EU to help boost exports of generic pharmaceuticals

The Romanian presidency will start negotiations with the European Parliament with the aim of adopting the regulation at first reading.
EU to help boost exports of generic pharmaceuticals
17 January 10:53 2019 Print This Article

The EU has come a step closer to adopting new rules that will boost the export of generic medicines and biosimilar products to third countries. EU ambassadors meeting today in Coreper agreed on the Council’s position on a draft regulation which introduces an exception for manufacturing for export purposes (manufacturing waiver) to the protection granted to an original medicine by a supplementary protection certificate (SPC).

EU-based makers of generics and biosimilars will be entitled to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the SPC if done exclusively for the purpose of exporting to a non-EU market where protection has expired or never existed.

The draft regulation is expected to remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established outside the EU in global markets.

Until a set date (three years from the entry into force of the regulation), the regulation will affect only SPCs that are applied for on or after the date of entry into force of the regulation.

The EU harmonised SPC system was introduced in 1992. It sought to compensate for the loss of effective patent protection due to the time required in order to obtain marketing authorisation (including research and clinical trials).

The draft regulation should contribute to Europe’s competitiveness as a hub for pharmaceutical R&D and manufacturing. It will help new pharmaceutical companies start up and scale up in high growth areas, and is projected to generate, over the next 10 years, additional net annual export sales of well in excess of EUR 1 billion, which could translate into 20 000 to 25 000 new jobs over that period.

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