A new pharmaceutical strategy for Europe
In “Promoting our European Way of Life”
On 25 November 2020, the European Commission adopted a pharmaceutical strategy for Europe. The strategy is major initiative under the European health union, a process launched by the Commission on 11 November 2020 with a first set of proposals to reinforce preparedness and response during health crises. Its goal is to give the EU's pharmaceutical policy a long-term vision: to ensure it is crisis-resilient and sustainable, and to reinforce the EU's position as a global leader in this critical area while ensuring access to affordable medicines for patients. According to the Commission, the strategy supports diversified and secure supply chains, ensuring the EU's open strategic autonomy in the world, and promotes environmentally sustainable pharmaceuticals. It will also support innovations and accommodate digital and technological change. The strategy has four main objectives:
- Ensuring access to affordable medicines for patients, and addressing unmet medical needs (e.g. in the areas of antimicrobial resistance, cancer, rare diseases);
- Supporting competitiveness, innovation and sustainability of the EU's pharmaceutical industry and the development of high-quality, safe, effective and greener medicines;
- Enhancing crisis preparedness and response mechanisms and addressing security of supply;
- Ensuring a strong EU voice in the world by promoting a high level of quality, efficacy and safety standards.
The strategy covers pharmaceuticals and some aspects of medical devices. It will create synergies with other initiatives, such as the Green Deal and the EU strategic approach to pharmaceuticals in the environment. Under the strategy, legislative and non-legislative actions will be launched over the coming years. These will include:
- a revision of the basic pharmaceutical legislation (Directive 2001/83/EC and Regulation (EC) No 726/2004) and of the legislation on medicines for children and for people with rare diseases (Regulations (EC) No 1901/2006 and 141/2000);
- a proposal for an EU Health Emergency Response Authority (HERA);
- cooperation between national authorities on pricing, payment and procurement policies;
- the creation of a digital infrastructure, including a proposal for a European health data space.
Health and Food Safety Commissioner Stella Kyriakides presented the strategy in the European Parliament on 26 November 2020. MEPs broadly welcomed the new strategy, which puts into effect both Parliament's requests to step up efforts to tackle medicines shortages and to move towards a more sensible use and disposal of pharmaceuticals so as to prevent risks to the environment and public health.
In Council, health ministers discussed the strategy on 2 December 2020. On cooperation, they expressed their wish to see Member States fully involved in discussions on the strategy's implementation. In relation to medicines shortages and access to medicines, many delegations referred to the need to ensure European strategic autonomy.
On 26 February 2021, the Commission launched a structured dialogue with the actors in the pharmaceuticals manufacturing chain. According to the Commission, the initiative will put forward policy recommendations to address vulnerabilities in the chain, with the aim of strengthening the EU's resilience.
In Parliament, the Committee on the Environment, Public Health and Food Safety (ENVI) is the lead committee for the file, which follows the own-initiative procedure (INI). The Committee on Industry, Research and Energy (ITRE) is the associated committee. The ENVI rapporteur is Dolors Montserrat (EPP, Spain).
The vote on the draft report in ENVI took place on 12 October 2021. The report underlines the need for increasing the affordability and availability of medicine, for more transparency on prices, for addressing the root causes of shortages, and for more investment in pharmaceutical research.
On 24 November 2021, the European Parliament adopted an own-initiative resolution on a pharmaceutical strategy for Europe (527 votes in favour, 92 against and 70 abstentions).
The European Commission was expected to propose an update of EU pharmaceutical legislation towards the end of 2022. The Commission put forward its proposals on 26 April 2023 (see separate fiche).
References:
- EP Legislative Observatory, A pharmaceutical strategy for Europe, 2021/2013(INI)
- 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, 2023/0131(COD)
- 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, 2023/0132(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 Parliament resolution of 24 November 2021 on a pharmaceutical strategy for Europe (2021/2013/INI)
- European Commission, A pharmaceutical strategy for Europe, website
- European Commission, Structured dialogue on security of medicines supply, website
- European Committee of the Regions, Opinion – European Health Union: Reinforcing the EU's resilience, CDR 5487/2020
- European Economic and Social Committee, Opinion – Building a European Health Union, SOC/665-EESC-2020
- Council, information note from the Commission -Revision of Pharmaceutical legislation, 2 December 2022
Further reading:
- European Parliament, EPRS, A pharmaceutical strategy for Europe: First steps, At a glance, June 2020
- 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
Author: Laurence Amand-Eeckhout, Members' Research Service, legislative-train@europarl.europa.eu