Legal Updates

Commercial Law – Free Movement of Medicinal Products – Medicinal Products – Distribution to Pharmacist of Lists of Non Approved Medicinal Products –  Advertising of Medicinal Products

The recent case of Ludwigs-Apotheke Munchen International Apotheke v Juers Pharma Import-Export Gmbh (Case C-143/06) [2007] was in connection with the free movement of medicinal goods in the EC. In this case a reference for a preliminary ruling, which concerned the interpretation of the third indent of Article 86(2) of Parliament and Council Directive (EC) 2001/83 (on the Community code relating to medicinal products for human use) as amended by Parliament and Council Directive (EC) 2004/27, was made by the regional court to the Court of Justice.

The reference was made in connection with proceedings concerning the claimant and defendant companies. The proceedings were brought to settle a dispute regarding the sending of lists of medicinal products not approved in Germany by the defendant to a number of pharmacists.

Under German legislation, paragraph 8 of the Heilmittlewerbegesetz (“HWG”) on the advertising of medicines prohibits all advertising of medicinal products not approved in Germany, but which could potentially be acquired by pharmacists from another state in which those products can be lawfully circulated.

The questions in the reference essentially asked whether the third indent of Article 86(2) of Directive (EC) 2001/83 had to be interpreted as precluding a national provision such as paragraph 8 of the HWG.

In answering the questions, consideration was given to Article 28 EC and 30 of the EC Treaty, as well as to Article 11 and 13 of the agreement on the European Economic Area of May 1992.

The court ruled that a prohibition on advertising such as that laid down by paragraph 8 of the HWG had to be assessed in the light not of the provisions on advertising of Directive (EC) 2001/83, as amended, but of Article 28 EC and 30 EC in addition to Article 11 and 13 of the agreement on the European Economic Area.

Article 28 EC and Article 11 of the Agreement on the European Economic Area precluded such a prohibition. It was held that the preclusion applied to the distribution to pharmacists of lists of non-approved medicinal products, the importation of which from another member state (or non-member state) party to the Agreement on the European Economic Area was authorised only on an exceptional basis. The list would have to contain no information other than information relating to the trade name, packing size, dose and price of those medicinal products.

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© RT COOPERS, 2008. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances.