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.