Industry Prepares For Advent Of SPC Manufacturing Waiver
As the generics and biosimilars industries prepare for the European SPC manufacturing waiver to come into effect on 1 July, Generics Bulletin traces the history of the mechanism from early industry lobbying efforts to its ultimate entry into force.
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A globally co-ordinated approach to sourcing that rewards non-pricing criteria is imperative to bolster the security of the off-patent industry’s supply chain in the wake of the coronavirus pandemic, James Burt tells Generics Bulletin in the second part of our exclusive interview.
Changes to how the UK plans to implement the SPC manufacturing waiver after it separates itself fully from the EU following the current Brexit transition period have been criticized by the generics industry, while originators have welcomed the move.
International off-patent industry body the IGBA has urged Australia’s government to “hold firm” against intellectual-property proposals made by the European Commission as part of negotiations over an Australia-EU trade deal. The organization believes the EU proposals would negatively impact access to generics and biosimilars in Australia.