The ECJ recently considered a German ban on third party statements and prize promotions to market over the counter pharmaceutical products. Did these controls, applied in this case to ginseng products, exceed what was required by the Medicines Advertising Directive? Anja Kops of Osborne Clarke Cologne reports.
Topic: Health and Beauty
Who: Gintec Int. Import-Export GmbH vs. Verband sozialer Wettbewerb
When: November 8, 2007
Where: European Court of Justice ref. C-374/05
Law stated as at: 12 December 2007
Gintec, a German distributor of ginseng products, was sued by Verband sozialer Wettbewerb, a German association for the defence of free competition, because of its advertising for medicinal products. In the first instance, it was ruled that Gintec's advertising was incompatible with the relevant German legislation. The ruling concerned marketing material including statements from third persons as well as a monthly prize draw for ginseng products. Both types of advertising are forbidden under German laws controlling advertising for pharmaceutical products (HWG).
The appellate court referred the case to the ECJ in order to obtain clarification regarding the scope of harmonisation through the Medicines Directives and the compatibility of the HWG with the respective directives.
The ECJ pronounces judgment
In response to the first question the ECJ stated that the harmonization brought by the Directive 2001/83 was complete so that the member states were only authorised to lay down provisions that comply with the rules established in the directive. Therefore the provisions in the HWG that constitute an absolute prohibition of advertising with statements from third persons are not compatible with European law.
Concerning advertising with statements of third persons, the Directive sets forth that only a misleading or exaggerating statement is prohibited: there is no general and absolute prohibition of such advertising as provided by the HWG.
The second issue referred to the ECJ was whether a general positive evaluation of consumers concerning the ginseng product constituted a "claim of recovery" in the sense of Art. 90 (j) of Directive 2001/83 and is therefore forbidden. The ECJ held that all information with regard to pharmaceutical products is a "claim of recovery" under the condition that it refers to particular health problems. However, this was not the case for the consumers' evaluation in question. This only contained information conducive to the well being of persons in general. Nevertheless, the ECJ pointed out that also such general information may not comply with European law in case that it is misleading, exaggerating or alarming.
Prize promotions and OTC medicines incompatible?
Concerning the use of prize draws as a marketing tool to promote sales of pharmaceutical products, the ECJ briefly clarified that the Directive itself does not contain a general prohibition of this practice. However, in the preamble of the Directive it is stated that an advertisement encouraging an irrational and excessive use of medicinal products by presenting it as a gift or a prize is prohibited. Due to this fact the provisions in the HWG – where a general prohibition of prize draws is provided – comply with the Directive.
Why this matters:
The court ruling of the ECJ clarified for the first time the scope of harmonisation through the respective Directives and in addition critically reviewed the absolute prohibitions contained in the HWG that are highly disputed in Germany by the pharmaceutical industry.