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24 January 2019Big Pharma

EU committee approves SPC waiver

Legal Committee of the European Parliament (JURI) has voted in favour of the proposed supplementary protection certificate (SPC) waiver.

The vote passed by 21 votes to 2 yesterday, January 23.

An SPC allows for an additional five years of exclusivity after a patent’s original expiration date.

The European Commission proposed the waiver last May.

The proposed changes would allow generic and biosimilar versions of drugs to be manufactured during the term of their patent protection, provided they are intended for export to non-EU markets.

It also allows the manufacture and stockpiling of these generics during the last two years of the drug’s patent protection, in preparation for release on the EU market.

JURI holds responsibility for producing a report on the waiver to the Parliament. Amendments from the trade and health committees were included in the legal committee’s proposal.

Last December, LSIPR  reported that both the trade and health committees had proposed amendments to the waiver, calling for a “day one” option which would allow the release of generics onto the market immediately following the expiration of a drug’s SPC.

Medicines for Europe (MFE), which represents generic and biosimilar manufacturers, and which has campaigned in favour of the waiver, welcomed the vote.

In a statement published yesterday, MFE hailed the vote as “another step in the right direction to ensure that the SPC manufacturing waiver delivers on its promise of industrial jobs and lower costs for patients and healthcare systems”.

MFE president Adrian van den Hoven praised the parliamentary committees’ “thorough review” of the proposal and the “many positive changes” to the waiver.

Following the trade committee’s endorsement of the waiver last month, the European Federation of Pharmaceutical Industries Association (EFPIA) released a statement sharply criticising the proposals.

EFPIA represents the research-based pharmaceutical sector, including companies marketing patent protected drugs.

“The proposal to introduce an export manufacturing waiver to the SPC regulation sends a signal to the world that Europe is weakening its commitment to IP incentives and innovation”, EFPIA said.

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6 December 2018   The European Federation of Pharmaceutical Industries and Associations has sharply criticised an opinion on supplementary protection certificate proposals that was issued by a European Parliament committee.
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More on this story

Big Pharma
6 December 2018   The European Federation of Pharmaceutical Industries and Associations has sharply criticised an opinion on supplementary protection certificate proposals that was issued by a European Parliament committee.
Generics
15 February 2019   The European Council has reached a political agreement on a proposal for the supplementary protection certificate manufacturing waiver for patent-protected pharmaceuticals.
Big Pharma
19 February 2019   While the final text of the European Council’s agreement on a supplementary protection certificate manufacturing waiver has yet to be released, the reported stockpiling provision has attracted criticism.

More on this story

Big Pharma
6 December 2018   The European Federation of Pharmaceutical Industries and Associations has sharply criticised an opinion on supplementary protection certificate proposals that was issued by a European Parliament committee.
Generics
15 February 2019   The European Council has reached a political agreement on a proposal for the supplementary protection certificate manufacturing waiver for patent-protected pharmaceuticals.
Big Pharma
19 February 2019   While the final text of the European Council’s agreement on a supplementary protection certificate manufacturing waiver has yet to be released, the reported stockpiling provision has attracted criticism.