EU: Commission proposes waiver for manufacturers of generic drugs

Patent protection rules that curb competition for medicines in markets outside the European Union should be changed, the European Commission has proposed, reported Reuters.

The Commission says it wants to introduce an “export manufacturing waiver” to protections for the pharmaceuticals sector known as supplementary protection certificates (SPC).

An SPC is an EU-wide intellectual property right that extends the protection of a patented medicine by up to five years. SPCs effectively compensate patent holders for time lost in getting regulatory approval for medicines.

According to the Irish Times, under the current regulation, European-based manufacturers are prevented from producing medicines even for regions outside the EU during the period of an SPC, despite the fact that those markets may not be subject to a supplementary protection certificate or where it might already have expired.

Generics and biosimilar manufacturers, which produce “me too” versions of drugs that have come off patent, have been pressing for a number of years for a waiver covering European manufacture for such markets outside the EU.

The European Commission last year launched a public consultation on SPCs. The announcement Monday, May 28, is the outcome of that process.

Full Content: Reuters, Irish Times

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