Holders of marketing authorizations are entitled to judicially appeal against the approval of a generic medicinal product

Summary: In Spain and in other EU Member States, holders of marketing authorizations for reference medicinal products face obstacles when trying to bring national authorities to court in connection with the grant of generic approvals. In many cases, Spanish Courts have denied locus standi claiming that the interest that the claimant is not sufficient to bring the matter to Court because the damage that it may suffer as a result of the approval of the generic results not from the action of the administration but from the effective commercialization of the product.

In the Olainfarm judgement of 23 October 2014, the ECJ ruled that holders of the MA for reference products must have the right to judicial review of the grant of approval for the generic if the rights that EU law grants to such holders have been violated.

The rational of the Court is based on the Charter of Fundamental Rights of the European Union, and will require a review of Spanish case law in this matter.

The Court also ruled that medicines approved on the basis of the “well-established use” exemption may qualify as reference products.