European Commission proposes SPC waiver to boost generics
The European Commission has proposed a change in IP rules to allow pharmaceutical companies to produce generic drugs for export to non-EU countries that don’t have patent protection.
Yesterday, May 28, the Commission announced an amendment called the “export manufacturing waiver” to supplementary protection certificates (SPCs). It is aimed at removing “a major competitive disadvantage of EU manufacturers”.
The amendment will allow EU companies to make generic/biosimilar versions of an SPC-protected medicine during the term of the certificate if the manufacture is done exclusively for export to a non-EU market where protection has expired or never existed.
According to the Commission, the waiver will “support Europe’s pioneering role in pharmaceutical research and development”.
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 and up to 25,000 new jobs over ten years.
However, the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the research-based pharmaceutical industry operating in Europe, said it was “deeply concerned” by the proposal.
The proposal amends regulation 469/2009. Once adopted by the European Parliament and Council, it will be directly applicable in all EU member states.
The EFPIA said that the proposal reduces IP rights and jeopardises 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,” the federation added.
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