The OMP Regulation in context: EU environment for the development of OMPs

EUCOPE’s approach to the EU environment for the development of OMPs

On 11 August 2020, the European Commission published its evaluation on the legislation for medicines for rare diseases and for children. In November this was followed by an Inception Impact Assessment outlining policy options based on the outcomes of the evaluation. EUCOPE seize the opportunity to contribute to this process, outlining ways to strengthen the EU environment for the development of OMPs. The elements composing this framework are the OMP Regulation itself, the broader pharmaceutical regulatory framework, Health Technology Assessment (HTA) and national market structures for access to OMPs. These elements should be fully complementary and integrated.

Sadly, gaps still remain.

In consequence, EUCOPE wishes to promote a comprehensive view of the system for the development of OMPs.

Our vision is bridging the gaps in the EU environment for the development of rare disease treatments to foster the cycle of biopharmaceutical innovation

A shared responsibility

In its inception impact assessment, the Commission outlined possible options for the revision of the incentives system provided by the two Regulations. As we continue engaging in the evaluation process, we strive to maintain a global and holistic approach that allows to clearly identify the role of the OMP regulation in the broader context.

We believe that access to therapies for rare diseases is a shared responsibility and no stakeholder should act alone in devising policies to this goal.

 EUCOPE is committed to lead and partake in targeted partnerships aimed at developing actionable proposals across the lifecycle of orphan medicinal products.

Read more below on our approach in the factsheet ‘The Orphan Medicines Regulation – the Way Forward” and further details on the recommendations for the EU environment for the development of OMPs in the accompanying briefing document.