Response to the OMP & Paediatric Consultation- A Call for a Constructive Conversation
The European Commission is consulting stakeholders as part of its revision process of two major pieces of legislation, on medicines for rare diseases and paediatric patients. Central to the development of innovative treatments for these specific categories of patients, this revision process represents an important milestone for the European industry and patients’ communities.
Published on 7 May 2021, the consultation details the options the Commission is considering for the revision on these two important Regulations. As part of our contribution to the review process, EUCOPE published two position papers, on the Orphan Medicinal Products and Paediatric Regulation respectively, complementing the input we provided through the consultation process.
We note with concern that some aspects of the consultation present a narrow view of the process of pharmaceutical innovation and its benefits to patients in need of medicines for rare diseases and paediatric medicines. We are particularly concerned about the suggestion of linking incentives to product availability, that will affect disproportionately small- to mid-sized companies and restricting both designation and incentives for rare diseases medicines development.
Commenting on the Regulation reviews, EUCOPE Secretary General Alexander Natz added: “The development of orphan and paediatric medicines is a global endeavour – developers concentrate their efforts in those environments which stimulate the most innovation. EUCOPE’s membership consists of European and global companies – we are all committed to Europe. The Regulations review should support the goal of ensuring that Europe remains an attractive place to undertake research and launch products for rare and paediatric disease patients.’’
The Regulations review will not provide a silver bullet to improve access and affordability of paediatric and orphan medicines. We call for cooperation and dialogue among Member States, medical and research communities, biopharmaceutical industry and patients. In line with this approach, EUCOPE co-leads the Expert Group on OD Incentives, which brings together representatives of the rare disease community, including researchers, academia, patient representatives, members of the investor community and industry. These experts developed 14 recommendations aimed at improving the European environment for the development of orphan medicines. These recommendations could be a starting point to identify actionable solutions to address rare diseases unmet needs across the whole lifecycle of medicines.
EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs
EUCOPE is Europe’s trade body for small to medium-sized innovative companies working in the field of pharmaceuticals and medical technologies.
Based in Brussels, EUCOPE gives voice to more than 900 research-orientated innovative companies and associations active in research, development of pharmaceuticals, biotechnologies and medical devices. Many of its members are developing therapeutic solutions for persons living with a rare disease, who had little to no treatment available just a few years ago.
For further information please contact:
EUCOPE Associate Director Government Affairs
+32 (0)2 842 69 81
EUCOPE Senior Manager Communications & Public Affairs
+32 (0) 2 842 69 85