EU plans export waiver for pharma manufacturing
pharmafile | November 3, 2015 | News story | Manufacturing and Production | EGA, European Commission, biologics, biosimilars, generics, manufacturing, supplementary protection certificates
The European Commission plans to bring in an export waiver for supplementary protection certificates, in order to boost pharma industry manufacturing in Europe.
In the European Economic Area (EEA) supplementary protection certificates (SPCs) extend a company’s intellectual property rights for a drug following the expiry of the original patent for medicines and biologics. The certificates were created to compensate companies for the long approval time for products.
Currently, pharma manufacturers in Europe are forced to outsource production to supply countries without SPCs or to regions where SPCs expire early in comparison to Europe, creating competition as soon as the SPCs expire in Europe.
However, according to the European Genetics and Biosimilar Medicines Association (EGA), in order to increase manufacturing and R&D in Europe, the exemption of SPCs is essential. The EGA says it will create new high skilled jobs within the pharma industry and stimulate economic growth.
Adrian Van Den Hoven, director-general of the EGA says: “The European genetics and biosimilar medicines industry is on the cusp of creating many more jobs as it expands access to high quality medicines for patients. Europe needs to rapidly introduce a targeted SPC waiver to capitalise on this tremendous opportunity for pharmaceutical manufacturing in the EU.”
Evidence suggests global spending on generics will rise from 27% in 2012 to 36% by 2017 and 80% by 2020. An SPC manufacturing waiver for the purposes of export into countries which are not SPC protected could allow the European genetics and biosimilar industries to develop, creating thousands of technical jobs and giving a boost to new smaller companies.
The plans, revealed in a European Commission strategy document, suggest that the waiver will allow for granting SPCs in Europe, giving greater transparency and certainty to European regulators and generic companies about products’ IP statuses.
The planned SPC export waiver will allow manufactures of generic and biosimilar medicines based in the EU to compete equally with competitors not within the EU, and will also allow generic manufactures to conduct research before the original drug comes off the its patent.
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