What changed

Taken together, the proposed changes enhance the Commission's proposal in a balanced way. They provide a more resilient and secure supply of critical medicines, ensure clearer and more coherent rules, and support the successful implementation of the Critical Medicines Act, benefiting patients across Europe.

AMENDMENT

AMENDMENTS

The Committee on the Internal Market and Consumer Protection submits the following to the Committee on Public Health, as the committee responsible:

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

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

(2) In recent years, the Union has experienced an increasing number of shortages of medicinal products, including shortages of medicinal products for which insufficient supply and lack of transparency of supply chains and stocks result in serious harm or risk of serious harm to patients.

Amendment 2

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

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

(10) The smooth functioning of the internal market and a high level of protection of human health should be ensured as regards medicinal products and it should be aimed to complementing other Union pharmaceutical legislation by providing for a harmonised framework supporting Member States’ coordinated efforts to encourage investments in new and existing manufacturing capacities for critical medicinal products, encouraging the strategic use of public procurement instruments by the Member States as well as the coordination of the Member States’ approaches, including through leveraging aggregated demand through Commission facilitated collaborative procurement procedures of critical medicinal products and medicinal products of common interest. Those instruments should be aligned with Directive 2014/24/EU. Due to the international dimension of the security of supply, in particular taking into account that diversification of supply chains and an overall increase of supply are elements of a solution for ensuring the security of supply, international cooperation should be encouraged.

Amendment 3

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

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

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

Amendment 4

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

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

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

Amendment 5

Proposal for a regulation

Recital 18

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

(18) To avoid unnecessary delays and the creation of additional administrative layers, the verification of whether a project fulfils the strategic project criteria should be performed by any Member State authority requested to provide advantages offered in this Regulation. A designated authority should, when solicited, verify whether a given project is a strategic project. In order to accelerate and facilitate their deployment, strategic projects should benefit from streamlined administrative processes, priority status in the context of permit granting procedures and related dispute resolution procedures, as well as, be offered targeted regulatory support. In this context, the Member States should give particular attention to small and medium sized enterprises (SMEs)(SMEs), as well as small mid-cap enterprises as defined in Commission Recommendation (EU) 2025/1099, which should have a fair chance to initiate strategic projects.projects, and should offer them clear guidance throughout the application, permitting, and regulatory procedures with the aim of reducing the administrative burden on SMEs and small mid-caps.

Or. en

Amendment 6

Justification

In the pharmaceutical industry in particular, mid-caps often play a key role in drug production, especially for generic preparations and supply-relevant active ingredients. These companies are typically not only not part of large group structures, but also lack the administrative resources of large pharmaceutical companies to handle complex regulatory requirements completely independently.

Amendment 2

Proposal for a regulation

Recital 19 a (new)

Text proposed by the Commission

Amendment

(19a) In order to strengthen the Union’s capacity to respond effectively and in a coordinated manner to critical shortages of medicinal products, the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), as part of its work to ensure Union coordination on the availability of medicines, should contribute to the strengthening and effective implementation of the Solidary Mechanism framework, in particular through communication between Member States and relevant stakeholders, taking into account the principles of solidarity, proportionality, and confidentiality.

Amendment 7

Proposal for a regulation

Recital 19 b (new)

Text proposed by the Commission

Amendment

(19b) Member States should cooperate in good faith and should, where necessary, provide mutual support to any other Member State that has requested assistance through the Solidarity Mechanism, with a view to preventing or mitigating shortages of critical medicinal products.

Amendment 8

Proposal for a regulation

Recital 24

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

(24) Given that public authorities or entities are the principal buyers of medicinal products for the inpatient sector and that the public procurement of medicinal products is a powerful tool to improve security of supply and the availability and accessibility of critical medicines and other medicinal products of common interest, it is necessary to establish rules that require the use of the procurement requirements referring to Most Economically Advantageous Tender (MEAT) that take into account the supply security and availability considerations. Procurement requirements based on such considerations should include a significant weighting of qualitative and non-price criteria, including stockholding obligations, diversification of supply, efficient and effective monitoring of supply chains for potential supply bottlenecks, their transparency to the contracting authority,authority contract performance clauses on timely delivery and measures in case of non-timely delivery or the number of diversified suppliers. Supply chain structures vary significantly between market segments. While supplier diversification is often feasible for widely used generics, niche medicines, complex biopharmaceuticals or critical medicinal products with low sales, including so-called orphan medicinal products, might have only one or two manufacturers worldwide. In such cases, rigid diversification requirements risk undermining supply.delivery. Procurement obligations should therefore be applied proportionately and adapted to the specific market conditions. Where diversification of supply chains is de facto not possible or not economically feasible, targeted exemptions from certain award criteria may be granted. At the sameContracting time,authorities alternativeshould measuresnot suchbe asprecluded stockpilingfrom orusing reinforcedadditional riskqualitative managementrequirements, planswhere couldrelevant, helpincluding tosustainability ensureand thesocial continuedfactors, availabilityin ofaccordance thesewith medicinalDirective products.2014/24/EU.

Or. en

Amendment 9

Justification

The application of supply chain diversification as an award criterion, as set out in Article 18 (1) of this Regulation, must reflect market realities. In specific cases, such as those involving low-demand critical medicines or orphan drugs, diversification is often not feasible. Requiring more than a single qualified supplier could be disproportionate and may even lead to market withdrawal. This is why the possibility of targeted exemptions may be essential to safeguard supply and ensure practical feasibility.

Amendment 3

Proposal for a regulation

(26) To ensure a high level of health protection and security of supply, it is necessary to procure in a way that promotes diversification of suppliers where dependency on a single or a limited number of third countries, threatening the security of supply, has been established through a vulnerability evaluation. In such situations, contracting authorities in the Member States should introduce procurement requirements that favour suppliers of critical medicinal products that manufacture a significant portion of these products in the EU. Moreover, the contracting authorities in the Member States, when justified by market analysis and public health considerations, may apply procurement requirements that favour suppliers of medicinal products of common interest that manufacture a significant portion of these medicinal products in the EU. These measures should be designed and applied in line with the Union's international obligations including the principles of non-discrimination and proportionality.

(26) To ensure a high level of health protection and security of supply, it is necessary to procure in a way that promotes diversification of suppliers where dependency on a single or a limited number of third countries, threatening the security of supply, has been established through a vulnerability evaluation.evaluation, taking into account product-specific characteristics. In such situations, contracting authorities in the Member States should introduce procurement requirements that favour suppliers of critical medicinal products that manufacture a significant portion of these products in the EU. Moreover, the contracting authorities in the Member States, when justified by market analysis and public health considerations, may apply procurement requirements that favour suppliers of medicinal products of common interest that manufacture a significant portion of these medicinal products in the EU. These measures should not lead to protectionism and weakened competition and be designed and applied in line with the Union's international obligations including the principles of non-discrimination and proportionality. To safeguard the Union’s strategic autonomy and reduce critical dependencies, a significant proportion of the production of critical medicinal products, medicinal products of common interest, or their active pharmaceutical ingredients intended for the Union market should be located within the Union, as defined in this Regulation. While trusted international cooperation and strategic partnerships remain important, ensuring resilience and security of supply means that production capacity needs to meet thata certain threshold on Union territory. The assessment of whether this threshold is met should be carried out by the Commission or, where appropriate, by the competent authorities of the Member States, taking into account product-specific characteristics, market conditions, and risk-related considerations. This approach will ensure that the Union retains the capacity to respond effectively to public health needs and future crises.

Or. en

Amendment 10

Amendment 4

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

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

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

Amendment 11

Proposal for a regulation

Recital 35

(35) To ensure that the collaborative procurement initiatives contribute to the achievement of the objectives of this Regulation, while fully respecting the principle of subsidiarity, the Commission’s involvement in joint procurement and procurement on behalf, or in the name of the Member States, should be limited to defined cases. For this reason derogations from Article 168 (2) and (3) of Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council12 should be provided.

(35) To ensure that the collaborative procurement initiatives contribute to the achievement of the objectives of this Regulation, while fully respecting the principle of subsidiarity, the Commission’s involvement in joint procurement and procurement on behalf, or in the name of the Member States, should be limited to defined cases.cases with defined timelines. For this reasonreason, the Commission should assess the proportionality of any collaborative procurement request, taking into account factors such as the necessity and scale of the procurement, the ability of Member States to act individually or collectively, and the potential impact on the internal market, and derogations from Article 168 (2) and (3) of Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council12 should be provided. The Commission should ensure sufficient resources are allocated to joint procurement procedures in order to guarantee an efficient and robust process.

__________________

12 Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union (OJ L, 2024/2509, 26.9.2024, ELI: http://data.europa.eu/eli/reg/2024/2509/oj).

Or. en

Amendment 12

Amendment 5

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

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

(37) Ensuring a structured and coordinated approach to strengthening the security of supply of critical medicinal products requires collaboration between the Member States and the Commission. To facilitate this, the Critical Medicines Coordination Group (‘the Critical Medicines Group’) should be established to facilitate effective coordination across the relevant policy areas. The Critical Medicines Group should be composed of high-level representatives of Member States with expertise in medicinal product procurement policies, industrial policy related to pharmaceuticals and public health. The Critical Medicines Group may invite representatives from relevant industry associations, patient, consumer and professional healthcare organisations to participate as observers or provide input on specific issues within the group's remit. The Commission should be a member of the group. To ensure structured discussions, the Commission should chair the Critical Medicines Group and perform the functions of its secretariat.

Amendment 13

Proposal for a regulation

Recital 37 a (new)

Amendment

(37a) Ensuring a reliable supply of critical medicinal products requires coherent coordination between pharmaceutical policy and Union policies on environmental protection and climate change. ToThe identifyCritical andMedicines mitigateGroup potentialmay conflictsprovide ofopinions interestand earlyrecommendations on,to the Critical Medicines Coordination Group should alsoCommission assessconcerning the potential impact of existingrelevant andenvironmental, forthcomingclimate environmentalor policysustainability regulationslegislation on the availability and security of medicinalsupply productsof andcritical submitmedicines correspondingin recommendationsthe Union, including with regard to themanufacturing Commission.sites, supply chains and market availability.

Or. en

Amendment 14

Justification

The coordination group should be empowered to recognise potential interactions between environmental and climate protection measures, and the supply of medicinal products, at an early stage. Increasing regulatory pressure, for instance through industry emissions regulations or sustainability reporting requirements, can have unintended consequences for the production and supply of medicinal products, as well as their availability. A systematic assessment of these impacts is essential to ensure security of supply and system resilience.

Amendment 6

Proposal for a regulation

Recital 39

Text proposed by the Commission

Amendment

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

(39) The Union could further enhance the availability and security of supply of critical medicinal products by providing access to alternative sources of supply in third countries through international trade agreements or other forms of international cooperation. The Union could, to that end, rely on its network of existing trade agreements and additionally pursue strategic partnerships with third countries to further deepen bilateral cooperation, especially with candidate countries. During accession negotiations, it is important that the Commission promote the gradual harmonisation of candidate countries with the Union acquis in the field of medicinal products, with a view to facilitating their integration into the internal market and to reinforcing the resilience of supply chains for critical medicines. In this context, the Commission should assess whether existing partnerships effectively address the intended aims or could be further improved or upgraded, and what types of potential partnerships could be concluded with the most relevant third countries. This should be done without prejudice to the prerogatives of the Council in accordance with the Treaties.

Amendment 15

Proposal for a regulation

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

Amendment

(18a) 'significant proportion' means that the Commission or, where appropriate, the competent authority of the Member States concerned, has assessed that at least 25%30% of the annual production volume of a critical medicinal product, a medicinal product of common interest, or their active pharmaceutical ingredient (API), intended for the Union market, is manufactured within the Union , taking into account product-specific characteristics, market conditions, and risk-related considerations.Union;

Or. en

Amendment 16

Justification

Including a clear definition of “significant proportion” would strengthen the Regulation by providing legal certainty and ensuring a resilient supply of critical medicinal products. Setting the threshold at 25% strikes a balanced compromise: it is high enough to incentivise meaningful production within the Union and reduce external dependencies, yet not so high as to impose disproportionate burdens on manufacturers or risk shortages. This level thus safeguards both supply security and market availability while remaining realistic and achievable for the industry.

Amendment 7

Proposal for a regulation

Article 4 – paragraph 1

Text proposed by the Commission

Amendment

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

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

Amendment 17

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

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

2. The Member States and the Commission shall work together to strengthen the security of supply and continuous availability of critical medicinal products in the Union through measures that take full advantage of the potential of the internal market, while reflecting the principles of solidarity and coordination between Member States and safeguarding the free movement of goods.

Amendment 18

Proposal for a regulation

Article 18 – paragraph 1

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 resilienceresilience, security and diversification of supply in the Union.Union Whereand appropriate,shall contractingbase authoritiesthe mayaward applyof multi-winnerpublic procurements.contracts on the most economically advantageous tender. The procurement requirements shall be defined in accordance with Directive 2014/24/EU and may relate to stockholding obligations, volume or value of manufacturing of the final product or availability of the key ingredients and components within the Union, monitoring of supply chains for potential supply bottlenecks, their transparencytransparency, including final contract value, upon request ofto the contracting authority and, subject to safeguarding the confidentiality of trade secrets, contract performance clauses on timely delivery or the number of diversified suppliers. In particular with regard to supplier diversification, procurementContracting requirementsauthorities shall be proportionate and adapted to the specific characteristics of the relevant market segment. Where diversification of supply chains is not technically possible or not economically feasible, targeted exemptions from certain criteria may be granted, so as not to jeopardise the availability ofalso criticalallow medicinalfor productsmulti-winner onprocurements, thewhere market.appropriate.

Or. en

Contracting authorities may take into account the views of economic operators and other relevant stakeholders when defining procurement requirements as set out in the first subparagraph. In particular with regard to supplier diversification, procurement requirements shall be proportionate and adapted to the specific characteristics of the relevant market segment. Where diversification of supply chains is demonstrably not technically possible or not economically feasible, targeted exemptions from certain criteria may be granted, so as not to jeopardise the availability of critical medicinal products on the market.

Justification

Amendment 19

Multi-winner procurements can ensure the security of the supply of critical medicinal products by reducing dependency on a single supplier and lowering the risk of shortages. They can also foster competition while maintaining resilience. Furthermore, in accordance with Article 18(1) CMA, the possible consideration of supply chain diversification as an award criterion should be carried out in a differentiated manner with regard to different market conditions. In specific segments, such as those involving critical medicinal products in low demand or so-called “orphan drugs”, actual diversification is often not feasible. In these cases, the contractual obligation of a single qualified provider can pose a challenge in itself. Such an obligation could be disproportionate and have counterproductive effects, such as market withdrawals. Therefore, targeted exemptions are necessary in order to avoid jeopardising the supply of such products and to take account of the practical realities of supply.

Amendment 8

Proposal for a regulation

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.

2. Contracting authorities shall apply procurement requirementsrequirements, for critical medicinal products that favour suppliers that manufacture a significant proportion of these critical medicinal products in the Union, the European Economic Area (EEA) or the European Free Trade Association (EFTA) area, in order to ensure security of supply, and, when feasible, shall apply multi-winner procurements. These requirements shall be applied in compliance with the Union’s international commitments.

Or. en

Amendment 20

Justification

In order to achieve the objectives of this regulation, it is crucial to promote and strengthen the production of critical medicinal products within the European Union while adhering to the Union’s international obligations. In this context, ensuring supply security must be a central priority. Therefore, the criteria should apply to all products within the CMA’s remit, not just particularly vulnerable medicinal products with a high dependency on third countries, in order to prevent them from becoming vulnerable in the first place. With this in mind, strong preference should be given to suppliers that manufacture a significant proportion of all products within the CMA’s remit within the EU, thereby safeguarding the highest possible level of supply security.

Amendment 9

Proposal for a regulation

Article 18 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. The Commission shall, by ... [18 months from the date of entry into force of this Regulation], adopt guidelines to support public procurement practices in the field of medicinal products covered by this Regulation. The guidelines adopted by the Commission shall illustrate the effective application of the criteria for the most economically advantageous tender, in particular on the application of non-price criteria, ensuring that such criteria shall be allocated a significant weighting in order to promote resilience and diversification of the supply in the Union. The guidelines shall also provide guidance on the assessment and practical application of the concept of significant proportion as defined in Article 3 of this Regulation including its implementation in specific market situations and the methodology for verifying compliance. They shall ensure a common understanding and legal certainty, while balancing the promotion of Union production with the need to avoid protectionism and weakened competition.

Amendment 21

Proposal for a regulation

Article 18 – paragraph 3

3. With regard to 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 22

Amendment 10

Proposal for a regulation

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 requirementsrequirements, in accordance with Directive 2014/24/EU, that aim to contribute to improving supply chain security and the availability of critical medicinal products or medicinal products of common interest.interest, which may take into account, where relevant, considerations related to sustainability and social factors.

Or. en

Amendment 23

Justification

The application of qualitative requirements in relation to environmental sustainability and social rights by contracting authorities, does not help to achieve the overarching goal of a strengthened security of supply and availability of critical medicinal products or medicinal products of common interest within the Union as set out in Article 1 (1) of this regulation.

Amendment 11

Proposal for a regulation

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, on the basis of a market analysis or where they can demonstrate that the application of these provisions would lead to a disproportionately high price in the procurement concerned.concerned Thisor impact negatively affordability of critical medical products for patients. That derogation shall be clearly justified in writing and specify the circumstances relied upon. It mayshall be subject to ex-post review by the supervisory authority designated by the Member State.

Or. en

Amendment 24

Justification

In exceptional cases, it may be necessary to derogate from the designated criteria if their strict application would place an excessive burden on those responsible for procurement or prevent potential bidders from participating. However, exemptions should only be granted in exceptional circumstances and must allow for review by the relevant authorities.

Amendment 12

Proposal for a regulation

Article 2220 – titleparagraph 1

Text proposed by the Commission

Amendment

Commission procurement on behalf of or in the name of Member States

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.

deleted

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

Or. en

Amendment 25

Justification

Merged with Article 23.

Amendment 13

Proposal for a regulation

Article 2220 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

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

1a. To facilitate a coordinated approach between Union and national authorities as well as marketing authorisation holders, the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), as part of its work to ensure Union coordination on the availability of medicines, shall contribute to the strengthening and effective implementation of the Solidary Mechanism framework, in particular the communication between Member States, marketing authorisation holders on the movement of stocks including, where appropriate, for medicinal products other than critical medicines, in cases of identified or imminent risk of shortage.

deleted

Amendment 26

(a) critical medicinal products for which a vulnerability evaluation has identified a vulnerability in the supply chains or for which the MSSG has recommended a common procurement initiative;

(b) medicinal products of common interest, for which a joint clinical assessment report has been published pursuant to Article 12(4) Regulation (EU) 2021/2282 of the European Parliament and the Council29 , or which have undergone a clinical assessment carried out under the voluntary cooperation among Member States as per Article 23(1) point (e) of that Regulation.

__________________

29 Regulation (EU) 2021/2282 of the European Parliament and the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, ELI: http://data.europa.eu/eli/reg/2021/2282/oj)

Or. en

Amendment 14

Proposal for a regulation

Article 2220 – paragraph 2

Text proposed by the Commission

Amendment

2. The joint request referred to in paragraph 1 shall only be made where the medicinal product concerned fulfils one of the criteria set out in that paragraph and if the requested procurement procedure will help to improve the security of supply and availability of critical medicinal products in the Union or ensure the availability and accessibility of medicinal products of common interest, as applicable.

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.

deleted

Member States shall ensure that any requirements they impose on public or private entities in the supply chain to hold contingency stocks, or any restrictions they establish on the free movement of medicines, are proportionate and respect the principles of transparency and solidarity. Member States shall, in cases where such requirements may have an impact on other Member States, without undue delay, notify the European Medicines Agency and inform other Member States of their intentions in the Critical Medicines Group, as specified in Article 26, using a common notification mechanism established for this purpose.

Or. en

Amendment 27

Amendment 15

Proposal for a regulation

Article 2220 – paragraph 32 a (new)

Text proposed by the Commission

Amendment

3.2a. The participationEuropean inMedicines Agency shall assess the procurementnotified proceduremeasures shallin belight openof totheir allpotential Memberimpact States.on Thethe Commissionavailability shallof informmedicinal allproducts in other Member States ofand on the request,functioning throughof the Critical Medicinesinternal Group,market and inviteshall themreport its findings to jointhe Commission and the procedure.Critical Medicines Coordination Group.

deleted

Amendment 28

Or. en

Amendment 16

Proposal for a regulation

Article 2220 – paragraph 42 b (new)

Text proposed by the Commission

Amendment

4. The Commission shall assess the utility, necessity and proportionality of the request and whether the request is justified in light of the objectives of this Regulation. The Commission shall in particular verify whether the procurement could constitute discrimination or restriction to trade or a distortion to competition.

2b. Any Member State that considers itself negatively affected by measures adopted by another Member State may submit an opinion describing the negative impacts to the Critical Medicines Group and the Commission. The Commission shall, without delay, engage with the Member State concerned and other affected Member States to promote coordinated solutions.

deleted

Amendment 29

Or. en

Amendment 17

Proposal for a regulation

Article 2221 – paragraph 52

Text proposed by the Commission

Amendment

5.2. TheHaving received the request, the Commission shall inform theall interestedother Member States within one month of the requestinitiative ofand itsset decisionan andappropriate statedeadline itsfor reasonsthem into casedeclare ofinterest. Such a refusal.deadline shall not exceed three weeks.

deleted

2. Having received the request, the Commission shall inform all other Member States of the initiative and set an appropriate deadline for them to declare interest, provided the product qualifies as a medicinal product of common interest in their jurisdiction. Such a deadline shall not exceed three weeks.

Or. en

Amendment 30

Amendment 18

Proposal for a regulation

Article 2221 – paragraph 63

Text proposed by the Commission

Amendment

6. If in light of3. theThe Commission assessment,shall itassess isthe necessary,request in order tolight achieveof the objectives of this Regulation, to conductRegulation. theThe procurementCommission asshall exclusivecommunicate forto the interested Member States or to agreeits todecision minimumon bindingwhether quantities,it theagrees, Commissionor agreementnot, to pursuefacilitate the procedure mayproposed beinitiative conditionedwithin uponthree acceptanceweeks of these conditions by interestedreceiving Memberthe States.request.

deleted

3. The Commission shall assess the necessity and proportionality of the request in light of the actual access hurdles in the Member States and in light of the objectives of this Regulation, taking into account, where necessary, the views of relevant stakeholders, including market authorisation holders.

Or. en

Amendment 31

Amendment 19

Proposal for a regulation

Article 2221 – paragraph 74

Text proposed by the Commission

Amendment

7. Except for the derogations provided for in this Regulation, the procurement referred to in this Article shall be carried out in accordance with Article 168 (3) of Regulation (EU, Euratom) 2024/250930 .

4. If the Commission declines the request, it shall provide reasons for the refusal.

4. The Commission shall communicate to the interested Member States its decision on whether it agrees, or not, to facilitate the proposed initiative within three weeks of receiving the request. Where the Commission declines the request, it shall provide reasons for the refusal.

Amendment 32

Proposal for a regulation

Article 21 – paragraph 5

Text proposed by the Commission

Amendment

5. If the Commission accepts the request, the Commission shall provide secretarial and logistical support to the interested Member States. The Commission shall facilitate communication and cooperation between the involved Member States and provide advice on applicable Union public procurement rules and on regulatory matters related to medicinal products.

5. If the Commission accepts the request, the Commission shall provide secretarial and logistical support to the interested Member States. The Commission shall facilitate communication and cooperation between the involved Member States and provide advice on applicable Union public procurement rules and on regulatory and intellectual property matters related to medicinal products.

Amendment 33

Proposal for a regulation

Article 22

Text proposed by the Commission

Amendment

[...]

deleted

__________________

Amendment 34

30 Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union (recast) (OJ L, 26.9.2024, p. 1, ELI: http://data.europa.eu/eli/reg/2024/2509/oj).

Or. en

Amendment 20

Proposal for a regulation

Joint Procurement and procurement on behalf of Member States

Or. en

Amendment 35

Justification

Some of the objectives of Article 22 and 23, as defined in the Commission proposal, seem to overlap and their respective scope is unclear. To be more coherent and improve legal certainty, it seems necessary to merge them in an expedient way.

Amendment 21

Proposal for a regulation

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

1. Under the conditions laid down in this Article and by way of derogation from Article 168(2) and (3) of Regulation (EU, Euratom) 2024/2509, if a contract is necessary for the implementation of the joint action between the Commission and Member States, the Commission and at least nine Member States may engage, as contracting parties, in a joint procurement procedure, or the Commission may procure, on behalf of, or in the name of nine or more Member States, in accordance with paragraphs 2 to 8 of this Article.

Or. en

Amendment 36

Amendment 22

Proposal for a regulation

2. A joint procurement procedure may be organised following a request by the Member States or at the Commission’s initiative when the procurement relates to medicinal products belonging to one of the categories below:

2. A procurement procedure as referred to in paragraph 1 may be organised following a request by the Member States or at the Commission’s initiative, provided that, when the procurement relates to medicinal products belonging to one of the categories below:

Or. en

Amendment 37

Amendment 23

Proposal for a regulation

(b) medicinal products of common interest, for which a joint clinical assessment report has been published pursuant to Article 12(4) Regulation (EU) 2021/2282 of the European Parliament and the Council31 , or which have undergone a clinical assessment carried out under the voluntary cooperation among Member States as per Article 23(1) point (e) of that Regulation.

(b) medicinal products of common interest, for which a joint clinical assessment report has been published pursuant to Article 12(4) of Regulation (EU) 2021/2282 of the European Parliament and the Council31 , or which have undergone a clinical assessment carried out under the voluntary cooperation among Member States as per Article 23(1) point (e) of that Regulation.Regulation, where such products have been identified as being subject to clearly defined supply risks under the mechanisms set out in this Regulation; procurement procedures shall be designed with the objective of facilitating timely patient access to such products.

__________________

31 Regulation (EU) 2021/2282 of the European Parliament and the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (OJ L 458, 22.12.2021, ELI: http://data.europa.eu/eli/reg/2021/2282/oj)

Or. en

Amendment 38

Amendment 24

Proposal for a regulation

3. The Commission may decide to conduct the joint procurement procedure if the procurement procedure helps to improve the security of supply and availability of critical medicinal products in the Union or ensure the availability and accessibility of medicinal products of common interest, as applicable.

3. The Commission mayshall onlyassess launchthe necessity and proportionality of the procurement procedure referred to in paragraph 11. It shall in particular verify whether the procurement could constitute discrimination or restriction to trade or a distortion to competition and only launch it if it assesses that the procedure demonstrably contributes to improving the security of supply and availability of critical medicinal products in the Union or ensuring the availability and accessibility of medicinal products of common interest, as applicable. ThisThat assessment shall be based on objective criteria, including market conditions, risk assessments, and product-specific characteristics.characteristics, and may also be conducted on the basis of a consultation with the marketing authorisation holder and relevant stakeholders.

Or. en

Amendment 39

Amendment 25

Proposal for a regulation

Article 23 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4a. The procurement procedure set out in this Article shall be preceded by a joint procurement agreement between the Commission and the participating Member States in order to determine the practical arrangements governing the procurement, the duration of the procedure and the award criteria, in accordance with relevant Union law.

Amendment 40

Proposal for a regulation

Article 23 – paragraph 5

5. The Commission shall assess the necessity of a joint action and whether the request is justified in light of the objectives of this Regulation. The Commission shall in particular verify whether the procurement could constitute discrimination or restriction to trade or a distortion to competition.

5. The Commission shall assess the utility, necessity and proportionality of the procurement procedure referred to in paragraph 1 and whether it is justified in light of the objectives of this Regulation. The Commission shall in particular verify whether the procurement could constitute discrimination or restriction to trade or a distortion to competition.

deleted

Or. en

Amendment 41

Amendment 26

Proposal for a regulation

6. If in light of the Commission assessment, it is necessary, in order to achieve the objectives of this Regulation, to conduct the procurement as exclusive for the Member States or to agree to minimum binding quantities, the Commission agreement to pursue the procedure may be conditioned upon acceptance of these conditions by interested Member States.

6. If, in light of the Commission assessments referred to in paragraphs 3 andparagraph 5,3, it is necessary, in order to achieve the objectives of this Regulation, the procurement procedure may be conditionedconditional upon interested Member States accepting specific requirements, including conducting the procurement as exclusive to those Member States or agreeing to minimum binding quantities.

Or. en

Amendment 42

Amendment 27

Proposal for a regulation

Amendment

7a. TheIn order to promote the resilience, availability, and diversification of the supply chain, the Commission shall ensure that any procurement procedure under this Article applies, to the greatest extent possible,applies the award criteria and requirements referred to in Article 18(1) to (4), in order to promote supply chain resilience, availability, and diversification.18.

Or. en

Amendment 43

Amendment 28

Proposal for a regulation

8. Except for the derogations provided for in this Regulation, the joint procurement procedure shall be carried out by the Commission in accordance with Article 168 (2) and (3) of Regulation (EU, Euratom) 2024/2509.

Or. en

Amendment 44

Amendment 29

Proposal for a regulation

Article 23 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8a. The Commission shall inform the European Parliament about any procurement procedures conducted in accordance with this Article and, upon request, grant access to the contracts that are concluded as a result of those procedures, subject to the adequate protection of commercially sensitive information, including business secrets, commercial relations and the interests of the Union.

Amendment 45

Proposal for a regulation

Article 23 – paragraph 8 b (new)

Text proposed by the Commission

Amendment

8b. Where the Commission cancels the procurement procedure in accordance with Article 174 of Regulation (EU, Euratom) 2024/2509, it shall immediately inform the participating Member States thereof, so that they can initiate their own procurement procedures without delay.

Amendment 46

Proposal for a regulation

Article 24 – title

Text proposed by the Commission

Amendment

Agreement concerning procedures under Articles 22 and 23

Agreement concerning procedures under Article 23

Amendment 47

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States participating in the procurement procedures covered by Articles 22 and 23 shall share with the Commission any information relevant for the procurement procedure. Member States shall provide resources necessary for the successful conclusion of the procedure, in particular through involvement of staff with expertise and knowledge.

1. Member States participating in the procurement procedures covered by Article 23 shall share with the Commission any information relevant for the procurement procedure. Member States shall provide resources necessary for the successful conclusion of the procedure, in particular through involvement of staff with expertise and knowledge.

Amendment 48

Proposal for a regulation

Article 24 – paragraph 2

Text proposed by the Commission

Amendment

2. An agreement between the Member States and the Commission shall determine the practical arrangements governing the procurement procedure, liabilities to be assumed and the decision-making process.

2. An agreement between the Member States and the Commission shall determine the practical arrangements governing the procurement procedure, liabilities to be assumed and the decision-making process. It shall, where appropriate, also include safeguards to ensure transparency of award criteria and the prevention of discriminatory practices.

Amendment 49

Proposal for a regulation

Article 24 a (new)

Text proposed by the Commission

Amendment

Article 24a

During accession negotiations, the Commission shall promote the gradual harmonisation of candidate countries with the Union acquis in the field of medicinal products, with a view to facilitating their integration into the internal market and to reinforcing the resilience of supply chains for critical medicines.

Amendment 50

Proposal for a regulation

Article 26 – paragraph 1

1. The Critical Medicines Group shall facilitate coordination in the implementation of this Regulation and, where appropriate, advise the Commission, including with regard to the assessment of the impact of other Union legal acts on the availability of critical medicines and the development of appropriate countermeasures, so as to maximise the impact of the measures envisaged and to avoid any unintended effects on the internal market.

Or. en

Amendment 51

Justification

The coordination group should also be enabled to examine the impact of other regulations (such as environmental legislation) on security of supply and propose appropriate countermeasures.

Amendment 30

Proposal for a regulation

Article 26 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. To ensure the views of relevant stakeholders are taken into account, the Critical Medicines Group may invite representatives from relevant industry associations, pharmaceutical organisations, manufacturers, patient, consumer and professional healthcare organisations or market authorisation holders to participate as observers or provide input on specific issues within the group's remit.

Amendment 52

Proposal for a regulation

Article 26 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(aa) monitor the availability and distribution of critical medicinal products and medicinal products of common interest across the Union;

Amendment 53

Proposal for a regulation

Article 26 – paragraph 2 – point d a (new)

Amendment

(da) assess the impact of existing and forthcoming environmental, climate or sustainability legislation on the availability and security of supply of critical medicinal products in the Union, including the potential impact on production sites, supply chains and market availability, including issuing opinions and making recommendations to the Commission.

(da) issue guidelines and exchange best practices on the use of resilience criteria in the framework of public procurement and on the use of qualitative criteria in the context of public procurement;

Or. en

Amendment 54

Justification

This addition would allow an early examination of the conflicting objectives between environmental policy and security of supply without fundamentally jeopardising the environmental objectives.

Amendment 31

Proposal for a regulation

Article 26 – paragraph 2 – point d b (new)

Text proposed by the Commission

Amendment

(db) support the Commission in its dialogue with Member States on national security of supply measures, where relevant and feasible, with the aim of identifying coordinated solutions that make full use of, and protect, the proper functioning of the internal market.

Amendment 55

Proposal for a regulation

Article 26 – paragraph 5 a (new)

Amendment

5a. The Critical Medicines Group may provide recommendations to the Commission on regulatory exemptions that are necessary for the short-term redistribution of critical medicinal products, such as modifications to packaging, language or labelling requirements. The Critical Medicines Group may also provide opinions and recommendations to the Commission concerning the potential impact of relevant legislation on the availability and security of supply of critical medicines in the Union, including with regard to manufacturing sites, supply chains and market availability.

Or. en

ANNEX: DECLARATION OF INPUT

Justification

Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteur for opinion declares that she included in her opinion input on matters pertaining to the subject of the file that she received, in the preparation of the opinion, prior to the adoption thereof in committee, from the following interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register, or from the following representatives of public authorities of third countries, including their diplomatic missions and embassies:

This addition could allow a certain degree of regulatory flexibility (e.g. multi-country packs) in the event of supply bottlenecks.

1. Interest representatives falling within the scope of the Interinstitutional Agreement on a mandatory transparency register

European Commission, Directorate-General for Health and Food Safety

Bundesärztekammer

CSL Behring

European Federation of Pharmaceutical Industries and Associations (EFPIA)

Medicines for Europe

Kassenärztliche Bundesvereinigung

Pharma Deutschland e.V.

Permanent Representation of Germany to the EU

Deutsche Sozialversicherung

Merck

Bristol-Myers Squibb Company

Johnson & Johnson

Pfizer Inc.

Pharmaceutical Group of the European Union (PGEU)

Viatris

GSK

Bundesverband Medizintechnologie e.V.

2. Representatives of public authorities of third countries, including their diplomatic missions and embassies

The list above is drawn up under the exclusive responsibility of the rapporteur for opinion.

Where natural persons are identified in the list by their name, by their function or by both, the rapporteur for opinion declares that she has submitted to the natural persons concerned the European Parliament's Data Protection Notice No 484 (https://www.europarl.europa.eu/data-protect/index.do), which sets out the conditions applicable to the processing of their personal data and the rights linked to that processing.

PROCEDURE – COMMITTEE ASKED FOR OPINION

Title

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

References

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

Committee(s) responsible

Date announced in plenary

SANT

21.5.2025

Opinion by

Date announced in plenary

IMCO

21.5.2025

Rapporteur for the opinion

Date appointed

Marion Walsmann

23.6.2025

Discussed in committee

15.7.2025

25.9.2025

16.10.2025

Date adopted

11.11.2025

Result of final vote

+:

–:

0:

44

2

1

Members present for the final vote

Alex Agius Saliba, Pablo Arias Echeverría, Jeannette Baljeu, Arno Bausemer, Biljana Borzan, Anna Cavazzini, Stefano Cavedagna, David Cormand, Henrik Dahl, Dóra Dávid, Adnan Dibrani, Klara Dostalova, Hanna Gedin, Sandro Gozi, Maria Grapini, Elisabeth Grossmann, Maria Guzenina, Svenja Hahn, Anna-Maja Henriksson, Virginie Joron, Pierre Jouvet, Arba Kokalari, Nikola Minchev, Piotr Müller, Reinis Pozņaks, Christel Schaldemose, Andreas Schwab, Tomislav Sokol, Dimitris Tsiodras, Inese Vaidere, Adina Vălean, Kim Van Sparrentak, Marion Walsmann

Substitutes present for the final vote

Marc Angel, José Cepeda, Veronika Cifrová Ostrihoňová, Salvatore De Meo, Dirk Gotink, Sophia Kircher, Alice Kuhnke, Marlena Maląg, Gaetano Pedulla’, Joanna Scheuring-Wielgus, Tomáš Zdechovský, Kosma Złotowski

Members under Rule 216(7) present for the final vote

Siegbert Frank Droese, Pál Szekeres

FINAL VOTE BY ROLL CALL BY THE COMMITTEE ASKED FOR OPINION

Key to symbols: