Report for the Hearing in Case C-290/90

I — Summary of the facts

A — Legislative background

(a) Community law

1. Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relation to proprietary medicinal products (OJ, English Special Edition 1965-1966, p. 20) has as its aim, according to the third recital in its preamble, to remove hindrances to trade in proprietary medicinal products within the Community arising from disparities between national provisions in the subject-matter. According to the first recital in the preamble to the directive, the efforts of harmonisation of the Community are guided, in this regard, by the principle according to which the primary purpose of any rules concerning the production and distribution of proprietary medicinal products must be to safeguard public health.

(b) National law

2. The German Law on Medicinal Products (Arzneimittelgesetz), as amended by the Law of 24 August 1976 reforming the legislation relating to medicinal products (BGBl. I, p.2445), transposed Directive 65/65 into German law. Paragraph 2(1) of that Law gives the following definition of medicinal product:

B — Background to the dispute

3. A complaint from a French manufacturer (the Prevor company, whose registered office is at Valmondois) brought to the Commission's attention the fact that certain lotions produced by that manufacturer, which may be employed, by way of first aid in the context of the safety at the workplace, in undertakings and workshops to remove from the skin and eyes dust and dangerous chemical substances, are, in so far as they are used a an eyewash, regarded by the German authorities as medical products within the meaning of Directive 65/65 and provisions of the German Law of 1976 on medicinal products.

4. Since numerous bilateral contacts between the German Government and the French Government had proved fruitless, the Commission, by letter of 20 April 1988, requested the German Government, pursuant to Article 169 of the EEC Treaty, to submit its observations with respect to the specific requirement of an authorization to place the lotions in question on the market as medicinal products.

II — Written procedure and forms of order sought by the parties

5. The Commission's application was lodged at the Court Registry on 20 September 1990.

Ill — Pleas in law and arguments of the parties

6. The Commission considers, as a preliminary point, that there is no justification for regarding as medicinal products the lotions in question, whether they are intended for the human eye or skin, since these products have no therapeutic effect, which places them outside the provisions of Article 1 of Directive 65/65. Consequently, the fact that the German authorities refuse access to their market to products coming from other Member States constitutes a measure having equivalent effect to a quantitative restriction, which is incompatible with Article 30 of the EEC Treaty, and which cannot be justified on grounds of protection of health under Article 36 of the Treaty or other mandatory requirements.

7. The German Government states first that the capacity to absorb the products in question is not restricted, contrary to the Commission's contention, to the surface of the eye. They may also be absorbed through the upper layers of the cornea and the conjunctiva as well as through the epithelium and the stroma of the cornea. It goes on to state that the lotions should therefore be regarded as being used inside the eye and, consequendy, inside the body.

1 Language of the case: German.