What changed between the plenary report and the adopted text

Removed:DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

Added:TEXTS ADOPTED

Removed:on the proposal for a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006

Added:P9_TA(2024)0221

Removed:(COM(2023)0193 – C90144/2023 – 2023/0131(COD))

Added:Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency

Added:Committee on the Environment, Public Health and Food Safety

Added:PE753.550

Added:European Parliament legislative resolution of 10 April 2024 on the proposal for a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006 (COM(2023)0193 – C9-0144/2023 – 2023/0131(COD))

14 unchanged paragraphs

(Ordinary legislative procedure: first reading)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0193),

– having regard to Article 294(2) and Article 114 and Article 168(4), point (c), of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90144/2023),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the opinion of the European Economic and Social Committee of 25 October 2023,

– after consulting the Committee of the Regions,

– having regard to Rule 59 of its Rules of Procedure,

– having regard to the opinion of the Committee on Industry, Research and Energy,

– having regard to the letters from the Committee on Budgets and the Committee on Agriculture and Rural Development,

– having regard to the report of the Committee on the Environment, Public Health and Food Safety (A9-0141/2024),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Change 1

Removed:Recital -1 (new): (-1) Ensuring that patients receive the medicines they need, when they need them, regardless of where they live in the Union, is a central objective of the European Health Union. Ensuring the competitiveness of the European pharmaceutical industry, whilst providing better availability of medicines and more equal and timely access for patients, is a key objective of the proposed Union pharmaceutical reform.

Added:P9_TC1-COD(2023)0131

Removed:Recital 1 a (new): (1a) This Regulation should contribute to the implementation of the One Health Approach, stressing the well-established interconnectedness between human, animal and ecosystem health, and the need to include those three dimensions when addressing public health threats. Environmental stress and degradation, including biodiversity loss, contribute to the transmission of diseases between, and the disease burden of, humans and animals. In addition, pollution from active pharmaceutical ingredients negatively affects the quality of waters and ecosystems, causes antimicrobial resistance to increase rapidly, posing risks to public health globally.

Added:Position of the European Parliament adopted at first reading on 10 April 2024 with a view to the adoption of Regulation (EU) 2024/… of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006

Removed:Recital 2: (2) The Pharmaceutical Strategy for Europe marks a turning point with the addition of further key objectives and by aiming to create an attractive environment for research, development and production of medicinal products in the Union, along with a modern framework that makes innovative and established medicinal products available to patients and healthcare systems at affordable prices, while strengthening the fight against shortages of medicinal products and ensuring security of supply and addressing environmental concerns.

Added:(Text with EEA relevance)

Removed:Recital 2 a (new): (2a) To supplement the measures to address shortages of medicinal products, the communication of the Commission of 24 October 2023 entitled ‘Addressing medicine shortages in the EU’ aims to address critical shortages of medicines and strengthen security of supply in the Union by, among other things, introducing the launch of a European voluntary solidarity mechanism for medicines allowing Member States to redistribute their available stock in the event of shortages.

Added:THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Removed:Recital 3: (3) Addressing unequal patient access of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe as has been highlighted by the Council and the European Parliament. Member States and the European Parliament have called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring that the process is transparent, patient access and availability as well as affordability of medicinal products in all Member States.

Added:Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 and Article 168(4), point (c), thereof,

Removed:Recital 4: (4) Previous amendments to the Union pharmaceutical legislation have addressed access to medicinal products by providing for accelerated assessment for marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies in some areas, and many unaddressed public health priorities remain, these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicines.

Added:Having regard to the proposal from the European Commission,

Removed:Recital 5: (5) The COVID-19 pandemic further underlined critical issues, which require a reform of the Union pharmaceuticals framework to strengthen its resilience, while improving the availability of medicinal products and to ensure that it corresponds to public health needs and serves the people under all circumstances.

Added:After transmission of the draft legislative act to the national parliaments,

Removed:Recital 5 a (new): (5a) The COVID-19 pandemic also highlighted disparities in terms of, the capacity of health systems, national immunisation infrastructure, shortages and preparation. In addition to the measures in this Regulation, Member States should strengthen their national immunisation programmes, ensuring their population is better sufficiently protected against infectious diseases and strengthening pandemic preparedness and response.

Added:Having regard to the opinion of the European Economic and Social Committee,

Removed:Recital 6: (6) It is therefore necessary to replace Regulation (EC) No 726/2004 of the European Parliament and of the Council38 with a new Regulation.

Added:Having regard to the opinion of the Committee of the Regions,

Removed:Recital 9: (9) As to the scope of this Regulation, the authorisation of antimicrobials is in the interest of patients' health at Union level and therefore it should be made possible to authorise them at Union level.

Added:Acting in accordance with the ordinary legislative procedure,

Removed:Recital 12: (12) The structure and operation of the various bodies making up the Agency should be designed in such a way as to take into account the need to constantly renew scientific expertise, the need for cooperation between Union and national bodies, the need for adequate involvement of civil society, and the future enlargement of the Union. The various bodies of the Agency should establish and develop appropriate contacts with the parties concerned, in particular with representatives of patients, consumers and healthcare professionals.

Added:Whereas:

Removed:Recital 13: (13) The chief task of the Agency should be to provide Union institutions and Member States with the best possible scientific opinions to enable them to exercise the powers of authorisation and supervision of medicinal products conferred on them by Union legal acts in the field of medicinal products. Marketing authorisation should be granted by the Commission only after a single scientific evaluation procedure addressing the quality, safety, efficacy of high-technology medicinal products has been conducted by the Agency, applying the highest possible standards and the completion of an environmental risk assessment.

Added:(-1) Ensuring that patients receive the medicines they need, when they need them, regardless of where they live in the Union, is a central objective of the European Health Union. Ensuring the competitiveness of the European pharmaceutical industry, whilst providing better availability of medicines and more equal and timely access for patients, is a key objective of the proposed Union pharmaceutical reform. [Am. 1]

Removed:Recital 15: (15) The Agency's budget should be transparent and composed of fees and charges paid by the private sector and contributions from the Union budget to implement Union policies and contributions paid from third countries. Although the majority of its funding comes from fees, the Agency is a public authority. It is of utmost importance to safeguard its integrity and independence in order to maintain public trust in the Union regulatory framework.

Added:(1) The Union pharmaceutical framework has enabled the authorisation of safe, efficacious and high-quality medicines in the Union, contributing to a high level of public health and a smooth functioning of the internal market of these products.

Removed:Recital 18 a (new): (18a) The Agency should set transparent criteria for the appointment of patients’ and healthcare professionals’ representatives to the Committee for Medicinal Products for Human Use and the Pharmacovigilance Risk Assessment Committee in order to ensure there is a well-balanced representation of medical specialties and diseases amongst appointed members and alternates, and there are robust rules on the prevention of conflicts of interests. Declaration of direct or indirect financial or other interests in the pharmaceutical or other medical industry which could affect the impartiality of appointed stakeholders should be an integral part of the selection process and subsequently should be made publicly available.

Added:(1a) This Regulation should contribute to the implementation of the One Health Approach, stressing the well-established interconnectedness between human, animal and ecosystem health, and the need to include those three dimensions when addressing public health threats. Environmental stress and degradation, including biodiversity loss, contribute to the transmission of diseases between, and the disease burden of, humans and animals. In addition, pollution from active pharmaceutical ingredients negatively affects the quality of waters and ecosystems, causes antimicrobial resistance to increase rapidly, posing risks to public health globally. [Am. 2]

Removed:Recital 19: (19) Scientific advice for future applicants seeking a marketing authorisation should be provided more generally and in greater depth and should be adapted to the specificities of the medicinal product concerned. Similarly, structures allowing the development of advice for companies, in particular small and medium-sized enterprises (‘SMEs’) and not-for-profit entities, should be put in place. The Agency should also promote open and public exchanges about latest scientific developments and updates of scientific guidelines.

Added:(2) The Pharmaceutical Strategy for Europe marks a turning point with the addition of further key objectives and by creatingaiming to create an attractive environment for research, development and production of medicinal products in the Union, along with a modern framework that makes innovative and established medicinal products available to patients and healthcare systems at affordable prices, while strengthening the fight against shortages of medicinal products and ensuring security of supply and addressing environmental concerns. [Am. 3]

Removed:Recital 20: (20) Promising medicinal products and certain combinations products of medicinal products and medical devices, as well as medicinal products in exclusive use with medical devices that have the potential to significantly address patients’ unmet medical needs should benefit from early and enhanced scientific support, including through supporting patient-relevant in vitro and in silico technologies which are key to the development of those products. Such support will ultimately help patients benefit from new therapies as early as possible.

Added:(2a) To supplement the measures to address shortages of medicinal products, the communication of the Commission of 24 October 2023 entitled ‘Addressing medicine shortages in the EU’ aims to address critical shortages of medicines and strengthen security of supply in the Union by, among other things, introducing the launch of a European voluntary solidarity mechanism for medicines allowing Member States to redistribute their available stock in the event of shortages. [Am. 4]

Removed:Recital 20 a (new): (20a) Next to unmet medical needs already recognised in the pediatric, antimicrobial, oncological, rare, and neurodegenerative diseases, attention should also be given to unmet medical needs in the mental health sphere and treatments therein.

Added:(3) Addressing unequal patient access of medicinal products has become a key priority of the Pharmaceutical Strategy for Europe as has been highlighted by the Council and the European Parliament. Member States and the European Parliament have called for revised mechanisms and incentives for development of medicinal products tailored to the level of unmet medical need, while ensuring that the process is transparent, patient access and availability as well as affordability of medicinal products in all Member States. [Am. 5]

Removed:Recital 21 a (new): (21a) Based on the European Ombudsman’s decision in its strategic inquiry OI/7/2017/KR of 17 July 2019 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 Union, the Agency should enhance the transparency of scientific advice. In addition, staff and experts from national competent authorities providing scientific advice should, to the extent possible, not be involved in a subsequent evaluation of a marketing authorisation application for the same products. However, in duly justified cases, such as where the indication of a medicinal product concerns a rare disease, that expert should be able to carry out a subsequent evaluation of the same product, provided that that is duly documented.

Added:(4) Previous amendments to the Union pharmaceutical legislation have addressed access to medicinal products by providing for accelerated assessment for marketing authorisation applications or by allowing conditional marketing authorisation for medicinal products for unmet medical need. While these measures accelerated the authorisation of innovative and promising therapies in some areas, and many unaddressed public health priorities remain, these medicinal products do not always reach the patient and patients in the Union still have different levels of access to medicines. [Am. 6]

Removed:Recital 25: (25) In certain cases, shortcomings in Member States’ system of supervision and related enforcement activities could risk to substantially hinder the achievement of the objectives of this Regulation and those of revised Directive 2001/83/EC which could even lead to the emergence of risks to public health or to the environment. To address these challenges, harmonised inspection standards should be ensured through the establishment of a joint audit programme within the Agency. This joint audit programme will also further harmonise the interpretation of good manufacturing and distribution practices on the basis of Union legislative requirements. Moreover, it will support further mutual recognition of inspection outcomes between Member States and with strategic partners. Within the joint audit programme, the competent authorities are subject to regular audits conducted by other Member States to maintain an equivalent and harmonised quality system and to ensure an appropriate implementation of relevant good manufacturing and distribution practices into national laws and equivalence with other EEA inspectorates.