Sofinnova and LSAA joint letter on the draft reform of the European Union’s pharmaceutical strategy and orphan drugs
The European Commission is preparing a major overhaul of the European Union’s 20-year-old pharmaceutical strategy. The reform includes rules for products that treat unmet medical needs, as well as measures to protect regulatory data and streamline administrative processes. It also aims to provide incentives to address antimicrobial resistance and to secure the EU’s drug supply.
With regard to orphan drugs, the Commission’s draft text aims to reduce the period of market exclusivity from 10 to 5 years. While the objective is to accelerate patient access to treatments, the end result could be quite different, as happened in the United States following the enactment of the Inflation Reduction Act, which reduced the market exclusivity of small molecules that are new chemical entities from 14 to 9 years. German MEPs and the Danish government have already alerted the Commission to the risks that these measures represent for therapeutic innovation in Europe and access to treatment for European patients.
This note provides some warning points on the draft text presented by the Commission on April 26 and makes some recommendations for a therapeutic innovation strategy for the European Union.
Read Sofinnova and LSAA’s full joint note here.