Revision of the EU's basic pharmaceutical legislation
In “Promoting our European Way of Life”
In its pharmaceutical strategy, adopted on 25 November 2020, the European Commission announced that, over the coming years, it would launch several legislative and non-legislative actions. These would include, among others, a revision of the basic pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No 726/2004).
The evaluation will cover the period from 2005 to present (date covering the last fundamental amendments to the directive and regulation). In particular, it will assess:
- the extent to which existing measures can still effectively reply to the problems identified within the pharmaceutical strategy, also taking into account the international context and regulatory developments globally;
- the coherence and complementarity with other related pieces of legislation, including those on medical devices, medicines for children and rare diseases, the proposal for the European health data space, and the EU blood, tissues and cells legislation;
- the mechanisms for the continuous and timely adaptation of technical requirements in light of emerging science and technologies, as well as potential administrative burden and complexity linked to the implementation of this legislation.
According to the Commission, the revision of the general pharmaceutical legal framework aims to ensure access to affordable medicines in the EU; foster innovation, including in areas of unmet medical need (such as in antimicrobials); and enhance supply security while adapting to new scientific and technological developments and reducing regulatory burden where possible. Drawing lessons from the COVID-19 pandemic, it will support a future-proof and crisis-resistant pharmaceuticals system.
The roadmap/inception impact assessment was published on 30 March 2021. A feedback period closed on 27 April 2021. This was followed by a public consultation for citizens and stakeholders. According to the Commission work programme for 2022, the initiative would be put forward in December 2022 (postponed).
The revision of the general pharmaceutical legal framework aims to ensure access to quality, safe, efficacious and affordable medicines in the EU. It aims to foster innovation including in areas of unmet medical needs (including antimicrobials) and to enhance security of supply while adapting to new scientific and technological developments and reducing regulatory burden where possible. Drawing lessons from the COVID-19 pandemic, it will support a futureproof and crisis-resistant pharmaceuticals system. The initiative will simplify legislation and create an efficient regulatory environment, among others through reduction of administrative burden and digitalisation in processes and procedures, with an expected positive impact on regulators and companies.
On 30 November, ENVI Members held an exchange with Stella Kyriakides, Commissioner for Health and Food Safety, on the upcoming pharmaceutical package, to be presented at the end of March 2023 (postponed).
In the area of health, the Swedish Presidency of the Council announced that it would advance the Commission’s forthcoming proposals on updating the general pharmaceutical legislation and proposals on new regulations concerning orphan medicinal products and paediatric medicines.
On 26 Avril 2023, the European Commission put forward a 'pharmaceutical package' to revise the EU's pharmaceutical legislation and make medicines more available, accessible and affordable while supporting competitiveness and attractiveness of the EU pharmaceutical industry, with higher environmental standards. The package includes proposals for a new directive and a new regulation, which replace the existing pharmaceutical legislation, including the legislation on medicines for children and for rare diseases. A communication and a Council recommendation to step up the fight against antimicrobial resistance (AMR). The legislative proposals are now in the hands of the co-legislators (the European Parliament and the Council). In the European Parliament, the Committee on Environment, Public Health & Food Safety (ENVI) is responsible for the file.
At the ENVI Committee meeting on 26 April 2023, Stella Kyriakides, Commissioner for Health and Food Safety, presented the proposals revising the pharmaceutical legislation. It was followed by an exchange of views. Questions were raised on the system of transferable vouchers for the development of new antimicrobials, on preventing shortages of medicines, especially with regard to children’s medicines, on transparency regarding public investments in research, on access to medicines and exemptions.
- Legislative observatory, Proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC, COM(2023) 192 final 2023/0132 (COD)
- Legislative observatory, 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) 193 final 2023/0131 (COD)
- European Commission, Proposal for a Council recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach, COM(2023) 191 2023/0125 (NLE)
- European Commission, Communication from the Commission 'Reform of the pharmaceutical legislation and measures addressing antimicrobial Resistance', COM(2023) 190 final
- Directive 2001/83/EC on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67)
- Regulation (EC) No 726/2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1)
- European Commission, Commission Work Programme 2022 'Making Europe stronger together', COM(2021) 645 final
- European Commission, Evaluation and revision of the general pharmaceutical legislation, website
- European Commission, Communication ‑‑A Pharmaceutical Strategy for Europe, COM(2020) 761
- European Commission, A pharmaceutical strategy for Europe, website
- European Commission, consultation on the revision of the EU general pharmaceuticals legislation, website
- European Parliament, EPRS, A pharmaceutical strategy for Europe: First steps, At a glance, June 2020
- European Parliament, EPRS, Fostering coherence in EU health research: Strengthening EU research for better health, October 2022
- European Parliament, EPRS, Towards a new EU pharmaceutical strategy, At a glance, December 2022
Author: Laurence Amand-Eeckhout, Members' Research Service, email@example.com
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