EU Considers Draft Regulation in Support of EU-Based Generics and Biosimilars Producers

On February 20, 2019, the Committee of Permanent Representatives of the Governments of the Member States to the European Union (Coreper) endorsed a deal reached on February 14, 2019 with the European Parliament on a draft regulation that introduces an exception allowing EU-based manufacturers of original generics and biosimilars to manufacture a generic or biosimilar version of an SPC-protected drug during the supplementary protection certificate (SPC) term, for export and/or stockpiling purposes.

The draft regulation, which will soon be submitted to the European Parliament and the Council for formal adoption, is expected to remove the competitive disadvantages EU-based generics and biosimilars manufacturers are currently facing when competing beyond home markets with manufacturers based outside the EU.

The exception will apply only if:

• Generics or biosimilars are produced exclusively for export purposes to non-EU countries where protection of the original drug does not exist or has expired, or for the purpose of creating a stock that will be placed on the EU market once the SPC expires;
• The manufacturer has provided the information required by the regulation to both the production state authorities and the SPC holder, at least three months in advance;
• The manufacturer has informed all those involved in the commercialization of the product;
• The manufacturer has included a specific logo on the packaging indicating that the product is manufactured for export purposes only, as provided for by the regulation.

In the first three years from the entry into force of the regulation, the regulation will only affect SPCs that are applied for on or after the date of entry into force of the regulation. After the first three years, 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.

By: Aura Campeanu

For more information, please contact Aura Campeanu at our Romania office.