SPC waiver proposal could discourage innovation, says pharma group
A proposed change to supplementary protection certificate (SPC) rules in the EU could lead to the development of less innovative medicines, according to the Irish Pharmaceutical Healthcare Association ( IPHA).
In May, the European Commission proposed altering SPC rules to allow pharmaceutical companies to produce generic drugs for export to non-EU countries that don’t have patent protection.
LSIPR reported at the time that the “export manufacturing waiver” is aimed at removing “a major competitive disadvantage” of EU manufacturers against non-EU based generic and biosimilar companies.
This would allow EU companies to make generic or biosimilar versions of an SPC-protected medicine during the term of the certificate, as long as the product is manufactured to be exclusively exported to a non-EU market.
The Irish Times reported on Monday, August 6 that the IPHA, which represents the pharmaceutical industry in Ireland, submitted a warning to the Department of Business, Enterprise and Innovation that drug manufacturers’ IP rights could be weakened. In addition, the association said that research facilities could be placed at risk if the amendment goes ahead.
Currently, an SPC provides an extension of up to five years after the standard 20-year patent protection period comes to an end.
“By curtailing IP rights, Ireland and Europe are sending a signal to the world that we undervalue our commitment to IP incentives and innovation,” the IPHA reportedly said.
At the time of the proposal, Elżbieta Bieńkowska, commissioner for internal market, industry, entrepreneurship and SMEs, said that the proposal could generate €1 billion ($1.2 billion) net additional sales per year, on top of 25,000 new jobs over a ten-year period.
The IPHA’s concerns echo those of the European Federation of Pharmaceutical Industries and Associations ( EFPIA). The organisation, which represents the European research-based pharmaceutical industry, said in May that it was “deeply concerned” about the proposal.
The EFPIA said that the proposal could reduce IP rights and jeopardise patient access to innovative treatments.
“It also sends a global signal that Europe is weakening its commitment to IP, putting this investment, these jobs, this opportunity for economic growth and the advancement of patient care in Europe at serious risk,” added the EFPIA.
The European Council and Parliament will now consider whether any amendments need to be made to the proposed regulation or whether it can be brought into effect as it is. The Commission hopes to have the regulation passed by Spring 2019.
The topic of SPCs will be discussed at the Life Sciences Patent Network North America Fall conference on October 16 in San Francisco. To find out more, click here.
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