Written by Fabio Rotermund,

Faculty of Law, University of Hamburg, Germany

Erasmus student at Faculty of Law in Maribor, Slovenia

Email: fabio.rotermund@gmail.com

Usually in Germany fixed prices of prescription-only medicinal products for humans use exist. Thus it is guaranteed that all pharmacies sell the prescription-only medicinal products for the same price. Certainly it is problematic for the German market, especially for the German pharmacies, if foreign pharmacies offer prescription-only medicinal products at lower prices in Germany. The European Court of Justice (ECJ) decided to this difficulty (Deutsche Parkinson Vereinigung v Zentrale zur Bekämpfung unlauteren Wettbewerbs e.V.).

Backgrounds

The grounds for the proceeding was a claim from 2009 submitted by the German Centre for Combating Unfair Competition („Zentrale zur Bekämpfung unlauteren Wettbewerbs e.V.“) against the German Parkinson’s patients association („Deutsche Parkinson Vereinigung e.V.“). The German Parkinson’s patients association (DPV) is a self-help organization which has as its objective to improve the lives of patients suffering from Parkinson’s and those of their families. For the members of the DPV it was available through the cooperation between the DPV and the Dutch mail-order pharmacy „DocMorris“ to get various bonuses for prescription-only medicinal products for Parkinson’s disease from „DocMorris“. According to paragraph 78 II of the Law on medicinal products provides („Arzneimittelgesetz“) a uniform pharmacy retail price shall be guaranteed in Germany for medicinal products that may not be sold other than through pharmacies. Medicinal products that may not be sold other than through pharmacies are prescription-only medicinal products. According to paragraph 78 I 4 read in conjunction with paragraph 73 I 1 Nr. 1a of the Law on medicinal products provides („Arzneimittelgesetz“) this regulation is also applicable to pharmacies established in other Member States. Thus it was not allowed to sell prescription-only medicinal products on the German market cheaper than usual like „DocMorris“ (Dutch-Prices Case). For this reason the German Centre for Combating Unfair Competition (ZBUW) took the view in front of the Court that the bonus system infringes German legislation.

Court decision

The Düsseldorf Higher Regional Court („Oberlandesgericht Düsseldorf“) identified a need for clarification under European law and appealed to the ECJ in 2015. The Düsseldorf Higher Regional Court refer the question to the ECJ, if the Art. 34 TFEU must be interpreted as meaning that a system of fixed prices for prescription-only medicinal products laid down by national law, constitutes a measure having equivalent effect within the meaning of Art. 34 TFEU. Moreover they asked the ECJ in the case that the Court answers the first question in the affirmative, if the system of fixed prices for prescription-only medicinal products is justified under Art. 36 TFEU on grounds of the protection of health and life of humans when that system is the only means of ensuring a consistent supply of medicinal products to the population across all parts of the country, in particular in rural areas. The ECJ answered to the first question that Art. 34 TFEU should be interpreted as meaning that national legislation, which provides for a system of fixed prices for the sale by pharmacies of prescription-only medicinal products for human use, constitutes a measure having equivalent effect to a quantitative restriction on imports in pursuance to Art. 34 TFEU. The ECJ grounds the answer thereby that the legislation has a greater impact on the sale of prescription-only medicinal products by pharmacies established in other Member States than on the sale of the same medicinal products by pharmacies established within the national territory. Moreover the ECJ declares that Art. 36 TFEU must be interpreted as meaning that national legislation, which provides for a system of fixed prices for the sale by pharmacies of prescription-only medicinal products for human use, cannot be justified on grounds of the protection of health and life of humans, since that legislation is not appropriate for attaining the objectives pursued. Especially the price competition between the pharmacies guaranteed the effective protection of health and life of humans, because this price competition would be conducive to a uniform supply of medicinal products, also in areas where scarcity of pharmacies exists. Furthermore the effective protection of health and life of humans demands, that medicinal products be sold at reasonable prices (De Peijper Case).

Furthermore it is a positive effect when traditional pharmacies are in price competition with mail-oder pharmacies, because this would be supporting the producing of prescription medicinal products or maintaining a given stock and selection of medicinal products.

Consequences

Thus the ECJ confirmed that discounts on prescription-only medicine is permissible for non-German mail-order pharmacies in the European Union and the German legislation of fixed prices of prescription-only medicinal products for humans use is set out of order for non-German mail-order pharmacies. That means that german consumer can order prescription-only medicinal products for humans use by non-German mail-order pharmacies cheaper than usual and despite the fact that fixed prices of prescription-only medicinal products for humans use exist in Germany.