EU Generics Group Takes Issue With US Interference on SPC Manufacturing Waivers

Regulatory NewsRegulatory News | 26 October 2018 |  By 

Medicines for Europe, which represents the EU’s generic and biosimilar medicines industry, raised concerns earlier this month with discussions at the European Council, which the group said “will neuter the potential benefits” of the proposed Supplementary Protection Certificate (SPC) manufacturing waiver. The group also took issue with a US meeting this week with EU officials on the waivers, raising concerns about the external pressure.
Unafraid to express its opinion this month when discussing SPC manufacturing waivers, the EU group has made clear changes to the legislation might water it down.
“Unfortunately, it is becoming increasingly clear that vested interests are exerting pressure on policymakers in the Council to remove clauses or add new ones that will jeopardize the whole legislation in an attempt to limit competition in unprotected markets at the expense of European competitiveness and growth,” the group wrote.
On the other side of the coin, brand name manufacturers oppose the idea of SPC manufacturing waivers.
EFPIA General Counsel Kristine Peers said: “The EU introduced Supplementary protection certificates (SPCs) to attract and drive research in Europe. Approximately half the patent life of a new treatment is lost during the research, development and regulatory processes and the SPC went some way to restoring some of that patent life. Changing any part of this carefully constructed framework destabilises the IP incentives system in Europe. Granting an SPC manufacturing waiver, erodes the foundations of medical research, putting the future of medical research in Europe at risk.”
Supplementary Protection Certificates (SPCs) in the EU extend the 20-year market exclusivity by up to five years. 
They are designed to compensate for the time lapse between the patent application and the granting of marketing authorization, and when the originator company has to complete the development of its product and obtain regulatory approval. The relevant EU regulation is Regulation (EC) No. 469/2009
An SPC manufacturing waiver will allow EU-based companies to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the certificate, if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed, according to the European Commission.
Medicines for Europe has said an SPC waiver, if applied correctly, has the potential to generate an additional €9.5 billion in net sales for generic and biosimilar companies.
Anger With US
But on Tuesday in Brussels, the US patent and trademark office (USPTO), together with the US Trade Office and the US Department of Commerce, held a government official-only briefing on the EU legislative proposal for an SPC manufacturing waiver.
According to Medicines for Europe, the aim of the meeting was to convey the position of the US commercial bodies on an SPC manufacturing waiver in Europe and influence the outcome of this EU legislative proposal.
Adrian van den Hoven, director general at Medicines for Europe, said: “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!”
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products


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