SPC waiver to remove major competitive disadvantage of EU drugmakers

By PharmaCompass

2019-07-04

Impressions: 112 Article

A new EU regulation — SPC waiver — came into force on July 1, 2019. SPC stands for supplementary protection certificate for medicinal products. This waiver will allow EU-based biosimilar and generic manufacturers to start manufacturing medicinal products protected by an SPC before expiry of the SPC, under certain conditions.

The EU regulation concerning SPC waiver was published in the Official Journal of the European Union on June 11, 2019.

In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse between when the patent application is filed and when marketing authorization is granted.

According to the European Commission, the SPC waiver regulations will “remove a major competitive disadvantage of EU manufacturers compared to manufacturers based in non-EU countries and ultimately ensure a better deal for patients.”

The Commission also estimates that SPC manufacturing waivers could generate upwards of US$ 1.13 billion (€1 billion) in annual sales of generics and biosimilars and create 25,000 jobs over the next decade.

Amongst the conditions put forth by this new legislation is that an “EU export” logo must be affixed to the packaging of products made for the purpose of export to countries outside the EU.

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