The reform of European Community legislation as to medicinal products for human use by Directive 2004/27/EC as from November 2005 changed certain aspects of the regulatory data protection regime for such products and prevents an applicant for a generic authorisation relying on the clinical data filed by the originator for a certain period. The main change was to introduce a uniform “8+2+1” term of such protection where marketing authorisations were sought after the measure came into effect. It also addressed a number of issues that the previous legislation had left unclear and that had been the subject of references to the ECJ over the previous several years. Despite this, uncertainties remain, and one of these is reflected in the first reference to the ECJ on this topic under the revised legislation, Case C-527/07 Generics (UK) Ltd, Regina v Licensing Authority (acting via the Medicines and Healthcare products Regulatory Agency).

In this case the English High Court has referred the following questions to the ECJ for a preliminary ruling:

(1) Where a medicinal product falling outside the scope of the Annex to Regulation 2309/93 (1) has been placed on the market in a Member State, (Austria) under its national authorisation procedure prior to the accession of that Member State to the EEA or the EC and:

(a) that Member State has subsequently acceded to the EEA and then the EC, and as part of the conditions of its accession it has transposed into its national law the authorisation provisions of Directive 65/65 (now Directive 2001/83 (2)), no transitional provisions applying in this respect;

(b) the product in question has remained on the market in that Member State for some years after its accession to the EEA and the EC;

(c) following the accession of that Member State to the EEA and the EC, the marketing authorisation for the product in question has been varied by adding a new indication, and the variation was considered by the authorities of that Member State to be consistent with the requirements of Community law;

(d) the dossier of the product in question was not updated in accordance with Directive 65/65 (now Directive 2001/83) after that Member State's accession to the EEA and the EC; and

(e) a product containing the same active ingredient has subsequently been authorised under Article 6 of Directive 2001/83 and placed on the market in the EC;

is the medicinal product to be considered to be ‘a reference medicinal product which is or has been authorised under Article 6 … in a Member State’ within the meaning of Article 10(1) of Directive 2001/83, and if so which of the above conditions is/are decisive in this respect?

(2) In circumstances where the competent authority of a reference Member State erroneously refuses an application for a marketing authorisation made under Article 10(1) of Directive 2001/83 in the context of the decentralised procedure provided for in that Directive, on the ground that the medicinal product referred to in Question 1 above was not a ‘reference medicinal product’ within the meaning of Article 10(1), what guidance, if any, does the Court of Justice think it appropriate to provide as to which circumstances the national court ought to take into consideration when it comes to determine whether the breach of Community law is a sufficiently serious breach within the meaning of the judgment in Brasserie du Pecheur and Factortame?

The first question referred in essence asks what is the starting point for the period of such protection (which is keyed to the first marketing authorisation as a medicinal product for a particular active in the Community) when the first marketing authorisation for the originator product was originally granted in a Member State before it joined the Community, but remained in force afterwards in accordance with European Community law. The second question is directed to what remedy is available to an applicant for a generic authorisation in the event that a regulatory body has wrongly refused it.