Sittings · Document

Draft report (COM(2025)0102 – 2025/0102(COD)) 2025-10-13

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

Committee on Public Health

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AM_Com_LegReport

Amendment 570

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 4 a (new)

Text proposed by the Commission

Amendment

Article4a

List of medicinal products with no adequate Union substitute

1. The Commission shall establish and maintain a regularly updated list of medicinal products originating from third countries for which no adequate substitute produced within the Union is available.

2. The list shall serve to identify and monitor strategic dependencies and to support the adoption of appropriate measures aimed at ensuring the continuous supply and availability of such medicinal products within the Union.

3. In developing and updating the list, the Commission shall take into account the public health relevance, therapeutic importance, and criticality of the medicinal products, as well as market and supply chain factors, including potential shortages and vulnerabilities.

Or. en

Amendment 571

Christine Anderson

Proposal for a regulation

Chapter III

Text proposed by the Commission

Amendment

III [...]

deleted

Or. en

Justification

This creates a heavy-handed mechanism for designating "strategic" manufacturing projects. It invites lobbying, central planning, and rent-seeking for those, who are able to acquire fast-track permitting, prioritised support, and public interest presumptions. All of this will likely crowd out more agile, decentralised private initiatives. It would be preferable to cut red-tape across the board, instead of political cherry-picking.

Amendment 572

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

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

A project located in the Union and related to creating, modernising or increasing manufacturing capacity, with priority given to critical medicinal products for whose supply chain vulnerabilities have been established through the vulnerability evaluation under Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] shall be considered as a strategic project if it meets at least one of the following criteria:

Or. en

Amendment 573

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

A project located in the Union and related to creating or increasing manufacturing capacity, including of distributed or local production platforms for critical medicines enabled by technologies such as additive manufacturing, shall be considered as a strategic project if it meets at least one of the following criteria:

Or. en

Amendment 574

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it contributes to the security of supply and availability of such critical medicinal product or products in the Union and it meets at least one of the following criteria:

Or. en

Amendment 575

Alessandra Moretti

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it contributes to the security of supply and availability of such a critical medicinal product or products in the EU and meets at least one of the following criteria:

Or. en

Amendment 576

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

A project located in the Union and related to creating, increasing or innovating manufacturing capacity or strengthening the resilience of healthcare systems in case of supply chain disruptions shall be considered as a strategic project if it meets at least one of the following criteria:

Or. en

Amendment 577

András Tivadar Kulja

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

A project located in the Union and related to creating or increasing manufacturing capacity or strengthening the resilience of healthcare systems in case of supply chain disruptions shall be considered as a strategic project if it meets at least one of the following criteria:

Or. en

Amendment 578

Margarita de la Pisa Carrión

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

A project located in the Union and related to creating or increasing manufacturing capacity or ensure sufficient critical distribution infrastructure capacity shall be considered as a strategic project if it meets at least one of the following criteria:

Or. en

Amendment 579

Laurence Trochu

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria with a view to satisfying primarily the Union market;

Or. fr

Amendment 580

Tilly Metz

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

A project located in the Union and related to creating or increasing manufacturing capacity for critical medicinal products shall be considered as a strategic project if it meets at least one of the following criteria:

Or. en

Amendment 581

Laurent Castillo

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

A project located in the Union and related to creating or increasing manufacturing capacity for the Union market shall be considered as a strategic project if it meets at least one of the following criteria:

Or. fr

Amendment 582

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

A project located in the Union and related to creating, increasing or sustaining manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

Or. en

Amendment 583

Aurelijus Veryga

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

A project located in the Union and related to creating, improving or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

Or. en

Amendment 584

Laurence Trochu, Ondřej Krutílek

Proposal for a regulation

Article 5 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

A project located in the Union and related to creating or increasing manufacturing capacity shall be considered as a strategic project if it meets at least one of the following criteria:

A project related to creating or increasing manufacturing capacity in the Union shall be considered as a strategic project if it meets at least one of the following criteria:

Or. en

Amendment 585

Letizia Moratti

Proposal for a regulation

Article 5 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it creates or increases manufacturing capacity for one or more critical medicinal products or for collecting or manufacturing their active substances;

(a) it creates or increases manufacturing or collection capacity for one or more critical medicinal products or medicinal products of common interest or for collecting or manufacturing their active substances, or it sets aside a defined portion of manufacturing capacity for the production of specific pharmaceutical forms and their active substances within a fixed timeframe and at the request of the Critical Medicines Group, in order to address potential or emerging shortages;

Or. en

Amendment 586

Laurent Castillo

Proposal for a regulation

Article 5 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it creates or increases manufacturing capacity for one or more critical medicinal products or for collecting or manufacturing their active substances;

(a) it creates or significantly increases manufacturing capacity for one or more critical medicinal products or for collecting or manufacturing their active substances or reserves a narrowly defined share, in minimal quantities, of its production capacity for the production of critical medicines, their active substance, or key input in the event of an ongoing or forthcoming shortage;

Or. fr

Amendment 587

Aurelijus Veryga

Proposal for a regulation

Article 5 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it creates or increases manufacturing capacity for one or more critical medicinal products or for collecting or manufacturing their active substances;

(a) it creates or increases manufacturing capacity including through innovative manufacturing processes and new technologies for one or more critical medicinal products or for collecting or manufacturing their active substances;

Or. en

Amendment 588

Tilly Metz

Proposal for a regulation

Article 5 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it creates or increases manufacturing capacity for one or more critical medicinal products or for collecting or manufacturing their active substances;

(a) it creates or increases manufacturing capacity for one or more critical medicinal products or for collecting or manufacturing their active substances or it creates advanced pharmacy or hospital compounding techniques;

Or. en

Amendment 589

Christophe Clergeau

Proposal for a regulation

Article 5 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it creates or increases manufacturing capacity for one or more critical medicinal products or for collecting or manufacturing their active substances;

(a) it creates or increases manufacturing capacity for one or more critical medical countermeasures or critical medicinal products or for collecting or manufacturing their active substances;

Or. en

Amendment 590

Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 5 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it creates or increases manufacturing capacity for one or more critical medicinal products or for collecting or manufacturing their active substances;

(a) it creates or increases manufacturing capacity for one or more critical medicinal products or novel antimicrobials or for collecting or manufacturing their active substances;

Or. en

Amendment 591

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

Article 5 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it creates or increases manufacturing capacity for one or more critical medicinal products or for collecting or manufacturing their active substances;

(a) it creates or increases manufacturing capacity for one or more critical medicinal products or for collecting or manufacturing their active substances or key inputs;

Or. en

Amendment 592

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 5 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) it creates or increases manufacturing capacity for one or more critical medicinal products or for collecting or manufacturing their active substances;

(a) it sustains, creates or increases manufacturing capacity for one or more critical medicinal products or for collecting or manufacturing their active substances;

Or. en

Amendment 593

Catarina Martins, Sebastian Everding, Anthony Smith

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 medicinal products of common interest and their active substances through environmental, digital and/or skills modernisation processes with the aim to strengthen supply chain resilience and security, ensuring greater sustainability or increased efficiency;

Or. en

Amendment 594

Tilly Metz

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 and social sustainability, overall sustainability or increases efficiency, such as innovative processes that improve production quality, resilience, or reliability;

Or. en

Amendment 595

Aurelijus Veryga

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, including through innovative manufacturing processes and new technologies, for one or more critical medicinal products or their active substances to ensure greater sustainability or increased efficiency;

Or. en

Amendment 596

Laurent Castillo

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, particularly to implement environmental legislation, for one or more critical medicinal products or their active substances to ensure greater sustainability or increased efficiency;

Or. fr

Amendment 597

Christophe Clergeau

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 medical countermeasures or critical medicinal products or their active substances to ensure greater sustainability or increased efficiency;

Or. en

Amendment 598

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

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 sustainability or increased efficiency and achieve higher social standards;

Or. en

Amendment 599

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

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 or key inputs to ensure greater sustainability or increased efficiency;

Or. en

Amendment 600

Christophe Clergeau

Proposal for a regulation

Article 5 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) it creates or increases manufacturing capacity for key inputs necessary for the manufacturing of one or more critical medicinal products or their active substances;

(c) it creates or increases manufacturing capacity for key inputs necessary for the manufacturing of one or more critical medical countermeasures, critical medicinal products or their active substances;

Or. en

Amendment 601

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

Article 5 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) it creates or increases manufacturing capacity for key inputs necessary for the manufacturing of one or more critical medicinal products or their active substances;

(c) it creates or increases manufacturing capacity for key inputs necessary for the manufacturing of one or more critical medicinal products or their active substances or key inputs;

Or. en

Amendment 602

Tilly Metz

Proposal for a regulation

Article 5 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) it creates or increases manufacturing capacity for key inputs necessary for the manufacturing of one or more critical medicinal products or their active substances;

(c) it creates or substantially increases manufacturing capacity for key inputs essential for the manufacturing of one or more critical medicinal products or their active substances;

Or. en

Amendment 603

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

Proposal for a regulation

Article 5 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) it creates or increases manufacturing capacity for key inputs necessary for the manufacturing of one or more critical medicinal products or their active substances;

(c) it creates, modernises or increases manufacturing capacity for key inputs necessary for the manufacturing of one or more critical medicinal products or their active substances;

Or. en

Amendment 604

Laurent Castillo

Proposal for a regulation

Article 5 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) it creates or increases manufacturing capacity for key inputs necessary for the manufacturing of one or more critical medicinal products or their active substances;

(c) it creates, reserves or increases manufacturing capacity for key inputs necessary for the manufacturing of one or more critical medicinal products or their active substances;

Or. fr

Amendment 605

Tilly Metz

Proposal for a regulation

Article 5 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) it contributes to the roll-out of a technology that plays a key role in enabling the manufacturing of one or more critical medicinal products, their active substances or key inputs.

deleted

Or. en

Amendment 606

Aurelijus Veryga

Proposal for a regulation

Article 5 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) it contributes to the roll-out of a technology that plays a key role in enabling the manufacturing of one or more critical medicinal products, their active substances or key inputs.

(d) it contributes to the roll-out of a technology, including through innovative manufacturing processes and new technologies, that plays a key role in enabling the manufacturing of one or more critical medicinal products, their active substances or key inputs.

Or. en

Amendment 607

Laurent Castillo

Proposal for a regulation

Article 5 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) it contributes to the roll-out of a technology that plays a key role in enabling the manufacturing of one or more critical medicinal products, their active substances or key inputs.

(d) it contributes to the roll-out or transfer of a technology that plays a key role in enabling the manufacturing or the strengthening of the supply chain of one or more critical medicinal products, their active substances or key inputs.

Or. fr

Amendment 608

Christophe Clergeau

Proposal for a regulation

Article 5 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) it contributes to the roll-out of a technology that plays a key role in enabling the manufacturing of one or more critical medicinal products, their active substances or key inputs.

(d) it contributes to the roll-out of a technology that plays a key role in enabling the manufacturing of one or more critical medical countermeasures, critical medicinal products, their active substances or key inputs.

Or. en

Amendment 609

András Tivadar Kulja

Proposal for a regulation

Article 5 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) it contributes to the roll-out of a technology that plays a key role in enabling the manufacturing of one or more critical medicinal products, their active substances or key inputs.

(d) it contributes to the roll-out of innovative technology that plays a key role in enabling the manufacturing or supply of one or more critical medicinal products, their active substances or key inputs.

Or. en

Amendment 610

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Margarita de la Pisa Carrión

Proposal for a regulation

Article 5 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) it contributes to the roll-out of a technology that plays a key role in enabling the manufacturing of one or more critical medicinal products, their active substances or key inputs.

(d) it contributes to the roll-out of a technology that plays a key role in enabling the manufacturing or supply of one or more critical medicinal products, their active substances or key inputs.

Or. en

Amendment 611

Dan-Ştefan Motreanu

Proposal for a regulation

Article 5 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) it contributes to the roll-out of a technology that plays a key role in enabling the manufacturing of one or more critical medicinal products, their active substances or key inputs.

(d) it contributes to the roll-out of a technology that plays a key role in enabling the manufacturing or supply of one or more critical medicinal products, their active substances or key inputs.

Or. en

Amendment 612

Dario Tamburrano, Valentina Palmisano, Catarina Martins

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d a) it commits, through a production contract, a defined portion of the production capacity (as a percentage of the site or number of batches / production lines), to be allocated to a reserve that can be activated for the production of pharmaceutical forms, active substances or specified basic production factors, which can be mobilized within a defined time period (eg. 30-90 days) at the request of the Coordination Group for Critical Medicinal Products. This commitment can be recognized as a qualifying element for the recognition of the strategic project;

Or. en

Amendment 613

Stine Bosse, Billy Kelleher

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d a) it sets aside a defined portion of its manufacturing capacity for the production of specific pharmaceutical forms or technologies within a fixed timeframe as marketing authorisation holder or contract manufacturer and at the request of the Critical Medicines Coordination Group in order to address potential or emerging shortages.

Or. en

Justification

The dedication of production capacity should be considered a strategic project because it contributes to the scale-up of production capacity and ensures flexibility to respond to supply risks or shortages. By not only increasing output but also setting aside a defined portion of manufacturing capacity that can be mobilised within a fixed timeframe upon request from the Critical Medicines Coordination Group, it strengthens the Union’s preparedness and supports the timely availability of essential medicines, including antimicrobials, in times of need.

Amendment 614

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d a) it reserves a defined portion of manufacturing capacity, within a fixed timeframe, for the production of specific pharmaceutical forms, their active substances, key inputs, or enabling technologies, at the request of the Critical Medicines Coordination Group, in order to address potential or emerging shortages.

Or. en

Amendment 615

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d a) it substantially improves the stockpiling of critical medicinal products, medicinal products of common interest, their active substances or key inputs, by creating or optimising storage capacity, waste reduction and efficiency, logistics processes or digital systems for demand analysis, monitoring and control.

Or. en

Amendment 616

Tilly Metz

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d a) it creates or strengthens flexible, multi-product manufacturing capacities within the Union, mirroring the ‘ever-warm’ production facilities under HERA that can rapidly switch or scale production of critical medicinal products or active substances across various therapeutic classes or technological platforms.

Or. en

Amendment 617

Marta Temido, Pierre Jouvet

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d a) it has a positive impact on the security and resilience of supply chain of critical medicinal products and downstream sectors, contributing to skills and workforce development and to creating new employment and improving regional dynamics;

Or. en

Amendment 618

András Tivadar Kulja

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

(d a) it strengthens the capacity of healthcare facilities and within them - hospital pharmacies - to compound medicines in the event of a shortage of an authorised critical medicine, where no valid therapeutic alternatives are available

Or. en

Amendment 619

Laurent Castillo

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) it contributes to the purchase of an intellectual property right that plays a key role in the manufacturing of one or more critical medicinal products, their active substances or key inputs;

Or. fr

Amendment 620

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

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d a) The strategic project declaration must establish the causal link between criteria in article 5 and their contribution to the security of supply and availability of medicinal products within the Union.

Or. en

Amendment 621

Emmanouil Fragkos

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) it incorporates a verifiable plan for the transfer of know-how and skills development within the Union that directly contributes to reducing an identified vulnerability in the supply chain.

Or. el

Amendment 622

Margarita de la Pisa Carrión

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d a) it guarantees the critical distribution infrastructure capacity for critical medicinal products.

Or. en

Amendment 623

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

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d a) it supports innovative manufacturing processes.

Or. en

Amendment 624

Dan-Ştefan Motreanu

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d a) it supports innovative manufacturing processes.

Or. en

Amendment 625

Catarina Martins, Sebastian Everding

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d b) it strengthens the capacity of hospital pharmacies to compound medicines in the event of a shortage of an authorised critical medicine, where no valid therapeutic alternatives are available, or in cases where treatment is lacking for patients with extraordinary medical conditions or needs.

Or. en

Amendment 626

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d b) it has a positive impact on the translational research and development of critical medicinal products, including the development of medicines for rare diseases (orphan medicinal products) or novel antimicrobials;

Or. en

Amendment 627

Laurent Castillo

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(db) its purpose is to develop an innovation that could replace critical medicines.

Or. fr

Amendment 628

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d c) in addition, for a project to be considered strategic, it has a positive impact on the industry supply chain and downstream sectors contributing to skills and workforce development and contributing to creating new employment and improving regional dynamics within the Union.

Or. en

Amendment 629

Marta Temido, Pierre Jouvet

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(d c) it has a positive impact on regional cohesion by fostering economic, social, and territorial development and timely availability of critical medicinal products in certain Member States.

Or. en

Amendment 630

Tilly Metz

Proposal for a regulation

Article 5 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

For the purpose of this Article, critical medicinal products shall fall in at least one of the following categories:

(a) critical medicinal products or their active substances for which Union import dependency on a single third country exceeds 60%;

(b) critical medicinal products or their active substances that are subject to recurrent or persistent supply disruptions, as evidenced by Union-level or national shortage monitoring systems, including the European Shortages Monitoring Platform (ESMP) coordinated by the European Medicines Agency;

(c) medicinal products in therapeutic areas with a known pattern of shortages, to be determined by the Critical Medicines Coordination Group established under this Regulation, including but not limited to antibiotics, oncology treatments, and widely used off-patent or generic medicines that are essential to public health but subject to market failure or fragile supply chains.

Or. en

Amendment 631

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

Proposal for a regulation

Article 5 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

In order to address potential or emerging shortages within the Union and at the request of the Critical Medicines Coordination Group, a project can also be considered as strategic when it sets aside a defined portion of its manufacturing capacity for the production of specific pharmaceutical forms or their active substances and key inputs or technologies within a fixed timeframe as marketing authorisation holder or contract manufacturer and commits to supply in the Union to address shortages.

Or. en

Amendment 632

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic

Proposal for a regulation

Article 5 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Notwithstanding the first paragraph, a project shall not be considered strategic if it results in unnecessary duplication of existing or planned manufacturing capacities for the same medicinal product, its active substances, or key inputs within the Union, unless such duplication is justified by clearly demonstrated needs related to security of supply, geographical distribution of production sites, or the overall resilience of the Union’s pharmaceutical supply chain.

Or. en

Amendment 633

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 5 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

For as long as the critical medicinal product is on the Union list of critical medicinal products, an undertaking that has benefited from financial support for a strategic project under this Section shall prioritise supply to the Union market, make all necessary efforts to ensure that the critical medicinal product remains available in the Member States where it is being marketed and adopt measures that contribute to the affordability of the product across the Union.

Or. en

Amendment 634

Ondřej Krutílek, Laurence Trochu

Proposal for a regulation

Article 5 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

For as long as the critical medicinal product is on the Union list of critical medicinal products, an undertaking that has benefited from support for a strategic project in accordance with this Section shall prioritise supply to the Union market and use its very best efforts to ensure that the critical medicinal product remains available in the Member State where it is being marketed.

Or. en

Amendment 635

Christine Anderson

Proposal for a regulation

Article 5 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Strategic projects shall prioritise decentralised manufacturing models where possible, including small and medium-sized enterprises and regional supply chains, in order to avoid centralised production bottlenecks and enhance local resilience.

Or. en

Amendment 636

Christine Anderson

Proposal for a regulation

Article 5 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

The Commission shall publish annually a report evaluating whether recognised strategic projects have demonstrably improved security of supply without distorting competition or displacing more efficient suppliers.

Or. en

Amendment 637

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Each Member State shall designate an authority (‘the designated authority’) that shall assess and verify whether or not a project meets at least one of the criteria set out in Article 5 and if it substantially contributes to the supply, security and availability of one or more critical medicinal products, medicinal products of common interest or active ingredients, in order to be granted the statute of a strategic project.

Or. en

Amendment 638

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

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Each Member State shall, without undue delay, designate an authority (‘the designated authority’) that shall assess and verify whether or not a project

(a) meets at least one of the criteria set out in Article 5 and therefore constitutes a strategic project;

(b) contributes to the security of supply and availability of the critical medicinal product on the Union market;

Or. en

Amendment 639

Alessandra Moretti

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Each Member State shall designate an authority (‘the designated authority’) that shall assess and verify whether or not a project contributes to the security of supply and availability of such a critical medicinal product or products in the EU and meets at least one of the criteria set out in Article 5 and therefore constitutes a strategic project.

Or. en

Amendment 640

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

No later than 3 months after the entry into force of this Regulation. Each Member State shall designate a national authority (‘the designated authority’) that shall assess and verify whether or not a project meets at least one of the criteria set out in Article 5 and therefore constitutes a strategic project.

Or. en

Amendment 641

Dan-Ştefan Motreanu

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

After 3 months after the entry into force of this Regulation, each Member State shall designate an authority (‘the designated authority’) that shall assess and verify whether or not a project meets at least one of the criteria set out in Article 5 and therefore constitutes a strategic project.

Or. en

Amendment 642

Aurelijus Veryga

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 643

Laurent Castillo

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Each Member State shall designate an authority (‘the designated authority’), six months after the entry into force of this Regulation, that shall assess and verify whether or not a project meets at least one of the criteria set out in Article 5 and therefore constitutes a strategic project.

Or. fr

Amendment 644

Nikos Papandreou, Romana Jerković

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

Within 90 days of this Regulation’s entry into force, each Member State shall designate the authority referred to in paragraph 1 and notify the Commission accordingly;

Or. en

Amendment 645

Tilly Metz

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

A promoter may request the designated authority to assess whether a project is a strategic project.

deleted

Or. en

Amendment 646

Laurent Castillo

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

A promoter may request the designated authority to assess whether a project is a strategic project.

A promoter may request the designated authority to assess whether a project is a strategic project. The designated authority has 3 months to make its decision after filing a request for assessment. In the event of a dispute by the developer, the designated authority must provide reasons for its conclusions. The developer may appeal the decision before the Commission.

Or. fr

Amendment 647

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

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

A promoter may request the designated authority to assess whether a project is a strategic project.

A promoter shall request the designated authority to assess whether a project is a strategic project.

Or. en

Amendment 648

Ondřej Krutílek, Laurence Trochu

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

A promoter may request the designated authority to assess whether a project is a strategic project.

A promoter shall request the designated authority to assess whether a project is a strategic project.

Or. en

Amendment 649

Ondřej Krutílek, Laurence Trochu

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

Any Member State authority may request the designated authority to verify its determination of whether a project is a strategic project.

deleted

Or. en

Amendment 650

Tilly Metz

Proposal for a regulation

Article 6 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

Any Member State authority may request the designated authority to verify its determination of whether a project is a strategic project.

Any Member State authority may request the designated authority to verify whether a project is a strategic project.

Or. en

Amendment 651

Tilly Metz

Proposal for a regulation

Article 6 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. To be qualified as a strategic project, a project promoter shall submit an application to any designated authority. This application shall include and be assessed on:

(a) an estimation of expected output volume and share of Union or national market covered;

(b) a timeline for operational readiness; and

(c) measurable commitments on supply security, transparency through regular public reporting, and environmental policy compliance.

Or. en

Amendment 652

Tilly Metz

Proposal for a regulation

Article 6 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1 b. The Commission shall adopt implementing acts to provide a template for the application referred to in paragraph 1a of this Article.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in this Article.

Or. en

Amendment 653

Marta Temido, Pierre Jouvet

Proposal for a regulation

Article 6 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall communicate to the Commission what is the designated authority for the purposes of paragraph 1.

2. Member States shall communicate to the Commission, within 60 days of the entry into force of this Regulation, what is the designated authority for the purposes of paragraph 1.

Or. en

Amendment 654

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 6 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Commission shall act as a coordinator for cross-border strategic projects and shall ensure effective cooperation between the designated authorities of the Member States concerned, to avoid duplication of efforts in bordering Member States and to promote complementarity and efficiency in the implementation of such projects.

Or. en

Amendment 655

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 6 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall provide a simple, accessible webpage on which the contact details and other relevant information on the Member States’ designated authorities shall be clearly listed.

3. The Commission shall provide a simple, easily accessible and transparent webpage as to be used as the central hub for all the interested parties on which the following information shall be clearly published:

a) the contact details and other relevant information on the Member States' designated authorities;

b) list of opportunities for financial support from the Union and at National/ Regional level

c) eligibility criteria for application for strategic projects

The Commission shall also provide the necessary technical support for the interested applicants, in case of SMEs or public institutions such as hospital pharmacies, special training and tailored support should be made available;

Or. en

Amendment 656

Laurent Castillo

Proposal for a regulation

Article 6 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall provide a simple, accessible webpage on which the contact details and other relevant information on the Member States’ designated authorities shall be clearly listed.

3. The Commission shall provide a simple, accessible webpage for project leaders and designated authorities. This webpage shall provide access to contact details and other relevant information on the Member States’ designated authorities, a standard form published by the Commission in all official languages of the Union, to be completed by each promoter, and any other useful information and guidelines.

Or. fr

Amendment 657

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

Article 6 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall provide a simple, accessible webpage on which the contact details and other relevant information on the Member States’ designated authorities shall be clearly listed.

3. The Commission shall provide a simple, accessible webpage on which the contact details and other relevant information on the Member States’ designated authorities and on the administrative and regulatory support defined in Articles 8 and 11 shall be clearly listed. The Commission shall establish a one-stop shop for the submission and assessment of strategic project requirements.

Or. en

Amendment 658

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

Proposal for a regulation

Article 6 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall provide a simple, accessible webpage on which the contact details and other relevant information on the Member States’ designated authorities shall be clearly listed.

3. The Commission shall provide a user-friendly, simple, accessible webpage on which the contact details and other relevant information on the Member States’ designated authorities shall be clearly listed. The webpage shall also include a common application template for promoters available in all official languages of the Union,

Or. en

Amendment 659

Tilly Metz

Proposal for a regulation

Article 6 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Strategic project recognition shall be subject to monitoring and periodic performance review and assessed based on real-world health system needs.

Or. en

Amendment 660

Tilly Metz

Proposal for a regulation

Article 6 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3 b. The designated authorities shall publish a list of recognised strategic projects and relevant project promoters.

Or. en

Amendment 661

Ondřej Krutílek

Proposal for a regulation

Article 6 – paragraph 4

Text proposed by the Commission

Amendment

4. Any other Member State authority that receives a request from a promoter concerning Articles 8 to 14 shall assess whether that given project meets the criteria to be considered a strategic project as provided for in Article 5 and where necessary, request the verification of its determination from the designated authority.

deleted

Or. en

Amendment 662

Ton Diepeveen, Aleksandar Nikolic, Tomáš Kubín, Valérie Deloge

Proposal for a regulation

Article 6 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the verification whether a project is a strategic project has been performed by an authority in accordance with this Article, any other authority shall rely on that verification.

deleted

Or. en

Justification

No definition and therefore no lower limit for quality guarantees.

Amendment 663

Ondřej Krutílek

Proposal for a regulation

Article 6 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the verification whether a project is a strategic project has been performed by an authority in accordance with this Article, any other authority shall rely on that verification.

deleted

Or. en

Amendment 664

Ondřej Krutílek

Proposal for a regulation

Article 6 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the verification whether a project is a strategic project has been performed by an authority in accordance with this Article, any other authority shall rely on that verification.

deleted

Or. en

Amendment 665

Tilly Metz

Proposal for a regulation

Article 6 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the verification whether a project is a strategic project has been performed by an authority in accordance with this Article, any other authority shall rely on that verification.

5. Where the verification whether a project is a strategic project has been performed by a designated authority in accordance with this Article, any other authority shall rely on that verification.

Or. en

Amendment 666

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 6 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. In order to ensure a transparent and coordinated approach across the Union and to provide legal certainty and for project promoters, the Commission shall adopt guidelines setting out common criteria, procedural rules for the assessment and recognition of projects as strategic projects for critical medicinal products and medicinal products of common interest, which should specify the following:

a) Objective criteria for the assessment of strategic impact, including the project's potential to promote the EU strategic autonomy and health preparedness, improve environmental impact and waste reduction, increase manufacturing capacity and resilience, ensure security of supply and tackle supply vulnerabilities, increase stockpiling efficiency;

b) Rules of application, grids of evaluation and timelines

c) Technical support available at national and Union level, including trainings and information sessions

The Commission shall carry out the assessment of the project in due time and shall publish the results of the assessment and reasoning in the dedicated webpage.

The Commission shall carry out an ex-post assessment, on a regular basis, to the strategic projects and evaluate their impact, compliance with the proposed objectives under article 5a), including the environmental impact, corporate and social responsibility.

In case of non compliance, or serious breach of the contract agreement, the Commission shall impose due penalties, including the reimbursement of the Union funding received.

Or. en

Amendment 667

Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 6 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. The Strategic Projects recognised by the Commission under the Critical Medicines Act should explicitly link to priorities under the EU Medical Countermeasures Strategy, including prioritising 'dual purpose', i.e. products that can include both routine use and use as countermeasures.

Such projects should aim to reduce non-financial barriers to the construction of new manufacturing capacity, including by streamlining regulatory and administrative barriers.

The Strategic Projects should also link to the Innovation Accelerators and Hubs foreseen under the EU Medical Countermeasures Strategy, including in order to innovate in and manufacture novel antimicrobials.

Or. en

Amendment 668

Laurent Castillo

Proposal for a regulation

Article 6 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. With a view to the coordination of cross-border projects, the promoter shall notify the competent authorities of each Member State involved and the Commission. The Commission shall play a coordinating role so that a single authority may take the lead in designating the project as strategic.

Or. fr

Amendment 669

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic

Proposal for a regulation

Article 6 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. Medicinal products manufactured within the framework of Strategic Projects financed wholly or partially through Union funds shall primarily be made available for distribution and use within the Union.

Or. en

Amendment 670

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

Article 6 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. The Commission shall facilitate the exchange of experience between national competent authorities.

Or. en

Amendment 671

Laurent Castillo

Proposal for a regulation

Article 6 – paragraph 5 b (new)

Text proposed by the Commission

Amendment

5b. With a view to supporting the Member States' implementation of this article, the Commission shall develop guidelines to assist designated authorities in identifying and assessing common criteria for determining the eligibility of an applicant for strategic project status without establishing a unified model to take account of Member States' specific characteristics by [18 months from the date of entry into force of this Regulation].

Or. fr

Amendment 672

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

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

Strategic projects shall be considered as contributing to the security of supply of critical medicinal products in the Union and, therefore, to be in the public interest.

Strategic projects shall be considered as contributing to the security of supply of critical medicinal products in the Union, in particular by integrating a number of levels of the pharmaceutical supply chain, and, therefore, to be in the public interest.

Or. fr

Amendment 673

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

Strategic projects shall be considered as contributing to the security of supply of critical medicinal products in the Union and, therefore, to be in the public interest.

Strategic projects shall be considered as contributing to the security of supply of critical medicinal products in the Union and, therefore, to be in the public interest as serving the objectives of public health and the protection of patients’ interests.

Or. en

Amendment 674

Tilly Metz

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

Strategic projects shall be considered as contributing to the security of supply of critical medicinal products in the Union and, therefore, to be in the public interest.

Strategic projects shall be considered as contributing to the security of supply of critical medicinal products in the Union and, therefore, to be in the public interest with particular emphasis on safeguarding public health.

Or. en

Amendment 675

Christophe Clergeau

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

Strategic projects shall be considered as contributing to the security of supply of critical medicinal products in the Union and, therefore, to be in the public interest.

Strategic projects shall be considered as contributing to the security of supply of critical medicinal products and critical medical countermeasures in the Union and, therefore, to be in the public interest.

Or. en

Amendment 676

Alessandra Moretti

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

Strategic projects shall be considered as contributing to the security of supply of critical medicinal products in the Union and, therefore, to be in the public interest.

Strategic projects effectively contributing to the security of supply of critical medicinal products in the Union shall be considered to be in the public interest.

Or. en

Amendment 677

Dario Tamburrano, Valentina Palmisano

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 within a maximum of 45 working days of receipt of all necessary information, except in duly justified cases, making available, in particular, any form of accelerated procedures that exists in applicable Union and national law. For entities qualified as SMEs, the Member State shall establish a priority channel and a simplified procedure with a maximum timeframe reduced to thirty-five (35) working days; where applicable, administrative burdens and investigation fees for SMEs may be reduced or exempted.

Or. en

Amendment 678

Dan-Ştefan Motreanu

Proposal for a regulation

Article 7 – paragraph 2

Text proposed by the Commission

Amendment

The Member States’ authorities, under the coordination of the European Commission, shall ensure that the relevant permit granting processes related to strategic projects will obtain fast track approval processes (including identification), making available, in particular, any form of accelerated procedures that exists in applicable Union and national law.

The European Commission should establish a 'one-stop-shop' to coordinate the funds, centralise information on funding and state aid for market authorisation holders and support each designated authority with the prioritisation of strategic projects.

Or. en

Amendment 679

Aurelijus Veryga

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 will obtain fast track approval processes, including identification, making available, in particular, any form of accelerated procedures that exists in applicable Union and national law. Such procedures shall be conditional on the undertaking’s obligations regarding security of supply, affordability of end-products, and transparency in the use of public funds.

Or. en

Amendment 680

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

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 and corresponding certification and inspection processes related to strategic projects are carried out without undue delay, 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.

Or. en

Amendment 681

Tilly Metz

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 without undermining the quality and robustness of assessments and while not lowering the level of environmental protection.

Or. en

Amendment 682

Catarina Martins, Sebastian Everding, Anthony Smith

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 urgency of the permit shall never undermine the application of the highest environmental and social standards.

Or. en

Amendment 683

Laurent Castillo

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 and legislative and administrative processes related to strategic projects are carried out by means of any form of accelerated procedures that exists in applicable Union and national law.

Or. fr

Amendment 684

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 7 – paragraph 2 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

Manufacturers and marketing authorisation holders shall be required to communicate to the Commission and the European Medicines Agency detailed information on the costs of production, research and development, as well as on public support received, as a condition for access to funding or procurement procedures under this Regulation. Where accelerated procedures or public funding are granted, Member States shall ensure that they are subject to clear and binding commitments by beneficiaries regarding security of supply, affordability of final products and transparency in the use of funds. Medicines developed under strategic projects must be made equally available in all Member States; in the event of non-compliance, authorisation holders shall be subject to penalties, including reimbursement of the aid received.

Or. en

Amendment 685

Laurent Castillo

Proposal for a regulation

Article 7 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

In return, the promoter shall undertake to make every effort to comply with at least one of the criteria of Article 5 and shall ensure as a priority supplies of critical medicines and their availability within the Union under normal conditions and in times of shortage. A performance contract shall be concluded between the designated authority in charge of the strategic project and the sponsor. It shall provide for the deadline(s) by which the sponsor must send the designated authority a set amount of information defined by the two parties, including on the use of funds, the diversification of supply sources, the destination of the critical medicinal products produced and production volumes.

Or. fr

Amendment 686

Aurelijus Veryga

Proposal for a regulation

Article 7 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

The Member States shall provide strategic projects located within their borders with all necessary administrative and technical support to mitigate unplanned interruptions in the supply of energy, gas and heat required for the creation or expansion of manufacturing capacity.

Or. en

Amendment 687

András Tivadar Kulja

Proposal for a regulation

Article 7 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

The Commission shall establish a 'one-stop-shop' to coordinate the funds and support each designated authority with the prioritisation of strategic projects.

Or. en

Amendment 688

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 8 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Upon request of a project promoter, a Member State shall provide to a strategic project located on its territory all the administrative support necessary to facilitate its timely and effective implementation. It also creates a national 'digital one-stop shop' for strategic projects (One-Stop-Shop), which coordinates all administrative bodies, provides standard checklists, binding deadlines, a single point of contact for practice, including assistance:

Or. en

Amendment 689

Tilly Metz

Proposal for a regulation

Article 8 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) with regard to informing the public, with the aim of increasing public acceptance of the strategic project;

(b) with regard to informing the public, with the aim of increasing public acceptance of the strategic project; and where relevant facilitating meaningful consultations of local communities, organisations and social partners;

Or. en

Amendment 690

Tilly Metz

Proposal for a regulation

Article 8 – paragraph 2

Text proposed by the Commission

Amendment

2. When providing the administrative support and the assistance referred to in paragraph 1, the Member State shall pay particular attention to small and medium size enterprises (SMEs) and, where appropriate, establish a dedicated channel for communication with SMEs to provide guidance and respond to queries related to the implementation of this Regulation.

2. When providing the administrative support and the assistance referred to in paragraph 1, the Member State shall pay particular attention to small and medium size enterprises (SMEs), as well as not-for-profit undertakings, and, where appropriate, establish a dedicated channel for communication with them to provide guidance and respond to queries related to the implementation of this Regulation.

Or. en

Amendment 691

Aurelijus Veryga

Proposal for a regulation

Article 8 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Member States shall ensure, in accordance with their competences, that employees of strategic projects whose roles are necessary for creating or increasing manufacturing capacity are exempted from active military service, for the purpose of safeguarding the operational continuity of strategic projects in times of crisis and national emergency.

As an alternative to exemption, Member States may provide such employees with a mobilisation assignment within the strategic project concerned.

Or. en

Amendment 692

Marta Temido, Pierre Jouvet

Proposal for a regulation

Article 8 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Member States may adopt supplementary national measures, such as administrative simplification or procedures for industrial licensing, aimed at fostering local productive investment with an impact on streamlined sectors, provided that such measures are compatible with Union law and do not distort competition within the internal market.

Or. en

Amendment 693

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Article 8 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2 b. Member States shall provide to a strategic project located on its territory all the administrative and technical support necessary to counteract unplanned interruptions in the supply of energy, gas and heat required to creating or increasing manufacturing capacity.

Or. en

Amendment 694

Margarita de la Pisa Carrión

Proposal for a regulation

Article 11 – paragraph 1

Text proposed by the Commission

Amendment

1. Upon request of a project promoter, a Member State shall provide regulatory support to a strategic project located on its territory, including by prioritising Good Manufacturing Practices inspections for approval of new and extended manufacturing sites and for the manufacturing sites modernised in the context of the concerned strategic project.

1. Upon request of a project promoter, a Member State shall provide regulatory support to a strategic project located on its territory, including by prioritising Good Manufacturing and Good Distribution Practices inspections for approval of new and extended manufacturing or wholesale warehousing sites and for the manufacturing or wholesale warehousing sites modernised in the context of the concerned strategic project.

Or. en

Amendment 695

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

Proposal for a regulation

Article 11 – paragraph 1

Text proposed by the Commission

Amendment

1. Upon request of a project promoter, a Member State shall, where possible through a single point of contact, provide regulatory support to a strategic project located on its territory, including by prioritising Good Manufacturing Practices inspections for approval of new and extended manufacturing sites and for the manufacturing sites modernised in the context of the concerned strategic project.

Or. en

Amendment 696

Laurent Castillo

Proposal for a regulation

Article 11 – paragraph 1

Text proposed by the Commission

Amendment

1. Upon request of a project promoter, a Member State shall provide regulatory support to a strategic project located on its territory, including by prioritising safety inspections and Good Manufacturing Practices inspections for approval of new and extended manufacturing sites and for the manufacturing sites modernised in the context of the concerned strategic project.

Or. fr

Amendment 697

Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 11 – paragraph 1

Text proposed by the Commission

Amendment

1. Upon request of a project promoter, a Member State shall provide regulatory support to a strategic project located on its territory, including by prioritising Good Manufacturing and Good Distribution Practices inspections for approval of new and extended manufacturing sites and for the manufacturing sites modernised in the context of the concerned strategic project.

Or. en

Amendment 698

Laurent Castillo

Proposal for a regulation

Article 11 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. At the request of a project promoter, a Member State shall provide regulatory support for medicinal products manufactured at a manufacturing site designated as a strategic project, in particular by giving priority to marketing authorisation procedures for critical medicinal products or their substitutes and to pricing and reimbursement procedures. Every Member State shall be free to exempt strategic projects from administrative fees.

Or. fr

Amendment 699

Laurence Trochu

Proposal for a regulation

Article 11 – paragraph 2

Text proposed by the Commission

Amendment

2. Upon request of a project promoter, the European Medicines Agency (‘the Agency’) shall provide dedicated advice to assist project promoters developing projects relying on innovative manufacturing processes.

2. Upon request of a project promoter, the European Medicines Agency (‘the Agency’) shall provide dedicated advice to assist project promoters, including those developing projects relying on innovative manufacturing processes but also operators whose role could be critical for the value chain.

Or. fr

Amendment 700

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

Article 11 – paragraph 2

Text proposed by the Commission

Amendment

2. Upon request of a project promoter, the European Medicines Agency (‘the Agency’) and/or national competent authorities for medicinal products, where appropriate, shall provide dedicated advice to assist project promoters developing projects relying on innovative manufacturing processes.

Or. en

Amendment 701

Laurent Castillo

Proposal for a regulation

Article 11 – paragraph 2

Text proposed by the Commission

Amendment

2. Upon request of a project promoter, the European Medicines Agency (‘the Agency’) shall provide, within the limits of its mandate and expertise, specialist advice to assist project promoters.

Or. fr

Amendment 702

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

Article 11 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. When providing the regulatory support referred to in paragraph 1, the Member State shall pay particular attention to small and medium size enterprises (SMEs) and, where appropriate, establish a dedicated channel for communication with SMEs to provide guidance and respond to queries related to the implementation of applicable regulations.

Or. en

Amendment 703

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

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.

_________________

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).

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).

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).

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).

Or. en

Amendment 704

Aurelijus Veryga

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 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.

_________________

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).

Or. en

Amendment 705

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

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 17 , 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.

_________________

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).

Or. en

Amendment 706

András Tivadar Kulja

Proposal for a regulation

Article 12 – paragraph 1 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

The Commission and Member States shall coordinate the implementation of this Regulation with forthcoming environmental and chemical legislation to prevent undue restrictions on the manufacture and availability of critical medicinal products. Where such legislation risks significantly hindering production or supply, the Commission shall carry out a coordinated impact assessment and consult with the Critical Medicines Coordination Group to propose mitigating actions including possible regulatory proposals.

Or. en

Amendment 707

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

Proposal for a regulation

Article 12 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

Under the joint procedure referred to in the first subparagraph, a competent authority shall provide for a single assessment of the environmental impact of a particular project required by the relevant Directive.

Or. en

Amendment 708

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

Proposal for a regulation

Article 12 – paragraph 1 – subparagraph 3 a (new)

Text proposed by the Commission

Amendment

In the case of strategic projects related to the manufacture of antimicrobial substances, the authorisation procedure shall ensure the adoption of appropriate emission control measures to prevent the release of active pharmaceutical ingredients into water and soil.

Or. en

Amendment 709

Galato Alexandraki, Emmanouil Fragkos

Proposal for a regulation

Article 12 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. The Commission may not impose the mandatory participation of Member States in common procurements where this would be detrimental to national health policy or lead to an increase in costs for the national health system.

Or. el

Amendment 710

Tilly Metz

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.

Or. en

Amendment 711

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

Proposal for a regulation

Article 12 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 712

Tilly Metz

Proposal for a regulation

Article 12 – paragraph 5

Text proposed by the Commission

Amendment

5. With regard to the environmental impacts or obligations referred to in Article 4(7) of Directive 2000/60/EC, Article 9(1), point (a), of Directive 2009/147/EC, Articles 6(4) and 16(1) of Directive 92/43/EEC and for the purposes of Article 4(14) and (15) and Article 5(11) and (12) of Regulation (EU) 2024/1991 strategic projects in the Union may be considered to have an overriding public interest and to serve the interests of public health and safety provided that all the conditions set out in those acts are fulfilled.

The assessment as to whether a project meets the criteria for overriding public interest shall be carried out by the competent authority designated under national law, in close consultation with relevant environmental and public health authorities, and in accordance with applicable Union legislation.

The justification for this designation, including a summary of the assessment, the authorities consulted, and the mitigation or compensatory measures applied, shall be made publicly available through a centralised and easily accessible Union-level online register. This information shall be published in a timely manner and updated regularly to reflect project progress and compliance with environmental obligations.

Or. en

Amendment 713

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

Proposal for a regulation

Article 12 – paragraph 5

Text proposed by the Commission

Amendment

5. With regard to the environmental impacts or obligations referred to in Article 4(7) of Directive 2000/60/EC, Article 9(1), point (a), of Directive 2009/147/EC, Articles 6(4) and 16(1) of Directive 92/43/EEC and for the purposes of Article 4(14) and (15) and Article 5(11) and (12) of Regulation (EU) 2024/1991 strategic projects in the Union may, in exceptional and duly justified cases, be considered to have an overriding public interest and to serve the interests of public health and safety provided that all the conditions set out in those acts are fulfilled.

Or. en

Amendment 714

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Article 12 – paragraph 5

Text proposed by the Commission

Amendment

5. With regard to the environmental impacts or obligations referred to in Article 4(7) of Directive 2000/60/EC, Article 9(1), point (a), of Directive 2009/147/EC, Articles 6(4) and 16(1) of Directive 92/43/EEC and for the purposes of Article 4(14) and (15) and Article 5(11) and (12) of Regulation (EU) 2024/1991 strategic projects in the Union are recognized to have an overriding public interest and to serve the interests of public health and safety.

Or. en

Amendment 715

Adam Jarubas, Ewa Kopacz, Letizia Moratti

Proposal for a regulation

Article 12 – paragraph 5

Text proposed by the Commission

Amendment

5. With regard to the environmental impacts or obligations referred to in Article 4(7) of Directive 2000/60/EC, Article 9(1), point (a), of Directive 2009/147/EC, Articles 6(4) and 16(1) of Directive 92/43/EEC and for the purposes of Article 4(14) and (15) and Article 5(11) and (12) of Regulation (EU) 2024/1991 strategic projects in the Union shall be considered to have an overriding public interest and to serve the interests of public health and safety.

Or. en

Amendment 716

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

Proposal for a regulation

Article 12 – paragraph 5

Text proposed by the Commission

Amendment

5. With regard to the environmental impacts or obligations referred to in Article 4(7) of Directive 2000/60/EC, Article 9(1), point (a), of Directive 2009/147/EC, Articles 6(4) and 16(1) of Directive 92/43/EEC and for the purposes of Article 4(14) and (15) and Article 5(11) and (12) of Regulation (EU) 2024/1991 strategic projects in the Union shall be considered to have an overriding public interest and to serve the interests of public health and safety provided that all the conditions set out in those acts are fulfilled.

Or. en

Amendment 717

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Article 12 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. Strategic projects may be presumed to be in the overriding public interest and to serve public health and safety when weighing legal interests in individual cases.

Or. en

Amendment 718

Sebastian Everding

Proposal for a regulation

Article 12 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

(5a) Compliance with the requirements set out in Directive 2010/63 on the protection of animals used for scientific purposes must be ensured.

Or. de

Amendment 719

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Article 12 – paragraph 5 b (new)

Text proposed by the Commission

Amendment

5 b. Member States and Commission may:

a) prioritise strategic projects in administrative procedures;

b) introduce temporary and proportionate exemptions from environmental obligations where:

i) no alternative solutions exist,

ii) measures minimising environmental impact are applied.

Without prejudice to further-reaching exemptions under specific legal acts, the exemptions referred to above shall apply for a maximum period of 36 months from the commencement of investment and 36 months from the start of operational activities of the strategic project, with the possibility of extension by an additional period of 36 months in exceptional cases.

Or. en

Amendment 720

Letizia Moratti, Adam Jarubas

Proposal for a regulation

Article 12 a (new)

Text proposed by the Commission

Amendment

Article12a

Assessment of impacts of environmental legislation on the availability of critical medicines

1. The Commission shall carry out regular assessments of the impact of environmental, climate and chemical legislation on the availability of critical medicines and on the security of medicines supply in the Union.

2. Where such assessments identify a negative impact on the availability of critical medicines or on the security of medicines supply, the Commission shall, where necessary, propose appropriate mitigating measures after consultation with Member States and relevant stakeholders.

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

4. The application of the Extended Producer Responsibility provisions set out in Article 9 and 10 and Annex III of Directive (EU) 2024/3019 on Urban Wastewater Treatment shall be suspended until the Commission has completed a revised impact assessment. The assessment shall address, inter alia, the effects of those provisions on the accessibility, availability and affordability of medicinal products, the updated cost estimates of quaternary treatment, and a science-based reassessment of toxic load data. Within two months of the completion of the assessment, the Commission shall, where appropriate, submit legislative proposals to amend the Directive accordingly.

Or. en

Amendment 721

Laurent Castillo

Proposal for a regulation

Article 12 a (new)

Text proposed by the Commission

Amendment

Article 12(a)

Special status for critical medicines

The Commission and the Member States shall ensure that producers on Union soil of critical medicinal products, along with producers of active substances and active principles acting on Union soil for the purpose of producing a critical medicinal product, have special status to mitigate the environmental and chemical obligations imposed on them where those obligations unintentionally restrict the manufacture, availability or investment in critical medicinal products. The Commission shall carry out an impact assessment to assess the consequences of that legislation, upon referral to the Critical Medicines Coordination Group, with a view, in particular, to identifying significant obstacles to the production or continued availability of the critical medicinal product, and shall propose mitigating measures to address them.

Or. fr

Amendment 722

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

Proposal for a regulation

Article 12 a (new)

Text proposed by the Commission

Amendment

Article 12a

Coordination with environmental and chemical legislation

1. The Commission and Member States shall ensure that the application of this Regulation is coordinated with the application of environmental and chemical legislation to prevent unintended restrictions on the manufacturing and availability of critical medicinal products.

2. Where such legislation is likely to create substantial barriers to the continued production or availability of critical medicinal products, the Commission shall conduct a coordinated impact assessment and consult with the Critical Medicines Group to propose mitigating actions including, where appropriate, legislative proposals. This coordination shall not further delays the production or availability of critical medicinal products.

Or. en

Amendment 723

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

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. Such provisions shall take into account long-term needs for resilience, sustainability, and the security of supply of critical medicinal products. To facilitate the development of strategic projects, Member States shall ensure that all relevant spatial planning data is available in a timely, transparent and easily accessible manner.

Or. en

Amendment 724

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

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.

_________________

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).

Or. en

Amendment 725

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 13 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Where the development of Strategic Projects or their related infrastructure has potential cross-border implications, the Member States concerned shall coordinate their planning and assessment procedures, with the support of the Commission, in order to avoid duplication of efforts, ensure complementarity, and reflect the principles of solidarity and cooperation between Member States.

Or. en

Amendment 726

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

Proposal for a regulation

Article 14

Text proposed by the Commission

Amendment

Article 14

deleted

Applicability of UNECE Conventions

1. This Regulation is without prejudice to the obligations under the United Nations Economic Commission for Europe (UNECE) Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters, signed at Aarhus on 25 June 1998, and under the UNECE Convention on environmental impact assessment in a transboundary context, signed at Espoo on 25 February 1991 and its Protocol on Strategic Environmental Assessment, signed in Kyiv on 21 May 2003.

2. All decisions adopted pursuant to the Articles in this section shall be made publicly available.

Or. en

Amendment 727

Christine Anderson

Proposal for a regulation

Chapter III – Section III

Text proposed by the Commission

Amendment

III [...]

deleted

Or. en

Justification

These provisions will reinforce subsidy culture and create dependence on EU funding. It misuses programmes like Horizon Europe and EU4Health for industrial policy purposes. It creates risks of distorting competition and rewarding politically favoured players.

Amendment 728

Alessandra Moretti

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. Without prejudice to Articles 107 and 108 TFEU, Member States may grant financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products identified following a vulnerability evaluation and with due consideration to the strategic orientations of the Critical Medicines Group referred to in Article 26(2) point (a). Financial support must be proportionate to the financing needs of the strategic project and shall be subject to clear conditionalities in terms of transparency in the use of public funds, including through disclosing actual costs of R&D, and in terms of accessibility, affordability and availability of the interested medicinal products in all member states;

Or. en

Amendment 729

Laurence Trochu

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. Without prejudice to Articles 107 and 108 TFEU, Member States may prioritise financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products identified following a vulnerability evaluation and with due consideration to the strategic orientations of the Critical Medicines Group referred to in Article 26(2) point (a). Financial support may take the form, inter alia, of capital investment, liquidity support, guarantees or tax incentives. Each Member State shall be free to determine the most appropriate form of support for each project.

Or. fr

Amendment 730

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. Without prejudice to Articles 107 and 108 TFEU, Member States shall prioritise financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products identified following a vulnerability evaluation and with due consideration to the strategic orientations of the Critical Medicines Group referred to in Article 26(2) point (a). Financial support shall be proportionate to the financing needs of the strategic project and shall be subject to transparency requirements.

Or. en

Amendment 731

Christophe Clergeau

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 732

Letizia Moratti, Adam Jarubas

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States may prioritise financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products identified following a vulnerability evaluation and with due consideration to the strategic orientations of the Critical Medicines Group referred to in Article 26(2) point (a).

Or. en

Amendment 733

Aurelijus Veryga

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 734

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 735

Dan-Ştefan Motreanu

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 736

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

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 737

Laurent Castillo

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. Without prejudice to Articles 107 and 108 TFEU, Member States must prioritise financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products identified following a vulnerability evaluation and with due consideration to the strategic orientations of the Critical Medicines Group referred to in Article 26(2) point (a).

Or. fr

Amendment 738

Tilly Metz

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. Without prejudice to Articles 107 and 108 TFEU, Member States are strongly encouraged to prioritise proportional financial support to strategic projects that meet the criteria as set out in Article 5. Together with a vulnerability evaluation and aligned with the strategic orientations of the Critical Medicines Group referred to in Article 26(2) point (a).

Or. en

Amendment 739

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 15 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Manufacturers and marketing authorisation holders shall be required to communicate to the Commission and the European Medicines Agency detailed information on the costs of production, research and development, as well as on public support received, as a condition for access to financial support under this Regulation. Where public support is granted, Member States shall ensure that they are subject to clear and binding commitments by beneficiaries regarding security of supply, affordability of final products and transparency in the use of funds. Manufacturers should ensure that the critical medicinal product for whose production financial support was received remain available in the Member States where it is being marketed and should use their very best efforts to make them made equally available in all Member States; in the event of non-compliance, authorisation holders shall be subject to penalties, including reimbursement of the aid received.

Or. en

Amendment 740

András Tivadar Kulja

Proposal for a regulation

Article 15 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. For the purpose of safeguarding sufficient supply to the Union market, an undertaking that has received financial support for a strategic project shall be required to submit a roll-out plan with detailed information on the supply of the critical medicinal product within the Member State concerned. The roll-out plan shall be prepared by the undertaking and agreed with the relevant Member State. The Member State may also require the undertaking to update the roll-out plan as necessary.

Or. en

Amendment 741

Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 15 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Without prejudice to Articles 107 and 108 TFEU, the Member States and the Commission may establish financial mechanisms, including revenue guarantees or compensatory remuneration, to facilitate enhancing patients’ access and support the sustainable availability of novel antimicrobials on the EU market, including for contingency stockpiling and emergency preparedness in line with the EU Medical Countermeasures Strategy and the EU Stockpiling Strategy.

Or. en

Amendment 742

Alessandra Moretti

Proposal for a regulation

Article 15 – paragraph 2

Text proposed by the Commission

Amendment

2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, an undertaking that has benefitted from financial support for a strategic project shall prioritise supply to the Union market and use its very best efforts to ensure that the critical medicinal product remains available in the Member States where it is being marketed.

2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, an undertaking that has benefitted from financial support for a strategic project shall ensure supply to the Union market and guarantee that the critical medicinal product remains available in all Member States, particularly if no valid therapeutic alternative is available to patients;

Or. en

Amendment 743

Christophe Clergeau

Proposal for a regulation

Article 15 – paragraph 2

Text proposed by the Commission

Amendment

2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products or the critical medical countermeasures is on the EU List of Medical Countermeasures for Priority Threats, an undertaking that has benefitted from financial support for a strategic project shall prioritise supply to the Union market and use its very best efforts to ensure that the critical medicinal product or critical medical countermeasures remains available in the Member States where it is being marketed.

Or. en

Amendment 744

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 15 – paragraph 2

Text proposed by the Commission

Amendment

2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, an undertaking that has benefitted from financial support for a strategic project under this Article shall prioritise supply to the Union market, make all necessary efforts to ensure that the critical medicinal product remains available in the Member States where it is being marketed and adopt measures that contribute to the affordability of the product across the Union.

Or. en

Amendment 745

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

Proposal for a regulation

Article 15 – paragraph 2

Text proposed by the Commission

Amendment

2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, an undertaking that has benefitted from financial support for a strategic project shall prioritise supply to the Union market in sufficient quantities to cover patient needs and use its very best efforts to ensure that the critical medicinal product remains available in the Member States where it is being marketed.

Or. en

Amendment 746

Ondřej Krutílek

Proposal for a regulation

Article 15 – paragraph 2

Text proposed by the Commission

Amendment

2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, an undertaking that has benefitted from financial support for a strategic project based on this Article shall prioritise supply to the Union market and use its very best efforts to ensure that the critical medicinal product remains available in the Member States where it is being marketed.

Or. en

Amendment 747

Tilly Metz

Proposal for a regulation

Article 15 – paragraph 2

Text proposed by the Commission

Amendment

2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, an undertaking that has benefitted from financial support for a strategic project shall prioritise supply to the Union market and shall ensure that the critical medicinal product remains available in sufficient quantities in the Member States where it is being marketed.

Or. en

Amendment 748

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

Proposal for a regulation

Article 15 – paragraph 2

Text proposed by the Commission

Amendment

2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, an undertaking that has benefitted from financial support for a strategic project shall prioritise supply to the Member States and use its very best efforts to ensure that the critical medicinal product remains available in the Member States where it is being marketed.

Or. en

Amendment 749

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Margarita de la Pisa Carrión

Proposal for a regulation

Article 15 – paragraph 2

Text proposed by the Commission

Amendment

2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, an undertaking that has benefitted from financial support for a strategic project shall prioritise supply to the Union market and ensure that the critical medicinal product remains available in the Member States where it is being marketed for at least 5 years.

Or. en

Amendment 750

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 15 – paragraph 2

Text proposed by the Commission

Amendment

2. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, an undertaking that has benefitted from financial support for a strategic project shall prioritise supply to the Union market and shall ensure that the critical medicinal product remains available in the Member States where it is being marketed.

Or. en

Amendment 751

Ingeborg Ter Laak

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Member State that provided financial support to a strategic project may request such undertaking to provide the necessary supplies of a critical medicinal product, active substance or key inputs, as applicable, to the Union market to avoid shortages in one or several Member States. Financial support by Member States shall be limited to targeted and time-bound interventions. The use of financial incentives by Member States to structurally support projects that distort the functioning of the internal market remains prohibited. In case of imminent shortage, supply to the Union market shall take precedence over exports to third countries.

Or. en

Amendment 752

Tilly Metz

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Member State that provided financial support to a strategic project shall require the undertaking to submit a shortage prevention and mitigation plan referred to in Article 117 of Regulation EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] as a condition for benefiting from financial support and shall request such undertaking to provide the necessary supplies of a critical medicinal product, active substance or key inputs, as applicable, to the Union market to avoid shortages in one or several Member States.

Or. en

Amendment 753

Laurent Castillo

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Member State that provided financial support to a strategic project shall request counterparts from such undertaking. These counterparts may specify sufficient guarantees of supply during and outside episodes of supply strain concerning a critical medicinal product, active substance or key inputs, as applicable, in order to provide an appropriate and continuous supply to the market. The definition and implementation procedures for these counterparts will be set out in guidelines.

Or. fr

Amendment 754

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

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Member State that provided financial support to a strategic project may request such undertaking to prioritise and provide the necessary supplies of a critical medicinal product, active substance or key inputs, as applicable, to the Union market as a priority to avoid shortages in one or several Member States.

Or. en

Amendment 755

Christophe Clergeau

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The Member State that provided financial support to a strategic project may request such undertaking to provide the necessary supplies of a critical medical countermeasure or a critical medicinal product, active substance or key inputs, as applicable, to the Union market to avoid shortages in one or several Member States.

Or. en

Amendment 756

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

Member States may prioritise financial support to strategic projects that address a vulnerability in the supply chains of critical medicinal products identified following a vulnerability evaluation and with due consideration to the strategic orientations of the Critical Medicines Group referred to in Article 26(2) point (a). Such support shall be considered to be in accordance with Articles 107 and 108 TFEU if it is necessary, proportionate, and contributes effectively to increasing the security of supply of critical medicinal products within the Union.

Or. en

Amendment 757

Alessandra Moretti

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

Undertakings receiving public financial support for a strategic project shall ensure affordability, availability and guarantee of supply of the critical medicinal product in all member states, particularly if no therapeutic alternative is available to patients;

Or. en

Amendment 758

Marta Temido, Pierre Jouvet

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

Member States may adopt supplementary financial support, including targeted fiscal incentives and dedicated financing instruments to support industrial modernisation, technological innovation roll-out, energy transition and digital transformation.

Or. en

Amendment 759

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

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

Any Member State that encounters a threat of shortages of the critical medicinal product in question may demand the Member State that provided financial support to submit a request on its behalf.

Any Member State that encounters a threat of shortages of the critical medicinal product in question may demand the Member State that provided financial support to submit a request on its behalf. The undertaking shall undertake its very best efforts to supply the critical medicinal product in the requesting Member State.

Or. en

Amendment 760

Christophe Clergeau

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

Any Member State that encounters a threat of shortages of the critical medicinal product in question may demand the Member State that provided financial support to submit a request on its behalf.

Any Member State that encounters a threat of shortages of the critical medicinal product or the critical medical countermeasure in question may demand the Member State that provided financial support to submit a request on its behalf.

Or. en

Amendment 761

Aurelijus Veryga

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

Failure to comply with the obligations laid down in paragraphs 2 and 3 shall render the undertaking receiving financial support for a strategic project liable to penalties. The Member State concerned may terminate or recover, in whole or in part, the financial support granted to the strategic project. In addition, the undertaking may be subject to a financial penalty or excluded from eligibility for future public funding. Such measures shall be proportionate to the impact and severity of the non-compliance.

Or. en

Amendment 762

Galato Alexandraki, Fragkos

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

The Union shall pay particular attention to the availability of critical medicinal products for children and patients with rare diseases, as these groups are often the most vulnerable to shortages.

Or. el

Amendment 763

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

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

Any financial support shall be granted only on condition of compliance with social standards, including, where applicable, collective agreements and workers’ participation.

Or. en

Amendment 764

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

Proposal for a regulation

Article 15 – paragraph 3 – subparagraph 2 b (new)

Text proposed by the Commission

Amendment

Where financial support has been granted, the project promoter shall demonstrate that the funds have been used within the Member State providing such financial support.

Or. en

Amendment 765

Emmanouil Fragkos

Proposal for a regulation

Article 15 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. The granting of public financial support in accordance with this Article shall be subject to the promoter of the strategic project submitting and implementing a Plan for the Transfer of Know-How and Skills within the Union.

The Plan shall include, to the extent appropriate and respecting intellectual property rights and trade secrets:

(a) measures for transferring know-how and providing training for SMEs, universities and research organisations established in the Union;

(b) the availability, on fair, reasonable and non-discriminatory (FRAND) terms, of non-exclusive licences for the use of procedural know-how strictly necessary for increasing production capacity within the Union;

(c) an annual public progress summary for the Critical Medicines Coordination Group. Non-compliance may lead to proportionate adjustments to the support, in accordance with applicable State aid law.

Or. el

Amendment 766

Dan-Ştefan Motreanu

Proposal for a regulation

Article 15 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Commission shall adopt guidelines to facilitate the consistent application of this Article by Member States and the granting of aid to strategic projects for critical medicines, or for public security interest.

The CMA state aid guidelines should include specific provisions for financing projects that are aimed to improve the security of supply of medicines in Europe both in terms of new or existing capacity (increase manufacturing of medicines in Europe) as well as in terms of innovative manufacturing processes (improved manufacturing of medicines in Europe).

This obligation shall not apply if the Commission amends Commission Regulation (EU) No 651/2014 to extend its scope to cover such investment aid.

Or. en

Amendment 767

Aurelijus Veryga

Proposal for a regulation

Article 15 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Commission shall adopt guidelines to facilitate the consistent application of this Article by Member States in the granting of aid to strategic projects for critical medicines and projects of public security interest. Those guidelines shall include specific provisions on the financing of projects that aim to improve the security of supply of medicines in the Union, both by creating or expanding manufacturing capacity and by developing innovative manufacturing processes.

Or. en

Amendment 768

Laurent Castillo

Proposal for a regulation

Article 15 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. A performance contract shall be concluded between the designated authority in charge of the strategic project and the undertaking in question. It shall establish the deadline(s) by which the sponsor must send the designated authority a set amount of information defined by the two parties, including on the use of funds, the diversification of supply sources, the destination of the critical medicinal products produced and production volumes.

Or. fr

Amendment 769

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 15 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. An undertaking that has received financial support for a strategic project, if it hasn't done so yet, shall submit a marketing authorisation application to the competent authority in the Union either before or no later than 90 days after submitting its first application outside the Union.

Or. en

Amendment 770

Tilly Metz

Proposal for a regulation

Article 15 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Member State providing financial support to a strategic project shall require the beneficiary undertaking to adopt measures that contribute to the affordability of the critical medicinal product in the Union market, following guidelines referred to in Article 26(2) point (ca).

Or. en

Amendment 771

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc

Proposal for a regulation

Article 15 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Commission shall adopt specific guidelines to facilitate the consistent application of this Article by Member States and the granting of State aid to strategic projects that meet the criteria of Article 5.

Or. en

Amendment 772

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 15 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3 b. For the purpose of safeguarding sufficient supply to the Union market, an undertaking that has received financial support for a strategic project shall be required to submit a roll-out plan with detailed information on the supply of the critical medicinal product within the Member State concerned. The roll-out plan shall be prepared by the undertaking and agreed with the relevant Member State. The Member State may also require the undertaking to update the roll-out plan as necessary.

Or. en

Amendment 773

Dan-Ştefan Motreanu

Proposal for a regulation

Article 15 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3 b. The State Aid Guidance shall include sufficiently grant amounts to incentivise investments in capacity and innovative manufacturing processes in line with paragraph 5 of this Article, and cover costs including but not limited to R&D, factory construction and expansion, and supply chain security. It shall also outline accelerated application and approval processes.

Or. en

Amendment 774

Tilly Metz

Proposal for a regulation

Article 15 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3 b. In the event of a public health emergency declared according to Regulation (EU) 2022/2371, the Member State providing financial support can require that the beneficiaries of financial support commit to grant non-exclusive licences to third parties for critical medicinal products that may contribute to address the crisis.

Or. en

Amendment 775

Tilly Metz

Proposal for a regulation

Article 15 – paragraph 3 c (new)

Text proposed by the Commission

Amendment

3 c. Where there is a risk that export of a critical medicinal product would undermine supply within the Union, and upon request by at least one Member State, the Commission may require the undertaking benefiting from financial support to obtain an export authorisation before transferring such products outside the Union. This measure shall be proportionate, time-limited, and targeted to safeguard public health within the Union.

Or. en

Amendment 776

Tilly Metz

Proposal for a regulation

Article 15 – paragraph 3 d (new)

Text proposed by the Commission

Amendment

3 d. Non-compliance with the obligations set out in this Article by an undertaking that has received financial support for a strategic project may result in appropriate penalties. This may include the suspension, termination, or recovery - in full or in part - of the financial support granted by the Member State, particularly in cases where the undertaking fails to prioritise supply to the Union market or does not comply with shortage prevention obligations.

Or. en

Amendment 777

Viktória Ferenc, Aleksandar Nikolic, Ondřej Knotek, Marie-Luce Brasier-Clain, Valérie Deloge

Proposal for a regulation

Article 15 a (new)

Text proposed by the Commission

Amendment

Article15a

The financial framework under this Act shall be exempted from any restrictive rules on state aid, in order to allow access to support for undertakings located in developed regions, given that the geographical location of manufacturing sites within the Union constitutes a structural factor not easily subject to change.

Or. en

Amendment 778

András Tivadar Kulja

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. If an undertaking has received financial support for a strategic project from Union funding, it shall prioritise supply to the Union market and shall ensure that the critical medicinal product remains available in the Member States where it is being marketed.

_________________

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

Amendment 779

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

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. The Union shall guarantee that strategic projects may be supported by Union funding in the next Multiannual Financial Framework, given the strategic importance of critical medicinal products, or in the financial mechanisms of the new defence package.

_________________

Or. en

Amendment 780

Alessandra Moretti

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. Undertakings receiving public financial support must ensure affordability, availability and guarantee of supply of the critical medicinal product in all member states, particularly if no therapeutic alternative is available to patients;

_________________

Or. en

Amendment 781

Catarina Martins, Sebastian Everding

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 shall be supported by Union funding, including but not limited to such Union programmes as the EU4Health Programme25 , Horizon Europe26 , and the Digital Europe Programme27as 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 Strategic project, during the designated period shall not be less than 300 billion Euros.

_________________

Or. en

Amendment 782

Tilly Metz

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 proportional 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. In the Multiannual Financial Framework for the period 2028–2035, the Union shall provide for dedicated funding in order to support the achievement of the objectives laid down in this Regulation.

_________________

Or. en

Amendment 783

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

Proposal for a regulation

Article 16 – paragraph 1

Text proposed by the Commission

Amendment

1. For the duration of the Multiannual Financial Framework 2021-2027[1] strategic projects shall be supported by all relevant Union funding, including but not limited to such Union programmes as the regional funds, EU4Health Programme[2], Horizon Europe[3], the Digital Europe Programme[4], the European Defence Fund (for dual-use manufacturing enablers where eligible), and Union instruments supporting competitiveness and industrial resilience, provided that eligibility criteria are met and that such support is in line with the objectives set out in the regulations establishing those programmes.

_________________

Or. en

Amendment 784

Dario Tamburrano, Valentina Palmisano

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, including pilot or demonstration projects of distributed or local production platforms for critical medicines enabled by technologies such as additive manufacturing, 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.

_________________

Or. en

Amendment 785

Michalis Hadjipantela

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; the Union shall work to allocate sufficient funding to support the implementation of this regulation.

_________________

Or. en

Amendment 786

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová

Proposal for a regulation

Article 16 – paragraph 1

Text proposed by the Commission

Amendment

1. Strategic projects may be supported by Union funding, including under current and future Union programmes provided that such support is in line with the objectives set out in the regulations establishing those programmes. Beneficiaries of Union funding shall adopt measures that contribute to the affordability of the resulting critical medicinal product across the Union and ensure that such product remains available on the Union market.

_________________

Or. en

Amendment 787

Adam Jarubas, Ewa Kopacz, Letizia Moratti

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 shall be supported by Union funding, including but not limited to such Union programmes as the EU4Health Programme25, Horizon Europe26 , European Defence Fund26a and the Digital Europe Programme27 provided that such support is in line with the objectives set out in this regulation or in the regulations establishing those programmes.

_________________

26a Regulation (EU) 2021/697 of the European Parliament and of the Council of 29 April 2021 establishing the European Defence Fund and repealing Regulation (EU) 2018/1092 (OJ L 170, 12.5.2021, pp. 149–177) https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32021R0697

Or. en

Amendment 788

Aurelijus Veryga

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 , European Defence Fund, EU Competitiveness Fund, the Digital Europe Programme27 provided that such support is in line with the objectives set out in the regulations establishing those programmes.

_________________

Or. en

Amendment 789

Laurent Castillo

Proposal for a regulation

Article 16 – paragraph 1

Text proposed by the Commission

Amendment

1. Strategic projects may be supported by Union funding, including but not limited to new Union programmes and such existing Union programmes as the EU4Health Programme25, Horizon Europe26, RearmEU and the Digital Europe Programme27. The Cohesion Fund and the European Defence Fund must also be used.

_________________

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. 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. fr

Amendment 790

Ondřej Krutílek, Laurence Trochu

Proposal for a regulation

Article 16 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, an undertaking that has benefited from financial support for a strategic project based on this Article shall prioritise supply to the Union market and use its very best efforts to ensure that the critical medicinal product remains available in the Member States where it is being marketed. While the financial incentives from the Member States require the subsequent supply of critical medicines manufactured under such support to the Union market, the Union financial incentives are not linked with such an obligation.

Or. en

Amendment 791

Adam Jarubas, Ewa Kopacz, Letizia Moratti

Proposal for a regulation

Article 16 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. For the duration of the Multiannual Financial Framework 2028-2034 strategic projects shall be supported by Union funding, including already existing and future Union programmes dedicated to public health, research and innovation, competitiveness, digital technology, defence, resilience and preparedness, including such Union programmes as European Economic, Territorial, Social, Rural and Maritime Sustainable Prosperity and Security Fund and European Competitiveness Fund, provided that such support is in line with the objectives set out in this regulation or the regulations establishing those programmes.

Or. en

Amendment 792

Elena Nevado del Campo, Dolors Montserrat

Proposal for a regulation

Article 16 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Subject to the negotiations of the 2028–2034 Multiannual Financial Framework and any subsequent amendments, strategic projects under this Regulation shall be financed from the allocations foreseen in the MFF 2028–2034 for health, biotechnology, and bioeconomy within the Competitiveness, Prosperity and Security heading, including any programmes or budgetary instruments approved under the Union Competitiveness Fund. Furthermore, a Critical Medicines Security Fund (CMSF) may be established under this MFF to support the achievement of the objectives set out in this Regulation.

Or. en

Amendment 793

Aurelijus Veryga

Proposal for a regulation

Article 16 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. A Critical Medicines Security Fund (CSMF) is hereby established under the Multiannual Financial Framework for the period 2028–2034 to support the achievement of the objectives laid down in Article 4 of this Regulation. The CSMF shall be implemented in coordination with, and in complementarity to, other relevant Union programmes and instruments, including the EU4Health Programme, Horizon Europe, the European Defence Fund, the EU Competitiveness Fund and the Digital Europe Programme.

Or. en

Amendment 794

Nikos Papandreou

Proposal for a regulation

Article 16 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The Commission shall establish a one-stop-shop to coordinate Union and national funding streams, centralise information on funding opportunities and State aid relevant to strategic projects and marketing authorisation holders, and support designated authorities in the prioritisation and sequencing of strategic projects.

Or. en

Amendment 795

Letizia Moratti, Adam Jarubas

Proposal for a regulation

Article 16 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. A Critical Medicines Security Fund (CSMF) shall be established under the Multiannual Financial Framework 2028–2034 to support the objectives set out in Article 4. The CSMF shall operate in coordination with other relevant Union programmes and instruments.

Or. en

Amendment 796

Dan-Ştefan Motreanu

Proposal for a regulation

Article 16 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. A Critical Medicines Security Fund (CSMF) shall be established under the Multiannual Financial Framework for the period 2028–2034 within the Competitiveness Pillar to support the achievement of the objectives laid down in Article 4 of this Regulation.

Or. en

Amendment 797

Tilly Metz

Proposal for a regulation

Article 16 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Beneficiaries shall be required to adopt measures that contribute to the availability, continued supply, and affordability of the critical medicinal product in the Union, following guidelines referred to in Article 26(2) point (ca).

Or. en

Amendment 798

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

Proposal for a regulation

Article 16 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The Commission shall establish a dedicated Critical Medicines Fund in accordance with Article 16(a).

Or. en

Amendment 799

Adam Jarubas, Ewa Kopacz, Letizia Moratti

Proposal for a regulation

Article 16 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1 b. After the Multiannual Financial Framework 2027-2034 strategic projects shall be supported by Union funding, including already existing and future Union programmes dedicated to public health, research and innovation, competitiveness, digital technology, defence, resilience and preparedness.

Or. en

Amendment 800

Elena Nevado del Campo, Dolors Montserrat

Proposal for a regulation

Article 16 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1 b. Cohesion funds and other structural instruments, may be used to co-finance strategic projects under this Regulation, only where such projects foster regional economic growth, measured through indicators of regional development, innovation capacity, or employment generation.

Or. en

Amendment 801

Aurelijus Veryga

Proposal for a regulation

Article 16 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1 b. Where relevant, the Commission shall ensure the coordination of projects undertaken pursuant to this Regulation with relevant international security organisations, including NATO, in order to strengthen the resilience and security of supply of critical medicines.

Or. en

Amendment 802

Tilly Metz

Proposal for a regulation

Article 16 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1 b. For the duration of the Multiannual Financial Framework 2021-2027, the European Regional Development Fund may also be used to support the capacity of public hospitals to perform the activities described in Articles 5 and 6 of this Regulation.

Or. en

Amendment 803

Aurelijus Veryga

Proposal for a regulation

Article 16 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

1 c. Strategic projects intended to reinforce Europe’s capacity to produce and supply critical medicines may also benefit from EU instruments supporting strategic autonomy and security. To this end, the Commission shall explore the integration of this regulation into the Union’s broader strategic autonomy and security framework. Where appropriate, defence-related funding mechanisms may be leveraged, in accordance with Union law, to support pharmaceutical production as a matter of public health and economic and military security.

Or. en

Amendment 804

Tilly Metz

Proposal for a regulation

Article 16 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

1 c. For as long as the critical medicinal product is on the Union List of Critical Medicinal Products, an undertaking that has benefitted from financial support from the Union for a strategic project shall prioritise supply to the Union market and shall ensure that the critical medicinal product remains available in the Member States where it is being marketed.

Or. en

Amendment 805

Elena Nevado del Campo, Dolors Montserrat

Proposal for a regulation

Article 16 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

1 c. Financing from the MFF shall ensure continuity and predictability of strategic projects, safeguarding the security of supply of critical medicines and long-term industrial resilience across the Union.

Or. en

Amendment 806

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Article 16 – paragraph 1 d (new)

Text proposed by the Commission

Amendment

1 d. The aid intensity from the regional aid program within the meaning of Regulation (EU) 651/2014 for the implementation of a strategic project does not depend on the intensity level specified in the regional aid map.

Or. en

Amendment 807

Ondřej Krutílek

Proposal for a regulation

Article 16 – paragraph 2

Text proposed by the Commission

Amendment

2. At the request of a project promoter, justified by necessity to provide results of vulnerability evaluation for the purpose of an application for Union funding, the designated authority shall assess whether a strategic project addresses a vulnerability in the supply chains identified following the vulnerability evaluation. The designated authority shall provide its assessment to a project promoter within 15 working days of its request. The designated authority shall inform the Commission about the strategic projects identified as addressing an existing vulnerability in the supply chains without delay.

2. At the request of a project promoter, justified by necessity to provide results of vulnerability evaluation for the purpose of an application for Union funding, the Commission shall assess whether a strategic project addresses a vulnerability in the supply chains identified following the vulnerability evaluation. The Commission shall provide its assessment to a project promoter within 15 working days of its request.

Or. en

Amendment 808

Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Procurement procedures (as referenced in articles 21, 22 and 23) may be supported by Union funding, in accordance with relevant guidelines to be developed by the European Commission. Such funding could include, but should not be limited to, such Union Programmes as the EU4Health Programme, Horizon Europe, and the Digital Europe Programme, as well as the Cohesion Fund, provided that such support is in line with the objectives set out in the regulations establishing those Funds and programmes.

Or. en

Amendment 809

Radan Kanev

Proposal for a regulation

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Procurement procedures (as referenced in articles 21, 22 and 23) may be supported by Union funding, in accordance with guidelines to be developed by the European Commission. Such funding could include, but should not be limited to, such Union Programmes as the EU4Health Programme, Horizon Europe, and the Digital Europe Programme, as well as the Cohesion Fund, provided that such support is in line with the objectives set out in the regulations establishing those Fund and programmes.

Or. en

Justification

There is a concern that by pooling of Member States with significant differences in GDP per capita ratios, procurement negotiations may lead to price levels that would make procurement processes commercially inviable. In addition to recommending the pooling of Member States of similar socioeconomic profiles (see suggestions on a new Art 18a), we recommend enablingthe targeted use of EU funds to alleviate such differences when necessary and ensure all EU Member States can benefit equally from such procurement procedures.

Amendment 810

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

Proposal for a regulation

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. A project promoter which has received financial support for a strategic project shall be under an obligation to ensure the adequate supply of the medicinal product concerned in the Member States where it is placed on the market. Where that obligation is not complied with, the project promoter shall be required to reimburse in full the financial support granted, without prejudice to any other remedies or penalties provided for under Union or national law.

Or. en

Amendment 811

Tilly Metz

Proposal for a regulation

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Where there is a risk that export of a critical medicinal product would undermine supply within the Union, and upon request by at least one Member State, the Commission may require the undertaking benefiting from financial support to obtain an export authorisation before transferring such products outside the Union. This measure shall be proportionate, time-limited, and targeted to safeguard public health within the Union.

Or. en

Amendment 812

Laurent Castillo

Proposal for a regulation

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. One year after the entry into force of this Regulation, the Commission will present a draft regulation that seeks to establish a European health fund based on the criteria and objectives of this Regulation, in particular Article 4, with a dedicated budget. This fund will be established in conjunction with and with the support of existing Union programmes.

Or. fr

Amendment 813

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. State aid granted to a strategic project shall be deemed compatible with the internal market within the meaning of Article 107(1) of the Treaty on the Functioning of the European Union, provided that the State aid is intended exclusively for the pursuit of objectives relating to the protection of public health.

Or. en

Amendment 814

Sebastian Everding

Proposal for a regulation

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

(2a) Under the conditions set out in points 1 and 2, the European Union shall in particular support projects focusing on the 'One Health' approach, on reducing multidrug-resistance or on innovations in animal testing based on the '3R principle'.

Or. de

Amendment 815

Peter Agius

Proposal for a regulation

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. When an undertaking requests funding under this article, the Commission may, of its own initiative or upon request by Member States, include a public service obligation to supply a number or all Member States amongst the conditions for the funding.

Or. en

Justification

When an undertaking is benefiting from EU EU funds, it is important, when feasible, that the Commission may impose a public service obligation to supply some Member States, which request such obligation

Amendment 816

Emmanouil Fragkos

Proposal for a regulation

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. The Commission shall ensure that the Union programmes referred to in paragraph 1 may finance, where appropriate, measures for transferring know-how and skills development in strategic projects in accordance with Article 15(4).

Or. el

Amendment 817

Aurelijus Veryga

Proposal for a regulation

Article 16 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. An undertaking receiving financial support under this Article shall give priority to supply within the Union and ensure availability of the critical medicinal product in all Member States where it is marketed.

Or. en

Amendment 818

Emmanouil Fragkos

Proposal for a regulation

Article 16 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2b. The Commission, in cooperation with the European Institute of Innovation and Technology (EIT), shall ensure the strengthening and targeted expansion of the Knowledge and Innovation Community in the area of health (EIT Health) with the aim of:

(a) establishing specialised hubs for critical pharmaceutical products, active substances and key inputs;

(b) supporting pilot lines, test facilities and advanced production training programmes;

(c) transferring know-how between industry, universities and research organisations and interlinking with strategic projects referred to in Chapter III.

2. Actions referred to in this Article may be financed under the programmes referred to in Article 16(1), subject to their terms.

Or. el

Amendment 819

Tilly Metz

Proposal for a regulation

Article 16 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2 b. Non-compliance with the obligations set out in this Article by an undertaking that has received financial support for a strategic project may result in appropriate penalties. This may include the suspension, termination, or recovery - in full or in part - of the financial support granted by the Union, particularly in cases where the undertaking fails to prioritise supply to the Union market or does not comply with shortage prevention obligations.

Or. en

Amendment 820

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Article 16 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2 b. State aid granted to a strategic project shall be deemed compatible with the internal market within the meaning of Article 107(1) of the Treaty on the Functioning of the European Union, provided that the State aid is intended exclusively for the pursuit of objectives relating to the protection of public health.

Or. en

Amendment 821

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 16 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2 b. If an undertaking has received financial support for a strategic project from Union funding, it shall prioritise supply to the Union market and shall ensure that the critical medicinal product remains available in the Member States where it is being marketed.

Or. en

Amendment 822

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

Proposal for a regulation

Article 16 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2 b. Where financial support has been granted, the project promoter shall demonstrate that the funds have been used within the territory of the Union.

Or. en

Amendment 823

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 16 – paragraph 2 c (new)

Text proposed by the Commission

Amendment

2 c. An undertaking that has received financial support for a strategic project, if it hasn't done so yet, it shall submit a marketing authorisation application to the competent authority in the Union either before or no later than 90 days after submitting its first application outside the Union.

Or. en

Amendment 824

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

Proposal for a regulation

Article 16 – paragraph 2 c (new)

Text proposed by the Commission

Amendment

2 c. The Commission shall annually assess Union funding provided and, where necessary, propose complementary funding instruments or increased budgetary allocations to support achieving the objectives set out in this Regulation.

Or. en

Amendment 825

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 16 – paragraph 2 d (new)

Text proposed by the Commission

Amendment

2 d. For the purpose of safeguarding sufficient supply to the Union market, an undertaking that has received financial support for a strategic project shall be required to submit a roll-out plan with detailed information on the supply of the critical medicinal product within the Union market. The roll-out plan shall be prepared by the undertaking and approved by the Critical Medicines Coordination Group. The Critical Medicines Coordination Group may also require the undertaking to update the roll-out plan as necessary.

Or. en

Amendment 826

Oliver Schenk

Proposal for a regulation

Article 16 a (new)

Text proposed by the Commission

Amendment

Article 16a

Coordination of financing

1. The Critical Medicines Group shall examine the bottlenecks and Union-wide financial needs of strategic projects, advise on ways of coordinating Union and national financing with regard to those financial needs, and collect potential best practices, for the purpose of, inter alia, developing Union cross-border supply chains, in particular on the basis of regular exchanges and recommendations of the Critical Medicines Group and with the relevant industrial alliances.

2. The Critical Medicines Group, where appropriate within a dedicated working group, shall, at the request of the strategic project promoter, discuss and advise on how the financing of the project can be completed, taking into account the funding already secured and considering at least the following elements:

(a) additional private sources of financing;

(b) support through resources from the EIB Group or other international financial institutions including the European Bank for Reconstruction and Development;

(c) existing Member State instruments and programmes, including from national promotional banks, institutions and Export Credit Agencies;

(d) relevant Union funding and financing programmes.

3. The Critical Medicines Group shall regularly provide recommendations on ways to ensure sufficient funding, including through the Union budget, to pursue the objectives of this Regulation.

4. Member States and, where appropriate, the Commission shall undertake activities to accelerate public investments in strategic projects. Such activities may, without prejudice to Articles 107 and 108 TFEU, include advising on and coordinating support for strategic projects which are facing difficulties in accessing finance.

Or. en

Amendment 827

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

Proposal for a regulation

Article 16 a (new)

Text proposed by the Commission

Amendment

Article16a

Critical Medicines Fund

1. This Regulation establishes the Critical Medicines Fund as part of the post-2027 Multiannual Financial Framework. The CMF shall contribute to the objectives set out in this Regulation and provide financial support to strategic projects recognised under article 6 of this regulation.

2. The CMF shall be implemented in accordance with the Financial Regulation and integrated into the general budget of the Union under a dedicated budget line.

Or. en

Amendment 828

Ondřej Krutílek, Laurence Trochu

Proposal for a regulation

Article 16 a (new)

Text proposed by the Commission

Amendment

Article 16a

The Commission shall in close collaboration with Member States create and update a Union investment strategy for critical medicinal products to ensure a diversified market and to avoid supporting similarly targeted strategic projects

Or. en

Amendment 829

Tilly Metz

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall inform the Critical Medicines Coordination Group (‘the Critical Medicines Group’) referred to in Article 24 of the intention to provide financial support to strategic projects sufficiently in advance to allow the group to carry out its coordination task as set out in Article 25. This information shall include a description of how the project addresses one or more of the priority areas identified in Article 5.

Or. en

Amendment 830

Christophe Clergeau

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall inform the Critical Medicines and Medical Countermeasures Coordination Group (‘the Critical Medicines and Medical Countermeasures Group’) referred to in Article 25 of the intention to provide financial support to strategic projects sufficiently in advance to allow the group to carry out its coordination task as set out in Article 25.

Or. en

Amendment 831

Laurent Castillo

Proposal for a regulation

Article 17 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall inform the Critical Medicines Coordination Group (‘the Critical Medicines Group’) referred to in Article 24 at least every six months of financially supported strategic projects to allow the group to carry out its coordination task as set out in Article 25.

Or. fr

Amendment 832

Ondřej Krutílek, Laurence Trochu

Proposal for a regulation

Article 17 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. When Member State informs the Critical Medicines Group according to paragraph 1, it shall provide information on the expected creation or increase of manufacturing capacity, including the quantity of manufactured critical medicinal product, and the expected date of creation or increase of manufacturing capacity of the strategic project.

Or. en

Amendment 833

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 17 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. When informing the Critical Medicines Group pursuant to paragraph 1, Member States shall provide details on the planned creation or expansion of manufacturing capacity, including the projected quantities of the critical medicinal product to be manufactured and the anticipated date on which such capacity will become operational.

Or. en

Amendment 834

Aurelijus Veryga

Proposal for a regulation

Article 17 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. All information concerning administrative, regulatory, scientific and financial support granted to a strategic project pursuant to Article 8, 11, 15 and 16 shall be made transparently available to the competent public authorities, including those responsible for pricing and reimbursement decisions.

Or. en

Amendment 835

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 17 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1 b. Member States shall notify the Critical Medicines Group that the financial support has been granted in accordance with Article 15.

Or. en

Amendment 836

Ondřej Krutílek, Laurence Trochu

Proposal for a regulation

Article 17 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1 b. Member State shall inform the Critical Medicines Group that the financial support was provided in accordance with Article 15.

Or. en

Amendment 837

Tilly Metz

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall inform periodically the Critical Medicines Group of the strategic projects that benefited from financial support from the Union.

The Commission shall inform periodically the Critical Medicines Group of the strategic projects that benefited from financial support from the Union, including information on how these projects align with the strategic priorities outlined in Article 5.

Or. en

Amendment 838

Christophe Clergeau

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall inform periodically the Critical Medicines Group of the strategic projects that benefited from financial support from the Union.

The Commission shall inform periodically the Critical Medicines and Medical Countermeasures Group of the strategic projects that benefited from financial support from the Union.

Or. en

Amendment 839

Laurent Castillo

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall inform periodically the Critical Medicines Group of the strategic projects that benefited from financial support from the Union.

The Commission shall inform at least once every six months the Critical Medicines Group of the strategic projects that benefited from financial support from the Union.

Or. fr

Amendment 840

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

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall inform periodically the Critical Medicines Group of the strategic projects that benefited from financial support from the Union.

The Commission shall inform monthly the Critical Medicines Group of the strategic projects that benefited from financial support from the Union.

Or. en

Amendment 841

Ondřej Krutílek

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall inform periodically the Critical Medicines Group of the strategic projects that benefited from financial support from the Union.

The Commission shall inform the Critical Medicines Group of the strategic projects that benefited from financial support from the Union.

Or. en

Amendment 842

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall inform periodically the Critical Medicines Group of the strategic projects that benefited from financial support from the Union.

The Commission shall inform the Critical Medicines Group of the strategic projects that benefited from financial support from the Union.

Or. en

Amendment 843

András Tivadar Kulja

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

A periodic and transparent ex-post assessment shall be conducted by the European Commission - involving the national designated authority - on strategic projects receiving financial support from the Union, to ensure they continue to effectively pursue the objectives outlined in Article 1(1) of this Regulation.

Or. en

Amendment 844

Christophe Clergeau

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The Commission may inform the Critical Medicines Group of the intention to propose the establishment of funding possibilities specifically designed to address vulnerabilities in the supply chains as well as inform of any other programmes that may benefit the availability of critical medicinal products, under specific rules and conditions of these Union funding programmes.

The Commission may inform the Critical Medicines and Medical Countermeasures Group of the intention to propose the establishment of funding possibilities specifically designed to address vulnerabilities in the supply chains as well as inform of any other programmes that may benefit the availability of critical medicinal products or critical medical countermeasures, under specific rules and conditions of these Union funding programmes.

Or. en

Amendment 845

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The Commission shall inform the Critical Medicines Group of the intention to propose the establishment of funding possibilities specifically designed to address vulnerabilities in the supply chains as well as inform of any other programmes that may benefit the availability of critical medicinal products, under specific rules and conditions of these Union funding programmes.

Or. en

Amendment 846

Ondřej Krutílek

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 847

Aurelijus Veryga

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 848

Oliver Schenk

Proposal for a regulation

Article 17 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The Commission shall inform the Critical Medicines Group of its intention to propose the establishment of funding possibilities to support strategic projects. It shall also inform the Critical Medicines Group of any other programmes that may benefit the availability of critical medicinal products, under specific rules and conditions of these Union funding programmes

Or. en

Amendment 849

Dan-Ştefan Motreanu

Proposal for a regulation

Article 17 a (new)

Text proposed by the Commission

Amendment

Article 17a

Public–private partnerships for resilient distribution chains

1. Member States and the Commission shall encourage the establishment of public–private partnerships (PPPs) to strengthen the security of supply and resilience of distribution chains for critical medicines.

2. Eligible activities of such partnerships may include:

(a) coordinated investment in warehousing, logistics hubs and cold-chain infrastructure;

(b) development of digital platforms for real-time monitoring of stocks and flows;

(d) pilot projects on innovative distribution models, including regional pooling of reserves or shared emergency transport capacity.

3. Public–private partnerships shall operate on the basis of:

(a) transparent governance structures and clearly defined responsibilities;

(b) open, non-discriminatory participation of economic operators meeting quality and safety standards;

4. The Commission and the Critical Medicines Coordination Group shall facilitate the exchange of best practices among Member States regarding PPPs in distribution, and may provide guidance on model contractual clauses, governance templates, and performance indicators.

5. Where appropriate, PPPs may benefit from Union funding instruments, in line with the objectives of the relevant programmes and with applicable Union law.

Or. en

Amendment 850

Christine Anderson

Proposal for a regulation

Article 18

Text proposed by the Commission

Amendment

Article 18

deleted

Incentivising resilience, sustainability and positive social impacts in public procurement procedures

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.

2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, where justified, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

3. With regard to other medicinal products of common interest, where justified by market analysis and public health considerations, the contracting authorities may apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

4. This Article shall not preclude contracting authorities from using additional qualitative requirements, including in relation to environmental sustainability and social rights.

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services.

Or. en

Justification

These are de facto protectionist measures that violate WTO principles and distort the internal market. They raise prices, reduce supplier diversity, and reward location over performance.

Amendment 851

Emmanouil Fragkos

Proposal for a regulation

Article 18 – paragraph -1 (new)

Text proposed by the Commission

Amendment

-1. For critical medicinal products for which the vulnerability evaluation has shown a high dependence on third countries, contracting authorities shall include, where justified, award criteria giving higher scores to bids from suppliers that demonstrate that a substantial part of the production of the relevant finished forms, active substances or key inputs takes place within the Union, as well as commitments to local transfer of know-how and training. The criteria shall be designed and applied in accordance with the Union's international obligations, the principles of equal treatment and proportionality, and the Union's public procurement law.

Or. el

Amendment 852

András Tivadar Kulja

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 implement multi-winner procurements, which scope is designed based on clinical and patient needs in consultation with environmental experts and healthcare professionals, patient organizations with predictable procurement timelines and volume commitments 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 in consultation with the economic operators, including marketing authorization holders, clinical experts, patient organizations to decide procurement terms and should include an appropriate and predictable mix and weighting of qualitative criteria. These shall include patient impact and clinical value, environmental sustainability, innovation, supply chain robustness and agility, may relate to stockholding obligations, the number of diversified suppliers, monitoring of supply chains, their transparency to the contracting authority subject to safeguarding the confidentiality of trade secrets, and contract performance clauses on timely delivery. In multiannual contracts, or in contracts unilaterally prolonged by the contracting authority, suppliers shall have access to a mechanism allowing for price adjustments only in duly justified and exceptional circumstances. Such circumstances shall be strictly limited to situations where the contracted product(s) is at severe risk of becoming unavailable on the market, where there is a proven shortage of supply, or where the economic sustainability of the supply chain is threatened. Any price adjustment must be proportionate, evidence-based, and subject to the prior approval of the contracting authority.

Or. en

Amendment 853

Peter Liese

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 implement multi-winner procurements, wherever feasible, the scope of which is designed based on clinical needs in consultation with healthcare professionals, with predictable procurement timelines and minimum binding quantities, and apply procurement requirements other than price-only award criteria. Those requirements shall include award criteria that promote the resilience of supply in the Union, support the diversification of supply sources, and take into account the geographical proximity of manufacturing within the Union, the EEA or the Swiss Confederation. Where justified, such criteria shall be given greater weight than price in the evaluation of tenders. Those procurement requirements shall be defined in accordance with Directive 2014/24/EU and shall include an appropriate and predictable mix and weighting of qualitative criteria. Those criteria shall include patient impact and clinical value, innovation, supply chain robustness and agility, the number of diversified suppliers, where appropriate, depending on the product’s indication, clinical and supply chain characteristics, monitoring of supply chains, their transparency upon request of the contracting authority and subject to safeguarding the confidentiality of trade secrets, and contract performance clauses on timely delivery.

Or. en

Amendment 854

Tilly Metz

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 implement multi-winner procurements, wherever feasible, and apply procurement requirements other than price-only award criteria such as procurement requirements that promote the resilience and diversification of supply in the Union. Those procurement requirements shall be defined in accordance with Directive 2014/24/EU and should include, but not be limited to, stockholding obligations, manufacturing of the final product or availability of the key ingredients and components within the EU, the number of diversified suppliers of the tenderer, monitoring of supply chains by the tenderer, environmental and social standards, and transparency requirements, including on prices, to the contracting authority and contract performance clauses on timely delivery, as well as pricing and reimbursement policies that ensure fair and sustainable access to critical medicinal products while safeguarding supply security.

Contracting authorities shall allocate a minimum of 50-70% weighting to non-price criteria promoting resilience and diversification of the supply in the Union.

Or. en

Amendment 855

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

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 apply procurement requirements other than price-only award criteria such as procurement requirements that promote the resilience of supply in the Union. 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 multi-winner approaches where feasible and ensure that procurement procedures give primary consideration to criteria other than price. Such non-price criteria shall form the main basis for award decisions and may include, in particular, requirements that strengthen the Union’s supply resilience, promote social and environmental standards, and support sustainable manufacturing within 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.

Or. en

Amendment 856

Laurent Castillo

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 and medicinal products of common interest 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 multi-awardee public procurement contracts, where possible, the scope of which shall be designed to address needs, in consultation with healthcare professionals, with predictable supply times and binding minimum quantities.

In the award criteria and the associated weighting, contracting authorities in the Member States shall apply procurement requirements other than price-only award criteria to 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 against fixed remuneration, the number of diversified suppliers, monitoring of supply chains, their transparency to the contracting authority, subject to the protection of the confidentiality of business secrets and contract performance clauses on timely delivery.

Or. fr

Amendment 857

Catarina Martins, Sebastian Everding, Anthony Smith

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 implement multi-winner procurements, wherever feasible with predictable procurement timelines and minimum binding quantities, and apply procurement requirements other than price-only award criteria such as procurement requirements that promote the resilience, diversification and security of supply in the Union. Those procurement requirements shall be clear, transparent and predictable and defined in accordance with Directive 2014/24/EU and shall include stockholding obligations, the number of diversified suppliers, monitoring and resilience of supply chains, their transparency to the contracting authority, contract performance clauses on timely delivery, compliance with corporate, social and environmental obligations as well as impact on the healthcare system and patient needs.

Or. en

Amendment 858

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc

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 apply multi-winner approaches, wherever feasible, and shall apply procurement requirements other than price-only award criteria such as procurement requirements that promote the resilience of supply in the Union, including for expensive cancer and rare diseases therapies. 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. In multiannual contracts or contracts that have been unilaterally prolonged by the contracting authority, suppliers shall have, where duly justified, a mechanism allowing for price adjustments.

Or. en

Amendment 859

Radan Kanev

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.

Or. en

Amendment 860

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

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 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, contract performance clauses on timely delivery and a resilience criterion based on the share of added value achieved in the Union (including at least the final formulation, quality control with release by the QP and packaging).

Or. fr

Amendment 861

Christine Anderson

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 may apply procurement requirements beyond price-only criteria, provided these are proportionate, transparent, and do not create unnecessary barriers to competition 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.

Or. en

Amendment 862

Dario Tamburrano, Valentina Palmisano

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 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, environmental sustainability, monitoring of supply chains, their transparency to the contracting authority, including prices, and contract performance clauses and contract performance clauses on timely delivery.

Or. en

Amendment 863

Dan-Ştefan Motreanu

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 apply multi-winner approaches, wherever feasible, and 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.

Or. en

Amendment 864

Dolors Montserrat, Elena Nevado del Campo

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 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 apply multi-winner approaches, wherever feasible, and 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.

Or. en

Amendment 865

Christophe Clergeau

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 or critical medical countermeasures 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.

Or. en

Amendment 866

Oliver Schenk

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 apply procurement requirements other than price-only award criteria such as procurement requirements and multi-winner approaches 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.

Or. en

Amendment 867

Sirpa Pietikäinen

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 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, including price, and contract performance clauses on timely delivery.

Or. en

Amendment 868

Kristian Vigenin

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 may 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.

Or. en

Justification

Forcing MS with lower GDP to apply other criteria is likely to significantly burden their healthcare budgets and thus negatively impact the patients.

Amendment 869

Victor Negrescu

Proposal for a regulation

Article 18 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Contracting authorities may include procurement requirements that encourage suppliers to engage in research, development and innovation activities, as well as cooperation with universities, research institutes and public research infrastructures. Such activities should aim to strengthen pathways from research to market, while also supporting improvements in the sustainable manufacturing capacity and availability of both critical and commonly used medicinal products and their key inputs.

Or. en

Amendment 870

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

Proposal for a regulation

Article 18 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. Member States shall aim for at least 30 % of public procurement contracts to be reserved for SMEs producing in the Union by 2030, and imports from third countries limited to a maximum of 40 % of purchases.

Or. fr

Amendment 871

Laurent Castillo

Proposal for a regulation

Article 18 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. In multiannual contracts or contracts that have been unilaterally prolonged by the contracting authority, suppliers shall have, where duly justified, a mechanism allowing for price adjustments.

Or. fr

Amendment 872

Aurelijus Veryga

Proposal for a regulation

Article 18 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. In multiannual contracts or contracts that have been unilaterally prolonged by the contracting authority, suppliers shall have, where duly justified, a mechanism allowing for price adjustments.

Or. en

Amendment 873

Peter Liese

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union. Where these requirements are introduced, the contracting authority shall apply multi-winner approaches and shall ensure that significant quantities are purchased from suppliers that manufacture a significant proportion in the Union. Those requirements shall be applied in compliance with the Union’s international commitments.

For the purposes of this paragraph, a ‘significant proportion' of the manufacture of a critical medicinal product shall be considered to take place within the Union if at least one of the following conditions is met:

(a) at least 50% of the active pharmaceutical ingredient used in the manufacture of the product is produced within the Union or, where appropriate, the EEA or the Swiss Confederation;

(c) essential manufacturing steps, including the synthesis or biological production of active substances or the fill and finish of vaccines, are carried out within the Union or, where appropriate, the EEA or the Swiss Confederation.

The European Commission shall adopt guidelines further defining these criteria and the methodologies.

Or. en

Amendment 874

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, where justified, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union, while taking into account the distinctive characteristics of the supply chains of different medicines. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 875

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

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, where justified, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union, while taking into account the distinctive characteristics of the supply chains of different medicines. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 876

Nikos Papandreou

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, where justified, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products or their critical steps (including APIs and essential intermediates) in the Union or candidate countries. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 877

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

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

Or. fr

Amendment 878

Christophe Clergeau

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products or critical medical countermeasures for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, where justified, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products or critical medical countermeasures in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 879

Galato Alexandraki, Emmanouil Fragkos

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, where justified, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union, with specific provision for the participation of small and medium-sized enterprises (SMEs) and domestic producers in Member States with a less developed pharmaceutical industry.

Or. el

Amendment 880

Laurent Castillo

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation, the contracting authorities shall apply an award criterion of X% of the total weighting favouring suppliers that manufacture a significant proportion of these critical medicinal products in the Union, except those with whom the Union has a strategic partnership pursuant to Article 27 of this Regulation.

Or. fr

Amendment 881

Oliver Schenk

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall, where justified and proportionate based upon objective criteria, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 882

Marta Temido, Pierre Jouvet

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products and to other medical products of common interest where justified by public health considerations and market analysis, the contracting authorities shall, where justified, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 883

Emmanouil Fragkos

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products for which a vulnerability evaluation has confirmed a high dependency on a single or a limited number of third countries, the contracting authorities shall, where justified, apply procurement requirements that favour suppliers that produce a significant proportion of the relevant critical products in the Union and commit to measures for the transfer of know-how, in line with the Union's international obligations.

Or. el

Amendment 884

Radan Kanev

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities may, where justified, apply procurement requirements that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Justification

The mandatory introduction of the MEAT criteria is an interference in the Member States competence for the organisation and financing of the healthcare systems. It contradicts Art. 168 (7) TFEU and undermines the legality of the instrument. There is no data, which demonstrates that most of the Member States apply MEAT criteria instead of the price – in fact the common practice appears to be the opposite. Thus, the scaled-up solution will likely result in problems for the majority of the Member States: reduced affordability, increased spending on pharmaceuticals, reduced funding for other priorities. This obligation will be particularly detrimental for lower GDP Member States. Excessive and uncoordinated stockholding obligations that are not risk-based, on the other hand, can be detrimental as they may lead to inefficiencies, increase the risk of medicine wastage, and create artificial supply pressures that exacerbate shortages rather than prevent them. In addition, any stockholding obligation being imposed as MEAT procurement criteria may be duplicative with MAH contingency stock obligations under EU and national legislation on ensuring the security of supply of medicines.

Amendment 885

Tilly Metz

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

2. With regard to critical medicinal products for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation pointing to the high level of dependency on a single or a limited number of third countries, the contracting authorities shall apply procurement requirements that favour suppliers that manufacture at least 50% of the volume or value of these critical medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 886

Kristian Vigenin

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 887

Nicolás González Casares, Vytenis Povilas Andriukaitis, Pierre Jouvet, Romana Jerković, Leire Pajín

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 888

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

Proposal for a regulation

Article 18 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 889

Laurent Castillo

Proposal for a regulation

Article 18 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. For the purposes of paragraph 2, a ‘significant proportion' of the manufacturing of a critical medicinal product shall be considered as taking place within the Union if at least one of the following conditions is met:

(a) at least 50% of the active substance used in the manufacture of the product is produced within the Union or, where appropriate, the EEA or the Swiss Confederation;

(c) essential manufacturing steps, including the synthesis or biological production of active substances, are carried out within the Union or, where appropriate, the EEA or the Swiss Confederation.

Or. fr

Amendment 890

Tilly Metz

Proposal for a regulation

Article 18 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Contracting authorities shall set and pursue progressive targets for the proportion of critical medicinal products, referred to in paragraph 2, sourced from suppliers manufacturing within the Union.

Or. en

Amendment 891

Radan Kanev

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Limiting the scope to CMA: it addresses medicinal products of common interest which do not suffer from supply chain disruptions or shortages, but rather from broader market access challenges. Applying procurement requirements that favor Union-based manufacturing is not appropriate in this context, as these products are not at risk of security of supply due to production failures. Maintaining a clear distinction between shortage-driven and access-driven interventions is essential to ensure that regulatory tools are applied proportionately and effectively.it addresses medicinal products of common interest which do not suffer from supply chain disruptions or shortages, but rather from broader market access challenges. Applying procurement requirements that favor Union-based manufacturing is not appropriate in this context, as these products are not at risk of security of supply due to production failures. Maintaining a clear distinction between shortage-driven and access-driven interventions is essential to ensure that regulatory tools are applied proportionately and effectively.

Amendment 892

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

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

3. With regard to other medicinal products of common interest, the contracting authorities may apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union.

Or. fr

Amendment 893

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

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

3. With regard to other medicinal products of common interest, where justified by market analysis and public health considerations, the contracting authorities may apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union, while taking into account the distinctive characteristics of the supply chains of different medicines. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 894

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

3. With regard to other medicinal products of common interest, where justified by market analysis and public health considerations, the contracting authorities may apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union, while taking into account the distinctive characteristics of the supply chains of different medicines. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 895

Christophe Clergeau

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

3. With regard to other medicinal products of common interest and medical countermeasures of common interest, where justified by market analysis and public health considerations, the contracting authorities may apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 896

Marta Temido

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

3. Contracting authorities shall apply a multi-winner approach and base the award of public contracts on the most economically advantageous tender the award criteria as defined Directive 2014/24/EU of the European Parliament and of the Council, particularly in the context of procurements falling under Article 22 and Article 23.

Or. en

Amendment 897

Nikos Papandreou

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

3. With regard to other medicinal products of common interest, where justified by market analysis and public health considerations, the contracting authorities may apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union or candidate countries. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 898

Laurent Castillo

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

3. With regard to medicinal products of common interest, the contracting authorities shall apply an award criterion of X% of the total weighting favouring suppliers that manufacture a significant proportion of these critical medicinal products in the Union, except those with whom the Union has a strategic partnership pursuant to Article 27 of this Regulation.

Or. fr

Amendment 899

Nicolás González Casares, Vytenis Povilas Andriukaitis, Pierre Jouvet, Romana Jerković, Leire Pajín

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

3. With regard to other medicinal products of common interest, where justified by market analysis and public health considerations, the contracting authorities shall apply procurement requirements that favour suppliers that manufacture at least a significant proportion of these medicinal products in the Union. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 900

Tilly Metz

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 901

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

Proposal for a regulation

Article 18 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 902

Laurent Castillo

Proposal for a regulation

Article 18 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. For the purposes of paragraph 3, a ‘significant proportion' of the manufacturing of a medicinal product of common interest shall be considered as taking place within the Union if at least one of the following conditions is met:

(a) at least 50% of the active substance used in the manufacture of the product is produced within the Union or, where appropriate, the EEA or the Swiss Confederation;or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation;

(b) at least 50 % of the value of the final medicinal product results from manufacturing or processing operations carried out within the Union or, where appropriate, the EEA or the Swiss Confederation;or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation;

(c) essential manufacturing steps, including the synthesis or biological production of active substances, are carried out within the Union or, where appropriate, the EBA or the Swiss Confederation. or, in the case of medicinal products of common interest for which no relevant substitute is produced within the Union, any third country with which the Union has established a strategic partnership within the meaning of Article 27 of this Regulation;

Or. fr

Amendment 903

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová

Proposal for a regulation

Article 18 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Contracting authorities, as well as the competent authorities in Member States responsible for pricing and reimbursement, may require candidates or tenderers to submit audited data on research and development costs, as well as production and distribution costs, related to the medicinal product concerned. Such information shall be treated in accordance with applicable Union and national rules on confidentiality and the protection of commercially sensitive information.

Or. en

Amendment 904

Ondřej Krutílek

Proposal for a regulation

Article 18 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Commission shall create and maintain a database containing information on other than price award criteria, including if the significant proportion of the critical medicinal product was manufactured in the Union. The database shall allow the contracting authority to verify such information.

Or. en

Amendment 905

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

Proposal for a regulation

Article 18 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Member States shall include in the tenders

(a) pre-qualification criteria related to:

(i) responsible business conduct;

(ii) cyber security and data security;

(iii) ability to manufacture the medicinal products fully and on time;

Or. en

Amendment 906

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

Proposal for a regulation

Article 18 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3 b. Tenders shall also contribute to at least one of the following objectives, by implementing award criteria beyond price related to:

(a) environmental sustainability going beyond the minimum requirements in applicable law;

(b) innovation by providing entirely new solutions or improving comparable state-of-the-art solutions for improving manufacturing capacity or quality;

(d) vocational formation and skills improvement of medicinal products manufacturing workforce.

(e) carbon footprint reduction.

This paragraph shall not preclude Member States from using additional non-price criteria beyond those listed in this paragraph nor preclude contracting authorities or contracting entities from using additional minimum requirements or award criteria in relation to environmental sustainability.

Or. en

Amendment 907

Nicolás González Casares, Romana Jerković, Leire Pajín

Proposal for a regulation

Article 18 – paragraph 3 c (new)

Text proposed by the Commission

Amendment

3 c. Contracting authorities and contracting entities may, on an exceptional basis, decide not to apply paragraphs 3a to 3c, where:

(a) the required medicinal product can only be supplied by a specific economic operator and no reasonable alternative or substitute exists and the absence of competition is not the result of an artificial narrowing down of the parameters of the public procurement procedure;

(b) no suitable tenders or no suitable requests to participate have been submitted in response to a similar former public procurement procedure launched by the same contracting authority or contracting entity in the two years immediately before the commencement of the planned new procurement procedure;

(c) their application would oblige that contracting authority or contracting entity to acquire equipment having disproportionate costs or would not favour actual production.

Estimated cost differences above 20 %, based on objective and transparent data, may be presumed by contracting authorities and contracting entities to be disproportionate.

Or. en

Amendment 908

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

Proposal for a regulation

Article 18 – paragraph 3 d (new)

Text proposed by the Commission

Amendment

3 d. Six months after the publication in the Official Journal, the Commission shall adopt an implementing act further specifying the pre-qualification and award criteria referred to in paragraph 3a to 3b.

Or. en

Amendment 909

Nicolás González Casares, Pierre Jouvet, Leire Pajín

Proposal for a regulation

Article 18 – paragraph 3 e (new)

Text proposed by the Commission

Amendment

3 e. Based on an assessment, by the Commission, using existing data and reports, of skills in medicinal products manufacturing, and fully respecting the competence of Member States in the field of education and training, the Commission shall support, including through the provision of seed-funding, the launch of European pharmaceutical industry academies as organisations or consortia or projects of relevant stakeholders, which have the following objectives:

Or. en

Amendment 910

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

Proposal for a regulation

Article 18 – paragraph 3 f (new)

Text proposed by the Commission

Amendment

3 f. (a) developing, for voluntary use by Member States and education and training providers on their territories, learning programmes, content and learning and training materials for training and education, such as on developing, producing, installing, commissioning, operating, maintaining, repairing, ecodesigning, re-using and recycling pharmaceutical products manufacturing equipment and technology, and on raw materials as well as relevant occupational health and safety aspects and transversal competences; this shall reflect the assessment of skills shortages and support the capacities of public authorities.

(b) promoting the voluntary use of the learning programmes, content and materials by education and training providers in the Member States;

(c) offering support to the education and training providers that use the learning programmes, content and materials produced to uphold the quality of the training offered and to develop mechanisms to ensure the quality of the training offered;

Or. en

Amendment 911

Tilly Metz

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. To further ensure responsible and accountable procurement practices in line with Union values and policy, contracting authorities shall also incorporate additional qualitative requirements, such as measures for the prevention and treatment of pharmaceutical waste and emissions, contribution to circular economy objectives along life-cycle of the product, reduction of carbon foot-print, respect for Union labour and social standards across the supply chain and compliance with transparency obligations including on supply chain information, origin of key ingredients and components, and production sites to enable effective monitoring of supply risks.

Or. en

Amendment 912

András Tivadar Kulja

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. Contracting authorities should procure by adopting a balanced and comprehensive approach, applying the MEAT criteria as defined by Article 3[(14) to be added] of this Regulation, with the objective of ensuring the transparent availability, accessibility, affordability, quality, and safety of medicines.

This Article shall not preclude contracting authorities from using additional qualitative requirements, including in relation to environmental sustainability and social rights.

Or. en

Amendment 913

Catarina Martins, Sebastian Everding, Anthony Smith

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. Contracting authorities shall procure adopting a balanced and comprehensive approach, applying the MEAT criteria as defined by Article 3 (18a) of this regulation, with the objective of ensuring a transparent availability, affordability, equitable access, quality and safety of medicines. Additional qualitative requirements such environmental sustainability and social rights shall be included in the guidelines criteria.

Or. en

Amendment 914

Ingeborg Ter Laak

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. Such requirements shall include, where relevant, compliance with international environmental and labour standards to ensure fair competition between EU and non-EU producers.

Or. en

Amendment 915

Nikos Papandreou

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, and ease of use, but those requirements should not be at the expense of patient access to information and patient safety.

Or. en

Amendment 916

Alessandra Moretti

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, social rights, transparency, affordability, availability and guaranty of supply;

Or. en

Amendment 917

Laurent Castillo

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. The contracting authorities may use additional qualitative requirements, including in relation to environmental sustainability and social rights, provided that they do not affect the economic viability of critical medicinal products and medicinal products of common interest.

Or. fr

Amendment 918

Tilly Metz

Proposal for a regulation

Article 18 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. To support the implementation of this Article by the Member States, the Commission shall develop guidelines for application of non-price criteria by ... [18 months from the date of entry into force of this Regulation].

Or. en

Amendment 919

Tilly Metz

Proposal for a regulation

Article 18 – paragraph 4 b (new)

Text proposed by the Commission

Amendment

4 b. For medicinal products of common interest, including antibiotics, with small sales volumes, contracting authorities shall assess the ongoing sustainability of the supplier, in particular ensuring that small and medium-sized enterprises (SMEs) producing such products are able to maintain continuous supply. This assessment shall form part of the procurement procedure, alongside other applicable criteria, to safeguard the availability of essential but low-volume medicines.

Or. en

Amendment 920

Peter Liese

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services.

deleted

Or. en

Justification

This deletion prevents a loophole that would allow Member States to ignore the qualitative procurement criteria of Article 18. While the regulation already provides justified flexibility in how criteria are weighted, the additional use of non-price criteria should be mandatory. Allowing full opt-outs would risk undermining this regulation's core goal. Without binding obligations, short-term cost pressures may continue to override long-term strategic needs.

Amendment 921

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

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services.

deleted

Or. en

Amendment 922

Laurent Castillo

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services.

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2, 3 and 4 where justified by market analysis or considerations related to the financing of health services, particularly where applying those requirements would lead to disproportionate prices. They shall draw up a duly justified written statement and send it to the designated authority in each Member State if this paragraph is applied.

Or. fr

Amendment 923

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services.

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2, 3 and 4 where justified by market analysis or considerations related to the financing of health services. This decision from contracting authorities shall be made public in the dedicated webpage, at the time of the decision, and be duly justified in the evaluation report.

Or. en

Amendment 924

Victor Negrescu

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services.

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services. The Commission shall carry out an assessment of the impact on local production and supply chain security within the Union, and include results in its decision-making.

Or. en

Amendment 925

Tilly Metz

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services.

5. Contracting authorities may exceptionally and in duly justified cases decide not to apply paragraphs 1, 2, 3 and 4 where market analysis or considerations related to the financing of health services indicate a severe negative impact on the affordability, availability and accessibility of medicinal product referred to in paragraphs 1, 2, 3 and 4.

Or. en

Amendment 926

Kristian Vigenin

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services.

5. Contracting authorities may decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services such as when these provisions impact negatively the management of health services and medical care and the allocation of resources to them.

Or. en

Justification

This paragraph should be deleted altogether, if the provision in par. 2 is changed to 'may' instead of 'shall'.

Amendment 927

András Tivadar Kulja

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services.

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services. This decision from contracting authorities shall be duly justified in an evaluation report.

Or. en

Amendment 928

Radan Kanev

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services.

5. Contracting authorities may decide not to apply paragraphs 1, 2 and 3 whenever these provisions impact the management of health services and medical care and the allocation of the resources assigned to them.

Or. en

Justification

Contracting authorities should preserve their full autonomy in decision making and need not to justify their decisions. This is the status quo in accordance with the Treaties

Amendment 929

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

Article 18 – paragraph 5

Text proposed by the Commission

Amendment

5. Contracting authorities may exceptionally decide not to apply paragraphs 1, 2 and 3 where justified by market analysis or considerations related to the financing of health services.

Or. en

Amendment 930

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

Proposal for a regulation

Article 18 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. As a general principle, with regard to procurement procedures for critical medicinal products and medicinal products of common interest for which a vulnerability in the supply chains has been confirmed through a vulnerability evaluation demonstrating a high level of dependency on a single or a limited number of third countries, the contracting authorities shall, where justified, apply procurement requirements that:

(a) give priority to suppliers that manufacture a significant proportion of these critical medicinal products within the Union;

(b) where supply based on paragraph (a) is not available, give priority to suppliers established in the United Kingdom, the European Economic Area or the Swiss Confederation; and

(c) where such supply is not available under (a) or (b), include suppliers from a third countries which is a Party to the WTO Agreement on Government Procurement or in a third country with which the Union has concluded a free trade agreement covering government procurement.

These requirements shall be applied in full compliance with the Union’s international commitments.

Or. en

Amendment 931

András Tivadar Kulja

Proposal for a regulation

Article 18 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. If a tender appears to be abnormally low in relation to the medicinal product provided, the contracting authority shall request, in writing, details of the constituent elements of its offer, including its capacity to maintain supply commitments throughout the duration of the contract. Based on the evidence submitted by the tenderer, the contracting authority shall assess whether the offer is economically and operationally viable. If the tender is found to be unsustainable or poses a risk to continuous supply, it shall be deemed irregular and rejected. This decision, along with the reasoning behind it, must be documented in the evaluation report.

Or. en

Amendment 932

Dario Tamburrano, Valentina Palmisano, Catarina Martins

Proposal for a regulation

Article 18 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. Within 18 months from the entry into force of this regulation, the Commission shall publish, within the framework of Directive 2014/24/EU, detailed guidelines to support public procurement practices in the pharmaceutical field, in particular as regards the implementation of the most economically advantageous tender (MEAT) criteria, with a view to establishing remedies against single-win and price-only procurement.

Or. en

Amendment 933

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc, Marie-Luce Brasier-Clain, Valérie Deloge, Aleksandar Nikolic

Proposal for a regulation

Article 18 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. By 6 months from the date of entry into force of this Regulation, the Commission shall develop guidelines setting out a clear definition of what constitute a 'significant proportion' of the Union manufacture of a medicinal product within the Union, as well as on the application of procurement requirements other than price-only according to this Article.

Or. en

Amendment 934

Sirpa Pietikäinen

Proposal for a regulation

Article 18 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. Where information required in procurement procedures is held only by the marketing authorisation holder or manufacturer, it shall be made accessible to all participants on equal terms. The application of procurement requirements shall take into account their impact on competition and market access.

Or. en

Amendment 935

Tilly Metz

Proposal for a regulation

Article 18 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. Contracting authorities, as well as national competent authorities responsible for pricing and reimbursement, may require candidates or tenderers to provide audited information on the research and development, production, and distribution costs associated with the medicinal product.

Or. en

Amendment 936

Laurent Castillo

Proposal for a regulation

Article 18 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. To support the implementation of this Article by the Member States, the Commission shall develop guidelines for application of non-tariff criteria by ... [18 months from the date of entry into force of this Regulation].

Or. fr

Amendment 937

Aurelijus Veryga

Proposal for a regulation

Article 18 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. The exemptions referred to in paragraph 5 shall be limited to specific cases where the application of security of supply criteria would result in a disproportionate increase in price.

Or. en

Amendment 938

Tilly Metz

Proposal for a regulation

Article 18 – paragraph 5 b (new)

Text proposed by the Commission

Amendment

5 b. In the public procurement of critical medicines for supply to hospitals, hospital pharmacists shall be involved in the procurement process.

Or. en

Amendment 939

Laurence Trochu

Proposal for a regulation

Article 19

Text proposed by the Commission

Amendment

Article 19

deleted

Programmes supporting sustainability and resilience in public procurement procedures

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes may also include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures.

2. Member States shall notify their programmes to the Commission in its role of the secretariat of the Critical Medicines Group. The Commission shall ensure the distribution to all members of the Critical Medicines Group forthwith. The Critical Medicines Group shall facilitate a discussion aiming to ensure coordination of national programmes including as regards the application of criteria mentioned in Article 18(2) and may issue opinions. Where the Critical Medicines Group issues an opinion concerning the national programmes, Member States shall give it due consideration and may take it into account when revising their programmes.

Or. fr

Justification

The obligation for Member States to establish a national plan of that kind is incompatible with the principle of national supply management.

Amendment 940

Marie-Luce Brasier-Clain, Aleksandar Nikolic

Proposal for a regulation

Article 19

Text proposed by the Commission

Amendment

Article 19

deleted

Programmes supporting sustainability and resilience in public procurement procedures

Or. fr

Amendment 941

Ton Diepeveen, Aleksandar Nikolic, Tomáš Kubín, Valérie Deloge

Proposal for a regulation

Article 19

Text proposed by the Commission

Amendment

Article 19

deleted

Programmes supporting sustainability and resilience in public procurement procedures

Or. en

Justification

Paragraph 2 does not comply with the principle of subsidiarity.

Amendment 942

Christine Anderson

Proposal for a regulation

Article 19

Text proposed by the Commission

Amendment

Article 19

deleted

Programmes supporting sustainability and resilience in public procurement procedures

Or. en

Justification

This duplicates national responsibilities. It encourages Member States to conform to a Commission-driven agenda. It centralises procurement policy under the guise of coordination.

Amendment 943

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 19 – title

Text proposed by the Commission

Amendment

Programmes supporting sustainability and resilience in public procurement procedures

Programmes supporting sustainability, resilience in public procurement procedures and security of supply of critical medicinal products

Or. en

Amendment 944

Aurelijus Veryga

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures, by introducing a regular structured discussion involving stakeholders, such as also patient groups, healthcare professionals, to base the programmes on real-world needs and to enhance their relevance and effectiveness. Each national programme shall include, at a minimum, measures to promote the use of procurement award criteria relating to supply chain resilience and diversification of supply sources in accordance with Article 18.

Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes shall also analyse and implement policies, which support the economic sustainability of the critical medicines ecosystem in the Member States, and shall consider the impacts of national cost containment measures and the need for adjusted regimes to all or certain critical medicines. Such programmes may also, where appropriate and non-discriminatory, include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures as well as review any price freezes, cost containment measures or stockholding obligations applicable. Member States may involve their national pricing and reimbursement authorities in the planning and evaluation of such programmes.

Or. en

Amendment 945

Peter Liese

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Each national programme shall include, at a minimum, measures to promote the use of procurement award criteria relating to supply chain resilience, diversification of supply sources, geographical proximity of production, in accordance with Article 18. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes may also include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures.

Or. en

Amendment 946

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

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis and shall align reporting and shortage signals with mechanisms operated by MSSG to avoid duplication. Such programmes shall also include measures for pricing and reimbursement supporting diversity and security of supply of those critical medicinal products that are not purchased through public procurement procedures.

Or. en

Amendment 947

Radan Kanev

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. If necessary and justified, after entry into force of this Regulation each Member State may decide to establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis.

Or. en

Justification

The pricing and reimbursement measures are national competence, the Union does not need to allow for actions. This contradicts with the principles of subsidiarity and proportionality.

Amendment 948

Dan-Ştefan Motreanu

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes shall also include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures, as well as review any price freezes, cost containment measures or stockholding obligations applicable to critical medicines.

Or. en

Amendment 949

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes shall also include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures. as well as review any price freezes, cost containment measures or stockholding obligations applicable to critical medicines.

Or. en

Amendment 950

Adam Jarubas, Ewa Kopacz, Letizia Moratti

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes shall also include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures, as well as review any price freezes, cost containment measures or stockholding obligations applicable to critical medicines.

Or. en

Amendment 951

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis.

Member States shall conduct annual reviews of national programmes.

Or. en

Amendment 952

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

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products including in public procurement procedures, whose integration with the MSSG general strategy shall be assured. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes may also include measures for pricing and reimbursement supporting security and redundancy of supply of those critical medicinal products that are not purchased through public procurement procedures.

Or. en

Amendment 953

Christophe Clergeau

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products and critical medical countermeasures, including in public procurement procedures. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes may also include measures for pricing and reimbursement supporting security of supply of those critical medicinal products and critical medical countermeasures that are not purchased through public procurement procedures.

Or. en

Amendment 954

Ondřej Krutílek

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after the adoption of implementing act according to paragraph 2a, each Member State shall establish a binding national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes may also include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures.

Or. en

Amendment 955

Elena Nevado del Campo, Dolors Montserrat

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes shall also include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures.

Or. en

Amendment 956

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes shall also include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures.

Or. en

Amendment 957

Kristian Vigenin

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 12 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches, where beneficial in light of the market analysis. Such programmes may also include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures.

Or. en

Amendment 958

Laurent Castillo

Proposal for a regulation

Article 19 – paragraph 1

Text proposed by the Commission

Amendment

1. By 6 months after entry into force of this Regulation each Member State shall establish a national programme supporting security of supply of critical medicinal products, including in public procurement procedures including a section on multi-awardee public procurement. Such programmes shall promote the consistent use of procurement requirements by contracting authorities within a given Member State as well as multi-winner approaches. Such programmes may also include measures for pricing and reimbursement supporting security of supply of those critical medicinal products that are not purchased through public procurement procedures.

Or. fr

Amendment 959

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

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall notify their programmes to the Commission in its role of the secretariat of the Critical Medicines Group. The Commission shall ensure the distribution to all members of the Critical Medicines Group forthwith. The Critical Medicines Group shall facilitate an annual structured discussion involving relevant stakeholders such as patient and consumer organisations, healthcare professionals and marketing authorisation holders, aiming to ensure coordination of national programmes including as regards the application of criteria mentioned in Article 18(2) and 18(3) and may issue opinions. Where the Critical Medicines Group issues an opinion concerning the national programmes, Member States shall give it due consideration and may take it into account when revising their programmes.

Or. en

Amendment 960

Laurent Castillo

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall notify their programmes to the Commission in its role of the secretariat of the Critical Medicines Group. The Commission shall ensure the distribution to all members of the Critical Medicines Group forthwith. The Critical Medicines Group shall set up an annual meeting and facilitate a discussion aiming to ensure coordination of national programmes in the presence of market authorisation holders, patient organisations and any other economic operator, including as regards the application of criteria mentioned in Article 18(2) and may issue opinions. Where the Critical Medicines Group issues an opinion concerning the national programmes, Member States shall give it due consideration and may take it into account when revising their programmes.

Or. fr

Amendment 961

Christophe Clergeau

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall notify their programmes to the Commission in its role of the secretariat of the Critical Medicines and Medical Countermeasures Group. The Commission shall ensure the distribution to all members of the Critical Medicines and Medical Countermeasures Group forthwith. The Critical Medicines and Medical Countermeasures Group shall facilitate a discussion aiming to ensure coordination of national programmes including as regards the application of criteria mentioned in Article 18(2) and may issue opinions. Where the Critical Medicines and Medical Countermeasures Group issues an opinion concerning the national programmes, Member States shall give it due consideration and may take it into account when revising their programmes.

Or. en

Amendment 962

Aurelijus Veryga

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall notify their programmes to the Commission in its role of the secretariat of the Critical Medicines Group. The Commission shall ensure the distribution to all members of the Critical Medicines Group forthwith. The Critical Medicines Group shall facilitate a discussion, involving marketing authorisation holders and other relevant actors in the supply chain, aiming to ensure coordination of national programmes including as regards the application of criteria mentioned in Article 18(2) and may issue opinions. Where the Critical Medicines Group issues an opinion concerning the national programmes, Member States shall give it due consideration and may take it into account when revising their programmes.

Or. en

Amendment 963

Radan Kanev

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States may share their programmes with the Commission. In those cases the Commission shall ensure the distribution to all members of the Critical Medicines Group forthwith. The Critical Medicines Group shall facilitate best practice exchanges on national programmes including as regards the application of criteria mentioned in Article 18(2). The Critical Medicines Group shall act in an advisory capacity only. Its opinions shall be non-binding and shall not entail an obligation for Member States to adapt or revise national programmes.

Or. en

Amendment 964

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

Proposal for a regulation

Article 19 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall notify their programmes to the Commission in its role of the secretariat of the Critical Medicines Group. The Commission shall ensure the distribution to all members of the Critical Medicines Group forthwith. The Critical Medicines Group shall facilitate a discussion aiming to ensure coordination of national programmes including as regards the application of criteria mentioned in Article 18(2) and may issue opinions maintaining due coordination with MSSG. Where the Critical Medicines Group issues an opinion concerning the national programmes, Member States shall give it due consideration and may take it into account when revising their programmes.

Or. en

Amendment 965

Ondřej Krutílek

Proposal for a regulation

Article 19 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Commission shall adopt implementing acts to support Member States in implementing their obligations according to this Article to use procurement requirements, including award criteria beyond price considerations with a view to strengthen the security of medicine supply.

Or. en

Amendment 966

Emmanouil Fragkos

Proposal for a regulation

Article 19 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. The Commission shall issue guidelines clarifying indicators for determining the 'significant proportion' of production and model clauses on supply resilience and timely delivery.

Or. el

Amendment 967

Laurence Trochu

Proposal for a regulation

Article 20

Text proposed by the Commission

Amendment

Article 20

deleted

Safeguards related to Member States’ contingency stocks requirements and other security of supply measures

Measures on security of supply applied in one Member State shall not result in any negative impact in other Member States. Member States shall, in particular, avoid such an impact when proposing and defining the scope and timing of any form of requirements for companies to hold contingency stocks.

Member States shall ensure that any requirements they impose on companies in the supply chain to hold contingency stocks are proportionate and respect the principles of transparency and solidarity.

Or. fr

Justification

Member States must maintain their autonomy regarding the levels and methods of building up safety stocks, as each state has its own health priorities, logistical capacities and continuity of care strategies.

Amendment 968

Marie-Luce Brasier-Clain, Aleksandar Nikolic

Proposal for a regulation

Article 20

Text proposed by the Commission

Amendment

Article 20

deleted

Safeguards related to Member States’ contingency stocks requirements and other security of supply measures

Member States shall ensure that any requirements they impose on companies in the supply chain to hold contingency stocks are proportionate and respect the principles of transparency and solidarity.

Or. fr

Amendment 969

Ton Diepeveen, Aleksandar Nikolic, Tomáš Kubín, Valérie Deloge

Proposal for a regulation

Article 20

Text proposed by the Commission

Amendment

Article 20

deleted

Safeguards related to Member States’ contingency stocks requirements and other security of supply measures

Member States shall ensure that any requirements they impose on companies in the supply chain to hold contingency stocks are proportionate and respect the principles of transparency and solidarity.

Or. en

Justification

Does not comply with the principle of subsidiarity.