The prohibition on advertising unregistered medicinal products applies not only to pharmaceutical companies but also to independent third parties, including journalists whose right of freedom of expression may be limited for the purpose of protecting public health. This follows from an interesting decision that was rendered by the European Court of Justice on 2 April 2009 (Case C-421/07, Frede Damgaard).
The Danish journalist Damgaard had mentioned a product on his website that had been classified as a medicinal product by the Danish authorities and that was not registered. He described the effect of the product and added that the medicinal product was on sale in Sweden and Norway. The Danish public prosecutor commenced criminal proceedings and Mr Damgaard was found guilty of advertising an unregistered medicinal product. On appeal, the Court of Appeal referred the matter to the ECJ for a preliminary ruling.
In its decision, the ECJ pointed out that the Medicines Directive (2001/83/EC) does not rule out the possibility that a message originating from an independent party (i.e. not a pharmaceutical company) may constitute advertising and that this may also be the case if the message is disseminated outside the context of any commercial or industrial activity. It noted that the essential aim of the Medicines Directive is to safeguard public health and reasoned that public health may be harmed by an independent non-commercial party. The Court added that the relationship between the author of a communication and the pharmaceutical industry is a factor that may help to determine whether a communication constitutes advertising, but stressed that this factor must be evaluated together with other circumstances, such as the nature of the activity carried out and the content of the message.
As regards Mr Damgaard's right to freedom of expression, the ECJ noted that its review powers are limited to an examination of the reasonableness and proportionality of the interference with that right. It added that this holds true for the commercial use of freedom of expression, particularly in a field as complex and fluctuating as advertising. Within this limited manoeuvring space, the ECJ stated that if the information disseminated by Mr Damgaard is indeed to be considered advertising, his criminal conviction could be considered reasonable and proportionate in light of the legitimate aim pursued, namely the protection of public health.
Thus, the protection of public health is the key element on the basis of which several aspects of this matter were decided. It is furthermore interesting that the decision seems to support the position that communications and activities performed by healthcare insurers may indeed also be subject to the restrictive advertising regime of the Medicines Directive. Thus far, this has not been acknowledged in Dutch case law.