7 December 2017Big Pharma

Advocate general gives opinion on data exclusivity

An advocate general (AG) has said that regulatory authorities in “concerned” EU member states handling drug marketing authorisations (MAs) are co-responsible for approved documents on data exclusivity.

The case involves German drug company Helm, which had obtained a Finnish MA for a generic version of products developed by Astellas Pharma, a Japanese pharmaceutical company.

The MA was granted under the decentralised procedure outlined by the EU directive on medicinal products for human use (2001/83/EC).

Under this system, the “reference” member state is the first to evaluate the application, before notifying this decision to other countries, known as “concerned” member states. These latter countries have to suspend their assessments until the reference state has made its decision.

In the case at hand, Finland was one of the concerned states, while Denmark was the reference state.

In January 2014, the authorities in Denmark were handling Helm’s MA for Alkybend. They found that ribomustin—an MA for which Astellas had been granted in 2005—should be the reference medicinal product for Helm’s later application.

Helm’s application was then granted by the Finnish Medicines Agency (FIMEA) later in 2014.

Astellas filed a lawsuit against that decision before the Administrative Court of Helsinki, which later rejected the case. It did so because Astellas was granted the first MA for the reference medicinal product (ribomustin) on July 19, 2005, and because the data exclusivity period had expired after six years, meaning FIMEA was able to issue the MA for Helm’s 2012 application.

In response, Astellas appealed before the Supreme Administrative Court of Finland, asking it to set aside the first instance decision and the 2014 Alkybend MA. It wanted the data exclusivity date to start from 2010 instead of 2005, based on a later MA granted to Astellas.

According to AG Michal Bobek, who gave his opinion today, December 7, the Supreme Administrative Court asked whether a regulator of a concerned member state (eg, Finland) and/or the courts in that country can review a previous determination of the data exclusivity period made within the decentralised procedure.

Bobak said articles 28(5) and 29(1) of the 2001/83/EC directive should be interpreted as meaning that authorities in the concerned state are not competent “to determine unilaterally the time from which the data exclusivity period for the reference medicinal product begins to run” when it issues the national MA.

“However, that authority takes part in that assessment at an earlier stage in the decentralised procedure pursuant to article 28(3) and (4) of Directive 2001/83. The participation of the competent authority of the concerned member state in the approval process thus makes that authority co-responsible for the documents approved in that procedure.”

He added that the courts in the concerned jurisdiction are able to review a finding of the competent authority in that state “regarding the time from which the period of data exclusivity starts to run” when deciding an appeal brought by the MA holder for the reference medicinal product.

“That national court, however, cannot review the legality of the original marketing authorisation granted in another member state, as that legality, including under Directive 2001/83, must be assessed in the member state that issued that initial marketing authorisation.”

The AG’s opinion will be considered by the Court of Justice of the European Union.

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