On 26th of April 2023, the European Commission published proposal for the reform of the EU’s pharmaceutical legislation and a proposal for the repeal of Directives 2001/83/EC and 2009/35/EC with Annex. The proposal should pave the way for the biggest reform in more than 20 years and aims to reshape the regulation of the pharmaceutical sector. The draft is the result of a long debate on the future of the pharmaceutical industry in Europe. With the proposed legislation, the European Commission aims to ensure that medicines are accessible, available, and affordable at all times for European citizens, regardless of where they live. It also aims to increase the competitiveness of the European pharmaceutical industry.
Specifically, Directive 2001/83 (Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use) and Directive 2009/35/EC are to be replaced. The proposal for a new Regulation 726/2004 (authorisation of medicinal products and establishment of the European Medicines Agency) is intended to replace Regulation 141/2000 for orphan drugs and Regulation 1901/2006 for paediatric medicinal products, but also brings several new and adapted regulations.
Planned amendments with GMP relevance:
- adapted requirements for the qualification of the Qualified Person (QP), which are so far regulated in Article 48 of Directive 2001/83/EU. These are now defined in an annex to Directive 2023/132 (Annex III).
- Member States may waive the requirement of the “Written Confirmation” within the scope of the period of validity of the GMP certificate (Art. 158 of Directive 2023/132).
- facilitation for inspectorates regarding remote inspections and risk-based approaches to inspection frequency.
- focus is on the security of supply of medicinal products. This is to be regulated in the new Regulation (Art. 116 ff): The proposal contains provisions for the monitoring and management of shortages and critical shortages of medicinal products. Marketing authorisation holders are obliged to inform the competent authority of a Member State where the medicinal product is placed on the market and the EMA of any permanent or temporary cessation or suspension of the marketing or supply of the medicinal product. They must also draw up a plan to prevent supply shortages. The competent authority and EMA shall monitor any potential or actual shortage of medicinal products and the competent authority may request additional information from the marketing authorisation holder, such as a plan to limit the shortage or a risk assessment. The marketing authorisation holder must submit the requested information without delay.
Some other proposed changes in brief:
- Reducing the minimum period of protection for innovative medicines to eight years from the current 10 years.
- Manufacturers will be able to extend protection to a maximum of 12 years if they market medicines in all Member States, address unmet medical needs and develop new therapeutic indications. This measure is designed to make more generic medicines available at lower prices on the single market.
- Accelerating the approval of medicines by streamlining and modernising the regulatory framework and authorisation procedures.
- Both the EMA and the European Commission (EC) are reducing the time it takes to assess a marketing authorisation (EMA from 210 to 180 days, EC from 67 to 46 days), which is expected to save time, money, and resources for both authorities and companies.
- The reform will also introduce the Commission’s controversial plans for transferable exclusivity vouchers for developers of certain antimicrobial medicines. The vouchers can be used or sold and are intended to provide an extra year of protection from competition.
- The development and introduction of an EU-wide list of critical medicines (probably by the end of this year) should identify weaknesses in the supply chain and give companies concrete recommendations for action. In addition, the Commission will be able to take legally binding measures to ensure the security of the supply of medicines.