The new “SPC waiver” regulation, that will allow EU-based biosimilar and generic manufacturers to start making medicinal products protected by an SPC before expiry of the SPC at certain conditions, became final on 14 May after adoption by the Council of the EU and is expected to enter into force by 1 July 2019.

Formal adoption by Council of the European Union on 14 May 2019 has finalised a new regulation that introduces into European Union law a manufacturing waiver for Supplementary Protection Certificates (SPCs). The European Parliament had approved the text of the new regulation less than a month earlier, on 17 April 2019.

The aim of the SPC waiver, according to official statements, is to boost the competitiveness of EU-based biosimilar and generic companies.

What has changed?

The adopted regulation has not changed much since the original proposal tabled in May 2018.

In essence, the includes further measures to ensure respect of the waiver’s limits.

What will the waiver apply to?

The waiver will apply to the production in the territory of the European Union, during the term of validity of the SPC, of generic or biosimilar medicines intended exclusively for export to countries outside the European Union where protection of the original medicine does not exist or has expired.

It will also apply to the stockpiling the product in European Union territory during the last 6 months of the term of the SPC to allow day-1-launch of the generic or biosimilar product on the European Union market as soon as the SPC expires.

Which SPCs will the waiver apply to?

For three years after its entry force, the new regulation will affect only SPCs that are applied for on or after the date of entry into force of the regulation. As from the fourth year, the regulation will also affect SPCs applied for before the entry into force of the regulation, but which have become effective after the entry into force of the regulation.

Waiver conditions

3 months at the latest before starting production, the manufacturer must notify the SPC holder and the national patent office that granted the SPC.

An “EU export” logo must be affixed to the packaging of products made for the purpose of export to countries outside the European Union.

The manufacturer must inform its supply chain that the product is made under the waiver and is intended either for export outside the European Union or for day-1-launch in the EU market.

When will the new regulation enter into force?

The regulation is yet to be published in the Official Journal of the European Union. According to a release of the Council of the European Union, the regulation is expected to enter into force by 1 July 2019.

Related articles

Flash news – SPC waiver: draft EU regulation takes a step forward

Flash news – European Commission proposes SPC waiver