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.”

 

Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 190,000 people at over 450 manufacturing and 124 R&D sites in Europe and invest up to 17% of their turnover in medical innovation. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.