The Rx-mail order German affair

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In Germany since 2004 pharmacies, both retail and on-line, are allowed to sell medicines upon receipt of a mail order. Free market-price is allowed for non prescription medicines, while a fixed price is used for the prescription ones, which are subject to the Drug Price Ordinance.

According to the German law, foreign pharmacies are also allowed to ship human medicines to Germany only if located in the following countries: Iceland, the Netherlands (only if also an associated retail pharmacy exists), Sweden (for prescription medicine only), the Czech Republic (for non-prescription medicine only), the United Kingdom. Veterinary medicines may currently be shipped to Germany from the Czech Republic (for non-prescription medicine only) or the United Kingdom.

On October 19th, 2016 the European Court of Justice (ECJ) sentenced against Germany’s fixed prices for prescription drugs (Judgment in Case C-148/15), as they may represent an unjustified restriction of the free movement of goods in the European Union.

In doing so, the ECJ has deviated from previous health care related rulings and also overturned leading decisions made by the German court system”, states the position paper published after the sentence by ABDA, the Federal Union of German Associations of Pharmacists.

The Union is now working together with the German Parliament and Government to safeguard the domestic pharmaceutical supply system.

A possible action suggested by the position paper could be the general ban on the mail-order trade of prescription pharmaceuticals, which would reflect the situation already in place in the vast majority of EU Member States.

The sentence of the ECJ refers to the cause promoted by the Zentrale zur Bekämpfung unlauteren Wettbewerbs (an association for protection against unfair competition) against the Deutsche Parkinson Vereinigung, a patient association those members used mail orders to buy medicines from the Dutch-based on-line pharmacy DocMorris on the basis of a special bonus system agreed upon the two parts.

A first judgement of the Regional Court, Dusseldorf, upon which the bonus scheme should have been ended up, was first appealed at the Higher Regional Court to finally end up at the European Court of Justice, which inverted the decision stating that fixed prices could prevent competition from other EU countries to enter the German market.

According to Abda, fixed prices avoids patients to compare the cost of Rx-drugs at different pharmacies, both in doctors’ practices as well as in hospitals. But the main impact would be for German pharmacies, which are facing many economical challenges and suffer from the general reduction of their density on the German territory. According to the position paper, the price maintenance system is also the cause of the sustainability of the benefits-in-kind principle within the statutory health insurance (SHI) system.

As the result of the entering into force of the European “falsified medicines” directive (2011/62/EU), each website selling human medicinal products per mail order should be registered into a national register and should be easily identified by consumers thanks to a special security logo. These prescriptions have been implemented also in the German Drug Law since June 2015 (section 8 of paragraph 67): the German Register of Online Medicine Retailers and the EUsecurity logo – both provided by the German Institute of Medical Documentation and Information (DIMDI) on behalf of the Federal Ministry of Health – are the operative measures set in place in Germany to fullfill EU’s obligations.

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