In Germany, prices for medicines are not subject to competition for they are set nationally. Consequently, is it contrary to EU law for members of a German patients’ association to buy their prescription medicines from a Dutch mail order company and qualify for bonuses on their purchases?
In Germany, there is a self-help group known as the German Parkinson’s Association [Deutsche Parkinson Vereinigung]. Its mission is to improve the lot of sufferers of Parkinson’s disease.
To that end, the Association concluded an agreement with a Dutch ‘mail order’ pharmacy whereby the members of the Association could qualify for bonuses every time the pharmacy dispensed prescription medicines. The Association advertised this scheme to its members.
However, the scheme was said to contravene German law. According to a German body that polices Germany’s unfair competition laws, the Association’s bonus-model undermined the prices that were being charged by German pharmacies. The Dutch set up was illegal because German prices for medicines are laid down in German statute, and those prices are uniform across the entire country.
At court, the Association claimed that the German statutory pricing rules did not apply to a company established in another Member State; and if they did apply, then those rules were contrary to EU law.
The Landgericht duly applied an earlier judgment from the German Supreme Court in which a pharmacy had been stopped from offering a 5 euro voucher on every prescription it processed.
The Association appealed to the Oberlandesgericht Düsseldorf. There were three issues troubling the court.
First, the court noted that this was a fixed price system but it was restricted to prescription-only drugs, so was this akin to a measure having ‘equivalent effect’ within the meaning of Article 34 TFEU?
Second, if it was, then could it be justified on the basis that a uniform price was designed to ensure that people living in rural areas could access medicines at the same price? In that context, the CJEU’s recent judgment in Case C-367/12, Susanne Sokoll-Seebacher ECLI:EU:C:2014:68 could be a relevant justification because the CJEU recognised the need to ensure the adequate supply of medicinal products to the public, particularly in geographically isolated or disadvantaged areas. However, should that reasoning be qualified? After all, people in those areas could also access the medicines via the postal system.
Third, if it was justified, then what criteria should the national judge apply to determine this? The difficulty facing the referring court was the fact that the EU Commission had written to Germany indicating that the German authorities had still to prove that foreign pharmacies offering bonuses and discounts presented a real danger of people not being able to get their medicine; in other words, the national authorities had yet to establish the necessity of the German statutory regime.
The Oberlandesgericht Düsseldorf duly decided to make a preliminary reference to the CJEU.
According to the Curia website, the Oberlandesgericht Düsseldorf has asked:
[1.] Must Article 34 TFEU be interpreted as meaning that a system of fixed prices laid down by national law applicable to prescription-only medicinal products constitutes a measure having equivalent effect within the meaning of Article 34 TFEU?
[2.] If the Court answers Question 1 in the affirmative:
Is the system of fixed prices for prescription-only medicinal products justified under to Article 36 TFEU on grounds of the protection of health and life of humans if that system is the only means of ensuring a consistent supply of medicinal products to the population across the whole of Germany, in particular in rural areas?
[3.] If the Court also answers Question 2 in the affirmative:
What is the degree of judicial scrutiny required when determining whether the condition mentioned in Question 2 is in fact satisfied?
France’s regulation of veterinary medicines, which stops French farmers from buying medicines in Spain, is at stake in another reference made to the CJEU; see further, Case C-114/15, AUDACE – audacious French farmers buy Spanish veterinary medicinal products.
Update – 21 February 2016
The First Chamber is due to hear this case on 17 March 2016.
Update – 3 May 2016
The Opinion of Advocate General Szpunar is to be handed to the First Chamber on 2 June 2016.
Update – 25 September 2016
The judgment of the First Chamber is due on 19 October 2016.