The Court of Justice of the European Union has ruled that the holder of a marketing authorisation for a reference medicinal product in a decentralised procedure does have the right the challenge in the courts of the concerned Member States the grant of a marketing authorisation for a generic medicinal product on the basis that the data exclusivity period has expired.

The EU Medicines Directive provides for a decentralised procedure for the grant of marketing authorisations during which the national competent authorities of Member States nominated by the applicant co-operate to reach one collective decision. This promotes the free movement of medicinal products described in Recital 14 to the Directive. The procedure is co-ordinated by a reference Member State who prepares an assessment report together with the approved summary of product characteristics, labelling and package leaflet. The other national participants, the competent authorities of the concerned Member States, then have 90 days to approve these documents or to object to them. The only ground of objection permitted by the Directive is a potential serious risk to public health. If no objections are received, the reference Member State and each of the concerned Member States must adopt a decision to issue a marketing authorisation in conformity with the approved documents.

In Astellas Pharma GmbH, Case C-557/16, the Court of Justice was asked to decide if Astellas had the right to challenge a decision of the Finnish Medicines Agency, FIMEA, to grant a marketing authorisation to Helm AG for Alkybend, Helm’s generic copy of Astellas’ reference medicinal product, Levact. Astellas argued that the Danish medicines agency, acting for the reference Member State, had incorrectly calculated the applicable period of data exclusivity by referring to an older product, Ribomustin. The data exclusivity for Levact in Finland had not expired according to Astellas so that no marketing authorisation for a generic copy could yet be issued.

The counter argument from Helm was that Astellas had no remedy to protect its rights to data exclusivity in the courts of the concerned Member States. FIMEA and a number of other Member States who intervened in the case when it was referred to the Court of Justice by the Finnish Supreme Court also took this line. They argued that a company in the position of Astellas could bring a judicial review to protect its data exclusivity only in the courts of the reference Member State.

The Court confirmed that the competent authorities of the concerned Member States may not repeat the verification of the data exclusivity period performed by the reference Member State once they have acknowledged the documents and the procedure has been closed. They must act on the basis of the “co-decision” they have made and issue a marketing authorisation in accordance with the documents prepared by the reference Member State.

But Astellas itself was not and could not be a party to the decentralised procedure, with the consequence that it had no access to the documents or decisions made by the reference Member State until the procedure was closed. So Astellas could not bring effective proceedings in the reference Member State.

The Court of Justice was, therefore, asked to balance Astellas’ right to an effective remedy, as guaranteed by Article 47 of the Charter of Fundamental Rights of the European Union, against the overarching objective of the Union acquis which is to promote a single market in medicinal products.

The Court followed the opinion of Advocate- General Bobek, who had concluded that “a decentralised administrative procedure is to be followed by decentralised judicial review”. Whilst this could lead to the possibility of conflicting judgments in different Member States, the Advocate-General had observed that “…market integration is not a good reason for creating black holes in judicial protection.”

The Court of Justice, therefore, ruled that

  • in a decentralised marketing authorisation procedure for a generic medicinal product, the competent authority of a Member State concerned by the procedure cannot itself determine the time from which the data exclusivity period for the reference medicinal product starts to run

but

  • the court of a Member State involved in a decentralised procedure for marketing authorisation, hearing an action brought by a holder of the marketing authorisation for the reference medicinal product against a decision in that Member State taken by its competent authority has jurisdiction to review the determination of the point in time from which the data exclusivity period for the reference medicinal product starts to run.

There was a subsidiary argument made by Astellas that the Ribomustin marketing authorisation had not been granted in accordance with Directive 2001/83. The approval of Ribomustin had preceded the Alkybend marketing authorisation by five years and should not, according to Astellas, be used for the purpose of calculating the data exclusivity period.

On this point the Court of Justice ruled that

  • the court of a Member State involved in a decentralised procedure for marketing authorisations does not have jurisdiction to review whether the initial marketing authorisation for the reference medicinal product granted in another Member State was granted in accordance with Directive 2001/83

The Court of Justice reasoned on this point that the holder of a marketing authorisation for the reference medicinal product already had an opportunity to challenge the conformity of the grant with Directive 2001/83 at the time the grant was made. So no issue of the availability of an effective remedy arose.

The judgment is good news for innovators as it confirms their rights to challenge the grants of marketing authorisations in concerned Member States following a decentralised procedure. But it does seem to lead to the odd result for national competent authorities that they will be forced to grant marketing authorisations in circumstances where they may consider that the data exclusivity period has been wrongly calculated by the reference Member State and knowing that their decision will be open to review by the courts. Of course they can challenge the assessment report before closure of the procedure but the only ground on which they can do this remain a potential serious threat to public health.

Advocate-General Bobek had offered his opinion that the calculation of the data exclusivity period is an indispensible part of the approval process. If the data protection period has not lapsed, he argued, there is no data to be relied on and it is logically impossible to conduct any scientific assessment of the generic medicinal product at issue. If a marketing authorisation could be granted without a scientific assessment then this could give rise to an issue of a potential threat to public health. So a failure to agree on this by Member States before the closure of the procedure could lead to the arbitration process envisaged by Articles 29 and 32. The Court of Justice did not refer to this intriguing argument in reaching their decision but it may not be too long before we see it invoked by an innovator company seeking to challenge the approval by a competent authority of the documents prepared by a reference Member State.