EU Takes Another Step Towards Adopting SPC Waiver Proposal

Regulatory NewsRegulatory News | 20 February 2019 |  By 

The European Union’s proposal to allow manufacturing waivers to supplementary protection certificates (SPC) is one step closer to adoption after EU ambassadors endorsed a compromise reached on 14 February with the European Parliament during a meeting of the Committee of the Permanent Representatives (Coreper) on Wednesday.
Now that the draft regulation has been agreed to, it will undergo a legal and linguistic review before being sent to the European Parliament and Council for formal adoption.
Under the proposal, generic and biosimilar makers would be able to manufacture products protected by an SPC for export to non-EU countries where market protection for those products have either expired or never existed during the final six months of the SPC. The proposal would also allow for the stockpiling of generic and biosimilars intended for the EU market during those six months to promote faster market entry.
To qualify for a waiver under the proposal, a generic or biosimilar manufacturer will be required to notify both regulators in the member state where production will take place and the SPC holder three months before production begins.
Products produced under an SPC waiver for export will also be required to bear a label marking them as export-only under the proposed regulation.
The proposal also includes a three-year transition period during which SPC waivers will only be granted for SPCs that were applied for on or after the regulation enters into force. Afterwards, the regulation will be extended to SPCs that were applied for prior to the regulation that were issued after the regulation came into effect.
Despite the proposal limiting all manufacturing under an SPC waiver to the last six months of the SPC term, the European Federation of Pharmaceutical Industries and Associations (EFPIA) still strongly opposes the regulation.
“These unbalanced and disproportionate amendments allowing the stockpiling of generic medicines for six months, an early implementation date and a lack of safeguards recalibrates the European economy from a knowledge-based region at the cutting edge of research, development and medical innovation to a Europe that is not competitive on the global R&D stage and fails to attract investments for the benefit of patients,” EFPIA wrote last week following the trilogue agreement on the proposal.
However, the Council of the EU argues the proposal will “contribute to Europe’s competitiveness as a hub for pharmaceutical R&D and manufacturing” for generic and biosimilar medicines, and estimates that over the next decade the proposal will lead to the creation of 20,000-25,000 new jobs and generate more than €1 billion in net annual export sales.
Medicines for Europe, which represents European generic and biosimilar manufacturers, says it applauds the compromise but argues that the notification requirements under the proposal are “unnecessary and redundant.”
“This will require generic and biosimilar medicines manufacturers to publish commercially confidential information to allegedly prevent our industry from circumventing the rules of the waiver – notably the re-import of medicines manufactured under the export waiver for day-one launch. This is obviously redundant now that the manufacturing waiver also authorizes its use for day-one launch manufacturing,” Medicines for Europe writes.
Press Release, Draft Regulation


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