Articles 9 and 10 of the Medicines Act of 25 March 1964 (“Medicines Act”) and the Royal Decree of 7 April 1995 relating to the information and advertising concerning medicinal products for human use (“Royal Decree of 7 April 1995”) provide the main rules for advertising of medicinal products for human use in Belgium. They are the result of the transposition into Belgium law of articles 86 to 100 of the EC Directive 2001/83/CE of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (“EC Directive 2001/83”).
Article 9 of the Medicines Act defines “advertising of medicinal products” as any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.
As a basic rule, a distinction is made between advertising to the general public, on the one hand, and advertising to persons qualified to prescribe or supply medicinal products, on the other hand. Advertising to the general public for prescription medicines is prohibited but, under certain conditions, allowed for OTC products. Advertising to persons qualified to prescribe or supply medicinal products is allowed, but should meet the requirements set forth in Article 9 of the Medicines Act and the Royal Decree of 7 April 1995.
Article 9.1 of the Medicines Act, implementing Article 86.2 of the EC Directive 2001/83, provides a list of communications which are not to be considered as advertising of medicinal products. This is for instance the case for factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims.
Infringement and/or interpretation discussions are most often debated between pharmaceutical companies before the disciplinary bodies of the Belgian Pharmaceutical Industry Association (pharma.be), at least when it concerns a dispute between originator companies, and generally relate to prescription medicines.
Exceptionally disputes concerning advertising of medicinal products are brought before the ordinary courts. This can be the case in the event the Federal Agency for Medicines and Health Products (“FAGG-AFMPS”) takes action against a pharmaceutical company for infringement of the legal provisions concerning advertising of medicinal products. The FAGG-AFMPS isempowered to act against companies that, in its opinion, are not respecting the aforementioned provisions. In the event it is of the opinion that a company is infringing, it will draw up an official report and propose an amicable settlement to the infringing company, consisting in the payment of a fine. The infringing company has the right to dispute the decision of the FAGG-AFMPS. However, if the FAGG-AFMPS stands firm on its position, the case will be transferred to the Public Prosecutor for summoning the infringing company to court. This recently happened to Eurogenerics.
On 3 October 2014, the FAGG-AFMPS drew up an official report against Eurogenerics for the distribution of a brochure to healthcare professionals. The Eurogenerics brochure contained a list of all its medicinal products marketed in Belgium, including their price. According to the FAGG-AFMPS, the Eurogenerics brochure was infringing because it mentioned the indications of the medicinal products or provided information concerning their mechanism of action. The FAGG-AFMPS concluded that the Eurogenerics brochure had to be considered as advertisement of medicinal products and did not comply with the applicable requirements of the Royal Decree of 7 April 1995. An amicable settlement was proposed. However, Eurogenerics refused essentially because it was of the opinion that its brochure could not be considered as advertising for medicinal products on the basis that it fell under the exceptions contained in Article 9.1 of the Medicines Act. The FAGG-AFMPS stood firm on its position and the case was brought in court by the Public Prosecutor. On 15 January 2016 the Brussels Court of First Instance (Criminal Division) (“Brussels Court”) gave judgment in this case and decided that the Eurogenerics brochure did not infringe the applicable legal provisions on advertising of medicinal products. The decision of the Brussels Court can be summarised as follows:
- The provisions of the Belgian legislation should be interpreted in conformity with the Directive 2001/83, and, more precisely, in accordance with the decision of the Court of Justice of the European Union in the case MSD Sharp & Dohme GmbH v Merckle GmbH (C-316/09) of 5 Mai 2011 (cons. 39-38 and 43).
- Article 9.1 of the Medicines Act and Article 86.2 of the EC Directive 2001/83 both provide an exception to the applicable rules concerning advertising of medicinal products when it comes to “trade catalogues” and “price lists”, notwithstanding both terms imply a certain degree of promoting medicinal products. As a result, there is an inherent tension between the definition of “advertising of a medicinal product” in the Belgian legislation and the exceptions thereto (i.e. what should not be considered as advertising for medicinal products). Whilst, there is no doubt the objective of a trade catalogue is to promote sales of the medicinal products contained therein, a trade catalogue is nevertheless generally not considered as advertising of a medicinal product. In the circumstances a trade catalogue may lose the benefit of the Article 9.1 exemption, as discussed below, but only the FAGG-AFMPS can demonstrate that it contains product claims and, as such, is not neutral.
- The Eurogenerics brochure contains several lists of medicinal products offered by Eurogenerics, including the name, packaging forms and prices. The lists were divided in several categories, according to the disease for which they are effective and, in some cases, the effect of the medicinal product. The Eurogenerics brochure also showed several aspects of an advertising-like format. However, given its set-up, format and content, the Eurogenerics brochure should be considered as “trade catalogue”.
- If a trade catalogue contains publicity messages or information on the medicinal products as such, it cannot be considered “neutral” in the sense of the Article 9.1 of the Royal Decree of 7 April 1995 and will lose the benefit of the exception to advertising of medicinal products.
- There will only be an indirect impact on the demand or decision of the patients or on the consumption of medicinal products in the event a trade catalogue is addressed to healthcare professionals and reflects a classification which was drawn-up by a neutral body and which has been recognised by the competent authorities. Such trade catalogues, containing no additional information on the effects of the medicinal products, leading to inducement to prescribe the medicinal products listed therein, offers only a helping hand to the prescriber. This was the case for the Eurogenerics brochure.
- A trade catalogue must at least contain a minimum of information on the medicinal products. If the information contained in a trade catalogue is presented in a neutral form, stems from an objective source and has a guiding and not a descriptive character, which was the case for the Eurogenerics brochure, it is to be considered as informative and qualifies as a genuine trade catalogue, falling under the exception provided in Article 9.1 of the Medicines Act.