DIRECTIVE 87/21/EEC 6.3

DIRECTIVE 87/21/EEC 6.3.1

The objectives of the new Directive

Directive 87/21/EEC was adopted by the Council of Health Ministers on 21 December 1986 and introduced into the EC Member States on 1 July 1987. It amended 65/65/EEC and had two main objectives—the protection of

pharmaceutical innovation (particularly for biotechnology products), and to ensure greater harmonisation of all of the requirements for ‘copy products’ which are submitted without full pharmacotoxicological and clinical documentation.

The Directive was implemented in all Member States except for Greece, Portugal, and Spain, who have a derogation until 1992. In those countries applicants can apply under the old ‘literature references/bibliography’ requirements.

6.3.2

Protection of pharmaceutical innovation

As mentioned above, one of the objectives of this new Directive was to provide a certain form of ‘market exclusivity’ for high technology/biotechnology products. The CEC had felt that the protection offered by the patent law under the Munich convention to pharmaceutically innovative products was not always sufficient, because the theoretical twenty years patent term is always substantially eroded— both by the testing necessary to obtain a marketing authorisation and also by the process of obtaining the authorisation through the national authorities. In addition, for biotechnology products the patent law was not considered to provide adequate protection for innovation.

In nine out of the twelve of the EC Member States, this ‘second applicant protection’ period of ten years is applied to any new active substance (NAS) product. In Denmark, Ireland, and Luxembourg the period of second applicant protection is six years for an NAS product.

In all EC Member States a full ten years second applicant protection is given to any product submitted through the Directive 87/22/EEC concertation procedure. Thus, this includes obligatory applications made by companies for List A biotechnology products (see Chapter 15 for details). However, it also includes List B high technology products, where in the first place the company chooses to apply voluntarily and to justify the application under one of the headings in List B, and the EC Member State chosen as rapporteur then has to accept this case (or not). The main effect, in terms of second applicant protection for high technology products, is to increase the term of protection from six to ten years in Denmark, Ireland and Luxembourg.

6.3.3

Harmonisation of the rules for products which are copies of established medicinal products

The objective of stipulating the cases (for copy products) in which the results of the preclinical (animal toxicology and pharmacology) and clinical studies do not have to provided was to prevent unnecessary testing on humans and animals. The new section of Article 4(8)(a) (introduced in the Directive 87/21/EEC 76 ABRIDGED APPLICATIONS [CH. 6

amendment) defines the circumstances where it is not necessary to provide the systematic results of animal toxicology and clinical studies. These are:

4(8)(a)(i): either that the new product is essentially similar to the original product authorised in the country concerned with the application and that the person responsible for marketing of the product has consented to the pharmacological, toxicological, or clinical references contained in the file on the original proprietary medicinal product being used for the purpose of examining the new application;

4(8)(a)(ii): or, that 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 proprietary medicinal product have a well established medicinal use, with recognised efficacy and an acceptable level of safety;

4(8)(a)(iii): or, that the new 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 ten years in the case of high technology 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 has been followed; furthermore, a Member State may also extend this period to ten years by a single Decision covering all the products marketed on its territory where it considers this is necessary in the interests 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 proprietary medicinal product is intended for different therapeutic use from that of the other proprietary medicinal products marketed or is to be administered by different routes or in different doses, the results of appropriate pharmacological and toxicological tests and/or clinical trials must be provided.

6.3.4

Harmonisation of the rules for combination products

Article 4(8)(b) of Directive 65/65/EEC now deals with the question of combination products. It states that in the case of new products containing known constituents not hitherto used in combination, the results of pharmacological and toxicological tests and of clinical trials relating to that combination must be

provided, but that it is not necessary to provide references relating to each individual constituent.

6.4

REQUIREMENTS FOR INFORMATION ON SECOND