EU: Proposal on Reform of Pharmaceutical Legislation

On 26 April 2023, the European Commission published a 182-page proposal for the reform of the EU's pharmaceutical legislation and a 184-page proposal for the repeal of Directives 2001/83/EC and 2009/35/EC with a 103-page 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.

The "Green Deal"

The EC intends to approach the new regulations with the European Green Deal in mind to also promote higher environmental standards along the reform. With the green deal, the 27 EU member states claim to become climate-neutral by 2050. An example is that the share of renewable energies in the EU is to be raised to 40 % by 2030. So far, the share of renewable energies (as of 2021) in Europe is just under 22%. The pollution of water and soil with pharmaceutical residues, which is increasingly in focus, will be considered in regulatory terms, as will an environmental risk assessment and environmental impact assessment for chemicals, just to name a few examples.

Some 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.

Feedback:

• After an incomplete draft was leaked in February, the EFPIA (European Federation of Pharmaceutical Industries and Association) has already taken a position, saying among other things that the European Commission would be taking Europe backward economically with this proposal. This would affect global investment, clinical research, the entire healthcare system, and of course, all related jobs.
• Smaller EU countries proposed a patent-based approach instead of the one presented, which would balance the availability, accessibility, and affordability of medicines in Europe.

The timeline:

The next step is now the transmission of the legislative proposals to the European Parliament and the Council. The current Commission will be in charge until the end of October 2024. It is yet unclear whether the texts will be finalised by then. Please visit the EU website for more information. There you will also find a detailed Q & A document on the review.

Source:

EC: Press Release

EC: FAQ on the Revision of the Pharmaceutical Legislation