EU nears rule change aimed at boosting exports of generics and biosimilars

The EU has pressed on with its planned regulation change which aims to level the playing field between pharmaceuticals, and biosimilars and generics, though it has encountered some resistance from the pharmaceutical industry.

The regulation change will introduce a ‘manufacturing waiver’ to the supplementary protection certificate (SPC). The SPC currently extends market exclusivity for branded medicines inside the EU.

This change has been resisted by the pharmaceutical industry. According to European pharmaceutical industry body EFPIA, this news indicates that:

“[Europe is] weakening its commitment to IP incentives and innovation” – EFPIA

However, voices in the biosimilars and generics sector say this change would not do any harm to innovation-based pharma and would only boost exports and create jobs. Furthermore, proponents of the changes are highlighting that they would not reduce any intellectual property protection or curtail the SPC period.

In addition, the European Commission says that this boost in exports will equate to excess of €1bn over the next 10 years, creating 20,000-25,000 jobs over the period.

The EFPIA however are arguing that the approval of regulations such as this could cause a ‘slippery slope’ towards further changes.

These changes have been agreed by Ministers of EU member states. They could apply from 2021, with the European Parliament left to agree the change.

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Published 23. January 2019 in News, News EU