Das Arzneimittelgesetz in der Fassung der Bekanntmachung vom Dezember BGBl. L vom Bundesgesetzblatt Jahrgang Teil I Nr.
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Judgment of the Court First Chamber of 19 October Reference for a preliminary ruling — Articles 34 TFEU and 36 TFEU — Free movement of goods — National legislation — Prescription-only medicinal products for human use — Sale by pharmacies — Setting of fixed prices — Quantitative restriction on imports — Measure having equivalent effect — Justification — Protection of the health and life of humans.
Silva de Lapuerta, President of the Chamber, E. Regan Rapporteur , A. Arabadjiev, C. Fernlund and S. Rodin, Judges,. Deutsche Parkinson Vereinigung eV, by T. Diekmann, Rechtsanwalt, K. Nordlander, advokat, M. Meulenbelt, advocaat, and D. Costesec, Solicitor,. Dechamps, Rechtsanwalt, and J. Palmieri, acting as Agent, assisted by M.
Russo, avvocato dello Stato,. Falk, C. Meyer-Seitz, U. Persson, N. Otte Widgren, E. Karlsson and L. Swedenborg, acting as Agents,.
Manhaeve, J. Herkommer and A. Sipos, acting as Agents,. Regulation on the pricing of medicinal products. That regulation does not apply to medicinal products which do not require a prescription. Law on the advertising of medicinal products. The facts in the main proceedings and the questions referred for a preliminary ruling.
The ZBUW takes the view, inter alia, that the bonus system infringes German legislation which provides for a system of fixed prices for the supply by pharmacies of prescription-only medicinal products.
The referring court takes the view that the bonus system infringes the relevant national legislation not only in the case where a pharmacist supplies a medicinal product at a price differing from that which must be charged under the Regulation on the pricing of medicinal products, but also in the case where, in parallel to the purchase of a medicinal product at the fixed price, the customer is afforded a benefit which makes the purchase appear more economically advantageous to him.
The referring court takes the view that the assessment as to whether a system of fixed prices for prescription-only medicinal products alone can ensure a uniform supply to the population of prescription-only medicinal products across all parts of the country will, in all probability, be decisive in resolving the case at issue in the main proceedings. That court notes that, up to the present, the ZBUW has not made submissions addressing that issue in detail or presented evidence supporting such a line of argument.
The explanatory memorandum to the national legislation at issue in the main proceedings also merely refers to the alleged risks that the fixed-price system at issue in the main proceedings seeks to counteract. In that regard, the referring court also harbours doubts as to whether, as regards the possibility of a mail-order supply, it would be appropriate, where relevant, to tolerate potential threats to traditional pharmacies, particularly in rural areas.
If the Court also answers the second question in the affirmative: what is the degree of judicial scrutiny required when determining whether the condition mentioned in the second question is in fact satisfied?
Consideration of the questions referred. In the case in the main proceedings, it is common ground that the system of fixed prices applies both to pharmacies established in Germany and to those established in other Member States. The Court has also held, in relation to a prohibition under German law of mail-order sales of medicinal products the sale of which is, in the Member State concerned, restricted to pharmacies, that such a prohibition is more of an obstacle to pharmacies outside Germany than to those within Germany.
Although there is little doubt that, as a result of the prohibition, pharmacies in Germany cannot use an extra or alternative method of gaining access to the German market consisting of end consumers of medicinal products, they are nonetheless able to sell the products in their dispensaries. By contrast, for pharmacies not established in Germany, the internet provides a more significant way by which to gain direct access to the German market. In the present case, it must be found that, as the ZBUW and the German and Swedish Governments have each noted, traditional pharmacies are, in principle, better placed than mail-order pharmacies to provide patients with individually-tailored advice given by the staff of the dispensary and to ensure a supply of medicinal products in cases of emergency.
In so far as mail-order pharmacies cannot, given the limited services that they offer, adequately replace such services, it must be held that price competition is capable of providing a more important factor of competition for mail-order pharmacies than for traditional pharmacies, since price competition lays the basis for their potential to access the German market directly and to continue to be competitive in it. Consequently, and in so far as sales by mail order constitute a more important means of accessing the German market directly for pharmacies established in Member States other than Germany, if not, given the particular characteristics of the German market evidenced in the documents in the case file submitted to the Court, potentially the only means of accessing that market directly, the national legislation at issue in the main proceedings does not affect the sale of national medicinal products in the same way as it affects the sale of medicinal products originating in other Member States.
In the light of the foregoing, it must be held that a system of fixed sales prices, such as that laid down in the German legislation, has a greater impact on pharmacies established in a Member State other than the Federal Republic of Germany than on those which are established within German territory, a fact which could impede market access for products from other Member States more than it impedes such access for domestic products.
As regards a national measure coming within the field of public health, the Court has on numerous occasions held that the health and life of humans rank foremost among the assets and interests protected by the Treaty and that it is for the Member States to determine the level of protection which they wish to afford to public health and the way in which that level is to be achieved. Although it is common ground, in the case in the main proceedings, that the sale by mail order of prescription-only medicinal products is no longer prohibited in Germany, the ZBUW and the German and Swedish Governments argue that a system of fixed prices which applies to the sale of such medicinal products is justified in order to ensure a safe and high-quality supply of medicinal products to the German population.
In particular, according to the German Government, that system seeks to ensure that mail-order pharmacies do not engage in ruinous price competition which would result in the closure of traditional pharmacies, especially in rural or underpopulated areas which are less attractive areas for traditional pharmacies to set up business.
The German Government insists that such pharmacies alone are capable of ensuring safe and high-quality supplies, especially in cases of emergency, tailored advice and effective checks on the medicinal products supplied. As the Court has previously held, it is, in each case, for the national authorities to provide the necessary evidence to that effect.
Quite to the contrary, certain factors on which the Commission relies tend to suggest that increased price competition between pharmacies would be conducive to a uniform supply of medicinal products by encouraging the establishment of pharmacies in regions where the scarcity of dispensaries allows for higher prices to be charged.
As regards the argument based on a high-quality supply of prescription-only medicinal products, it must be found that, contrary to what the German Government claims, no factor has been laid before the Court that is capable of establishing that, in the absence of a system such as that at issue in the main proceedings, mail-order pharmacies would be able to compete in terms of price in such a way that essential services, such as emergency care, could no longer be ensured in Germany due to a consequential fall in the number of dispensing pharmacies.
Similarly, the elements laid before the Court in the present case do not suffice to show that price competition for prescription-only medicinal products would adversely affect traditional pharmacies in performing certain activities in the general interest, such as producing prescription medicinal products or maintaining a given stock and selection of medicinal products.
Such general conjecture made in that regard does not in any way suffice to prove that the possibility for the consumer to seek to acquire prescription-only medicinal products at lower prices poses an actual risk to public health.
Moreover, the Court notes, as did DPV and the Netherlands Government, that, in the present case, price competition could be capable of benefiting the patient in so far as it would allow, where relevant, for prescription-only medicinal products to be offered in Germany at more attractive prices than those currently imposed by that Member State. Having regard to all of the foregoing considerations, it must be found that a restriction such as that resulting from the legislation at issue in the main proceedings has not been shown to be an appropriate means of attaining the objectives relied on and cannot therefore be regarded as justified by the attainment of those objectives.
Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable. Cuardach tapa. Tuilleadh roghanna cuardaigh uait? Bain triail as Cuardach casta. Teideal agus tagairt. Rodin, Judges, Advocate General: M.
Szpunar, Registrar: K. Schwarze, — the German Government, by T. Henze and A. Lippstreu, acting as Agents, — the Italian Government, by G. Russo, avvocato dello Stato, — the Netherlands Government, by M. Bulterman and M. Swedenborg, acting as Agents, — the European Commission, by E.
Costs 47 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court, the decision on costs is a matter for that court. Lippstreu, acting as Agents,. On those grounds, the Court First Chamber hereby rules:.
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