EU Policymakers Under Industry Pressure To 'Neuter' SPC Waiver Plan
“Vested interests” are pressuring EU policymakers to water down further European Commission plans for an exemption intended to allow generic and biosimilar firms to manufacture their versions of products for export while SPCs are still in effect, claims the industry sector body Medicines for Europe.
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A proposal to allow generics firms to manufacture versions of supplementary protection certificate-protected medicines in preparation for EU launch immediately on SPC expiry is making progress through the European parliamentary process, to the delight of the generics industry – and the dismay of originator companies.
A European Commission legislative proposal to change the EU’s rules on supplementary protection certificates and allow for the production of versions of patent-protected medicines for sale outside the EU has been welcomed by the generics and biosimilars industry – albeit with caveats – but criticized by the originator industry as an attack on intellectual property that could hit investment in Europe.
A project is about to begin to understand the factors that influence marketing decisions in the various EU member states.