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Firms fear Council could neuter waiver

 
• By Aidan Fry

Vested interests based outside of the European Union (EU) could persuade the European Council to “neuter” a proposed manufacturing waiver that would allow EU-based generics and biosimilars firms to manufacture products during the supplementary protection certificate (SPC) term, local industry fears. European offpatent industry association Medicines for Europe is calling on EU member state governments, as well as health and industry ministers, “to rapidly improve the legislative proposal for a manufacturing waiver and withstand efforts to undermine it”.

Vested interests based outside of the European Union (EU) could persuade the European Council to “neuter” a proposed manufacturing waiver that would allow EU-based generics and biosimilars firms to manufacture products during the supplementary protection certificate (SPC) term, local industry fears. European offpatent industry association Medicines for Europe is calling on EU member state governments, as well as health and industry ministers, “to rapidly improve the legislative proposal for a manufacturing waiver and withstand efforts to undermine it”.

According to Medicines for Europe, “disproportionate influence” being exerted on the EU Council is leading to a “concrete risk” of the draft SPC waiver legislation being rendered unusable

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