Arzneiverordnungs-Report pp Cite as. Mit einem durchschnittlichen ungewichteten Packungspreis von 4. Rund 17,5 Mrd. Biologika mit Nettokosten von 10,6 Mrd. Starke Dynamik ist auch im Bereich der Orphan Drugs zu finden. Unable to display preview.
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On the contrary, the same legal questions resurface in the context of different factual circumstances. Quite apart from this, and in a less obvious manner, this case provides yet another example of the value of the preliminary reference procedure.
Finally, we should call a spade a spade: this is the third time that the Court is called upon to assess the compatibility of a German measure with the Treaty provisions on free movement where the Dutch pharmacy DocMorris is endeavouring to obtain access to the German market. Further to the first DocMorris case, Germany altered its legislation and allowed for mail order, not only of non-prescription, but also of prescription-only medicinal products.
On the basis of the information provided to the Court, it appears that, at least for some time, there were no rules on uniform prices as regards prescription-only medicinal products imported from other Member States. Later on, such rules were also to apply to such products. This leads us to the legal framework.
A uniform pharmacy retail price shall be guaranteed for medicinal products that may not be sold other than through pharmacies. This regulation does not apply to medicinal products not requiring a prescription. It held that the letter constituted commercial conduct on the part of DPV that was unfair because the bonus system promoted was prohibited under competition rules.
Moreover, the Landgericht continued by holding that, at the material time, the legislative rules at issue were applicable also to supplies effected by DocMorris, which is not established on German territory. The definition of a measure having equivalent effect to a quantitative restriction is so well known that it hardly needs to be recalled.
Fixed prices are a thorn in the flesh of any economic operator not present on a market, given that competition, is, by its very essence, determined by price. By depriving an economic operator of the possibility of undercutting a certain price, it is deprived of a factor allowing it to be competitive. Goods originating from Member States other than Germany therefore face difficulties when entering the German market.
The provisions at issue are liable to reduce imports into Germany. Ergo, under Dassonville , the provisions at issue qualify as constituting a measure having equivalent effect. They are more than capable of hindering trade.
This has also been evidenced by the decline in sales of DocMorris in Germany of prescription-only medicinal products, further to the introduction of the provisions under examination. If so, the consequence would be that it would fall outside the scope of the Treaty provisions on the free movement of goods. A fixed-price imposed on a specific product comes extremely close to a rule on presentation, labelling or packaging.
After all, products often have a physical price tag on them, which forms part of the packaging. Moreover, any measure which regulates one of the major aspects of a product, the price, is, in my view, more than a selling arrangement.
Measures on price directly affect the competitive advantage of an economic operator and are far more severe from the perspective of economic operators and free movement rules, than, say, a prohibition of sale at a loss or provisions regulating opening hours of shops.
Rather, it would be sufficient, in my view, to check whether the conditions of the Dassonville formula have been fulfilled or not. A uniform pharmacy retail price, such as the one in the case at issue undoubtedly applies, in law, to both German and non-German pharmacies and, by extension, both to German and imported products. Germany argues that the same can be said of the position in fact. The Joint Chamber of the Superior Federal Courts also takes the view that the fixed-price system applies in law and in fact equally to domestic and foreign pharmacies.
By contrast, the European Commission considers there to be a measure having equivalent effect. It takes the view that the fixed-price system imposes a greater burden on foreign pharmacies as they can offset the disadvantage of being able to obtain access to the German market only via mail order only by means of the advantage of being permitted to sell their products in accordance with the pricing rules of the Member State of their establishment.
In contrast, for German pharmacies, mail order is simply an additional distribution channel. As DPV, the Dutch Government and the Commission correctly point out, pharmacies not located in Germany have only one means to gain access to the German market, namely via the internet. Measures that apply in law but not in fact in the same way are habitually known as indirectly discriminatory measures. Establishing any kind of discrimination is always a delicate matter.
It hinges on the comparator to be applied, as the case at issue neatly illustrates. If one takes as the comparator, as the Joint Chamber does, internet pharmacies, then it is difficult to detect an indirect discrimination. However, this is not the right angle from which to examine the question of indirect discrimination in the case at issue. Surely, it is not internet pharmacies that should be compared but pharmacies in general. And then a different picture emerges, for the simple reason that, as DPV correctly points out, German and non-German pharmacies rely on the internet to varying degrees.
A pharmacy already present in Germany will, typically, if at all, resort to the internet in a limited capacity only, whereas a pharmacy based outside Germany does not have any means other than the internet to serve patients based in Germany. In other words, while for a German pharmacy, delivery by way of mail order constitutes but an additional channel of distribution, for a non-German one it is the only channel of distribution. However, for pharmacies not established in Germany, the internet provides a more significant way to gain direct access to the German market.
A prohibition which has a greater impact on pharmacies established outside German territory could impede access to the market for products from other Member States more than it impedes access for domestic products. In Ker Optika , the Court extended such reasoning to a prohibition on selling contact lenses by mail order. It held that such a prohibition deprived traders from other Member States of a particularly effective means of selling those products and thus significantly impeded access of those traders to the market of the Member State concerned.
In a situation where the effect of a measure is to block or at least reduce market access for internet pharmacies, which are typically foreign, so as to maintain a viable structure of physical pharmacies, I deem it impossible to speak of an indistinctly applicable selling arrangement.
This brings me to a final consideration on the classification of the German provisions: my finding is fully in line not only with the letter of Keck and Mithouard but also with its rationale, described above.
Sensitive matters of a non-economic nature which are only marginally linked to free movement as such and which are non-discriminatory should be left to Member States.
I do not see any room for such sensitivity when the effect of the measure is to limit competition and the market access of foreign economic operators. The last sub-ground of justification cannot be invoked. Against this background, I should like to examine the proportionality of the German measure with respect to the necessity of ensuring a consistent supply of pharmaceutical products throughout Germany, the quality of such supply and the protection of patients.
Inevitable market failure would lead to a concentration of pharmacies in certain areas, leaving behind the remote, the immobile, the vulnerable and the old. Germany is afraid that with increased competition German traditional retail pharmacies committed to a high degree of professionalism in the advice and consultancy they offer to consumers would have to lower the quality of such services in order to keep up with competition. It is for me difficult to conceive how, with increased competition, pharmacists would lower the quality of their services.
I would expect the opposite to be the case. In this context, I allow myself to refer to Advocate General Poiares Maduro who makes a similar argument with incisiveness and elegance in Blanco Perez. Such suitability for securing attainment of the objective relied upon is accepted only if the measure at issue genuinely reflects a concern to attain that objective in a consistent and systematic manner.
The same goes for a measure adopted on the basis of a manifest error of assessment. ZBW and the German Government take the view that the provisions in question are suitable for ensuring the consistent and comprehensive supply of medicinal products throughout the German territory.
Moreover, the Joint Chamber, having regard to the discretion afforded to the legislature, has deemed the system justified on the basis that no alternative system is apparent that, in the interests of a reliable and high-quality supply of medicinal products to the population, is equally capable as the fixed-price system of counteracting the risk of cutthroat price competition between pharmacies, of ensuring a consistent supply of prescription-only medicinal products to the entire population and of reducing the risk of misuse or overuse of medicinal products.
The link between the German measure and the purported goal, that is the consistent supply of pharmaceutical products appears to me to be too tenuous, which leads me to believe that the measure in question is unsuitable to attaining the purported objectives, for the following reasons. First, as the Commission correctly points out, it is not the number of pharmacies that automatically implies that there is a consistent and comprehensive coverage across the German territory.
On the contrary, price competition among pharmacies could be conducive to a consistent coverage of medicinal products. I would assume that by allowing internet pharmacies to compete, remote areas will be better served.
People with reduced mobility could greatly benefit from being able to place orders online and having them delivered directly to their home. Even if they are not accustomed to the alleged intricacies of ordering online, they will often have someone at their side a carer, a grand child, a neighbour etc. Secondly, as regards prescription-only medicinal products it is less the pharmacies one should concentrate on, but the number of doctors.
Typically, where there is no doctor to prescribe medicinal products, there will be no pharmacy. Thirdly, as regards the more delicate and sensitive matter of supply in emergency situations, it should not be forgotten that Germany has addressed this issue with a dedicated law, the Apothekennotdienstsicherstellungsgesetz. A charge is levied on medicinal products sold.
Incidentally, on the basis of the information available, it appears that medicinal products imported into Germany are also subject to this charge, which means that foreign pharmacies selling their products on the German market contribute financially to this fund.
I cannot see how the provisions under examination would have an additional impact on ensuring consistent supply of medicinal products. As regards quality of supply, it cannot be stressed enough that we are dealing with prescription-only medicinal products. Moreover, it should be kept in mind that the burden of proof of justification and proportionality lies on Germany.
It is for that Member State to prove the suitability of the measure in question. Germany has not submitted any evidence in support of its provisions. In this context, it also refers to the precautionary principle.
The said passage is indeed regularly resorted to by the Court. It finds its origins in the case-law on the precautionary principle. To my knowledge, it was first employed by the Court in relation to the EU institutions in in two judgments in the context of the BSE crisis. All cases were ones where there was indeed no scientific certainty as to the existence or extent of a risk to human health.
There have been occasions where an Advocate General has referred to the precautionary principle, but not the Court. In , matters took a certain turn in the case-law of the Court. In both these cases the Court, by referring to case-law on the precautionary principle, used the said formula. It did not, however, further mention that principle as such. In those cases, the Court found that, as a result, Member States may make persons entrusted with the retail supply of medicinal products subject to strict requirements, including as regards the way in which the products are marketed and the pursuit of profit.
The same statement was repeated in Venturini. The extension of the said formula to pharmacies since is unfortunate for it blurs the origin of the said formula and what the precautionary principle is really about: risk management in the context of scientific uncertainty. It applies both where the extent of a risk is uncertain and where there is doubt as to its very existence. However, it does not come into play in a situation of uncertainty surrounding the effectiveness of a policy option aimed at tackling a previously identified hazard.
In the latter concept, there is no element of uncertainty as to the existence or extent of a risk. In prevention, the danger is identified. Yet, the cases since , referred to above, related to pharmacies and involve no scientific uncertainty whatsoever about the health risk of misuse or overconsumption of pharmaceutical products. Moreover, such products are already legally on the market following a strict marketing process. The uncertainty is confined to the viability or effectiveness of the measure envisaged.
The precautionary principle does, therefore, not play a role in deciding the case at issue. This constitutes consistent case-law of the Court. Over the years, the Court has refined this principle to one imposing specific obligations on Member States. The German provisions are therefore not suitable to attaining the objective of public health.
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