The European Commission (EC) is advancing an update to Europe’s 20-year-old pharmaceutical legislation, with the dual goals of enhancing drug accessibility and bolstering research and development (R&D). The proposed changes have faced opposition from pharmaceutical associations, which argue that the new package shifts from fixed regulatory protection periods to a more flexible incentive-based system, prompting some companies to consider leaving the European market.
Details of the Proposed Legislation
Announced in April, the proposal reduces the current data protection and market protection period from 8 years plus 2 years to 6 plus 2 years. This reduction is offset by potential extensions: an additional 2 years for products launched across all European Union (EU) countries, 6 months for drugs addressing unmet medical needs, and 6 months if comparative trial data is provided.
For orphan drugs, the EC suggests a minimum market protection period of 9 years, with an additional year for pan-EU launches, another year for addressing high unmet medical needs, and up to 2 more years if new indications are developed post-approval.
Commission’s Defense and Industry’s Concerns
The Commission justifies the new scheme as a means to foster innovation and address the disparity in access to innovative medicines, which are currently available primarily in wealthier EU nations. However, the pharmaceutical industry contends that drug accessibility is influenced by local healthcare systems and insurers, and warns that the new legislation could lead to a reduction in R&D investment in the region by EUR 2 billion (USD 2.2 billion) per year.- Flcube.com
