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Proposed SPC waiver has to go all the way

 
• By Dave Wallace

Tangible proposals for a waiver allowing manufacturing during the term of a supplementary protection certificate (SPC) have been announced by the European Commission, in a move that has been welcomed by off-patent industry association Medicines for Europe. However, the industry group cautions, such a mechanism must allow for both manufacturing for export and stockpiling for European launch upon SPC expiry to be truly effective and workable.

Tangible proposals for a waiver allowing manufacturing during the term of a supplementary protection certificate (SPC) have been announced by the European Commission, in a move that has been welcomed by off-patent industry association Medicines for Europe. However, the industry group cautions, such a mechanism must allow for both manufacturing for export and stockpiling for European launch upon SPC expiry to be truly effective and workable.

A European Commission college agenda indicates that an SPC manufacturing waiver for medicines will be discussed on 23 May, after a public consultation closed at the start of this year (Generics bulletin, 19 January 2018, page 9)

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