The general legal rules on the advertising of medicines for human use are provided by the Law on Medicinal Products for human use of 25 March 1964 (LMP) (particularly Articles 9 and 10) and the Royal Decree on information and advertising of medicinal products for human use of 7 April 1995 (RDAMP).

The Law of 18 December 2016 on “various provisions on health”, which entered into force on 23 June 2017 (the “Sunshine Act”), is also highly relevant in the context of pharmaceutical advertising in Belgium. The Sunshine Act imposes an obligation of legal transparency on pharmaceutical companies to document and to (annually) disclose premiums and benefits that were granted to healthcare professionals, healthcare organisations or patient organisations. The Sunshine Act is further executed by the Royal Decree of 14 June 2017 on the execution of the Sunshine Act (the “RD Sunshine Act”).

Self-Regulatory Deontological Codes

Four self-regulatory deontological codes provide specific provisions on pharmaceutical advertising in Belgium. They were issued by the following professional associations:

• pharma.be, a professional association of innovative pharma companies based in Belgium;
• the Belgian Association for the Consumer Healthcare Industry (BACHI), which focuses on over-the-counter medicines and healthcare products sold in pharmacies;
• Mdeon, a common platform between different professional associations and healthcare professionals/organisations; and
• Medaxes, a professional association of Belgium-based generic/biosimilar medicine companies.

In addition, the general principles laid down in the Code of Practice of the European Federation of Pharmaceutical Industries and Associations (the “EFPIA Code of Practice”) provide important guidelines for pharmaceutical advertising in Belgium.

Legal Framework

This chapter focuses on the general legal framework for the advertising of medicinal products (including the Sunshine Act) applicable to all pharmaceutical companies in Belgium. The self-regulatory deontological codes referred to above (notably the pharma.be Code of Deontology, which applies to 90% of Belgian innovative pharmaceutical companies) will be addressed if they add information or insights to further interpret or better understand the general legal framework; they contain further material obligations for their members or install relevant a priori or a posteriori approval or control procedures regarding pharmaceutical advertising.

Advertising to the General Public and Healthcare Professionals

The LMP and the RDAMP make a clear distinction between advertising medicinal products for human use towards the “general public” on the one hand, and towards “healthcare professionals” on the other hand. Within the scope of the LMP and the RDAMP, only medical doctors, dentists and pharmacists are considered “healthcare professionals”. Nursing personnel are regarded as part of the general public. However, under the Sunshine Act, nurses, paramedics and hospital directors also fall under the definition of “healthcare professionals”.

Each of the four self-regulatory deontological codes discussed in 1.1 Laws and Self-Regulatory Codes Concerning the Advertisement and Promotion of Medicines is binding (only) to the members of the relevant professional associations (although Mdeon has been entrusted with formal regulatory authority in relation to the granting of visas for sponsoring scientific manifestations under Article 10 of the LMP; see 9.3 Sponsorship of Scientific Meetings).

Article 9 of the LMP defines advertising as “any form of door-to-door information, canvassing activity or stimulation which is designed to promote the prescription, release, supply, sale or consumption of medicinal products”. However, patient information leaflets, product labels and general information regarding health and disease areas with no direct or indirect reference to a medicinal product are excluded from the definition of “advertising”. Information and documentation provided in the context of package changes, compliance with pharmacovigilance requirements, and sales catalogues and pricing lists also fall outside the definition of advertising, to the extent such information and documentation do not include product-specific information.

The provision of so-called “unsolicited” medical information about a particular drug product, given by a pharmaceutical company following a patient’s or healthcare professional’s specific request, is also not regarded as advertising, as long as such information is strictly necessary to answer such particular request and does not contain unsolicited promotional content (see 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information for the distinction between information and advertising).

The definition and exclusions provided under Article 9 of the LMP are identical to those of Article 86 of Directive 2001/83/EC of 6 November 2001 on the Community Code relating to Medicinal Products for Human Use.

Article 2, Section 2 of the RDAMP further supplements the definition of advertising by naming specific examples, such as:

• providing samples;
• visiting healthcare professionals;
• sponsoring scientific conferences; and
• inciting to deliver or prescribe medicines by providing financial or in-kind benefits.

The difference between information and advertising is extremely relevant for the pharmaceutical sector, since the provision of mere medical information is subject to fewer restrictions and regulations than the advertising of pharmaceutical products. However, in practice, said distinction is often difficult to draw. The test generally used to differentiate between both types of communication is the question of whether the communication promotes or enhances, or intends to promote or enhance, the sale of a particular pharmaceutical product.

The definition of advertising is commonly interpreted broadly by the supervising authorities, which will often be inclined to assume that any type of medical communication is promotional, unless clearly proven otherwise.

General Information

Article 9 of the LMP explicitly provides that general information regarding health and disease areas, with no reference (directly or indirectly) to a medicinal product, is not regarded as advertising. Therefore, disease awareness campaigns would typically not qualify as advertising, provided that such campaigns cannot be considered as soliciting requests for information from the addressee. A Patient Information Leaflet (PIL) will reasonably not be qualified as a form of advertising, since it is intended to inform the patient about the characteristics of a certain medicinal product after it has been purchased by the patient. Information about patient support programmes, which usually pertain to a specific medicinal product, should only be provided upon the specific request of the patient. Otherwise, such information will likely be considered to have a promotional purpose.

Borderline Cases

For borderline cases, pharmaceutical companies often apply the following rules-of-thumb to mitigate the risk of a re-qualification of “scientific information” as “advertising” by the supervising authorities:

• ensuring that the communication emanates from the medical affairs department (and not from the sales team); and
• keeping a written file able to demonstrate (if need be) the clear non-promotional intent of said communication (and the assessment made by the company prior to sending it).

The implementation of such rules-of-thumb can, of course, never entirely eliminate the re-qualification risk.

Given the broad interpretation applied by the supervising authorities, press releases are very often to be considered as advertising medicinal products and must, in such cases, comply with the general rules and requirements concerning advertising towards the general public or healthcare professionals, as the case may be. Since it is prohibited to promote prescription-only medicines to the general public (see 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public), no such press releases may be issued in the general media, unless it can be established that they are purely informative (see 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information).

Conversely, it is permitted to publish articles concerning prescription-only medicines in specialised trade magazines that are only consulted by healthcare professionals, as long as the general rules provided in Articles 9 and 10 of the RDAMP are complied with (see 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals).

Finally, the advertising of unauthorised products or off-label indications is prohibited under Article 9 of the LMP (see 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications). Therefore, a press release concerning such unauthorised products or off-label indications is only allowed if such press release is purely informative and is not considered promotional (see 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information).

It is generally accepted that companies may provide the specialised media with updates on their pipeline pharmaceutical products during the development or marketing authorisation phases. However, such press releases must be drafted in such a way that they cannot be considered as an advertising tool, inter alia, by only providing objective and scientifically verifiable information and by mentioning the non-proprietary name of the active pharmaceutical ingredient rather than the anticipated trade name of the product.

It is interesting to note that the Belgian Financial Services Market Authority has issued specific guidance for (listed) biotech companies regarding the provision of information on their pipeline. Pursuant to such guidance, listed biotech and pharmaceutical companies have a regulatory obligation to proactively communicate on their pipeline when concrete development milestones have been reached, which is generally done via press releases. This is based on the more general Belgian Market Abuse Regulation principle, which stipulates that inside information needs to be shared with the public as soon as possible, and that false or misleading signals must be avoided.

Notwithstanding this obligation to proactively communicate, companies should be careful and ensure that the communication remains factual and balanced, does not contain any promotional content and is not aimed at encouraging the sale or prescription of the relevant product (see 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications).

The requirements for legitimate comparative advertising are laid down in Article VI.17 of the Code of Economic Law. Comparative advertisements must:

• compare similar products;
• compare one or more essential, relevant, verifiable and representative elements of the product (such as the price);
• not be misleading;
• not create confusion between the advertiser and the competitor nor between their brands, trade names or other distinguishing marks;
• not discredit or disparage the competitor and its products/activities; and
• not represent products as being a counterfeit or imitation of products whose brand or trade name is protected.

Moreover, pursuant to the pharma.be Code of Deontology, comparative advertisements must present the compared product in a way that is fair, complete, scientifically accurate and based on the most recently available data.

Given the general prohibition on advertising non-approved medicines or indications (see 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications), making comparative advertisements concerning a medicinal product that has not (yet) been authorised would be deemed illegal (even if such comparison is in line with the above requirements). Comparative scientific statements concerning a medicinal product that has not (yet) been authorised may be permitted if such statements are purely informative, scientifically validated (eg, on the basis of objective head-to-head clinical data) and not considered promotional (see 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information).

Article 9 of the LMP explicitly forbids all advertising of medicines that are not yet authorised, including the advertising of a medicine for indications for which it has not (yet) been granted marketing authorisation (off-label indications). However, this prohibition applies only to advertisements and not to medical information. Note also that the provision of unsolicited medical information does not constitute an advertisement of a pharmaceutical product, regardless of who requests such information (see 2.1 Definition of Advertising). Therefore, a pharmaceutical company can give a patient/healthcare professional specific information on unauthorised medicines or off-label indications in the following circumstances:

• if such information is provided at the specific, unsolicited request of a patient/healthcare professional;
• if such information does not contain any promotional content and is not aimed at encouraging the sale or prescription of the relevant product; and
• to the extent the information is necessary to answer the patient’s or the healthcare professional’s request.

Besides this, information on non-authorised medicines or off-label indications can be published in independent scientific (preferably peer-reviewed and, in any case, non-commercial) magazines or journals. These publications may not be used as promotional material by a pharmaceutical company (eg, by extending copies of the journal to healthcare professionals).

All other publications of non-authorised medicines or off-label indications will, in principle, be deemed promotional and therefore illegal.

It is generally accepted that scientific information on non-authorised medicines or off-label indications (eg, results of clinical studies) can be presented to healthcare professionals during scientific meetings, insofar as the presentation remains strictly scientific and is not (blatantly) intended to promote the relevant medicine. Such intention can be harder to refute when the meeting is (materially) sponsored by the product owner. In addition, it is always preferable to have such presentations brought by an independent expert faculty.

With respect to the provision of information during international scientific congresses, in accordance with Article 8 of the EFPIA Code of Practice, it is also permitted to provide promotional information in relation to medicines or indications that are not authorised in the country where the congress takes place, or that are registered under different conditions, as long as:

• any such promotional material is accompanied by a suitable statement indicating the countries in which the medicine is registered and makes clear that the medicine or indication is not registered locally; and
• any such promotional material that refers to the prescribing information (indications, warnings, etc) authorised in a country or countries where the medicine is registered must be accompanied by an explanatory statement indicating that registration conditions differ internationally.

In principle, the circulation of information on unauthorised medicines or unauthorised indications, even to healthcare professionals, would qualify as advertising (which in accordance with Article 9 of the LMP is not allowed), unless the information was shared reactively, upon the unsolicited request of a relevant third party.

The provision of information on unauthorised medicines or indications to healthcare institutions is likely to be considered advertising and in breach of Article 9 of the LMP, unless the healthcare institutions expressly requested this information.

The publication of the availability of compassionate use programmes or other forms of early access falls under the general prohibition on the advertising of unauthorised medicines (see 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications) and is therefore, in principle, illegal.

However, a pharmaceutical company can provide information on such early access programmes if such information:

• is given at the specific, unsolicited request of a patient or a healthcare professional;
• does not contain any promotional content and is not aimed at encouraging the sale or prescription of a medicinal product; and
• is necessary to answer the patient’s or healthcare professional’s request.

Furthermore, it is acceptable for information on early access programmes to be published in independent scientific (preferably peer-reviewed and, in any case, non-commercial) magazines or journals (see 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications).

Belgian law (Article 9 of the LMP) expressly prohibits the advertising of prescription-only medicines to the general public.

Advertising over-the-counter medicines is permitted, except when such advertising:

• gives the impression that a medical consultation or surgical operation is redundant;
• suggests that the effects of taking the medicinal product are guaranteed or that no side effects exist;
• suggests that the patient’s health can be enhanced by taking the medicinal product or can be affected by not taking it;
• is directed exclusively or primarily at children;
• refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who could encourage the medicinal products’ consumption due to their status;
• suggests that the medicinal product is a foodstuff, cosmetic or other consumer product;
• suggests that the efficacy or safety of the product stems from the fact that it is natural;
• could lead to an incorrect self-diagnosis; or
• uses improper, alarming or misleading terms or pictorial representations (see Article 7 of the RDAMP).

Pursuant to Article 5 of the RDAMP, certain means for advertising medicinal products are prohibited (irrespective of the public to whom the advertising is directed) – eg, advertising by means of aeroplanes, billboards, telephone, text messages, fax, email, mailing, children’s magazines, leaflets, contests and software programs. It is equally prohibited to promote medicinal products by promising, offering or granting any direct or indirect compensation where the patient is unsatisfied with the product.

For the sake of completeness, it should be mentioned that the advertising of pharmaceutical products is also governed by the general rules on advertising included in the Belgian Code of Economic Law; see 2.4 Comparative Advertising for Medicines.

Generally, all advertisements (both to the general public and to healthcare professionals) must present the characteristics of the medicinal product in such a manner that it is compatible with the Summary of Product Characteristics (SmPC) and ensures a rational use of the medicinal product (Article 9 of the LMP). Moreover, the applicable legal framework and deontological codes provide that the presentation of a medicinal product in advertisements must:

• be accurate, up to date, objective, sufficiently complete, truthful, verifiable and compatible with the most recent content of its marketing authorisation file;
• reflect generally accepted scientific knowledge; and
• be backed by bibliographical data.

In terms of advertising of over-the-counter medicines directed at the general public, Article 8 of the RDAMP requires that such advertisements should be designed in such a way that it is clear that the message is an advertisement, and include the following minimum information:

• the name of the product (as well as the generic name if the medicinal product contains only one active substance);
• the information required for correct use;
• the statement “this is a medicinal product, no long-term use without medical advice”;
• an explicit, legible invitation to carefully read the instructions on the package leaflet or on the outer packaging, as the case may be – in the case of radio advertisements, such an invitation must be explicit and clearly audible; and
• the (trade) name of the product’s marketing authorisation holder.

There is no legal or deontological rule that requires the price of the pharmaceutical product to be mentioned in the advertisement.

Neither the LMP nor the RDAMP contains provisions on relations with patient organisations. A patient organisation that includes a healthcare professional among its members should, in any event, be treated as a healthcare organisation to which Article 10 of the LMP applies (see 8.1 Anti-bribery Legislation Applicable to Interactions Between Pharmaceutical Companies and Healthcare Professionals and 8.2 Controls on the Provision by Pharmaceutical Companies of Benefits and/or Inducements to Healthcare Professionals). Pharmaceutical companies should ensure that their public interaction with patient organisations within a certain therapeutic area does not qualify as an advertisement to the general public regarding their related drug products.

Chapter 3 of pharma.be’s Code of Deontology does contain rules on interactions with patient organisations. Pharmaceutical companies may (while adhering to certain principles):

• provide financial support to a patient organisation;
• call on patient organisations for the performance of certain services for the support of healthcare or research; or
• sponsor events organised by patient organisations if such support is covered by a written agreement.

Gifts are prohibited. Sponsorships of events, hospitality, grants and donations are permitted under certain conditions, as are fee-for-service arrangements.

In addition, pharma.be requires its members to make the support the association has attributed to patient organisations available to the public on a yearly basis. This transparency obligation in respect of transfers of value to patient organisations is also included in the Sunshine Act, which applies to all companies, not only to the members of pharma.be.

As mentioned in 4.2 Information Contained in Pharmaceutical Advertising to the General Public, all advertising must present the characteristics of the medicinal product in such a manner that it is compatible with the SmPC and ensures a rational use of the medicinal product (Article 9 of the LMP). Moreover, the presentation of a medicinal product in advertisements must:

• be accurate, up to date, objective, sufficiently complete, truthful, verifiable and compatible with the most recent content of its marketing authorisation file;
• reflect generally accepted scientific knowledge; and
• be backed by bibliographical data.

Mandatory Data to Be Contained in Advertising to Healthcare Professionals

Article 9 of the RDAMP specifies that advertisements in the press directed towards healthcare professionals must contain the following essential data, which must cover at least 50% of the total advertisement space:

• the product’s name, its qualitative and quantitative composition in terms of active substances and its pharmaceutical form;
• all information regarding indications, posology, contraindications and side effects contained in the SmPC;
• the package leaflet or the labelling in the case of a homeopathic medicinal product; and
• the (trade) name of the marketing authorisation holder and the number of the marketing authorisation or product registration.

The Federal Agency for Medicines and Health Products (FAMHP) has issued very specific guidance regarding the layout and readability requirements for the advertising of pharmaceutical products (Circulars 407 and 441).

As opposed to advertisements of over-the-counter medicines, advertisements towards healthcare professionals should also contain the applicable retail price per approved formulation/pack size. Such prices must appear in bold, on a contrasting background in the advertisement’s upper right-hand corner, and should cover at least 0.5% of the print advertisement.

Lastly, advertisements towards healthcare professionals must explicitly mention the date of the product’s creation or the date of its last revision.

For the sake of completeness, it must be mentioned that the restrictions on the means of advertising provided under Article 5 of the RDAMP (see 4.1 Main Restrictions on Advertising Pharmaceuticals to the General Public) also apply to advertising towards healthcare professionals.

In accordance with the LMP, all information in an advertisement for medicinal products must comply with the information as set out in the SmPC. Further to the European Court of Justice decision in Novo Nordisk AS v Ravimiamet (C-249/09; 5 May 2011), it is generally accepted that the inclusion of information that is not part of the SmPC in advertisements directed to healthcare professionals is allowed as long as such information confirms, clarifies or supplements (ie, does not directly or indirectly contradict) the specifications made in the SmPC and is not misleading.

Reference to a combined use of products is acceptable if such combined use is authorised for the particular indication for which it is being promoted (otherwise it would constitute an illegal promotion for an unauthorised indication; see 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications), if this reference does not directly or indirectly contradict the specifications made in the SmPC (see 5.2 Reference to Data Not Included in the Summary of Product Characteristics) and if the promotional claim is presented in an accurate, up-to-date, objective, sufficiently complete, truthful, verifiable and faithful manner.

As a medical device, companion diagnostics are subject to the advertising regulations on medical devices.

The Belgian advertising rules for medical devices differ depending on whether the medical device is implantable or not:

• similar to advertising rules for prescription-only medicinal products, advertising for implantable medical devices is only permitted towards healthcare professionals; and
• advertising for non-implantable medical devices (such as diagnostics) is allowed to both healthcare professionals and the general public, and is subject to the general advertising rules under the Belgian Code of Economic Law.

In addition, in any advertising of devices, it is prohibited to use text, names, trade marks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:

• ascribing functions and properties to the device that it does not have;
• creating a false impression regarding treatment or diagnosis, functions or properties the device does not have;
• failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; or
• suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment for that device was carried out.

If the diagnostic is advertised without making reference to the medicinal product, only the medical device advertising framework will apply; if the advertising includes references to the medicinal product, the (more stringent) framework for advertising medicinal products will apply. In addition, there is always a risk that advertising for a specific diagnostic is considered as indirectly promoting the medicinal product to which the diagnostic is a companion.

See also 5.3 Advertising of Combination Products regarding the companion diagnostic products that are specified in the SmPC, and see 5.2 Reference to Data Not Included in the Summary of Product Characteristics if the above-mentioned products are not included in the SmPC.

The distribution by a pharmaceutical company to healthcare professionals of scientific papers (or proceedings of congresses) that refer directly or indirectly to a drug product of said company will, in principle, be considered an advert and will therefore be subject to those rules (including the prohibition of advertising of unauthorised products/off-label indications). Distribution by pharmaceutical companies will also be subject to the rules related to the provision of gifts to healthcare professionals.

Medical science liaisons (MSLs) are regarded as therapeutic-area scientific experts within the pharmaceutical company, who act as a liaison between the company and healthcare professionals and other external stakeholders. MSLs are responsible for discussing the company’s pipeline, products, patient treatment trends and studies in the therapeutic areas in which the company is involved, on a peer-to-peer basis with an audience of external clinical and non-clinical stakeholders.

The MSL’s communications with healthcare professionals must always comply with applicable legislation. Therefore, the MSL may only respond to unsolicited questions raised by healthcare professionals about unapproved products or off-label uses of approved products, and may not proactively provide such information. The MSL is, however, allowed to proactively exchange information on ongoing trials and to communicate scientific information on the company’s products within label.

For advertisements towards the general public, the applicable approval and notification procedure depends on the medium used for such an advertisement.

If an advertisement is made on the radio and/or television, the company must obtain prior approval from the Ministry of Health (Article 16, Section 1 of the RDAMP), which will base its decision on advice from the Commission on the Supervision on Advertising of Medicinal Products. This commission operates as an independent commission within the FAMHP. The Ministry of Health must make a decision within 45 days of receiving a complete request for approval (Article 17, Section 5 of the RDAMP).

All other forms of advertising (of medicinal products) to the general public (eg, in a newspaper or online) should merely be notified to the Ministry of Health 30 days prior to their publication (Article 16, Section 2 of the RDAMP). The Ministry of Health may require the company to provide additional documents in the context of this notification, which could potentially lead to a postponement of the relevant advertisement. The Ministry of Health may also prevent any (intended) advertising, if it does not comply with the applicable legal requirements. Both the visa and notification require the payment of a retribution by the company (EUR995.20 and EUR592.33, respectively) and are valid for a period of two years.

For advertising towards healthcare professionals, prior notification to or approval by the Ministry of Health is not required.

Pursuant to Article 13 of the RDAMP, every marketing authorisation-holding company must designate a qualified person (responsible for the information) to be accountable for the advertising and for providing scientific information on medicinal products for that company. The qualified person must be a pharmacist or physician, and must be registered with the Ministry of Health. Information as well as advertisements to healthcare professionals and the general public should always be ratified in advance by that qualified person.

There are no relevant legal or code requirements to have specific standard operating procedures in place to cover advertising activities.

Also note that pharmaceutical companies must adequately train sales representatives visiting healthcare professionals (including on the scientific aspects of the medicinal products).

The general rules for pharmaceutical advertising as already set out, and in particular Article 9 of the LMP and the principles of the RDAMP, also apply to internet advertising. The FAMHP must be notified at least 30 days before the publication of advertising broadcast on media other than radio or television.

Book XII of the Code of Economic Law sets forth the rules on the digital economy and contains more specific rules on electronic advertising (on websites, by email or through other electronic means). Pharma.be has also issued guidelines on mandatory information to be included in internet advertising.

In a nutshell, an advertisement on a website by a pharmaceutical company must comply with the following rules:

• it must contain a clearly visible, legible and unambiguous statement that it is an advertisement;
• the pharmaceutical company must be identifiable;
• the relevant general requirements for pharmaceutical advertisements must be complied with; and
• the advertisement must have been notified to the Ministry of Health in advance.

There are no specific rules regarding website security for advertisements directed at healthcare professionals. Nevertheless, a company should take all security measures necessary to prevent access by the general public to a website that contains information regarding prescription-only medicinal products, as a lack of adequate measures will constitute a violation of Article 9 of the LMP.

The same applies to websites that contain scientific information regarding non-authorised medicines or off-label indications. A company should take all security measures necessary to prevent unrestricted access by the general public to such a website, as any provision of scientific information should generally occur based on a specific unsolicited request (see 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications).

It is a common practice for pharmaceutical companies to make certain parts of their website accessible to healthcare professionals only if they log in with their RIZIV/INAMI-number (RIZIV/INAMI is the Belgian National Institute for Health and Disability Insurance).

As mentioned in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information, the provision of disease awareness information generally does not qualify as advertising, as long as no direct or indirect reference is made to a specific medicinal product. Therefore, companies are allowed to provide such disease awareness information to patients online. The online provision of information is not subject to any stricter rules than the offline provision of information; however, the potentially broader reach of online information affects the risk associated therewith.

Mdeon has issued specific rules governing the sponsorship of online scientific meetings or virtual attendance by healthcare professionals. A pharmaceutical company’s contribution to virtual scientific meetings shall logically be limited to the organisational cost (the cost of the meeting host, compensation for the speakers, etc) or the registration fees for the healthcare professional’s attendance at the event. It will not be permissible to sponsor or provide any travel, accommodation or meals in the context of an online scientific meeting, since there is no required travel that would justify the provision of such hospitality. Furthermore, it is clarified that the sponsoring of virtual meetings is subject to the visa requirement if such meetings take place over several consecutive calendar days of which the registration fee is offered (see 9.3 Sponsorship of Scientific Meetings).

As set forth in 9.3 Sponsorship of Scientific Meetings, any offered hospitality must in any case be subordinate to the scientific purpose of an event.

In addition, pharmaceutical industry federations EFPIA, PhRMA and IFPMA have issued specific joint guidance to clarify the rules and principles in relation to virtual events. For information that is shared during such a virtual event, the guidance requires that the pharmaceutical company incorporates adequate safeguards in the virtual booth to be able to identify those wishing to view its booth (HCP or non-HCP) and therefore determine what information is appropriate for such audience.

There are no specific rules for the advertising of medicinal products on social media in Belgium. Such communications are subject to the general rules on advertising and communication on the internet. For the advertising of medicinal products on social media, see 7.1 The Advertisement of Medicinal Products on the Internet. EFPIA has also included guidelines on the use of digital channels in Annex G of the EFPIA Code of practice.

The general rules concerning advertising to the general public apply – namely, the advertising of over-the-counter medicines is allowed under certain conditions. The advertising of prescription medicines on the other hand is forbidden.

Articles 504 bis and 504ter of the Belgian Criminal Code provide the Belgian anti-bribery rules concerning the bribery of private legal entities and private individuals (ie, private bribery), which are applicable to pharmaceutical companies.

Articles 246 to 252 of the Belgian Criminal Code provide the rules concerning the bribery of public legal entities and individuals holding a public function (ie, public bribery). The rules on public bribery will apply to state-owned (university) hospitals and to healthcare professionals employed by such hospitals, since they are then considered to hold a public office.

Pursuant to Article 10 of the LMP, it is forbidden, within the framework of the supply, prescription or administration of medicines, to offer, supply or promise (in)direct benefits to healthcare professionals and the healthcare organisations where they work. There are, however, certain exceptions to this prohibition; see 9.1 Gifts to Healthcare Professionals.

Article 10 of the LMP contains a broad prohibition on providing premiums or benefits in cash or in kind to “wholesalers, intermediaries, persons who are entitled to prescribe, dispense or administer medicinal products or to institutions where such prescription, dispersion or administration takes place”.

However, Article 10 of the LMP also contains a limited number of exceptions to this prohibition. As such, it is permitted to provide gifts to healthcare professionals to the extent such gift has a very low value and relates directly to the medical profession of the healthcare professional concerned. Other exceptions are the invitation to and the funding of participation in a scientific event, including hospitality (see 9.3 Sponsorship of Scientific Meetings) and the reimbursement of legitimate services of a scientific nature, insofar as this reimbursement remains within reasonable limits (see 9.7 Payment for Services Provided by Healthcare Professionals).

During the parliamentary discussions on the LMP it was acknowledged that EUR50 (VAT included) per gift per healthcare professional or organisation could be considered sufficiently limited, with an absolute maximum of EUR125 (VAT included) per healthcare professional or organisation per year. Even though these thresholds were not explicitly withheld in the LMP, these amounts are considered as the standard within the entire sector (also, pharma.be uses these amounts as the maximum amounts for all its members).

It is not possible to give cash to healthcare professionals, as this cannot be considered “directly related to the medical profession”. The Mdeon Code of Ethics further provides concrete examples of other types of gifts that are generally not deemed appropriate, such as:

• decorative objects;
• digital photo frames;
• iPods;
• champagne coolers;
• coffee machines;
• mp4 players;
• gift vouchers;
• discount vouchers;
• cameras;
• bottles of wine;
• tickets for the theatre or other cultural, sporting or recreational events;
• mobile phones;
• photo scanners;
• radios;
• suitcases;
• sport/travel bags;
• alarm clocks;
• cups; and
• watches.

Gifts that may be appropriate include medical/pharmaceutical scientific reference works, writing instruments, clinical material and professional-use IT accessories.

The provision of free samples is possible, as long as the rules and obligations of Article 12 of the LMP and the Royal Decree of 11 January 1993 on medical samples are respected.

As a general principle, samples may only be provided to a healthcare professional who is authorised to prescribe such a product at their specific request – on the condition that a marketing authorisation has been obtained in Belgium for such medicinal products. The provision of samples is limited to eight samples per product (in its smallest available pack size), per year, per treating physician. In addition, each healthcare professional may receive no more than 600 samples, in total, per year.

Pharmaceutical companies may, in principle, sponsor the attendance of healthcare professionals to continuing medical education (including hospitality) and sponsor the associations that organise such continuing medical education (see 9.1 Gifts to Healthcare Professionals). Article 10 of the LMP, however, determines that this is only allowed if:

• the event is by its nature exclusively scientific;
• the hospitality is strictly limited to the scientific objective of the event;
• the location, date and duration of the event do not create confusion about the scientific nature of the event;
• the financial contribution to the participation (including the offered hospitality) is strictly limited to the official duration of the event; and
• the coverage of the costs is strictly limited to the healthcare professionals concerned by the event.

For events with an overnight stay or for online events that take place over several consecutive calendar days of which the registration fee is offered, a prior visa must be obtained from Mdeon (see 1.1 Laws and Self-Regulatory Codes Concerning the Advertisement and Promotion of Medicines). Mdeon has provided additional guidelines regarding the hospitality that can be offered to healthcare professionals in the framework of a scientific event. For example, the cost of an overnight stay (breakfast and taxes included) is, in principle, limited to EUR250. An exception applies to destinations where a higher limit is set according to the Ministerial Decree of 2 July 2018, in which case this higher limit applies. Furthermore, the cost of lunch is limited to EUR45; the cost of a dinner is limited to EUR90; the cost of refreshments is limited to EUR23; and the maximum hospitality for meals and drinks is limited to EUR23 per hour per person, with a maximum of EUR135. This maximum amount implies that there are at least six hours of scientific programme that day and is all-inclusive (drinks, coffee breaks, VAT, hall rental). Travel within Europe should always be in economy class.

These rules are applicable to hospitality offered to Belgian healthcare professionals or healthcare professionals exercising their profession in Belgium, for scientific events in Belgium as well as abroad.

The hospitality offered within the framework of a scientific congress must be limited to the organisation, payment or reimbursement of the healthcare professional’s travel, meals, overnight stay and registration for the congress. The hospitality may in no case comprise the organisation or funding of any cultural, sports or other leisure activities or any other form of entertainment.

Grants and donations to healthcare professionals or healthcare organisations/charitable organisations are not expressly exempt from the prohibition under Article 10 of the LMP.

In practice, however, the industry can provide grants or donations (eg, money to organise an activity, research equipment) for educational, humanitarian or philanthropic purposes to healthcare organisations and charitable organisations. Grants or donations directly to healthcare professionals are not allowed.

The pharma.be Code of Deontology specifies further that these donations are allowed only if they are made available for supporting healthcare or research and if they do not constitute an inducement to recommend, prescribe, purchase, sell, supply or administer medicinal products. A grant or donation can be provided in cash or in kind.

A typical example of a permitted grant would be the financial support of a scientific research project organised by a healthcare organisation. A permitted donation could consist of making company expertise available for free to an NGO for a humanitarian purpose. However, as the scope of the exception to Article 10 of the LMP in relation to grants and donations is not expressly codified in the legal texts, such events should always be evaluated on a case-by-case basis. Donations relating to the day-to-day operations of the healthcare organisation (payment of the salary of the nursing personnel, renovation works in the hospital, etc) should always be considered as borderline at best and treated with appropriate restraint.

Discounts/rebates (including volume-related discounts) are permitted if they are in line with the (general) principles of economic law (in particular those included in the Code of Economic Law) and applicable competition principles (including on abuse of dominance). The rules on advertisement and inducement may, however, still have an impact on the validity of certain discounts. It is, for instance, almost impossible to offer free authorised medicinal products (except in the case of samples as discussed in 9.2 The Provision of Samples of Medicinal Products to Healthcare Professionals, or in other very specific circumstances that would require expert regulatory assistance).

Paying healthcare professionals for the provision of services is possible if such services are of a scientific nature and have a legitimate character – eg, speaker engagements, participation in advisory boards, consultancy and clinical trial services.

Specific Mdeon guidelines prescribe that the healthcare professional’s compensation should be reasonable, proportionate and consistent, and should be a reflection of the “fair market value of the services and be in line with the scope and duration of the services” (in function of the complexity, level of experience of the healthcare professional, degree of urgency, etc). It is allowable to reimburse reasonable costs incurred by such healthcare professional in the performance of these services, such as travel, meal and accommodation costs. The prescription behaviour of the healthcare professional must not be a factor for determining the applicable compensation. The provision of services by a healthcare professional may not be used as a loophole to provide (prohibited) advantages to healthcare professionals.

As mentioned in 9.3 Sponsorship of Scientific Meetings, a prior visa must be obtained from Mdeon in the case of hospitality for healthcare professionals for scientific events with an overnight stay, or for online events that take place over several consecutive calendar days of which the registration fee is offered.

The provision of expert services by a healthcare professional may be subject to explicit prior approval from such healthcare professional’s employer. In such cases, it is recommended to request proof of such approval from the healthcare professional.

This requirement is set out in Chapter 1 of Title 3 of the Sunshine Act, which obliges pharmaceutical (and medical devices) companies, whether Belgian or foreign, to document and annually disclose the premiums and benefits they granted (in)directly to healthcare professionals, healthcare organisations or patient associations, on the betransparent.be platform (the Belgian Transparency Register co-created by multiple deontological organisations).

The transparency obligation is applicable to contributions to the costs of a scientific manifestation, fees for services and consultancy, and donations or grants provided to – as applicable – healthcare professionals having a practice in Belgium, healthcare organisations established in Belgium or patient organisations established in Belgium. Gifts, meals and drinks offered during a scientific manifestation, samples and arms’ length market discounts offered for the sale of medicinal products do not fall within the transparency obligation under the Sunshine Act.

The provision of premiums and benefits must be made public on an individual basis (on behalf of the recipient who received them directly or indirectly). Each company subject to the notification obligation must make public, for each individual beneficiary, the amounts of the premiums and benefits granted during a calendar year.

The Belgian Transparency Register (betransparent.be) is used for all disclosures under the Sunshine Act. As a general principle, companies must disclose the relevant transfers as described above on a yearly basis, and ultimately on May 31st of the year following the calendar year in which the transfer of value has been made. When a premium or benefit was granted to a healthcare professional indirectly, such as through a healthcare organisation or corporation, the disclosure should still be made in the name of the healthcare professional.

Disclosure and Transparency

The disclosure must include the name and company number of the company subject to notification, the name and company number/RIZIV-INAMI number of the beneficiary or any other number that allows the FAMHP to identify the beneficiary, and the total amount of the attributed premiums and benefits in respect of the relevant calendar year.

Data published on betransparent.be remains public for three years and will then be removed.

The transparency obligations are binding upon all companies within the pharmaceutical (and medical devices) sector (including pharmaceutical companies, importers, manufacturers and distributors), irrespective of whether they are based in Belgium or abroad.

Companies that consist of different legal entities (in different countries) may combine their disclosures in a single publication. In this case, the company that makes the disclosure must provide an explanatory note explaining which legal entities (both Belgian and foreign) were grouped in the single publication.

According to Article 1.3 of the RD Sunshine Act, companies that are established outside the European Union and subject to notification must make the notification by and in the name of an affiliated company established in the European Union or by a legal representative established in the European Union.

The companies subject to the notification obligation are:

• the holders of an authorisation for placing the medicinal products on the market;
• importers, manufacturers and distributors of medicinal products;
• persons engaged in the brokering of medicinal products; and
• distributors, retailers and manufacturers (Article 41, Section 1.1 of the Sunshine Act).

Companies that do not yet have a marketing authorisation are hence not subject to the notification obligation.

Since breaches of the rules on the advertising of pharmaceutical products are penalised with criminal sanctions under the LMP and the Belgian Criminal Code, the public prosecutor and the criminal courts are primarily responsible for the enforcement of the pharmaceutical advertising rules. The public prosecutor will typically only open a file upon the request of the FAMHP, which may also propose a settlement with the company instead of requesting prosecution with the prosecutor.

The pharmaceutical professional associations also have a separate set of penalties that can be imposed on their members following a breach of the applicable deontological code. For example, the Committee for Deontology and Ethics in the Pharmaceutical Industry (DEP Committee) of pharma.be may impose various corrective, supervisory and financial sanctions on its members. It is also possible for individuals (eg, patients) and competitors to submit a complaint against a pharma.be member at the secretariat of pharma.be for the attention of the DEP Committee, which will then rule on such complaints. An appeal can be brought before pharma.be’s Chamber of Appeal.

Although direct actions by competitors before the court are not expressly organised under the rules governing the advertising of medicines, competitors can initiate proceedings under general torts law or for breaches of the Code of Economic Law that includes general market practice principles – eg, if they believe that a company’s advertising is misleading or creates unfair competition. The Code of Economic Law provides remedies such as cease and desist procedures and the request for compensation for damages on the grounds of unfair competition.

As breaches of the advertising rules are criminally sanctioned, a competitor can also file a complaint with a view to the initiation of criminal proceedings by the public prosecutor (see 11.3 Sanctions for Violating Pharmaceutical Advertising Rules and Rules on Inducements to Prescribe).

Infringements of the rules governing the advertising of pharmaceutical products are sanctioned with fines ranging from EUR1,600 to EUR120,000 and imprisonment from one month to one year for individuals, and with fines ranging from EUR4,000 to EUR240,000 for legal entities. Both the beneficiary of an inducement to prescribe (generally a healthcare professional) and the pharmaceutical company providing such inducement can be sanctioned.

The self-regulatory deontological codes must be considered as independent rules and means of enforcement. Nevertheless, the pharma.be Code of Deontology explicitly determines that no procedures can be started before the pharma.be deontological bodies if another procedure (on similar grounds) was already conducted in front of another competent authority. If a procedure is initiated before the deontological bodies of pharma.be and a separate procedure is initiated before another competent authority during such procedure, the decision by the pharma.be deontological body will be deferred until the other competent authority has taken a decision (Article 78 of the pharma.be Code of Deontology).

It is also possible for a deontological organisation to notify a breach by one of its members to the regulatory authorities or the public prosecutor (this is, for instance, explicitly provided for in the pharma.be Code of Deontology). Of course, regulatory authorities, courts or the public prosecutor will only be competent to decide on a breach of a deontological code if such breach also constitutes a breach of the applicable legal framework (notably the LMP and the RDAMP).

There are no recent noteworthy developments in relation to the enforcement of the rules on pharmaceutical advertising.

With the entry into force of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (VMR), and the subsequent new and revisited national legislation (such as the Act of 5 May 2022 regarding veterinary medicinal products and the Act of 28 August 1991 regarding the exercising of the veterinary profession), the main legal framework applicable to veterinary medicinal products and medicinal products for human use, which previously were both largely governed by the same legal instruments such as the LMP, has now been split. Consequently, veterinary medicinal products are now subject to a separate, dedicated legal framework, and the LMP has been expressly dedicated to medicinal products for human use.

However, the legal framework specifically applicable to the advertising of veterinary medicinal products is not currently entirely clear. The debate is ongoing in Belgium as to the extent the Belgian legislature may implement national rules on the advertising of veterinary medicinal products, going beyond strictly procedural measures implementing the main substantive rules embedded in Articles 119 to 121 of the VMR.

Furthermore, Article 10 of the LMP still regulates the provision of premiums and benefits to veterinarians, despite the above-mentioned split between legal frameworks.

Article 119 et seq of the VMR contain the following requirements for advertising veterinary medicinal products:

• advertising is only permitted for veterinary medicinal products that are authorised in the relevant member state;
• it must be clear that the communication constitutes an advertisement and that it aims to promote the supply, sale, prescription, distribution or use of the veterinary medicinal product;
• the advertising must be formulated in such a way as to suggest that the veterinary medicinal product could be a feed or a biocide;
• the advertising must be in compliance with the summary of product characteristics of the advertised veterinary medicinal product;
• the advertising cannot include information in any form that could be misleading or lead to incorrect use of the veterinary medicinal product;
• the advertising must encourage the responsible use of the veterinary medicinal product, by presenting it objectively and without exaggerating its properties;
• advertising during suspension of the marketing authorisation of the veterinary medicinal product is prohibited in the member state in which it is suspended;
• only small quantities of promotional samples can be distributed, and samples are not allowed for antimicrobial veterinary medicinal products or for products that contain psychotropic or narcotic substances;
• such samples must be appropriately labelled, indicating that they are samples, and shall be given directly to veterinarians or pharmacists during sponsored events or by sales representatives during their visits; and
• specifically for prescription-only veterinary medicinal products, advertising is only allowable towards veterinarians and pharmacists.

Finally, pharma.be has issued a separate Code of Deontology for veterinary medicinal product manufacturers.