The Medicines for Europe Board unanimously applauds last night’s vote in the European Parliament where, once again, parliamentarians voted for a comprehensive Supplementary Protection Certificate (SPC) manufacturing waiver. This has the potential of unlocking huge industrial job opportunities and healthcare savings as SPCs expire on blockbuster medicines over the next few years.
The International Trade Committee (INTA) introduced several important amendments to improve the original proposal while maintaining the exclusivity rights of the originator industry under the SPC.
The Trade Committee confirmed the opinion of the Health Committee by introducing the possibility of ‘Day 1’ launch to allow manufacturing for European patients and by removing requirements to disclose confidential business information under the notification procedure. The Trade Committee also introduced a proposal to improve the uniform application of the legislation across Europe with an improved applicability period.
The SPC manufacturing waiver will correct the implementation of the Supplementary Protection Certificate system which forces European manufacturers to delocalise manufacturing outside of Europe if they want to supply countries where the SPC does not apply, or to allow for ‘Day 1’ launches after SPC expiry in the EU. This has led to the loss of manufacturing capability in Europe while our non-European competitors such as Canada, India, China or the United States flourish.
Commenting, Adrian van den Hoven, Director General of Medicines for Europe, said “we thank the Trade Committee for not caving in to vested interests and foreign pressure by voting for a comprehensive SPC manufacturing waiver. This is not a technical measure. The manufacturing waiver is the first step in a policy to ensure Europe’s security of supply of medicines, to stop the delocalisation of production and to stimulate competition after SPC expiry. We now call on the Parliament’s Legal Committee to adopt a final report that will strengthen Europe’s ecosystem for pharmaceutical manufacturing.”