Medicine advertising in Belgium: a brief regulatory overview

Medicine advertising: regulatory framework

The regulations for medicine advertising are laid out in

• Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 establishing a Community Code on medicinal products for human use,
• the law of 25 March 1964 on medicines,
• and the Royal Decree of 7 April 1995 about information and advertising concerning medicinal products for human use.

Medicine advertising in Belgium must be consistent with the data that has been approved under the marketing authorization of the medicinal product on the market. The advertisement must encourage the rational use of the medicinal product by presenting it objectively, without exaggerating its properties, and without being misleading. Different rules are applicable for the advertising of medicinal products to the general public and to healthcare professionals.

Only medicinal products that are not subject to medical prescription can be advertised to the general public. Before releasing the medicine ad to the public, it must be approved by the competent authority. Approval for radio and television advertisements is granted by the Minister of Public Health, whereas all other types of medicine advertising must be approved by the Federal Agency for Medicines and Health Products (FAMHP).

On the other hand, both medicinal products subject and not subject to medical prescription can be the subject of advertising for healthcare professionals (physicians, dentists, and pharmacists).

The medicine ad must be in line with the Summary of Product Characteristics (SPC) and with elements of the dossier accepted with the marketing authorization. Advertising for healthcare professionals is controlled inside the company by the RIP who must give his/her approval before distribution.

Premiums and advantages

Premiums and advantages are also regulated in the pharmaceutical industry. The law of 25 March 1964 states that:

it is forbidden when prescribing, providing, supplying or administering medicinal products, to promise, offer or grant, directly or indirectly, premiums or monetary advantages or benefits in kind to persons qualified to prescribe, dispense or administer medicinal products and to the institutions in which the prescribing, dispensing or administering of medicinal products take place.

For example, compensation for legitimate services of a scientific nature provided the conditions set forth in the law are strictly adhered to.

Mdeon, a common ethical platform, has as its main objective to guarantee that project sponsorship to organize or take part in scientific events is consistent with the relevant legislation and ethics. In this respect, Mdeon is responsible for granting visas for any scientific event comprising at least one night. It also provides guidelines relating to premiums and benefits of negligible value, guidelines for scientific events not requiring a visa, and guidelines relating to fees for scientific services.

A visa is obligatory for every pharmaceutical company that wishes to invite or pay for the participation of Belgian practitioners in a scientific event that includes at least one overnight stay. This applies to both Belgian and international companies.

Medical samples

Regulations for the delivery of free medicinal product samples by pharmaceutical companies also exist as this is considered a form of medicine advertising.

For example, a maximum of eight samples per medicinal product may be supplied only to a person qualified to prescribe medicinal products. Furthermore, the marketing authorization holder must have an adequate system of control and accountability in place.

Responsible for Information and Publicity

In order to guarantee that all the above is compliant with the laws and regulations, each firm responsible for the marketing of a medicinal product in Belgium needs the cooperation of a Person Responsible for Pharmaceutical Information or ‘RIP’.

The RIP must be the holder of a legal pharmacist, doctor, or veterinarian diploma and have at least one year of experience in the field of pharmaceutical information (for veterinarians: 5 years of experience before 29/08/1984). He/she can be a member of the company or a consultant.

The responsibilities of the RIP include:

• Verification of the compliance of the SPC, the leaflets, and their translations
• Approval of medicine advertising projects
• Oversight of the training of medicinal representatives who visit doctors, pharmacists, and other healthcare professionals
• Ensuring compliance with regulations on samples
• Establishment of an appropriate internal procedure for approving advertising and various promotional activities
• Responsible for the information provided by this company
• Ensuring compliance with regulations on premiums and advantages

Medicine advertising: conclusion

Medicine advertising is highly regulated in Belgium. Specific regulations are in place for advertising to the general public, to healthcare professionals, premiums and advantages, and sample distribution.

Do you need help with reviewing promotional material for the Belgian medicines market? Would you like advice in relation to the Mdeon Code of ethics or any of the above-mentioned topics?Then don’t hesitate to contact us.

Regulatory Affairs plays a key role in the pharmaceutical industry: from drug development to commercialization. QbD's regulatory team supports clients with large and small molecule products and the more complex ATMPs of both innovative and generic drug manufacturers to ensure that their medicinal product dossier is compiled with great accuracy and registrations are submitted and followed until the end of the procedure. Need support?

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