In the context of the European Commission proposal for the revision of the OMP Regulation which is expected by the end of 2022, the European Federation of Pharmaceutical Entrepreneurs (EUCOPE) indicates that the impact assessment currently being drafted to accompany the proposal could include the following provisions:
- The prevalence threshold could be cumulative (ie the threshold will apply to the cumulative patient population covered by all designations rather than applying to only one indication as is currently the case)
- The designation may have a temporal validity of 7 years (there is currently no time limit)
- Some options would reduce the prevalence threshold to 4 in 10000 people
- 8 years for products addressing high unmet need (ie for diseases without authorised alternatives or the new product is curative and/or products addressing rare paediatric diseases)
- 6 years for innovative products (ie new active ingredients)
- 5 years for all other orphan products
Products addressing a high unmet need/rare paediatric diseases can be extended to 2 years under the following conditions:
- Availability: to be placed on the market in the majority of EU member states within 4 years from authorisation OR
- Lack of ROI: to provide transparency on R&D costs and public funding received.
For example, 2 years of transferable market and data protection for high unmet needs that the company can apply to another product or sell to another company, or priority review ‘vouchers’ which could be linked to an accelerated review similar to the PRIME scheme.
EUCOPE notes that “while these proposals don’t necessarily represent the final options included in the new OMP regulation, there are many concerning aspects that could impact the number of designation and OMP products launched in Europe”.
EUCOPE, “Intelligence on OMP Regulation Review”, 11th April 2022