In the frame of the EU Pharmaceutical Strategy, the European Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines.
On 26 April, the European Commission unveiled the much awaited revision of the EU’s pharmaceutical legislation – the largest reform in over 20 years – to make it more agile, flexible, and adapted to the needs of citizens and businesses across the EU.
The revision will make medicines more available, accessible and affordable. It will support innovation and boost the competitiveness and attractiveness of the EU pharmaceutical industry, while promoting higher environmental standards. In addition to this reform, the Commission proposes a Council Recommendation to step up the fight against antimicrobial resistance (AMR).
The revision aims to achieve the following main objectives:
- Create a Single Market for medicines ensuring that all patients across the EU have timely and equitable access to safe, effective, and affordable medicines;
- Continue to offer an attractive and innovation-friendly framework for research, development, and production of medicines in Europe;
- Reduce drastically the administrative burden by speeding up procedures significantly, reducing authorisation times for medicines, so they reach patients faster;
- Enhance availability and ensure medicines can always be supplied to patients, regardless of where they live in the EU;
- Address antimicrobial resistance (AMR) and the presence of pharmaceuticals in the environment through a One Health approach;
- Make medicines more environmentally sustainable.
The legislative proposals will now be submitted to the European Parliament and the Council. We have been closely following the discussion around this topic and we have attended a considerable number of stakeholders meeting in Brussels. We will keep doing so and informing you accordingly.
Do not hesitate to reach out to me should you have any inputs on this proposal.