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Moving ahead in the European Union’s Pharmaceutical Debate

EU flag with medical stethoscope, syringes, and vials on a fabric background suggesting healthcare or medical research in Europe. Marking the end of the European Parliament’s legislative mandate with the last plenary session held last month, the Children’s Tumor Foundation Europe reflects on the progress achieved in the pharmaceutical debate at the European Union (‘EU’) level thus far.

The EU pharmaceutical package, issued in April 2023, contains two legislative revisions aiming to change the EU’s regulatory regime for approval of medicines through a proposal for a directive targeting generic and biosimilar medicines and a proposal for a regulation targeting pediatric and orphan medicinal products.

The two EU’s co-legislators, the European Parliament and the Council of the EU (representing Member States), have advanced with their respective negotiations, set to continue in the next legislature, under the new political mandate of the European Parliament.

The European Parliament endorsed its own negotiating mandate in a plenary session on 10 April, an important milestone for the negotiations. The agreement represents an ambitious and more realistic approach on the gradual market exclusivity periods for orphan drugs. The CEO of the Children’s Tumor Foundation, Annette Bakker, PhD, noted “I am delighted to this level of ambition on the market exclusivity periods for orphan drugs. I am also very pleased to acknowledge the enhanced role for patients in the drug development phase, where a more active role in the EMA consultations is proposed. More particularly, I am excited to see a more central role for rare diseases. The proposed Union Framework for Rare Diseases can be instrumental for a tangible change on the Member States’ approach on rare diseases, bringing more treatments and benefits to patients. As negotiations continue in Council, CTF Europe calls on Member States to follow the same ambitious and pragmatic approach in their negotiations, to ensure there will be a realistic regulatory process that can benefit the development of medicines for patients. Let’s not forget the lessons learned from the COVID-19 pandemic. This is a historic opportunity to establish clear and concrete regulatory processes to advance treatments for patients not only in Europe, but also across the world.”