Revision of the EU's basic pharmaceutical legislation, including medicines for children and for rare diseases.
In “A new plan for Europe's sustainable prosperity and competitiveness”
In its 2020 pharmaceutical strategy, the European Commission announced that, over the coming years, it would launch several legislative and non-legislative actions. These would include 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).
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 in March 2023 (postponed again).
On 26 Avril 2023, the 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). At the ENVI Committee meeting on 26 April 2023, Commissioner Stella Kyriakides presented the proposed reform.
The work on the revision of the EU pharmaceutical legislation was among the priorities of the Swedish Presidency of the Council . An informal meeting of Health ministers took place on 5 May 2023. 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 on 13 June 2023 during the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Council. 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 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. On 4 December 2023, the authors of the STOA Study on 'Improving access to medicines and promoting pharmaceutical innovation' held a presentation during ENVI meeting.
ENVI Committee adopted its reports on the proposals on 19 March 2024. To boost EU research and its market attractiveness, they ask for a regulatory data protection scheme of a minimum duration of seven and a half years for new medicines, in addition to a period of two years of market protection (during which generic or biosimilar products may not be sold) following market authorisation. Longer protection periods would be granted under certain circumstances (e.g. unmet medical needs, clinical trials). Medicines developed to treat rare diseases ('orphan drugs') would benefit from up to 11 years of 'market exclusivity' (protecting them from competition from similar medicines with similar indications, which could not be marketed during the exclusivity period) if they met a 'high unmet medical need'. New measures would promote the prudent use of antimicrobials (e.g. prescription limited to the amount required for the treatment, limited duration) and encourage the development of new antimicrobials. New rules would require companies to submit an 'environmental risk assessment' when applying for market authorisation, which should cover the entire life cycle of medicines.
A debate and vote in plenary took place during the April I plenary session. On 10 April 2024, the European Parliament supported fully the ENVI position without changes. It adopted with a very large majority its position at first reading: 495 votes in favour, 57 against and 45 abstentions for the proposed directive; 488 votes in favour, 67 against and 34 abstentions for the proposed regulation.Parliament reiterated its support to a comprehensive reform of the pharmaceutical legislation which aims to ensure safe, efficient and quality medicinal products, to foster innovation and development of medicines to address unmet medical needs and to boost research in novel antimicrobials to fight antimicrobial resistance.
The file is now in the hands of the Council, which has not yet adopted its position. During the EPSCO Council meeting on 21 June 2024 the Belgian presidency presented the state of play of the package. Ministers held a policy debate on the incentives system in the pharmaceutical package. Work continued under the Hungarian Presidency. On 23 September 2024, ENVI Committee had exchange of views with Dr Péter Takács, Secretary of State for Health, Ministry of the Interior of Hungary. On 3 December 2024, the EPSCO Council took note of a progress report on the pharmaceutical package. A meeting of the Working Party on Pharmaceuticals and Medical Devices took place on 9 December 2024.
Work is ongoing under the Polish Presidency.
References:
- 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 2023/C 220/01 (OJ C 220, 22.6.2023)
- 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, 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, Initial Appraisal of a European Commission Impact Assessment, Revision of the EU pharmaceutical legislation, September 2023.
- Council Competitiveness 25 September 2023
- European Parliament, press release on STOA Study on 'Improving access to medicines and promoting pharmaceutical innovation', 6 December 2023
- European Parliament, press releases 'EU pharmaceutical policy: MEPs support comprehensive reform', 19 March 2024; 'Parliament adopts its position on EU pharmaceutical reform' 10 April 2024
- European Parliament, EPRS, Revision of EU pharmaceutical legislation, legislative briefing May 2024; plenary at a glance April 2024
- Council, Employment, Social Policy, Health and Consumer Affairs Council (Health), 21 June 2024 - Main results
- Council, progress report, 3 December 2024
- European Parliament, EPRS, 'Priority dossiers under the Polish EU Council Presidency', briefing , January 2025
Author: Laurence Amand-Eeckhout, Members' Research Service, legislative-train@europarl.europa.eu