EC Says ‘Bolar Exemption’ Should Cover Pricing, Reimbursement & HTA Processes
Pricing and reimbursement processes as well as health technology assessments should be explicitly included in the procedures that can be conducted for generic and biosimilar products without infringing patent rights, according to the European Commission’s legislative revision proposals.
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The texts of the proposals cannot be formally presented to the European Parliament until they have been translated into all of the EU’s official languages.
A long-awaited package of European pharmaceutical legislation reforms unveiled by the European Commission contains a number of measures that will affect the generics and biosimilars industry – including changes to regulatory data protection periods, simplified marketing authorization procedures, and moves towards greater digitalization.
Proposals for the overhaul of the EU pharmaceutical legislation will make medicines more widely available, accessible and affordable while supporting innovation and boosting the “competitiveness and attractiveness” of Europe’s pharma industry, the European Commission claims. The research-based industry thinks otherwise, saying cuts in regulatory protections will undermine R&D.