The Queen v The Medicines Control Agency, ex parte Smith & Nephew Pharmaceuticals Ltd and Primecrown Ltd v The Medicine Control Agency.
Date: 1996-11-12
19 According to the first and second recitals in the preamble to Directive 65/65, the primary purpose of that directive is to ensure that, when a proprietary medicinal product is marketed, public health is safeguarded by means which cannot hinder the development of the pharmaceutical industry or trade in medicinal products within the Community. To that end, the directive requires that a series of documents as well as precise, detailed information be produced as a pre-condition to the granting of a marketing authorization, even where the proprietary medicinal product in question is covered by a marketing authorization granted by the competent authority of another Member State.
21 Consequently, the provisions of Directive 65/65 concerning the procedure for issue of marketing authorizations cannot apply to a proprietary medicinal product covered by a marketing authorization in one Member State which is being imported into another Member State as a parallel import of a product already covered by a marketing authorization in that other Member State. In such a case, the imported proprietary medicinal product cannot be regarded as being placed on the market for the first time in the Member State of importation.
22 That was the effect of the Court' s judgment in Case 104/75 De Peijper [1976] ECR 613, paragraphs 21 and 36, which stated that, if the public health authorities of the Member State of importation already have in their possession, as a result of importation on a previous occasion, all the pharmaceutical particulars relating to the medicinal product in question and considered to be absolutely necessary for the purpose of checking that the product is effective and not harmful, it is clearly unnecessary, in order to protect the health and life of humans, for those authorities to require a second trader who has imported a medicinal product which is in every respect the same or whose differences have no therapeutic effect, to produce these particulars again.
23 In De Peijper (paragraph 10) the Court considered the case of a proprietary medicinal product which was prepared in accordance with a uniform method of preparation and which had a well-defined qualitative and quantitive composition. The product was lawfully in circulation in several Member States since the authorizations required by the legislation of those States had been granted in relation to that product either to the manufacturer or to the person responsible for putting the product on the market. The product in question was in every respect the same as a product in respect of which the public health authorities of the Member State of importation already possessed documents relating to its method of preparation and its quantative and qualitative composition, these documents having been previously produced to them by the manufacturer or his duly appointed importer in support of an application for an authorization to place it on the market.
25 That case-law can be applied to a situation such as that at issue in the main proceedings, in which independent companies produce proprietary medicinal products, which have a common origin by virtue of the fact that they are manufactured pursuant to agreements concluded with the same licensor. Otherwise, such agreements could lead to partitioning of the national markets of the various Member States.
26 The competent authority in the Member State of importation must also verify that the two proprietary medicinal products, if not identical in all respects, have at least been manufactured according to the same formulation, using the same active ingredient, and that they also have the same therapeutic effects.
27 To that end, as the Court pointed out in De Peijper, paragraph 26, the competent authority has available to it legislative and administrative means capable of compelling the manufacturer, his duly appointed representative or the licensee for the proprietary medicinal product in question to supply information in their possession which the authority considers to be necessary. Moreover, the competent authority may consult the file submitted in connection with the application for a marketing authorization for the proprietary medicinal product already authorized.
28 Finally, as the Court also held in De Peijper, paragraph 27, simple cooperation between the authorities of the Member States would enable them to obtain the necessary substantiating documents on a reciprocal basis.
29 If, on completion of its examination, the competent authority of the Member State of importation finds that all the abovementioned criteria are satisfied, the proprietary medicinal product to be imported must be regarded as having already been placed on the market in the Member State of importation and, consequently, must be entitled to benefit from the marketing authorization issued for the proprietary medicinal product already on the market, unless there are countervailing considerations relating to the effective protection of the life and health of humans.
30 If the competent national authority concludes that the proprietary medicinal product to be imported does not satisfy all the abovementioned criteria and cannot therefore be regarded as having already been placed on the market in the Member State of importation, it cannot issue the new marketing authorization required for the marketing of the product to be imported unless the conditions listed in Directive 65/65, as amended by Directive 87/21, are fulfilled. The discretion enjoyed by the competent authority of the Member State under the directive is very limited. It cannot, on any view, extend to the possibility of issuing a marketing authorization under Article 3 of Directive 65/65 when the information referred to in Article 4 of that directive has not been supplied in full and the tests referred to therein have not been performed. Such a marketing authorization may be issued only when it is shown that all the obligations set out in Article 4 have been complied with (see Case C-440/93 R v Licensing Authority of the Department of Health, ex parte Scotia Pharmaceuticals [1995] ECR I-2851).
32 Consequently, when the competent authority of a Member State concludes that a proprietary medicinal product covered by a marketing authorization in another Member State and a proprietary medicinal product for which it has already issued a marketing authorization are manufactured by independent companies pursuant to agreements concluded with the same licensor and that those two products, although not identical in all respects, have at least been manufactured according to the same formulation, using the same active ingredient, and that they also have the same therapeutic effects, it must treat the imported product as being covered by the latter marketing authorization unless there are countervailing considerations relating to the effective protection of the life and health of humans. If the competent national authority concludes that the proprietary medicinal product to be imported does not satisfy those criteria, a new marketing authorization is required. That authorization can be issued only in accordance with the conditions laid down in Articles 3 and 4 of Directive 65/65, as amended by Directive 87/21.
The fourth question
33 The national court' s fourth question asks whether the fact that, in this case, the manufacturing licences for the proprietary medicinal products were granted by the same legal person, established outside the European Community, affects the answer given above.
34 In the light of the answer to the second and third questions, it suffices to state that the fact that the grantor of the licences in respect of the two proprietary medicinal products in question is situated outside the European Community does not affect the answer given above.
The first question
35 By this question the national court asks in essence whether the holder of the original authorization issued under the normal procedure referred to in Directive 65/65 may rely on the directive, and in particular on Article 5 thereof, in proceedings before a national court in which it contests the validity of a marketing authorization granted by a competent public authority to one of its competitors for a proprietary medicinal product bearing the same name.
36 In Case 301/82 Clin-Midy v Belgium [1984] ECR 251, paragraph 4, the Court held that the provisions of Directive 65/65 laying down the conditions for the grant, suspension or revocation of a marketing authorization, in particular Article 21 thereof, are unconditional and sufficiently precise for them to be relied upon before a national court by the persons concerned in order to challenge any national provision laid down by law, regulation or administrative action which is incompatible with the directive.
37 Although Article 5 of Directive 65/65 was not specifically referred to in the judgment in Clin-Midy, it is unconditional and sufficiently precise for it to be relied upon before a national court in order to challenge a marketing authorization issued by a competent national authority.
38 However, the provisions of Directive 65/65, as amended by Directive 87/21, may be relied upon only in order to challenge the validity of an authorization issued on the basis of that directive.
39 Consequently, the answer to the national court should be that the holder of an original marketing authorization issued under the procedure referred to in Directive 65/65 may rely on the provisions of that directive, as amended, in particular by Directive 87/21, and specifically on Article 5 thereof, in proceedings before a national court in order to challenge the validity of an authorization issued by the competent national authority on the basis of Directive 65/65, as amended, to one of its competitors for a proprietary medicinal product bearing the same name. The same applies where the authorization, although issued under another procedure laid down at national level, should have been issued on the basis of the directive.