Out-Law News 3 min. read

Europe allows ban on prescription drug sales on-line


European pharmacies are allowed to sell over-the-counter medicines on the internet, but not prescription medicines, the European Court of Justice ruled on Thursday. A German court had queried the legality of a national ban on all sales.

European pharmacies are allowed to sell over-the-counter medicines on the internet, but not prescription medicines, the European Court of Justice ruled last Thursday. A German court had queried whether a national ban on all sales breached EU rules on the free movement of goods.

A German pharmacy trade body, the Deutsche Apothekerverband, had complained that Dutch on-line pharmacy 0800DocMorris.com was selling prescription and non-prescription medicines, in languages including German, for consumers in Germany.

The seller is a registered pharmacy in the Netherlands. Its products include painkillers, immuno-stimulants and blood pressure treatments, some of which are authorised in Germany, and most of them in another Member State.

A particular medicine will be treated by 0800DocMorris.com as subject to prescription if it is so classified either in the Netherlands or in the Member State in which the customer lives. Delivery of such medicines does not take place until the original prescription is produced.

Delivery itself can take place in a number of ways. One possibility is for the customer personally to collect the order from the DocMorris pharmacy in Landgraaf, a town near the Germany/Netherlands border. Another, at no extra cost, is to use a courier service recommended by DocMorris.

The Deutsche Apothekerverband objected to medicines being offered to the public on the internet and their delivery by cross-border mail order. The Apothekerverband raised a court action in Germany, arguing that the German Arzneimittelgesetz (medicines law) and its Gesetz über die Werbung auf dem Gebiete des Heilwesens (law on advertising in the field of medicine) forbid such activity.

Several questions of European law arose in the course of the action, and the German Court delayed proceedings until the European Court of Justice could rule on these. It gave its opinion last week.

Firstly, the European Court considered the application of a ban under the medicines law, prohibiting the imports of medicinal products ordered over the internet from pharmacies authorised in other Member States.

The Court ruled that where these medicinal products had not already been authorised in Germany, then existing EU law requiring that such products must be authorised either in the Member State in which they are marketed, or under Community rules, applied. Accordingly the Court did not need to consider the medicines law in this context.

But the Court said: "Even if a measure is not intended to regulate trade in goods between Member States, the determining factor is its effect, actual or potential, on intra-Community trade."

It added: "A prohibition such as that at issue in the main proceedings is more of an obstacle to pharmacies outside Germany than to those within it."

Thus, where the ban related to medicinal products that had been authorised for sale on the German market, then there was a breach of the EU laws on the free movement of goods.

Such a breach is only acceptable if it is justified by circumstances specified in EU law. In this case, said the Court, the breach could be justified by reason of being necessary for the "health and life of humans".

Thus the ban could be justified with regard to authorised medicines only available on prescription, because "there may be risks attaching to the use of these medicinal products".

Accordingly, "the need to be able to check effectively and responsibly the authenticity of doctors' prescriptions and to ensure that the medicine is handed over either to the customer himself, or to a person to whom its collection has been entrusted by the customer, is such as to justify a prohibition on mail-order sales."

However, the ban was not justified for non-prescription medicines. Indeed, said the Court, "internet buying may have certain advantages, such as the ability to place the order from home or the office, without the need to go out, and to have time to think about the questions to ask the pharmacists".

The Court then considered provisions of the advertising law that prohibits the advertising of mail order sales of medicinal products.

The Court ruled that where a prohibition of that kind applies to medicinal products that require authorisation but have not been authorised, or to medicinal products available only on prescription, the prohibition is in keeping with an existing prohibition in EU law.

By contrast, an advertising ban in respect of medicinal products that are authorised and available without prescription is in breach of EU law.

The case will now be sent back to a court in Frankfurt for further consideration.

Any decision by the court may be academic because, according to a report by SiliconValley.com, Germany is planning to drop the ban next year.

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