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 970

Radan Kanev

Proposal for a regulation

Article 20 – title

Text proposed by the Commission

Amendment

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

Safeguards related to Member States’ contingency stocks requirements

Or. en

Amendment 971

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová

Proposal for a regulation

Article 20 – paragraph -1 (new)

Text proposed by the Commission

Amendment

-1 Marketing authorisation holders shall maintain contingency stocks of the products included in the Union list of critical medicinal products. The level of such contingency stocks shall be sufficient to ensure the continuous availability of the medicinal product in each Member State where it is being marketed, in accordance with criteria to be further specified.

Or. en

Amendment 972

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 20 – paragraph -1 a (new)

Text proposed by the Commission

Amendment

-1a Member States may, on their own initiative, impose additional obligations on marketing authorisation holders with regard to safety stocks for the products included in the Union list of critical medicinal products, as well as for other medicinal products deemed to be of major interest at national level. Such obligations shall be applied in full compliance with paragraphs 3 and 4.

Or. en

Amendment 973

Dan-Ştefan Motreanu

Proposal for a regulation

Article 20 – paragraph 1

Text proposed by the Commission

Amendment

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, prior to the implementation of such measures, notify them to the European Commission who shall assess the proportionality of the national contingency stock measure in line with the objectives of this Regulation.

Or. en

Amendment 974

Oliver Schenk

Proposal for a regulation

Article 20 – paragraph 1

Text proposed by the Commission

Amendment

Measures on security of supply applied in one or more Member States 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 communicate the introduction of stockpiling obligations to the Critical Medicines Coordination Group.

Or. en

Amendment 975

Laurent Castillo

Proposal for a regulation

Article 20 – paragraph 1

Text proposed by the Commission

Amendment

Measures on security of supply applied in one Member State shall not result in any negative impact on the availability of critical medicinal products and medicinal products of common interest 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 set up contingency stocks.

Or. fr

Amendment 976

Sirpa Pietikäinen

Proposal for a regulation

Article 20 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 977

Kristian Vigenin

Proposal for a regulation

Article 20 – paragraph 1

Text proposed by the Commission

Amendment

Measures on contingency stocks applied on a market authorisation holder 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.

Or. en

Justification

It is necessary to make clear that contingency stocks are only related to the MAH. The national stockpiles and state reserves should not be covered in the scope.

Amendment 978

Ondřej Krutílek

Proposal for a regulation

Article 20 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 979

Radan Kanev

Proposal for a regulation

Article 20 – paragraph 1

Text proposed by the Commission

Amendment

Measures on contingencies stock applied on MAH in one Member State shall not result in any negative impact on supply 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.

Or. en

Justification

It is necessary to make clear that contingency stocks are only related to the Marketing Authorization Holder. The national stockpiles and state reserves should not be covered in the scope.

Amendment 980

Ondřej Krutílek

Proposal for a regulation

Article 20 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 981

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 20 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 982

Ondřej Krutílek

Proposal for a regulation

Article 20 – paragraph 1 – point 1 (new)

Text proposed by the Commission

Amendment

(1) The Commission shall create and maintain a database containing information on contingency stocks. The database shall include at least information on API, size of the package, ATC group, the quantity of stocks and the possibility of sharing such medicinal products with other Member States in case of need.

Or. en

Amendment 983

Ondřej Krutílek

Proposal for a regulation

Article 20 – paragraph 1 – point 1 (new)

Text proposed by the Commission

Amendment

(1) The Commission may create Union contingency stocks to ensure security of medicine supply.

Or. en

Amendment 984

Tilly Metz

Proposal for a regulation

Article 20 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

In order to ensure a coordinated approach, requirements for contingency stocks of critical medicinal products shall be harmonised across the Union. Requirements of contingency stocks shall correspond to a quantity equivalent to maximum three months of average supply, calculated on the basis of the average monthly consumption of the preceding calendar year in the Union or the relevant Member State, as appropriate.

Or. en

Amendment 985

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 20 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Member States may require manufacturers to establish and maintain appropriate dynamic stocks of essential raw materials necessary for the production of medicinal products. This obligation must be proportionate, take into account supply chain vulnerabilities and implemented under the supervision and in agreement of the Critical Medicines Coordination Group.

Or. en

Amendment 986

Galato Alexandraki, Emmanouil Fragkos

Proposal for a regulation

Article 20 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Member States shall establish national strategic stocks for critical medicines, prioritising hospital and life-saving medicines. These stocks shall be regularly maintained and renewed in cooperation with national health authorities to ensure that the needs of patients are continuously met in the event of a crisis;

Or. el

Amendment 987

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

Article 20 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

In particular, stocks should be rolled over time in a way that avoids supply strains and waste, using adequate methods.

Or. en

Amendment 988

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 20 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

Member States facing shortages shall inform the European Medicines Agency of any security of supply measures planned or taken at national level. The Agency shall assess the measures notified by Member States, in relation to the impact they may have on the availability of medicinal products in other Member States and on the functioning of the internal market, and shall report this to the Commission. Where such measures may cause a negative impact in other Member States, the Commission shall take appropriate measures to address any concerns raised by the Agency's report and promote coordinated solutions.

Or. en

Amendment 989

Tilly Metz

Proposal for a regulation

Article 20 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

Any stockpiling measures shall be implemented in a manner that minimises waste and environmental impact. Stockpiling management system shall apply a ‘first in, first out’ principle and promote the use of shelf-life extension studies, in order to reduce expiry-related waste. The Commission, in cooperation with Member States and relevant agencies, shall develop guidelines on sustainable stockpiling, including practices to reduce waste and emissions, improve packaging, manage expiry dates, and ensure responsible disposal of unused or obsolete medicines

Or. en

Amendment 990

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 20 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

Member States shall inform the European Medicines Agency and the Critical Medicines Coordination Group of any security of supply measures planned or taken at national level. The Agency shall assess the measures notified by Member States, in relation to the impact they may have on the availability of medicinal products in other Member States and on the functioning of the internal market, and shall report this to the Commission. Where such measures may cause a negative impact in other Member States, the Commission shall take appropriate measures to address any concerns raised by the Agency's report and promote coordinated solutions.

Or. en

Amendment 991

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 20 – paragraph 1 d (new)

Text proposed by the Commission

Amendment

In addition to Member States’ emergency stocks, the European Health Emergency Preparedness and Response Authority (HERA) must, in close cooperation with Member States, establish and maintain strategic reserves of medicines at EU level. These reservations need to be discussed and defined in the Critical Medicines Coordination Group to address vulnerabilities identified in the Union list of critical medicinal products in order to address supply disruptions affecting one or more Member States.

Or. en

Amendment 992

Sirpa Pietikäinen

Proposal for a regulation

Article 20 – paragraph 2

Text proposed by the Commission

Amendment

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.

Member States shall ensure that any requirements they impose on companies 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. In case of export restrictions, the following conditions need to be met (i) a shortage is likely or certain; (ii) export restrictions are established through transparent criteria that are known in advance and open to be contested (iii) the existence of alternative treatments is taken into consideration; (iv) these measures are revised on a regular basis.

Or. en

Amendment 993

Laurent Castillo

Proposal for a regulation

Article 20 – paragraph 2

Text proposed by the Commission

Amendment

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.

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, and priority must be given to medicines for which a vulnerability evaluation has revealed vulnerabilities. Each Member State shall ensure stock rotation by disposing of stock in order of its expiry date, following the ‘first expired, first out’ system, so as to prevent any of the products concerned being destroyed.

Or. fr

Amendment 994

Tilly Metz

Proposal for a regulation

Article 20 – paragraph 2

Text proposed by the Commission

Amendment

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.

Member States shall ensure that any additional requirements they impose on companies in the supply chain to hold contingency stocks on critical medicinal products respect the principles of transparency, solidarity and coordination with other Member States. Such requirements shall be communicated by the relevant national authority to the Commission and other Member States within four weeks of their agreement with the company concerned.

Or. en

Amendment 995

Oliver Schenk

Proposal for a regulation

Article 20 – paragraph 2

Text proposed by the Commission

Amendment

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.

Member States shall ensure that any requirements they impose on companies in the supply chain to hold contingency stocks are proportionate, targeted, evidence-based and respect the principles of transparency, solidarity and non-discrimination. Those requirements shall also avoid unintended consequences for supply continuity and patient access in the Union.

Or. en

Amendment 996

Marta Temido, Pierre Jouvet

Proposal for a regulation

Article 20 – paragraph 2

Text proposed by the Commission

Amendment

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.

Member States shall ensure that any national measures or requirements they impose on companies in the supply chain to hold contingency stocks are proportionate, respect the principles of transparency and solidarity and promote equitable access to critical medicines across the Union.

Or. en

Amendment 997

Ondřej Krutílek

Proposal for a regulation

Article 20 – paragraph 2

Text proposed by the Commission

Amendment

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.

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

Or. en

Amendment 998

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 20 – paragraph 2

Text proposed by the Commission

Amendment

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.

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

Or. en

Amendment 999

Emmanouil Fragkos

Proposal for a regulation

Article 20 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

1. Member States shall ensure that minimum safety stocks are maintained for medicines included in the Union list of critical medicinal products and available within their territory. The minimum stocks shall be set, as a minimum common framework, at a number of ‘days of coverage’ of typical demand, equalling no less than four (4) weeks, which may be adjusted by active substance, form and seasonality, on the basis of the vulnerability evaluation and epidemiological data.

2. Stocks may be held at marketing authorisation holder, wholesaler, distributor and/or healthcare facility level, under the supervision of the competent national authority.

3. Member States shall ensure stock rotation (e.g. following the ‘first expired, first out’ principle) and compliance with rules on good distribution practices and quality.

4. Member States shall notify the Commission and the Critical Medicines Group of the calculation methodologies, the level of ‘days of coverage’ and the supervision arrangements. The group may issue recommendations for the harmonisation of methodologies and minimum levels for each therapeutic class.

5. To the extent necessary to prevent shortages in another Member State, solidarity and mutual assistance arrangements shall be implemented, including making parts of the stocks available temporarily, in line with the recommendations of the Critical Medicines Group.

6. The obligations in this Article shall be applied in a proportionate manner and shall be without prejudice to the competition law or the international obligations of the Union. Funding may be supported by national instruments, in accordance with State aid rules, and, where appropriate, by EU programmes. Within twelve (12) months from the entry into force of this Regulation, the Commission shall adopt guidelines setting out:

(a) harmonised indicators and calculation methods for the ‘days of coverage’;

(b) minimum reporting elements and reporting formats;

(d) procedures for activating solidarity mechanisms.

Or. el

Justification

This introduces a clear, quantifiable obligation for minimum stock levels (in ‘days of coverage’) with flexibility according to active substance/market, rotation rules and EU-level coordination in order to prevent shortages without causing distortions in the single market.

Amendment 1000

Laurent Castillo

Proposal for a regulation

Article 20 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

Where, for a critical medicinal product or medicinal product of common interest, a shortage or serious supply disruption is identified in one or more Member States producing a negative impact on the internal market or other Member States, the Commission shall facilitate and coordinate, upon request by the Member States concerned, active cooperation among the Member States concerned and the Member States in possession of national or contingency stocks. The Member States shall ensure they show solidarity and jointly decide on the quantities to transfer, delivery time, logistical aspects and the amount due, while avoiding a negative impact on the security of supply of the Member State or Member States transferring the medicinal product in question. Regulatory flexibilities shall be permitted and established among Member States.

Or. fr

Amendment 1001

Letizia Moratti, Adam Jarubas

Proposal for a regulation

Article 20 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

The Commission shall, after consultation with marketing authorisation holders and relevant stakeholders, adopt a delegated act to harmonise contingency stock requirements. Such requirements shall be necessary, proportionate and based on objective and verifiable criteria, and shall define maximum thresholds at national and Union level. Implementation of contingency stock requirements shall take into account the lead times necessary for companies to plan, manufacture, and prepare the relevant stocks in a practical manner. The Critical Medicines Coordination Group shall oversee implementation, address concerns, and reassess annually the need for such requirements. Products no longer deemed vulnerable shall be exempted.

Or. en

Amendment 1002

Sirpa Pietikäinen

Proposal for a regulation

Article 20 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

The Member State shall inform the Agency of any measure on security of supply foreseen or taken at national level. The Agency shall assess the measures notified by Member States in relation to the impact they may have on the availability of medicines in other Member States and the functioning of the internal market, and report this to the Commission. Where such measures may result in any negative impact in other Member States, the Commission shall take the appropriate steps to address any concerns raised by the report of the Agency and promote 3 alternative solutions in cooperation with the Member State, fully leveraging the functioning of the internal market.

Or. en

Amendment 1003

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Article 20 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

For critical medicinal products manufactured within the framework of the strategic project referred to in Article 5 of this Regulation, the applicant shall be exempted from the obligation to pay the fees to the competent authority of the Member State for processing the application for a national marketing authorization in accordance with the Directive (EU) …/… [reference to be added after adoption, cf. COM (2023) 192 final] and the fee for examination centralised marketing authorisation application referred to in Article 6 (3) Regulation (EU) …/… [reference to be added after adoption, cf. COM (2023) 193 final].

Or. en

Amendment 1004

Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 20 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

During a health emergency and crisis, Member States authorities and EU preparedness authorities shall closely coordinate distribution of critical medicinal products or medicinal products of common interest primarily with systemic wholesalers, in order to ensure equitable and fair distribution. Member States may also undertake the distribution via their civil preparedness authorities or military if deemed necessary.

Or. en

Amendment 1005

Tilly Metz

Proposal for a regulation

Article 20 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

A Union-level stockpiling coordination and monitoring platform shall be established to track contingency and national stock levels across Member States, identify critical gaps, and provide recommendations on priority stockpiling needs at EU level. The platform shall be coordinated by the Commission in collaboration with the European Medicines Agency and the Critical Medicines Coordination Group, established under Article 25.

Or. en

Amendment 1006

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

Proposal for a regulation

Article 20 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

Where Member Stats impose contingency stocks requirements on companies, they shall notify the Commission and the European Medicines Agency. Member States shall furthermore encourage the implementation of rolling stockpiling systems amongst manufactures.

Or. en

Amendment 1007

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 20 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

The Commission may adopt implementing measures concerning the application of the obligations referred to in paragraphs 1 and 2, including methodologies for determining adequate contingency stock levels.

Or. en

Amendment 1008

Dan-Ştefan Motreanu

Proposal for a regulation

Article 20 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

While a national stockholding obligation is in place, it shall not be permissible to export or to parallel export medicines subject to the obligation.

Or. en

Amendment 1009

Tilly Metz

Proposal for a regulation

Article 20 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

Member States shall ensure that the establishment, maintenance and use of national stockpiles of critical medicines are carried out in coordination with, and subject to the oversight of, the European Shortages Monitoring Platform (ESMP) and the stockpiling coordination mechanism established under this Regulation. National stockpiling requirements shall be designed and implemented in a manner that avoids duplications, ensures complementarity across Member States, and contributes to a coherent Union-wide approach to supply security, thereby enhancing transparency and the efficient allocation of available resources.

Or. en

Amendment 1010

Laurent Castillo

Proposal for a regulation

Article 20 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

No later than six months after this Regulation enters into force, each Member State shall notify the Commission and the Critical Medicines Group about stocks of medicinal products, any subsequent changes thereto and any new developments. The Critical Medicines Group shall assess those pieces of legislation against each other so as to uphold paragraphs 1 and 2 of this article and shall hold a meeting with the Member States on the matter every year.

Or. fr

Amendment 1011

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

Proposal for a regulation

Article 20 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

The Commission shall, following a consultation with relevant stakeholders, including patients’ and consumer organizations, healthcare professionals, public healthcare payers, and marketing authorization holders, issue Union guidelines establishing common standards for stockpiling to support Member States activities, ensuring predictability for companies.

Or. en

Amendment 1012

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 20 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

Member States shall cooperate in good faith and, 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.

Or. en

Amendment 1013

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová

Proposal for a regulation

Article 20 – paragraph 2 c (new)

Text proposed by the Commission

Amendment

Marketing authorisation holders shall periodically report to the competent national authorities, and upon request to the Commission, on the level and location of contingency stocks maintained under this Article. The frequency, format and content of such reporting shall be determined by the Commission through implementing measures.

Or. en

Amendment 1014

Tilly Metz

Proposal for a regulation

Article 20 – paragraph 2 c (new)

Text proposed by the Commission

Amendment

Member States shall make their very best efforts to support any other Member State that has requested assistance through the Solidarity Mechanism, particularly in addressing acute shortages of products listed on the Union list of critical medicinal products.

Or. en

Amendment 1015

Tilly Metz

Proposal for a regulation

Article 20 – paragraph 2 d (new)

Text proposed by the Commission

Amendment

Any stockpiling measures shall be implemented in a manner that minimises waste and environmental impact. The Commission, in cooperation with Member States and relevant agencies, shall develop guidelines on sustainable stockpiling, including practices to reduce emissions, improve packaging, manage expiry dates, and ensure responsible disposal of unused or obsolete medicines.

Or. en

Amendment 1016

Tilly Metz

Proposal for a regulation

Article 20 a (new)

Text proposed by the Commission

Amendment

Article 20a

Union Solidarity Mechanism for critical medicines

1. A Union Solidarity Mechanism is hereby established to ensure the equitable redistribution of critical medicinal products between Member States in the event of a critical shortage in a Member State.

2. The Union Solidarity Mechanism shall be coordinated by the Executive Steering Group on Shortages and Safety of Medicinal Products as referred to in Article 3 of the Regulation (EU) 2022/123 and supported by the Agency.

3. Each Member State shall designate a national contact point for the Union Solidarity Mechanism.

4. Member States shall communicate to the MSSG and the Commission what is the contact point for the Union Solidarity Mechanism.

5. Each Member State may request support from the Union Solidarity Mechanism if the following conditions are met:

a) the critical shortage in a Member State has been notified to the Agency;

b) the critical shortage in a Member State has been brought to the attention of the MSSG;

c) there is no appropriate alternative medicinal product available on the market in the Member State and the shortage of the critical medicinal product cannot be resolved.

6. Member State shall submit request for support from the Union Solidarity Mechanism to the MSSG.

7. The MSSG shall examine the request within three working days, verifying fulfilment of the conditions laid down in point 5. Where the MSSG considers that the request is incomplete, it shall inform the Member States and set a time limit for submitting the missing information.

8. If the conditions laid down in point 5 are met, the MSSG shall inform the Commission and launch the Union Solidarity Mechanism. The MSSG shall disseminate the request for support from the Union Solidarity Mechanism among the contact points referred to in point 3. Member States shall acknowledge receipt of the notification and shall respond within five working days, indicating whether they can provide support. Where justified, the deadline may be extended once, by no more than five working days.

9. The Agency shall compile the responses and, where support is available, facilitate contact between the requesting Member State and the Member States offering support, including relevant marketing authorisation holders, wholesalers or other actors as necessary, in order to define the operational and financial arrangements for supply.

10. The MSSG shall maintain a record of all requests submitted and outcomes of the Union Solidarity Mechanism. The records shall be published, while respecting commercially confidential information.

11. Where the Union Solidarity Mechanism and to foster the rapid reallocation of stocks across Member States, EU and national regulations shall allow flexibility with regard to:

(a) packaging and labelling requirements;

(b) package leaflets, including the possibility for electronic package leaflets, while ensuring that patients retain the right to request paper leaflet.

12. [12 months after entry into force of this Regulation] the Commission, in consultation with the MSSG and the Agency, shall adopt an implementing act laying down the templates, procedures for cost-sharing and the specific operational elements for the implementation of the Union Solidarity Mechanism.

13. Where, in the event of severe public health concerns, repeated requests for assistance under the Union Solidarity Mechanism remain unmet, the Commission may, after consultation with the Member State(s) where the shortages occur, adopt binding measures requiring the redistribution of critical medicinal products from national stockpiles or a contingency stock to (a) Member State(s) experiencing acute shortages. Such measures shall be proportionate, take into account the availability of stock and ongoing national needs, and aim to ensure equitable access to critical medicines across the Union.

Or. en

Amendment 1017

Michalis Hadjipantela

Proposal for a regulation

Article 20 a (new)

Text proposed by the Commission

Amendment

Article 20a

Safeguards relating to national contingency stock requirements and Union-level coordination measures to ensure security of supply

1. Measures adopted by Member States to safeguard the security of supply of critical medicinal products and medicinal products of common interest shall not adversely affect the availability of such products in other Member States or compromise the functioning of the internal market. In particular, Member States shall:

(a) refrain from introducing or maintaining requirements on economic operators in relation to the holding of contingency stocks that could result in disproportionate or discriminatory effects on the supply of such products in other Member States;

(b) ensure that any obligations they impose on economic operators in relation to the holding of contingency stocks are proportionate, non-discriminatory, and consistent with the principles of transparency and solidarity;

(c) take due account of any guidelines on improving the security of supply to and avoiding supply shortages that have been issued by the Commission pursuant to Article 134 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023)193 final], including those on facilitating the fulfilment of Member State’s obligations pursuant to points (a) and (b) of this subparagraph; (d) take due account of the guidelines referred to in point (c) of this subparagraph when establishing national programmes in accordance with Article 19 of this Regulation.

2. The Commission is empowered to adopt delegated acts, in accordance with Article 30a, in order to supplement this Regulation by specifying and harmonising the conditions applicable to Member States’ contingency stock requirements, taking into account the characteristics of specific categories of medicinal products, differences across Member State markets, and the supply risk and shortage prevention plans adopted by marketing authorisation holders pursuant to Article 117 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023)193 final]. Those conditions may include:

(a) the establishment of defined quantitative thresholds for contingency stocks at both national and aggregated Union level, to be determined in cooperation with economic operators and reviewed periodically in light of evolving risk assessments;

(b) provisions allowing for the holding of contingency stocks in the form of white-label semi-finished or bulk products, where appropriate to ensure flexibility and timely deployment;

(c) the use of harmonised packaging formats, including multi-language or Union-wide packs, with a view to facilitating cross-border supply and reducing relabelling burdens;

(d) the establishment of the volume and the duration of a contingency stock measure, which should be duly justified, based on data such as expected needs by authorities and contractual obligations..

By way of derogation from Article 63 [Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC], those delegated acts may provide that the package leaflet be made available electronically only for categories of critical medicinal products when such a measure may support the effective distribution and use of contingency stocks in emergency contexts. 3. When using contingency stocks in accordance with Article 20b, economic operators shall not be subject to penalties.

Or. en

Amendment 1018

Laurent Castillo

Proposal for a regulation

Article 20 a (new)

Text proposed by the Commission

Amendment

Article 20a

Creation of EU contingency stocks

1. Nine or more Member States may request that the Commission set up EU stocks of one or more 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.

2. 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.

3. The Commission shall inform all Member States of the request through the Critical Medicines Group.

4. The Commission shall inform the Member States concerned of its decision within one month of the request and state its reasons in the event of refusal.

5. If, in light of the Commission assessment, it is necessary, in order to achieve the objectives of this Regulation, to set up an EU stock of one or more critical medicinal products using an exclusivity clause for the Member States or agree to minimum binding quantities, the Commission agreement to pursue the procedure may be conditioned upon acceptance of these conditions by the interested Member States.

6. The Commission shall be responsible for setting up that stock under the terms of Article 23 of this Regulation. The Member States concerned and the Commission shall establish for how long stocks should be held.

7. The EU stocks shall be stored at the appointed company or companies. The Member States concerned shall pay a lump sum established in the contract to cover the storage costs.

8. No Member State that participates in the EU stock may impose a national stockpile for the critical medicinal product or products concerned or carry out parallel imports.

9. Regulatory flexibilities shall be granted to facilitate the creation of EU contingency stocks, including but not limited to the use of electronic packaging information (ePI), the harmonisation of pack sizes and labelling flexibilities.

Or. fr

Amendment 1019

Aurelijus Veryga

Proposal for a regulation

Article 20 a (new)

Text proposed by the Commission

Amendment

Article 20a

Union Stockpile

In order to ensure the timely and effective availability of critical medicinal products or medicinal products of common interest with identified vulnerabilities in their supply chains, a Union Stockpile may be established as a last-resort mechanism.

The Commission is empowered to adopt delegated acts in accordance with Article 30a to determine:

(a) the categories and types of products to be included;

(b) the minimum quantities to be stocked, taking into account Union-level risk assessments, including possible external or military threats, supply vulnerabilities and public health needs;

(d) the criteria and procedures for the deployment of the stockpiled products in coordination with Member States.

The Commission shall coordinate with national authorities to avoid duplication with national stockpiles and ensure that the Union Stockpile does not negatively affect availability in Member States.

The Commission shall further ensure that packaging, labelling and storage conditions enable the rapid and safe distribution and use of the medicinal products across the Union.

The establishment, maintenance and deployment of the Union Stockpile shall be supported by the general budget of the European Union.

Or. en

Amendment 1020

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 20 a (new)

Text proposed by the Commission

Amendment

Article 20a

Establishment of a Union coordination mechanism for critical medicinal products and medicinal products of common interest

A Union coordination mechanism for critical medicinal products and medicinal products of common interest is hereby established. It shall be operated by the Commission. Through that coordination mechanism the Commission shall:

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

(b) ensure effective, timely, and equitable redistribution in cases of shortage or supply disruption in one or more Member States.

In order to enhance transparency and to ensure timely and coordinated action, a centralized Union-wide portal shall be established as a one-stop shop. The portal shall be accessible to healthcare professionals, pharmacists, importers, distributors, patients, and organisations representing the interests of patients. It shall enable the systematic collection and real-time exchange of information concerning emerging shortages, thereby reinforcing early warning mechanisms, facilitating coordination, and ensuring more effective responses at Union level.

Or. en

Amendment 1021

Laurence Trochu

Proposal for a regulation

Article 20 a (new)

Text proposed by the Commission

Amendment

Article 20a

Commitment of the Member States to ensuring solidarity

In order to ensure the necessary solidarity in the event of a shortage occurring in one or more Member States, Member States with contingency stocks of critical medicinal products may voluntarily contribute to the creation of a centralised buffer stock managed by the Commission, provided that national stocks are compatible with the protection of their own populations and following an assessment carried out in consultation with the national authorities, the EMA and the ECDC. In the event of a significant shortage of a critical medicinal product, each Member State may request access to the buffer stock. Each request must be accompanied by detailed and justified estimates of needs and any corrective action already taken and planned in the short, medium and long term. In the event of requests linked to persistent and recurrent shortages with no corrective action taken by the Member State, the Member States contributing to the buffer stock may reconsider their participation in the scheme.

Or. fr

Justification

Critical medicines are a significant vulnerability and could be instrumentalised by foreign powers or interests with a view to weakening the Union or the Member States. Appropriate transparency with regard to critical medicines should therefore be guaranteed.

Amendment 1022

Margarita de la Pisa Carrión

Proposal for a regulation

Article 20 a (new)

Text proposed by the Commission

Amendment

Article 20a

Distribution of critical medicinal products or medicinal products of common interest in case of shortages, declared emergencies or crises

1. To ensure equitable, fair, fast and capillary distribution – reaching all patients – in the event of a declared shortage of a critical medicinal product or a medicinal product of common interest at national or Union level, national authorities responsible for medicinal products may prioritise distribution of that product through systemic wholesalers in their territory.

2. During a health emergency and crisis, distribution of critical medicinal products or medicinal products of common interest shall be preferentially undertaken by systemic wholesalers in close coordination with authorities, including preparedness authorities. Member States may also undertake the distribution via their civil preparedness authorities or military if deemed necessary.

Or. en

Amendment 1023

András Tivadar Kulja

Proposal for a regulation

Article 20 a (new)

Text proposed by the Commission

Amendment

Article 20a

If deemed necessary Member States or the Union may impose contingency stock requirements on manufacturers or other stakeholders for critical medicines with vulnerable supply chains. Such requirements must be necessary, justified, proportionate, and adopted after consulting marketing authorization holders. The requirements shall take into account the specific characteristics of the medicinal products concerned, like manufacturing, shelf life, storage, and stockpiling suitability, with tailored regimes for critical medicines manufactured with substances of human origin, where this triggers constraints in the supply chain. These requirements must be combined with other measures that address the root causes of supply risks. Should the Commission establishes Union-level contingency stocks for vulnerable critical medicines, it shall coordinate with national authorities to avoid duplication with national stockpiles.

Or. en

Justification

The amendment seeks to prevent uncoordinated national stock requirements that waste capacity, increase burdens, and divert medicines from areas of greatest need.

Amendment 1024

Ondřej Knotek, Tomáš Kubín, Viktória Ferenc

Proposal for a regulation

Article 20 a (new)

Text proposed by the Commission

Amendment

Article 20a

Union-Level Strategic Reserves

1. The Commission shall, in cooperation with Member States, the European Medicines Agency and relevant stakeholders, conduct a feasibility assessment on the establishment of Union-level strategic reserves of critical medicinal products and their active pharmaceutical ingredients.

2. The feasibility assessment shall include: (a) criteria for selecting medicinal products and APIs to be included in the reserve; (b) models for shared governance and financing; (c) options for physical and virtual stockpiling, including logistics, warehousing, and distribution; (d) legal and regulatory implications including liability and quality assurance.

3. Where justified by the outcome of the assessment, the Commission shall launch pilot projects to test and validate models for Union-level strategic reserves in cooperation with interested Member States.

Or. en

Amendment 1025

Laurent Castillo

Proposal for a regulation

Article 20 b (new)

Text proposed by the Commission

Amendment

Article 20b

Monitoring related to Member States’ contingency stock requirements, authorised medicinal product shortages and other security of supply measures

1. For the purposes of implementing this Regulation, the Agency shall expand the scope of the European Shortages Monitoring Platform (ESMP). The platform shall, in particular, allow for the monitoring of stocks of the medicinal products on the list of critical medicinal products referred to in Article 131(3) of Regulation (EU) .../... of the European Parliament and of the Council, laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (OJ...). [D.G.: Title according to COM(2023) 193 final. Please check against latest version of this draft Regulation], and shall be continually updated in real time using data sent every month by the Members States' competent authorities and the companies holding the stocks. The Agency shall ensure that, where relevant, data is interoperable between the ESMP, Member States’ IT systems and other relevant IT systems and databases, without duplication of reporting.

2. The ESMP platform shall have a public database of medicinal products to consolidate existing databases and shall include:

(a) all authorised medicinal products in the EU and their marketing status by Member State;

(b) information on the availability, strain or shortages of medicinal products;

(c) information on medicinal products deemed critical by the EU or certain Member States, alternative medicinal products in the EU by therapeutic class, as well the vulnerabilities identified in the supply chains.

3. The Commission shall ensure that the Agency is automatically notified of medicinal product shortages by the designated national authorities.

4. The Commission shall encourage the marketing authorisation holders to automatically notify the Agency of shortages of authorised medicinal products.

Or. fr

Amendment 1026

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 20 b (new)

Text proposed by the Commission

Amendment

Article 20b

Redistribution decisions

Where, for a critical medicinal product or medicinal product of common interest, a shortage or supply disruption is identified in one or more Member States, the Commission shall, upon request of the Member States concerned and subject to the prior approval of the Critical Medicines Group, adopt a binding decision requiring a redistribution from a national stockpile or a contingency stock. Such a decision shall:

(a) be based on an objective risk assessment and real-time data establishing both the shortage or supply disruption;

(b) specify the quantities to be transferred, the timeframe for delivery, and any logistical arrangements;

Or. en

Amendment 1027

Christine Anderson

Proposal for a regulation

Chapter IV – Section II

Text proposed by the Commission

Amendment

II [...]

deleted

Or. en

Justification

These provisions are based on a proven failure during COVID: The Commission's centralised procurement led to delays, inefficiencies, and poor accountability. The proposal mirrors this and undermines subsidiarity and national flexibility. It encourages uniform contracts ill-suited to national health systems. As a reminder, at least 215 million doses of COVID‑19 vaccines purchased by EU countries have been thrown away, the value of those wasted doses is estimated at approximately 4 billion Euro.

Amendment 1028

Ondřej Krutílek

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

1. Upon a reasoned request of three or more Member States (‘the request’), the Commission may act as facilitator for the requesting Member States’ cross-border procurement as laid down in Article 39 of Directive of the European Parliament and of the Council 2014/24/EC28 for medicinal products of common interest.

1. Upon a reasoned request of three or more Member States (‘the request’), the Commission shall act as facilitator for the requesting Member States’ cross-border procurement as laid down in Article 39 of Directive of the European Parliament and of the Council 2014/24/EC28 for medicinal products of common interest. The Commission may decline the request only if the request does not meet the conditions set in this Article.

_________________

28 Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (OJ L 94, 28.3.2014, p. 65, ELI: http://data.europa.eu/eli/dir/2014/24/2024-01-01 ).

Or. en

Amendment 1029

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 1030

Kristoffer Storm

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

1. Upon a reasoned request of three or more Member States with similar epidemiologic and economic situations (‘the request’), the Commission may act as facilitator for the requesting Member States’ cross-border procurement as laid down in Article 39 of Directive of the European Parliament and of the Council 2014/24/EC28 for medicinal products of common interest.

_________________

Or. en

Amendment 1031

Christophe Clergeau

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 1032

Galato Alexandraki, Emmanouil Fragkos

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

1. Upon a reasoned request of three or more Member States (‘the request’), the Commission may facilitate a procurement procedure, if requested by the participating Member States and without prejudice to national competence in the organisation of health policy. Member States’ participation shall always be voluntary.

_________________

Or. el

Amendment 1033

Kristoffer Storm

Proposal for a regulation

Article 21 – paragraph 2

Text proposed by the Commission

Amendment

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. Such a deadline shall not exceed three weeks.

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 they demonstrate that they face similar epidemiologic and economic situations and that the product qualifies as a medicinal product of common interest in their respective jurisdiction . Such a deadline shall not exceed three weeks.

Or. en

Amendment 1034

Kristoffer Storm

Proposal for a regulation

Article 21 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall assess the request in light of the objectives of this Regulation. 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.

3. The Commission shall consult with the marketing authorisation holder and other relevant stakeholders to 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. Such consultations shall be extended to facilitate the planning and conduct of the proposed procurement procedure if the Commission accepts the request under this Article after having first verified in all cases that the procurement would not constitute discrimination or restriction of trade or a distortion of competition. 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.

Or. en

Amendment 1035

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

Proposal for a regulation

Article 21 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall assess the request in light of the objectives of this Regulation. The Commission shall communicate to the interested Member States and to the European Parliament its decision on whether it agrees, or not, to facilitate the proposed initiative within three weeks of receiving the request.

Or. en

Amendment 1036

Tilly Metz

Proposal for a regulation

Article 21 – paragraph 4

Text proposed by the Commission

Amendment

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

4. If the Commission declines the request, it shall provide a detailed public explanation for the refusal.

Or. en

Amendment 1037

Kristoffer Storm

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 the planning and conduct of the proposed procurement procedure in light of the assessment referred to under paragraph 3 of this Article, applicable Union public procurement rules and on regulatory and intellectual property matters related to medicinal products.

Or. en

Amendment 1038

Christophe Clergeau

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 and medical countermeasures.

Or. en

Amendment 1039

Peter Agius

Proposal for a regulation

Article 21 – paragraph 6

Text proposed by the Commission

Amendment

6. The facilitation offered by the Commission shall be limited in time and end at the latest upon signature of the procurement contract by the participating contracting authorities.

6. The facilitation offered by the Commission shall be limited in time and end upon delivery of the medicinal product. In the case of frameworks for collaborative procurement, the Commission may extend this facilitation on the request of the participating Member States.

Or. en

Justification

When the collaborative procurement is to setup a framework in Benelux, this can last over time so there should be the possibility for the Commission to remain involved, if the Member States and the Commission see added value. The current text is too prescriptive, in that it makes it impossible for the Commission to remain involved.

Amendment 1040

Laurent Castillo

Proposal for a regulation

Article 21 – paragraph 6

Text proposed by the Commission

Amendment

6. The facilitation offered by the Commission shall be limited in time and end at the latest upon signature of the procurement contract by the participating contracting authorities.

6. The facilitation offered by the Commission shall be limited in time and end at the latest upon delivery of the medicinal products of common interest or following a decision taken by the requesters.

Or. fr

Amendment 1041

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová

Proposal for a regulation

Article 21 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7a. The provisions of this Article shall apply, mutatis mutandis, to candidate countries that choose to participate in the procedures established herein, without prejudice to their accession negotiations or to the rights and obligations reserved to Member States under Union law.

Or. en

Amendment 1042

Peter Agius

Proposal for a regulation

Article 21 a (new)

Text proposed by the Commission

Amendment

Article 21a

Upon a reasoned request of three or more Member States (‘the request’), the Commission may act as facilitator for the requesting Member States’ cross-border procurement as laid down in Article 39 of Directive of the European Parliament and of the Council 2014/24/EC for a critical medicine or for medicinal products of common interest.

Or. en

Justification

This article is intended to support cooperation like the Benelux, where Member States get together to support the procurement of medicines. Such cooperation is not set up just for one product since the necessary arrangements for procurement may apply horizontally to most procurement. Article 168(2) of the TFEU does not have any minimum threshold and this should not be included within this legislation. In this regard, it is important to make the Commission support available to two Member States when the collaboration is intended to set up such a mechanism with a long-term collaboration. In the case of the procurement of one product, the three Member State threshold is more understandable. Furthermore, the scope of the collaborative procurement should remain wide and should not be restricted to medicinal products of common interest. Member States would not decide to go for collaborative procurement capriciously, but because they see the need. For example, some Member States have problems with accessibility and availability of critical medicines and collaborative procurement could be helpful. For example, it is more difficult to award contracts to multiple suppliers in small markets, yet this could be possible with collaborative procurement, thereby strengthening the security of supply for these Member States.

Amendment 1043

Radan Kanev

Proposal for a regulation

Article 22

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 1044

Christophe Clergeau

Proposal for a regulation

Article 22 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

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

1. By way of derogation from Article 168(3) of Regulation (EU, Euratom) 2024/2509 where 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 or medical products belonging to one of the following categories below;

Or. en

Amendment 1045

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 22 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

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

Or. en

Amendment 1046

Ondřej Krutílek

Proposal for a regulation

Article 22 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 1047

Michalis Hadjipantela

Proposal for a regulation

Article 22 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

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

Or. en

Amendment 1048

Tilly Metz

Proposal for a regulation

Article 22 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 1049

Marta Temido, Pierre Jouvet

Proposal for a regulation

Article 22 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 1050

Laurent Castillo

Proposal for a regulation

Article 22 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(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;

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

Or. fr

Amendment 1051

Christophe Clergeau

Proposal for a regulation

Article 22 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(aa) critical medical countermeasures for which a vulnerability evaluation has identified a vulnerability in the supply chains or for which the Critical Medicines and Medical Countermeasures Group has recommended a common procurement initiative;

Or. en

Amendment 1052

Ondřej Krutílek

Proposal for a regulation

Article 22 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(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.

(b) medicinal products of common interest, for which a clinical assessment has been done by at least one Member State

_________________

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 1053

Laurent Castillo

Proposal for a regulation

Article 22 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(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.

(b) medicinal products of common interest, active substances or key inputs 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.

_________________

Or. fr

Amendment 1054

Christophe Clergeau

Proposal for a regulation

Article 22 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(ba) medical countermeasures 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.

Or. en

Amendment 1055

Laurent Castillo

Proposal for a regulation

Article 22 – 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.

2. The joint request referred to in paragraph 1 shall only be made where the medicinal product concerned, the active substance or the key input 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, active substances or key inputs in the Union or ensure they are available and accessible, as applicable.

Or. fr

Amendment 1056

Tilly Metz

Proposal for a regulation

Article 22 – 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 affordability, security of supply and availability of critical medicinal products in the Union or ensure the affordability, availability and accessibility of medicinal products of common interest, as applicable.

Or. en

Amendment 1057

Kristian Vigenin

Proposal for a regulation

Article 22 – 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, availability and affordability of critical medicinal products in the Union or ensure the availability and accessibility of medicinal products of common interest, as applicable.

Or. en

Amendment 1058

Christophe Clergeau

Proposal for a regulation

Article 22 – paragraph 2

Text proposed by the Commission

Amendment

2. The joint request referred to in paragraph 1 shall only be made where the medicinal or medical 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.

Or. en

Amendment 1059

Ondřej Krutílek

Proposal for a regulation

Article 22 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. The Commission may decline the joint request by the Member States only if the request does not meet the conditions set in this Article

Or. en

Amendment 1060

Christophe Clergeau

Proposal for a regulation

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

3. The participation in the procurement procedure shall be open to all Member States. The Commission shall inform all Member States of the request, through the Critical Medicines Group, and invite them to join the procedure.

Or. en

Amendment 1061

Christophe Clergeau

Proposal for a regulation

Article 22 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1062

András Tivadar Kulja

Proposal for a regulation

Article 22 – paragraph 4

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.

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. An observer group composed of patients and healthcare professionals responsible for prescribing, managing, dispensing, and monitoring medication shall be established to advise the Commission in this assessment. The Commission shall, in particular, verify whether the procurement could constitute discrimination, a restriction to trade, or a distortion of competition.

Or. en

Amendment 1063

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

Proposal for a regulation

Article 22 – paragraph 4

Text proposed by the Commission

Amendment

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

Or. en

Amendment 1064

Laurent Castillo

Proposal for a regulation

Article 22 – paragraph 6

Text proposed by the Commission

Amendment

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. The Commission agreement to pursue the procedure shall be conditional upon the establishment of minimum quantities that the interested Member States must accept and may be conditioned upon acceptance of an exclusivity clause by interested Member States.

Or. fr

Amendment 1065

Kristian Vigenin

Proposal for a regulation

Article 22 – paragraph 6

Text proposed by the Commission

Amendment

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 interested Member States, the Commission agreement to pursue the procedure may be conditioned upon acceptance of certain conditions by those Member States.

Or. en

Amendment 1066

Galato Alexandraki, Emmanouil Fragkos

Proposal for a regulation

Article 22 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7a. The participation of a Member State in procurement procedures carried out by the Commission shall remain voluntary. No Member State may be obliged to participate in a common procurement where this negatively affects national health policy, the level of prices or the sustainability of national health budgets.

Or. el

Amendment 1067

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová

Proposal for a regulation

Article 22 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 1068

Kristian Vigenin

Proposal for a regulation

Article 23

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Justification

It is unclear what is the added value of this article is compared to art. 22.

Amendment 1069

Radan Kanev

Proposal for a regulation

Article 23

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 1070

Peter Agius

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 1071

Ondřej Krutílek

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

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

Or. en

Amendment 1072

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

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

Or. en

Amendment 1073

Marta Temido, Pierre Jouvet

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

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

Or. en

Amendment 1074

Michalis Hadjipantela

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

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

Or. en

Amendment 1075

Aurelijus Veryga

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

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

Or. en

Amendment 1076

Tilly Metz

Proposal for a regulation

Article 23 – paragraph 1

Text proposed by the Commission

Amendment

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

Or. en

Amendment 1077

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

Proposal for a regulation

Article 23 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. Participation in joint procurement shall remain voluntary. Non-participation shall not preclude access to critical medicinal products or fair conditions under this Regulation.

Or. en

Amendment 1078

Ondřej Krutílek

Proposal for a regulation

Article 23 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

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

Or. en

Amendment 1079

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 23 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 1080

Christophe Clergeau

Proposal for a regulation

Article 23 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

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 or medical products belonging to one of the categories below:

Or. en

Amendment 1081

Laurent Castillo

Proposal for a regulation

Article 23 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(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;

Or. fr

Amendment 1082

Christophe Clergeau

Proposal for a regulation

Article 23 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 1083

Ondřej Krutílek

Proposal for a regulation

Article 23 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(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 clinical assessment has been done by at least one Member State.

_________________

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 1084

Laurent Castillo

Proposal for a regulation

Article 23 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(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, active substances or key inputs 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.

_________________

Or. fr

Amendment 1085

Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 23 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(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, including orphan drugs, 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.

_________________

Or. en

Amendment 1086

Christophe Clergeau

Proposal for a regulation

Article 23 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

(ba) medical countermeasure 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 Council31a, 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.

_________________

31a 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 1087

Aurelijus Veryga

Proposal for a regulation

Article 23 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. At the Commission’s initiative, the Commission and at least five Member States may engage, as contracting parties, in a joint procurement procedure as provided for in Article 168(2) of Regulation (EU, Euratom) 2024/2509, if the requirements laid down in paragraph 2 of this Article are fulfilled. Such a joint procurement procedure shall be conducted in accordance with paragraphs 4 to 7 of this Article.

Or. en

Amendment 1088

Ondřej Krutílek

Proposal for a regulation

Article 23 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. The Commission may decline the request by the Member States only if the request does not meet the conditions set in this Article.

Or. en

Amendment 1089

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 23 – paragraph 3

Text proposed by the Commission

Amendment

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, prior multidisciplinary consultation with relevant stakeholders including patient organisations and healthcare professionals responsible for selecting, prescribing, managing, dispensing, and monitoring medicinal products, may decide to conduct the joint procurement procedure if the procurement procedure helps to improve the security of supply, affordability, equitable access and availability of critical medicinal products and medicinal products of common interest, as applicable.

Or. en

Amendment 1090

András Tivadar Kulja

Proposal for a regulation

Article 23 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission, following multidisciplinary consultation with healthcare professionals responsible for selecting, prescribing, managing, dispensing, and monitoring medicinal products, 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.

Or. en

Amendment 1091

Christophe Clergeau

Proposal for a regulation

Article 23 – paragraph 3

Text proposed by the Commission

Amendment

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 or critical medical countermeasures in the Union or ensure the availability and accessibility of medicinal products of common interest or medical countermeasures of common interest, as applicable.

Or. en

Amendment 1092

Laurent Castillo

Proposal for a regulation

Article 23 – paragraph 3

Text proposed by the Commission

Amendment

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, active substances or key inputs in the Union or ensure the availability and accessibility of medicinal products of common interest, as applicable.

Or. fr

Amendment 1093

Christophe Clergeau

Proposal for a regulation

Article 23 – paragraph 4

Text proposed by the Commission

Amendment

4. The participation in the procurement procedure shall be open to all Member States. The Commission shall inform all Member States of the request through the Critical Medicines Group and invite them to join the procedure.

Or. en

Amendment 1094

Laurent Castillo

Proposal for a regulation

Article 23 – paragraph 6

Text proposed by the Commission

Amendment

Or. fr

Amendment 1095

Nicolás González Casares, Leire Pajín

Proposal for a regulation

Article 23 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8a. When a Member State is not participating in a joint procurement model rised by other countries, companies shall not refuse a national tender, without prejudice of the possibility of a Member State to engage the joint procurement initiative.

The existence of joint procurement does not preclude the obligations and liability that the holder of a market authorisation have under the Directive (EU) …/… [reference to be added to corresponding Article after adoption of cf. COM(2023)192 final];

Or. en

Amendment 1096

Tilly Metz

Proposal for a regulation

Article 23 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8a. For the attainment of the objectives of improving affordability, strengthening the security of supply, and safeguarding the availability of critical and commonly needed medicinal products within the Union, economic operators shall be strongly encouraged to participate in joint procurement procedures.

Or. en

Amendment 1097

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 23 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8a. The provisions of this Article shall apply, mutatis mutandis, to candidate countries that choose to participate in the procedures established herein, without prejudice to their accession negotiations or to the rights and obligations reserved to Member States under Union law.

Or. en

Amendment 1098

Christine Anderson

Proposal for a regulation

Article 23 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8a. The Commission shall, within 6 months of any joint procurement contract signature, publish a summary report assessing the cost-efficiency, delivery performance, and transparency of the process, including a comparison with decentralised procurement mechanisms.

Or. en

Amendment 1099

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

Proposal for a regulation

Article 23 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8a. Participation in the procedures provided for in Articles 21, 22 and 23 shall be optional. Any Member State may withdraw from such procedures at any time, without penalty, until the contract is awarded.

Or. fr

Amendment 1100

Tilly Metz

Proposal for a regulation

Article 23 – paragraph 8 b (new)

Text proposed by the Commission

Amendment

8b. Participation in such joint procurement shall be deemed to constitute sufficient evidence of compliance with the obligation of the marketing authorisation holder to place the medicinal product on the market in all Members Sates as laid down in Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final].

Or. en

Amendment 1101

Tilly Metz

Proposal for a regulation

Article 23 – paragraph 8 c (new)

Text proposed by the Commission

Amendment

8c. Marketing authorisation holders that participate in joint procurement procedures shall be eligible for priority inclusion in Union-level stockpiling mechanisms.

Or. en

Amendment 1102

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

Proposal for a regulation

Article 23 a (new)

Text proposed by the Commission

Amendment

Article 23a

Subscription model for the joint procurement of antimicrobials

1. The Commission and any of the Member States may engage, as contracting parties, in a joint procurement procedure conducted pursuant to Article 165(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council1a with a view to the advance purchase of antimicrobials that are considered as critical medicines or medicines of common interest.

2. A joint procurement procedure as referred to in paragraph 1 shall be preceded by a joint procurement agreement between the parties determining the practical arrangements governing the subscription model system and other procedures, including the length of the subscription contract and the possibility of parallel procurement.

3. The joint procurement agreement shall take the form of a multi-year subscription and include the following conditions:

(a) delinkage or partial delinkage of funding from the volume of sales of the antimicrobial;

(b) commitment to continuous and sufficient supply in pre-agreed quantities;

(c) commitment to the antimicrobial stewardship and access plans as referred to in Article 17(1), point (a), of [revised Directive 2001/83/EC];

(d) commitment to the environmental risk assessment as referred to in Article 22 of [revised Directive 2001/83/EC];

(e) submission of a global access plan to supply third countries in critical need, including through development partners or voluntarily licensing.

4. Participation in the joint procurement procedure shall be open to all Member States and third countries, including the European Free Trade Association States and Union candidate countries, as well as the Principality of Andorra, the Principality of Monaco, the Republic of San Marino and the Vatican City State, by way of derogation from Article 165(2) of Regulation (EU, Euratom) 2018/1046.

5. The Commission shall inform the European Parliament about procedures concerning the joint procurement of antimicrobials and, upon request, grant access to the contracts that are concluded as a result of those procedures, subject to the adequate protection of business secrecy, commercial relations and the interests of the Union. The Commission shall communicate information to the European Parliament regarding sensitive documents in accordance with Article 9(7) of Regulation (EC) No 1049/2001.

Or. en

Amendment 1103

Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 23 a (new)

Text proposed by the Commission

Amendment

Article 23a

Coordination Framework for Antimicrobials

7a. The Commission may establish a specific coordination framework for antimicrobials considered critical medicines or medicines of common interest. 7b. The coordination framework may serve as: (a) a pull incentive for the development of priority antimicrobials, as defined in [Regulation (EC) No 726/2004]; (b) a mechanism to facilitate access by Member States to antimicrobials already granted a marketing authorisation. 7c. The coordination framework shall combine: (a) the coordination of national subscription contracts; and (b) a service contract ensuring timely availability of the antimicrobial for Member States participating in a national subscription contract. 7d. The Commission shall, by means of a delegated act, lay down the detailed modalities of the coordination framework. These shall include in particular: (a) criteria and assessment methods for the evaluation of antimicrobials, including a scoring mechanism to classify products into categories; (b) value bands assigning a reference value to each category; (c) rules for calculating the EU’s fair contribution to a global PULL mechanism and the percentage share to be borne by each Member State; (d) the features of the service contracts, including their size, which shall be proportional to the number of participating Member States, and the source of financing from the general budget of the Union. 7e. The Commission shall operate the coordination framework. In particular, it shall: (a) conduct the assessment of antimicrobials and assign them to the appropriate value band; (b) implement the availability service contract; (c) calculate the financial contribution due from each participating Member State; (d) coordinate the implementation of the national subscription contracts.

Or. en

Justification

The PULL incentive mechanism for antimicrobials in Europe would function as follows:• The antimicrobial would be assessed using an evaluation grid developed with the support of the Agency (1) and assigned a value band (nominal value) (2).• Member States would decide whether to participate, and the duration of the procurement would be established.• Based on the number of participating Member States, the Commission would conclude a service contract with the MAH to ensure availability of the antimicrobial during the procurement period (3).• The value of the service contract would be deducted from the total value (4). The resulting amount would then be annualised over the procurement period and distributed among Member States according to a fair share contribution (e.g. based on GDP) (5).

Amendment 1104

Laurent Castillo

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 Articles 21, 22 and 23

Or. fr

Amendment 1105

Laurent Castillo

Proposal for a regulation

Article 24 – paragraph -1 (new)

Text proposed by the Commission

Amendment

-1. The Commission shall ensure that any procurement procedure complies with the following requirements:

(a) contracting authorities from the participating Member States agree to minimum binding quantities and take the necessary steps to ensure that a product is promptly made available to meet patient needs in their jurisdictions;

(b) commercially sensitive contractual terms are considered as trade secrets under applicable law and are protected as such;

(c) permanent regulatory flexibilities shall be granted to facilitate the process, including but not limited to the use of electronic packaging information (ePI), the harmonisation of pack sizes and labelling flexibilities;

(d) participating countries will not engage in any parallel procurement or negotiation activities related to the essential medicinal product or medicinal product of common interest that is the subject of that procurement procedure.

(e) innovation is a factor that may be taken into account when selecting products.

Or. fr

Amendment 1106

Victor Negrescu

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. Procurement procedures shall ensure that smaller Member States and SMEs can participate effectively, avoiding market distortion and ensuring equitable access to critical medicinal products.

Or. en

Amendment 1107

Marie-Luce Brasier-Clain, Aleksandar Nikolic

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. This agreement shall fully respect the competences set out in the Treaties and focus on improving the existing procedures. Consequently, any amendment to the scope of procurement agreements should be based on an impact analysis, dialogue between the competent authorities and industry, and the lessons learned from previous joint procurement experiences in the EU.

Or. fr

Amendment 1108

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

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. Such information shall, inter alia, include the arrangements established in advance of the initiation of the procurement procedures referred to in Articles 22 and 23, in particular with regard to the designation of the contracting authority, the allocation and distribution of the procured stock, and the identification of the Member States in which such stock is to be stored.

Or. en

Amendment 1109

Tilly Metz

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. Regulatory flexibilities may be granted in regards to packaging and labelling requirements, including the use of electronic package leaflets, while ensuring that patients retain the right to request paper leaflet.

Or. en

Amendment 1110

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

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. Regulatory flexibilities may be granted in regards to packaging and labelling requirements, including the use of electronic package leaflets, while ensuring that patients retain the right to request paper leaflet.

Or. en

Amendment 1111

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

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. These arrangements shall also cover, where appropriate, the designation of the contracting authority, the distribution of procured stock, and the identification of storage locations.

Or. en

Amendment 1112

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

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 including the contribution of resources, governing the procurement procedure, liabilities to be assumed and the decision-making process.

Or. en

Amendment 1113

Victor Negrescu

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. The agreement between the Commission and Member States shall include mechanisms for rapid dispute resolution, audit procedures, and clear allocation of liabilities.

Or. en

Amendment 1114

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 24 – paragraph 2 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The agreement shall include safeguards to ensure transparency of award criteria, prior publication of the planned allocation between Member States (indicative quotas), and mechanisms for the inclusion of small and medium-sized producers (lot-splitting). The agreement shall also contain clauses preventing discriminatory practices and establish a mechanism for monitoring and reviewing the consequences on competition and availability in smaller markets.

Or. en

Amendment 1115

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

Proposal for a regulation

Article 24 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Where Member States participate in procedures covered by Articles 22, 23 and 23a, they shall not undertake national or cross-border procurement procedures for the same product, nor have a running contract for that product. Member States shall also refrain from additional price negotiations.

Or. en

Amendment 1116

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

Proposal for a regulation

Article 24 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2b. The Commission shall, following a consultation with relevant stakeholders, including patients’ and consumer organizations, healthcare professionals, public healthcare payers, and marketing authorization holders, issue Union guidelines via an implementing act establishing common standards for procurement activities under Article 22 and 23 of this Regulation, ensuring predictability for companies.

Or. en

Amendment 1117

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

Proposal for a regulation

Article 24 a (new)

Text proposed by the Commission

Amendment

Article 24a

Voluntary Solidarity Mechanism

1) In order to prevent or mitigate critical shortages of critical medicinal products or medicinal products of common interest, Member States may, on a voluntary basis, activate the voluntary solidarity mechanism coordinated by the Medicines Shortages Steering Group and supported by the Commission.

2) The mechanism may be activated by a Member State only where the following conditions are met:

a) The European Medicines Agency has been notified of the critical shortage, the shortage has been brought to the attention of the Medicines Shortages SPOC Working Party, and escalated to the Medicines Shortages Steering Group (MSSG) for further EU-coordinated action;

b) There are no or insufficient therapeutic alternatives available in the Member State concerned;

c) There are insufficient quantities of the medicinal product to treat critical indications;

d) Importation of foreign stock or other short-term measures do not provide a solution in a timely manner or in sufficient quantities;

e) The situation is urgent, with a risk of stockout within one month or less.

3) Where the conditions are met and the information is complete, EMA shall, within two days, start the procedure for the solidarity mechanism and notify the members of the MSSG, and inform the European Commission, as well as the Critical Medicines Coordination Group in parallel.

4) The notified Member States shall respond to the MSSG within five days regardless of their availability to provide assistance using the template provided for in EMA/323316/2023. In case more time is needed to gather information from the concerned parties, a request for an extension of the timeline for an additional maximum of 5 working days may be sent to the MSSG Secretariat.

5) The MSSG shall also monitor the implementation of assistance provided under this article and report to the Commission and Member States

6) The European Medicines Agency shall facilitate the exchange of information between Member States, coordinate requests for support, and, where necessary, liaise with marketing authorisation holders.

7) Where appropriate, a Member State may, through the Commission’s Emergency Response Coordination Centre, request the activation of the Union Civil Protection Mechanism pursuant to Regulation (EU) 2016/369, including the mobilisation of rescEU capacities, to support the logistics and delivery of critical medicinal products and medicinal products of common interest between Member States.

8) Where the Voluntary Solidarity Mechanism is activated by a Member State, and to foster the rapid reallocation of stocks across Member States, EU and national regulations shall allow flexibility with regard to:

(a) packaging and labelling requirements;

(b) package leaflets, including the possibility for electronic package leaflets, while ensuring that patients retain the right to request paper leaflet.

9) Where the voluntary Solidarity Mechanism is activated and provided that the security of supply in the originating market is not jeopardized, manufacturers of critical medicinal products shall not be subject to sanctions if they temporarily draw on stockpiles to mitigate supply shortages in other Member States.

Or. en

Amendment 1118

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 24 a (new)

Text proposed by the Commission

Amendment

Article 24a

Revenue guarantee scheme for critical antimicrobials

1. Upon the request of at least three Member States, the Commission shall facilitate cross-border procurement incorporating a revenue guarantee scheme for antimicrobials classified as critical medicinal products or medicines of common interest. Upon the request of at three nine Member States, the Commission shall also combine the collaborative procurements referred to in Articles 22 and 23 with such a revenue guarantee scheme.

2. The revenue guarantee scheme for critical antimicrobials may serve one or more of the following purposes:

(a) to incentivise the development of priority antimicrobials, as defined in [reference to be added after adoption cf. COM(2023) 193 final];

(b) to facilitate Member States’ access to antimicrobials that have already been granted a marketing authorisation.

3. The scheme may provide for a coordinated or joint revenue guarantee independent of procurement by Member States. 4. The Commission shall establish the modalities and operational rules of the scheme by means of a delegated act, ensuring that the scheme is proportionate, transparent, and consistent with Union principles of solidarity.

Or. en

Amendment 1119

Tilly Metz

Proposal for a regulation

Article 24 a (new)

Text proposed by the Commission

Amendment

Article 24a

Specific measures applicable to antimicrobials

1. In application of Article 22, 23 and 24 and when a medicinal product of common interest concerns an antimicrobial medicinal product, the Commission should implement specific measures aiming at improved availability and accessibility. Such measures may include:

(a) a pull incentive for the development of priority antimicrobials as defined in the [revised Regulation (EC) 726/2004];

(b) a mechanism to facilitate access by Member States to antimicrobials that have already been granted a marketing authorisation.

2. Such measures may facilitate a multi-annual subscription or revenue guarantee mechanism, especially for low volume products, ensuring predictable remuneration for marketing authorisation holders in return for secure and equitable supply to participating Member States. Such contracts shall be delinked from volumes purchased, and conditional on stewardship and availability across the Union.

3. The Commission shall adopt implementing acts laying down modalities for such measures.

Or. en

Amendment 1120

Ondřej Krutílek

Proposal for a regulation

Article 24 a (new)

Text proposed by the Commission

Amendment

Article 24a

A marketing authorisation holder may offer the Commission a medicinal product for collaborative procurement according to Article 21, 22 and 23. The Commission shall inform the Member States of such offer.

Or. en

Amendment 1121

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 24 b (new)

Text proposed by the Commission

Amendment

Article 24b

Revenue guarantee scheme for orphan medicinal products

1. Upon the request of at least three Member States, the Commission shall facilitate cross-border procurement incorporating a revenue guarantee scheme for orphan medicinal products. Upon the request of at least nine Member States, the Commission may also combine such collaborative procurements with the revenue guarantee scheme.

2. The revenue guarantee scheme for orphan medicinal products may serve one or more of the following purposes:

(a) to improve market viability and incentivise the development of orphan medicinal products, as defined in [reference to be added after adoption cf. COM(2023) 193 final];

(b) to facilitate Member States’ access to orphan medicinal products that have already been granted a marketing authorisation.

3. The scheme may provide for a coordinated or joint revenue guarantee independent of procurement by Member States, taking into account the specific characteristics of orphan products and the limited patient populations.

4. The Commission shall establish the modalities and operational rules of the scheme by means of a delegated act, ensuring that the scheme is proportionate, transparent, and consistent with Union principles of solidarity.

Or. en

Amendment 1122

Tilly Metz

Proposal for a regulation

Chapter V – title

Text proposed by the Commission

Amendment

V Critical Medicines Coordination Group

V Exceptional Measures in Response to Acute Shortages and Critical Medicines Coordination Group

Or. en

Amendment 1123

Christophe Clergeau

Proposal for a regulation

Chapter V – title

Text proposed by the Commission

Amendment

V Critical Medicines Coordination Group

V Critical Medicines and Medical Countermeasures Coordination Group

Or. en

Amendment 1124

Tilly Metz

Proposal for a regulation

Article -25 (new)

Text proposed by the Commission

Amendment

Article -25

Exceptional Measures in Response to Acute Shortages

1. In the event of an acute shortage of a medicinal product, and upon notification by the European Medicines Agency (EMA) pursuant to Article 120 of Regulation (EU) 2023/193, the Commission may, by means of implementing acts, activate one or more of the exceptional measures listed in this Article, in coordination with the Critical Medicines Coordination Group established under this Act.

2. These measures may include:

(a) in accordance with Article 66 of Regulation (EU) …/… of the European Parliament and of the Council [reference to be added after adoption cf. COM(2023) 193 final]; medicinal products may be dispensed in single doses or in reduced packaging sizes, provided that the labelling particulars required under Article 66(1) and Annex IV of Regulation (EU) …/… of the European Parliament and of the Council [reference to be added after adoption cf. COM(2023) 193 final]; are preserved to the extent necessary for safe use;

(b) the restriction of dispensing and stock allocation of critical medicines to patients with the highest therapeutic priority, in accordance with guidance from the EMA and the European Health Emergency Preparedness and Response Authority (HERA);

(c) the extension of the expiry date of specific batches of a critical medicine may be extended beyond the period granted under Article 7(1) of Directive 2001/83/EC, subject to conditions ensuring quality, safety, and efficacy, in accordance with guidance from the EMA;

(d) the placing on the market and use of critical medicines presenting minor quality defects that do not compromise safety or therapeutic efficacy, in accordance with EMA assessment and the principles of Article 116 of Directive (EU) …/… [reference to be added to corresponding Article after adoption of cf. COM(2023)192 final];

3. All measures adopted under this Article shall be publicly notified, time-limited, and subject to continuous monitoring by national authorities.

Or. en

Amendment 1125

Christophe Clergeau

Proposal for a regulation

Article 25 – title

Text proposed by the Commission

Amendment

Establishment of Critical Medicines Coordination Group

Establishment of Critical Medicines and Medical Countermeasures Coordination Group

Or. en

Amendment 1126

Laurent Castillo

Proposal for a regulation

Article 25 – paragraph 1

Text proposed by the Commission

Amendment

1. A Critical Medicines Coordination Group (‘Critical Medicines Group’) is hereby established.

1. A Critical Medicines Coordination Group (‘Critical Medicines Group’) shall be established in the 12 months after this Regulation enters into force and shall meet at least twice a year.

Or. fr

Amendment 1127

Christophe Clergeau

Proposal for a regulation

Article 25 – paragraph 1

Text proposed by the Commission

Amendment

1. A Critical Medicines Coordination Group (‘Critical Medicines Group’) is hereby established.

1. A Critical Medicines and Medical Countermeasures Coordination Group (‘Critical Medicines and Medical Countermeasures Group’) is hereby established.

Or. en

Amendment 1128

Laurent Castillo

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

2. The Member States and the Commission are Members of the Critical Medicines Group. Each Member State shall appoint a maximum of two high-level permanent representatives, with the expertise relevant for implementing all the different measures set out in this Regulation. Where relevant as regards the function and expertise, Member States may appoint different representatives in relation to different tasks of the Critical Medicines Group. Appointed permanent representatives shall ensure the necessary coordination within their respective Member State. The Agency shall have an observer status.

2. The Member States, the Agency, two Members of the European Parliament and the Commission are Members of the Critical Medicines Group. Each Member State shall appoint a maximum of two high-level permanent representatives, with the expertise relevant for implementing all the different measures set out in this Regulation. Where relevant as regards the function and expertise, Member States may appoint different representatives in relation to different tasks of the Critical Medicines Group. Appointed national permanent representatives shall ensure the necessary coordination within their respective Member State. The Agency shall appoint two permanent representatives from the Critical Medicines Alliance. The Critical Medicines Group shall appoint two permanent representatives of patients’ associations. Other stakeholders may also be invited occasionally following a proposal by a Member of the Critical Medicines Group.

Or. fr

Amendment 1129

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

The Critical Medicines Group shall also include representatives from patient and consumer organisations, including women's health organisations as well as healthcare professionals involved in the selection, procurement, management, administration and monitoring of medicinal products.

Or. en

Amendment 1130

Tilly Metz

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1131

Michele Picaro, Ruggero Razza

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

2. 2. The Member States, the Agency and the Commission are Members of the Critical Medicines Group. Each Member State shall appoint a maximum of two high-level permanent representatives, with the expertise relevant for implementing all the different measures set out in this Regulation. Where relevant as regards the function and expertise, Member States may appoint different representatives in relation to different tasks of the Critical Medicines Group. Appointed national permanent representatives shall ensure the necessary coordination within their respective Member State. The Agency shall appoint two members of the MSSG as permanent representatives. The Critical Medicines Group shall appoint two permanent representatives from patient organisations and two permanent representatives from healthcare professionals.

Or. en

Amendment 1132

Aurelijus Veryga

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

2. The Member States and the Commission are Members of the Critical Medicines Group. Each Member State shall appoint a maximum of two high-level permanent representatives, with the health expertise relevant for implementing all the different measures set out in this Regulation. Where relevant as regards the function and expertise, Member States may appoint different representatives in relation to different tasks of the Critical Medicines Group. Appointed permanent representatives shall ensure the necessary coordination within their respective Member State. The Agency shall have an observer status.

The Critical Medicines Group shall also include two permanent representatives, one from patient organisations and one from healthcare professional organisations.

Or. en

Amendment 1133

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1134

Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1135

Nikos Papandreou

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1136

Oliver Schenk

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1137

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

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

Or. fr

Amendment 1138

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

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

2. The Member States and the Commission, represented by DG HERA, are Members of the Critical Medicines Group. Each Member State shall appoint a maximum of two high-level permanent representatives, with the expertise relevant for implementing all the different measures set out in this Regulation. Where relevant as regards the function and expertise, Member States may appoint different representatives in relation to different tasks of the Critical Medicines Group. Appointed permanent representatives shall ensure the necessary coordination within their respective Member State. The Agency and the European Parliament shall have an observer status.

Or. en

Amendment 1139

Christophe Clergeau

Proposal for a regulation

Article 25 – paragraph 2

Text proposed by the Commission

Amendment

2. The Member States and the Commission are Members of the Critical Medicines and Medical Countermeasures Group. Each Member State shall appoint a maximum of two high-level permanent representatives, with the expertise relevant for implementing all the different measures set out in this Regulation. Where relevant as regards the function and expertise, Member States may appoint different representatives in relation to different tasks of the Critical Medicines and Medical Countermeasures Group. Appointed permanent representatives shall ensure the necessary coordination within their respective Member State. The Agency shall have an observer status.

Or. en

Amendment 1140

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

Article 25 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. To ensure that decisions reflect the needs and experience of frontline healthcare professionals, the Critical Medicines Coordination Group should include a permanent and qualified representation of doctors, pharmacists, patient and consumer associations and other health professionals, as well as representatives of Member States and the Commission.

Or. en

Amendment 1141

Tilly Metz

Proposal for a regulation

Article 25 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Members of the Critical Medicines Coordination Group shall not have financial or other conflict of interest which could affect their impartiality. They shall be obliged to publicly report their financial and other interests relevant to the work of the Critical Medicines Coordination Group.

Or. en

Amendment 1142

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

Proposal for a regulation

Article 25 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Members of the Critical Medicines Group shall not have financial or other conflict of interests which could affect their impartiality. They shall undertake to act in the public interest and in an independent manner, and shall make an annual declaration of their financial interests.

Or. en

Amendment 1143

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

Proposal for a regulation

Article 25 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2b. The list of Members of the Critical Medicines Group shall be publicly available.

Or. en

Amendment 1144

Laurent Castillo

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

3. The Critical Medicines Group shall work closely with the MSSG, the Agency, and national authorities responsible for medicinal products. For discussions where input from the medicines regulatory authorities’ perspective is necessary, the Critical Medicines Group may organise joint meetings with the MSSG.

3. The Critical Medicines Group shall work closely with the MSSG, the Agency, the marketing authorisation holders, national authorities responsible for medicinal products and any other relevant public and private stakeholders. For discussions where input from the medicines regulatory authorities’ perspective is necessary, the Critical Medicines Group may organise joint meetings with the MSSG and the Critical Medicines Group. The Critical Medicines Group shall consult representatives of the medicinal product manufacturers in its work.

Or. fr

Amendment 1145

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

3. The Critical Medicines Group shall work closely with the MSSG, the Agency, and national authorities responsible for medicinal products. Where relevant they shall ensure the structured involvement of patient representatives and advocates, and civil society stakeholders, including pharmacists, doctors, and nurses. For discussions where input from the medicines regulatory authorities’ perspective is necessary, the Critical Medicines Group may organise joint meetings with the MSSG.

Or. en

Amendment 1146

Aurelijus Veryga

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1147

András Tivadar Kulja

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1148

Stine Bosse, Billy Kelleher

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1149

Radan Kanev

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

3. The Critical Medicines Group shall work closely with the relevant marketing authorisation holders, MSSG, the Agency, and national authorities responsible for medicinal products. For discussions where input from the medicines regulatory authorities’ perspective is necessary, the Critical Medicines Group may organise joint meetings with the MSSG.

Or. en

Amendment 1150

Christophe Clergeau

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

3. The Critical Medicines and Medical Countermeasures Group shall work closely with the MSSG, the Agency, the ECDC, and national authorities responsible for medicinal and medical products. For discussions where input from the medicines regulatory authorities’ perspective is necessary, the Critical Medicines and Medical Countermeasures Group may organise joint meetings with the MSSG.

Or. en

Amendment 1151

Dan-Ştefan Motreanu

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

3. The Critical Medicines Group shall work closely with the MSSG, the Agency, national authorities responsible for medicinal products and the relevant marketing authorisation holders. For discussions where input from the medicines regulatory authorities’ perspective is necessary, the Critical Medicines Group may organise joint meetings with the MSSG.

Or. en

Amendment 1152

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

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

3. The Critical Medicines Group shall work closely with the MSSG, the Agency, relevant marketing authorisation holders and national authorities responsible for medicinal products. For discussions where input from the medicines regulatory authorities’ perspective is necessary, the Critical Medicines Group may organise joint meetings with the MSSG.

Or. en

Amendment 1153

Radan Kanev

Proposal for a regulation

Article 25 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall organise and coordinate the work of the Critical Medicines Group by means of the Secretariat.

4. The Commission shall organise and coordinate the work of the Critical Medicines Group by means of the Secretariat. Meetings of the Critical Medicines Group shall be convened by the Commission on a regular basis.

Or. en

Justification

This group should act as a technical coordination platform rather than a centralized regulatory authority, ensuring that its role remains supportive and non-duplicative. To enhance the effectiveness and practicality of the measures discussed, structured and regular opportunities should be provided for industry stakeholders to contribute input, particularly concerning the feasibility of proposed actions, realistic implementation timelines, and potential supply chain challenges. Furthermore, it is critical to maintain coherence with the existing mandates of EMA and HERA, to prevent overlap, reduce regulatory fragmentation, and support efficient policy execution.

Amendment 1154

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

Proposal for a regulation

Article 25 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall organise and coordinate the work of the Critical Medicines Group by means of the Secretariat.

4. The Commission shall organise and coordinate the work and organise regular meetings of the Critical Medicines Group by means of the Secretariat.

Or. en

Amendment 1155

Christophe Clergeau

Proposal for a regulation

Article 25 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall organise and coordinate the work of the Critical Medicines Group by means of the Secretariat.

4. The Commission shall organise and coordinate the work of the Critical Medicines and Medical Countermeasures Group by means of the Secretariat.

Or. en

Amendment 1156

Laurent Castillo

Proposal for a regulation

Article 25 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall organise and coordinate the work of the Critical Medicines Group by means of the Secretariat.

4. The Commission shall organise and coordinate the work of the Critical Medicines Group by means of the Secretariat on a regular basis.

Or. fr

Amendment 1157

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

Proposal for a regulation

Article 25 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall organise and coordinate the work of the Critical Medicines Group by means of the Secretariat.

4. The Commission shall organise regular meetings and coordinate the work of the Critical Medicines Group by means of the Secretariat.

Or. en

Amendment 1158

Dan-Ştefan Motreanu

Proposal for a regulation

Article 25 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall organise and coordinate the work of the Critical Medicines Group by means of the Secretariat.

4. The Commission shall organise regular meetings and coordinate the work of the Critical Medicines Group by means of the Secretariat.

Or. en

Amendment 1159

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

Proposal for a regulation

Article 25 – paragraph 5

Text proposed by the Commission

Amendment

5. A representative of the Commission shall chair the meetings of the Critical Medicines Group.

5. A representative of a Member State, assisted by a representative of the Commission, shall chair the meetings of the Critical Medicines Group in rotation.

Or. fr

Amendment 1160

Ondřej Krutílek

Proposal for a regulation

Article 25 – paragraph 5

Text proposed by the Commission

Amendment

5. A representative of the Commission shall chair the meetings of the Critical Medicines Group.

5. A representative of the Member States and a representative of the Commission shall co- chair the meetings of the Critical Medicines Group.

Or. en

Amendment 1161

Christophe Clergeau

Proposal for a regulation

Article 25 – paragraph 5

Text proposed by the Commission

Amendment

5. A representative of the Commission shall chair the meetings of the Critical Medicines Group.

5. A representative of the Commission shall chair the meetings of the Critical Medicines and Medical Countermeasures Group.

Or. en

Amendment 1162

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

Proposal for a regulation

Article 25 – paragraph 6

Text proposed by the Commission

Amendment

6. The Critical Medicines Group, at the proposal of the Chair or any its members, may decide to establish a working group.

6. The Critical Medicines Group shall organise biannual meetings with the Critical Medicines Alliance to exchange information on vulnerabilities in supply chains and on mitigation measures to address structural risks and reinforce supply.

Or. en

Amendment 1163

Christophe Clergeau

Proposal for a regulation

Article 25 – paragraph 6

Text proposed by the Commission

Amendment

6. The Critical Medicines Group, at the proposal of the Chair or any its members, may decide to establish a working group.

6. The Critical Medicines and Medical Countermeasures Group, at the proposal of the Chair or any its members, may decide to establish a working group.

Or. en

Amendment 1164

Ondřej Krutílek

Proposal for a regulation

Article 25 – paragraph 6

Text proposed by the Commission

Amendment

6. The Critical Medicines Group, at the proposal of the Chair or any its members, may decide to establish a working group.

6. The Critical Medicines Group, at the proposal of the co-Chair or any its members, may decide to establish a working group.

Or. en

Amendment 1165

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

Proposal for a regulation

Article 25 – paragraph 6 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The Critical Medicines Group shall have biannual meetings to consult with the Critical Medicines Alliance and additional meetings when needed.

Or. en

Amendment 1166

Dan-Ştefan Motreanu

Proposal for a regulation

Article 25 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6a. The Critical Medicines Group shall have biannual meetings to consult with the Critical Medicines Alliance and additional meetings when needed.

Or. en

Amendment 1167

Ondřej Krutílek

Proposal for a regulation

Article 25 – paragraph 7

Text proposed by the Commission

Amendment

7. The Critical Medicines Group shall use its best endeavours to reach consensus, where possible. Members with diverging positions may request that their positions and the grounds on which they are based be recorded in the Critical Medicines Group’s position.

7. The Critical Medicines Group shall use its best endeavours to reach consensus

Or. en

Amendment 1168

Christophe Clergeau

Proposal for a regulation

Article 25 – paragraph 7

Text proposed by the Commission

Amendment

7. The Critical Medicines and Medical Countermeasures Group shall use its best endeavours to reach consensus, where possible. Members with diverging positions may request that their positions and the grounds on which they are based be recorded in the Critical Medicines and Medical Countermeasures Group’s position.

Or. en

Amendment 1169

Victor Negrescu

Proposal for a regulation

Article 25 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7a. The Critical Medicines Group shall ensure that the perspectives of patients are duly taken into account. To this end, it shall establish structured consultation mechanisms with patient organisations at Union level, in particular when discussing measures likely to impact access to critical medicinal products.

Or. en

Amendment 1170

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 25 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7a. Members of the Critical Medicines Group shall not hold any financial or other interests that could compromise their independence or impartiality. The composition of the Group shall be made publicly available.

Or. en

Amendment 1171

Victor Negrescu

Proposal for a regulation

Article 25 – paragraph 7 b (new)

Text proposed by the Commission

Amendment

7b. The Critical Medicines Group shall establish and maintain a Strategic Project Foresight process, including periodic horizon-scanning and scenario analysis, in order to identify emerging or likely future vulnerabilities affecting critical medicinal products and their key inputs. The Critical Medicines Group shall publish, at least annually, a Foresight Note indicating indicative priority areas for strategic projects.

Or. en

Amendment 1172

Oliver Schenk

Proposal for a regulation

Article 25 a (new)

Text proposed by the Commission

Amendment

Article 25a

Integration of findings from the Critical Medicines Alliance

1.The findings already obtained, as well as those to be developed in the future by the established Critical Medicines Alliance, shall be taken into account and actively incorporated into the work of the Critical Medicines Group, where relevant and in accordance with relevant Union or national law.

2. The Commission, in its role as the secretariat of the Critical Medicines Group, shall ensure regular, targeted and transparent communication with the Critical Medicines Alliance.

Or. en

Amendment 1173

Christophe Clergeau

Proposal for a regulation

Article 26 – title

Text proposed by the Commission

Amendment

Tasks of the Critical Medicines Coordination Group

Tasks of the Critical Medicines and Medical Countermeasures Coordination Group

Or. en

Amendment 1174

Nikos Papandreou

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the Commission

Amendment

1. The Critical Medicines Group shall facilitate coordination in the implementation of this Regulation and, where appropriate, advise the Commission, so as to maximise the impact of the measures envisaged and to avoid any unintended effects on the internal market.

Or. en

Amendment 1175

Radan Kanev

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

There are predictable effects on national healthcare (incl. pharmaceutical) policies and budgets

Amendment 1176

Kristian Vigenin

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1177

Christophe Clergeau

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the Commission

Amendment

1. The Critical Medicines and Medical Countermeasures Group shall facilitate coordination in the implementation of this Regulation and, where appropriate, advise the Commission, so as to maximise the impact of the measures envisaged and to avoid any unintended effects on the internal market.

Or. en

Amendment 1178

András Tivadar Kulja

Proposal for a regulation

Article 26 – paragraph 1 – point 1 (new)

Text proposed by the Commission

Amendment

(1) 6. The Critical Medicines Coordination Group shall include in its rules of procedure, provisions for the systematic consultation of EU and national patient organisations and other relevant stakeholder to encourage the exchange of information about the working group’s activities and promote transparency.

Or. en

Amendment 1179

Christophe Clergeau

Proposal for a regulation

Article 26 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. In order to attain the objectives referred to in paragraph 1, the Critical Medicines Group shall perform the following tasks:

2. In order to attain the objectives referred to in paragraph 1, the Critical Medicines and Medical Countermeasures Group shall perform the following tasks:

Or. en

Amendment 1180

Emmanouil Fragkos

Proposal for a regulation

Article 26 – paragraph 2 – point α

Text proposed by the Commission

Amendment

a. facilitate coordination on strategic orientation of the financial support for strategic projects, including by exchanging information on the manufacturing capacity for a given critical medicinal product, existing or planned, in the Member States and facilitate discussion on the capacity needed in the Union to strengthen its supply security and availability of critical medicinal products within the Union;

Or. el

Amendment 1181

Radan Kanev

Proposal for a regulation

Article 26 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) facilitate coordination on strategic orientation of the financial support for strategic projects, including by exchanging information on the manufacturing capacity for a given critical medicinal product, existing or planned, in the Member States and facilitate discussion on the capacity needed in the Union to strengthen its supply security and availability of critical medicinal products within the Union;

Or. en

Justification

Funding in support of strategic projects should be provided through common European funds, rather at the expense of national healthcare budgets, which are allocated for specific national healthcare needs.

Amendment 1182

Laurent Castillo

Proposal for a regulation

Article 26 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) facilitate coordination on strategic orientation of the financial support for strategic projects, in particular by reporting on the application of national and EU funding and by exchanging information on the manufacturing capacity for a given critical medicinal product, existing or planned, in the Member States and facilitate discussion on the capacity needed in the Union to strengthen its supply security, sustainability and availability of critical medicinal products, active substances and key inputs within the Union;

Or. fr

Amendment 1183

Christophe Clergeau

Proposal for a regulation

Article 26 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) facilitate coordination on strategic orientation of the financial support for strategic projects, including by exchanging information on the manufacturing capacity for a given critical medicinal product or critical medical countermeasure, existing or planned, in the Member States and facilitate discussion on the capacity needed in the Union to strengthen its supply security and availability of critical medicinal products and critical medical countermeasures within the Union;

Or. en

Amendment 1184

Ondřej Krutílek

Proposal for a regulation

Article 26 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) facilitate coordination based on the Union investment strategy for critical medicinal products on strategic orientation of the financial support for strategic projects, including by exchanging information on the manufacturing capacity for a given critical medicinal product, existing or planned, in the Member States and facilitate discussion on the capacity needed in the Union to strengthen its supply security and availability of critical medicinal products within the Union;

Or. en

Amendment 1185

Dolors Montserrat, Elena Nevado del Campo

Proposal for a regulation

Article 26 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) facilitate coordination on strategic orientation of the financial support for strategic projects, including by exchanging information on the manufacturing capacity for a given critical medicinal product, existing or planned, in the Member States as well as critical distribution infrastructure capacity and facilitate discussion on the capacity needed in the Union to strengthen its supply security and availability of critical medicinal products within the Union;

Or. en

Justification

This amendment ensures the Critical Medicines Group considers not only manufacturing but also the infrastructure needed to store and distribute critical medicines. Without adequate warehousing and distribution, higher production cannot improve availability. It reflects the interdependence of manufacturing and logistics, ensuring strategic planning under the Critical Medicines Act covers the full supply chain.

Amendment 1186

Margarita de la Pisa Carrión

Proposal for a regulation

Article 26 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) facilitate coordination on strategic orientation of the financial support for strategic projects, including by exchanging information on the manufacturing capacity for a given critical medicinal product, existing or planned, in the Member States as well as critical distribution infrastructure capacity and facilitate discussion on the capacity needed in the Union to strengthen its supply security and availability of critical medicinal products within the Union;

Or. en

Amendment 1187

Kristian Vigenin

Proposal for a regulation

Article 26 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) facilitate coordination on the financial support for strategic projects, including by exchanging information on the manufacturing capacity for a given critical medicinal product, existing or planned, in the Member States and facilitate discussion on the capacity needed in the Union to strengthen its supply security and availability of critical medicinal products within the Union;

Or. en

Justification

The wording by COM is unclear and unnecessary complicated

Amendment 1188

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(aa) facilitate the development and implementation of cross-border strategic projects;

Or. en

Amendment 1189

Radan Kanev

Proposal for a regulation

Article 26 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) facilitate exchanges on the national programmes referred to in Article 19 and enable cooperation on and coordination of Member States public procurement policies with regard to critical medicinal products;

Or. en

Justification

The idea is to limit the exchange to best practice solutions that may inspire national policies, rather than to create a burdensome reporting mechanism of no clear value, or attempt coordination of procurement policies. National procurements are adapted to national needs and budgets: the purpose of these procedures is not alignment with Union level goals but with patients’ needs at national level.

Amendment 1190

Ondřej Krutílek

Proposal for a regulation

Article 26 – paragraph 2 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 1191

Christophe Clergeau

Proposal for a regulation

Article 26 – paragraph 2 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 1192

Kristian Vigenin

Proposal for a regulation

Article 26 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) facilitate exchanges on the national programmes referred to in Article 19 and enable voluntary cooperation on and coordination of Member States public procurement policies with regard to critical medicinal products;

Or. en

Amendment 1193

Laurent Castillo

Proposal for a regulation

Article 26 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) facilitate discussion of the need for a collaborative procurement initiative for a given medicinal product, active substance or key input;

Or. fr

Amendment 1194

Christophe Clergeau

Proposal for a regulation

Article 26 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) facilitate discussion of the need for a collaborative procurement initiative for a given medicinal product or medical product;

Or. en

Amendment 1195

Tilly Metz

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ca) issue guidelines on measures to support affordability in the Union market of critical medicinal products that received financial support for strategic projects;

Or. en

Amendment 1196

Sebastian Everding

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ca) involve additional stakeholders, committees and experts, such as the EMA, EFSA, the Eurogroup for Animals and the EESC;

Or. de

Amendment 1197

Christophe Clergeau

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ca) perform vulnerability evaluation in the supply chain of a given critical medical countermeasure;

Or. en

Amendment 1198

Tilly Metz

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(cb) examine the Union-wide financial needs of strategic projects and advise on the coordination of financing by the Union, the Member States, the European Investment Bank or other international financial institutions, including the European Bank for Reconstruction and Development, and the private sector;

Or. en

Amendment 1199

Tilly Metz

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(cc) regularly issue recommendations on how to ensure adequate financing, including from the Union budget, for the achievement of the objectives of this Regulation;

Or. en

Amendment 1200

Tilly Metz

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) advise the Commission and the national competent authorities on the activation of one or more of the exceptional measures referred to in Article -25 in the following ways:

(i) assess the criticality and the therapeutic importance of the medicinal product concerned;

(ii) provide recommendations to the Commission and the national competent authorities on the appropriate exceptional measures to be adopted;

(iii) monitor the implementation and the effectiveness of the measures adopted pursuant to this Article; and

(iiii) facilitate coordination among Member States in order to ensure equitable access to critical medicines.

Or. en

Amendment 1201

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

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) facilitate discussion and exchange among members of the Critical Medicines Coordination Group and, where appropriate, coordinate and exchange with the EU stockpiling network in relation to Article 20 of this Regulation, specifically sharing best practices in stock management, including real-time tracking, condition monitoring, expiry alerts, stock rotation, shelf-life and waste management, including waste reduction facilities, and evaluations where necessary;

Or. en

Amendment 1202

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 26 – paragraph 2 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The Critical Medicines Group shall ensure transparency in the implementation of this Regulation. This shall include, where appropriate, the publication of meeting agendas and outcomes, public reporting on strategic orientations and decisions, and the consultation of relevant stakeholders, including patient representatives, healthcare professionals, and civil society organisations.

Or. en

Amendment 1203

Radan Kanev

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) facilitate structured dialogue discussions with marketing authorization holders and other relevant stakeholders [BB1] on a regular basis, in particular to discuss the feasibility and effectiveness of measures adopted under this Regulation in light of the objectives thereof including implementation timelines, supply chain and other constraints imposed under this Regulation.

Or. en

Justification

Regular, structured discussions with marketing authorization holders ensure that proposed measures are realistic, align with industry capabilities, and account for and are proportionate to the actual supply chain and access constraints. It helps build consensus, improve implementation planning, and avoid unintended disruptions, ultimately strengthening the availability and resilience of critical medicines and accessibility of medicinal products of common interest.

Amendment 1204

Dario Tamburrano, Valentina Palmisano

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) supports the Commission, where relevant, in its dialogue with Member States on national security of supply measures with a view to identifying coordinated solutions that make full use of and protect the proper functioning of the internal market;

Or. en

Amendment 1205

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

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) ensure that third-country manufacturers exporting to the Union comply with standards equivalent to those applicable in the Union for imported critical medicinal products, active pharmaceutical ingredients and key inputs.

Or. fr

Amendment 1206

Sirpa Pietikäinen

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) support the Commission, where relevant, in the dialogue with Member States concerning national measures on security of supply with a view to identifying coordinated solutions that fully leverage the functioning of the internal market.

Or. en

Amendment 1207

Nikos Papandreou

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) The Group shall hold at least one annual stakeholder meeting with marketing authorisation holders, manufacturers (including off-patent sector), wholesalers, patient groups, and healthcare providers;

Or. en

Amendment 1208

Laurent Castillo

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) facilitate the development of strategic projects, including cross-border projects, and develop a harmonised framework for applications for strategic project funding.

Or. fr

Amendment 1209

Dan-Ştefan Motreanu

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) maintain a centralised mapping of Union-wide manufacturing, storage and distribution capacities for critical medicinal products, updated on a regular basis;

Or. en

Amendment 1210

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

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(da) draw up a list of medicinal products whose supply chain is vulnerable.

Or. fr

Amendment 1211

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

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(db) assess national stockpiling strategies, their proportionality, compatibility with the internal market, and feasibility for implementation by industry, and shall, where appropriate, issue recommendations on Union-wide minimum standards;

Or. en

Amendment 1212

Dan-Ştefan Motreanu

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(db) define, where appropriate, minimum indicative production targets for categories of critical medicinal products, taking into account European demand, supply chain vulnerabilities and risks of discontinuity;

Or. en

Amendment 1213

Laurent Castillo

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(db) be a point for exchange by organising a structured dialogue with marketing authorisation holders at least twice a year.

Or. fr

Amendment 1214

Dan-Ştefan Motreanu

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(dc) identify gaps in capacity at national or regional level and recommend corrective interventions or targeted investment priorities to address such gaps;

Or. en

Amendment 1215

Laurent Castillo

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(dc) be consulted on the cumulative impact of different laws on implementing and achieving the objectives of the draft regulation.

Or. fr

Amendment 1216

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

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(dc) establish the process for the strategic foresight report;

Or. en

Amendment 1217

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

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(dd) prepare the annual strategic foresight report on strategic projects;

Or. en

Amendment 1218

Radan Kanev

Proposal for a regulation

Article 26 – paragraph 3

Text proposed by the Commission

Amendment

3. The Critical Medicines Group shall enable the exchanges of information between the Member States and the Commission as referred to in Article 17 and shall enable, where necessary, a coordination of respective actions aiming to attain the objectives of this Regulation.

3. The Critical Medicines Group shall enable the exchanges of information between the Member States and the Commission as referred to in Article 17.

Or. en

Amendment 1219

Christophe Clergeau

Proposal for a regulation

Article 26 – paragraph 3

Text proposed by the Commission

Amendment

3. The Critical Medicines and Medical Countermeasures Group shall enable the exchanges of information between the Member States and the Commission as referred to in Article 17 and shall enable, where necessary, a coordination of respective actions aiming to attain the objectives of this Regulation.

Or. en

Amendment 1220

Leire Pajín

Proposal for a regulation

Article 26 – paragraph 4

Text proposed by the Commission

Amendment

4. The Critical Medicines Group shall periodically discuss the potential contribution of strategic partnerships to the objectives of this Regulation, prioritisation of third countries for this purpose, and the consistency and potential synergies between Member States’ cooperation with relevant third countries and the actions carried out by the Union. In its assessment, the Group shall take into account the Union’s commitments to sustainable development and global health, in particular the objectives set out in Article 208 of the Treaty on the Functioning of the European Union, the United Nations Sustainable Development Goals, and the EU Global Health Strategy, including strengthening local manufacturing capacities in partner countries, in line with the Team Europe MAV+ initiative.

Or. en

Amendment 1221

Victor Negrescu

Proposal for a regulation

Article 26 – paragraph 4

Text proposed by the Commission

Amendment

4. The Critical Medicines Group shall periodically discuss the potential contribution of strategic partnerships to the objectives of this Regulation, prioritisation of third countries for this purpose, and the consistency and potential synergies between Member States’ cooperation with relevant third countries and the actions carried out by the Union. Strategic partnerships with third countries shall complement, not replace, the strengthening of EU-based production capacities, with priority given to projects that enhance the Union’s autonomy and resilience in critical medicinal product supply.

Or. en

Amendment 1222

Christophe Clergeau

Proposal for a regulation

Article 26 – paragraph 4

Text proposed by the Commission

Amendment

4. The Critical Medicines and Medical Countermeasures Group shall periodically discuss the potential contribution of strategic partnerships to the objectives of this Regulation, prioritisation of third countries for this purpose, and the consistency and potential synergies between Member States’ cooperation with relevant third countries and the actions carried out by the Union.

Or. en

Amendment 1223

Laurent Castillo

Proposal for a regulation

Article 26 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall consult the Critical Medicines Group to assess the potential contribution of strategic partnerships to the objectives of this Regulation, prioritisation of third countries for this purpose, and the consistency and potential synergies between Member States’ cooperation with relevant third countries and the actions carried out by the Union.

Or. fr

Amendment 1224

Radan Kanev

Proposal for a regulation

Article 26 – paragraph 5

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Such opinions on Commission request on a file of such a broad scope may have an impact on national competences.

Amendment 1225

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

Proposal for a regulation

Article 26 – paragraph 5

Text proposed by the Commission

Amendment

5. The Critical Medicines Group, at the Commission’s request, may provide an opinion on matters related to the application of this Regulation in the context of performing tasks as referred to in this Article. In particular, the Critical Medicines Group shall assess the Union-wide financial needs of strategic projects and issue recommendations on how to ensure adequate financing, including through the Union budget, in order to support the achievement of the objectives of this Regulation.

Or. en

Amendment 1226

Christophe Clergeau

Proposal for a regulation

Article 26 – paragraph 5

Text proposed by the Commission

Amendment

5. The Critical Medicines and Medical Countermeasures Group, at the Commission’s request, may provide an opinion on matters related to the application of this Regulation in the context of performing tasks as referred to in this Article.

Or. en

Amendment 1227

Kristian Vigenin

Proposal for a regulation

Article 26 – paragraph 5

Text proposed by the Commission

Amendment

5. The Critical Medicines Group may provide an opinion on matters related to the application of this Regulation in the context of performing tasks as referred to in this Article.

Or. en

Justification

CMG should be able to provide opinions, should it wishes so, not only at the request of the Commission

Amendment 1228

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

Proposal for a regulation

Article 26 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. The Critical Medicines Group shall write an annual progress report on strategic projects established within the Union and submit it to the European Parliament and Member States. The report shall as a minimum include:

(a) the number and nature of projects confirmed, supported, or recommended by the Critical Medicines Group under this Regulation;

(b) data on the number of new manufacturing sites opened or modernised within the Union and the number of existing manufacturing lines extended;

Or. en

Amendment 1229

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 26 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. The Critical Medicines Coordination Group shall include in its rules of procedure, provisions for the systematic consultation of EU and national patient organisations, healthcare professionals and other relevant stakeholder encouraging the exchange of information about the working group’s activities in order to promote transparency and improve efficient policy making decisions.

Or. en

Amendment 1230

Aurelijus Veryga

Proposal for a regulation

Article 26 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. The Critical Medicines Coordination Group shall ensure the systematic consultation of Union and national patient organisations and other relevant stakeholders, in order to facilitate the exchange of information on the Group’s activities and to promote transparency.

Or. en

Amendment 1231

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

Proposal for a regulation

Article 26 a (new)

Text proposed by the Commission

Amendment

Article 26a

Strategic Foresight on Critical Medicinal Products

1. In order to strengthen the Union’s preparedness and ensure a coordinated approach to future challenges in the supply of critical medicinal products, the Critical Medicines Group shall establish a strategic foresight process.

2. The strategic foresight process shall be established after consultation with the Commission, the European Medicines Agency, and the Critical Medicines Alliance.

3. The strategic foresight process shall identify and assess potential strategic projects, taking into account long-term trends, vulnerabilities, opportunities for enhancing the resilience and sustainability of supply chains within the Union and patients unmet medical needs.

4. The Critical Medicines Group shall prepare the report and communicate it to the Commission, Agency and European Parliament

5. Following the preparation of the foresight report, the Critical Medicines Group shall make recommendations to the Commission and Member States on actions to be taken, including the identification and support of projects. Where there is a need to strategically reserve manufacturing capacity, recommendations shall specifically include proposals for strategic projects pursuant to Article 5(2), for the production of specific pharmaceutical forms, active substances, key inputs, or technologies within a defined timeframe.

Or. en

Amendment 1232

Oliver Schenk

Proposal for a regulation

Article 27 – title

Text proposed by the Commission

Amendment

Strategic partnerships

International cooperation and strategic partnerships

Or. en

Amendment 1233

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

A list of countries and manufacturers that meet European safety and quality regulatory standards for import of medicinal products, including key inputs and active substances, shall be made public and accessible by the Commission to contracting authorities and healthcare professionals, in particular those involved in selecting, procuring, prescribing, managing, dispensing, and monitoring such products.

The list should be annually updated and, in case of relevant breach with the compliance of the European safety and quality standards, the Commission shall revise the current list and duly inform Member States and all contracting parties of the decisions adopted.

Or. en

Amendment 1234

Nikos Papandreou

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Without prejudice to the prerogatives of the Council, the Commission, shall conclude and further develop strategic partnerships aiming to diversify sourcing of critical medicinal products, their active substances, key inputs and critical raw materials, thereby increasing the security of supply of critical medicinal products in the Union. In doing so, the Commission shall prioritise partnerships which: (a) foster the development of resilient and transparent supply chains for active pharmaceutical ingredients and other key inputs; (b) encourage investment in manufacturing and research capacity in accession and candidate countries that complement Union production capabilities and strengthen shared supply-chain resilience; (c) promote cooperation on regulatory convergence and crisis-response mechanisms to prevent export restrictions during public health emergencies; and (d) reinforce efforts to build on existing forms of cooperation to expand the production of critical medicinal products and their inputs within the Union and its partner countries. The Commission shall also ensure that strategic partnerships include, where appropriate, provisions on health security and open trade, and reflect the Union’s broader industrial and security objectives.

Or. en

Amendment 1235

Leire Pajín

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Without prejudice to the prerogatives of the Council, the Commission, shall explore possibilities of concluding strategic partnerships aiming to diversify sourcing of critical medicinal products, their active substances and key inputs to increase the security of supply of critical medicinal products in the Union. The Commission shall also explore the possibility of building on existing forms of cooperation, when possible, to support security of supply and reinforce efforts to strengthen the production of critical medicinal products in the Union. Such partnerships shall also (a) promote improved and equitable access to critical medicines in third countries, especially low- and middle-income countries, by supporting sustainable local manufacturing and capacity-building initiatives, in close collaboration with local authorities; (b) assess the distributional impact of these interventions in partner countries and local communities, as well as availability and affordability of critical medicines, through rigorous evidence-based frameworks and monitorable indicators; (c) facilitate technology transfer and voluntary licensing consistent with EU and international law; (d) develop joint procurement or pooled purchasing pilots with regional bodies;

Or. en

Amendment 1236

Laurent Castillo

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Without prejudice to the prerogatives of the Council, the Commission, shall explore possibilities of concluding strategic partnerships aiming to diversify sourcing of critical medicinal products, medicinal products of common interest, their active substances and key inputs to increase the security of supply of critical medicinal products in the Union. The Commission shall also explore the possibility of building on existing forms of cooperation, when possible, to support security of supply and reinforce efforts to strengthen the production of critical medicinal products in the Union. The strategic partnerships shall guarantee that the Union takes priority in export markets and shall include robust guarantees of cooperation in the event of health crises. They shall also include cooperation on scientific research. In order to ensure fair competition and prevent any disadvantages for EU producers, the Commission shall promote, as far as possible, regulatory convergence of the third country's legislation following an accurate assessment of differences in production standards, especially with regard to social and environmental matters.

Or. fr

Amendment 1237

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

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

The Commission shall seek in its international agreements the inclusion of provision for information exchange and cooperation in monitoring medicine shortages in order to facilitate and increase cooperation between member states and third states and shortage prevention information exchanges.

The Commission shall cooperate with the WHO and Member states, in order to promote world-wide enhanced cooperation between Member states and third states on information exchange for preventing shortages of critical medicines and monitoring supply chains.

Or. en

Amendment 1238

Aurelijus Veryga

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Without prejudice to the prerogatives of the Council, the Commission, shall explore possibilities of concluding strategic partnerships aiming to diversify sourcing of critical medicinal products, their active substances and key inputs to increase the security of supply of critical medicinal products in the Union. The Commission shall also explore the possibility of building on existing forms of cooperation, when possible, to support security of supply and reinforce efforts to strengthen the production of critical medicinal products in the Union. As part of these partnerships, the Commission shall promote a collaborative innovation ecosystem that integrates small and medium-sized enterprises, start-ups and deep-tech innovators alongside established pharmaceutical companies in order to enhance resilience, foster technological advancement and boost the competitiveness of the Union’s pharmaceutical sector.

Or. en

Amendment 1239

Ingeborg Ter Laak

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Without prejudice to the prerogatives of the Council, the Commission, shall explore possibilities of concluding strategic partnerships aiming to diversify sourcing of critical medicinal products, their active substances and key inputs to increase the security of supply of critical medicinal products in the Union. The Commission shall also explore the possibility of building on existing forms of cooperation, when possible, to support security of supply and reinforce efforts to strengthen the production of critical medicinal products in the Union. Diversification through international partnerships shall be the first course of action, as it can provide timely and effective solutions. The Commission shall also engage in structured dialogue with third countries and regularly submit to the Member States concrete proposals for new strategic partnerships in support of diversification objectives.

Or. en

Amendment 1240

Tilly Metz

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Without prejudice to the prerogatives of the Council, the Commission, shall explore possibilities of concluding strategic partnerships, including with not-for-profit undertakings, aiming to diversify sourcing of critical medicinal products, their active substances and key inputs to increase the security of supply of critical medicinal products in the Union. The Commission shall also explore the possibility of building on existing forms of cooperation, when possible, to support security of supply and reinforce efforts to strengthen the production of critical medicinal products in the Union. However, such partnership must fulfil the same requirements in terms of safety, quality, environmental protection and labour standards.

The Commission shall also ensure specific attention for critical medicinal products facing market failure, including antimicrobials.

Or. en

Amendment 1241

Marta Temido, Vytenis Povilas Andriukaitis, Pierre Jouvet

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1242

Dario Tamburrano, Valentina Palmisano, Catarina Martins

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1243

Christine Anderson

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1244

Emmanouil Fragkos

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Or. el

Amendment 1245

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

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1246

Christophe Clergeau

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1247

Vlad Vasile-Voiculescu, Veronika Cifrová Ostrihoňová, Olivier Chastel

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1248

Oliver Schenk

Proposal for a regulation

Article 27 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1249

Dan-Ştefan Motreanu

Proposal for a regulation

Article 27 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

The Commission shall endeavour to incorporate health security provisions into free trade agreements and other relevant international agreements and instruments. Such provisions may include measures to promote open and resilient supply chains, including through crisis response mechanisms and collaboration to prevent export restrictions during public health emergencies, and to foster regulatory convergence and cooperation in the pharmaceutical sector.

Or. en

Amendment 1250

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

Proposal for a regulation

Article 27 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

The Commission shall make a list of countries that meet European regulatory standards for the quality and safety of medicinal products, including key inputs and active substances, available to contracting authorities and healthcare professionals involved in the selection, procurement, prescribing, management, dispensing, and monitoring of such products.

Or. en

Amendment 1251

Oliver Schenk

Proposal for a regulation

Article 27 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

The Commission shall explore the possibility of including chapters related to health security that support the achievement of the objectives of this Regulation in existing and future partnerships, agreements, and other relevant international cooperation frameworks.

Or. en

Amendment 1252

Galato Alexandraki, Emmanouil Fragkos

Proposal for a regulation

Article 27 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Strategic partnerships with third countries shall be accompanied by strict quality and compliance checks on imports of medicines and raw materials in order to protect public health and ensure that European production is not undermined.

Or. el

Amendment 1253

Ondřej Krutílek

Proposal for a regulation

Article 27 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Third countries are allowed to participate in the collaborative procurement according to Articles 21, 22 and 23. Third countries shall not change the conditions of the collaborative procurement set by the Member States or the Commission.

Or. en

Amendment 1254

Dan-Ştefan Motreanu

Proposal for a regulation

Article 27 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

In the context of accession negotiations, the Commission shall support the progressive alignment of candidate countries with the Union acquis in the field of pharmaceuticals, with a view to facilitating their gradual integration into the Union’s internal market and strengthening the resilience of the Union’s supply chains for critical medicinal products.

Or. en

Amendment 1255

Oliver Schenk

Proposal for a regulation

Article 27 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

The Commission shall inform the Critical Medicines Group about possible strategic partnerships on an annual basis.

Or. en

Amendment 1256

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

Proposal for a regulation

Article 27 a (new)

Text proposed by the Commission

Amendment

Article 27a

Trade Agreements

The Commission shall endeavour to include health security provisions into free trade agreements and other relevant international agreements and instruments. Such provisions may include measures to promote open and resilient supply chains, including through crisis response mechanisms and collaboration to prevent export restrictions during public health emergencies.

The Commission shall endeavour the inclusion of access to API starting materials and active pharmaceutical ingredients in the scope of trade agreements, in order to ensure timely availability of critical medicinal products under this mechanism.

Or. en

Amendment 1257

Veronika Cifrová Ostrihoňová, Vlad Vasile-Voiculescu, Olivier Chastel, Stine Bosse

Proposal for a regulation

Article 27 a (new)

Text proposed by the Commission

Amendment

Article 27a

Accession Negotiations

During accession negotiations, the Commission shall promote the gradual harmonisation of candidate countries with the EU acquis in the field of pharmaceuticals, with the aim of facilitating their integration into the internal market and enhancing the resilience of supply chains for critical medicines;

Or. en

Amendment 1258

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

Proposal for a regulation

Article 27 b (new)

Text proposed by the Commission

Amendment

Article 27b

Accession Negotiations

In accession negotiations, the Commission shall support progressive alignment of candidate countries with the Union acquis in pharmaceuticals to facilitate integration into the internal market and strengthen supply-chain resilience for critical medicines

Or. en

Amendment 1259

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Chapter VII – title

Text proposed by the Commission

Amendment

VII Amendments to Regulation (EU) 2024/795

VII Amendments to Regulation (EU) 2024/795 and Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final]

Or. en

Amendment 1260

Aurelijus Veryga

Proposal for a regulation

Article 28 – paragraph 1 – point a

Regulation (EU) 2024/795

Article 2, (1) point (a), subparagraph (iii)

Text proposed by the Commission

Amendment

biotechnologies, and any other technologies relevant for manufacturing of critical medicinal products as defined in Critical Medicines Act *;

biotechnologies, and directly related enabling technologies necessary for the development or manufacturing of critical medicinal products and other medicinal products as defined in Critical Medicines Act *;

Or. en

Amendment 1261

Christophe Clergeau

Proposal for a regulation

Article 28 – paragraph 1 – point a

REGULATION (EU) 2024/795

Article 2, (1) point (a), subparagraph (iii)

Text proposed by the Commission

Amendment

biotechnologies, and any other technologies relevant for manufacturing of critical medicinal products as defined in Critical Medicines Act *;

biotechnologies, and any other technologies relevant for manufacturing of critical medicinal products as defined in Critical Medicines and Medical Countermeasures Act *;

Or. en

Amendment 1262

Christophe Clergeau

Proposal for a regulation

Article 28 – paragraph 1 – point a

REGULATION (EU) 2024/795

Article 2, (1) point (a), subparagraph (iii)

Text proposed by the Commission

Amendment

* Regulation (EU) … of the European Parliament and of the Council laying down a framework for strengthening the availability and security of supply of critical medicinal products as well as for improving the availability of, and access to, medicinal products of common interest, and amending Regulation (EU) 2024/795.’ [D.G.: reference to be completed with the definitive title of the ‘Critical Medicines Act’ and with its publications references once they are available];

* Regulation (EU) … of the European Parliament and of the Council laying down a framework for strengthening the availability and security of supply of critical medicinal products and critical medical countermeasures as well as for improving the availability of, and access to, medicinal products of common interest and medical countermeasures of common interest, and amending Regulation (EU) 2024/795.’ [D.G.: reference to be completed with the definitive title of the ‘Critical Medicines Act’ and with its publications references once they are available];

Or. en

Amendment 1263

Waldemar Buda, Kosma Złotowski

Proposal for a regulation

Article 28 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(ea) Article 6a is added

In cases where, at the time of submission of the marketing authorisation application, no reference medicinal product is or has been authorised or if a reference medicinal product has been authorised but is not available on the market within the Union for the active substance of the medicinal product concerned, the applicant shall, by way of derogation from Article 6(1) of this Regulation and Article 6(2) [revised Directive 2001/83/EC], not be required to provide the results of non-clinical tests or clinical studies if the applicant can demonstrate that the active substances of the medicinal product:

a) have been in well-established medicinal use within the Union for the same therapeutic use and route of administration and for at least ten years, with recognised efficacy and an acceptable level of safety in terms of the conditions set out in Annex II;

b) have been included in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM (2023) 193 final] and

c) have been manufactured as part of the Strategic Project referred to in Article 5 of Regulation (EU) …/…. [reference to be added after adoption cf. COM (2025) 102 final].

In that event, the test and trial results shall be replaced by appropriate bibliographic data in the form of scientific literature, and the applicant shall establish a scientific bridge between the bibliographic data and the medicinal product concerned.

Or. en

Amendment 1264

Adam Jarubas, Ewa Kopacz

Proposal for a regulation

Article 28 a (new)

Text proposed by the Commission

Amendment

Article 28a

II) Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] is amended as follows:

(a) Article 6a

b) have been included in the Union List of Critical Medicinal Products referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] and

c) have been manufactured as part of the Strategic Project referred to in Article 5 of Regulation (EU) …/…. [reference to be added after adoption cf. COM (2025) 102 final].

Or. en

Amendment 1265

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

Proposal for a regulation

Chapter VIII – title

Text proposed by the Commission

Amendment

VIII Final provisions

VIII Monitorization & support scheme to the supply chain

Or. en

Amendment 1266

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

Proposal for a regulation

Article 29 – title

Text proposed by the Commission

Amendment

Obligation of the market actors to provide information

Supply Chain Transparency Obligations

Or. en

Amendment 1267

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

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

1. Marketing authorisation holders and other economic operators in the supply and distribution chains of critical medicinal products including their key inputs and active substances or medicinal products of common interest shall upon request provide the Commission or national authorities, as relevant, the requested information necessary for the purpose of application of this Regulation.

1. Marketing authorisation holders, manufacturers, and importers of critical medicines shall provide to the European Medicines Agency and the Commission, upon request and at such intervals as may be determined by the Commission stablishing a specific monitoring plan, comprehensive information regarding:

a. the location of all manufacturing sites for finished products, APIs and key inputs;

b. the identity and role of all contract manufacturers and key suppliers;

c. the capacity of production facilities and the extent of their reliance on single-source suppliers;

d. contingency plans for alternative sourcing and manufacturing, where applicable;

e. availability of skilled workers relevant to medicines production.

Or. en

Amendment 1268

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

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

Or. fr

Amendment 1269

Christophe Clergeau

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

1. Marketing authorisation holders and other economic operators in the supply and distribution chains of critical medical countermeasures and critical medicinal products including their key inputs and active substances or medicinal products of common interest and medical countermeasures of common interest shall upon request provide the Commission or national authorities, as relevant, the requested information necessary for the purpose of application of this Regulation.

Or. en

Amendment 1270

Ondřej Krutílek

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

1. Marketing authorisation holders and other actors in the supply and distribution chains of critical medicinal products or medicinal products of common interest including their key inputs and active substances shall upon request provide the Commission or national authorities, as relevant, the requested information necessary for the purpose of application of this Regulation.

Or. en

Amendment 1271

Laurent Castillo

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

1. Marketing authorisation holders and other economic operators in the supply and distribution chains of critical medicinal products including their key inputs and active substances or medicinal products of common interest shall upon request provide the Commission, the Agency or national authorities, as relevant, the requested information necessary for the purpose of application of this Regulation.

Or. fr

Amendment 1272

Radan Kanev

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

1. Marketing authorisation holders and other economic operators in the supply and distribution chains of critical medicinal products including their key inputs and active substances shall upon request provide the Commission or national authorities, as relevant, the requested information necessary for the purpose of application of this Regulation.

Or. en

Amendment 1273

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

Proposal for a regulation

Article 29 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission and national authorities of the Member States shall aim to avoid duplication of the information requested and submitted.

2. The European Medicines Agency and the Commission shall make full use of information already available to them under Union pharmaceutical legislation, including data submitted in the context of marketing authorisation procedures, variations, inspections, and other regulatory filings, so as to minimise additional administrative burden on economic operators. Requests for supplementary information shall be aimed to what is necessary to ensure effective monitoring, analysis and assessment.

Or. en

Amendment 1274

Aurelijus Veryga

Proposal for a regulation

Article 29 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission and national authorities of the Member States shall aim to avoid duplication of the information requested and submitted.

2. The Commission and the competent national authorities of the Member States shall take all appropriate measures to avoid duplication of information requests and submissions, and shall ensure that such information is integrated into a fully interoperable Union-wide database. That database shall incorporate national databases and provide real-time visibility of supply chain vulnerabilities through secure and resilient digital infrastructure

Or. en

Amendment 1275

Radan Kanev

Proposal for a regulation

Article 29 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission and national authorities of the Member States shall aim to avoid duplication of the information requested and submitted.

2. The Commission and national authorities of the Member States shall aim to avoid duplication of the information requested and submitted by maximizing the use of data already submitted by marketing authorization holders (e.g. during registration process) as well as existing tools, such as the European Medicines Verification System (EMVS) and the European Shortages Monitoring Platform (ESMP).

Or. en

Justification

Timely and targeted data-sharing is essential for effective supply chain oversight. However, introducing additional data requirements, for instance to monitor stock levels or conduct a vulnerability evaluation, would be disproportionate, especially when relevant data has already been collected from marketing authorisation holders during earlier exercises and is accessible via the European Medicines Verification System (EMVS). Such an approach would fail to capitalise on existing tools and data, conflicting with the principles of Better Regulation and proportionality. Authorities should prioritise the use of data already submitted by marketing authorisation holders, such as during the registration process, and fully leverage existing systems like the EMVS and the European Shortages Monitoring Platform (ESMP), in order to minimise duplication and reduce administrative burden. Data from the EMVS, including information on the supply and demand of medicinal product packs, stock levels within Member States, and market share estimations, offers valuable insights that can support a streamlined vulnerability evaluation process while alleviating the reporting burden on manufacturers.

Amendment 1276

Laurent Castillo

Proposal for a regulation

Article 29 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission and national authorities of the Member States shall aim to avoid duplication of the information requested and submitted.

2. The Commission, the Agency and national authorities of the Member States shall aim to avoid duplication of the information requested and submitted by using the data already submitted by marketing authorisation holders, e.g. by way of the European Medicines Verification System (EMVS) or the European Shortages Monitoring Platform (ESMP).

Or. fr

Amendment 1277

Michele Picaro, Ruggero Razza

Proposal for a regulation

Article 29 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission and national authorities of the Member States shall aim to avoid duplication of the information requested and submitted.

2. The Commission, the Agency and national authorities of the Member States shall aim to avoid duplication of the information requested and submitted, by maximising the use of data already submitted by marketing authorisation holders (e.g. during registration process) the European Shortages Monitoring Platform (ESMP).

Or. en

Amendment 1278

Marta Temido, Pierre Jouvet

Proposal for a regulation

Article 29 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission and national authorities of the Member States shall aim to avoid duplication of the information requested and submitted.

2. In implementing the provisions of this Regulation, the Commission and national authorities of the Member States shall aim to avoid duplication of the information requested and submitted and make use of existing systems and infrastructures.

Or. en

Amendment 1279

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

Proposal for a regulation

Article 29 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. When assessing the shortage of skilled labour in relation to difficulties in the pharmaceutical supply chain, employers and workers' unions relevant to the pharmaceutical sector will be consulted when identifying labour needs, as well as defining professional categories, training needs, and vocational training programs aimed at reducing the shortage of skilled labour.

Or. en

Amendment 1280

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

Proposal for a regulation

Article 29 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission and national authorities of the Member States shall assess the merits of duly substantiated confidentiality claims made by marketing authorisation holders and other economic operators, requested to provide information per paragraph 1, and shall protect any information that is commercially confidential against unjustified disclosure.

3. Supply chain data submitted under this Article shall be treated as strictly confidential and used solely for the purposes of preventing or mitigating shortages of critical medicines and ensuring preparedness for health emergencies. The Commission, the Agency, and the competent authorities of the Member States may exchange such data between themselves under strict confidentiality arrangements and to the extent necessary for the effective performance of their respective duties. The mechanism shall be governed in a technologically and competitively neutral manner.

Or. en

Amendment 1281

Aurelijus Veryga

Proposal for a regulation

Article 29 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1282

Laurent Castillo

Proposal for a regulation

Article 29 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission, the Agency and national authorities of the Member States shall assess the merits of duly substantiated confidentiality claims made by marketing authorisation holders and other economic operators, requested to provide information per paragraph 1, and shall protect any information that is commercially confidential against unjustified disclosure. Trade secrets and commercially sensitive information shall be strictly protected.

Or. fr

Amendment 1283

Tilly Metz

Proposal for a regulation

Article 29 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1284

Ondřej Krutílek

Proposal for a regulation

Article 29 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission and national authorities of the Member States shall assess the merits of duly substantiated confidentiality claims made by marketing authorisation holders and other actors, requested to provide information per paragraph 1, and shall protect any information that is commercially confidential against unjustified disclosure.

Or. en

Amendment 1285

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

Proposal for a regulation

Article 29 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. The European Medicines Agency shall compile, update, and analyse the supply chain data submitted under this Article, and shall make available to Member States and the Commission a Union-wide mapping of critical medicines’ supply chains. A non-confidential summary of the analysis shall be made public at regular intervals.

Specific evaluation on the specific features and vulnerabilities of supply chains related to products that use substances of human origin (SoHO) as key input shall be made.

Or. en

Amendment 1286

Galato Alexandraki, Emmanouil Fragkos

Proposal for a regulation

Article 29 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. Marketing authorisation holders and suppliers are required to make publicly available, on an annual basis, their investments in production, research and development within the Union, as well as their pricing practices. This transparency is essential to prevent speculative practices and artificial shortages.

Or. el

Amendment 1287

Christine Anderson

Proposal for a regulation

Article 29 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. Any information requested under this Article shall be limited to what is strictly necessary, proportionate, and non-duplicative. Confidential commercial information shall be protected rigorously and not disclosed beyond what is essential for public interest oversight.

Or. en

Amendment 1288

Aurelijus Veryga

Proposal for a regulation

Article 29 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. The Commission shall ensure that any information collected is handled in full compliance with applicable data protection legislation and is only used for the purposes outlined in this Regulation.

Or. en

Amendment 1289

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

Proposal for a regulation

Article 29 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3b. The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) of the EMA shall provide alerts based on the pooled data, duly aggregated, as a provided market intelligence available for manufacturers end-to-end supply chain orchestration .

Manufacturers and market authorization holders can request an assessment by the MSSG on specific concerns about the supply chain, the possibilities or threats of shortages, caused both by demand or supply.

The assessment will be published and will address relevant information for all manufacturers of risk of market distortions and previsions from the MSSG based on the available pool of data.

Neither the Commission nor the EMA shall be liable for any damages or loss of profit resulting from decisions made based on published reports or alerts.

Or. en

Amendment 1290

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

Proposal for a regulation

Article 29 – paragraph 3 c (new)

Text proposed by the Commission

Amendment

3c. In conducting its analysis and issuing recommendations under this Article, the Commission and the EMA shall take into account potential or ongoing public health crises, including pandemics, epidemics, and other serious cross-border health threats, with a view to strengthening the Union’s preparedness and resilience.

Should one of these events occur, the Commission and the EMA are entitled to request real time data on the supply chain to the concerned authorisation holders, manufacturers and suppliers to assess and coordinate supply chain reorganisation measures and other emergency measures to be established by the Commission or the Member States.

Or. en

Amendment 1291

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

Proposal for a regulation

Article 29 – paragraph 3 d (new)

Text proposed by the Commission

Amendment

3d. The Commission may impose financial penalties previewed in article 172 of Regulation EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] on the marketing authorisations holders and the manufacturers if they fail to comply with any of the obligations laid down in this Regulation.

Member States shall adapt the fines scheme developed for Regulation EU) …/… [reference to be added after adoption cf. COM(2023) 193 final] application.

Or. en

Amendment 1292

Christophe Clergeau

Proposal for a regulation

Article 29 a (new)

Text proposed by the Commission

Amendment

Article 29a

Review

No later than … [OP: please insert 5 years after the entry into force of this Regulation], the Commission shall assess and adopt a report on the production and availability of medical countermeasures in the Union, and whether supply chains of medical countermeasures are stable and resilient enough to ensure a supply of medical countermeasures that are critical to ensure the health of patients and medical workers.

The Commission shall, based on the findings of this report, assess the appropriateness of expanding the scope of this Regulation to medical countermeasures listed on the EU List of Medical Countermeasures for Priority Threats, and may present a legislative proposal, as appropriate.

Or. en

Justification

As an alternative to expanding the scope of this Regulation to medical countermeasures in this procedure, the text should task the Commission to conduct a review of this Regulation to include critical medical countermeasures in the mid to long term.

Amendment 1293

Ondřej Krutílek

Proposal for a regulation

Article 29 a (new)

Text proposed by the Commission

Amendment

Article 29a

Penalties

Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.

Or. en

Amendment 1294

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

Proposal for a regulation

Article 30 – paragraph 1

Text proposed by the Commission

Amendment

1. By [OP please insert the date of:] five years after the date of application of this Regulation and every five years thereafter, the Commission shall evaluate this Regulation and present a report on the main findings to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions.

1. By [OP please insert the date of:] two years after the date of application of this Regulation and every five years thereafter, the Commission shall evaluate this Regulation and present a report on the main findings to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions.

Or. en

Amendment 1295

Tilly Metz

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved.

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved. The Commission shall assess whether the Union Solidarity Mechanism for critical medicines requires strengthening by adoption of binding measures requiring redistribution of critical medicines between Member States.

The evaluation shall in particular assess:

(a) data on the number of new manufacturing sites opened or modernized within the Union and the number of existing manufacturing lines extended;

(b) progress made in diversifying sources of active substances, API starting materials, and other key inputs;

(d) the impact on SMEs and not-for-profit undertakings and competition;

(e) the added value and effectiveness of the joint procurement.

Or. en

Amendment 1296

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

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved.

(a) data on the number of new manufacturing sites opened or modernized within the Union and the number of existing manufacturing lines extended;

(b) the number and nature of projects confirmed, supported, or recommended by the Critical Medicines Group under this Regulation;

(d) the effectiveness of measures adopted to mitigate structural risks and strengthen supply resilience;

Or. en

Amendment 1297

Laurence Trochu

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved.

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved. If the objectives are fully achieved, meaning the relocation of production of critical medicinal products and a drastic reduction in shortages, the Commission may assess the relevance of extending certain articles to critical medical devices, following a thorough impact assessment.

Or. fr

Amendment 1298

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

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved.

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved. It shall also identify any distortions of competition between the European Union and third countries, and their impact on industrial competitiveness, environmental risks and public health in the EU.

Or. fr

Amendment 1299

Laurent Castillo

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved.

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved. The evaluation shall include an economic analysis of the critical medicinal products market in the Union and shall put forward recommendations, including legislative recommendations, in collaboration with the Critical Medicines Group.

Or. fr

Amendment 1300

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

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved.

2. The Commission shall in its evaluation assess the impact of this Regulation, including its effects on Member States’ healthcare systems, public procurement and supply chain costs, and to what extent its objectives as established in Article 1 have been achieved. If needed, the report should be accompanied by a legislative proposal to amend this Regulation.

Or. en

Amendment 1301

Aurelijus Veryga

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved.

2. The Commission shall, in its evaluation, assess the impact of this Regulation and the extent to which the objectives set out in Article 1 have been achieved. The evaluation shall also examine any unintended effects on competition, innovation, and market access, and determine whether the Regulation remains proportionate and effective.

Or. en

Amendment 1302

Christine Anderson

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall in its evaluation assess the impact of this Regulation and to what extent its objectives as established in Article 1 have been achieved.

2. The Commission shall in its evaluation assess whether the Regulation has improved medicine availability, reduced shortages, and delivered better value than decentralised alternatives. If it finds that the Regulation has not achieved these aims in a cost-effective and proportionate manner, it shall recommend its repeal.

Or. en

Amendment 1303

András Tivadar Kulja

Proposal for a regulation

Article 30 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. The Commission shall report to the European Parliament by one year after the date of application of this Regulation and every year thereafter, the application of this Regulation, including investments, demand-side measures, and international cooperation.

Or. en

Amendment 1304

Dan-Ştefan Motreanu

Proposal for a regulation

Article 30 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. The Commission shall report to the European Parliament one year after the date of application of this Regulation and every year thereafter, the application of this Regulation, including investments, demand-side measures, and international cooperation.

Or. en

Amendment 1305

Radan Kanev

Proposal for a regulation

Article 30 – paragraph 3

Text proposed by the Commission

Amendment

3. The national authorities and the economic operators shall, upon request, provide the Commission with any relevant information they have and that the Commission may need for its assessment pursuant to in paragraph 1.

3. The requests should be limited to what is necessary to evaluate the effect of the concrete measures, and should in any case not include information about national decision making within competences of Member States, such as pricing and reimbursement, national negotiations or sensitive public procurement information.

Or. en

Amendment 1306

Catarina Martins, Sebastian Everding, Anthony Smith

Proposal for a regulation

Article 30 – paragraph 3

Text proposed by the Commission

Amendment

3. The national authorities, the economic operators, patient and consumer organisations, as well as healthcare professionals shall, upon request, provide the Commission with any relevant information they have and that the Commission may need for its assessment pursuant to in paragraph 1.

Or. en

Amendment 1307

Dario Tamburrano, Valentina Palmisano, Catarina Martins

Proposal for a regulation

Article 30 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. The evaluation shall include specific public and measurable indicators covering:

(i) the actual availability of critical medicinal products (number of shortages reported per therapeutic class);

(ii) the additional European production capacity deployed and the use of the reserved capacity deployed;

(iii) the impact on SMEs and competition;

(iv) the cumulative impact of environmental and chemical regulations on pharmaceutical production;

(v) the effectiveness of joint procurement mechanisms.

The evaluation should be accompanied by a public consultation and hearings with representatives of businesses, SMEs, patient and consumer organisations and national authorities.

Or. en

Amendment 1308

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

Proposal for a regulation

Article 30 a (new)

Text proposed by the Commission

Amendment

Article 30a

Delegated acts

The Commission shall adopt delegated acts to establish:

(a) comprehensive guidance on Union assessment standards where a medicinal product falls in the category of ‘medicinal products of common interest’ following an assessment of the availability and accessibility to patients in the quantities and presentations necessary to cover the needs of patients in those Member States;

(b) comprehensive guidance on the design and use of resilience-oriented procurement (including multi-winner models) under Articles 18 and 21–23.

(d) common application template to be used by promoters for the application enshrined in article 6;

2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in paragraph 3 of this article.

3. The Commission shall be assisted by a committee within the meaning of Regulation (EU) No 182/2011. That committee shall be a committee within the meaning of Article 5 of that Regulation.

Or. en

Amendment 1309

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

Proposal for a regulation

Article 31 – paragraph 2

Text proposed by the Commission

Amendment

It shall apply from [….].

It shall apply from [….] the later of:

Or. en

Amendment 1310

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

Proposal for a regulation

Article 31 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

(a) the date specified in the implementing regulation establishing the Union List of critical medicinal products un referred to in Article 131 of Regulation (EU) …/… [reference to be added after adoption cf. COM(2023) 193 final]; or

Or. en

Amendment 1311

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

Proposal for a regulation

Article 31 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

(b) 12 months after the date of its entry into force.

Or. en

Amendment 1312

Oliver Schenk

Proposal for a regulation

Article 31 a (new)

Text proposed by the Commission

Amendment

Article 31a

Efficient Implementation and Reporting

The Commission, Member States and the competent national authorities shall ensure that the implementation of this Regulation is consistent with relevant Union law. The reporting obligations for market players shall be limited to cases that are necessary and duly justified. Unnecessary duplication or overlap of structures and procedures shall be avoided. Competent authorities shall, to the extent possible, make use of existing data infrastructures and databases at Union or national level.

Or. en

Amendment 1313

Christine Anderson

Proposal for a regulation

Article 31 a (new)

Text proposed by the Commission

Amendment

Article 31a

Sunset Clause

This Regulation shall expire five years after its date of application, unless the Commission, following a comprehensive impact evaluation under Article 30, proposes its continuation based on clear, independently verified evidence of effectiveness.

Or. en