The Queen v The Licensing Authority established by the Medicines Act 1968 (acting by The Medicines Control Agency), ex parte Generics (UK) Ltd, The Wellcome Foundation Ltd and Glaxo Operations UK Ltd and Others.
Date: 1998-12-03
2 Those questions were raised in three sets of proceedings between Generics (UK) Limited (`Generics'), The Wellcome Foundation Limited (`Wellcome'), and Glaxo Operations UK Limited and Others (`Glaxo'), on the one hand, and the Licensing Authority established by the Medicines Act 1968 (represented by The Medicines Control Agency (`the MCA')), on the other, concerning, as regards the first dispute, the MCA's refusal to grant, under the procedure provided for in Article 4.8(a)(iii) of Directive 65/65 (hereinafter `the provision at issue'), a marketing authorisation for a medicinal product known as `captopril' and, as regards the other two disputes, the grant to competing undertakings, under that procedure, of a marketing authorisation for medicinal products known as `aciclovir' and `ranitidine', respectively.
3 Article 4 of Directive 65/65, as amended by Directive 87/21, provides:
`In order to obtain an authorisation to place a medicinal product on the market as provided for in Article 3, the person responsible for placing that product on the market shall make application to the competent authority of the Member State concerned.
The application shall be accompanied by the following particulars and documents:
...
8. Results of:
- physico-chemical, biological or microbiological tests; - pharmacological and toxicological tests; - clinical trials.
However, and without prejudice to the law relating to the protection of industrial and commercial property:
(a) The applicant shall not be required to provide the results of   pharmacological and toxicological tests or the results of clinical trials
if he can demonstrate:
(i)  either that the medicinal product is essentially similar to a product authorised in the country concerned by the application and that the person responsible for the marketing of the original medicinal product has consented to the pharmacological, toxicological or clinical references contained in the file on the original medicinal product being used for the purpose of examining the application in question;
(ii)  or by detailed references to published scientific literature    presented in accordance with the second paragraph of Article 1 of Directive 75/318/EEC that the constituent or constituents of the medicinal product have a well established medicinal use, with recognised efficacy and an acceptable level of safety;
(iii)  or that the medicinal product is essentially similar    to a product which has been authorised within the Community, in accordance with Community provisions in force, for not less than six years and is marketed in the Member State for which the application is made; this period shall be extended to 10 years in the case of high-technology medicinal products within the meaning of Part A in the Annex to Directive 87/22/EEC or of a medicinal product within the meaning of Part B in the Annex to that Directive for which the procedure laid down in Article 2 thereof has been followed; furthermore, a Member State may also extend this period to 10 years by a single Decision covering all the products marketed on its territory where it considers this necessary in the interest of public health. Member States are at liberty not to apply the abovementioned six-year period beyond the date of expiry of a patent protecting the original product.
However, where the medicinal product is intended for a different therapeutic use from that of the other medicinal products marketed or is to be administered by different routes or in different doses, the results of appropriate pharmacological and toxicological texts and/or of appropriate clinical trials must be provided.
(b) ...'
4 The abridged procedure established by that provision in the cases referred to in subparagraphs (i), (ii) and (iii) enables a second applicant for marketing authorisation for a given product to save the time and expense necessary in order to gather the pharmacological, toxicological and clinical data.  In accordance with the fourth recital in the preamble to Directive 87/21, it also avoids, on public policy grounds, the repetition of tests on humans or animals where not absolutely necessary.
22 Having regard in particular to the fact that, as is stated in the first recital in the preamble to Directive 65/65, the primary purpose of any rules concerning the production and distribution of medicinal products must be to safeguard public health, the concept of an essentially similar medicinal product cannot be interpreted in such a way that the abridged procedure, and in particular that laid down in Article 4.8(a)(iii), amounts to a relaxation of the requirements of safety and efficacy which must be met by medicinal products (see, to that effect, Case C-440/93 Scotia Pharmaceuticals [1995] ECR I-2851, paragraph 17).
23 That procedure is merely intended to reduce the time needed to prepare an application for authorisation by freeing the applicant from the obligation to carry out the pharmacological and toxicological tests and clinical trials referred to in Article 4.8 of Directive 65/65, the objective of which is to prove the safety and efficacy of medicinal products (see Scotia Pharmaceuticals, cited above, paragraph 17).
24 Consequently, under the procedure provided for in Article 4.8(a)(iii) the obligation to carry out those tests is replaced by an obligation to show that the medicinal product is so similar to a product which has been authorised for not less than 6 or 10 years in the Community and is marketed in the Member State for which the application is made that it does not differ significantly from that product as regards safety and efficacy.
26 According to the case-law of the Court, a declaration recorded in the minutes of the Council on the occasion of the adoption of a directive cannot be used for the purpose of interpreting a provision of that directive where no reference is made to the content of the declaration in the wording of the provision in question (Case C-292/89 Antonissen [1991] ECR I-745, paragraph 18, and Case C-329/95 VAG Sverige [1997] ECR I-2675, paragraph 23).
32 However, according to the Commission's observations and, in particular, the latest edition of its Rules governing medicinal products in the European Union (p. 235), a medicinal product which satisfies the three criteria referred to in paragraph 25 of this judgment may nevertheless raise questions of safety related to its excipients.
36 Having regard to the foregoing, the answer to the first part of the first question must be that Article 4.8(a)(iii) of Directive 65/65, as amended, is to be interpreted as meaning that a medicinal product is essentially similar to an original medicinal product where it satisfies the criteria of having the same qualitative and quantitative composition in terms of active principles, of having the same pharmaceutical form and of being bioequivalent, unless it is apparent in the light of scientific knowledge that it differs significantly from the original product as regards safety or efficacy.
61 The Court has consistently held that the general principle of equality, which is one of the fundamental principles of Community law, requires that similar situations not be treated differently unless differentiation is objectively justified (see, inter alia, Joined Cases C-248/95 and C-249/95 SAM Schiffahrt and Stapf v Germany [1997] ECR I-4475, paragraph 50).
66 According to the case-law of the Court, in order to establish whether a provision of Community law complies with the principle of proportionality it must be ascertained whether the means which it employs are suitable for the purpose of achieving the desired objective and whether they do not go beyond what is necessary to achieve it (see, in particular, Case C-127/95 Norbrook Laboratories v MAFF [1998] ECR I-1531, paragraph 89).
67 In a sphere in which the Community legislature is called on to undertake complex assessments, judicial review of the exercise of its powers must be limited to examining whether it is vitiated by a manifest error of assessment or a misuse of powers or whether the legislature has manifestly exceeded the limits of its discretion (see, to that effect, the judgment in Norbrook Laboratories, cited above, paragraph 90).
71 In fact, as stated in paragraph 4 of this judgment, one of the principal objectives of the abridged procedure is to avoid the repetition of tests on humans or animals unless absolutely necessary.
72 However, the second recital to Directive 87/21 intimates that it is necessary to state more precisely the cases in which the results of pharmacological and toxicological tests or clinical trials do not have to be provided with a view to obtaining authorisation for a medicinal product which is essentially similar to an authorised product, while ensuring that innovative firms are not placed at a disadvantage.
73 Safeguarding the interests of innovative firms is precisely the aim of granting them a period of protection for their data of 6 or 10 years from the date of the first marketing authorisation obtained in the Community for a particular product.
79 Under the Court's case-law, the right to property forms part of the general principles of Community law. Those principles are not absolute, however, but must be viewed in relation to their social purpose. Consequently, the exercise of the right to property may be restricted, provided that the restrictions in fact correspond to objectives of general interest pursued by the Community and do not constitute disproportionate and unacceptable interference, impairing the very substance of the right guaranteed (see, in particular, the judgment in SAM Schiffahrt and Stapf v Germany, cited above, and Case C-200/96 Metronome Musik [1998] ECR I-1953, paragraph 21).