Current EU legislation prohibits production of a generic or biosimilar medicinal product during the “supplementary protection certificates” (SPC) protection period of the original - even if that production is intended exclusively for export to a country where the protection period has already expired. Production in preparation for the day following expiration of the SPC in the EU is also prohibited. This forces manufacturers of generic and biosimilar medicines to systematically build up production capacity outside the EU.
The EU Commission’s initiative to introduce an “SPC manufacturing waiver” is aimed at removing this contradiction and consequently the competitive disadvantage for EU-based generic and biosimilar manufacturers without undermining existing intellectual property rights. Medicines for Europe, the association that represents the European generic, biosimilar and value added medicines industries, has just launched a website to inform interested parties about the prospects of this proposal. Fresenius Kabi has been a corporate member of this association for almost a decade and supports this initiative.