal product and cannot be subject to any requirements that expose an applicant to a risk of infringement of the relevant patent or SPC.

Or. en

Justification

This recital intends to remove patent linkage, i.e. the link between the status of patents/SPCs and regulatory or administrative decisions, as strongly stressed in the 2009 Report on the Pharmaceutical Sector Inquiry that defines patent linkage “unlawful”(p. 315) and potentially anticompetitive, as it is used strategically to delay generic and biosimilar market entry.

Amendment 305

Margrete Auken

Proposal for a directive

Recital 65 a (new)

Text proposed by the Commission

Amendment

(65 a) The One Health Approach is needed in order to address antimicrobial resistance, one of the biggest current health threats as it is estimated that more than 35 000 people in the EU/EEA and more than 1.2 million people globally die each year as a direct consequence of an infection due to bacteria resistant to antibiotics1a. High levels of cooperation are required across sectors and globally; this Directive puts in place coordinated action order to ensure prevention and minimisation of environmental risk assessment throughout the supply chain, use and disposal, awareness raising among patients, consumers and healthcare professionals and prudent and responsible use of antimicrobials;

_________________

1a 4 Murray, C.J.L., Ikuta, K.S., Sharara, F., et al. ‘Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis’, Lancet, Vol. 399, No 10325, pp. 629-655:

Or. en

Amendment 306

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 65 a (new)

Text proposed by the Commission

Amendment

(65 a) Under EU law, originator reference product patent protection status is not a criterion to be considered by authorities when granting a marketing authorisation, approving pricing or granting reimbursement status or any regulatory approval for a generic medicinal product, due to its anitcompetitive effects. In the context of the goals of the revision of the pharmaceutical framework, it is therefore appropriate to explicitly prohibit patent linkage practices in this context.

Or. en

Amendment 307

Margrete Auken

Proposal for a directive

Recital 66

Text proposed by the Commission

Amendment

(66) In order to address the challenge of antimicrobial resistance, antimicrobials should be packaged in quantities that are appropriate for the therapy cycle relevant for that product and national rules on antimicrobial subject to prescription ensure that they are dispensed in a way that corresponds to the quantities described by the prescription.

(66) In order to address the challenge of antimicrobial resistance, per unit dispensing of antimicrobials has been recognised as a core element in medical guidelines and the marketing authorisation holders should ensure, whenever possible, that antimicrobials may be dispensed in a number corresponding to the quantities prescribed by the treating physician. Dispensing the exact number of units needed would help address antimicrobial resistance as well as environmental impact related to stocking and waste. National rules on antimicrobial subject to prescription ensure that they are dispensed in a way that corresponds to the quantities described by the treating physician based on a personalised approach.

Or. en

Amendment 308

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen

Proposal for a directive

Recital 67

Text proposed by the Commission

Amendment

(67) The provision of information to healthcare professionals and to patients on the appropriate use, storage and disposal of antimicrobials is a joint responsibility of marketing authorisation holders and of Member States who should ensure appropriate collection system for all medicinal products.

(67) The provision of information to healthcare professionals and to patients on the appropriate use, storage and disposal of antimicrobials is a joint responsibility of marketing authorisation holders and of Member States. Member States should ensure appropriate collection system for all medicinal products.

Or. en

Amendment 309

Margrete Auken

Proposal for a directive

Recital 67

Text proposed by the Commission

Amendment

Or. en

Amendment 310

Peter Liese

Proposal for a directive

Recital 68

Text proposed by the Commission

Amendment

(68) While this Directive restricts the use of antimicrobials by setting certain categories of antimicrobials under prescription status, due to the growing antimicrobial resistance in the Union, competent authorities of the Member States should consider further measures for example expanding the prescription status of antimicrobials or the mandatory use of diagnostic tests before prescription. Competent authorities of the Member States should consider such further measures according to the level of antimicrobial resistance in their territory and the needs of patients.

(68) While this Directive restricts the use of antimicrobials by setting systemic antimicrobials under prescription status, due to the growing antimicrobial resistance in the Union, competent authorities of the Member States should consider further a number of measures, including expanding the prescription status of antimicrobials or the mandatory use of diagnostic tests before prescription. Additionally, the combined use of several antimicrobial active substances may represent a particular risk with respect to the development of antimicrobial resistance. Such combined use should therefore only be prescriped in exceptional cases where the benefit-risk balance of the combination is favourable. Competent authorities of the Member States should consider such further measures according to the level of antimicrobial resistance in their territory and the needs of patients.

Or. en

Justification

This approach aligns with the wording used in the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6). This consistency in regulatory language across different frameworks helps to maintain a uniform standard in managing the risk of antimicrobial resistance.

Amendment 311

Margrete Auken

Proposal for a directive

Recital 68

Text proposed by the Commission

Amendment

(68) While this Directive restricts the use of antimicrobials by setting certain categories of antimicrobials under prescription status, due to the growing antimicrobial resistance in the Union, competent authorities of the Member States should put in place further measures, where appropriate, for example expanding the prescription status of antimicrobials or the mandatory use of diagnostic tests before prescription. Competent authorities should ensure availability of rapid diagnostic tests in the Member States and should consider such further measures according to the level of antimicrobial resistance in their territory and the needs of patients.

Or. en

Amendment 312

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 68 a (new)

Text proposed by the Commission

Amendment

(68 a) In line with European Green Deal and the European Union Strategic Approach to Pharmaceuticals in the Environment, this regulatory framework should also contribute to avoiding potential risks to the environment. The evaluation of the framework showed that strengthened measures to reduce the environmental impact of medicinal products in the would be necessary.

Or. en

Amendment 313

Margrete Auken

Proposal for a directive

Recital 69

Text proposed by the Commission

Amendment

(69) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem, and there is scientific evidence that the presence of those substances in the environment from their manufacturing, use and disposal poses a risk to the environment and public health. The evaluation of the legislation showed that strengthening of existing measures to reduce the impact of medicinal products' lifecycle on the environment and public health is required. Measures under this Regulation complement the main environmental legislation, in particular the Water Framework Directive (2000/60/EC50 ), the Environmental Quality Standard Directive (2008/105/EC51 ) the Groundwater Directive (2006/118/EC52 ), the Urban Wastewater Treatment Directive (91/271/EEC53 ), the Drinking Water Directive (2020/218454 ) and the Industrial Emissions Directive (2010/75/EU55 ).

(69) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem, and there is scientific evidence that the presence of those substances in the environment from their manufacturing, use and disposal poses a risk to the environment and public health. The evaluation of the legislation showed that strengthening of existing measures to reduce the impact of medicinal products' lifecycle on the environment and public health is required. Measures under this Directive complement the main environmental legislation, in particular the Water Framework Directive (2000/60/EC50 ), the Environmental Quality Standard Directive (2008/105/EC51 ) the Groundwater Directive (2006/118/EC52 ), the Urban Wastewater Treatment Directive (91/271/EEC53 ), the Drinking Water Directive (2020/218454 ) and the Industrial Emissions Directive (2010/75/EU55 ).

_________________

50 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).

51 Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy, amending and subsequently repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/EC of the European Parliament and of the Council (OJ L 348, 24.12.2008, p. 84).

52 Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19).

53 Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40).

54 Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23.12.2020, p. 1).

55 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (recast) (OJ L 334, 17.12.2010, p. 17).

Or. en

Amendment 314

Stanislav Polčák

Proposal for a directive

Recital 69

Text proposed by the Commission

Amendment

(69) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem, and there is scientific evidence that the presence of those substances in the environment from their manufacturing, use and disposal poses a risk to the environment and public health. The evaluation of the legislation showed that strengthening of existing measures to reduce the impact of medicinal products' lifecycle on the environment and public health is required. Measures under this Regulation complement the main environmental legislation, in particular the Water Framework Directive (2000/60/EC50), the Environmental Quality Standard Directive (2008/105/EC51) the Groundwater Directive (2006/118/EC52), the Urban Wastewater Treatment Directive (91/271/EEC53), the Drinking Water Directive (2020/218454) and the Industrial Emissions Directive (2010/75/EU55).

(69) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem, and there is scientific evidence that the presence of those substances in the environment from their manufacturing, use and disposal poses a risk to the environment and public health. The evaluation of the legislation showed that strengthening of existing measures to reduce the impact of medicinal products' lifecycle on the environment and public health is required. Measures under this Regulation complement the main environmental legislation, in particular the Water Framework Directive (2000/60/EC[1]), the Environmental Quality Standard Directive (2008/105/EC[2]) the Groundwater Directive (2006/118/EC[3]), the Urban Wastewater Treatment Directive (91/271/EEC[4]), the Drinking Water Directive (2020/2184[5]), the Industrial Emissions Directive (2010/75/EU) and the Waste Framework Directive (2008/98/EC18a).

_________________

50 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).

52 Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19).

53 Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40).

54 Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23.12.2020, p. 1).

55 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (recast) (OJ L 334, 17.12.2010, p. 17).

Or. cs

Amendment 315

Fulvio Martusciello

Proposal for a directive

Recital 69

Text proposed by the Commission

Amendment

(69) The pollution of waters and soils with pharmaceutical residues is an emerging environmental problem, and there is scientific evidence that the levels of some of these substances may pose a risk to the environment from their manufacturing, use and disposal. The evaluation of the legislation showed that strengthening of existing measures to reduce the impact of medicinal products' lifecycle on the environment and public health is required. Measures under this Regulation complement the main environmental legislation, in particular the Water Framework Directive (2000/60/EC50 ), the Environmental Quality Standard Directive (2008/105/EC51 ) the Groundwater Directive (2006/118/EC52 ), the Urban Wastewater Treatment Directive (91/271/EEC53 ), the Drinking Water Directive (2020/218454 ) and the Industrial Emissions Directive (2010/75/EU55 ).

_________________

50 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).

52 Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (OJ L 372, 27.12.2006, p. 19).

53 Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ L 135, 30.5.1991, p. 40).

54 Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (recast) (OJ L 435, 23.12.2020, p. 1).

55 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (recast) (OJ L 334, 17.12.2010, p. 17).

Or. en

Amendment 316

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen

Proposal for a directive

Recital 69 a (new)

Text proposed by the Commission

Amendment

(69 a) A progressive reform towards unitary packaging of medicines, in particular in hospital pharmacies, could result in a decrease of the materials used for the packaging of medicines, a reduction of the carbon footprint of the transport of medicines, a reduction in medicines waste, a better management of pollution from pharmaceutical waste, a prevention of tension and shortages of medicines, and an innovative tool to fight against antimicrobial resistance. The use of single dose unit containing all usefull information, in hospital environnement, could represent an improvement in favor of minimizing the risk of medication errors and therefore increased patient protection.

Or. en

Amendment 317

Margrete Auken

Proposal for a directive

Recital 69 a (new)

Text proposed by the Commission

Amendment

(69 a) The wide use of pharmaceuticals in human and veterinary medicines, including antimicrobials, and their concentrations in many environmental reservoirs such as soils, sediments and waterbodies has increased in the past 20 years and their environmental concentration and prospected to grow in the coming years due to increased use and aging populations; the occurence of pharmaceutical substances in the environment negatively impact human health as well as wildlife and ecosystems; the chemical and metabolic stability of certain pharmaceuticals means that up to 90 % of their active substances are released into the environment in their original form after use.

Or. en

Amendment 318

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 69 a (new)

Text proposed by the Commission

Amendment

(69 a) There is strong scientific evidence that the emissions of active substances during manufacturing are a threat to the environment and public health. Therefore, the requirements to protect the environment and public health should be extended in order to cover the entire lifecycle of medicinal products, starting from manufacturing, through use and to disposal.

Or. en

Amendment 319

Margrete Auken

Proposal for a directive

Recital 69 b (new)

Text proposed by the Commission

Amendment

(69 b) There are currently 1,763 centrally authorised substances, yet, only 27 (1.5%) have sufficient empirical data for risk assessment and for 1,201 (68%) there is no monitoring nor ecotoxicological data currently available2b. This Directive should therefore aim to address this lack of monitoring data, lack of data on toxicity to environment, organisms and ecosystems.

_________________

2b Spilsbury (2023) “ Defining the Data Gap: What Do We Know about Environmental Exposure, Hazards and Risks of Pharmaceuticals in the European Aquatic Environment?” bioRxiv, doi: 10.1101/2023.07.10.548305.

Or. en

Amendment 320

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 70

Text proposed by the Commission

Amendment

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. The proven efficacy and safety of a medicinal product for human use should remain a top criteria in terms of marketing authorisation. However, applicants for marketing authorisation should ensure they complete the ERA in parallel with the marketing authorisation application to be able to sufficiently mitigate negative environmental impacts. The ERA should also evaluate the risks to the environment and public health, including antimicrobial resistance that arise in the manufacturing of medicinal products. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated in a timely manner when new data or knowledge about relevant risks become available and risk mitigation measures should be adapted accordingly. Moreover, to take into account the additional exposure resulting from the use of the medicinal product, the ERA should be updated in any case five years after the initial authorisation.

Or. en

Amendment 321

Erik Poulsen, Asger Christensen, Morten Løkkegaard

Proposal for a directive

Recital 70

Text proposed by the Commission

Amendment

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation could be refused. Refusal of a marketing authorization should not be considered if the medicinal product can be authorized under the conditional marketing authorization process or the Temporary Emergency Marketing Authorization in order to not prohibit or delay patient access to medicines. The ERA should be updated when new data or knowledge about relevant risks become available.

Or. en

Amendment 322

Susana Solís Pérez

Proposal for a directive

Recital 70

Text proposed by the Commission

Amendment

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures in instances where the ERA indicates that medicinal products may be hazardous to the environment. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment and does not rectify deficiencies highlighted by the Agency or relevant authority, the marketing authorisation holder should be subject to proportionate measures taken to ensure compliance while not hindering or postponing patient access to medications. The ERA should be updated when new data or knowledge about relevant risks become available.

Or. en

Amendment 323

Fulvio Martusciello

Proposal for a directive

Recital 70

Text proposed by the Commission

Amendment

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures where medicinal products are demonstrated to pose a risk to the environment according to the ERA. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, and fails to address short-comings indicated by the Agency or competent authority, the marketing authorisation shall be provisional while not prohibiting or delaying patient access to medicines. The ERA should be updated when new data that changes the ERA conclusions or evidence about relevant risks become available.

Or. en

Amendment 324

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a directive

Recital 70

Text proposed by the Commission

Amendment

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused. The ERA should be updated when new data or knowledge about relevant risks become available. The Commission may explore creating an ecolabeling of medicinal products which respect the ERA's guidelines during their entire life cycle.

Or. en

Amendment 325

Joanna Kopcińska

Proposal for a directive

Recital 70

Text proposed by the Commission

Amendment

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation should be refused unless health benefits from authorisation of medicine outweight the enviromental risk. The ERA should be updated when new data or knowledge about relevant risks become available.

Or. en

Amendment 326

István Ujhelyi

Proposal for a directive

Recital 70

Text proposed by the Commission

Amendment

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation holder should be subject to proportionate measures to establish compliance. The ERA should be updated when new data or knowledge about relevant risks become available.

Or. en

Amendment 327

Margrete Auken

Proposal for a directive

Recital 70

Text proposed by the Commission

Amendment

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment, they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment or the environmental risk is deemed unacceptable, the marketing authorisation should be refused. The ERA should be updated each time when new data or knowledge about relevant risks become available.

Or. en

Amendment 328

Jessica Polfjärd

Proposal for a directive

Recital 70

Text proposed by the Commission

Amendment

(70) Marketing authorisation applications for medicinal products in the Union should include an Environmental Risk Assessment (ERA) and risk mitigation measures. If the applicant fails to submit a complete or sufficiently substantiated environmental risk assessment or they do not propose risk mitigation measures to sufficiently address the risks identified in the environmental risk assessment, the marketing authorisation holder should be subject to proportionate measures to establish compliance. The ERA should be updated when new data or knowledge about relevant risks become available.

Or. en

Justification

Refusing or withdrawing a marketing authorization may cause delays in the authorization process or in the availability of products hence it risks jeopardizing patient’s timely access to innovative and very often life-saving therapies. Consequently, proportionate measures to establish compliance of market authorization holder that do not fulfil the ERA requirements are more appropriate.

Amendment 329

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 70 a (new)

Text proposed by the Commission

Amendment

(70 a) In exceptional cases where the ERA is incomplete due to missing data and this can be duly justified and substantiated by the marketing authorisation holder it should still be able to be placed on the market for reasons in the interest of public health, and with certain post authorisation conditions and oblgiations. Where a medicinal product has been authorised and the ERA is imcomplete for the reason above, the marketing authorisation holder should submit the completed ERA in the timeline agreed with the authorities and deliver upon any other post authorisation obligations.

Or. en

Amendment 330

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 70 b (new)

Text proposed by the Commission

Amendment

(70 b) Detailed requirements for an ERA should be set out in the annexes to this Directive for medicinal products that have been authorised prior to October 2005, i.e. prior to the requirement of submitting an ERA, and specific provisions should be introduced to set up a programme for the environmental risk assessement of those products that are identified as potentially harmful to the environment. Moreover, the establishment of a single Union assessment of the environmental properties of active substances for veterinary use by means of an active substance based review (‘monograph’) system could be potential alternative. Such a system should be set up by the Agency following a positive recommendation of the Commission.

Or. en

Amendment 331

Fulvio Martusciello

Proposal for a directive

Recital 71

Text proposed by the Commission

Amendment

(71) Marketing authorisation applicants should take into account environmental risk assessment procedures of other EU legal frameworks that may apply to chemicals dependent on their use. Further to this Regulation, there are four main other frameworks: (i) Industrial chemicals (REACH, (Regulation (EC) No 1907/2006); (ii) Biocides (Regulation (EC) No 528/2012); (iii) Pesticides (Regulation (EC) No 1107/2009); and (iv) Veterinary medicines (Regulation (EU) 2019/6)). As a part of the Green Deal, the Commission has proposed a ‘one-substance one-assessment’ (OS-OA) approach for chemicals56 , in order to increase the efficiency of the registration system, reduce costs and unnecessary animal testing.

(71) Marketing authorisation applicants should consider the relevance of environmental risk assessments of other EU legal frameworks that may apply to chemicals dependent on their use. Further to this Regulation, there are four main other frameworks: (i) Industrial chemicals (REACH, (Regulation (EC) No 1907/2006); (ii) Biocides (Regulation (EC) No 528/2012); (iii) Pesticides (Regulation (EC) No 1107/2009); and (iv) Veterinary medicines (Regulation (EU) 2019/6)). As a part of the Green Deal, the Commission has proposed a ‘one-substance one-assessment’ (OS-OA) approach for chemicals56 , in order to increase the efficiency of the registration system, reduce costs and unnecessary animal testing while not prohibiting or delaying patient access to medicinal products.

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56 Communication from the Commission to the European Parliament, the European Council, the Council, the European Economic and Social Committee and the Committee of the Regions, The European Green Deal, Brussels (2019), COM(2019) 640 final.

Or. en

Amendment 332

Margrete Auken

Proposal for a directive

Recital 72

Text proposed by the Commission

Amendment

(72) The emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to antimicrobial resistance (“AMR”), which is a global concern regardless where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobials, including manufacturing.

(72) Like every industrial sector, the production of medicines has a negative impact on the environment through CO2 emissions emitted by the medicine’s global supply chains and through pharmaceutical effluents from the production, use and disposal. In addition, the emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to antimicrobial resistance (“AMR”), which is a global concern regardless where the emissions and discharges take place. Therefore, addressing manufacturing, use and disposal through monitoring, assessing and preventing the negative impact, addressing inefficiencies and developing greener pharmaceuticals is crucial in order to mitigate threats to public health.

Or. en

Amendment 333

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 72

Text proposed by the Commission

Amendment

(72) The emissions and discharges of antimicrobials to the environment from manufacturing sites may lead to the proliferation of antimicrobial resistance (“AMR”), which is a global concern regardless of where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of AMR selection during the entire life cycle of antimicrobials, including manufacturing.

Or. en

Amendment 334

Pietro Fiocchi

Proposal for a directive

Recital 72

Text proposed by the Commission

Amendment

(72) The emissions and discharges of antibiotics to the environmental from manufacturing sites may lead to antibiotic resistance (‘’ABR’’), which is a global concern regardless of where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of antibiotic resistance selection during manufacturing of the antibiotics.

Or. en

Amendment 335

Fulvio Martusciello

Proposal for a directive

Recital 72

Text proposed by the Commission

Amendment

(72) The emissions and discharges of antibiotics to the environment from manufacturing sites may lead to antibiotic resistance (“ABR”), which is a global concern regardless where the emissions and discharges take place. Therefore, the ERA scope should be extended to cover the risk of antibiotic resistance selection during manufacturing of the antibiotics.

Or. en

Amendment 336

Margarita de la Pisa Carrión

Proposal for a directive

Recital 74

Text proposed by the Commission

Amendment

(74) For medicinal products authorised prior to October 2005, without any ERA, specific provisions should be introduced to set up a risk based prioritisation programme for the ERA submission or update by the market authorisation holders.

Or. en

Amendment 337

Fulvio Martusciello

Proposal for a directive

Recital 74

Text proposed by the Commission

Amendment

Or. en

Amendment 338

Margrete Auken

Proposal for a directive

Recital 74 a (new)

Text proposed by the Commission

Amendment

(74 a) In order to reduce duplication, optimise resources, reduce the use of animals in research, address current lack of understanding and resources on the individual and aggregated impact of pharmaceutical substances in the environment, and in line with the Aarhus Convention, all data related to the environmental risk assessment studies should be made publicly available and easily accessible in a database stablished by the Agency.

Or. en

Amendment 339

Pietro Fiocchi

Proposal for a directive

Recital 76

Text proposed by the Commission

Amendment

(76) To ensure that all children in the Union have access to the products specifically authorised for paediatric use, when an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other therapeutic indications, the marketing authorisation holder should be obliged to place the product in the same markets within two years of the date of approval of the indication.

(76) To ensure that all children in the Union have access to the products specifically authorised for paediatric use, when an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other therapeutic indications, the marketing authorisation holder should be obliged to make the medicinal product available to patients and the prescribing doctors who requested it in the same markets within two years of the date of approval of the indication.

Or. en

Amendment 340

Dolors Montserrat, Nathalie Colin-Oesterlé, Tomislav Sokol

Proposal for a directive

Recital 76

Text proposed by the Commission

Amendment

(76) To ensure that all children in the Union have access to the products specifically authorised for paediatric use, when an agreed paediatric investigation plan has led to the authorisation of a paediatric indication for a product already marketed for other therapeutic indications, the marketing authorisation holder should be obliged to make the product available for ordering for paediatric patients in the same markets within two years of the date of approval of the indication.

Or. en

Amendment 341

Sunčana Glavak

Proposal for a directive

Recital 76 a (new)

Text proposed by the Commission

Amendment

(76 a) For the purpose of paediatric marketing authorization of medicinal products already approved for use in adults, when the agreed paediatric investigation plan cannot be timely accomplished due to failure to conduct paediatric clinical studies, the competent authorities may consider the evidence obtained from extrapolation of adult data and from the appropriately designed post-marketing long-term studies for monitoring safety and efficacy.

Or. en

Amendment 342

Margrete Auken

Proposal for a directive

Recital 79

Text proposed by the Commission

Amendment

(79) As a general rule, risk management plans for generic and biosimilar medicinal products should not be developed and submitted, considering that the reference medicinal product has such a plan, except in specific cases, where a risk management plan should be provided. Furthermore, as a general rule a marketing authorisation for products other than generics should be granted for a period of five years in order to allow for the integration of real world evidence and re-assessment of the risk-benefit balance; once renewed, the marketing authorisation should be valid for an unlimited period unless the competent authority exceptionally decides that an additional five-year renewal or revocation of the marketing authorisation is necessary based on justified grounds related to the safety of the medicinal product.

Or. en

Amendment 343

Sirpa Pietikäinen

Proposal for a directive

Recital 90

Text proposed by the Commission

Amendment

(90) It is recognised that the development of pharmaceuticals is an area where neither science, nor technology stand still. The last decades have seen new categories of medicinal products emerging from biological medicinal products to biosimilars or advanced therapy medicinal products or in the future phages therapies. Those categories of products may in some instances require adapted rules to fully take account of their specific characteristics. For that reason a forward looking legal framework should include provisions to enable such adapted frameworks subject to strict criteria and under a Commission empowerment guided by the scientific input of the European Medicines Agency.

Or. en

Amendment 344

Margrete Auken

Proposal for a directive

Recital 91

Text proposed by the Commission

Amendment

(91) The adaptations may entail adapted, enhanced, waived or deferred requirements compared to standard medicinal products. They could in particular include changes to the dossier requirements for such medicinal products, the way their quality, safety and efficacy is demonstrated by applicants or tailored manufacturing controls and good manufacturing practices requirements, as well as additional control methods prior and during their administration and use. The adaptions should however not go beyond what is necessary for the attainment of the objective of adaptation to the specific characteristics.

(91) The adaptations may entail adapted, enhanced, waived or deferred requirements compared to standard medicinal products. They could in particular include changes to the dossier requirements for such medicinal products, the way their quality, safety, efficacy and environmental risk is demonstrated by applicants or tailored manufacturing controls and good manufacturing practices requirements, as well as additional control methods prior and during their administration and use. The adaptions should however not go beyond what is necessary for the attainment of the objective of adaptation to the specific characteristics.

Or. en

Amendment 345

Kateřina Konečná

Proposal for a directive

Recital 93

Text proposed by the Commission

Amendment

(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance.

(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products, including radionuclides and their salts for radionuclide radiopharmaceuticals, and cell and gene therapies, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use of a certification scheme also for additional master files, including quality master files, i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, chemical precursors for complex radiopharmaceuticals, radionuclides for radiolabelling purposes and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance, as well as for raw materials and starting materials used for manufacturing of cell therapy and gene therapy.

Or. en

Amendment 346

Susana Solís Pérez, Catherine Amalric, Ondřej Knotek

Proposal for a directive

Recital 93

Text proposed by the Commission

Amendment

(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products and cell and gene therapies, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance as well as for the raw and initial materials employed in the production of cell and gene therapies, such as cytokines, culture media, reagents, plasmids, and viral vectors.

Or. en

Amendment 347

István Ujhelyi

Proposal for a directive

Recital 93

Text proposed by the Commission

Amendment

(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products, marketing authorisation applicants should be able to rely on an active substance master file certificate or a monograph of the European Pharmacopeia, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by a monograph of the European Pharmacopeia or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, raw materials, viral vectors and other starting materials, growth media, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance.

Or. en

Amendment 348

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 93

Text proposed by the Commission

Amendment

(93) To optimise the use of resources for both applicants for marketing authorisation and competent authorities and avoid duplication of assessment of chemical active substances of medicinal products, marketing authorisation applicants should be able to rely on an active substance master file certificate, instead of submitting the relevant data as required in accordance with Annex II. An active substance master file certificate may be granted by the Agency when the relevant data on the active substance concerned is not already covered by or by another active substance master file certificate. The Commission should be empowered to establish the procedure for the single assessment of an active substance master file. To further optimise the use of resources, the Commission should be empowered to allow use a certification scheme also for additional quality master files i.e. for active substances other than chemical active substances, or for other substances present or used in the manufacture of a medicinal product, required in accordance with Annex II, e.g. in case of novel excipients, adjuvants, radiopharmaceutical precursors and active substance intermediates, when the intermediate is a chemical active substance by itself or used in conjugation with a biological substance.

Or. en

Amendment 349

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 100

Text proposed by the Commission

Amendment

(100) It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance.

(100) It is necessary to take account of changes arising as a result of international harmonisation of definitions, terminology and technological developments in the field of pharmacovigilance and digitalisation.

Or. en

Amendment 350

Margrete Auken

Proposal for a directive

Recital 101

Text proposed by the Commission

Amendment

(101) The increasing use of electronic networks for communication of information on adverse reactions to medicinal products marketed in the Union is intended to allow competent authorities to share the information at the same time. In that regard, patients, consumers and healthcare professionals who report adverse reactions should be able to opt in to be notified in case there exists any update on the safety profile of the products.

Or. en

Amendment 351

Margrete Auken

Proposal for a directive

Recital 104

Text proposed by the Commission

Amendment

(104) The use of colours in human and veterinary medicinal products is currently regulated by Directive 2009/35/EC of the European Parliament and of the Council60 , and restricted to those authorised in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives61 , for which specifications are laid down in Commission Regulation (EU) No 231/201262 . Uses of excipients other than colours in medicinal products are subject to the Union rules on medicinal products and are evaluated as part of the overall benefit risk profile of a medicinal product.

(104) The use of colours in human and veterinary medicinal products is regulated by Directive 2009/35/EC of the European Parliament and of the Council60 , and restricted to those authorised in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives61 , for which specifications are laid down in Commission Regulation (EU) No 231/201262 . Uses of excipients other than colours in medicinal products are subject to the Union rules on medicinal products and are evaluated as part of the overall benefit risk profile of a medicinal product.

_________________

60 Directive 2009/35/EC of the European Parliament and of the Council of 23 April 2009 on the colouring matters which may be added to medicinal products (OJ L 109, 30.4.2009, p. 10).

61 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16).

62 Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

Or. en

Amendment 352

Margrete Auken

Proposal for a directive

Recital 105

Text proposed by the Commission

Amendment

(105) Experience has shown the need to maintain to a certain extent the principle of the use in medicinal products of those colours authorised as food additives. However, it is also appropriate to foresee a specific assessment for the use of the colour in medicines when a food additive is removed from Union list of food additives. Therefore, in this specific case, EMA should carry out its own assessment for the use of the colour in medicines, taking into account the EFSA opinion and its underlying scientific evidence, as well as any additional scientific evidence and giving particular consideration to the use in medicines. EMA should also be responsible for following any scientific evidence for the colours retained for specific medicine use only. Directive 2009/35/EC should therefore be repealed.

(105) Experience has shown the need to maintain the principle of the use in medicinal products of those colours authorised as food additives. However, it is also appropriate to foresee, in exceptional circumstances, the necessity for a specific assessment for the use of the colour in medicines when a food additive is removed from Union list of food additives. Therefore, in this specific case, EMA should carry out its own assessment for the use of the colour in medicines, taking into account the EFSA opinion and its underlying scientific evidence, as well as any additional scientific evidence and giving particular consideration to the use in medicines. EMA should establish a list of substances which has been banned in food, but for specific reasons are still authorised in medicines. The authorisation of substances on the list should be limited to maximum additional five years. Within that period, marketing authorisation holders who use the excipients should conduct studies to ensure use of available alternatives complying with the Union list of food additives.

Or. en

Amendment 353

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 105

Text proposed by the Commission

Amendment

(105) Experience has shown the need to maintain to a certain extent the principle of the use in medicinal products of those colours authorised as food additives. However, it is also appropriate to foresee a specific assessment for the use of the colour in medicines when a food additive is removed from Union list of food additives when it has a functionality beyond colouring. Therefore, in this specific case, EMA should carry out its own assessment for the use of the colour in medicines, taking into account the EFSA opinion and its underlying scientific evidence, as well as any additional scientific evidence and giving particular consideration to the use in medicines. EMA should also be responsible for following any scientific evidence for the colours retained for specific medicine use only. Directive 2009/35/EC should therefore be repealed.

Or. en

Amendment 354

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 109

Text proposed by the Commission

Amendment

(109) There may be cases where manufacturing or testing steps of medicinal products need to take place in sites close to patients, for example advanced therapy medicinal products with short shelf-life. In such cases, these manufacturing or testing steps may need to be decentralised to multiple sites to reach patients across the Union. When the manufacturing or testing steps are decentralised, they should be carried out under the responsibility of the qualified person of an authorised central site. The decentralised sites should not require a separate manufacturing authorisation from the one granted to the relevant central site but should be registered by the competent authority of the Member State in which the decentralised site is established. In the case of medicinal products containing, consisting or derived from autologous SoHO, the decentralised sites have to be registered as a SoHO entity as defined in and pursuant to [SoHO Regulation] for the activities of donor review and eligibility assessment, donor testing and collection, or just for collection in the case of products manufactured for autologous use.

(109) There may be cases where manufacturing or testing steps of medicinal products need to take place in sites close to patients, for example advanced therapy medicinal products with short shelf-life. In such cases, these manufacturing or testing steps may need to be decentralised to multiple sites to reach patients across the Union. When the manufacturing or testing steps are decentralised, they should be carried out under the responsibility of the qualified person of an authorised central site. Additionally, in order to ensure smooth functioning of decentralised sites under this framework with the activities relevant for other Union legal frameworks, competent authorities of Member States supervising the decentralised site should coordinate their acitivities and supervisory tasks with the relevant authorities responsible for the supervision of the manufacturing or testing activities under other Union acts. The decentralised sites should not require a separate manufacturing authorisation from the one granted to the relevant central site but should be registered by the competent authority of the Member State in which the decentralised site is established. In the case of medicinal products containing, consisting or derived from autologous SoHO, the decentralised sites have to be registered as a SoHO entity as defined in and pursuant to [SoHO Regulation] for the activities of donor review and eligibility assessment, donor testing and collection, or just for collection in the case of products manufactured for autologous use.

Or. en

Amendment 355

Margrete Auken

Proposal for a directive

Recital 111

Text proposed by the Commission

Amendment

(111) Verification of compliance with the legal requirements of manufacturing, distribution and use of medicinal products by relevant entities through a system of supervision, is of fundamental importance to ensure that the objectives of this Directive are effectively achieved. Therefore, the competent authorities of the Member States should have the power to perform on site or remote inspections, as part of the system of supervision at all stages of manufacturing, distribution and use of medicinal products or active substances and rely on the outcome of inspections conducted by trusted third countries competent authorities. To preserve the effectiveness of the inspections, the competent authorities should have the possibility to perform joint inspections and also, where necessary, unannounced inspections.

Or. en

Amendment 356

Maria Angela Danzì

Proposal for a directive

Recital 118

Text proposed by the Commission

Amendment

(118) It is therefore appropriate to harmonise the basic principles applicable to the prescription status of medicinal products in the Union or in the Member State concerned, while taking as a starting point the principles already established on this subject by the Council of Europe as well as the work of harmonisation completed within the framework of the United Nations, concerning psychotropic or narcotic substances - the United Nations Single Convention of 1961 on narcotic drugs and Convention on Psychotropic Substances of 1971.

Or. en

Amendment 357

Catherine Amalric, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen

Proposal for a directive

Recital 123

Text proposed by the Commission

Amendment

(123) Certain Member States impose on wholesalers who supply medicinal products to pharmacists and on persons authorised to supply medicinal products to the public certain public service obligations. Those Member States should be able to continue to impose those obligations on wholesalers established within their territory. They should also be able to impose them on wholesalers in other Member States on condition that they do not impose any obligation more stringent than those that they impose on their own wholesalers and provided that such obligations may be regarded as warranted on grounds of public health protection and are proportionate in relation to the objective of such protection.

Or. en

Amendment 358

István Ujhelyi

Proposal for a directive

Recital 123

Text proposed by the Commission

Amendment

Or. en

Amendment 359

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen, Ondřej Knotek

Proposal for a directive

Recital 123 a (new)

Text proposed by the Commission

Amendment

(123 a) Pharmacists have always had a role in primary care, particularly to compound, dispense and sell medicinal products that patients need, to provide advice on their proper use and possible adverse effects and to support patients suffering of acute and chronic illnesses. As responsible for dispensing the medicinal products, pharmacists also monitor their proper use and compliance by the patient, provide advice in particular to avoid the risks of iatrogenics (all the undesirable effects caused by taking one or more medications) and carry out medication reviews. In an hospital environment, hospital pharmacists are even setting up pharmaceutical consultations and designing personalised pharmaceutical plans, in cooperation with health professionals, patients and carers. Hospital pharmacists and community pharmacists could play a major role in the progressive use of electronic package leaflets.

Or. en

Amendment 360

Margrete Auken

Proposal for a directive

Recital 125

Text proposed by the Commission

Amendment

(125) The provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information.

(125) Sharing accurate information with the general public in order to ensure trust in science and the regulatory system and supporting health literacy of patient and consumers is crucial. Competent authorities should also share up to date information with healthcare professionals, including pharmacists, and the scientific community. The provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information.

Or. en

Amendment 361

Margrete Auken

Proposal for a directive

Recital 127

Text proposed by the Commission

Amendment

(127) The use of electronic and technological possibilities other than paper package leaflets can facilitate access to medicinal products, medicinal products distribution and should always guarantee equal or better quality of information to all patients compared to the paper form of product information.

(127) The use of electronic and technological possibilities other than paper package leaflets, which is complementary to the paper leaflets which are crucial for patients with limited digital health literacy, can facilitate access to medicinal products, medicinal products distribution and should always guarantee equal quality of information to all patients compared to the paper form of product information. Ensuring the protection of personal data pursuant to Regulation 2016/679 and prohibition of the identification, profiling or tracking of individuals is necessary in this regard.

Or. en

Amendment 362

Margrete Auken

Proposal for a directive

Recital 128

Text proposed by the Commission

Amendment

(128) Member States have varying levels of digital literacy and internet access. In addition, patient and healthcare professional needs may differ. It is therefore necessary that Member States have a discretion on the adoption of measures enabling the electronic provision of product information while ensuring that no patient is left behind, taking into account the needs of different age categories and the different levels of digital literacy in the population, and making sure that product information is easily accessible to all patients. Member States should progressively allow the possibility for electronic product information, while ensuring full compliance with the rules on protection of personal data, and adhere to harmonised standards developed at EU level.

(128) Member States have varying levels of digital literacy and internet access. In addition, patient and healthcare professional needs may differ. It is therefore necessary that Member States have a discretion on the adoption of measures enabling the electronic provision of product information while ensuring that no patient is left behind, taking into account the needs of different age categories and the different levels of digital literacy in the population, and making sure that product information is easily accessible to all patients. Member States should progressively allow the possibility for electronic product information, as an addition to the paper leaflet, while ensuring full compliance with the rules on protection of personal data, and adhere to harmonised standards developed at EU level. The information in digital format should be easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet.

Or. en

Amendment 363

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen, Ondřej Knotek

Proposal for a directive

Recital 128

Text proposed by the Commission

Amendment

Or. en

Amendment 364

Margrete Auken

Proposal for a directive

Recital 129

Text proposed by the Commission

Amendment

(129) Where Member States decide that the package leaflet should be made available in principle only electronically, they should also ensure that a paper version of the package leaflet is to be made available on demand and without additonal cost to patients. They should also ensure that the information in digital format is easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet.

deleted

Or. en

Justification

see recital 128

Amendment 365

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 129

Text proposed by the Commission

Amendment

(129) Member States should make the package leaflet available electronically and they should also ensure that a paper version of the package leaflet is provided.. They should also ensure that the information in digital format is easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode, which would direct the patient to the electronic version of the package leaflet. However, Member States should be able to choose to use only electronic leaflets for a limited range of medicinal products dispensed to in hospital patients where the provision of medical information can be ensured by a health professional. The Commission should be empowered in the future to, by means of delegated acts, transition completely to electronic leaflets.

Or. en

Amendment 366

Sirpa Pietikäinen

Proposal for a directive

Recital 129

Text proposed by the Commission

Amendment

(129) Where Member States decide that the package leaflet should be made available in principle only electronically, they should also ensure that a paper version of the package leaflet is, by default, available on demand and without additonal cost to patients, for example printed by pharmacies. They should also ensure that the information in digital format is easily accessible to all patients, for instance by including in the outer packaging of the product a digitally readable barcode or a QR code, which would direct the patient to the electronic version of the package leaflet.

Or. en

Amendment 367

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Susana Solís Pérez, Erik Poulsen, Ondřej Knotek

Proposal for a directive

Recital 130

Text proposed by the Commission

Amendment

(130) The use of multi-language packages can be a tool for access to medicinal products, in particular for small markets and in public health emergencies. Where multi-language packages are used, Member States may allow the use on the labelling and package leaflet of an official language of the Union that is commonly understood in the Member States where the multi-language package is marketed. While electronic medicinal product information will facilitate their redistribution between Member States, language requirements on labels will remain a challenge. Removing the obligation for an official language and introducing the obligation to use the international non-proprietary name for medicinal products not intended for self-administration by the patient, in addition to providing electronic product information, could improve the availability of medicinal products and enable easier redistribution between Member States.

Or. en

Amendment 368

Nathalie Colin-Oesterlé

Proposal for a directive

Recital 130 a (new)

Text proposed by the Commission

Amendment

(130a) Medium-term harmonisation of the provisions on e-leaflets can be a tool to tackle the problem of shortages of medicinal products. The Commission should be empowered to swiftly harmonise requirements concerning paper or electronic formats. If the electronic format were made generally applicable, a single European system would have to ensure that patients had access to e-leaflets for their products.

Or. fr

Amendment 369

Alessandra Moretti

Proposal for a directive

Recital 131

Text proposed by the Commission

Amendment

(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial support, such as direct grants or contracts. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct financial support received from any public authority or public body to carry out any activities for the research and development of medicinal products.

(131) To ensure a high level of transparency on research and development costs of medicinal products, the reporting of all public contributions at any stage of the development, including but not limited to contracts, grants, tax breaks, and advance purchase agreements for the development, production and procurement of a particular medicinal product and its underlying technology and intellectual property should be a requirement for all all market authorizations for medical products. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any form of financial support received from any public authority or public body to carry out any activities for the research and development of medicinal products.

Or. en

Amendment 370

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 131

Text proposed by the Commission

Amendment

(131) To ensure a high level of transparency of public and private support to the research and development of medicinal products, the reporting of public and private contribution for the development of a particular medicinal product should be a requirement for all medicines. This should apply also to any independent legal entity from which it obtained a license in relation to the medicinal product in its previous phases of development. The information should be dissagregated to each stage of drug research and development, basic research, pre-clinical research, phase I, II, III of the clinical investigation of the medicinal product; as well as post-market studies. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct and indirect financial support received from any public authority or public body to carry out any activities for the research and development of medicinal products.

Or. en

Amendment 371

Margrete Auken

Proposal for a directive

Recital 131

Text proposed by the Commission

Amendment

(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public contribution for the development of a particular medicinal product should be a requirement for all medicines. The provisions of this Directive are without prejudice to the rules on the protection of confidential and personal data, and ensure transparency regarding any direct and indirect financial support received from any public authority, public body, philanthropic and other non-profit organisation including academia to carry out any activities for the research and development of medicinal products. In addition, when submitting a request for pricing and reimbursement, marketing authorisation holders should disclose, upon request, the company’s expenditure related to the research and development costs of the product.

Or. en

Amendment 372

Susana Solís Pérez

Proposal for a directive

Recital 131

Text proposed by the Commission

Amendment

(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial support, such as direct grants or contracts. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct financial support received from any EU public authority or EU public body to carry out any activities for the research and development of medicinal products.

Or. en

Amendment 373

István Ujhelyi

Proposal for a directive

Recital 131

Text proposed by the Commission

Amendment

(131) To ensure a high level of transparency of public support to the research and development of medicinal products, the reporting of public contribution for the development of a particular medicinal product should be a requirement for all medicines. Given however the practical difficulty to identify how indirect public funding instruments, such as tax advantages, have supported a particular product, the reporting obligation should only concern the direct public financial support, such as direct grants or contracts. Therefore, the provisions of this Directive ensure, without prejudice to the rules on the protection of confidential and personal data, transparency regarding any direct financial support received from any EU public authority or EU public body to carry out any activities for the research and development of medicinal products.

Or. en

Amendment 374

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 133

Text proposed by the Commission

Amendment

(133) In order to ensure a harmonised and consistent reporting of public contribution for the development of a particular medicinal products, the Commission should be able to adopt implementing acts to clarify the principles and format that the marketing authorisation holder should adhere to when reporting this information.

(133) In order to ensure a harmonised and consistent reporting of public and private contribution for the development of a particular medicinal products, the Commission should be able to adopt implementing acts to clarify the principles and format that the marketing authorisation holder should adhere to when reporting this information.

Or. en

Amendment 375

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 133 a (new)

Text proposed by the Commission

Amendment

(133 a) It is imperative to clarify in the legislative framework that all those products that have not been subject to an authorisation process provided for in this Directive or in [revised Regulation] and cannot be considered as a medicinal product, but rather as non-medicinal products, should not be presented to the public with pharmacological properties or unproven therapeutic benefits. The presentation and promotion of non-medicinal products for unauthorised therapeutic indications poses an obvious risk, which can encourage people to abandon science-based therapeutic treatments and put their health at risk. Products classified as non-medicinal must be explicitly prohibited from using these types of false claims linked to improving health. Likewise, citizens should be given the education and tools to reject and report such unsubstantiated health claims.

Or. en

Amendment 376

Margrete Auken

Proposal for a directive

Recital 135

Text proposed by the Commission

Amendment

(135) Advertising, even of medicinal products not subject to a prescription, could affect public health and distort competition. Therefore, advertising of medicinal products should meet certain criteria. Persons qualified to prescribe, administer or supply medicinal products can properly evaluate the information available in advertising because of their knowledge, training and experience. The advertising of medicinal products to persons who cannot properly assess the risk associated with their use may lead to medicinal product misuse or overconsumption which is liable to harm public health. Therefore advertisement to the general public of medicinal products that are available only on medical prescription should be prohibited. Furthermore, distribution of samples free of charge to the general public for promotional ends is to be prohibited, also teleshopping for medicinal products shall be prohibited pursuant to Directive 2010/13/EU of the European Parliament and of the Council65 . It should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarise themselves with new products and acquire experience in dealing with them.

(135) Advertising, even of medicinal products not subject to a prescription, could affect public health and distort competition. Therefore, advertising of medicinal products should meet certain criteria. The advertising of medicinal products to persons who cannot properly assess the risk associated with their use may lead to medicinal product misuse or overconsumption which is liable to harm public health. Therefore advertisement to the general public of medicinal products that are available only on medical prescription should be prohibited. Furthermore, distribution of samples free of charge to the general public for promotional ends is to be prohibited, also teleshopping for medicinal products shall be prohibited pursuant to Directive 2010/13/EU of the European Parliament and of the Council65 . It should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarise themselves with new products and acquire experience in dealing with them.

_________________

65 Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 095 15.4.2010, p. 1).

Or. en

Amendment 377

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 135

Text proposed by the Commission

Amendment

(135) Advertising, even of medicinal products not subject to a prescription, could affect public health and distort competition. Therefore, advertising of medicinal products should meet certain criteria ensuring high standards of protection. Persons qualified to prescribe, administer or supply medicinal products can properly evaluate the information available in advertising because of their knowledge, training and experience. The advertising of medicinal products to persons who cannot properly assess the risk associated with their use may lead to medicinal product misuse or overconsumption which is liable to harm public health. Therefore advertisement to the general public of medicinal products that are available only on medical prescription should be prohibited. Furthermore, distribution of samples free of charge to the general public for promotional ends is to be prohibited, also teleshopping for medicinal products shall be prohibited pursuant to Directive 2010/13/EU of the European Parliament and of the Council [1]. It should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarise themselves with new products and acquire experience in dealing with them.

_________________

Or. en

Amendment 378

Margrete Auken

Proposal for a directive

Recital 136

Text proposed by the Commission

Amendment

(136) Advertising of medicinal products should aim at disseminating objective and unbiased information about the medicinal product. For that purpose, it is expressly forbidden highlight negatively another medicinal product or to suggest that advertised medicinal product might be safer or more effective than another medicinal product. Comparison of medicinal products should only be allowed if such information is listed in the summary of product characteristics of the medicinal product being advertised. This prohibition covers any medicinal product, also biosimilars, and therefore it would be misleading to refer in the advertising, that a biosimilar medicinal product would not be interchangeable with the original biological medicinal product or another biosimilar from the same original biological medicinal product. Additional strict rules about negative and comparative advertising of competitor medicinal products will prohibit claims that can mislead persons qualified to prescribe, administer or supply them.

(136) Advertising of medicinal products should aim at disseminating objective and unbiased information about the medicinal product. For that purpose, it is expressly forbidden highlight negatively another medicinal product or to suggest that advertised medicinal product might be safer or more effective than another medicinal product. This prohibition covers any medicinal product, also biosimilars, and therefore it would be misleading to refer in the advertising, that a biosimilar medicinal product would not be interchangeable with the original biological medicinal product or another biosimilar from the same original biological medicinal product. Additional strict rules about negative and comparative advertising of competitor medicinal products will prohibit claims that can mislead persons qualified to prescribe, administer or supply them.

Or. en

Amendment 379

Margrete Auken

Proposal for a directive

Recital 138 a (new)

Text proposed by the Commission

Amendment

(138 a) While it is prohibited for companies to use celebrities for advertising of their medicinal products in the EU, patients and consumers are increasingly exposed to such promotional practices due to the global reach of social media. Online advertising, including on social media, may be initiated by companies in other regions or promoted be celebrities and influencers. Therefore, the Commission should assess the exposure and impact of pharmaceutical advertising and promotions online, and adopt specific rules to regulate such advertising and promotional practices and limit content exposure on consumers and patients which would be otherwise prohibited.

Or. en

Amendment 380

Margrete Auken

Proposal for a directive

Recital 139 a (new)

Text proposed by the Commission

Amendment

(139 a) Evidence gathered by healthcare professional organisations suggests that even minimal inducement may result in bias decisions in regard to prescription behaviour of physicians. In order to avoid conflict of interest and unethical or biased behaviours, full transparency about the relationship between the pharmaceutical industry and healthcare professionals and organisations should be guaranteed. Member States should maintain a transparency register of transfer of value regarding advertising activities, including hospitality at congresses and other events, which target persons qualified to prescribe medicinal products. The Commission should establish a web portal to list all national registers of transfers of value regarding to persons qualified to prescribe medicinal products.

Or. en

Amendment 381

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Recital 145

Text proposed by the Commission

Amendment

(145) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council66 .

(145) In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council[1].

_________________

66 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

Or. en

Amendment 382

Margrete Auken

Proposal for a directive

Recital 150

Text proposed by the Commission

Amendment

(150) This Directive seeks to enable the right access to preventive healthcare and to benefit from medical treatment under the conditions established by national laws and practices and to ensure a high level of human health protection in the definition and implementation of all the Union’s policies and activities as laid down in Article 35 of the Charter of Fundamental Rights of the European Union.

Or. en

Amendment 383

Nathalie Colin-Oesterlé

Proposal for a directive

Article premier – paragraph 1

Text proposed by the Commission

Amendment

1. This Directive lays down rules for the placing on the market, manufacturing, import, export, supply, distribution, pharmacovigilance, control and use of medicinal products for human use.

1. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.

Or. fr

Amendment 384

Peter Liese

Proposal for a directive

Article 1 – paragraph 2

Text proposed by the Commission

Amendment

2. This Directive shall apply to medicinal products for human use intended to be placed on the market.

2. The provisions of this Directive shall apply to industrially produced medicinal products for human use intended to be placed on the market in Member States.

Or. en

Justification

Removing the 'industrial production' limitation from this directive could lead to a narrower interpretation of the 'formula officinalis' exemption, risking the practice of compounding in pharmacies. Industrial processes differ from artisanal ones in both production methods and the quantities produced. Artisanal processes can be particularly important in providing care during supply shortages and in individual cases.

Amendment 385

Dolors Montserrat

Proposal for a directive

Article 1 – paragraph 2

Text proposed by the Commission

Amendment

2. This Directive shall apply to medicinal products for human use intended to be placed on the market.

2. This Directive shall apply to medicinal products for human use intended to be placed on the market in the Member States and which are either prepared industrially or manufactured by a method involving an industrial process.

Or. es

Justification

La elaboración de compuestos farmacéuticos por parte de farmacéuticos comunitarios y hospitalarios debe preservarse y promoverse aún más a nivel nacional como una solución para las necesidades médicas no satisfechas de poblaciones pequeñas, así como para la escasez de medicamentos para los que no existen alternativas adecuadas disponibles en los mercados, a través de una serie de regímenes nacionales que permiten la elaboración de compuestos farmacéuticos que se encuentran por debajo del umbral de ser de naturaleza 'industrial' o que involucran un 'proceso industrial' además de las exenciones de fórmulas magistrales y oficiales. No hay ningún análisis en la evaluación de impacto que sugiera que dichos regímenes, que han estado vigentes durante más de dos décadas, presenten deficiencias, particularmente a la luz de los beneficios de abordar las necesidades médicas no satisfechas y la escasez.Como tal, se debe dar una justificación clara y basada en la evidencia para respaldar la decisión de incluir ahora en el alcance todos los medicamentos, independientemente de su método de preparación, y se necesita una excepción clara para garantizar que las farmacias permanezcan exentas cuando mezclen utilizando productos no farmacéuticos.

Amendment 386

Margarita de la Pisa Carrión

Proposal for a directive

Article 1 – paragraph 2

Text proposed by the Commission

Amendment

2. This Directive shall apply to medicinal products for human use intended to be placed on the market.

2. This Directive shall apply to medicinal products for human use intended to be placed on the market in the Member States and which are industrially prepared or manufactured by a method involving an industrial process.

Or. en

Amendment 387

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Andreas Glück

Proposal for a directive

Article 1 – paragraph 2

Text proposed by the Commission

Amendment

2. This Directive shall apply to medicinal products for human use intended to be placed on the market.

2. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.

Or. en

Amendment 388

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 1 – paragraph 4

Text proposed by the Commission

Amendment

4. In cases where, taking into account all its characteristics, a product falls within the definition of a ‘medicinal product’ and within the definition of a product covered by other Union law and there is a conflict between this Directive and other Union law, the provisions of this Directive shall prevail.

4. In cases where, taking into account all its characteristics, questions arise as to the regulatory status of product or a product falls within the definition of a ‘medicinal product’ and within the definition of a product covered by other Union law and there is a conflict between this Directive and other Union legislation, the Agency and the advisory and regulatory bodies established in other Union legislation shall consult as relevant, in order to find consensus on the regulatory status of the product or the application of Union law to the product.

Or. en

Amendment 389

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 1 – paragraph 4 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

Where the Agency and the advisory and regulatory bodies established in other Union legislation cannot reach consensus on the regulatory status or Union law applicable to the product:

Or. en

Amendment 390

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 1 – paragraph 4 – point a (new)

Text proposed by the Commission

Amendment

(a) the Commission shall be empowered to take a decision on the regulatory status or the Union law applicable to the law in question, duly taking into account the relevant opinions and conclusions of the Agency and other advisory bodies and regulatory bodies established under Union law. This decision along with the supporting analysis and conclusion shall be made publicly available;

Or. en

Amendment 391

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 1 – paragraph 4 – point b (new)

Text proposed by the Commission

Amendment

(b) for transparency purposes, the respective opinions and conclusions of the Agency and the relevant advisory and regulatory bodies should be made publicly available.

Or. en

Amendment 392

Margrete Auken

Proposal for a directive

Article 1 – paragraph 5 – point b

Text proposed by the Commission

Amendment

(b) medicinal product prepared in a pharmacy in accordance with a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question (‘officinal formula’);

(b) medicinal product prepared in a pharmacy in accordance with a pharmacopoeia and intended to be supplied directly to the patients served by the pharmacy in question or to another pharmacy which intends to supply the medicinal product directly to the patient (‘officinal formula’);

Or. en

Amendment 393

Nathalie Colin-Oesterlé

Proposal for a directive

Article premier – paragraph 5 – point c a (new)

Text proposed by the Commission

Amendment

(ca) medicinal products prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital preparations’). Hospital preparations shall be dispensed on medical prescription to one or more patients by the pharmacy supplying the hospital.

Or. fr

Amendment 394

Margrete Auken

Proposal for a directive

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

Text proposed by the Commission

Amendment

(c a) medicinal product prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital formula’), supplied on medical prescription to one or several patients by the hospital’s pharmaceutical department.

Or. en

Amendment 395

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a directive

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

Text proposed by the Commission

Amendment

(c a) medicinal product prepared in advance, in duly justified cases, by the pharmaceutical department of a hospital (‘hospital formula’). Hospital formulae are supplied on medical prescription to one or several patients by the hospital’s pharmaceutical department.

Or. en

Amendment 396

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a directive

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

Text proposed by the Commission

Amendment

(c b) radiopharmaceuticals, prepared in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member State concerned to carry out such process, or in accordance with a pharmacopoeia and if the radiopharmaceutical is intended to be used in-house, for diagnostic as well as therapeutic applications.

Or. en

Amendment 397

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 1 – paragraph 6

Text proposed by the Commission

Amendment

6. Medicinal products referred to in paragraph 5, point (a), may be prepared in duly justified cases in advance by a pharmacy serving a hospital, on the basis of the estimated medical prescriptions within that hospital for the following seven days.

deleted

Or. en

Justification

The Directive does not apply to this (point 5)

Amendment 398

Kateřina Konečná

Proposal for a directive

Article 1 – paragraph 6

Text proposed by the Commission

Amendment

6. Medicinal products referred to in paragraph 5, point (a), may be prepared in advance by a pharmacy serving a hospital, on the basis of the estimated medical prescriptions within that hospital for a given period of time in duly justified cases, including medicine shortages as described in [revised Regulation (EC) No 726/2004] and supply disruptions caused by market withdrawals for commercial reasons.

By way of derogation from points (a) and (b) in paragraph 5, pharmacies may prepare medicinal products dispensed outside the hospital pharmacy on a routine basis in the situations described in the first subparagraph

Or. en

Amendment 399

Margrete Auken

Proposal for a directive

Article 1 – paragraph 6

Text proposed by the Commission

Amendment

6. Medicinal products referred to in paragraph 5, point (a), (b), (ca) and (cb), may be prepared in duly justified cases in advance by a pharmacy on the basis of the estimated medical prescriptions l within a time limit set based on the appropriate stability of the product.

Or. en

Amendment 400

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a directive

Article 1 – paragraph 6

Text proposed by the Commission

Amendment

Or. en

Amendment 401

István Ujhelyi

Proposal for a directive

Article 1 – paragraph 6

Text proposed by the Commission

Amendment

Or. en

Amendment 402

Margarita de la Pisa Carrión

Proposal for a directive

Article 1 – paragraph 6

Text proposed by the Commission

Amendment

6. Medicinal products referred to in paragraph 5, point (b), may be prepared in duly justified cases in advance by a pharmacy serving a hospital, on the basis of the estimated medical prescriptions within that hospital for the following seven days.

Or. en

Amendment 403

Margarita de la Pisa Carrión

Proposal for a directive

Article 1 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. The stipulations mentioned in paragraph 5, points (a) and (b), as well as paragraph 6, are contingent upon the provision that all referenced items are formulated to cater to the unique requirements of individual patients. Furthermore, these items must adhere to all protocols set forth by the Convention on the Elaboration of a European Pharmacopoeia. This includes conformity with all relevant general and specific Monographs that have been ratified in accordance with that Convention.

Or. en

Amendment 404

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 1 – paragraph 7

Text proposed by the Commission

Amendment

7. Member States shall take the necessary measures to develop the production and use of medicinal products derived from substances of human origin coming from voluntary unpaid donations.

7. Member States shall take the necessary measures to achieve autonomy of supply of substances of human origin, to develop the production and use of SoHO therapies and medicinal products derived from substances of human origin coming from voluntary unpaid donations, under the provisions on [Regulation (EC) repealing Directives 2002/98/EC and 2004/23/EC].

Or. en

Amendment 405

Margrete Auken

Proposal for a directive

Article 1 – paragraph 7

Text proposed by the Commission

Amendment

7. Member States shall take the necessary measures to develop the production and use of medicinal products derived from substances of human origin coming from voluntary unpaid donations.

7. Member States shall take the necessary measures to develop the production and use of medicinal products derived from substances of human origin coming from voluntary unpaid donations, in accordance with rules established under [SoHO Regulation].

Or. en

Amendment 406

Nicolás González Casares, Tiemo Wölken

Proposal for a directive

Article 1 – paragraph 10

Text proposed by the Commission

Amendment

10. This Directive shall not affect the application of national legislation prohibiting or restricting the following:

deleted

(a) the sale, supply or use of medicinal products as contraceptives or abortifacients;

(b) the use of any specific type of substance of human origin or animal cells, on grounds not dealt with in the aforementioned Union law;

(c) the sale, supply or use of medicinal products containing, consisting of or derived from these animal cells or substances of human origin, on grounds not dealt with in Union law.

Or. en

Justification

Already covered in point 8

Amendment 407

Peter Liese

Proposal for a directive

Article 1 – paragraph 10 – introductory part

Text proposed by the Commission

Amendment

10. This Directive shall not affect the application of national legislation prohibiting or restricting the following:

10. In accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union, and in line with the decisions of the European Court of Justice, this Directive shall not affect the application of national legislation prohibiting or restricting the following:

Or. en

Justification

The principle of subsidiarity is a cornerstone of the European Union's functioning. When it comes to sensitive and ethically nuanced matters such as the sale, supply, or use of medicinal products as contraceptives or abortifacients, the principle of subsidiarity takes on heightened significance.

Amendment 408

Catherine Amalric, Frédérique Ries, Max Orville, Billy Kelleher

Proposal for a directive

Article 1 – paragraph 10 – point a

Text proposed by the Commission

Amendment

(a) the sale, supply or use of medicinal products as contraceptives or abortifacients;

deleted

Or. en

Amendment 409

Tilly Metz

Proposal for a directive

Article 1 – paragraph 10 – point a

Text proposed by the Commission

Amendment

(a) the sale, supply or use of medicinal products as contraceptives or abortifacients;

deleted

Or. en

Amendment 410

Isabella Adinolfi, Sirpa Pietikäinen

Proposal for a directive

Article 1 – paragraph 10 – point a

Text proposed by the Commission

Amendment

(a) the sale, supply or use of medicinal products as contraceptives or abortifacients;

deleted

Or. en

Amendment 411

Malin Björk

Proposal for a directive

Article 1 – paragraph 10 – point a

Text proposed by the Commission

Amendment

(a) the sale, supply or use of medicinal products as contraceptives or abortifacients;

deleted

Or. en

Amendment 412

Susana Solís Pérez

Proposal for a directive

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared incidentally and exceptionally on a non-routine basis as defined in this paragraph and in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). For the purpose of this Article, 'non-routine basis' refers to the tailored preparation of an advanced therapy medicinal product under a hospital exemption, which occurs sporadically, under extraordinary circumstances, and is not part of a regular process, aimed at addressing the unique health requirements of a specific patient. This is applicable when no medicinal product with central authorization is accessible, nor is there a suitable clinical trial or program for compassionate use active for that particular medical need, for which the patient qualifies within the European Union.

Indicators that an activity is conducted routinely include: (a) production of a product through processes that are standardized or repetitive; (b) engagement in planning processes that extend beyond the immediate clinical requirements of individual patients.

The Agency is authorized to formulate guidelines for the practical application of what constitutes a 'non-routine basis'. In doing so, it shall engage with national regulatory authorities and key stakeholders, including entities holding hospital exemption approvals, the pharmaceutical industry, and patient groups. Reflecting advancements in science and technology, the Commission has the authority to update the definition of 'non-routine' through implementing acts.

Or. en

Amendment 413

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared incidentally and exceptionally on a non-routine basis as defined in this paragraph and in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a product custom-made to meet the special need of an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). For the purpose of this article “non-routine basis” means advanced therapy medicinal products, prepared on an incidental and exceptional basis to meet the special needs of an individual patient, where there is neither a centrally authorised medicinal product nor a relevant clinical trial or compassionate use program for the same indication with an advanced therapy medicinal product for which the patient is eligible [in the Union] and which shall not result in any one of the following conditions over the course a year: (a) standardised process; (b) repetitive process and (c) process involving pre-planning other than that which is required for an urgent ad-hoc situation.

Or. en

Amendment 414

István Ujhelyi

Proposal for a directive

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

Such use shall not be made in any one of the following situations:

(a) there is a similar advanced therapy medicinal product that is covered by a marketing authorisation granted under [revised Regulation (EC) No 726/2004] and the use in the individual patient is not excluded by the terms of the summary of product characteristics of that product or ;

(b) the individual patient is eligible for enrolment in an ongoing clinical trial or compassionate use programme for a similar advanced therapy medicinal product.

Or. en

Amendment 415

Maria Angela Danzì

Proposal for a directive

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient (‘advanced therapy medicinal products prepared under hospital exemption’). A non-routine basis entails a treatment scale that does not exceed the treatment capacity of a hospital. Member States shall ensure that only hospitals are granted hospital exemption approvals. A transition period of 5 years is granted to holders of a hospital exemption (public and private) that exceed preparation on a nonroutine basis to obtain a centralised marketing authorisation. During the transition period, deviations from a non-routine basis guarantee patient access. Member States shall ensure that the scope for use is centred around targeting unmet medical need, in situations when similar treatment is not available and/or affordable.

Or. en

Justification

Approvals should be granted per hospital where treatment occurs. The definition of non-routine should be centred around a treatment scale that is limited to the treatment capacity of the hospital. If the treatment scale exceeds the capacity of a hospital, or multiple hospitals provide one treatment under several licences, a transition period should be offered to enable centralised marketing authorisation and possible decentralised manufacturing.

Amendment 416

Pietro Fiocchi

Proposal for a directive

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

1. By way of derogation from Article 1(1), only this Article shall apply to advanced therapy medicinal products exceptionally prepared on a non-routine basis in accordance with the requirements set in paragraph 3 and used within the same Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a product custom-made to meet the special needs of an individual patient in cases of medical need when there is no suitable advanced therapy medicinal product available in the relevant indication, either as an authorised medicinal product, under a compassionate use programme referred to in Article 26 of [revised Regulation 726/2004] or under a clinical trial for which the patient is eligible [in the Union] (‘advanced therapy medicinal products prepared under hospital exemption’)

Or. en

Amendment 417

Cindy Franssen, Tom Vandenkendelaere

Proposal for a directive

Article 2 – paragraph 1

Text proposed by the Commission

Amendment

Or. en