The generic industry’s request for an SPC (supplementary protection certificates) manufacturing waiver, which would allow them to produce in the EU SPC-protected drugs for other markets, does not influence or harm innovators’ rights, Marc–Alexander Mahl told EURACTIV.com in an interview.
He said that the originators’ arguments for rejecting such a waiver and protecting their own rights are not “fully rational”. Referring to the Brexit negotiations, he voiced doubts as to whether the remaining 12 months will be sufficient to find solutions for the highly regulated pharmaceutical sector.
Marc–Alexander Mahl is the President of Medicines for Europe, which represents the European generic, biosimilar and valued added pharmaceutical industries.
He spoke to EURACTIV’s Sarantis Michalopoulos.
The European Commission has announced its intention to add a manufacturing waiver to supplementary protection certificates (SPC) as part of its upgraded Single Market Strategy in 2015.
An SPC is an intellectual property right that serves as an extension of a patent right in the EU. With a manufacturing waiver, generic drug-makers can manufacture SPC-protected drugs in the EU to sell in other markets and to prepare stocks for when the SPC expires, but would not be allowed to commercialise in SPC protected markets.
The EU executive also points out in a study that an SPC manufacturing waiver for exports to countries outside the EU could allow the bloc’s generics and biosimilars industries to create thousands of high-tech jobs in the EU and start many new companies.
However, the pharmaceutical industry opposes this view and warns of severe implications for innovation and investment in the EU.
Read more at Euractiv