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19 February 2019Big Pharma

SPC waiver stockpiling provision attracts criticism

While the final text of the European Council’s agreement on a supplementary protection certificate (SPC) manufacturing waiver has yet to be released, the reported stockpiling provision has attracted criticism.

Last week, the European Council  reached a political agreement on a proposal for the supplementary protection certificate (SPC) manufacturing waiver for patent-protected pharmaceuticals.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), a Brussels-based organisation which represents research-based pharmaceutical companies in Europe,  claimed that the EU institutions are taking a gamble on Europe’s future in medical innovation.

Under the proposed reforms, companies will reportedly be able to stockpile generic versions of patent-protected drugs intended for marketing in the EU during the last six months of their SPC protection. This provides generic makers with the opportunity for a day one launch so they are able to launch their products in the EU as soon as the SPC expires.

Speaking to LSIPR, the EFPIA added that the safeguards of the text agreed last week primarily addressed the manufacturing waiver for export.

“They were refined over five months in consultation with all member states and on the basis that the scope of the exception would remain limited as initially proposed by the Commission, ie manufacturing for export to third-countries only.”

However, during the trilogue, EFPIA said that there had been a “significant and disproportionate extension” of the scope right at the very end of the process, extending the waiver to cover stockpiling in the EU.

Paul England, senior professional support lawyer at Taylor Wessing’s London office, said that the most contentious issue to be resolved is whether stockpiling of product for the purpose of export should be permitted.

“The European Commission’s proposal never intended this. However, Parliament has proposed an amendment seeking a two year period in which product may be kept before export takes place. A lot of eyes will be on whether Parliament's proposal makes it through into law,” he said.

Trevor Cook, partner in the New York office of WilmerHale, said that the introduction of the EU stockpiling provision has moved towards the demands of the generic industry and to what he suspects was the real aim of some in that sector all along, “namely to legitimise stockpiling in the EU during an SPC’s term, and thereby also to make it easier for them to import into the EU and to stockpile active substances manufactured outside the EU”.

Cook added that all the EU will have succeeded in doing is “sending a message to the research-based pharmaceutical industry globally that it is insensitive to their needs”.

Others were more optimistic.  Medicines for Europe (an association representing the European generic and biosimilar industries) welcomed the move.

The waiver will “contribute to better patient access, to create manufacturing opportunity and jobs and to increase Europe’s capacity to manufacture and supply its own medicines,” it said.

The association thanked the EU for addressing many of its proposals for a comprehensive waiver, including the possibility to manufacture for export and day-one launch.

The proposal will now proceed to final approval by the Council and the European Parliament.

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More on this story

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
24 January 2019   The Legal Committee of the European Parliament has voted in favour of the proposed supplementary protection certificate waiver.
Generics
18 April 2019   The European Parliament has voted to approve the supplementary protection certificate manufacturing waiver, which will allow the stockpiling of generic versions of patented drugs.

More on this story

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
24 January 2019   The Legal Committee of the European Parliament has voted in favour of the proposed supplementary protection certificate waiver.
Generics
18 April 2019   The European Parliament has voted to approve the supplementary protection certificate manufacturing waiver, which will allow the stockpiling of generic versions of patented drugs.

More on this story

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
24 January 2019   The Legal Committee of the European Parliament has voted in favour of the proposed supplementary protection certificate waiver.
Generics
18 April 2019   The European Parliament has voted to approve the supplementary protection certificate manufacturing waiver, which will allow the stockpiling of generic versions of patented drugs.