EU Commission Proposal Would Boost Manufacture of Generics and Biologics for Export

Despite opposition from some stakeholders, the European Commission proposes to grant waivers to Europe’s drugmakers to produce generic drugs for export to countries outside the EU.

The proposed “export manufacturing waiver” would allow EU drugmakers to produce generics and biosimilars for drugs protected by supplementary protection certificates (SPCs). Currently, an SPC restricts the ability of branded drugmakers to manufacture product for non-EU countries. Under the proposed change, companies could manufacture such products if they are exclusively intended for export to a non-EU market without SPC protections.

The Commission’s goal is to create a more competitive climate within the pharmaceutical industry, including increased transparency and protections against the entry into EU member state markets by IP-infringing products.