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15 February 2019Generics

European Council agrees on SPC manufacturing waiver

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

The proposal will now proceed to final approval by the Council and the European Parliament. The news was confirmed in a  press release by the European Commission issued yesterday, February 14.

Under the proposed reforms, companies could manufacture generic versions of patent-protected drugs during the last two years of their SPC protection, provided they are intended for export to a market outside the EU.

Manufacturers could also stockpile generic versions of drugs for release onto the European market after the expiration of the SPC.

British and European law firm JA Kemp issued a  briefing on the Council’s amendments to the waiver. The Council’s proposed changes to the text would require generic manufacturers to notify the relevant national patent office and the SPC holder at least three months before the start date of manufacture.

Previously, it was touted that generics companies would have to inform only the national patent office 28 days before the intended start date of manufacture.

The Council’s proposals, however, would also require generic manufacturers to supply SPC holders with less information about their operations than was required in the original plans. If accepted, the Council’s amendments would not require generics companies to supply details of the maker’s manufacturing authorisation or a certificate of good manufacturing practice.

In its briefing, JA Kemp said that this “arguably makes it more likely ‘makers’ with no concrete plans to manufacture will file precautionary notifications in case they want to manufacture in the future”.

“It will be harder for an SPC holder to identify which makers will in fact enter the market for export outside the EU and when”, the firm said.

In its press release, the Commission said that it welcomed the news of a political agreement between EU leaders.

Elżbieta Bieńkowska, European commissioner for the internal market, industry, entrepreneurship and small-to-medium sized enterprises said that “with this well-calibrated adjustment to intellectual property rules, we are helping Europe's pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU”.

“We are removing a major competitive disadvantage of EU manufacturers who will soon be able to compete on equal terms on global markets where competition is fierce”, she added.

The waiver has been met with fierce opposition, however, from research-based pharmaceutical companies. In December, the European Federation of Pharmaceutical Industries Association (EFPIA) released a  statement criticising the proposals.

“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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More on this story

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.
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.
Generics
16 May 2019   The European Union has adopted the proposed supplementary protection certificate manufacturing waiver, despite criticism from parts of the pharmaceutical industry.

More on this story

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.
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.
Generics
16 May 2019   The European Union has adopted the proposed supplementary protection certificate manufacturing waiver, despite criticism from parts of the pharmaceutical industry.

More on this story

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.
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.
Generics
16 May 2019   The European Union has adopted the proposed supplementary protection certificate manufacturing waiver, despite criticism from parts of the pharmaceutical industry.