Revision of the EU's basic pharmaceutical legislation, including medicines for children and for rare diseases.
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 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 future proof 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 again).
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) (adopted by the Council on 13 June 2023).
The legislative proposals are now in the hands of the co-legislators (the European Parliament and the Council). In Parliament, the Committee on Environment, Public Health & Food Safety (ENVI) is responsible for the file and the rapporteurs are Tiemo Wölken (S&D, Germany) for the regulation and Pernille Weiss (EPP, Denmark) for the directive.
At the ENVI Committee meeting on 26 April 2023, Stella Kyriakides, Commissioner for Health and Food Safety, presented the proposed reform. It was followed by an exchange of views.
The work on the revision of the EU pharmaceutical legislation was among the priorities of the Swedish Presidency of the Council of the EU. An informal meeting of Health ministers took place on 5 May 2023 in Stockholm. They discussed challenges related to securing access to medicinal products in times of crises and how EU Member States can further strengthen the accessibility and affordability of medicines. A further informal discussion took place in a general context on 13 June 2023 during the EPSCO Council. The Council must wait until the pharmaceutical package has been translated into several languages before it can formally begin negotiations at a technical level. Negotiations are expected to begin in Autumn 2023.
At the Competitiveness Council on 25 September, the Austrian and German delegations gave a presentation on the EU’s pharmaceutical legislation from an industrial and competitiveness perspective.
On 24 October 2023, the European Commission published a communication on addressing medicine shortages in the EU.
A debate in ENVI Committee took place on 20 September 2023; followed by another one on 7 November 2023.
- 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)
- Council recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach, 13 June 2023, COM(2023) 191
- European Commission, Communication from the Commission 'Reform of the pharmaceutical legislation and measures addressing antimicrobial Resistance', COM(2023) 190 final
- European Commission, Commission Work Programme 2022 'Making Europe stronger together', COM(2021) 645 final
- European Commission, A pharmaceutical strategy for Europe, website
- European Commission, consultation on the revision of the EU general pharmaceuticals legislation, website
- European Commission communication Addressing medicines shortages in the EU, COM(2023) 672, 24 October 2023
- European Parliament, EPRS, European pharmaceutical research and development. Could public infrastructure overcome market failures? , December 2021
- 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
- European Parliament, EPRS, Revision of the EU's general pharmaceutical legislation, Implementation Appraisal, May 2023.
- European Parliament, EPRS, Revision of EU pharmaceutical legislation, legislative briefing, June 2023
- European Parliament, EPRS, Initial Appraisal of a European Commission Impact Assessment, Revision of the EU pharmaceutical legislation, September 2023.
- Council Competitiveness 25 September 2023
Author: Laurence Amand-Eeckhout, Members' Research Service, firstname.lastname@example.org
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