SOUNDS OF SCIENCE - EPISODE 10

Within the European Commission’s ongoing review of the General Pharmaceutical Legislation and Orphan Medicinal Products (OMP) Regulation, there are several potentially controversial policy options that aim to enhance access to medicine and overcome unmet medical need, including launch conditionality. Under the proposed system, companies would only receive their full Regulatory Data Protection if they meet a number of predefined conditions.

Two conditions under consideration are that companies must launch the product in most, if not all, EU Member States within a fixed timeframe and address a yet unspecified unmet medical need. Today’s discussion focuses on the launch condition, which is far-reaching and creates additional risk for small and mid-sized companies to launch products – particularly orphan medicinal products (OMPs) – in the EU.

Small and mid-sized companies are key drivers of biopharmaceutical innovation in Europe. They play an important role in the development of new and underserved medicines, so it is crucial that their needs and interests are looked after in order to reinforce an innovative and competitive biopharmaceutical ecosystem in Europe. The EU should avoid implementing policy that discourages innovation, disproportionally punishes small and mid-sized companies and might limit, not improve access.

To understand the potential impact of the launch condition on the small and mid-sized health technology company, we’ve invited two of our members on the show today: