The European Commission welcomes the political agreement to modernise the EUs pharmaceutical legislation, reached last night by the Council and the European Parliament. The reform is a crucial step in boosting innovation and investment in the EUs pharmaceutical sector, while ensuring that medicines are safe, effective and available for patients throughout Europe. The reform package revises the current EU rules, which are over 20 years old.
Todays agreement offers a more modern, flexible and competitive framework for the pharmaceutical sector, so that it can better deliver for European patients and compete globally. The new rules will:
- Expand access and availability of medicines. The EUs robust, science-based assessment process will continue to underpin all medicine authorisations to ensure the highest safety standards, while streamlined procedures will make it more efficient.
- Accelerate medicine supply chains, by cutting red tape for companies, reducing evaluation times for new medicines and reforming the European Medicines Agency (EMA). They will ensure that new medicines get to the market faster and that patients have better access to therapies, especially for unmet needs.
- Place the EU at the forefront of pharmaceutical innovation. The reform offers world-leading incentives for innovative products, introduces regulatory sandboxes as a secure testing environment for truly novel medicines and introduces adapted frameworks for certain non-standard treatments, like personalised therapies. In addition, fulfilment of unmet medical needs will receive strong recognition.
- Enable timely market entry for generic medicines. The reform brings clarifications regarding the application of the Bolar exemption, which allows certain activities during the patent protection without prejudice to international agreements.
- Address medicine shortages. The reform establishes an EU framework to better monitor medicine shortages, with a stronger coordination role for EMA. Companies will be subject to stronger obligations to prevent shortages, while an EU list of critical medicines will be established and vulnerability assessments carried out, amongst other things.
All these measures will substantially strengthen a sector that is vital for the EUs strategic autonomy. Reform of the pharmaceutical legislation is a key part of the Commissions agenda to ensure EU citizens have access to top-level medicines and treatments, and to support a more competitive and innovative healthcare sector in the EU. It is complemented by the Commissions proposal for a Critical Medicines Act, the recent Life Sciences Strategy and the upcoming Biotech Act, the targeted revision of the rules for medical devices, among other initiatives.
Next Steps
The political agreement is now subject to formal approval by the European Parliament and the Council.
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