European Parliament Proposes Amendments to SPCs, Supports Day 1 Launch

This week, the European Parliament’s Health Committee (ENVI) introduced amendments to Supplementary Protection Certificate (SPC) manufacturing waivers.

An SPC is an intellectual property right that grants an extension of up to 5 years on a 20-year patent term for an innovative pharmaceutical. The SPC is meant to offset the loss of patent protection that takes place during the development of a generic or biosimilar.

In May, the European Commission (EC) proposed revising SPCs in order to boost the development and manufacturing of biosimilars and generics. The proposal looked to introduce a manufacturing exemption for export purposes during the term of an SPC. The exemption would restrict the protection allowed by the SPC in order to remove competitive disadvantages to EU-based generic and biosimilar developers by allowing a drug maker to manufacture a product in an EU member state for the sole purpose of exporting a product to a non-EU market that is not subject to an SPC.

The current waiver also blocks the production and stockpiling of generics and biosimilars to allow for “day 1” launches after SPC expiry. Due to such restrictions, the EU pharmaceutical industry instead must delocalize production to non-EU countries such as Canada, India, China, and the United States.

In its most recently submitted amendments, ENVI “sent a clear signal of support with the adoption of a ‘day 1’ launch possibility to supply European patients with European manufactured medicines.” As the EU expects €90 billion (approximately $102 billion) worth of blockbuster medicines coming off patent in 2020, this amendment could have significant implications for industry.

ENVI additionally noted the need to protect trade secrets and commercially confidential information in the context of a procedure to notify other manufacturers of patent expiry. However, the committee also “maintained the very long lead time for implementing the waiver which will delay its ability to create manufacturing and access opportunities for many years.”

Adrian van den Hoven, director general of Medicines for Europe, commented in a statement, “We hope that this progress, together with a more reasonable date of application, will be agreed by the Parliament and the Council in a future final agreement. We urge the Parliament’s Legal Committee to adopt a final opinion that includes these important priorities for health, for jobs, and for a robust pharmaceutical ecosystem.”