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 | | ADVERTISING REGULATIONS | | | CHEManager Europe | | 18/09/2008 | | | What are the repercussions of the ruling by the European Court of Justice (ECJ) in the case against Gintec in November 2007?
The German Gintec International Import-Export GmbH (Gintec), in May 2000, advertised various ginseng preparations, which are registered in Germany as OTC medicinal products. Gintec’s advertising was accompanied by a consumer survey evaluation, in which testimonials of patients were described. In addition, Gintec announced on its internet site a monthly price draw with the chance of winning a pack of “Gintec’s Red Imperial Ginseng Extract Powder.”
This advertising conflicted with the German law on advertising of medicinal products, Heilmittelwerbegesetz (HGW), and was therefore referred to the German Federal Supreme Court. The discussion arose that the HGW contained stricter rules than the directive 2001/83/EC of the European Parliament. This lead to the German Federal Supreme Court requesting a preliminary ruling by the ECJ and clarification as to the degree of harmonisation brought about by directive 2001/83/EC in the area of medicinal product advertising. The main and among the EU-Member States heavily discussed question was, whether the directive 2001/83 provides minimum standards only, allowing the Member States to provide stricter rules on advertising or whether the Directive brought about complete harmonisation, which leads to the conclusion that the Member States are not entitled to provide for stricter rules than those laid down in the Directive 2001/83.
The ECJ stated that recitals four and five in the preamble to directive 2001/83 state that the directive aims do remove the hindrances to trade in medicinal products that are created by disparities between national provisions relating to medicinal products thus directly affecting the functioning of the internal market. Although the ECJ did reach the conclusion that Gintec’s advertising was not in line with directive 2001/83, the proceedings revealed the fact that directive 2001/83/EC sets a definitive minimum and maximum standard—complete harmonisation—in the field of advertising for medicinal products which limits the regulation by the member states, in future all national provisions, particularly with regard to the OTC-medications, which are not in line with the European regulations, are not applicable. The national authorities and courts, in applying the provisions of domestic law, have to interpret them in the light of the wording and the purpose of the directive in order to achieve the sought result.
To read the full article by Dr. Christian Tillmanns, don’t miss the current issue of CHEManager Europe, which is packed with pre-CPhI coverage!
Contact:
Ana Wood
Managing Editor, CHEManager Europe
Tel.: +49 (0)6151 8090 255
ana.wood@wiley.com
www.chemanager-europe.com
Source: CHEManager Europe; www.chemanager-europe.com | |
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