International Trade Committee Votes in Favor of SPC Amendments

Last month, the European Parliament’s Health Committee (ENVI) introduced amendments to Supplementary Protection Certificate (SPC) manufacturing waivers. On December 4, 2018, the committee voted in favor of the amendments.

Trade group Medicines for Europe praised the vote, saying in a statement that its board “unanimously applauds last night’s vote in the European Parliament where, once again, parliamentarians voted for a comprehensive Supplementary Protection Certificate 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 proposed amendments called for revising SPCs to boost the development and manufacturing of biosimilars and generics. The original SPC waivers were an intellectual property right that granted an extension of up to 5 years on a 20-year patent term for an innovative pharmaceutical.

The amendments sought to introduce a manufacturing exemption for export purposes during the term of an SPC that would restrict the protection in order to remove competitive disadvantages to European Union (EU)-based generic and biosimilar developers. The amendments allow a drug maker to manufacture a product in an EU member state for the purpose of exporting a product to a non-EU market that is not subject to an SPC. Additionally, the proposals favor of “day 1” launches of drugs after SPC expiry.

During the vote on Tuesday, the International Trade Committee (INTA) “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.”

Adrian van den Hoven, director general of Medicines for Europe, commented “We thank the Trade Committee for not caving in to vested interests and foreign pressure by voting for a comprehensive SPC manufacturing waiver…The manufacturing waiver 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.”

Medicines for Europe has now called on Parliament’s Legal Committee to adopt the amendments in a final report.