Important legal changes in Belgium's healthcare sector

Available languages: NL

A new law was adopted on 30 October 2018 containing various provisions on health. This law contains amendments to different regulations in the healthcare sector. Some of the main changes are as follows.

Various aspects of the law of 7 May 2017 on clinical trials on medicinal products for human use were clarified by the new law, such as the qualification required to obtain informed consent from clinical trial participants.

There is also a new legal basis for mandatory electronic prescriptions. A royal decree has yet to set the date for their introduction and the end of paper prescriptions.

The law also contains provisions on the distribution of pharmacies, aimed at renewing the legal framework for opening, transferring and merging pharmacies. The Minister of Social Affairs and Public Health, Maggie De Block, had already announced this modernization in her report of 15 March 2017. The new law now modifies the coordinated law of 10 May 2015 on the exercise of healthcare professions, which is the legal foundation for the distribution of pharmacies. Nevertheless, royal decrees have to be adopted before this can take place.

A pharmacy can only be operated if an “establishment permit” (i.e. a permit for opening, transferring or merging a pharmacy) and an “exploitation permit” are granted. The new law now rules that these permits are not only individual but cannot be transferred either. The operation permit expires if the pharmacy is transferred. Concerning this new requirement, the legislator explains that “it must be ensured that the establishment permits do not distort competition because they can be the subject of trade. If an establishment permit would be part of the business fund of a company, the same should apply. In case of transfer of the trade fund, establishment permits are not transferred because they would otherwise be the subject of a valuation. If the permit relates to a pharmacy from which the trade fund is transferred, the purchaser must therefore apply for a new permit if it wishes to operate the pharmacy.[1]

Furthermore, pharmacies may now use a location not covered by the establishment permit to carry out certain activities. It must however be situated next to the pharmacy sensu stricto where the medicines are delivered. If the pharmacy wants to operate “extra muros”, meaning on a location outside the pharmacy sensu stricto, the pharmacy must apply to amend its permit. Moreover, a royal decree can determine the conditions under which non-adjacent locations within a 50km radius of the pharmacy sensu stricto can be registered for long-distance sales of non-prescription medicines and for automated individual medication preparation.

Another modification under the law of October 2018 concerns the reduction in the fine when violating the ban on tobacco advertisements. The minimum fine is currently €80,000. However, the legislator considers this fine too severe for retailers. Consequently, the new law introduces a lower minimum fine of €2,000 for retailers. The higher fines remain valid for manufacturers, importers, printers and publishers.

Finally, the new law establishes a new legal provision on the information healthcare professionals may provide to the public in connection with their practices. This change was adopted as a result of the Vanderborght judgment (C-339/15) of the Court of Justice, which ruled that Directive 2000/31/EC on electronic commerce precludes national legislation that prohibits all advertising for oral and dental care in a general and absolute manner. As a result, the new law not only imposes less restrictive measures on dentists when informing the public about their practices, but at the same time regulates advertisements on healthcare practices for all healthcare professionals.

[1] Free translation from “[Er dient erover]gewaakt te worden dat de vestigingsvergunningen niet de mededinging gaan verstoren doordat zij het voorwerp kunnen uitmaken van handel. Indien een vestigingsvergunning deel zou uitmaken van het handelsfonds van een onderneming, dient hetzelfde te gelden. Bij overdracht van het handelsfonds gaan vestigingsvergunningen niet over omdat ze anders het voorwerp zouden uitmaken van een waardering. Indien de vergunning betrekking heeft op een apotheek waarvan het handelsfonds wordt overgedragen, dient de verkrijgende onderneming derhalve opnieuw een vergunning aan te vragen indien zij hiervan gebruik wenst te maken.