The European Union (EU) is adopting new rules which aim to increase the competitiveness of EU producers of generic medicines and biosimilar products. The EU’s proposal to allow manufacturing waivers to supplementary protection certificates (SPC) advances after EU ambassadors approved a compromise that was reached on 14th February with the European Parliament during a meeting of the Committee of the Permanent Representatives.
Under the proposal, “EU-based manufacturers of generics and biosimilars will be entitled to manufacture a generic or biosimilar version of an SPC-protected medicine during the term of the SPC either for the purpose of exporting to a non-EU market where protection has expired or never existed or (during the six months before the SPC expires) for the purpose of creating a stock that will be put on the EU market after the SPC has expired.” The proposal would allow for the stockpiling of generic and biosimilars intended for the EU market during those six months to promote faster market entry.
In order for manufacturers to qualify for a waiver under the proposal, a generic or biosimilar manufacturer will need to notify both regulators in the member state where the production will take place and the SPC holder, three months before production starts. Please note that products produced under an SPC waiver for export will also be required to have a label marking them as export-only under the proposed regulation.
The proposal includes a three-year transition period, in which SPC waivers will only be granted for SPCs that were applied for on or after the regulation enters into force. After this, the regulation will be extended to SPCs that were applied for prior to the regulation, that were issued after the regulation came into effect.
Now that the draft regulation has been agreed, it will go through a legal and linguistic review before being sent to the European Parliament and Council for formal adoption.
To read more on EU measures in support of generic pharmaceuticals producers, please click here.