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16 May 2019Generics

EU adopts SPC manufacturing waiver

The European Union has adopted the proposed supplementary protection certificate (SPC) manufacturing waiver, despite criticism from parts of the pharmaceutical industry.

In an announcement on Tuesday, May 14, the European Council said the regulation, which will introduce an exception to the protection granted to an original medicine by a supplementary protection certificate (SPC), is expected to enter into force by July 1.

The news comes after the EU parliament voted to approve the waiver in April.

The waiver will allow EU-based manufacturers to produce generic or biosimilar versions of SPC-protected medicines for the purpose of exporting to a non-EU market whether protection has expired or does not exist.

They will also be allowed to produce the medicines for the purpose of creating a stock that will be listed on the EU market after the SPC has expired.

Niculae Bădălău, the Romanian minister of economy, said the regulation “will enable generics manufacturers based within the EU to compete with non-EU manufacturers on equal terms”.

“It will create high-value jobs and boost the availability of generic medicines in the EU,” Bădălău added.

The council said the regulation will “remove the competitive disadvantages faced by EU-based manufacturers” when compared to manufacturers outside the EU.

But, the waiver has not been met with universal approval across the pharmaceutical industry.

In April, the European Federation of Pharmaceutical Industries and Associations said the waiver sends “a negative signal to the world that Europe is devaluing its intellectual property framework, making Europe a less attractive location for research and development”.

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1 July 2019   The controversial supplementary protection certificate manufacturing waiver has come into force today, July 1.
Generics
25 November 2020   The European Commission wants to increase access to generic medicines and crack down on anti-competitive behaviour in the pharmaceutical industry, a new plan has said.