US Interference In EU SPC Manufacturing Waiver “Unacceptable,” Says EU Generic Industry Group

Generics industry group Medicines for Europe has declared United States interference in the European Union legislative process on the supplementary protection certificate (SPC) manufacturing waiver “unacceptable,” and an attempt to “influence the outcome of this EU legislative proposal.”

The statement was made in a Medicines for Europe press release available here.

The US Patent and Trademark Office, the US Trade Representative and the US Department of Commerce held a closed-door meeting with EU government officials in Brussels yesterday, 23 October, “to convey the position of the US commercial bodies and representatives to EU officials on the introduction of an SPC manufacturing waiver in Europe,” according to the release.

The SPC manufacturing waiver would allow EU generic and biosimilar manufacturers to produce medicines for export during the 5-year SPC patent extension period in the EU, “to countries where the SPC does not apply,” the Medicines for Europe website explains.

“We are surprised to hear that the US is openly interfering in an EU domestic affair in an extremely delicate moment of the legislative process on the SPC manufacturing waiver. The EU, as an entity of 28 sovereign Member States, does not need and cannot accept such external pressure, let alone when it comes to the health of patients and investments in medicines’ development. Europe cannot be intimidated and will not capitulate before the defence of the economic concerns of US commercial interests,” Adrian van den Hoven, director general of Medicines for Europe, said in the release.

“Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines,” the release states. More information on Medicines for Europe can be found here.