Astellas – Pharmaceutical Regulation – is communal cooking in the kitchen too hot to handle?
The extent to which one NCA can depart from an MA that has been previouslygranted by another Member State raises rather dry and technical questions ofEuropean law. However, it has huge commercial significance for the entitiesinvolved, ie the actual or would be holder of the MA, on the one hand, andgeneric manufacturers on the other that would like to market and sell theirequivalent medicines based on the original relevant medicinal product.
The enforcement of the competing rights given to innovators and genericmanufacturers has become increasingly adversarial, either with genericsseeking multiple authorisations in different Member States or challenging theinitial MA that had been granted in favour of the MA holder or the innovator MA holder seeking to protect its rights conferred in terms data exclusivity.
Astellas was one example of such a case. Astellas challengeda generic MA that had been granted by the Finish NCA and the Supreme Administrative Courtreferred two questions for preliminary ruling to the CJEU. The first question waswhether a concerned Member State under the decentralised procedure wascompetent to determine the time at which the data exclusivity period startedto run. The second question was, assuming it was not, whether the nationalcourts could determine the period of data exclusivity and whether the principleof effective legal protection under Article 47 of the Charter required the nationalcourt to scrutinise the original MA granted in another Member State and/ordepart from it in order to give effect to the MA holder’s rights.
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George Peretz QC acted for the United Kingdom Government.
The comments made in this case note are wholly personal and do not reflect the views of any other members of Monckton Chambers, its tenants or clients.