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Regulatory Focus™ > News Articles > 2019 > 1 > EU Advances SPC Waiver Proposal

EU Advances SPC Waiver Proposal

Posted 16 January 2019 | By Michael Mezher 

EU Advances SPC Waiver Proposal

The European Union's proposal to allow manufacturing waivers to supplementary protection certificates (SPC) took a step forward on Wednesday after EU ambassadors backed the EU Council's position on the proposed regulation during a meeting of the Committee of the Permanent Representatives (Coreper).
"The draft regulation is expected to remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established outside the EU in global markets, but also in day-1 EU markets by building up production capacity," according to a Council of the EU press release.
In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse between when the patent application is filed and when marketing authorization is granted.
Earlier this year, the European Commission proposed an amendment to the regulation governing SPCs that would allow for generic and biosimilar manufacturers to begin making copies of medicines protected in the EU by a SPC so long as they are intended for export only. Under the waiver system proposed in the amendment, a generic or biosimilar maker would need to notify regulators in the member state where they would be making the products before they can begin manufacturing.
The position backed by the Council and EU ambassadors differs slightly from the opinion of the European Parliament's International Trade Committee (INTA) last month which also supported the stockpiling of medicines made under a waiver.
While the Council acknowledges the fact that current regulations make it "more difficult for [generic and biosimilar] makers to enter the Union market immediately after the expiry of a certificate," the Council's position does not expressly endorse stockpiling.
The Council's position also appears to be more palatable to Europe's branded drug industry, which strongly opposes stockpiling of generics and biosimilars while the original product is still covered by an SPC.
"Although the draft regulation undoubtably sends a signal to the world that Europe is weakening its commitment to [intellectual property] IP incentives and innovation, Member States' current support of the original scope of the Commission's proposal could go some way to prevent further erosion of Europe's IP framework," EFPIA writes.
In its statement, EFPIA also emphasizes its opposition to any form of retroactive implementation. The Council currently supports the regulation to apply retroactively three years after it comes into force.
EFPIA also says it wants to ensure that there is a "timely, effective and transparent" system for notifying SPC holders before a generic or biosimilar can be produced for export, as well as labeling requirements to prevent generics and biosimilars from being redirected to the EU.
Now that the Council of the EU and European Council are aligned on the regulation, the next step for the regulation will be for the European Parliament to agree to a negotiating mandate. From there it will be up to the Romanian Presidency of the Council of the EU to negotiate with the European Parliament to adopt the regulation.


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