Development of orphan medicines in the EU

Question for written answer  E-002001/2021
to the Commission
Rule 138
Cristina Maestre Martín De Almagro (S&D)

It is estimated that there are between 6 000 and 8 000 rare diseases in the EU, affecting some 30 million people. Given the scale of the issue, for decades, the European institutions have been legislating and investing in projects aimed at understanding and alleviating the effects of these diseases. At EU level, this includes the adoption of Regulation (EC) No 141/2000 on orphan medicinal products and the establishment of Committee for Orphan Medicinal Products within the European Medicines Agency.

With this in mind:

• 1.Since European legislation on orphan medicinal products was adopted over two decades ago, is the Commission considering revising Regulation (EC) No 141/2000 in order to provide greater facilities and incentives to develop orphan medicinal products in the EU?
• 2.With the experience gained in the COVID-19 pandemic, does the Commission intend to conduct collective negotiations to obtain equal access to orphan medicinal products approved by the EMA for all Member States to make sure that all patients in the EU have access to these medicines?