Sittings · Document
On the proposal for a regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795
Committee on the Environment, Climate and Food Safety · Rapporteur: Michele Picaro
PA_Legam
SHORT JUSTIFICATION
The amendments proposed by the rapporteur in his opinion on the proposal for a Regulation of the European Parliament and of the Council laying down a framework for strengthening the availability and security of supply of critical medicinal products, as well as the availability and accessibility of medicinal products of common interest, and amending Regulation (EU) 2024/795, aim to boost EU manufacturing of critical medicines by fast-tracking permits, simplifying environmental assessments, and supporting strategic projects. The proposal also promotes better coordination among Member States and introduces limited reporting obligations.
To avoid unintended disruptions resulting from overlapping environmental and chemical legislation, a balanced, data-driven approach is needed, one that safeguards the availability of medicines while upholding high environmental standards. The rapporteur believes that coordination between pharmaceutical, environmental, and chemical legislation is essential to prevent negative impacts on patient access to medicines and to ensure the sustainability and competitiveness of the European pharmaceutical and healthcare sectors.
To ensure transparency, all data related to environmental assessments, authorisations, and planning should be easily accessible (including online) and presented clearly through a centralised portal. These procedures must be efficient, time-bound, and must not create undue financial or administrative burdens, aligned with international conventions.
Rapid timelines for activating strategic projects should be maintained, especially when urgent action is needed to respond to shortages of critical medicines.
AMENDMENTS
The Committee on the Environment, Climate and Food Safety submits the following to the Committee on Public Health, as the committee responsible:
Amendment 1
Proposal for a regulation
Recital 4
Text proposed by the Commission
Amendment
(4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. Setting up new, or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages and the need for specialised skills in pharmaceutical manufacturing further add to the industrial challenges to manufacturing in the Union. Targeted financial incentives, simplified administrative processes, and better Union-level coordination can contribute to supporting efforts to increase manufacturing capacities in the Union and strengthen the supply chains for critical medicines.
(4) Industrial challenges and a lack of investments in manufacturing capacities in the Union have contributed to increased dependency on third country suppliers, in particular, for key raw pharmaceutical materials and active substances. Setting up new, or modernising existing manufacturing capacities in the Union for critical medicinal products, their key inputs and active substances, which have often been on the market for a long time and are considered to be relatively inexpensive, is currently not seen as a sufficiently attractive option for private investment, also in view of lower energy costs, lesser environmental and other legal requirements elsewhere in the world. Workforce shortages and the need for specialised skills in pharmaceutical manufacturing further add to the industrial challenges to manufacturing in the Union. Targeted financial incentives, simplified administrative processes, upholding social, health and environmental standards, and better Union-level coordination can contribute to supporting efforts to increase manufacturing capacities in the Union and strengthen the supply chains for critical medicines.
Amendment 2
Proposal for a regulation
Recital 4 a (new)
Text proposed by the Commission
Amendment
(4a) The 2019 Commission Strategic Approach to Pharmaceuticals in the Environment acknowledges that pharmaceuticals may pose risks to the environment and human health and highlights the need for a comprehensive and proportionate strategy, consistent with the Union’s commitment to the One Health approach.
Amendment 3
Proposal for a regulation
Recital 17
Text proposed by the Commission
Amendment
(17) Certain projects can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for critical medicinal products and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects should be introduced. Given their role in ensuring the Union’s security of supply for critical medicinal products, the relevant permitting authority should consider strategic projects to be in the public interest. To ensure their expedient implementation, national authorities should ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law. National authorities should consider, when possible, their streamlining as well as enable digital submission of required information.
(17) Certain projects can have a positive impact on security of supply as they increase the Union’s manufacturing capacity for critical medicinal products and strengthen the resilience of the Union’s supply chains. In order to encourage private investments in these projects, the concept of strategic projects should be introduced. Given their role in ensuring the Union’s security of supply for critical medicinal products, the relevant permitting authority should consider strategic projects to be in the public interest. To ensure their expedient implementation, national authorities should ensure that the relevant permit granting processes are carried out in the fastest way possible making available, in particular any form of accelerated procedures that exists in applicable Union and national law, upholding social, health and environmental standards. National authorities should consider, when possible, their streamlining as well as enable digital submission of required information.
Amendment 4
Proposal for a regulation
Recital 18 a (new)
Text proposed by the Commission
Amendment
(18a) It is essential to ensure that the production of pharmaceutical products within the Union is conducted in a safe, responsible and sustainable manner over the long term, such as by reducing environmental pollution by manufacturing waste, this form of pollution may contribute to the spread of antimicrobial resistance, impact ecosystems and biodiversity, and thereby create possible risks for public health.
Amendment 5
Proposal for a regulation
Recital 19
Text proposed by the Commission
Amendment
(19) The production of medicinal products has environmental implications and may negatively impact not only the environment itself but also human health. The environmental assessments and authorisations required under Union law are an integral part of the permit-granting process for strategic projects and an essential safeguard to ensure negative environmental impacts are prevented or minimised. However, to ensure that permit-granting processes for strategic projects are predictable and timely, it should be possible to streamline the required assessments and authorisations by the relevant authority, while not lowering the level of environmental protection.
(19) The production of medicinal products has environmental implications and may negatively impact not only the environment itself but also human health. The environmental assessments and authorisations required under Union law are an integral part of the permit-granting process for strategic projects and an essential safeguard to ensure negative environmental impacts are prevented or minimised. However, to ensure that permit-granting processes for strategic projects are predictable and timely, it should be possible to streamline the required assessments and authorisations by the relevant authority, without undermining the quality and robustness of the assessments and while not lowering the level of health and environmental protection.
Amendment 6
Proposal for a regulation
Recital 24
Text proposed by the Commission
Amendment
(24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Procurement requirements based on such considerations should include stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery and measures in case of non-timely delivery.
(24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Procurement requirements based on such considerations should include an appropriate and predictable balance of qualitative criteria including product quality measured by patient impact and clinical value, environmental sustainability, such as the use of sustainable and innovative manufacturing technologies and the minimisation of active substance emissions during production, pharmaceutical innovation for patients, and the society, in addition to stockholding obligations, a number of diversified suppliers, state of the art monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery and measures in case of non-timely delivery.
Amendment 7
Proposal for a regulation
Recital 39
Text proposed by the Commission
Amendment
(39) The Union could further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union could, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties.
(39) The Union could further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union could, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties. Any such partnership should support a high level of safety, environmental protection, quality, and efficacy.
Amendment 8
Proposal for a regulation
Recital 41
Text proposed by the Commission
Amendment
(41) In order to ensure that this Regulation effectively meets its objectives, it is essential to assess its implementation and impact over time. The Commission should carry out an evaluation of this Regulation five years after its application and every five years thereafter. This evaluation should include an assessment of the extent to which the Regulation’s objectives, as set out in Article 1, have been achieved, including its impact on stakeholders, regulatory procedures, and market dynamics. In particular, the Commission’s evaluation should take into account the views of Member States, economic operators, and other relevant stakeholders, ensuring that their feedback contributes to the continuous improvement of the regulatory framework. The results of this evaluation should be presented to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. In order to facilitate this evaluation, national authorities and economic operators should provide relevant data and information upon request to support the Commission’s assessment.
(41) In order to ensure that this Regulation effectively meets its objectives, it is essential to assess its implementation and impact over time. The Commission should carry out an evaluation of this Regulation five years after its application and every five years thereafter. This evaluation should include an assessment of the extent to which the Regulation’s objectives, as set out in Article 1, have been achieved, including its impact on stakeholders, regulatory procedures, and market dynamics. In particular, the Commission’s evaluation should take into account the views of Member States, economic operators, and other relevant stakeholders, ensuring that their feedback contributes to the continuous improvement of the regulatory framework. At the same time and to safeguard the availability and security of supply of critical medicinal products, all market actors, competent authorities, Member States and the Commission should ensure that all barriers, such as regulatory, economic and market-based, are identified and evaluated as part of the Commission’s assessment on the achievement of the objectives of this Regulation. The results of this evaluation should be presented to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. In order to facilitate this evaluation, national authorities and economic operators should provide relevant data and information upon request to support the Commission’s assessment.
Amendment 9
Proposal for a regulation
Recital 41 a (new)
Text proposed by the Commission
Amendment
(41a) This Regulation should be implemented in line with existing Union legislation. Where the evaluation has identified that such legislation has the possibility to impact in an adverse manner on the accessibility, availability or affordability of medicinal products, the Commission should carry out comprehensive, evidence-based assessments and, where appropriate, propose proportionate mitigating measures to safeguard supply, availability and affordability of medicinal products and to support the Union's competitiveness.
Amendment 10
Proposal for a regulation
Article 3 – paragraph 1 – point 13
Text proposed by the Commission
Amendment
(13) ‘innovative manufacturing process’ means a novel manufacturing process and technology or novel application of an existing technology, including, but not limited to, decentralised manufacturing, continuous manufacturing, Artificial Intelligence, platform techniques, 3D manufacturing;
(13) ‘innovative manufacturing process’ means a novel manufacturing process and technology or novel application of an existing technology, including, but not limited to, decentralised manufacturing, continuous manufacturing, yield improvements or other chemistry or biotechnology process that contribute to increasing the level of security, energy efficiency and environmental performance of the production, Artificial Intelligence, platform techniques, 3D manufacturing and sustainable manufacturing methods;
Amendment 11
Proposal for a regulation
Article 5 – paragraph 1 – point b
Text proposed by the Commission
Amendment
(b) it modernises an existing manufacturing site for one or more critical medicinal products or their active substances to ensure greater sustainability or increased efficiency;
(b) it modernises an existing manufacturing site for one or more critical medicinal products or their active substances to ensure greater environmental sustainability, overall sustainability or increased efficiency, such as innovative processes that improve production quality, resilience, or reliability;
Amendment 12
Proposal for a regulation
Article 7 – paragraph 2
Text proposed by the Commission
Amendment
The Member States’ authorities shall ensure that the relevant permit granting processes related to strategic projects are carried out in the fastest way possible, making available, in particular, any form of accelerated procedures that exists in applicable Union and national law.
The Member States’ authorities shall ensure that the relevant permit granting processes related to strategic projects are carried out in the fastest way possible, making available, in particular, any form of accelerated procedures that exists in applicable Union and national law, while ensuring compliance with the highest social, health and environmental standards.
Amendment 13
Proposal for a regulation
Article 12 – paragraph 1 – subparagraph 1
Text proposed by the Commission
Amendment
A project promoter may request, where the obligation to assess the effects on the environment arises simultaneously from two or more of Council Directive 92/43/EEC15 , Directive 2000/60/EC of the European Parliament and of the Council16 , Directive 2001/42/EC of the European Parliament and of the Council17 , Directive 2008/98/EC of the European Parliament and of the Council18 , Directive 2009/147/EC of the European Parliament and of the Council19 , Directive 2010/75/EU of the European Parliament and of the Council20 , Directive 2011/92/EU of the European Parliament and of the Council21 or Directive 2012/18/EU of the European Parliament and of the Council22 , that a coordinated or joint procedure fulfilling the requirements of those Union legislative acts are applied.
A project promoter may request, where the obligation to assess the effects on the environment arises simultaneously from two or more of Council Directive 92/43/EEC15 , Directive 2000/60/EC of the European Parliament and of the Council16 , Directive 2001/42/EC of the European Parliament and of the Council17 ,Directive 2008/98/EC of the European Parliament and of the Council18 , Directive 2009/147/EC of the European Parliament and of the Council19 , Directive 2010/75/EU of the European Parliament and of the Council20 , Directive 2011/92/EU of the European Parliament and of the Council21 or Directive 2012/18/EU of the European Parliament and of the Council22 , that a coordinated or joint procedure fulfilling the requirements of those Union legislative acts are applied. The application of the joint or coordinated procedure shall not affect the content or quality of the environmental impact assessment.
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15 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7, ELI: http://data.europa.eu/eli/dir/1992/43/oj).
15 Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora (OJ L 206, 22.7.1992, p. 7, ELI: http://data.europa.eu/eli/dir/1992/43/oj).
16 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, ELI: http://data.europa.eu/eli/dir/2000/60/oj).
16 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, ELI: http://data.europa.eu/eli/dir/2000/60/oj).
17 Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment (OJ L 197, 21.7.2001, p. 30, ELI: http://data.europa.eu/eli/dir/2001/42/oj).
17 Directive 2001/42/EC of the European Parliament and of the Council of 27 June 2001 on the assessment of the effects of certain plans and programmes on the environment (OJ L 197, 21.7.2001, p. 30, ELI: http://data.europa.eu/eli/dir/2001/42/oj).
18 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3, ELI: http://data.europa.eu/eli/dir/2008/98/oj).
18 Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3, ELI: http://data.europa.eu/eli/dir/2008/98/oj).
19 Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7, ELI: http://data.europa.eu/eli/dir/2009/147/oj).
19 Directive 2009/147/EC of the European Parliament and of the Council of 30 November 2009 on the conservation of wild birds (OJ L 20, 26.1.2010, p. 7, ELI: http://data.europa.eu/eli/dir/2009/147/oj).
20 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17, ELI: http://data.europa.eu/eli/dir/2010/75/oj).
20 Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (OJ L 334, 17.12.2010, p. 17, ELI: http://data.europa.eu/eli/dir/2010/75/oj).
21 Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012, p. 1, ELI: http://data.europa.eu/eli/dir/2011/92/oj).
21 Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012, p. 1, ELI: http://data.europa.eu/eli/dir/2011/92/oj).
22 Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC (OJ L 197, 24.7.2012, p. 1, ELI: http://data.europa.eu/eli/dir/2012/18/oj).
22 Directive 2012/18/EU of the European Parliament and of the Council of 4 July 2012 on the control of major-accident hazards involving dangerous substances, amending and subsequently repealing Council Directive 96/82/EC (OJ L 197, 24.7.2012, p. 1, ELI: http://data.europa.eu/eli/dir/2012/18/oj).
Amendment 14
Proposal for a regulation
Article 12 – paragraph 2
Text proposed by the Commission
Amendment
2. Member States shall ensure that the competent authorities issue the reasoned conclusion referred to in Article 1(2), point (g)(iv), of Directive 2011/92/EU on the environmental impact assessment within 45 days of receiving all necessary information.
2. Member States shall ensure that the competent authorities issue the reasoned conclusion referred to in Article 1(2), point (g)(iv), of Directive 2011/92/EU on the environmental impact assessment within 45 days of receiving all necessary information pursuant to Articles 5, 6 and 7 of that Directive and after completing the consultations referred to in Articles 6 and 7 of that Directive, with a possibility of extension by a maximum of 45 days in duly justified cases.
Amendment 15
Proposal for a regulation
Article 12 – paragraph 5 a (new)
Text proposed by the Commission
Amendment
5a. Member States shall ensure that their competent authorities and other authorities designated pursuant to Article 6(1) of Directive 2011/92/EU have a sufficient number of qualified staff and sufficient financial, technical and technological resources necessary to fulfil their obligations under this Article.
Amendment 16
Proposal for a regulation
Article 13 – paragraph 1
Text proposed by the Commission
Amendment
1. National, regional and local authorities responsible for preparing plans, including zoning, spatial plans and land use plans, shall consider including in such plans, where appropriate, provisions for the development of Strategic Projects, as well as the necessary infrastructure. To facilitate the development of strategic projects, Member States shall ensure that all relevant spatial planning data is available.
1. National, regional and local authorities responsible for preparing plans, including zoning, spatial plans and land use plans, shall consider including in such plans, where appropriate, provisions for the development of Strategic Projects, as well as the necessary infrastructure. To facilitate the development of strategic projects, Member States shall ensure that all relevant planning authorities have the resources needed to decide upon, in a timely manner, any planning application and that all relevant spatial planning data is available and accessible, including online.
Amendment 17
Proposal for a regulation
Article 13 – paragraph 2
Text proposed by the Commission
Amendment
2. Where plans including provisions for the development of strategic projects are subject to an assessment pursuant to Directive 2001/42/EC of the European Parliament and of the Council and pursuant to Article 6(3) of Directive 92/43/EEC, those assessments shall be combined. Where applicable, the combined assessment shall also address the impact on potentially affected water bodies referred to in Directive 2000/60/EC. Where Member States are required to assess the impacts of existing and future activities on the marine environment, including land-sea interactions, in accordance with Article 4 of Directive 2014/89/EU of the European Parliament and of the Council23 , the combined assessment shall also cover those impacts.
2. Where plans including provisions for the development of strategic projects are subject to an assessment pursuant to Directive 2001/42/EC of the European Parliament and of the Council and pursuant to Article 6(3) of Directive 92/43/EEC, those assessments shall be combined. Where applicable, the combined assessment shall also address the impact on potentially affected water bodies referred to in Directive 2000/60/EC. Where Member States are required to assess the impacts of existing and future activities on the marine environment, including land-sea interactions, in accordance with Article 4 of Directive 2014/89/EU of the European Parliament and of the Council23, the combined assessment shall also cover those impacts. The fact that assessments are combined pursuant to this paragraph shall not affect their content or quality or robustness of the assessment.
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23 Directive 2014/89/EU of the European Parliament and of the Council of 23 ELI: http://data.europa.eu/eli/dir/2014/89/oj July 2014 establishing a framework for maritime spatial planning (OJ L 257, 28.8.2014, p. 135, ELI: http://data.europa.eu/eli/dir/2014/89/oj).
23 Directive 2014/89/EU of the European Parliament and of the Council of 23 ELI: http://data.europa.eu/eli/dir/2014/89/oj July 2014 establishing a framework for maritime spatial planning (OJ L 257, 28.8.2014, p. 135, ELI: http://data.europa.eu/eli/dir/2014/89/oj).
Amendment 18
Proposal for a regulation
Article 14 – paragraph 2
Text proposed by the Commission
Amendment
2. All decisions adopted pursuant to the Articles in this section shall be made publicly available.
2. All decisions adopted pursuant to the Articles in this section shall be made publicly available in an easily understandable manner, including online, and all decisions concerning one project shall be available on the same website.
Amendment 19
Proposal for a regulation
Article 18 – paragraph 1
Text proposed by the Commission
Amendment
1. For award procedures of critical medicinal products falling within the scope of Directive 2014/24/EU of the European Parliament and of the Council, contracting authorities in the Member States shall apply procurement requirements other than price-only award criteria such as procurement requirements that promote the resilience of supply in the Union. Those procurement requirements shall be defined in accordance with Directive 2014/24/EU and may relate to stockholding obligations, the number of diversified suppliers, monitoring of supply chains, their transparency to the contracting authority and contract performance clauses on timely delivery.
1. For award procedures of critical medicinal products falling within the scope of Directive 2014/24/EU of the European Parliament and of the Council, contracting authorities in the Member States shall wherever feasible implement multi-winner procurements, which scope is designed based on clinical needs in consultation with healthcare professionals and relevant experts, with predictable procurement timelines. Contracting authorities in the Member States shall apply procurement requirements, other than price-only award criteria such as procurement requirements that promote the resilience of supply in the Union. Those procurement requirements shall be defined in accordance with Directive 2014/24/EU and shall include several qualitative criteria, such as patient impact and clinical value, environmental sustainability, innovation, diversity and robustness of supply chain, may relate to stockholding obligations, the number of diversified suppliers, monitoring of supply chains, their transparency to the contracting authority, and contract performance clauses on timely delivery.
Amendment 20
Proposal for a regulation
Article 18 – paragraph 4
Text proposed by the Commission
Amendment
4. This Article shall not preclude contracting authorities from using additional qualitative requirements, including in relation to environmental sustainability and social rights.
4. This Article shall not preclude contracting authorities from using additional qualitative requirements, including in relation to environmental sustainability, and social rights. In order to safeguard the integrity of the Single Market, the Commission shall support coordination and the exchange of best practices between Member States.
Amendment 21
Proposal for a regulation
Article 19 – paragraph 1 – subparagraph 1 a (new)
Text proposed by the Commission
Amendment
Member States shall aim to ensure that the design and periodic review of such programmes involve health professionals and patient organisations, as well as environmental expertise, to balance public health needs, affordability and sustainability.
Amendment 22
Proposal for a regulation
Article 20 – paragraph 2 a (new)
Text proposed by the Commission
Amendment
Stockpiling management system shall apply a “first in, first out” principle and promote the use of shelf-life extension studies, in order to reduce expiry-related waste. The Commission, in cooperation with the Member States and the relevant agencies, shall adopt guidelines on sustainable stockpiling, including measures to reduce emissions, improve packaging, manage expiry dates, and ensure the environmentally sound disposal of unused or obsolete medicinal products.
Amendment 23
Proposal for a regulation
Article 26 – paragraph 2 – point d a (new)
Text proposed by the Commission
Amendment
(da) recommend minimum common indicators for monitoring the environmental and supply-resilience performance of procurement programmes, ensuring proportionality and avoiding duplication.
Amendment 24
Proposal for a regulation
Article 27 – paragraph 1
Text proposed by the Commission
Amendment
Without prejudice to the prerogatives of the Council, the Commission, shall explore possibilities of concluding strategic partnerships aiming to diversify sourcing of critical medicinal products, their active substances and key inputs to increase the security of supply of critical medicinal products in the Union. The Commission shall also explore the possibility of building on existing forms of cooperation, when possible, to support security of supply and reinforce efforts to strengthen the production of critical medicinal products in the Union.
Without prejudice to the prerogatives of the Council, the Commission, shall explore possibilities of concluding strategic partnerships aiming to diversify sourcing of critical medicinal products, their active substances and key inputs to increase the security of supply of critical medicinal products in the Union. The Commission shall also explore the possibility of building on existing forms of cooperation, when possible, to support security of supply and reinforce efforts to strengthen the production of critical medicinal products in the Union. Such partnership shall support a high level of safety, environmental protection, quality, and efficacy.
Amendment 25
Proposal for a regulation
Article 30 – paragraph 1
Text proposed by the Commission
Amendment
1. By [OP please insert the date of:] five years after the date of application of this Regulation and every five years thereafter, the Commission shall evaluate this Regulation and present a report on the main findings to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions.
1. By [OP please insert the date of:] five years after the date of application of this Regulation and every five years thereafter, the Commission shall within its evaluation assess the impact of other relevant Union legislation on this Regulation and present a report on the main findings to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.
Amendment 26
Proposal for a regulation
Article 30 – paragraph 2 a (new)
Text proposed by the Commission
Amendment
2a. Where the evaluation referred to in paragraph 1 identifies a potential risk to the availability or security of supply of a critical medicinal product in the Union, the Commission shall carry out a coordinated, evidence-based impact assessment and, where appropriate, propose proportionate and appropriate mitigating measures in consultation with the Member States and relevant stakeholders.
ANNEX: DECLARATION OF INPUT
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur for opinion declares that he included in his opinion input on matters pertaining to the subject of the file that he received, in the preparation of the opinion, prior to the adoption thereof in committee, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:
1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register
Federchimica
Farmindustria
Menarini
2. Representatives of public authorities of third countries, including their diplomatic missions and embassies
The list above is drawn up under the exclusive responsibility of the rapporteur for opinion.
Where natural persons are identified in the list by their name, by their function or by both, the rapporteur for opinion declares that he has submitted to the natural persons concerned the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.
PROCEDURE – COMMITTEE ASKED FOR OPINION
Title
Laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795
References
COM(2025)0102 – C10-0048/2025 – 2025/0102(COD)
Committee(s) responsible
Date announced in plenary
SANT
21.5.2025
Opinion by
Date announced in plenary
ENVI
21.5.2025
Rapporteur for the opinion
Date appointed
Michele Picaro
18.6.2025
Date adopted
4.11.2025
Result of final vote
+:
–:
0:
63
4
11
Members present for the final vote
Christine Anderson, Pascal Arimont, Bartosz Arłukowicz, Sakis Arnaoutoglou, Anja Arndt, Monika Beňová, Alexander Bernhuber, Barbara Bonte, Stine Bosse, Lynn Boylan, Jorge Buxadé Villalba, Laurent Castillo, Mohammed Chahim, Christophe Clergeau, Annalisa Corrado, Ivan David, Ondřej Dostál, Viktória Ferenc, Heléne Fritzon, Andreas Glück, Hanna Gronkiewicz-Waltz, Martin Günther, Roman Haider, Esther Herranz García, Radan Kanev, Ondřej Knotek, Stefan Köhler, András Tivadar Kulja, Peter Liese, Javi López, César Luena, Elżbieta Katarzyna Łukacijewska, Ignazio Roberto Marino, Catarina Martins, Tilly Metz, Dolors Montserrat, Jana Nagyová, Jutta Paulus, Michele Picaro, Nicola Procaccini, Massimiliano Salini, Silvia Sardone, Majdouline Sbai, Lena Schilling, Günther Sidl, Jonas Sjöstedt, Sander Smit, Antonín Staněk, Marta Temido, Ingeborg Ter Laak, Beatrice Timgren, Zala Tomašič, Dimitris Tsiodras, Ana Vasconcelos, Aurelijus Veryga, Kristian Vigenin, Emma Wiesner, Michal Wiezik, Tiemo Wölken
Substitutes present for the final vote
Jeannette Baljeu, Biljana Borzan, Marie-Luce Brasier-Clain, Daniel Buda, Per Clausen, Raúl de la Hoz Quintano, Valérie Deloge, Sigrid Friis, Jens Gieseke, Michalis Hadjipantela, Martin Häusling, Paolo Inselvini, Sara Matthieu, Valentina Palmisano, Raffaele Topo, Laurence Trochu, Vlad Vasile-Voiculescu, Anders Vistisen
Members under Rule 216(7) present for the final vote
Francesco Torselli
FINAL VOTE BY ROLL CALL BY THE COMMITTEE ASKED FOR OPINION
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