On 26 April 2023, the European Commission presented its project to revise the EU's pharmaceutical legislation. This revision, which is part of the Pharmaceutical Strategy for Europe presented by the European Commission in November 2020, is the first major update of pharmaceutical legislation since 2004.
This reform aims to create a sustainable, patient-centric pharmaceutical environment, while promoting the sector's global competitiveness and preserving the EU's high standards for the authorisation of safe, effective, and quality medicines. Weaknesses highlighted by the COVID-19 pandemic are also taken into account, and measures are taken to strengthen the system.
The EU's pharmaceutical legislation reform covers the entire life cycle of medicines and includes:
- A new directive
which sets out the general framework applicable to medicinal products (requirements for authorization, vigilance, labeling, regulatory protection, and marketing, as well as other regulatory procedures for all medicinal products authorized at EU and national level).
- A new regulation
which lays down specific rules for medicinal products authorized at EU level. It sets out rules for the coordinated management of critical shortages and the security of supply of critical medicines as well as the rules governing the European Medicines Agency (EMA).
- A Council recommendation
on stepping up EU actions to combat antimicrobial resistance in a One Health approach (AMR).
The proposal, also known as the "pharmaceutical package", revises and replaces:
- The general pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC)
- The legislation on medicines for children (Regulation 1901/2006)
- The legislation on medicines for rare diseases (Regulation 141/2000/EC)
Key objectives of the EU's pharmaceutical legislation revision:
- Create a single market for medicines, ensuring that all patients throughout the EU have rapid and equitable access to safe, effective and affordable medicines.
- Continue to provide an attractive and stimulating environment for research, development and production of medicines in Europe.
- Prevent drug shortages and guarantee security of supply.
- Reduce the administrative burden by speeding up drug authorization procedures
- Fight against antimicrobial resistance (AMR)
- Combating the presence of pharmaceuticals in the environment through a One Health approach.
- Improve transparency in relation to access to documents and around funding of research and development of medicines
The new system aims to reward companies that meet important public health objectives, such as providing access to medicines in all member states or developing medicinal products in areas of unmet medical needs.
The discussion of the legislative proposals will follow the usual co-decision procedure between the European Parliament and the Council of the EU, and could take at least 3 years.
The reform of the EU’s pharmaceutical legislation is a crucial step towards a healthier, more resilient, and more equal Europe.
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