EUCOPE’s response to the Orphan Medicinal Products and Paediatrics Inception Impact Assessment

EUCOPE, the European association for small to medium-sized companies active in pharmaceuticals and biotechnologies submitted its response to the Paediatric and Orphan Medicinal Products (OMPs) inception impact assessment.

EUCOPE represents 130 companies, many focused on rare diseases, largely small to medium-sized, playing a key role in the European pharmaceutical environment. Some of them have unique profiles due to their highly specialised product portfolio, no or limited revenues to date, significant risky R&D investments. For these companies, incentives are crucial to sustain (re)investments and planning cycles required to foster research in rare and paediatric diseases.

Our response emphasises the need to tackle the incentives’ evaluation in a holistic and inclusive manner, involving the entire rare disease and paediatric community. 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. All of them working together to develop recommendations aimed at improving the European environment for the development of orphan medicines.

As noted by a study from the Office of Health Economics, curtailing incentives could risk significantly lower the numbers of OMPs being developed, or even threaten the survival of companies which solely produce them and further affect the attractiveness of Europe as a region for innovation.

Reflecting on the approach of the incentives review, EUCOPE’s Secretary General, Alexander Natz underlined:

We call for considering further measures to strengthen the incentives ecosystem. This approach should be coherent with the recently published EU IP Action plan, which rightly takes into account the role of a strong IP framework in fostering competitiveness and innovation.

Well knowing that the Regulations review will not directly provide solutions to improve access and affordability of paediatric and orphan medicines, we call for cooperation and dialogue between member states, medical and research community, biopharmaceutical industry and patients to strengthen the EU environment for the development of OMP  and the European innovation ecosystem as a whole.

Read our position paper accompanying the OMP and Paediatric Inception Impact Assessment Submission here.