From: news@paragraf.nbg.sub.org
Newsgroups: de.soc.recht
Subject: JUS 9239.3.1 Free trade                 
Date: Sun, 13 Dec 92 18:08:13 +0100
Organization: VDJ Nuernberg

ENR   : 2478
HD    : 3. Free Movement of Goods, Services and Capital
TI    : Judgment of the Court of Justice - notion of a medicinal product
RF    : JUS 9239.3.1
AB    : In the Netherlands, Mr. T.V. markets herb teas imported from South
        America under the name "Fitness Foundations Nederland". These herb
        teas are sold by Mr. T.V. without mentioning any curative or
        preventive properties. However, a Dutch foundation addresses
        notices to consumers on request, indicating the therapeutic
        properties of the products sold and mentioning that the herb tea
        is considered as complementary to any medicines taken.
        Action was taken against Mr. T.V. for marketing pharmaceuticals in
        the Netherlands in infringement of Dutch legislation on supplying
        medicines. The Arrondissementsrechtbank of Leeuwarden (Netherlands)
        before which appeal was lodged, referred to the Court of Justice for a
        number of preliminary rulings on the interpretation of Directive
        65/65/EEC (amended several times) on the harmonization of national
        legislations on pharmaceutical specialties. The references by the
        national court notably concerned :
        - whether a product such as herb tea, which is generally considered
        as a foodstuff having no known pharmacological properties, must be
        considered a medicinal product "by presentation" within the meaning
        of Directive 65/65/EEC when it is presented as having curative
        properties;
        - can a product be considered a medicinal product "by presentation"
        within the meaning of Directive 65/65/EEC when its therapeutic
        properties are exclusively indicated in a brochure addressed on
        request to the buyer after the sale or distributed by a third party
        independently of the sale;
        - can a product which is not medicinal within the meaning of
        Directive 65/65/EEC be subject nevertheless to regulations for
        medicinal products under the national law of a Member State.
        With regard to the first question, the Court of Justice recalled
        its case law according to which the criterion called "presentation"
        retained in Article 1 of Directive 65/65/EEC covers not only
        medicinal products having a real therapeutic or medical effect, but
        also products which are not sufficiently effective or which do not
        have the effect that their presentation would lead one to expect,
        to safeguard consumers not only from harmful or toxic medicines as
        such, but also various products used in lieu of adequate remedies.
        The Court concluded that a product recommended or described as
        having preventive or curative properties is a medicinal product
        within the meaning of Article 1, par. 2 (1) of Directive 65/65/EEC
        even if it is generally considered as a foodstuff and even if it
        has no known therapeutic effect given the current state of scientific
        knowledge. With regard to the second question, the Court observed
        first that:
        - the fact that the manufacture or seller addresses a publication
        to the buyer describing or recommending the product as having
        therapeutic effects constitutes a decisive indication of the
        intention of the manufacturer or seller to market the product as a
        medicinal product;
        - the circumstance that the publication is addressed to the buyer
        on request only does not in itself invalidate that intention of the
        manufacturer or seller;
        - the circumstance that the publication is addressed not by the
        manufacturer or the seller but by a third party acting on their
        behalf or in contact with them does not invalidate the seller's or
        manufacturer's intention to market the product as a medicinal product.
        However, the Court specified, the distribution of information on
        the curative or preventive properties of a product by a third party
        acting on its own initiative and totally independently of the
        manufacturer or seller does not, in itself, constitute a
        "presentation" within the meaning of Directive 65/65/EEC since it
        does not show the manufacturer's or seller's intention of marketing
        the product as a medicine.
        Finally, with regard to the third question, the Court noted that
        a product which is not a medicine within the meaning of Article 1,
        paragraph 2 of Directive 65/65/EEC can fall under legislation on
        medicines under national law of a Member State, subject to Articles
        30 and thereafter.
        Judgment of the Court of Justice of 28 October 1992, Case C-219/91
         J.S.W. Ter Voort, not yet published.
CT    : Free movement of goods; Pharmaceutical product
DT    : 921120