Keywords
Summary

Keywords

1 Community law - Interpretation - Acts of the institutions - Council declaration recorded in the minutes - To be taken into account - Condition

2 Approximation of laws - Medicinal products - Marketing authorisation - Abridged procedure - Essentially similar products - Meaning - Factors to be taken into account - Discretion enjoyed by the competent authority - No discretion

(Council Directive 65/65, as amended by Directive 87/21, Art. 4.8(a)(iii))

3 Approximation of laws - Medicinal products - Marketing authorisation - Abridged procedure - Essentially similar products - Waiver of the obligation to provide the results of pharmacological and toxicological tests or of clinical trials - Scope - Entry into force of Regulation No 541/95 - Irrelevant

(Council Directive 65/65, as amended by Directive 87/21, Art. 4.8(a)(iii); Commission Regulation No 541/95)

4 Approximation of laws - Medicinal products - Marketing authorisation - Abridged procedure - Essentially similar products - Waiver of the obligation to provide the results of pharmacological and toxicological tests or of clinical trials - Principle of non-discrimination - Principle of proportionality - Right to property - Breach - No such breach

(Council Directive 65/65, as amended by Directive 87/21, Art. 4.8(a)(iii))

Summary

1 Although a declaration recorded in the minutes of a meeting of the Council on the occasion of the adoption of a provision of secondary legislation cannot be used for the purpose of interpreting that provision where no reference is made in the wording thereof to the content of the declaration, that declaration may be taken into consideration in so far as it serves to clarify a general concept used in the provision in question.

2 Article 4.8(a)(iii) of Directive 65/65 concerning medicinal products, as amended by Directive 87/21, allows an abridged procedure to be used for the issue of authorisations to place medicinal products on the market where the product for which such authorisation is sought is essentially similar to a product which has been authorised within the Community, in accordance with the Community provisions in force, for not less than 6 or 10 years and is marketed in the Member State for which the application is made. That provision must be interpreted to the effect that a medicinal product is essentially similar to an original medicinal product where it satisfies the criteria set out in the minutes of the meeting of the Council at which Directive 87/21 was adopted 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. The competent authority of a Member State may not disregard those three criteria when it is required to determine whether a particular medicinal product is essentially similar to an original medicinal product.

3 A medicinal product that is essentially 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 may be authorised, under the abridged procedure provided for in Article 4.8(a)(iii) of Directive 65/65 concerning medicinal products, as amended by Directive 87/21, for all therapeutic indications already authorised for that product. It is irrelevant that original or abridged applications for marketing authorisations may have been made before the entry into force of Regulation No 541/95 concerning the examination of variations to the terms of a marketing authorisation granted by a competent authority of a Member State, since that Regulation has no bearing whatsoever on the application of Article 4.8(a)(iii) of Directive 65/65, as amended.

It is clear from the wording of Article 4.8(a)(iii) of Directive 65/65, interpreted in the light of the definition of what constitutes an essentially similar medicinal product, that having the same therapeutic indications is not one of the criteria which must be satisfied for two medicinal products to be regarded as essentially similar. It follows that an applicant for marketing authorisation in respect of a medicinal product that is essentially 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 is not required thereunder to supply pharmacological, toxicological and clinical documentation, whatever the therapeutic indications to which the documentation for the original medicinal product relates. Consequently, under the abridged procedure provided for in Article 4.8(a)(iii) of Directive 65/65, as amended, the applicant may receive marketing authorisation for all therapeutic indications covered by the latter documentation, including those indications authorised for less than 6 or 10 years.

4 Article 4.8(a)(iii) of Directive 65/65, as amended by Directive 87/21 - which permits recourse to an abridged procedure for the issue of authorisation to place medicinal products on the market where the product for which such authorisation is sought is essentially similar to a product which has been authorised within the Community, in accordance with the Community provisions in force, for not less than 6 or 10 years and is marketed in the Member State for which the application is made - is not inconsistent with the principle of non-discrimination or with the principle of proportionality; nor does it infringe the fundamental right to property.

First, the abridged procedure is not inconsistent with the principle of non-discrimination since the first and second applicants for marketing authorisation are not in comparable situations. The first applicant can show the efficacy and safety of the product only by means of the necessary tests. By contrast, where the second applicant shows that his product is essentially similar to that of the first applicant, a product which has already been authorised, he may merely - without risk to public health - refer to the data relating to the efficacy and safety of the original product which the first applicant has supplied.

Secondly, the abridged procedure does not undermine the principle of proportionality, since, in the light of the discretion enjoyed by the Community legislature in the context of its task of harmonising legislation, that procedure is not an inappropriate means of reconciling the underlying objectives, namely, of avoiding the repetition of tests on humans or animals where these are not absolutely necessary, and of safeguarding the interests of innovative firms by 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.

Lastly, the abridged procedure, which serves objectives of general public importance pursued by the Community, does nothing to impair the very substance of the right to property, since it does not make it impossible in practice for innovating firms to carry on their business of producing and developing medicinal products.