Revision of the EU's basic pharmaceutical legislation, including medicines for children and for rare diseases.

In “Promoting our European Way of Life”

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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. 

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. 

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. 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: the report on the proposal for a regulation with 67 votes in favour, 6 against and 7 abstentions and the report on the proposal for a directive with 66 votes in favour, 2 against and 9 abstentions. To boost the EU research and market attractiveness, they ask for a regulatory data protection period of minimum 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). Orphan drugs would benefit from up to 11 years of market exclusivity if they meet 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 research and 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. The report also asks for the European Health Emergency Preparedness and Response Authority (HERA) to become a separate structure under the European Centre for Disease Prevention and Control (instead of a European Commission service).

A debate and vote in plenary is expected in April (April I session).


 Further reading:

Author: Laurence Amand-Eeckhout, Members' Research Service,

 Visit the European Parliament homepage on EU health policy.

As of 20/03/2024.