Sittings · Document

Draft report (COM(2023)0193 – C9-0144/2023 – 2023/0131(COD)) 2023-11-21

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

Committee on the Environment, Public Health and Food Safety

Official HTML ↗ PDF DOCX

AM_Com_LegReport

Amendment 847

Fulvio Martusciello

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance and it has at least one of the following characteristics:

An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance.

Or. en

Amendment 848

Dolors Montserrat

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) it represents a new class of antimicrobials;

deleted

Or. en

Amendment 849

Fulvio Martusciello

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) it represents a new class of antimicrobials;

deleted

Or. en

Amendment 850

Jessica Polfjärd

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) it represents a new class of antimicrobials;

deleted

Or. en

Justification

The proposed amendments to this article aims to further clarify when a request for a transferable exclusivity voucher (TEV) can be undertaken to the EU-commission. A request should be able to be made at any time during the time the marketing authorization is under consideration and not be required to have a request made the same time as the application for marketing authorization is submitted to the EMA (as the original wording is implying). In addition, the key focus should be, while determining the priority status of antimicrobials, on evaluating their effectiveness and clinical benefit against resistance. Since it is important to ensure a robust and science-based evaluation, the Agency should establish an expert group and early dialogues to be conducted with developers. This would ensure a comprehensive assessment process with emphasis on the clinical benefits of the antimicrobials for subject matter.

Amendment 851

Margarita de la Pisa Carrión

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) it represents a new class of antimicrobials;

deleted

Or. en

Amendment 852

Pernille Weiss

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) it represents a new class of antimicrobials;

deleted

Or. en

Amendment 853

Andrey Slabakov

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) it represents a new class of antimicrobials;

(a) it represents a new class of narrow-spectrum antibiotics;

Or. en

Amendment 854

Pernille Weiss

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union;

deleted

Or. en

Amendment 855

Fulvio Martusciello

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union;

deleted

Or. en

Amendment 856

Jessica Polfjärd

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union;

deleted

Or. en

Justification

Amendment 857

Dolors Montserrat

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union;

deleted

Or. en

Amendment 858

Margarita de la Pisa Carrión

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union;

deleted

Or. en

Amendment 859

Margarita de la Pisa Carrión

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection.

deleted

Or. en

Amendment 860

Dolors Montserrat

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection.

deleted

Or. en

Amendment 861

Jessica Polfjärd

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection.

deleted

Or. en

Justification

Amendment 862

Fulvio Martusciello

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection.

deleted

Or. en

Amendment 863

Pernille Weiss

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

(c) it contains an active substance not previously authorised in a medicinal product in the Union that addresses a multi-drug resistant organism and serious or life threatening infection.

deleted

Or. en

Amendment 864

Sara Cerdas

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(c a) is of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation.

Or. en

Justification

In the context of an accelerated assessment procedure voucher.Ipsis verbis from Article 6(7).

Amendment 865

Margarita de la Pisa Carrión

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

In the scientific assessment of the criteria referred to in the first subparagraph, and in the case of antibiotics, the Agency shall take into account the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union level.

In the scientific assessment in the case of priority antibiotics, the Agency will develop a list of criterias

Or. en

Amendment 866

Pernille Weiss

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

In the scientific assessment of priority antimicrobials as referred to in the first subparagraph, the Agency shall develop a set of criteria taking into account the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union level; health system benefits, including with regard to safety and ease of administration; and pharmacological benefits, including novelty of the product.

Or. en

Amendment 867

Dolors Montserrat

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

In its scientific assessment in the case of antibiotics, the Agency shall take into account the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union level.

Or. en

Amendment 868

Jessica Polfjärd

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Justification

Amendment 869

Fulvio Martusciello

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 870

Pernille Weiss

Proposal for a regulation

Article 40 – paragraph 3 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

The Agency shall develop a weighting of each criteria and a corresponding scoring system allowing priority antimicrobials to be designated one of three categories of vouchers according to its expected impact on combatting antimicrobial resistance. The agency shall assign each voucher category a corresponding financial value which will be payed to the applicant following the auction process set out in Article 41.

Or. en

Amendment 871

Catherine Amalric, Max Orville

Proposal for a regulation

Article 40 – paragraph 4 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

To be granted the voucher by the Commission, the applicant shall:

To be granted any incentive from the scheme foreseen in paragraph 1 by the Commission, the applicant shall:

Or. en

Amendment 872

Andreas Glück, Peter Liese

Proposal for a regulation

Article 40 – paragraph 4 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) demonstrate capacity to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market;

(a) demonstrate capacity and ensure to supply the priority antimicrobial in sufficient quantities for the expected needs of the Union market;

Or. en

Justification

Only demonstrating capacity is not enough. Supply of the new antimicrobial should be ensured within the limits of the applicant.

Amendment 873

Jessica Polfjärd

Proposal for a regulation

Article 40 – paragraph 4 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) provide information on all direct financial support received for research related to the development of the priority antimicrobial.

(b) provide information on all publicly and direct financial support received from a body that is publicly funded or public authority located in the Union, for research related to the development of the priority antimicrobial.

Or. en

Justification

Amendment 874

Fulvio Martusciello

Proposal for a regulation

Article 40 – paragraph 4 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) provide information on all direct financial support received for research related to the development of the priority antimicrobial.

(b) provide information on all direct financial support received from any public authority of publicly funded body based in the European Union, for research related to the development of the priority antimicrobial.

Or. en

Amendment 875

Dolors Montserrat

Proposal for a regulation

Article 40 – paragraph 4 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) provide information on all direct financial support received for research related to the development of the priority antimicrobial.

Or. en

Amendment 876

Pernille Weiss

Proposal for a regulation

Article 40 – paragraph 4 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) provide information on all direct financial support received for research related to the development of the priority antimicrobial.

(b) provide information on all direct EU financial support received for research related to the development of the priority antimicrobial.

Or. en

Amendment 877

Sara Cerdas

Proposal for a regulation

Article 40 – paragraph 4 – subparagraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) provide information regarding the corporate sustainability reporting as referred to in Commission Directive (EU) 2022/24641a, where applicable, as well as any environmental plans to reduce its carbon footprint.

_________________

1a Directive (EU) 2022/2464 of the European Parliament and of the Council of 14 December 2022 amending Regulation (EU) No 537/2014, Directive 2004/109/EC, Directive 2006/43/EC and Directive 2013/34/EU, as regards corporate sustainability reporting (OJ L 322, 16.12.2022, p. 15–80).)

Or. en

Justification

Applicants using this voucher must send information about corporate sustainability reporting, when applicable, or any plans to commit to lower their environmental impact, in line with the EU Green Deal.

Amendment 878

Peter Liese

Proposal for a regulation

Article 40 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

Within 30 days after the marketing authorisation is granted, the marketing authorisation holder shall make the information referred to in point (b) accessible to the public via a dedicated webpage and shall communicate, in a timely manner the electronic link to that webpage to the Agency.

Within 45 days after the marketing authorisation is granted, the marketing authorisation holder shall make the information referred to in point (b) accessible to the public via a dedicated webpage and shall communicate, in a timely manner the electronic link to that webpage to the Agency.

Or. en

Justification

A 45-day window provides a more reasonable timeframe for marketing authorisation holders to make the information public

Amendment 879

Sara Cerdas

Proposal for a regulation

Article 40 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

Within 30 days after the marketing authorisation is granted, the marketing authorisation applicant shall make the information referred to in point (b) accessible to the public via a dedicated webpage and shall communicate, in a timely manner the electronic link to that webpage to the Agency.

Or. en

Justification

In the context of an accelerated assessment procedure voucher.

Amendment 880

Catherine Amalric, Max Orville

Proposal for a regulation

Article 40 – paragraph 4 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

By [18 months after the date of entry into force of this Regulation], the Commission shall have developed the Union scheme of push and pull incentives.

Or. en

Amendment 881

Catherine Amalric, Max Orville

Proposal for a regulation

Article 40 – paragraph 4 – subparagraph 2 b (new)

Text proposed by the Commission

Amendment

By [10 years after the date of entry into force of this Regulation], the Commission shall submit a report to the European Parliament and the Council assessing the implementation of the Union scheme of push and pull incentives.

Or. en

Amendment 882

Maria Angela Danzì

Proposal for a regulation

Article 40 a (new)

Text proposed by the Commission

Amendment

Article 40a

Establishment and role of the European Medicines Infrastructure

1. The European Public Medicines Infrastructure is hereby established.

2. The main missions and responsibilities of the Infrastructure shall be:

setting out a long-term vision of health priorities in the public interest at Union level in the form of a strategic roadmap with a number of specific purpose-led R&D projects; when drawing-up of the strategic roadmap, the EMI shall engage in transparent consultation with relevant stakeholders, including scientific communities, Union public health authorities, patient and consumer organisations as well as the relevant agencies established at Union level;

b) establishing, as a priority, a portfolio of priority pharmaceutical R&D projects addressing at least the following therapeutic areas:

i) the development of priority antimicrobials provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account as a priority any equivalent list of priority pathogens adopted at Union level;

ii) the development of medicinal products for high unmet medical needs as referred to in Article 70(1) of this Regulation and unmet medical needs as referred to in Article 83 of [revised Directive 2001/83/EC], in particular for conditions not sufficiently addressed by the private sector and where the private R&D pipeline is unlikely to deliver on medicinal products and therapies;

iii) the development of medicinal products for which the private sector charges excessive prices and for which alternatives or generic alternatives are non-existent or unaffordable;

c) voluntary joint procurement with subscription payment mechanisms or market entry rewards that delink or partially delink revenues and sales;

d) ‘play or pay’ fee systems in which pharmaceutical companies are subject to a levy on the sale of their existing medicinal products, unless they prove an equivalent investment in antibiotic research and development.

3. The Union push and pull incentive scheme shall be coordinated and managed by the Commission.

4. By ... [one year after the date of entry into force of this Regulation], the Commission shall have developed, and commenced the implementation of, the Union push and pull incentive scheme.

5. By ... [5 years after the date of entry into force of this Regulation], the Commission shall present a report to the European Parliament and to the Council reviewing the application of the scheme laid down in this Article. The report shall also assess the interplay between the ongoing work of the EMF and the effectiveness of the Union push and pull incentive scheme.

Or. it

Amendment 883

Alessandra Moretti

Proposal for a regulation

Article 40 a (new)

Text proposed by the Commission

Amendment

Article 40a

Establishment and role of the European Medicines Facility

1. The European Medicines Facility (‘EMF’) is hereby established.

2. The main missions and responsibilities of the EMF shall be:

(a) setting out a long-term vision of health priorities in the public interest at a Union level in the form of a strategic roadmap, also throughspecific purpose-led R&D projects to be carried out along the entire life cycle, including research, development, production and distribution; in the elaboration of the strategic roadmap and its overall activities and initiatives, the EMF shall engage in transparent consultation with relevant stakeholders, including scientific communities, Union public health authorities, patient and consumer organisations as well as the relevant agencies established at Union level;

(b) establishing, as a priority, a portfolio of priority pharmaceutical R&D projects addressing at least the following therapeutic areas:

(i) the development and manufacturing of priority antimicrobials provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account as a priority any equivalent list of priority pathogens adopted at Union level;

(ii) the development and manufacturing of medicinal products of health and strategic importance, for high unmet medical needs as referred to in Article 70(1) of this Regulation and unmet medical needs as referred to in Article 83 of [revised Directive 2001/83/EC], in particular for conditions not sufficiently addressed by the private sector and where the private R&D pipeline is unlikely to deliver on medicinal products and therapies;

(iii) the development of medicinal products neglected by the private sector or for which the private sector charges excessive prices and for which alternatives or generic alternatives are non-existent or unaffordable;

c) ensuring mechanisms for comparative research and data collection, including if necessary independent clinical trials, on the clinical efficacy, benefit-risk profile, and cost-effectiveness of authorized biomedical products and drugs, in full coordination and respect with the EMA prerogatives and competences; 3. The European Commission implements the EMF initially as an autonomous body with own resources, ensures that its governance is mainly expressed by the scientific communities of the Member States , after a transparent selection process, and that the EMF legal framework is open to partnerships with non Member States, in the spirit of a European research infrastructure of global significance

Or. en

Amendment 884

Tiemo Wölken

Proposal for a regulation

Article 40 a (new)

Text proposed by the Commission

Amendment

Article 40a

Establishment and legal status of the European Medicines Facility

The European Medicines Facility ( ‘EMF’) is hereby established, taking over the tasks and responsibilities of the Health Emergency Preparedness and Response Authority repealing Commission’s decision (2021) 67 and Council Regulation 2021/577.

The EMF shall have legal personality.

In each of the Member States, the EMF shall enjoy the most extensive legal capacity accorded to legal persons under their laws. It may, in particular, acquire or dispose of movable and immovable property, and be party to legal proceedings.

The EMF shall be represented by an Executive Director.

Or. en

Amendment 885

Annalisa Tardino

Proposal for a regulation

Article 40 a (new)

Text proposed by the Commission

Amendment

Article 40a

AMR designation

1. All AMR medicinal products developed to address a priority pathogen should be granted an AMR designation through an open and transparent Community procedure.

2. A medicinal product shall be designated as an AMR medicinal product if its sponsor can establish:

a) That it is intended for the diagnosis, prevention or treatment of a pathogen included in the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union level.

b) That there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorised in the Community or, if such method exists, that the medicinal product will be of significant benefit to those affected by that condition.

3. In order to obtain the designation of a medicinal product as an AMR medicinal product, the sponsor shall submit an application to the Agency before or at the moment of the application for marketing authorisation is made.The application shall be accompanied by the following particulars and documents:

a) name or corporate name and permanent address of the sponsor;

b) active ingredients of the medicinal product;

c) proposed therapeutic indication;

d) justification that the criteria laid down in Article x(y) are met, the indications expected and the relevant preclinical and clinical data. The Agency shall verify the validity of the application and ensure that an opinion is given within 90 days of the receipt of a valid application.

4. All products receiving AMR Designation shall be deemed to meet the criteria for Unmet Need specified in the Directive.

Or. en

Justification

All products developed for a WHO and matching EU Priority Pathogens list should be eligible for an AMR designation in order to target incentives at EU and national level. This designation and related incentives can leverage the model of OMPs which was driven by the EC and successfully developed, agreed and implemented by member states since 2000.

Complementing the existing TEV proposal and considering the limited extent and number of TEV proposed by the Commission, the introduction of an AMR Designation with reference to OMPs will provide a familiar and predictable model for companies wishing to invest in novel antimicrobials. This would also and addresses the important question of patient access support through the targeting of national incentives and creating coherence on which products to target with the additional incentives currently being discussed at Eu level (e.g. milestone payment, subscription model, public procurement).

Amendment 886

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 40 a (new)

Text proposed by the Commission

Amendment

Article40a

AMR designation

All AMR medicinal products designed to combat a priority pathogen should receive an AMR designation through a transparent and open Community procedure.

An AMR medicinal product will be identified as such when its sponsor can demonstrate:

a) That it is intended for the diagnosis, prevention or treatment of a pathogen included in the ‘WHO priority pathogens list for R&D of new antibiotics’, or a comparable list established at Union level.

b) that there is no approved method within the community for diagnosing, preventing, or treating the specified condition that is deemed satisfactory. If such a method does exist, the medicinal product must provide substantial benefits to individuals suffering from the condition.

3. To secure the classification of a pharmaceutical product as an AMR medicinal product, the sponsor must submit an application to the Agency either prior to, or concurrently, with the submission for marketing authorization. The application should include the specified details and accompanying documents:

a) name or corporate name and permanent address of the sponsor;

b) active ingredients of the medicinal product;

c) proposed therapeutic indication;

d) verification of compliance with the criteria specified in Article x(y), confirmation of anticipated indications, and review of pertinent preclinical and clinical information constitute the rationale for the approval process. The Agency is responsible for validating the application's legitimacy and issuing an opinion within 90 days of receiving a valid application.

Or. en

Amendment 887

Sirpa Pietikäinen

Proposal for a regulation

Article 40 a (new)

Text proposed by the Commission

Amendment

Article 40a

AMR Designation

1. All AMR medicinal products developed to address a priority pathogens should be granted an AMR designation through an open and transparent Community procedure.

2. A medicinal product shall be designated as an AMR medicinal product if its sponsor can establish:

3. In order to obtain the designation of a medicinal product as an AMR medicinal product, the sponsor shall submit an application to the Agency before or at the moment of the application for marketing authorisation is made. The application shall be accompanied by the following particulars and documents:

a) name or corporate name and permanent address of the sponsor;

b) active ingredients of the medicinal product;

c) proposed therapeutic indication;

d) justification that the criteria laid down in Article x(y) are met, the indications expected and the relevant preclinical and clinical data.

The Agency shall verify the validity of the application and ensure that an opinion is given within 90 days of the receipt of a valid application.

Or. en

Amendment 888

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher

Proposal for a regulation

Article 40 a (new)

Text proposed by the Commission

Amendment

Article40a

Push and pull incentives scheme to boost the development of priority antimicrobials

1. The Commission shall establish a Union push and pull incentives scheme to promote and urgently accelerate the development of novel antimicrobials, as well as promote increased access to existing and newly developed antimicrobials. Member States shall be encouraged to participate in the Union level scheme.

2. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by further defining the scheme and its funding, which shall include i.a. the following incentives:

(a) research grants under Union funds;

(b) milestone prizes for novel antimicrobial developers;

(c) voluntary joint procurement with subscription payment mechanisms or market entry rewards that delink or partially delink revenues and sales;

3. The Union push and pull incentives scheme shall be coordinated and managed by the Commission.

4. By ... [one year after the date of entry into force of this Regulation], the Commission shall have developed, and commenced the implementation of the Union push and pull incentives scheme.

5. By ... [7 years after the date of entry into force of this Regulation], the Commission shall present a report to the European Parliament and to the Council reviewing the application of the scheme laid down in this Article.

Or. en

Amendment 889

Kateřina Konečná

Proposal for a regulation

Article 40 a (new)

Text proposed by the Commission

Amendment

Article 40a

Development and access to antimicrobials

The Commission shall examine specific incentives and joint procurement procedures and propose measures to promote research, development, and accessibility of antimicrobials by [OP please insert the date = one year after the date of entering into force of this Regulation].

Or. en

Amendment 890

Massimiliano Salini, Francesca Peppucci

Proposal for a regulation

Article 40 a (new)

Text proposed by the Commission

Amendment

Article40a

Any product receiving AMR Designation shall be considered as meeting the criteria for Unmet Need outlined in the [revised Directive 2001/83/EC].

Or. en

Amendment 891

Sirpa Pietikäinen

Proposal for a regulation

Article 40 b (new)

Text proposed by the Commission

Amendment

Article 40b

Additional measures to incentivise the creation of antimicrobials

1. The Commission shall furthermore establish a Union push and pull incentive scheme targeted at those products meeting the criteria for AMR Designation to promote and accelerate the development of novel antimicrobials, as well as promote increased access to existing and newly developed antimicrobials. Member States shall be encouraged to participate in the Union level scheme.

2. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by further defining the scheme and its funding and shall at least include the development of the following incentives in such delegated acts:

a) research grants under Union funds with conditionalities linked to the affordability and supply of new and existing antimicrobials;

b) milestone prizes for novel antimicrobial developers with conditionalities linked to the affordability and supply of new and existing antimicrobials;

c) voluntary joint procurement with subscription payment mechanisms or market entry rewards that delink or partially delink revenues and sales;

3. The Union push and pull incentive scheme shall be coordinated and managed by the Commission.

4. By ... [one year after the date of entry into force of this Regulation], the Commission shall have developed, and commenced the implementation of, the Union push and pull incentive scheme.

Or. en

Amendment 892

Maria Angela Danzì

Proposal for a regulation

Article 40 b (new)

Text proposed by the Commission

Amendment

Article 40b

Additional measures to incentivise the creation of antimicrobials

1. The Commission shall furthermore establish a Union push and pull incentive scheme to promote and accelerate the development of novel antimicrobials, as well as to promote increased access to existing and newly developed antimicrobials. Member States shall be encouraged to participate in the Union-level scheme.

2. The Commission is empowered to adopt delegated acts in accordance with Article 175 to supplement this Regulation by further defining the scheme and its funding and shall, at the least, include the development of the following incentives in such delegated acts:

a) research grants under Union funds with conditionalities linked to the affordability and supply of new and existing antimicrobials;

b) milestone prizes for novel antimicrobial developers with conditionalities linked to the affordability and supply of new and existing antimicrobials;

Or. it

Amendment 893

Tiemo Wölken

Proposal for a regulation

Article 40 b (new)

Text proposed by the Commission

Amendment

Article40b

Objectives and tasks of the EMF

1. The EMF shall work to improve preparedness and response to serious cross-border health threats in the area of medical countermeasures, as well as support Member States and other Union Agencies in research and development in key areas of priority pharmaceuticals, including novel antibiotics and antivirals, improved diagnostics and treatments for emerging infectious diseases, and other areas of unmet medical need for which the development of orphan medicinal products is needed.

The EMF shall provide the Member States and the institutions of the Union with the best possible scientific opinion on any question relating to serious cross-border health threats and research and development in areas of high unmelt medical need and unmet medical need.

The EMF, acting particularly through its Committees, shall carry out the following tasks:

(a) set out a strategic roadmap with short and long-term vision of health priorities in the public interest at a Union level with a number of specific purpose-led R&D projects;

(b) establish a portfolio of priority pharmaceutical R&D projects addressing at least the following therapeutic areas

(i) the development of priority antimicrobials provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account as a priority any equivalent list of priority pathogens adopted at Union level;

(ii) the development of medicinal products for high unmet medical needs as referred to in Article 70(1) of this Regulation and unmet medical needs as referred to in Article 83 of [revised Directive 2001/83/EC], in particular for conditions not sufficiently addressed by the private sector and where the private R&D pipeline is unlikely to deliver on medicinal products and therapies;

(iii) the development of medicinal products for which the private sector charges excessive prices and for which alternatives or generic alternatives are non-existent or unaffordable;

(b) strengthen health security coordination within the Union during preparedness and crisis response times, and bringing together Member States, the industry and the relevant stakeholders in a common effort;

(c) address vulnerabilities and strategic dependencies within the Union related to the development, production, procurement, stockpiling and distribution of medical countermeasures;

(d) contribute to reinforce the global health emergency preparedness and response architecture;

(e) assess health threats and intelligence gathering relevant to medical countermeasures;

(f) promote advanced research and development of medical countermeasures and related technologies;

(g) search for, collect, collate, evaluate and disseminate relevant scientific and technical data in the field of antimicrobial countermeasures;

(h) address market challenges and boost the Union’s open strategic autonomy in medical countermeasures production; (i) swift procurement and distribution of medical countermeasures;

(j) increase stockpiling capacity of medical countermeasures;

(k) strengthen knowledge and skills in preparedness and response related to medical countermeasures;

(l) establish a Union push and pull incentive scheme to promote and accelerate the development of novel antimicrobials, as well as promote increased access to existing and newly developed antimicrobials;

(m) transmitting on request and making publicly available studies, assessment reports and summaries of conducted research;

(n) upon request, providing technical and scientific support in order to improve cooperation between the Union, its Member States, international organisations and third countries on scientific and technical issues relating to research and development of medicinal countermeasures especially on the field of antimicrobial resistance;

(o) establishing a mechanism of consultation of authorities or bodies active along the life cycle of medicinal products for human use for exchange of information and pooling of knowledge on general issues of scientific or technical nature related to the tasks of the EMF;

(p) cooperating with Union decentralised agencies and other scientific authorities and bodies established under Union law, notably the European Medicines Agency, European Chemicals Agency, the European Food Safety Authority, the European Centre for Disease Prevention and Control and the European Environment Agency as regards findings in the field of unmelt medical needs, especially novel antibiotics;

(q) coordinating the identification and management of the Union list of critical medicinal products referred to in Article 131.

Or. en

Amendment 894

Tiemo Wölken

Proposal for a regulation

Article 40 c (new)

Text proposed by the Commission

Amendment

Article 40c

International cooperation

1. In so far as is necessary in order to achieve the objectives set out in this Regulation, and without prejudice to the respective competences of the Member States and the institutions of the Union, the EMF may cooperate with the competent authorities of third countries and/or with international organisations. To this end, the EMF may, subject to prior approval by the Commission, establish working arrangements with the authorities of third countries and international organisations, with regard to:

(a) the exchange of information, including non-public information, where relevant jointly with the Commission;

(b) sharing of scientific resources and expertise, with a view to facilitating collaboration, while maintaining independent assessment and under conditions determined beforehand by the Management Board, in agreement with the Commission;

(c) the participation in certain aspects of the EMF 's work, under conditions determined beforehand by the Management Board, in agreement with the Commission. These arrangements shall not create legal obligations incumbent on the Union and its Member States.

2. The EMF shall ensure that it is not seen as representing the Union position to an outside audience or as committing the Union to international cooperation.

Or. en

Amendment 895

Tiemo Wölken

Proposal for a regulation

Article 40 d (new)

Text proposed by the Commission

Amendment

Article40d

Administrative and management structure of the European Medicines Facility

The EMF shall comprise:

(a) a Management Board;

(b) an Executive Director;

(d) the Committee for measures to incentivise the creation of antimicrobial; (e) the Committee on availability and supply of crisis-relevant medical countermeasures;

(f) EMF Advisory Forum;

(g) a pool of experts from Member States and relevant stakeholders to work in the ad hoc working groups; the members shall be selected based on relevant experience in relation to the different ad hoc working groups, so they can contribute to the regulatory support and scientific advice procedures, and they shall be free of any conflicts of interest;

(h) a Secretariat, which shall provide technical, scientific and administrative support to all bodies of the EMF and ensure appropriate coordination between them.

Or. en

Amendment 896

Tiemo Wölken

Proposal for a regulation

Article 40 e (new)

Text proposed by the Commission

Amendment

Article 40e

Management Board of the EMF

1. The EMF Management Board shall be composed of one representative from each Member State, two representatives of the Commission and two representatives of the European Parliament, all with voting rights.

In addition, two representatives of patients' organisations, one representative of doctors' organisations, and one representative of veterinarians' organisations, all without voting rights, shall be appointed by the Council in consultation with the European Parliament on the basis of a list drawn up by the Commission which includes appreciably more names than there are posts to be filled. The list drawn up by the Commission shall be forwarded to the European Parliament, together with the relevant background documents. As quickly as possible, and at the latest within three months of notification, the European Parliament may submit its views for consideration to the Council, which shall then appoint these representatives to the Management Board.

The members of the Management Board shall be appointed in such a way as to guarantee the highest levels of specialist qualifications, a broad spectrum of relevant expertise and the broadest possible geographic spread within the European Union.

2. Members of the Management Board and their alternates shall be appointed on the basis of their knowledge, recognised experience and commitment in the field of medical countermeasures, antimicrobial and other unmet medical neds, taking into account relevant managerial, administrative and budgetary expertise.

All parties represented in the Management Board shall make efforts to limit turnover of their representatives, in order to ensure continuity of the work of the Management Board. All parties shall aim to achieve a balanced representation between men and women on the Management Board.

3. Each Member State and the Commission shall appoint their members of the EMF Management Board as well as an alternate who will replace the member in their absence and vote on their behalf.

Or. en

Amendment 897

Tiemo Wölken

Proposal for a regulation

Article 40 f (new)

Text proposed by the Commission

Amendment

Article 40f

EMF Advisory Forum

1. The EMF Advisory Forum (‘Forum’) shall constitute a mechanism for an exchange of information on preparedness and response in the area of medical countermeasures and the pooling of knowledge and expertise. It shall ensure close cooperation between EMF and the competent bodies in the Member States, in particular on the planning and implementation of scientific, health and industrial activities of EMF.

2. The Forum shall be composed of members from technically competent bodies designated by each Member State. Members of the Forum shall not be members of the EMF Board.

3. The Forum shall support the EMF Board in providing scientific and technical advice.

4. The EMF Board may set up sub-groups of the Forum for the purpose of examining specific questions in the fields of science, research or industrial matters. In particular, a subgroup named ‘Joint Industrial Cooperation Forum’ composed of the representatives of the industry and Member States shall be set up. The sub-groups shall report to the Forum. They shall be dissolved as soon as their mandate is fulfilled.

5. The Forum and its sub-groups shall be chaired by a representative of the Commission. It shall meet regularly upon the invitation of the EMF Executive Director and at least four times per year.

6. Representatives of the Commission’s departments may participate in the work of the Forum.

7. The Commission shall provide the secretariat for the Forum.

8. The EMF Executive Director may invite experts or representatives of professional or scientific bodies, or non-governmental organisations with recognised experience in disciplines related to the work of EMF to cooperate in specific tasks and to take part in the relevant activities of the Forum.

Or. en

Amendment 898

Tiemo Wölken

Proposal for a regulation

Article 40 g (new)

Text proposed by the Commission

Amendment

Article 40g

Committee for measures to incentivise the creation of antimicrobials

1. The Committee on availability and supply of crisis-relevant medical countermeasures shall be responsible for drawing up strategies for the improvement of preparedness and response to serious cross-border threats in the area of medical countermeasures, in particular by:

(a) strengthen health security coordination within the Union during preparedness and crisis response times, and bringing together Member States, the industry and the relevant stakeholders in a common effort;

(b) address vulnerabilities and strategic dependencies within the Union related to the development, production, procurement, stockpiling and distribution of medical countermeasures;

3. The Committee on availability and supply of crisis-relevant medical countermeasures shall be composed of the following:

(a) one member and one alternate member appointed by each Member State, in accordance with paragraph 6;

(b) four co-opted members chosen by the Committee among experts proposed by Member States or the EMF on the basis of their specific academic or scientific competence and expertise, with a view to ensuring that the relevant expertise is available within the Committee for the purpose of working groups and ad-hoc working groups in the field of antimicrobial resistance;

(c) four members and one alternate members appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent healthcare professionals;

(d) four members and four alternate members appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent patient organisations.

4. The Committee on availability and supply of crisis-relevant medical countermeasures may co-opt a maximum of five additional members chosen on the basis of their specific academic or scientific competence. Those members shall be appointed for a term of three years, which may be renewed, and shall not have alternates. With a view to the co-opting of such members, the Committee on availability and supply of crisis-relevant medical countermeasures shall identify the specific complementary scientific competence of the additional member or members. Co-opted members shall be chosen among experts nominated by Member States or the EMF.

5. The alternates shall represent and vote for the members in their absence and may also be appointed to act as rapporteurs. Members and alternates shall be chosen for their role and experience in the evaluation of medicinal products for human use as appropriate and shall represent the competent authorities of the Member States.

6. The members and alternate members of the Committee on availability and supply of crisis-relevant medical countermeasures shall be appointed on the basis of their relevant expertise in the field of antimicrobial incentives, in order to guarantee the highest levels of specialist qualifications and a broad spectrum of relevant expertise. The Member States shall cooperate in order to ensure that the final composition of the Committee on availability and supply of crisis-relevant medical countermeasures provides appropriate and balanced coverage of all scientific areas relevant to its tasks taking into account scientific developments and new types of medicinal products. For this purpose, Member States shall liaise with the Management Board and the Commission.

7. The members and alternate members of the Committee on availability and supply of crisis-relevant medical countermeasures shall be appointed for a term of three years, which may be renewed following the procedures referred to in paragraph 6. The Committee shall elect its chairperson and vice-chairperson from among its members for a term of 3 years, which may be prolonged once.

8. The Committee on availability and supply of crisis-relevant medical countermeasures shall establish its own rules of procedure. These rules shall, in particular, lay down:

(a) procedures for appointing and replacing the chairperson;

(b) procedures relating to working parties and scientific advisory groups.

They shall enter into force after receiving a favourable opinion from the Commission and the Management Board.

Or. en

Amendment 899

Maria Angela Danzì

Proposal for a regulation

Article 41

Text proposed by the Commission

Amendment

Article 41

deleted

Transfer and use of the voucher

A voucher may be used to extend the data protection for a period of 12 months of the priority antimicrobial or another medicinal product authorised in accordance with this Regulation of the same or different marketing authorisation holder.

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection.

A voucher may only be used if the marketing authorisation of the priority antimicrobial for which the right was initially granted has not been withdrawn.

2. To use the voucher, its owner shall apply for a variation of the marketing authorisation concerned in accordance with Article 47 to extend the data protection.

3. A voucher may be transferred to another marketing authorisation holder and shall not be transferred further.

4. A marketing authorisation holder to whom a voucher is transferred shall notify the Agency of the transfer within 30 days, stating the value of the transaction between the two parties. The Agency shall make this information publicly available.

Or. it

Justification

The development of antimicrobials should be supported by other types of incentive, such as direct financial incentives.

Amendment 900

Kateřina Konečná

Proposal for a regulation

Article 41

Text proposed by the Commission

Amendment

Article 41

deleted

Transfer and use of the voucher

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection.

A voucher may only be used if the marketing authorisation of the priority antimicrobial for which the right was initially granted has not been withdrawn.

2. To use the voucher, its owner shall apply for a variation of the marketing authorisation concerned in accordance with Article 47 to extend the data protection.

3. A voucher may be transferred to another marketing authorisation holder and shall not be transferred further.

Or. en

Amendment 901

Tilly Metz

Proposal for a regulation

Article 41

Text proposed by the Commission

Amendment

Article 41

deleted

Transfer and use of the voucher

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection.

A voucher may only be used if the marketing authorisation of the priority antimicrobial for which the right was initially granted has not been withdrawn.

2. To use the voucher, its owner shall apply for a variation of the marketing authorisation concerned in accordance with Article 47 to extend the data protection.

3. A voucher may be transferred to another marketing authorisation holder and shall not be transferred further.

Or. en

Amendment 902

Alessandra Moretti

Proposal for a regulation

Article 41

Text proposed by the Commission

Amendment

Article 41

deleted

Transfer and use of the voucher

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection.

A voucher may only be used if the marketing authorisation of the priority antimicrobial for which the right was initially granted has not been withdrawn.

2. To use the voucher, its owner shall apply for a variation of the marketing authorisation concerned in accordance with Article 47 to extend the data protection.

3. A voucher may be transferred to another marketing authorisation holder and shall not be transferred further.

Or. en

Amendment 903

Frédérique Ries, Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 41

Text proposed by the Commission

Amendment

Article 41

deleted

Transfer and use of the voucher

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection.

A voucher may only be used if the marketing authorisation of the priority antimicrobial for which the right was initially granted has not been withdrawn.

2. To use the voucher, its owner shall apply for a variation of the marketing authorisation concerned in accordance with Article 47 to extend the data protection.

3. A voucher may be transferred to another marketing authorisation holder and shall not be transferred further.

Or. en

Amendment 904

Catherine Amalric, Max Orville

Proposal for a regulation

Article 41

Text proposed by the Commission

Amendment

Article 41

deleted

Transfer and use of the voucher

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection.

A voucher may only be used if the marketing authorisation of the priority antimicrobial for which the right was initially granted has not been withdrawn.

2. To use the voucher, its owner shall apply for a variation of the marketing authorisation concerned in accordance with Article 47 to extend the data protection.

3. A voucher may be transferred to another marketing authorisation holder and shall not be transferred further.

Or. en

Amendment 905

Catherine Amalric, Max Orville

Proposal for a regulation

Article 41 – paragraph 1

Text proposed by the Commission

Amendment

1. A voucher may be used to extend the data protection for a period of 12 months of the priority antimicrobial or another medicinal product authorised in accordance with this Regulation of the same or different marketing authorisation holder.

deleted

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection.

A voucher may only be used if the marketing authorisation of the priority antimicrobial for which the right was initially granted has not been withdrawn.

Or. en

Amendment 906

Catherine Amalric, Max Orville

Proposal for a regulation

Article 41 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 907

Pernille Weiss

Proposal for a regulation

Article 41 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

A voucher granted by the Commission shall be subject to a public auction by the Agency. The financial value to be payed to the applicant by the winner of the auction is predetermined by the voucher category as set out in Article 40. Thus, those wishing to participate in the auction shall bid for the shortest data protection extension for which they are willing to pay the financial amount of the voucher category to the applicant.

The voucher may be used to extend the data protection of a medicinal product authorised in accordance with this Regulation for the period of the winning bid.

Or. en

Amendment 908

Sara Cerdas

Proposal for a regulation

Article 41 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

A voucher may be used to accelerate the assessment procedure of the applicant priority antimicrobial or another medicinal product in accordance with Article 40(2) of this Regulation of the same or different marketing authorisation applicant.

Or. en

Justification

Giving 12 additional months of data protection for one authorised medicinal product means that a pharmaceutical company will chose to attribute it to a medicinal product with a high revenue and which data protection is about to expire. I believe that the consumer and Member States reimbursing consumers will not be benefited from this since they will keep paying a high price for an authorised medicinal product and in the future for the antimicrobial. This "double" expense is unnecessary. Therefore, adopting the accelerated assessment procedure does not pose any additional public spending on any medicinal product.

Amendment 909

Catherine Amalric, Max Orville

Proposal for a regulation

Article 41 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection.

deleted

Or. en

Amendment 910

Sara Cerdas

Proposal for a regulation

Article 41 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection.

A voucher shall only be used once and in relation to a single medicinal product.

Or. en

Justification

In the context of an accelerated assessment procedure voucher, this is not adequate as it is going to be used in a medicinal product still which is not authorised yet.

Amendment 911

Pernille Weiss

Proposal for a regulation

Article 41 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection.

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if at least two years of regulatory data protection is remaining for that product.

Or. en

Amendment 912

Jessica Polfjärd

Proposal for a regulation

Article 41 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection.

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product has at least two years of regulatory data protection remaining.

Or. en

Justification

This proposed amendment widens the scope of products eligible for TEV and at the same time ensuring sufficient predictability for generic manufacturers. A wider scope of products eligible improves the possibilities that TEV can be used and therefore improves the potential impact and appeal of the incentive programme.

Amendment 913

Fulvio Martusciello

Proposal for a regulation

Article 41 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection.

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product has at least two years of regulatory data protection remaining.

Or. en

Amendment 914

Tomislav Sokol, Stelios Kympouropoulos

Proposal for a regulation

Article 41 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first four years of regulatory data protection.

A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product has at least two years of regulatory data protection remaining.

Or. en

Amendment 915

Catherine Amalric, Max Orville

Proposal for a regulation

Article 41 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

A voucher may only be used if the marketing authorisation of the priority antimicrobial for which the right was initially granted has not been withdrawn.

deleted

Or. en

Amendment 916

Catherine Amalric, Max Orville

Proposal for a regulation

Article 41 – paragraph 2

Text proposed by the Commission

Amendment

2. To use the voucher, its owner shall apply for a variation of the marketing authorisation concerned in accordance with Article 47 to extend the data protection.

deleted

Or. en

Amendment 917

Sara Cerdas

Proposal for a regulation

Article 41 – paragraph 2

Text proposed by the Commission

Amendment

2. To use the voucher, its owner shall apply for a variation of the marketing authorisation concerned in accordance with Article 47 to extend the data protection.

deleted

Or. en

Justification

In the context of an accelerated assessment procedure voucher.

Amendment 918

Catherine Amalric, Max Orville

Proposal for a regulation

Article 41 – paragraph 3

Text proposed by the Commission

Amendment

3. A voucher may be transferred to another marketing authorisation holder and shall not be transferred further.

deleted

Or. en

Amendment 919

Pernille Weiss

Proposal for a regulation

Article 41 – paragraph 3

Text proposed by the Commission

Amendment

3. A voucher may be transferred to another marketing authorisation holder and shall not be transferred further.

3. When an auction is completed, and the voucher has been transfered to the auction winner, the voucher shall not be transferred further.

Or. en

Amendment 920

Sara Cerdas

Proposal for a regulation

Article 41 – paragraph 3

Text proposed by the Commission

Amendment

3. A voucher may be transferred to another marketing authorisation holder and shall not be transferred further.

3. A voucher may be transferred to another marketing authorisation applicant and shall not be transferred further.

Or. en

Justification

In the context of an accelerated assessment procedure voucher.

Amendment 921

Catherine Amalric, Max Orville

Proposal for a regulation

Article 41 – paragraph 4

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 922

Pernille Weiss

Proposal for a regulation

Article 41 – paragraph 4

Text proposed by the Commission

Amendment

4. The Agency shall make information regarding the voucher category value and the lenght of data exclusivity extension of the winning bid publicly available.

Or. en

Amendment 923

Peter Liese

Proposal for a regulation

Article 41 – paragraph 4

Text proposed by the Commission

Amendment

4. A marketing authorisation holder to whom a voucher is transferred shall notify the Agency of the transfer within 45 days, stating the value of the transaction between the two parties. The Agency shall make this information publicly available.

Or. en

Justification

A 45-day window provides a more reasonable timeframe for marketing authorisation holders to notify the Agency.

Amendment 924

Sara Cerdas

Proposal for a regulation

Article 41 – paragraph 4

Text proposed by the Commission

Amendment

4. A marketing authorisation applicant to whom a voucher is transferred shall notify the Agency its intention of the voucher transfer within 30 days, stating the value of the transaction between the two parties. The Agency shall make this information publicly available.

Or. en

Justification

In the context of an accelerated assessment procedure voucher. If a medicinal product is still in the pipeline of development, it might not possible to transfer the voucher so soon.

Amendment 925

Sara Cerdas

Proposal for a regulation

Article 41 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The acceleration assessment procedure voucher does not have an expiration date.

Or. en

Justification

The Priority Review Voucher (PRV) does not have a expiry date and so it doesn't this proposal as well. A medicinal product might take more than 10 years to develop and the accelerated assessment procedure shal cease to exist in different conditions.

Amendment 926

Maria Angela Danzì

Proposal for a regulation

Article 42

Text proposed by the Commission

Amendment

Article 42

deleted

Validity of the voucher

1. A voucher shall cease to be valid in the following cases:

(a) where the Commission adopts a decision in accordance with Article 47 to extend the data protection of the receiving medicinal product;

(b) where it is not used within 5 years from the date it was granted.

3. Without prejudice to patent rights, or supplementary protection certificates69, if a priority antimicrobial is withdrawn from the Union market prior to expiry of the periods of market and data protection laid down in Articles 80 and 81 of [revised Directive 2001/83/EC], those periods shall not prevent the validation, authorisation and placing on the market of a medicinal product using the priority antimicrobial as a reference medicinal product in accordance with Chapter II, Section 2 of [revised Directive 2001/83].

_________________

69 Regulation (EC) No 469/2009 of the European Parliament and of the Council, (OJ L 152, 16.6.2009, p. 1).

Or. it

Justification

The development of antimicrobials should be supported by other types of incentive, such as direct financial incentives.

Amendment 927

Tilly Metz

Proposal for a regulation

Article 42

Text proposed by the Commission

Amendment

Article 42

deleted

Validity of the voucher

1. A voucher shall cease to be valid in the following cases:

(a) where the Commission adopts a decision in accordance with Article 47 to extend the data protection of the receiving medicinal product;

(b) where it is not used within 5 years from the date it was granted.

3. Without prejudice to patent rights, or supplementary protection certificates69 , if a priority antimicrobial is withdrawn from the Union market prior to expiry of the periods of market and data protection laid down in Articles 80 and 81 of [revised Directive 2001/83/EC], those periods shall not prevent the validation, authorisation and placing on the market of a medicinal product using the priority antimicrobial as a reference medicinal product in accordance with Chapter II, Section 2 of [revised Directive 2001/83].

_________________

69 Regulation (EC) No 469/2009 of the European Parliament and of the Council, (OJ L 152, 16.6.2009, p. 1).

Or. en

Amendment 928

Alessandra Moretti

Proposal for a regulation

Article 42

Text proposed by the Commission

Amendment

Article 42

deleted

Validity of the voucher

1. A voucher shall cease to be valid in the following cases:

(a) where the Commission adopts a decision in accordance with Article 47 to extend the data protection of the receiving medicinal product;

(b) where it is not used within 5 years from the date it was granted.

3. Without prejudice to patent rights, or supplementary protection certificates69 , if a priority antimicrobial is withdrawn from the Union market prior to expiry of the periods of market and data protection laid down in Articles 80 and 81 of [revised Directive 2001/83/EC], those periods shall not prevent the validation, authorisation and placing on the market of a medicinal product using the priority antimicrobial as a reference medicinal product in accordance with Chapter II, Section 2 of [revised Directive 2001/83].

_________________

69 Regulation (EC) No 469/2009 of the European Parliament and of the Council, (OJ L 152, 16.6.2009, p. 1).

Or. en

Amendment 929

Catherine Amalric, Max Orville

Proposal for a regulation

Article 42

Text proposed by the Commission

Amendment

Article 42

deleted

Validity of the voucher

1. A voucher shall cease to be valid in the following cases:

(a) where the Commission adopts a decision in accordance with Article 47 to extend the data protection of the receiving medicinal product;

(b) where it is not used within 5 years from the date it was granted.

3. Without prejudice to patent rights, or supplementary protection certificates69 , if a priority antimicrobial is withdrawn from the Union market prior to expiry of the periods of market and data protection laid down in Articles 80 and 81 of [revised Directive 2001/83/EC], those periods shall not prevent the validation, authorisation and placing on the market of a medicinal product using the priority antimicrobial as a reference medicinal product in accordance with Chapter II, Section 2 of [revised Directive 2001/83].

_________________

69 Regulation (EC) No 469/2009 of the European Parliament and of the Council, (OJ L 152, 16.6.2009, p. 1).

Or. en

Amendment 930

Frédérique Ries, Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 42

Text proposed by the Commission

Amendment

Article 42

deleted

Validity of the voucher

1. A voucher shall cease to be valid in the following cases:

(a) where the Commission adopts a decision in accordance with Article 47 to extend the data protection of the receiving medicinal product;

(b) where it is not used within 5 years from the date it was granted.

3. Without prejudice to patent rights, or supplementary protection certificates69 , if a priority antimicrobial is withdrawn from the Union market prior to expiry of the periods of market and data protection laid down in Articles 80 and 81 of [revised Directive 2001/83/EC], those periods shall not prevent the validation, authorisation and placing on the market of a medicinal product using the priority antimicrobial as a reference medicinal product in accordance with Chapter II, Section 2 of [revised Directive 2001/83].

_________________

69 Regulation (EC) No 469/2009 of the European Parliament and of the Council, (OJ L 152, 16.6.2009, p. 1).

Or. en

Amendment 931

Kateřina Konečná

Proposal for a regulation

Article 42

Text proposed by the Commission

Amendment

Article 42

deleted

Validity of the voucher

1. A voucher shall cease to be valid in the following cases:

(a) where the Commission adopts a decision in accordance with Article 47 to extend the data protection of the receiving medicinal product;

(b) where it is not used within 5 years from the date it was granted.

3. Without prejudice to patent rights, or supplementary protection certificates69 , if a priority antimicrobial is withdrawn from the Union market prior to expiry of the periods of market and data protection laid down in Articles 80 and 81 of [revised Directive 2001/83/EC], those periods shall not prevent the validation, authorisation and placing on the market of a medicinal product using the priority antimicrobial as a reference medicinal product in accordance with Chapter II, Section 2 of [revised Directive 2001/83].

_________________

69 Regulation (EC) No 469/2009 of the European Parliament and of the Council, (OJ L 152, 16.6.2009, p. 1).

Or. en

Amendment 932

Sara Cerdas

Proposal for a regulation

Article 42 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) where the Commission adopts a decision in accordance with Article 47 to extend the data protection of the receiving medicinal product;

(a) where the Commission adopts a decision in accordance with Article 47 to transfer the voucher to another medicinal product;

Or. en

Justification

In the context of an accelerated assessment procedure voucher.

Amendment 933

Sara Cerdas

Proposal for a regulation

Article 42 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) In case the transfer of voucher occurs, the party holding the voucher does not comply with the corporate sustainability reporting as referred to in Commission Directive (EU) 2022/24641a, or does not present any environmental plans to reduce its carbon footprint.

Or. en

Justification

In the context of an accelerated assessment procedure voucher. Applicants who stop complying to corporate sustainability shall not use the voucher anymore in the future.

Amendment 934

Tomislav Sokol, Stelios Kympouropoulos

Proposal for a regulation

Article 42 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission may revoke the voucher prior to its transfer as referred to in Article 41(3) if in normal circumstances, a reasonable request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled, where such request is consistent with the expected needs of the Union market and the non-fulfilment is not due to circumstances beyond the control of the marketing authorisation holder .

Or. en

Amendment 935

Fulvio Martusciello

Proposal for a regulation

Article 42 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 936

Jessica Polfjärd

Proposal for a regulation

Article 42 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission may revoke the voucher prior to its transfer as referred to in Article 41(3) if a reasonable request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled, where such request is in line with the predicted needs of the market of the Union and the non-fulfilment not is due to situations beyond the control of the holder to the marketing authorisation.

Or. en

Justification

During urgent circumstances (e.g. pandemics or other unforeseen emergencies), the ability to supply products of the industry may be significantly hampered due to different factors beyond its control. These factors could involve global disruptions and trade restrictions (among others). In such situations, it is not reasonable that the industry should be held accountable for the inability to fulfil requests for the priority antimicrobial.

Amendment 937

Andrey Slabakov

Proposal for a regulation

Article 42 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission may revoke the voucher prior to its transfer as referred to in Article 41(3) if a request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled. Such a decision to revoke shall take into account whether the non-fulfilment is not due to circumstances beyond the control of the marketing authorisation holder.

Or. en

Amendment 938

Peter Liese

Proposal for a regulation

Article 42 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission may revoke the voucher as referred to in Article 41(3) if a request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled. To protect the buyer from damage resulting from a possible revocation of a voucher after the transfer, seller and buyer shall make contractual liability arrangements.

Or. en

Justification

The extension of market exclusivity through a voucher is conditional on the uninterrupted supply of the priority antimicrobial. If the supplier fails to meet this obligation, the voucher should be revoked. To mitigate any potential loss from this revocation, sellers and buyers should agree on liability terms in advance.

Amendment 939

Sara Cerdas

Proposal for a regulation

Article 42 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Where the priority antimicrobial is withdrawn from the Union market prior to expiry of the periods of market and data protection laid down in Articles 80 and 81 of [revised Directive 2001/83/EC], the marketing authorisation application for the medicinal product using the voucher shall proceed under the conditions set in the Article 6(6) of this Regulation.

Or. en

Justification

In the context of an accelerated assessment procedure voucher. If the antimicrobial is withdrawn from the market prior to the expiry of the periods of market and data protection, the medicinal product using the voucher shall be evaluated for marketing authorisation procedure in a regular assessment time.

Amendment 940

Maria Angela Danzì

Proposal for a regulation

Article 43

Text proposed by the Commission

Amendment

Article 43

deleted

43 This Chapter shall apply until [Note to OP:insert the date of 15 years after the date of entry into force of this Regulation] or until the date when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest.

This Chapter shall apply until [Note to OP: insert the date of 15 years after the date of entry into force of this Regulation] or until the date when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest.

Or. it

Justification

The development of antimicrobials should be supported by other types of incentive, such as direct financial incentives.

Amendment 941

Tilly Metz

Proposal for a regulation

Article 43

Text proposed by the Commission

Amendment

Article 43

deleted

Duration of application of Chapter III

Or. en

Amendment 942

Catherine Amalric, Max Orville

Proposal for a regulation

Article 43

Text proposed by the Commission

Amendment

Article 43

deleted

Duration of application of Chapter III

Or. en

Amendment 943

Alessandra Moretti

Proposal for a regulation

Article 43

Text proposed by the Commission

Amendment

Article 43

deleted

Duration of application of Chapter III

Or. en

Amendment 944

Frédérique Ries, Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 43

Text proposed by the Commission

Amendment

Article 43

deleted

Duration of application of Chapter III

Or. en

Amendment 945

Kateřina Konečná

Proposal for a regulation

Article 43

Text proposed by the Commission

Amendment

Article 43

deleted

Duration of application of Chapter III

Or. en

Amendment 946

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 43 – paragraph 1

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 947

Pernille Weiss

Proposal for a regulation

Article 43 – paragraph 1

Text proposed by the Commission

Amendment

This Chapter shall be subject to a review by the Commission by [Note to OP: insert the date of 15 years after the date of entry into force of this Regulation] or until the date when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest.

Or. en

Amendment 948

Fulvio Martusciello

Proposal for a regulation

Article 43 – paragraph 1

Text proposed by the Commission

Amendment

This Chapter shall apply from the entry into force of this Regulation.

[15 years after the date of entry into force of this Regulation] or when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest , the Commission shall submit a report to the European Parliament and to the Council containing a scientific assessment measuring progress towards sustainable antimicrobial research and development and according to future medical needs.

Or. en

Amendment 949

Dolors Montserrat

Proposal for a regulation

Article 43 – paragraph 1

Text proposed by the Commission

Amendment

This Chapter shall apply from the entry into force of this Regulation. 15 years after the date of entry into force of this Regulation, or when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest, the Commission shall submit a report to the European Parliament and to the Council containing a scientific assessment measuring progress towards sustainable antimicrobial research and development and according to future medical needs.

Or. en

Amendment 950

Tomislav Sokol, Stelios Kympouropoulos

Proposal for a regulation

Article 43 – paragraph 1

Text proposed by the Commission

Amendment

This Chapter shall apply from the entry into force of this Regulation. 15 years after the date of entry into force of this Regulation or when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest, the Commission shall submit a report to the European Parliament and to the Council containing a scientific assessment measuring progress towards sustainable antimicrobial research and development and according to future medical needs.

Or. en

Amendment 951

Margarita de la Pisa Carrión

Proposal for a regulation

Article 43 – paragraph 1

Text proposed by the Commission

Amendment

This Chapter shall apply from the entry into force of this Regulation. 15 years or when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest, the Commission shall submit a report to the European Parliament and to the Council containing a scientific assessment measuring progress towards sustainable antimicrobial research and development and according to future medical needs.

Or. en

Amendment 952

Andrey Slabakov

Proposal for a regulation

Article 43 – paragraph 1

Text proposed by the Commission

Amendment

This Chapter shall apply from the entry into force of this Regulation and until the measures established in the Action Plan referred to in Article 43a enter into force, or until the date when the Commission has granted a total of 10 vouchers in accordance with this Chapter, whichever date is the earliest.

Or. en

Amendment 953

Jessica Polfjärd

Proposal for a regulation

Article 43 – paragraph 1

Text proposed by the Commission

Amendment

This Chapter shall apply until [Note to OP: insert the date of 15 years after the date of entry into force of this Regulation] or until the date when the Commission has granted a total of 12 vouchers in accordance with this Chapter, whichever date is the earliest.

Or. en

Amendment 954

Andrey Slabakov

Proposal for a regulation

Article 43 a (new)

Text proposed by the Commission

Amendment

Article43a

Establishing long-term measures to address Antimicrobial Resistance in the Union

1. The Commission shall, by [one year after the date of entry into force of this Regulation], develop a comprehensive Action Plan against Antimicrobial Resistance (the "Action Plan"), building on the current and ongoing work in the field. The goal of the Action Plan will be to establish long-term measures addressing the pharmaceutical market failures in the Union and to develop appropriate incentives in order to secure access to novel antimicrobials.

2. The Action Plan shall:

(a) serve as a continuation and replacement of the measure established in Article 40 of this Regulation;

(b) set out long-term health priorities in the public interest at Union level, in the form of a strategic roadmap with a number of specific purpose-led R&D projects; the roadmap will be elaborated and updated through continuing, transparent consultations with:

(i) representatives of each Member State, including national public health authorities;

(ii) relevant stakeholders, including public health authorities at Union level, clinician representatives and patient organisations;

(iii) relevant agencies established at Union level;

(c) establish a portfolio of priority R&D projects addressing at least the development of priority antimicrobials provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account any equivalent list of priority pathogens adopted at Union level;

(d) establish a Union push and pull incentive scheme to promote and accelerate the development of novel antimicrobials, as well as promote increased access to existing and newly developed antimicrobials. Member States shall be encouraged to participate in the Union level scheme. The scheme will be established through separate legislative acts and contain at least the following elements:

(i) research grants under Union funds with conditionalities linked to the affordability and supply of new and existing antimicrobials;

(ii) milestone prizes for novel antimicrobial developers with conditionalities linked to the affordability and supply of new and existing antimicrobials;

(iii) voluntary joint procurement with subscription payment mechanisms or market entry rewards that delink or partially delink revenues and sales;

(iv) an annual revenue guarantee scheme, aimed at securing access to antibioticsin line with the 2021 Health Council Conclusions;

(e) contain appropriate and proportionate requirements for transparency and compliance, monitored by the Commission with assistance from public health authorities at Union and national level;

3. The Commission shall, as part of the Action Plan, develop a roadman for the application, and cessation thereof, of Article 40, in accordance with Article 43.

Or. en

Amendment 955

Stanislav Polčák

Proposal for a regulation

Article 44 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

If, in the event of a risk to public health, the marketing authorisation holder takes urgent safety or efficacy restrictions on their own initiative, the marketing authorisation holder shall immediately inform the Agency.

If, in the event of a risk to public health or the environment, the marketing authorisation holder takes urgent safety or efficacy restrictions on their own initiative, the marketing authorisation holder shall immediately inform the Agency.

Or. cs

Amendment 956

Stanislav Polčák

Proposal for a regulation

Article 44 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

In the event of a risk to public health, the Commission may vary the marketing authorisation to impose urgent safety or efficacy restrictions on the marketing authorisation holder.

In the event of a risk to public health or the environment, the Commission may vary the marketing authorisation to impose urgent safety or efficacy restrictions on the marketing authorisation holder.

Or. cs

Amendment 957

Sirpa Pietikäinen

Proposal for a regulation

Article 45 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

The marketing authorisation holder shall without undue delay inform the Agency and the Commission of any prohibition or restriction imposed on the marketing authorisation holder or any entity in contractual relationship with the marketing authorisation holder by the competent authorities of any country in which the medicinal product is marketed and of any other new information which might influence the evaluation of the benefits and risks of the medicinal product concerned. The information shall include both positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the marketing authorisation, as well as data on the use of the medicinal product where such use is outside the terms of the marketing authorisation.

The marketing authorisation holder shall without undue delay inform the Agency and the Commission of any prohibition or restriction imposed on the marketing authorisation holder or any entity in contractual relationship with the marketing authorisation holder by the competent authorities of any country in which the medicinal product is marketed and of any other new information which might influence the evaluation of the benefits and risks, both health risks and environmental risks, of the medicinal product concerned. The information shall include both positive and negative results of clinical trials or other studies in all indications and populations, whether or not included in the marketing authorisation, as well as data on the use of the medicinal product where such use is outside the terms of the marketing authorisation.

Or. en

Amendment 958

Tilly Metz

Proposal for a regulation

Article 45 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

The Agency may at any time request the marketing authorisation holder to submit data demonstrating that the benefit-risk balance remains favourable. The marketing authorisation holder shall answer fully and promptly any such request. The marketing authorisation holder shall also respond fully and within the time limit set to any request of a competent authority regarding the implementation of any measures previously imposed, including risk minimisation measures.

The Agency may at any time request the marketing authorisation holder to submit data demonstrating that the benefit-risk balance remains favourable. The marketing authorisation holder shall answer fully and within the time limit set to any such request. The marketing authorisation holder shall also respond fully and within the time limit set any such request of a competent authority regarding the implementation of any measures previously imposed, including risk minimisation measures.

Or. en

Justification

Aligned with the text in the Directive

Amendment 959

István Ujhelyi

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

An entity not engaged in an economic activity (‘not-for-profit entity’) may submit to the Agency or to a competent authority of the Member State substantive non-clinical or clinical evidence for a new therapeutic indication that is expected to fulfil an unmet medical need.

An entity not engaged in an economic activity (‘not-for-profit entity’) may submit to the Agency or to a competent authority of the Member State substantive nonclinical or clinical evidence for a new therapeutic indication.

Or. en

Amendment 960

Tilly Metz

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

Repurposing medicines reduces development costs and can make life-changing treatments available to patients in a shorter time frame. Repurposed medicines’ safety profile is often better understood as molecules have already been tested and their use is well-documented. Submission of data for a new therapeutic indication of an off-patent medicine should not be limited to areas of unmet medical need, but it should be possible for all indications and the definition of UMN should be kept rather strict as it is linked to further incentives

Amendment 961

Kateřina Konečná

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 962

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 963

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 964

Stanislav Polčák

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

An entity not engaged in an economic activity as its main activity (‘not-for-profit entity’) may submit to the Agency or to a competent authority of the Member State substantive non-clinical or clinical evidence for a new therapeutic indication that is expected to fulfil an unmet medical need.

Or. cs

Amendment 965

Tomislav Sokol

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

The Agency may, at the request of a Member State, the Commission, or on its own initiative and on the basis of all available evidence make a scientific evaluation of the benefit-risk of the use of a medicinal product with a new therapeutic indication that concerns an unmet medical need.

The Agency may, at the request of a Member State, the Commission, or on its own initiative and on the basis of all available evidence, including any additional evidence that may be submitted by the marketing authorisation holders of the medicinal products concerned, make a scientific evaluation of the benefit-risk of the use of a medicinal product with a new therapeutic indication that concerns an unmet medical need. The evaluation shall consider the position of the marketing authorisation holders on the totality of evidence submitted.

Or. en

Amendment 966

Kateřina Konečná

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 967

István Ujhelyi

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 968

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 969

Tilly Metz

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 970

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 971

Tomislav Sokol

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

The opinion of the Agency shall be made publicly available and the competent authorities of the Member States shall be informed.

The opinion of the Agency shall be made publicly available and the competent authorities of the Member States and the marketing authorisation holders shall be informed.

Or. en

Amendment 972

Tilly Metz

Proposal for a regulation

Article 48 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

The opinion of the Agency shall be made publicly available and the competent authorities of the Member States shall be informed.

The opinion of the Agency shall be made publicly available and the competent authorities of the Member States and the marketing authorisation holder shall be informed.

Or. en

Amendment 973

István Ujhelyi

Proposal for a regulation

Article 48 – paragraph 2

Text proposed by the Commission

Amendment

2. In cases where the opinion is favourable, marketing authorisation holders of the medicinal products concerned shall submit a variation to update the product information with the new therapeutic indication.

2. In cases where the opinion is favourable, marketing authorisation holders of the medicinal products concerned shall be notified and given the possibility to comment. After consultation with the marketing authorisation holder, the Agency may submit a variation to update the product information with the new therapeutic indication. The marketing authorisation holder shall inform relevant stakeholders, such as healthcare professionals, of the added indication.

Or. en

Amendment 974

Tilly Metz

Proposal for a regulation

Article 48 – paragraph 3

Text proposed by the Commission

Amendment

3. Article 81(2), point (c) of [revised Directive 2001/83/EC] shall not apply for variations under this Article.

deleted

Or. en

Amendment 975

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 48 – paragraph 3

Text proposed by the Commission

Amendment

3. Article 81(2), point (c) of [revised Directive 2001/83/EC] shall not apply for variations under this Article.

3. Article 81(2), point (c) of [revised Directive 2001/83/EC] may apply for variations under this Article.

Or. en

Amendment 976

Tilly Metz

Proposal for a regulation

Article 51 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Competent authorities and the Agency shall have procedures in place to ensure independence, impartiality, transparency and that personnel performing supervisory activities are free from any conflict of interest.

Or. en

Justification

Missing aspect in this Article, text taken from SoHO regulation

Amendment 977

Catherine Amalric, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Article 52 – paragraph 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) to lend its assistance by participating in a joint inspection with the supervisory authority of the site. In that case the supervisory authority leads the inspection and the follow up thereof. After completion of the inspection, the supervisory authority grants the relevant good manufacturing practice (GMP) certificate and enters the certificate in the Union database; or

(a) to lend its assistance by participating in a joint inspection with the supervisory authority of the site to assess the respect of the good manufacturing practice (GMP) including the practices relating to the environmental and social standards. In that case the supervisory authority leads the inspection and the follow up thereof. After completion of the inspection, the supervisory authority grants the relevant good manufacturing practice (GMP) certificate and enters the certificate in the Union database; or

Or. en

Amendment 978

Tilly Metz

Proposal for a regulation

Article 53 – paragraph 2

Text proposed by the Commission

Amendment

2. In cooperation with the Agency, the Commission may adopt detailed guidelines laying down the principles applicable to those international inspection programmes.

2. In cooperation with the Agency, the Commission shall adopt detailed guidelines laying down the principles applicable to those international inspection programmes. The guidelines shall include rules on impartially, independence and conflict of interest of inspectors.

Or. en

Amendment 979

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Erik Poulsen

Proposal for a regulation

Article 56 – paragraph 1

Text proposed by the Commission

Amendment

Where the Agency concludes that a holder of a marketing authorisation granted in accordance with Article 19, including a new therapeutic indication granted referred to Article 19, failed to comply with the obligations laid down in the marketing authorisation, the Agency shall inform the Commission accordingly.

Where the Agency concludes that a holder of a marketing authorisation, or a new therapeutic indication, including when grouped with an extension of the marketing authorisation, granted in accordance with Article 19, including a new therapeutic indication granted referred to Article 19, failed to comply with the obligations laid down in the marketing authorisation, the Agency shall inform the Commission accordingly.

Or. en

Amendment 980

Tomislav Sokol

Proposal for a regulation

Article 56 – paragraph 1

Text proposed by the Commission

Amendment

Where the Agency concludes that a holder of a marketing authorisation granted in accordance with Article 19, or a new therapeutic indication, including when grouped with an extension of the marketing authorisation, including a new therapeutic indication granted referred to Article 19, failed to comply with the obligations laid down in the marketing authorisation, the Agency shall inform the Commission accordingly.

Or. en

Amendment 981

Tilly Metz

Proposal for a regulation

Article 56 – paragraph 1

Text proposed by the Commission

Amendment

Where the Agency concludes that a holder of a marketing authorisation granted in accordance with Article 19, including a new therapeutic indication granted referred to Article 19, failed to comply with the obligations laid down in the marketing authorisation, or with post-authorisation studies laid down in Article 20, the Agency shall inform the Commission accordingly.

Or. en

Amendment 982

Maria Angela Danzì

Proposal for a regulation

Article 56 – paragraph 1

Text proposed by the Commission

Amendment

Where the Agency concludes that a holder of a marketing authorisation granted in accordance with Article 19, including a new therapeutic indication granted referred to Article 19, failed to comply with the obligations laid down in the marketing authorisation, including under Article 20, the Agency shall inform the Commission accordingly.

Or. it

Justification

The marketing authorisation shall be revoked when the post-authorisation studies the marketing authorisation holder is obliged to conduct are not delivered in a timely manner.

Amendment 983

Andrey Slabakov

Proposal for a regulation

Article 58 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Such advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC].

Such advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC]. The scientific advice provided for medicinal products falling under Articles 9 to 13, 15 and 84 of [revised Directive 2001/83/EC] shall be adapted to the specificities of these products.

Or. en

Amendment 984

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 58 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Such advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC].

Such advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC], and for medicinal products used with an in vitro diagnostic medical device.

Or. en

Amendment 985

Tomislav Sokol

Proposal for a regulation

Article 58 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Such advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC].

Such advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC] and for medicinal products used with an in vitro diagnostic medical device.

Or. en

Amendment 986

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 58 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Such advice can also be requested for medicinal products referred to in Articles 83 and 84 of [revised Directive 2001/83/EC].

Or. en

Amendment 987

Tilly Metz

Proposal for a regulation

Article 58 – paragraph 2

Text proposed by the Commission

Amendment

2. In the preparation of the scientific advice referred to in paragraph 1 and upon request by undertakings or, as relevant, not-for-profit entities that requested the scientific advice, the Agency may consult experts of the Member States with clinical trial or medical device expertise or the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745.

2. In the preparation of the scientific advice referred to in paragraph 1 and upon request by undertakings or, as relevant, not-for-profit entities that requested the scientific advice, the Agency shall promote an open discussion about latest scientific developments and the update of scientific guidelines, and where relevant, shall consult experts of the Member States with clinical trial or medical device expertise or the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745.

Or. en

Amendment 988

Tomislav Sokol

Proposal for a regulation

Article 58 – paragraph 2

Text proposed by the Commission

Amendment

2. In the preparation of the scientific advice referred to in paragraph 1 and upon request by undertakings or, as relevant, not-for-profit entities that requested the scientific advice, the Agency may consult experts of the Member States with clinical trial or device expertise or the expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745.

Or. en

Amendment 989

Tilly Metz

Proposal for a regulation

Article 58 – paragraph 3

Text proposed by the Commission

Amendment

3. In the preparation of the scientific advice referred to in paragraph 1 and the Agency may consult authorities established in other Union legal acts as relevant for the provision of the scientific advice in question or other public bodies established in the Union, in particular those listed in Article 162 of this Regulation.

Or. en

Amendment 990

Tomislav Sokol

Proposal for a regulation

Article 58 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 991

Catherine Amalric, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Article 58 – paragraph 3

Text proposed by the Commission

Amendment

3. In the preparation of the scientific advice referred to in paragraph 1 and in duly justified cases, the Agency may consult authorities established in other Union legal acts as relevant for the provision of the scientific advice in question or other public bodies established in the Union, as applicable. To avoid any conflict of interest, the Agency shall ensure a separation between the experts responsible for providing scientific advice to a medicinal product developer and those subsequently involved in evaluating marketing authorisation for the same medicine. In the absence of a sufficient panel in the context of a rare disease, an exception may be granted.

Or. en

Amendment 992

Kateřina Konečná

Proposal for a regulation

Article 58 – paragraph 4

Text proposed by the Commission

Amendment

4. The Agency shall include in the European public assessment report the key areas of the scientific advice once the corresponding marketing authorisation decision has been taken in relation to the medicinal product, after deletion of any information of a commercially confidential nature.

4. The Agency shall include in the European public assessment report a detailed log of pre-submission activities, including scientific advice, once the corresponding marketing authorisation decision has been taken in relation to the medicinal product, after deletion of any information of a commercially confidential nature, unless there is an overriding public interest in disclosure.

In addition, the Agency shall publish and update on a monthly basis the list of products accepted for scientific advice together with the following information: (a) Name of the active substance; (b) Substance type; (c) Therapeutic area; (d) Therapeutic indication; (e) Type of data supporting the request; (f) Type of applicant; (g) Date of acceptance of the scientific advice request.

Or. en

Amendment 993

Catherine Amalric, Max Orville, Billy Kelleher

Proposal for a regulation

Article 58 – paragraph 4

Text proposed by the Commission

Amendment

4. The Agency shall include in the European public assessment report the key areas of the scientific advice. The Agency shall also indicate the names of experts, rapporteurs and coordinators giving scientific advice. This report shall be made publicly available once the corresponding marketing authorisation decision has been taken in relation to the medicinal product.

Or. en

Amendment 994

Tilly Metz

Proposal for a regulation

Article 58 – paragraph 4

Text proposed by the Commission

Amendment

4. The Agency shall include in the European public assessment report a detailed log of pre-submission activities, including scientific advice once the corresponding marketing authorisation decision has been taken in relation to the medicinal product, after deletion of any information of a commercially confidential nature.

Or. en

Justification

Amendments 4, 4a and 4b are based on the European Ombudsman’s Decision in strategic inquiry OI/7/2017/KR on how the European Medicines Agency engages with medicine developers in the period leading up to applications for authorisations to market new medicines in the EU, July 2019

Amendment 995

István Ujhelyi

Proposal for a regulation

Article 58 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The Agency shall, to the greatest extent possible, ensure that there is continuation between those responsible for providing scientific advice to a given medicinal product developer and those subsequently responsible for the evaluation of the marketing authorisation application for the same medicinal product.When appointing rapporteurs for the purpose of evaluating marketing authorisation applications, the Agency’s Committee on Medicinal Products for Human Use shall duly take into account any involvement of individuals as coordinators in providing scientific advice for the same medicinal product in the pre-submission stage of activities. It should be noted in the summary minutes of the meetings in accordance with Article 147 (2) whether there was continuation between those responsible for providing scientific advice to a given medicinal product and those subsequently responsible for the evaluation of the marketing authorisation application.

Or. en

Amendment 996

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Billy Kelleher, Dacian Cioloş

Proposal for a regulation

Article 58 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. When granting scientific advice, the Agency shall ensure to the greatest extent possible that there is a separation between those responsible for providing scientific advice to a medicine developer and those subsequently involved in evaluating a marketing authorisation application for the same medicinal product. The Agency shall ensure that at least one of the two rapporteurs for a marketing authorisation application should not have taken part in any pre-submission activities concerning the medicinal product. The reasons for any exceptions shall be documented and published with the European Public Assessment Report.

Or. en

Amendment 997

Kateřina Konečná

Proposal for a regulation

Article 58 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

The Agency shall ensure that at least one of the two rapporteurs for a marketing authorisation application should not have taken part in any pre-submission activities concerning the medicinal product. The reasons for any exceptions shall be documented and published with the European Public Assessment Report.

Or. en

Amendment 998

Tilly Metz

Proposal for a regulation

Article 58 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The Agency shall make publicly available and update on a monthly basis the list of products undergoing scientific advise, including the information on the active substance, therapeutic indication, stage of development, type of applicant and date, as well as names and affiliations of staff, rapporteurs and experts involved in the scientific advise. A summary of such information, including statistics per type of developer, indication, affiliations of rapporteurs and experts, shall be published in the Agency’s annual report.

Or. en

Amendment 999

Andrey Slabakov

Proposal for a regulation

Article 58 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 1000

Susana Solís Pérez, Catherine Amalric

Proposal for a regulation

Article 58 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Disclosed conflicts of interest and the mitigating actions implemented by the concerned individual(s) must be documented in the abridged minutes of the meetings, following the stipulations of Article 147(2).

Or. en

Amendment 1001

Tilly Metz

Proposal for a regulation

Article 58 – paragraph 4 b (new)

Text proposed by the Commission

Amendment

4 b. The Agency staff and experts from national competent authorities providing the scientific advice shall not be involved in a subsequent evaluation of marketing authorisation application for the same products. In cases where such situation is unavoidable due to specific expertise, it shall be stated and duly justified in the products’ European Public Assessment Report.

Or. en

Amendment 1002

Kateřina Konečná

Proposal for a regulation

Article 58 – paragraph 4 b (new)

Text proposed by the Commission

Amendment

4 b. In addition to providing scientific advice, the Agency shall ensure that scientific guidelines are updated and shall promote public discussion on scientific developments.

Or. en

Justification

The revised legislation should shift as much as possible the provision of today’s confidential scientific advice to the public domain. This could be done by requiring regulators to prioritise the development and update of scientific guidelines for the conduct of clinical trials and other studies, and to organise regularly public workshops to promote discussion and consensus on scientific developments.

Amendment 1003

Tomislav Sokol

Proposal for a regulation

Article 59 – paragraph 2

Text proposed by the Commission

Amendment

2. In case of medicinal products involving a medical device, undertakings or, as relevant, not-for-profit entities may request scientific advice as referred to in Article 58(1) in parallel with the consultation of the expert panels referred to in Article 61(2) of Regulation (EU) 2017/745.

2. In case of medicinal products used with a medical device or an in vitro diagnostic medical device, undertakings or, as relevant, not-for-profit entities may request scientific advice as referred to in Article 58(1) in parallel with the consultation of the expert panels referred to in Regulation (EU) 2017/745 or Regulation (EU) 2017/746.

Or. en

Amendment 1004

Tomislav Sokol

Proposal for a regulation

Article 60 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Agency may offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products that, based on preliminary evidence submitted by the developer fulfil the following conditions:

1. The Agency shall offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products and new indications, including when grouped with an extension of the marketing authorization, that, based on preliminary evidence submitted by the developer fulfil one of the following conditions:

Or. en

Amendment 1005

Jessica Polfjärd

Proposal for a regulation

Article 60 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Agency shall offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products as well as new indications, including as an extension for the marketing authorization, that, based on preliminary evidence submitted by the developer fulfil one of the following conditions:

Or. en

Justification

Medicinal products for orphans address unmet medical needs. Thus, it is important that all medicinal products for orphans are eligible for enhanced regulatory and scientific support.

Amendment 1006

Pernille Weiss

Proposal for a regulation

Article 60 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Agency may offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products and new indications of medicinal products, that, based on preliminary evidence submitted by the developer fulfil one or more of the following conditions:

Or. en

Amendment 1007

Andrey Slabakov

Proposal for a regulation

Article 60 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Agency may offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products or certain medical devices that, based on preliminary evidence submitted by the developer fulfil the following conditions:

Or. en

Amendment 1008

Stelios Kympouropoulos, Peter Liese

Proposal for a regulation

Article 60 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Agency may offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products or medical devices that, based on preliminary evidence submitted by the developer fulfil the following conditions:

Or. en

Justification

Patients with unmet medical needs may find treatment through both medicinal products and/or medical technologies, thus ensuring the same criteria apply to both is important in order to secure access to innovative healthcare solutions.

Amendment 1009

Ondřej Knotek, Frédérique Ries, Billy Kelleher

Proposal for a regulation

Article 60 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Agency shall offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products that, based on preliminary evidence submitted by the developer fulfil at least one of the following conditions:

Or. en

Amendment 1010

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 60 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Agency shall offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products that, based on preliminary evidence submitted by the developer fulfil the following conditions:

Or. en

Amendment 1011

István Ujhelyi

Proposal for a regulation

Article 60 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 1012

Susana Solís Pérez

Proposal for a regulation

Article 60 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 1013

Cindy Franssen, Tom Vandenkendelaere

Proposal for a regulation

Article 60 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 1014

Alessandra Moretti

Proposal for a regulation

Article 60 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 1015

Maria Angela Danzì

Proposal for a regulation

Article 60 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. it

Justification

It is currently unclear whether the developer has to fulfil all three conditions (a b c) in order to receive the support, or whether it is sufficient for only one or two of them to be met.

Amendment 1016

István Ujhelyi

Proposal for a regulation

Article 60 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) are likely to address an unmet medical need as referred to in Article 83(1) of [revised Directive 2001/83/EC];

(a) are advanced therapy medicinal products

Or. en

Amendment 1017

Jessica Polfjärd

Proposal for a regulation

Article 60 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) are likely to address an unmet medical need as referred to in Article 83(1) of [revised Directive 2001/83/EC];

(a) are likely to address an unmet medical need as referred to in Article 83(1) of [revised Directive 2001/83/EC], including orphan medicinal products as referred to in Article 83(2);

Or. en

Justification

Medicinal products for orphans address unmet medical needs. Thus, it is important that all medicinal products for orphans are eligible for enhanced regulatory and scientific support.

Amendment 1018

Andrey Slabakov

Proposal for a regulation

Article 60 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) are likely to address an unmet medical need as referred to in Article 83(1) of [revised Directive 2001/83/EC];

(a) are likely to address an unmet medical need as referred to in Article 83(1) and (2) of [revised Directive 2001/83/EC];

Or. en

Amendment 1019

Ondřej Knotek, Frédérique Ries, Billy Kelleher

Proposal for a regulation

Article 60 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) are innovative Advanced Therapy Medicinal Products (ATMPs);

Or. en

Amendment 1020

Andrey Slabakov

Proposal for a regulation

Article 60 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) are orphan medicinal products and are likely to address a high unmet medical need as referred to in Article 70(1);

deleted

Or. en

Amendment 1021

Jessica Polfjärd

Proposal for a regulation

Article 60 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) are orphan medicinal products and are likely to address a high unmet medical need as referred to in Article 70(1);

deleted

Or. en

Justification

Medicinal products for orphans address unmet medical needs. Thus, it is important that all medicinal products for orphans are eligible for enhanced regulatory and scientific support.

Amendment 1022

Frédérique Ries, Catherine Amalric, Susana Solís Pérez, Max Orville, Ondřej Knotek, Billy Kelleher, Erik Poulsen

Proposal for a regulation

Article 60 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) are orphan medicinal products and are likely to address a high unmet medical need as referred to in Article 70(1);

(b) are orphan medicinal products listed on the register of designated orphan medicinal products referred to in article 67 (1) of this Regulation;

Or. en

Justification

To open PRIME to all orphan medicines.The orphan designation already requires medicinal products to demonstrate that they meet an unmet need or show significant benefit compared to existing treatments (art 63).

Amendment 1023

Tomislav Sokol

Proposal for a regulation

Article 60 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) are orphan medicinal products and are likely to address a high unmet medical need as referred to in Article 70(1);

(b) are orphan medicinal products;

Or. en

Amendment 1024

Kateřina Konečná

Proposal for a regulation

Article 60 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) are orphan medicinal products and are likely to address a high unmet medical need as referred to in Article 70(1);

(b) are orphan medicinal products;

Or. en

Amendment 1025

Pernille Weiss

Proposal for a regulation

Article 60 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) are orphan medicinal products and are likely to address a high unmet medical need as referred to in Article 70(1);

(b) are orphan medicinal products or advanced therapy medicinal products;

Or. en

Amendment 1026

Susana Solís Pérez, Frédérique Ries

Proposal for a regulation

Article 60 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) are orphan medicinal products and are likely to address a high unmet medical need as referred to in Article 70(1);

(b) are innovative advanced therapy medicinal products or orphan medicinal products

Or. en

Amendment 1027

Stelios Kympouropoulos, Peter Liese

Proposal for a regulation

Article 60 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) are orphan medicinal products and are likely to address a high unmet medical need as referred to in Article 70(1);

(b) are orphan medicinal products or certain medical devices and are likely to address a high unmet medical need as referred to in Article 70(1);

Or. en

Justification

Amendment 1028

Tilly Metz

Proposal for a regulation

Article 60 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) are expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation, taking into account the early stage of development, or antimicrobials provided for in the ‘WHO priority pathogens list for R&D of new antibiotics’, specifically those listed as priority 1 (critical) or priority 2 (high), or taking into account as a priority any equivalent list of priority pathogens adopted at Union level.

Or. en

Amendment 1029

Jessica Polfjärd

Proposal for a regulation

Article 60 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) can provide an advancement in therapeutic deemed to be exeptional or are expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation, taking into account the early stage of development, or antimicrobials with any of the characteristics mentioned in Article 40(3).

Or. en

Justification

Medicinal products for orphans address unmet medical needs. Thus, it is important that all medicinal products for orphans are eligible for enhanced regulatory and scientific support.

Amendment 1030

Ondřej Knotek, Billy Kelleher

Proposal for a regulation

Article 60 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) provide an exceptional therapeutic advancement or are expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation, taking into account the early stage of development, or antimicrobials with any of the characteristics mentioned in Article 40(3).

Or. en

Amendment 1031

Tomislav Sokol, Stelios Kympouropoulos

Proposal for a regulation

Article 60 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 1032

Susana Solís Pérez

Proposal for a regulation

Article 60 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 1033

Susana Solís Pérez, Ondřej Knotek

Proposal for a regulation

Article 60 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(c a) The Agency's working group on advanced therapy medicinal products is tasked with evaluating which products fulfill the criteria of innovative advanced therapy medicinal products as set out in point (b) of this article. The determinations made by the working group shall take into account the progressive development inherent to advanced therapy medicinal products.

Or. en

Amendment 1034

Andrey Slabakov

Proposal for a regulation

Article 60 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency, at the request of the Commission and after consulting the EMA Emergency Task Force, may offer enhanced scientific and regulatory support to developers of a medicinal product preventing, diagnosing or treating a disease resulting from serious cross border threats to health if access to such products is considered necessary to ensure high level of Union preparedness and response to health threats.

2. The Agency, at the request of the Commission and after consulting the EMA Emergency Task Force or expert panel referred to in Article 61(2) of Regulation (EU) 2017/745, may offer enhanced scientific and regulatory support to developers of a medicinal product or certain medical devices preventing, diagnosing or treating a disease resulting from serious cross border threats to health if access to such products is considered necessary to ensure high level of Union preparedness and response to health threats.

Or. en

Amendment 1035

Stelios Kympouropoulos, Peter Liese

Proposal for a regulation

Article 60 – paragraph 2

Text proposed by the Commission

Amendment

2. The Agency, at the request of the Commission and after consulting the EMA Emergency Task Force, may offer enhanced scientific and regulatory support to developers of a certain medicinal product or medical device preventing, diagnosing or treating a disease resulting from serious cross border threats to health if access to such products is considered necessary to ensure high level of Union preparedness and response to health threats.

Or. en

Amendment 1036

Stelios Kympouropoulos, Peter Liese

Proposal for a regulation

Article 60 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency may stop the enhanced support if it is established that the medicinal product will not address the identified unmet medical need to the anticipated extent.

3. The Agency may stop the enhanced support if it is established that the medicinal product or the medical device will not address the identified unmet medical need to the anticipated extent.

Or. en

Amendment 1037

Andrey Slabakov

Proposal for a regulation

Article 60 – paragraph 3

Text proposed by the Commission

Amendment

3. The Agency may stop the enhanced support if it is established that the medicinal product will not address the identified unmet medical need to the anticipated extent.

3. The Agency may stop the enhanced support if it is established that the medicinal product or the medical device will not address the identified unmet medical need to the anticipated extent.

Or. en

Amendment 1038

Andrey Slabakov

Proposal for a regulation

Article 60 – paragraph 4

Text proposed by the Commission

Amendment

4. The compliance of a medicinal product with the criteria set out in Article 83 of [revised Directive 2001/83/EC] shall be assessed on the basis of the relevant criteria, independently of whether it has received priority medicinal product support under this Article.

4. The compliance of a medicinal product with the criteria set out in Article 83 of [revised Directive 2001/83/EC] or of a medical device as set out in Regulation (EU) 2017/745 shall be assessed on the basis of the relevant criteria, independently of whether it has received priority medicinal product support under this Article.

Or. en

Amendment 1039

Andrey Slabakov

Proposal for a regulation

Article 60 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The Commission may adopt an implementing act, establishing the enhanced scientific and regulatory support for priority medical devices, taking into consideration the requirements set by Regulation (EU) 2017/745.

Or. en

Amendment 1040

Tomislav Sokol

Proposal for a regulation

Article 61 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

For products under development which may fall within the categories of medicinal products to be authorised by the Union listed in Annex I, a developer or a competent authority of the Member States may submit a duly substantiated request to the Agency for a scientific recommendation with a view to determining on scientific grounds whether the concerned product is potentially a ‘medicinal product’, including an ‘advanced therapy medicinal product’ as defined in Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council71 .

_________________

71 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).

Or. en

Amendment 1041

Ondřej Knotek, Catherine Amalric, Billy Kelleher

Proposal for a regulation

Article 61 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

For products under development which may fall within the categories of medicinal products to be authorised by the Union listed in Annex I, a developer or a competent authority of the Member States may submit a duly substantiated request to the Agency for a scientific recommendation with a view to determining on scientific grounds whether the concerned product is potentially a ‘medicinal product’, including an ‘advanced therapy medicinal product’ as defined in Article 4 (7), (29) and (30) of [revised Directive 2001/83/EC] and Article 2 of Regulation (EC) No 1394/2007 of the European Parliament and of the Council71 .

_________________

Or. en

Amendment 1042

Tiemo Wölken

Proposal for a regulation

Article 61 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

In view of delivering the scientific recommendation referred to in paragraph 1, the Agency shall first consult the compendium referred to in Regulation (EU) No [reference to be added after adoption cf. COM(2022)338 final] and shall consult, where appropriate and where there is a doubt of the regulatory status of a product under development , relevant advisory or regulatory bodies established in other Union legal acts in related fields. In the case of products which are based on substances of human origin, the Agency shall consult and where necessary, conduct joint meetings with the Substances of Human Origin (SoHO) Coordination Board as established in Regulation (EU) No [reference to be added after adoption cf. COM(2022)338 final].

Or. en

Amendment 1043

Susana Solís Pérez, Ondřej Knotek

Proposal for a regulation

Article 61 – paragraph 2 – subparagraph 1

Text proposed by the Commission

Amendment

When forming the recommendation referred to in paragraph 1, the Agency shall consult, where appropriate, relevant advisory or regulatory bodies established in other Union legal acts in related fields. In the case of products which are based on substances of human origin, the Agency shall consult the Substances of Human Origin (SoHO) Coordination Board as established in Regulation (EU) No [reference to be added after adoption cf. COM(2022)338 final], and classify all products that are significantly manipulated or utilized in a non-homologous manner, as either a medicinal product or an advanced therapy medicinal product, whichever is applicable.

Or. en

Amendment 1044

Tiemo Wölken

Proposal for a regulation

Article 61 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

The Agency shall publish summaries of the recommendations delivered in accordance with paragraph 1, after deletion of all information of a commercially confidential nature.

The Agency shall publish the recommendations delivered in accordance with paragraph 1, after deletion of all information of a commercially confidential nature.

Where an agreement by consensus on the scientific recommendation between the Agency and the advisory or regulatory bodies on the regulatory status of a product cannot be reached, the case shall be referred to the Commission for a decision on the regulatory status.

For transparency purposes, the respective opinions and conclusions of the Agency and the relevant advisory bodies on the regulatory status of the product shall be made publicly available after the consultations, and where applicable, joint meetings, have taken place.

Or. en

Amendment 1045

Tilly Metz

Proposal for a regulation

Article 61 – paragraph 2 – subparagraph 3

Text proposed by the Commission

Amendment

The Agency shall publish summaries of the recommendations delivered in accordance with paragraph 1, after deletion of all information of a commercially confidential nature.

The Agency shall publish summaries of the recommendations delivered in accordance with paragraph 1, including substantiated opinions received from other advisory bodies, after deletion of all information of a commercially confidential nature.

Or. en

Amendment 1046

Tilly Metz

Proposal for a regulation

Article 62 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

In the case of duly substantiated disagreement with the Agency’s recommendation, in accordance with Article 61(2), a Member State may request the Commission to decide whether the product is a product referred to in Article 61(1).

In the case of duly substantiated disagreement with the Agency’s recommendation, raised by other advisory bodies, in accordance with Article 61(2), a Member State may request the Commission to decide whether the product is a product referred to in Article 61(1).

Or. en

Amendment 1047

Tiemo Wölken

Proposal for a regulation

Article 62 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

In the case of duly substantiated disagreement with the scientific recommendation, in accordance with Article 61(2), a Member State may request the Commission to decide whether the product is a product referred to in Article 61(1).

Or. en

Amendment 1048

Tiemo Wölken

Proposal for a regulation

Article 62 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission may ask the Agency for clarifications or refer the recommendation back to the Agency for further consideration where a Member State's substantiated request raises new questions of a scientific or technical nature or on its own initiative.

2. The Commission may ask the Agency and the relevant advisory or regulatory bodies involved in the delivery of the scientific recommendation for clarifications or refer the recommendation back to the Agency for further consideration where a Member State's substantiated request raises new questions of a scientific or technical nature or on its own initiative.

Or. en

Amendment 1049

Tilly Metz

Proposal for a regulation

Article 62 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission may ask the Agency and other advisory bodies for clarifications or refer the recommendation back to the Agency for further consideration where a Member State's substantiated request raises new questions of a scientific or technical nature or on its own initiative.

Or. en

Amendment 1050

Tilly Metz

Proposal for a regulation

Article 62 – paragraph 3

Text proposed by the Commission

Amendment

3. The decision of the Commission referred to in paragraph 1 shall be adopted by means of implementing acts, in accordance with the examination procedure referred to in Article 173(2), taking into account the scientific recommendation of the Agency.

Or. en

Amendment 1051

Tomislav Sokol

Proposal for a regulation

Article 63 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the condition affects not more than five in 10 000 persons in the Union when the application for an orphan designation is submitted;

(a) the condition affects not more than 5 in 10 000 persons in the Union when the application for an orphan designation is submitted;

Or. en

Amendment 1052

Pernille Weiss

Proposal for a regulation

Article 63 – paragraph 2

Text proposed by the Commission

Amendment

2. By way of derogation from paragraph 1, point (a), and on the basis of a recommendation from the Agency, when the requirements specified in paragraph 1, point (a), are not appropriate due to the specific characteristics of certain conditions or any other scientific reasons, the Commission is empowered to adopt delegated acts in accordance with Article 175 in order to supplement paragraph 1, point (a), by setting specific criteria for certain conditions.

deleted

Or. en

Justification

Deletion proposed to preserve the predictability of criteria for designation.

Amendment 1053

Tilly Metz

Proposal for a regulation

Article 63 – paragraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1054

Margarita de la Pisa Carrión

Proposal for a regulation

Article 63 – paragraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1055

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 63 – paragraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1056

Fulvio Martusciello

Proposal for a regulation

Article 63 – paragraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1057

Anders Vistisen

on behalf of the ID Group

Aurélia Beigneux

Proposal for a regulation

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall adopt the necessary provisions for implementing this Article by means of implementing acts in accordance with the procedure laid down in Article 173(2) in order to further specify the requirements referred to in paragraph 1.

3. The Commission may adopt the necessary provisions for implementing this Article by means of implementing acts in accordance with the procedure laid down in Article 173(2)

Or. en

Amendment 1058

Margarita de la Pisa Carrión

Proposal for a regulation

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall adopt the necessary provisions for implementing this Article by means of implementing acts in accordance with the procedure laid down in Article 173(2)

Or. en

Amendment 1059

Pernille Weiss

Proposal for a regulation

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall adopt the necessary provisions for implementing this Article by means of implementing acts in accordance with the procedure laid down in Article 173(2).

Or. en

Justification

See amendment to Article 63 – paragraph 2.

Amendment 1060

Tilly Metz

Proposal for a regulation

Article 63 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall adopt the necessary provisions for implementing this Article by means of delegated acts in accordance with the procedure laid down in Article 175 in order to further specify the requirements referred to in paragraph 1.

Or. en

Justification

Current implementing act on this aspect provides a lot of criteria for designation and what constitutes a significant benefit which are rather political and therefore a delegated act would be more appropriate in this case

Amendment 1061

Tomislav Sokol

Proposal for a regulation

Article 64 – paragraph 1

Text proposed by the Commission

Amendment

1. The orphan medicine sponsor shall submit an application for the designation of the orphan medicinal product to the Agency at any stage of the development of the medicinal product before the application for marketing authorisation referred to in Articles 5 and 6 is submitted.

1. The orphan medicinal product sponsor shall submit an application for the designation of the orphan medicinal product to the Agency at any stage of the development of the medicinal product before the application for marketing authorisation referred to in Articles 5 and 6 is submitted.

Or. en