On 11 November 2020, the European Commission published a legislative proposal to extend the mandate of the European Medicines Agency (EMA). The initiative is among the first steps towards building the European health union announced by President Ursula von der Leyen in her State of the Union address. The proposals put forward aim to strengthen the EU's health security framework, and to reinforce the crisis preparedness and response role of key EU agencies.

As the Commission points out, the EMA and the European Centre for Disease Prevention and Control (ECDC) have been at the forefront of the EU's work to address the coronavirus pandemic. However, Covid-19 has shown that both agencies need to be reinforced and equipped with stronger mandates to better protect EU citizens and address cross-border health threats.

According to the Commission, the EMA's mandate will be reinforced so that it can facilitate a coordinated EU-level response to health crises by:

• monitoring and mitigating the risk of shortages of critical medicines and medical devices;
• providing scientific advice on medicines that may have the potential to treat, prevent or diagnose the diseases causing those crises;
• coordinating studies to monitor the effectiveness and safety of vaccines;
• coordinating clinical trials.

Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) is responsible for the file. The rapporteur, Nicolás González Casares (S&D, Spain), was appointed on 25 November 2020. The Commission presented its proposal in the ENVI committee meeting of 25 February 2021.

The rapporteur's draft report proposes various amendments to the Commission proposal. Among other things, it stresses the need to reinforce the application of the 'one health' approach in the EU. The draft report was discussed in the ENVI committee meeting of 15 April 2021. The Committee on Industry, Research and Energy (ITRE), as committee for opinion, adopted its opinion on 26 May 2021.

The Council agreed its position on 15 June 2021.

The ENVI votes took place on 21 June 2021 (amendments) and 22 June 2021 (final report). The committee report thus amended puts forward, among other things, the creation of an interoperable digital platform to monitor and report on medicines shortages. To address the shortcomings that experience with clinical trials revealed during the pandemic, it promotes coordinated, well-designed, large-scale clinical trials, highlighting the need to reinforce public information about them. The report also asks for the steering groups' work to be more transparent and made public. Parliament's plenary adopted the report on 8 July 2021 (587 votes in favour, 28 against and 81 abstentions).

Interinstitutional trilogue negotiations started on 13 July 2021. After three trilogues, the European Parliament and the Council reached a provisional agreement on 28 October. They agreed, amongst other things, on the setup of an IT platform on monitoring shortages to facilitate data collection, on what constitutes a 'major event' (that is likely to pose a serious risk to public health in relation to medicinal products), on transparency of data related to clinical trials and product information on authorised medicinal products, on data protection, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established. The agreed text was endorsed by Coreper, for the Council, on 10 November 2021, and then approved in the ENVI committee meeting of 30 November 2021. A vote in plenary took place on 20 January 2022. Parliament endorsed the provisional agreement with 655 votes in favour, 31 against and 8  abstentions.

The regulation was adopted on 25 January 2022 (Regulation (EU) 2022/123). 

The new rules applied from 1 March 2022.

References:

• EP Legislative Observatory, Procedure file on Reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices, 2020/0321(COD)
• European Commission, Building a European Health Union: Stronger crisis preparedness and response for Europe, Press release, 11 November 2020 
• Council, Provisional agreement between Council and European Parliament to reinforce European Medicines Agency, press release, 28 October 2021
• European Committee of the Regions, Opinion – A pharmaceutical strategy for Europe and legislative proposal for changing the mandate of the European Medicines Agency (EMA), CDR 5525/2020
• European Economic and Social Committee, Opinion – Building a European Health Union, SOC/665-EESC-2020
• European Parliament, Health Union: a stronger role for the European Medicines Agency, press release, 19 January 2022
• Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices, OJ L 20 31. 01. 2022.

Further reading:

• European Parliament, EPRS, Addressing shortages of medicines, Briefing, April 2020
• European Parliament, EPRS, Building up resilience to cross-border health threats: Moving towards a European health union, Briefing, April 2021
• European Parliament, EPRS, Reinforced role for European Medicines Agency, plenary at a glance, January 2022.

Author: Laurence Amand-Eeckhout, Members' Research Service, legislative-train@europarl.europa.eu