The Law of 25 March 1964 on medicinal products prohibits
- (i) publicity regarding medicinal products which are not registered
- or whose registrations have been suspended or withdrawn,
- (ii) publicity aimed at the public (as opposed to practitioners)
- regarding medicinal products which must be prescribed by
- physicians and
- (iii) publicity aimed at the public regarding medicinal products
- treating certain diseases which are listed by Royal Decrees
- (such as tuberculosis, poliomyelitis, cancer, diabetes or
- sexually transmitted diseases).
Specific rules are implemented by the Royal Decree of 9 July 1984 regarding information and publicity on medicinal products. This Royal Decree has been modified several times mainly in order to incorporate European legislation. The latest European Directive 92/28/EC of 31 March 1992, of which most provisions are already embodied in the above Decree, has not yet been formerly incorporated into Belgian legislation.
In summary, the Royal Decree contains
- (i) general provisions (e.g., prohibition of certain forms of media
- and means of communication, such as radio and television, posters in places accessible to the public, illuminated signs, publicity in magazines for children, etc., and prohibition of certain slogans, such as those guaranteeing the success of a given product, using exaggerated wording or deceiving simplifications, quoting a scientific text on therapeutical effects without complete reference to the original sources, using drawings or pictures unrelated to the product, etc.) and
- (ii) provisions regarding publicity meant for the public and
- publicity meant for practitioners (which must mainly comply with
- the scientific or public information leaflets on the product as approved by the Ministry of Public Health). As far as the public is concerned, the publicity must also explicitly indicate that the information leaflets must be carefully read by the user.
In addition, certain slogans are specifically prohibited in publicity aimed at the public, such as indication that the consultation of a physician is superfluous, description of the symptoms of a disease, pictures or drawings showing the condition of a patient before and after treatment, etc. Furthermore, specific sizes and limitations of the frequency of appearance are imposed for advertisements in newspapers and magazines.
The non-observance of the above rules may lead to criminal sanctions. In certain cases, the marketing authorisation of the infringer may also be suspended or even withdrawn.
The content of this article is intended to provide general information on the subject matter. It is therefore not a substitute for specialist advice.
De Bandt, van Hecke & Lagae - Brussels. (32-2) 517.94.53.