Generic and Branded Industry Groups Spar Over EU SPC Waiver Proposal

Regulatory NewsRegulatory News | 05 December 2018 |  By 

The European Parliament’s International Trade Committee (INTA) on Monday voted to adopt a draft opinion supporting changes to an amendment that would allow for manufacturing waivers to supplementary protection certificates (SPCs).
In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse between when the patent application is filed and when marketing authorization is granted.
Earlier this year, the European Commission proposed an amendment to the regulation governing SPCs that would allow for generic and biosimilar manufacturers to begin making copies of medicines protected in the EU by a SPC so long as they are intended for export only. Under the waiver system proposed in the amendment, a generic or biosimilar maker would need to notify regulators in the member state where they would be making the products before they can begin manufacturing.
However, the draft opinion proposes changes to the amendment supporting the possibility of a “day-1” launch for generics and biosimilars when an SPC expires and allowing for stockpiling of medicines made under a waiver. The changes suggested in the draft opinion are being referred to the Committee on Legal Affairs for review.
The draft opinion also suggests making the waivers apply retroactively to products already covered by a SPC “to boost the potential benefits for patients and for generics and biosimilars’ producers.”
While the draft opinion drew praise from Medicines for Europe, which represents the EU’s generic and biosimilars industry, the European Federation for Pharmaceutical Industries and Associations (EFPIA) said the proposal on SPC waivers “sends a signal to the world that Europe is weakening its commitment to [intellectual property] IP incentives and innovation.”
Instead, EFPIA is calling on lawmakers in Europe to limit the scope of SPC waivers to prevent stockpiling of drugs covered by a SPC and ensure the waivers only apply to newly issued SPCs. EFPIA also says that effective labeling measures are needed to ensure generics and biosimilars manufactured under a SPC waiver for export are not redirected to the European market.
Medicines for Europe, on the other hand, said the changes suggested in the draft opinion improve on the original proposal.
“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 the first step in a policy to ensure Europe’s security of supply of medicines, to stop the delocalization of production and to stimulate competition after SPC expiry,” said Medicines for Europe Director General Adrian van den Hoven.
INTA Meeting Agenda and Documents


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