EGA calls for removal of competition and trade barriers for generics

Generics/General | Posted 28/03/2014 post-comment0 Post your comment

The European Generic medicines Association (EGA) is calling on the EU to remove barriers to competition and free trade by introducing common sense reforms to European pharmaceutical intellectual property rules.

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The association made the request at its 10th Legal Affairs Forum. EGA believes that improving the efficiency of the patent system, introducing an export provision and clarifying the EU policy on patent settlements will all help to boost growth and jobs in Europe.

Patent system
Improving the quality of patent assessments and strengthening the application of the ‘inventive step’ criteria would, according to EGA, ensure that generics and biosimilars can enter markets at patent expiry. The association cited the fact that numerous pharmaceutical patents are subject to invalidity decisions as proof of the need for improvement in this area.

Export provision
EGA called on the EU to amend the Supplementary Protection Certificate (SPC) Regulation, to allow generics and biosimilars manufacturers to export to emerging markets where SPCs do not apply. According to Mr Adrian van den Hoven, EGA’s Director General, ‘The SPC unfairly blocks our industry from exporting to the rest of [the] world and encourages the delocalisation of our production.’

Patent settlements
EGA expressed concerns over the effect of the European Commission’s policy on patent settlements, which the association believes could limit the possibility for generics makers to challenge weak patents. EGA therefore called for more guidance from the Commission on what is authorized in a patent settlement.

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Source: EGA

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