Court Rules on Online Drugs Sales to Persons Unknown to Care Provider

Court of The Hague, 20 May 2010, LJN: BM5482 The Court of The Hague has recently delivered a judgment in preliminary relief proceedings on the online sale of drugs on prescription to unknown persons and the delivery of these drugs by a pharmacy. The reason was a request for injunctive relief from a pharmacy that had been ordered by outgoing Health Minister Klink to stop executing orders placed via the website. In this article I will discuss the background and the ruling in brief.

Legal Framework

Pursuant to Section 67 of the Medicines Act (Geneesmiddelenwet, "Gw") it is prohibited to prescribe drugs via the Internet to persons whom the prescriber has never personally met, or whom the prescriber does not know, or whose medication file the prescriber does not have at his disposal. The reasons for this prohibition speak for themselves. In the absence of thorough control over the drug use of persons, there is a threat of wrong combinations, too high doses or irresponsible use. In the offline world this control is exercised by the prescriber through personal contact or with the help of the patient's medication file. This is not necessarily the case online, which has prompted the legislator to include the prohibition - by amendment - into the Gw. The parliamentary history of this Act shows that the main reason for the prohibition was the protection of public health, and the possibility to prevent excesses.

Enforcement

The prohibition of Section 67 of the Gw has been used several times by the Healthcare Inspectorate (Inspectie voor de Gezondheidszorg, "IGZ") to take action against general practitioners who were prescribing drugs to unknown persons. Because of the prohibition, there are no large-scale online sales by Dutch pharmacies of drugs on prescription to unknown patients. However, there is (illegal) trade going on in some niche products (for example the so-called lifestyle drugs, such as Viagra and steroids). For a long time, one online provider seemed to dodge the bullet: dokteronline.com. This website cooperated with a German gynecologist who wrote out prescriptions to clients of the site on the basis of an online questionnaire, without ever having met these clients. The fact that the gynecologist was based in Germany and that therefore the Gw did not apply to him made it possible for dokteronline.com to go on selling drugs online unhindered for a long time, and not without success. The pharmacy Multatuli in Delft, which takes care of the actual shipment of the drugs for dokteronline.com, is shipping around 25,000 orders per year. Various parties - including the IGZ and the professional association of pharmacists KNMP - have been watching this development with displeasure. IGZ brought disciplinary proceedings against the Delft pharmacist and KNMP urged for tightening the legal rules if it would prove impossible to address this conduct. Also in Parliament, Minister Klink of Health, Welfare and Sports was asked questions about dokteronline.com. The Minister reacted by giving Multatuli an order, as set out in Section 8 of the Care Institutions Quality Act (Kwaliteitswet Zorginstellingen, "Kwz"), to stop delivering the online orders and any other orders that are prescribed in violation of Section 67 of the Gw with immediate effect. The pharmacy raised an objection to this order and also submitted a request for injunctive relief to the Court.

Ruling

The ground for the Minister's order is that Multatuli is not providing responsible care within the meaning of Section 2 of the Kwz, because it is providing drugs that have been prescribed in violation of Section 67 of the Gw. Since Multatuli does not know the persons whom it supplies with the drugs and is also not aware of their medication files, it is acting in violation of Section 2 of the Kwz, the Minister said. Multatuli raised various objections to this order, not all of which appear to be likely to succeed. For example, Multatuli has argued that a medication file is obtained indeed, because the persons have to fill out a questionnaire when they register. Besides, Multatuli is of the opinion that dokteronline.com itself also builds up a medication file because it registers previous orders. However, this information comes only from the visitor and is not checked any further. A more important objection of Multatuli is that the power to give an order does not serve to enforce compliance with Section 67 of the Gw, but relates only to Sections 2 through 4 of the Kwz. Furthermore, Section 67 Gw does not concern the pharmacist, but the prescriber, who is in this case located in Germany and as such is not bound by the Section. The Court in preliminary relief proceedings held that the Minister could reasonably have taken the position that by providing the drugs that were prescribed in violation of Section 67 of the Gw, Multatuli is cooperating in maintaining an irresponsible situation that creates danger, and causes detriment to the quality of care. Multatuli is subject to an obligation of its own to guard this quality of care, which obligation it has not fulfilled in this situation. The Court rejected the injunctive relief requested, so that the Minister's order stands.