EFPIA makes demands on SPC manufacturing waiver

As a draft regulation to introduce a manufacturing waiver to the protection granted by a supplementary protection certificate (SPC) moves closer in Europe, drug industry lobby groups show no sign of backing down on their positions.

The SPC allows drugmakers to extend the 20-year patent protection on their medicines by an additional five years. At present, European Union (EU)-based companies cannot produce generic or biosimilar versions of these medicines for sale in the EU during that time. Neither can they export these drugs to countries where the SPC does not apply, or produce and stockpile medicines for the EU market in advance of the day of SPC expiry.

Amid pressure from EU-based generics companies, led by the Medicines for Europe group, the SPC manufacturing waiver has been brought forward and has won support in the European Parliament.