In an Article 177 ruling of 5 October 1995 (Norgine Limited, case C-400/93), the European Court of Justice held, against the opinion of the U.K. government and the EC Commission, that national authorities have a limited discretionary power when they issue a marketing authorisation for a pharmaceutical product under the abridged procedure of Article 4(2)(8)(a)(ii) of EC Directive 65/65 (O.J. 1965, L22/369, as most recently amended by EC Directive 93/39, O.J.1993, L214/22).
Directive 65/65 lays down the rules on authorisation to put a medicinal product on the market. It provides that no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State. Under this Directive, an application for authorisation has to be accompanied by a number of documents which include the results of physico-chemical, biological or microbiological tests, pharmacological and toxological tests and clinical trials (Article 4(2)). However, in three well defined cases, where products are copies of established proprietary medicinal products, the results of such tests and trials do not have to be provided, thus allowing for an abridged application to be made (Article 4(2)(8)(a)(i),(ii) and (iii)).
The Norgine case concerns one of these three cases, i.e., the possibility to make an abridged application if the applicant can demonstrate by detailed reference to published scientific literature, that the constituent or the constituents of the generic product have a well established medicinal use, with recognised efficacy and an acceptable level of safety (Article 4(2)(8)(a)(ii)). Such detailed reference to published literature must be presented in accordance with the requirements of the Annex to Directive 75/318 (on the approximation of the laws of the Member States relating to analytical, pharmacological and clinical standards and protocols in respect of the testing of medicinal products) and supported by reports of experts whose role and duties are defined in Directive 75/319, completing Directive 65/65.
In the case at hand, a company had obtained, for the U.K., three marketing authorisations granted under Directive 65/65. Another company was granted a marketing authorisation in the U.K. for a product similar to those of the first company. This authorisation was granted under the abridged procedure laid down in Article 4(2)(8)(a)(ii), despite the fact that the documents in support of the application did not include the required scientific literature. The U.K. authority reasoned that it enjoyed a discretionary power enabling it to derogate from the requirements of the Directive.
The Court rejected this reasoning. It held that the abridged procedure is not intended to relax the requirements of safety and efficacy, nor the obligations with which experts must conform in accordance with Directive 75/319. Although the applicant need not carry out the required tests, it must still demonstrate that the tests have been carried out previously with satisfactory results.
On this basis, the Court ruled that the national competent authorities have no discretion to issue a marketing authorisation under the abridged procedure where the scientific literature concerning one of the tests required by the Annex to Directive 75/318 is incomplete. If such a discretion were given to national authorities, the aim of the abridged procedure, which is to state precisely the cases in which the tests need not be carried out, while ensuring that innovative firms are not placed at a disadvantage, would be undermined. The Court also rejected, on the grounds of protection of public health, the argument that the required documents are seldom likely to be found in scientific literature and that if no discretion were allowed to national authorities, this kind of abridged procedure would cease to serve any purpose.
The content of this article is intended to provide general information on the subject matter. It is therefore not a substitute for specialist advice.
De Bandt, van Hecke & Lagae - Brussels.(32-2) 501.91.80
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