In our newsletter of September last year, we already paid attention to the judgment of the Court in The Hague about the online internet pharmacy dokteronline.nl.
In 2017 and 2018, various fines were imposed by the Minister of Medical Care on the operator of this website (“Dokteronline”), located in Curaçao, for (1) offering without a license so-called prescription only and pharmacy only medicines and advertising such medicines, as well as (2) selling medicines online to Dutch consumers, while it does not have the mandatory EU logo for the online sale of medicines.
Dokteronline lodged an objection to these fines. However, these objections were declared unfounded, against which Dokteronline lodged an appeal. As discussed in the earlier newsletter the District Court of The Hague has declared the appeal unfounded on 8 January 2020. However Dokteronline lodged an appeal against this judgment.
On 30 June 2021, the highest administrative court, the Administrative Law Division of the Council of State, ruled that the Minister was right to impose two fines on Dokteronline in 2017 and 2018.
It is the first time that it has been ruled that the Dutch Medicines Act can be applicable to a website of a company established abroad, in this case Curacao.
Furthermore, the Division gives further substantiation to the concepts of “offering for sale” and “distance selling”. According to Dokteronline, the term “offering for sale” should be taken to mean the direct offering of medicines without the intervention of a doctor or pharmacist. In Dokteronline’s opinion, this was not the case on its website, since it was clear from the text of the website and the general terms and conditions that a pharmacy would sell and supply the medicines. According to Dokteronline it therefore only acted as a conduit, as is the case with other online platforms, such as booking.com and thuisbezorgd.nl, whereby payments in this case were passed on to the pharmacy. In addition, Dokteronline argued that since it does not offer medicines for sale, it cannot be blamed for the fact that its website does not have the EU logo for online providers of medicines.
The Division considers that the concept of “offering for sale” is not defined in the Medicines Act or in European regulations, but that in the legislative history of article 61, paragraph 1 of the Medicines Act, the Minister explained that the prohibition of offering UR or UA medicines for sale concerns offering them for sale directly to end users.
In the opinion of the Division, the question of whether there is a direct offering for sale of prescription only or pharmacy only drugs to end users should be assessed on the basis of all facts and circumstances of the case. The legal qualification of the service provided by a provider himself, as for example expressed in the disclaimer or general terms and conditions, is not decisive in this respect, but only one of the circumstances that is taken into account in the assessment. In the opinion of the Division, this explanation fits in with the public health interest that the Medicines Act and European legislation are intended to protect. In view of the serious health consequences that incorrect or excessive use of medicines can have, this objective justifies a factual and broad interpretation of the term “offering for sale”.
In the present case, a Netherlands consumer could place an order directly on the Dokteronline website for a prescription only or pharmacy only medicine (including a consultation), whereby the consumer paid Dokteronline the price quoted on the website for that medicine (including a consultation). In the majority of cases, the consumer did not need to take any action himself vis-à-vis third parties before, during and after the placing of the order to purchase and obtain delivery of a medicine offered by Dokteronline on the website. In the opinion of the Department, Dokteronline therefore distinguishes itself in its operation and presentation only to a very minor extent from other websites that offer products for sale directly to consumers.
The Department concludes that Dokteronline thus offered UR and UA medicines for sale online directly to end users (“distance selling”) and thereby offered UR-/UA medicines without a license, as well as advertised them (and even for medicines without a marketing authorization), which is impermissible. In the case of medicines being offered for sale online, Dokteronline should also have been in possession of the requisite EU logo.