Sittings · Document

Report (COM(2025)0102 – C10-0048/2025 – 2025/0102(COD)) 2026-01-13

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

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14.1.2026 A10-0272/243

Amendment 243

Catarina Martins, Anthony Smith

on behalf of The Left Group

Report A10-0272/2025

Tomislav Sokol

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

(COM(2025)0102 – C10-0048/2025 – 2025/0102(COD))

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission

Amendment

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

Or. en

14.1.2026 A10-0272/244

Amendment 244

Catarina Martins, Anthony Smith

on behalf of The Left Group

Report A10-0272/2025

Tomislav Sokol

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

(COM(2025)0102 – C10-0048/2025 – 2025/0102(COD))

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

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

Or. en

14.1.2026 A10-0272/245

Amendment 245

Anthony Smith, Catarina Martins

on behalf of The Left Group

Report A10-0272/2025

Tomislav Sokol

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

(COM(2025)0102 – C10-0048/2025 – 2025/0102(COD))

Proposal for a regulation

Recital 12 a (new)

Text proposed by the Commission

Amendment

(12 a) To ensure Europe’s long-term strategic autonomy in the pharmaceutical sector, it is imperative to establish a long-term planification of the industrial policy based on societal needs and the general interest. This policy must prioritise the reinforcement of European manufacturing capacities through strategic projects that secure the raw materials supply, the continuous and reliable production of medicines and active pharmaceutical ingredients within the Union. By investing in research and innovation, supporting the modernisation of infrastructure, guarantying quality working conditions and promoting sustainable and circular production, the EU can both strengthen its industrial base and reduce dependencies on third countries. Such an approach will significantly improve the Union’s autonomy and resistance in the face of future health crises or supply chain disruptions, ensuring that the availability of essential medicines is safeguarded under all circumstances.

Or. en

14.1.2026 A10-0272/246

Amendment 246

Catarina Martins

on behalf of The Left Group

Report A10-0272/2025

Tomislav Sokol

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

(COM(2025)0102 – C10-0048/2025 – 2025/0102(COD))

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(22) Union-level funding may be leveraged to facilitate investments in strategic projects. Strategic projects may benefit from access to existing EU funding instruments, such as the EU4Health Programme4 , Digital Europe Programme5 and Horizon Europe6 (relevant, for example, for active substances referred to in Article 5(d) of Regulation (EU)2021/695), as well as the Strategic Technologies for Europe Platform (STEP), when they fulfil the criteria established in these instruments. Authorities in charge of the Union programmes covered by Regulation (EU) 2024/795 of the European Parliament and of the Council7 (STEP) should in particular consider supporting strategic projects addressing a vulnerability in the supply chains of critical medicinal products and therefore Regulation (EU) 2024/795 should be amended.

(22) Union-level funding may be leveraged to facilitate investments in strategic projects. Strategic projects may benefit from access to existing EU funding instruments, such as the EU4Health Programme4 , European Defence Fund, Digital Europe Programme5 and Horizon Europe6 (relevant, for example, for active substances referred to in Article 5(d) of Regulation (EU)2021/695), as well as the Strategic Technologies for Europe Platform (STEP), when they fulfil the criteria established in these instruments. Authorities in charge of the Union programmes covered by Regulation (EU) 2024/795 of the European Parliament and of the Council7 (STEP) should in particular consider supporting strategic projects addressing a vulnerability in the supply chains of critical medicinal products and therefore Regulation (EU) 2024/795 should be amended.

_________________

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

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

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

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

Or. en

14.1.2026 A10-0272/247

Amendment 247

Catarina Martins

on behalf of The Left Group

Report A10-0272/2025

Tomislav Sokol

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

(COM(2025)0102 – C10-0048/2025 – 2025/0102(COD))

Proposal for a regulation

Recital 22 a (new)

Text proposed by the Commission

Amendment

(22 a) On 9 March 2025, 11 Union Health Ministers signed a letter stating that the Critical Medicines Act must be expanded into an effective, full-scale strategic programme, backed by EU defence funding, to secure the continent’s strategic autonomy and that anything less would be a grave miscalculation that could turn the Union's dependence on critical medicines into the Achilles’ heel of Europe’s security. In that context, it is essential that the Critical Medicines Act and the newly proposed Critical Medicines Security Fund act as robust instruments and that part of their funding be embedded in broader EU defence spending plans, including the financial mechanisms in the new Rearm Europe Plan.

Or. en

14.1.2026 A10-0272/248

Amendment 248

Catarina Martins, Anthony Smith

on behalf of The Left Group

Report A10-0272/2025

Tomislav Sokol

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

(COM(2025)0102 – C10-0048/2025 – 2025/0102(COD))

Proposal for a regulation

Article 3 – paragraph 1 – point 5

Text proposed by the Commission

Amendment

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

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

Or. en

14.1.2026 A10-0272/249

Amendment 249

Catarina Martins

on behalf of The Left Group

Report A10-0272/2025

Tomislav Sokol

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

(COM(2025)0102 – C10-0048/2025 – 2025/0102(COD))

Proposal for a regulation

Article 16 – paragraph 1

Text proposed by the Commission

Amendment

1. For the duration of the Multiannual Financial Framework 2021-202724 strategic projects may be supported by Union funding, including but not limited to such Union programmes as the EU4Health Programme25 , Horizon Europe26 , and the Digital Europe Programme27 provided that such support is in line with the objectives set out in the regulations establishing those programmes.

1. For the duration of the Multiannual Financial Framework 2021-202724 strategic projects may be supported by Union funding, including but not limited to such Union programmes as the EU4Health Programme25 , Horizon Europe26 , European Defence Fund, the Digital Europe Programme27 as well as the European Regional Development Fund and the Cohesion fund provided that such support is in line with the objectives set out in the regulations establishing those programmes. The amount of the Union support available for the Strategig projects during the designated period shall not be less than EUR 300 billion.

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24 Council Regulation (EU, Euratom) 2020/2093 laying down the multiannual financial framework for years 2021 to 2027, as amended (OJ LI 433, 22.12.2020, p.11, ELI: http://data.europa.eu/eli/reg/2020/2093/oj)

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

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

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

Or. en

14.1.2026 A10-0272/250

Amendment 250

Anthony Smith, Catarina Martins

on behalf of The Left Group

Report A10-0272/2025

Tomislav Sokol

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

(COM(2025)0102 – C10-0048/2025 – 2025/0102(COD))

Proposal for a regulation

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Undertakings benefiting from Union funding must comply with sectorial collective agreements, offer good working conditions and decent wages. They shall not be allowed to distribute excessive dividends, resort to tax heavens, or proceed with collective layoffs and shall reimburse public funding received in case of non-compliance with their obligations. They shall also comply with their obligations related to social and environmental reporting. Undertakings that do not comply with labour law and health and safety regulations shall not be able to benefit from direct public subsidies and shall be excluded from public procurement tendering procedures.

Or. en

14.1.2026 A10-0272/251

Amendment 251

Catarina Martins, Anthony Smith

on behalf of the The Left Group

Report A10-0272/2025

Tomislav Sokol

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

(COM(2025)0102 – C10-0048/2025 – 2025/0102(COD))

Proposal for a regulation

Article 22 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509 where nine or more Member States jointly request the Commission to procure on their behalf, or in their name, the Commission may initiate a procurement procedure under the conditions set out in this Article when the procurement relates to medicinal products belonging to one of the following categories below;

1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509 where three or more Member States jointly request the Commission to procure on their behalf, or in their name, the Commission may initiate a procurement procedure under the conditions set out in this Article when the procurement relates to medicinal products belonging to one of the following categories below;

Or. en

14.1.2026 A10-0272/252

Amendment 252

Catarina Martins, Anthony Smith

on behalf of the The Left Group

Report A10-0272/2025

Tomislav Sokol

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

(COM(2025)0102 – C10-0048/2025 – 2025/0102(COD))

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

1. Under conditions laid down in this Article and by way of derogation from Article 168(2) of Regulation (EU, Euratom) 2024/2509, if a contract is necessary for the implementation of the joint action between the Commission and Member States, the Commission and at least nine Member States may engage, as contracting parties, in a joint procurement procedure.

1. Under conditions laid down in this Article and by way of derogation from Article 168(2) of Regulation (EU, Euratom) 2024/2509, if a contract is necessary for the implementation of the joint action between the Commission and Member States, the Commission and at least three Member States may engage, as contracting parties, in a joint procurement procedure.

Or. en