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EU’s Unitary SPC System Must Maximize Access To Medicines & Not Block Generic Entry

 
• By Ian Schofield

A European Parliament committee says that some aspects of the EU’s proposed unitary supplementary protection certificate scheme could promote access to cheaper off-patent medicines while others could delay generic competition.

Patent skyline
The new uSPC system will offer wider extensions to effective patent life • Source: Shutterstock

It will be important to ensure that the European Commission’s proposals to increase access to medicines by linking regulatory rewards and incentives to EU-wide launch requirements are retained during the discussion of the pharmaceutical legislative reform at the parliament and Council of the EU, according to the European Parliament’s legal affairs committee (JURI).

If these proposals are weakened, “alternative provisions” could be considered that make eligibility for the grant of a supplementary protection certificate (SPC) dependent on compliance with specific EU marketing obligations,...

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