European Parliament approves SPC manufacturing waiver
The European Parliament has voted to approve the supplementary protection certificate (SPC) manufacturing waiver, which will allow the stockpiling of generic versions of patented drugs.
SPCs extend exclusivity on a drug after the expiration of its patent, for a period of up to five years.
Under the proposed waiver, however, EU-based companies will be make generics and biosimilars of patent-protected drugs during the last two years of their SPC-protected drugs, as long as they are intended for export to a market outside of the EU.
Companies will also be able to stockpile generics and biosimilars during the last six months of an SPC’s protection period ahead of entry onto the EU market.
The waiver must now be approved by the European Council before entering into law. If adopted, it will come into force in July 2019 and companies will be able to start manufacturing under the new rules in 2022.
In a statement issued yesterday, April 17, the European Commission said the waiver would remove “a major competitive disadvantage of EU manufacturers compared to manufacturers based in non-EU countries and ensure a better deal for patients”.
The statement added that the waiver would strike “a balance between ensuring the attractiveness of Europe for innovative pharmaceutical companies and allowing EU-based generics and biosimilar to compete on the global market”.
Medicines for Europe (MFE), which represents generics and biosimilars manufacturers in the EU, welcomed the decision.
“The SPC manufacturing waiver will enable the European pharmaceutical industry to compete on a level playing field globally for manufacturing opportunities in generic and biosimilar medicines which is growing year-on-year,” a MFE statement said.
Adrian van der Hoven, director general of MFE, added that “Europe has everything to gain from fully implementing the waiver to enable more competition on the pharmaceutical market and to improve its own security of medicines supply”.
The waiver has not been universally popular across the pharmaceutical industry, however.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) said the waiver sends “a negative signal to the world that Europe is devaluing its intellectual property framework, making Europe a less attractive location for research and development”.
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