[ Diretor: Mário Frota [ Coordenador Editorial: José Carlos Fernandes Pereira [ Fundado em 30-11-1999 [ Edição III [ Ano XII

sexta-feira, 13 de outubro de 2017

New Commission study fuels generic drugs industry ‘manufacturing dispute’

EFPIA: "An SPC manufacturing waiver would be detrimental to innovation, to research and development in Europe."
[Tom Small/Flickr]

Global medicines spending is expected to shift toward generic drugs, with an expected rise from 27% in 2012 to 36% of total sales by 2017, according to a Commission staff working document that accompanied the EU executive’s 2015 Single Market Strategy Communication,.

“Generics and biosimilars could represent 80% of the volume of medicines by 2020,” the document reads.

The Commission 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 drugs makers can manufacture SPC-protected drugs in the EU to sell in other markets, and to prepare stocks for when the SPC expires.

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