In Belgium there are currently two Acts and three implementing royal decrees that mainly regulate advertising on medicines for human use:

(i) the Act on Medicinal Products of 25 March 1964 (“AMP”) setting forth the general legal framework on advertising of medicines for humans;

(ii) the Royal Decree of 7 April 1995 (“RDAMP”) regarding information and advertising of medicines;

(iii) the Royal Decree of 11 January 1993 establishing the conditions for the provision of medicinal products as samples;

(iv) the Act of 18 December 2016 on various provisions on health (the “Sunshine Act”) containing a transparency obligation on pharmaceutical companies to document and disclose benefits granted to healthcare professionals and organisations and patient organisations;

(v) the Royal Decree of 14 June 2017 executing the Sunshine Act.

There are four main self-regulatory deontological codes, which contain specific provisions on pharmaceutical advertising. They are identified on the basis of the issuing professional bodies:

(i) Pharma.be, a professional association of innovative pharma/EFPIA companies based in Belgium

(ii) BACHI (the Belgian Association for the Consumer Healthcare Industry), focusing on over-the-counter medicines and healthcare products sold in pharmacies

(iii) Mdeon, a common platform between different professional associations and healthcare professionals/organisations

(iv) Medaxes, a professional association of Belgium-based generic and biosimilar medicine companies

a.

The deontological codes are only binding on the members of the respective professional associations, provided, however, that the Mdeon Code of Ethics applies to all pharmaceutical companies interacting with healthcare professionals in Belgium (since Mdeon has been assigned specific tasks by the Belgian lawmakers).

b.

It is a separate set of binding rules that can be enforced against the members by imposing various corrective, supervisory and financial sanctions in case of violation of the code.

Advertising for these purposes is “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” (article 9 AMP).

a.
The above definition is extended by naming specific examples, such as provisions of samples, visits to healthcare professionals, sponsorships of scientific conferences and incentives to deliver or prescribe medicines by providing financial or in-kind benefits (article 2 §2 RDAMP).

Excluded from the definition are patient information leaflets, product labels and general information regarding health and disease areas with no direct or indirect reference to a medicinal product, including disease-awareness campaigns.

Moreover, the definition does not cover medical information about a particular drug product given by a pharma company in reply to a patient’s or healthcare professional’s unsolicited request, as long as such information is strictly necessary to answer said request and does not contain unsolicited promotional content.

b.
See above under question 3.a.

In general, press releases regarding medicines for human use must comply with the general rules regarding advertisement of medicinal products. Pharmaceutical companies should at all times ensure that their press releases are factually correct, do not contain misleading information, and do not use sensational language or exaggerations. Note that specific guidance has been issued by the Belgian Financial Services and Markets Authority in its Opinion of 28 October 2020 for listed biotech companies, which are, in general, obliged to give updates on their pipeline and the progress and results of their clinical trials.

Belgian law requires every pharmaceutical company to appoint and maintain a qualified person (responsible for the information) who will be accountable for the advertising and for providing scientific information on medicinal products for human use by said company (article 13 RDAMP). The qualified person should be a pharmacist or physician and registered with the Ministry of Health.

Medical information as well as advertisements to healthcare professionals and the general public should always be ratified in advance by that qualified person.

Yes, for advertisement to the general public through radio/television prior approval (visa) from the Ministry of Health is required. That approval is based on the advice from an independent Commission within the Federal Agency for Medicines and Health Products (“FAMHP”). This decision must be taken within 45 days as of the receipt of a valid request (article 16 §1 and article 17 §5 RDAMP).

All other forms of advertisement of medicinal products for human use to the general public (e.g. advertisements in a newspaper or on the internet), should be notified to the Ministry of Health 30 days prior to their publication (article 16 §2 RDAMP).

To the extent advertising of medicinal products for human use is allowed, the advertisement must additionally observe the rules set forth in general rules of legitimate comparative advertisement (article VI.17 Code of Economic Law). This means that comparative advertisements:

· must compare similar products;

· must compare one or more essential, relevant, verifiable and representative elements of the product (such as the price);

· must not be misleading;

· must not create confusion between the advertiser and the competitor or between their brands, trade names or other distinguishing marks;

· must not discredit or disparage the competitor and its products/activities; and

· must not represent products as being a counterfeit or imitation of products whose brand or trade name is protected.

All advertising of unauthorised medicines or unauthorised indications is prohibited (article 9 AMP). However, providing scientific medical information on unauthorised medicines is allowed within the boundaries of the respective definition of information/advertisement (see above 3.a). This means, inter alia, that scientific information on unauthorised medicines:

(i) can be published in independent scientific magazines, so long as these are not used as promotional material by a pharma company;

(ii) can be presented to healthcare professionals during scientific meetings to the extent the presentation is strictly scientific;

The proactive communication of information of unauthorised medicines to healthcare professionals is in principle regarded as promotional. The reactive communication of information on unauthorized medicines to healthcare professionals following their spontaneous (i.e. unsolicited) request is in principle regarded as non-promotional (see above under question 3.a).

Note also, as set forth above, that for information to be regarded as scientific it must in all circumstances be factually correct, and it may not contain misleading information, aspirational language or exaggerations.

Advertisement for prescription only medicines for human use to the general public is expressly prohibited under Belgian law. Advertisement for over the counter-medicines is authorised unless such advertisement: (i) gives the impression that a medical consultation or surgical operation is redundant; (ii) suggests that the effects of taking the medicinal product are guaranteed or that no side effects exist; (iii) suggests that the patient’s health can be enhanced by taking the medicinal product or can be affected by not taking it; (iv) is directed exclusively or primarily at children; (v) 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; (vi) suggests that the medicinal product is a foodstuff, cosmetic or other consumer product; (vii) suggests that the efficacy or safety of the product stems from the fact that it is natural; (viii) could lead to an incorrect self-diagnosis; or (ix) uses improper, alarming or misleading terms or pictorial representations (see article 7 RDAMP).

Moreover, article 8 RDAMP requires that advertising of over the counter-medicines for human use should (i) be designed in such a way that it is clear that the message is an advertisement; and (ii) include the following minimum information:

• the name of the product (as well as the common 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 read carefully the instructions on the package leaflet or on the outer packaging, as the case may be. In case radio advertisements, such invitation must be explicit and clearly audible; and
• the (trade) name of the product’s marketing authorisation holder.

Also bear in mind that all advertisements must present the characteristics of the medicinal product in such a manner that it (i) is compatible with the summary of the product characteristics (ii) that it ensures a rational use of the medicine (article 9 AMP).

The FAMHP has issued very specific guidance regarding the lay-out and readability requirements for advertising of pharmaceutical products for human use on written materials and on broadcasted mediums (Circular 407 and 441).

Lastly, certain means for any advertising of medicinal products for human use are prohibited like advertising by means of airplanes, billboards, telephone, text-messages, children’s magazines, software programmes, etc. It is equally prohibited to promote medicinal products by promising, offering or granting any (in)direct compensation such the patient be unsatisfied with the product (article 5 RDAMP).

Belgian law does not contain provisions on relations with patient organisations. A patient organisation having a healthcare professional among its members should in any event be treated as a healthcare organisation to which article 10 AMP applies. Pharmaceutical companies should make sure 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 contains rules on relations with patient organisations. Pharmaceutical companies may (i) provide financial support to a patient organisation, (ii) call on patient organisations for the performance of certain services for the support of healthcare or research, or (iii) sponsor events organised by patient organisations if such support is covered by a written agreement.

These rules specify that in their interactions with patient organisations, pharma companies must assure the independence of patient organisations in terms of their political judgement, policies and activities, and all interactions between must be based on mutual respect, with the views and decisions of each partner having equal value. In addition, companies cannot require that they be the sole funder or sponsor, and must not influence the text of patient organisations’material they sponsor in a manner favourable to their own commercial interests

Moreover, patient organisations should not be involved in the promotion of a particular prescription-only medicine.

With respect to collaborations, their objectives and scope must be transparent, and financial and non-financial support must always be clearly acknowledged. For any (non-financial) support they must have in place a written agreement that includes as a minimum:

• the amount of the funding or, in case of indirect or non-financial support, a precise description of the support,
• the purpose of the funding, such as the allocation of an “unrestricted grant”, support for a particular meeting or publication, etc. and
• the code(s) of deontology applicable to the support

Finally, there are limits and restrictions on gifts, grants, hospitality and sponsoring that can be provided, and there are strict rules of engagement when calling upon patient organisations to provide scientific services.

First, Belgian law provides that the presentation of a medicinal product in advertisements must (i) be accurate, up to date, objective, sufficiently complete, truthful, verifiable, and compatible with the most recent content of its marketing authorisation file, (ii) reflect the generally accepted scientific knowledge, and (iii) be backed by bibliographical data.

Specifically, advertisements for medicinal products for human use towards healthcare professionals must contain the following essential data, which must cover at least 50% of the total advertisement space (article 9 RDAMP):

(i) the product’s name, its qualitative and quantitative composition in terms of active substances and its pharmaceutical form;

(ii) all information regarding indications, posology, contraindications and side-effects contained in the SmPC, or the package leaflet or the labelling in case of a homeopathic medicinal product; and

(iii) the (trade) name of the marketing authorisation holder and the number of the marketing authorisation or product registration.

Advertisements towards healthcare professionals should also contain the applicable retail price per approved formulation/pack size and explicitly mention the date of the material’s creation or the date of its last revision.

It is generally accepted that the inclusion in advertisements directed to healthcare professionals of information that is not part of the SmPC is allowed as long as such information confirms, clarifies or supplements (i.e., does not directly or indirectly contradict) the specifications made in the SmPC, and is not misleading.

Under Belgian law, gifts to healthcare professionals are prohibited, with the exception of gifts with a limited value and being directly related to the medical profession (article 10 AMP). As a standard for limited value, it is generally accepted that gifts for a maximum total value of EUR 125 per healthcare professional per year would be acceptable, with each gift costing no more than

EUR 50. Specific examples of appropriate and inappropriate gifts can be found in the MDeon Code of Ethics.

The provision of free samples is allowed within certain limits as specified hereafter (article 12 AMP and the Royal Decree of 11 January 1993 determining the conditions subject to which the provision of samples of medicinal products for human consumption is permitted). Generally, samples may only be provided to a healthcare professional authorized to prescribe such product on his specific request, on the condition that a marketing authorization 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. Additionally, each healthcare professional may receive no more than 600 samples, in total, per year.

Principally, pharmaceutical companies are allowed the sponsoring of (i) the attendance of healthcare professionals to continuing medical education (including hospitality) and of (ii) the organization that 7organizes such continuing medical education. This is only allowed if (article10 AMP):

(i) the event is in nature exclusively scientific;

(ii) the hospitality is strictly limited to the scientific objective of the event;

(iii) the location, date, and duration of the event do not create confusion about the scientific nature of the event;

(iv) the financial contribution to the participation (including the offered hospitality) is strictly limited to the official duration of the event; and

(v) the coverage of the costs are strictly limited to the healthcare professionals concerned by the event.

For events with an overnight stay, a prior visa must be obtained from Mdeon. Mdeon has set out additional guidelines regarding the hospitality that can be offered to healthcare professionals in the framework of a scientific event (e.g. the cost of an overnight stay is limited to EUR 250, cost of lunch is limited to EUR 45, cost of a dinner is limited to EUR 90, cost of a snack is limited to 23 EUR per hour of scientific activities (for short events), a total limit of EUR 135 per day for scientific events with at least 6 hours of scientific activities applies, travel within Europe should always be in economy class, etc.).

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.

Furthermore the pharmaceutical industry federations EFPIA, PhRMA and IFPMA have issued specific joint guidance to clarify the rules and principles in relation to virtual and hybrid events. According to such guidance, it is generally not permitted to provide hospitality to healthcare professionals who are attending virtually to events.

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

Yes, on the condition that the services provided by healthcare professionals are of a scientific nature and have a legitimate character. Examples of such services are speaker engagements, participation in advisory boards, consultancy, clinical trial services, etc.

Specific Mdeon guidelines set forth that the healthcare professional’s compensation should be (i) reasonable, (ii) proportionate, (iii) consistent, (iv) a reflection of the “fair market value” of the services, and (v) 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, …). The prescription behavior of the healthcare professional ought not to be a factor for determining the applicable compensation. It is not allowed to use the provision of services by a healthcare professional as a loophole to provide (prohibited) advantages to healthcare professionals.

Belgian law contains a broad prohibition to offer gifts to wholesalers, intermediaries, persons who are entitled to prescribe, dispense or administer medicinal products or to institutions where such prescriptions, dispersion or administration takes place (article 10 AMP). In principle, this means that donations to healthcare organisations fall within this prohibition.

In practice, however, the industry may donate (e.g. money to organise an activity, research equipment) to healthcare organisations for educational, humanitarian or philanthropic purposes. The pharma.be Code of Deontology further clarifies that such donations are only allowed if these are made available for the purpose of supporting healthcare or research and if these do not constitute an inducement to recommend, prescribe, purchase, sell, supply or administer medicinal products.

Considering the fact that the scope of this exception is not entirely clear, it must be assessed on a case-by-case basis.

The Sunshine Act makes it mandatory for pharmaceutical (and medical devices) companies, whether Belgian or foreign, to document and annually disclose on the platform betransparent.be (co-created by multi deontological organisations) the premiums and benefits that they grant (in)directly to healthcare professionals, healthcare organisations or patient associations (chapter 1 of title 3 of the Sunshine Act).

The transparency obligation covers (i) contributions to the costs of a scientific manifestation, (ii) fees for services and consultancy and (iii) donations or grants provided to – as applicable – (a) healthcare professionals having a practice in Belgium, (b) healthcare organisations established in Belgium or (c) patient organisations established in Belgium.

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.

In general, companies are required to disclose, on a yearly basis (ultimately on 31 May of the year following the calendar year in which the transfer of value has been made), the relevant transfers of value as describe above. Bear in mind that when a premium or benefit was granted to a healthcare professional indirectly, e.g. through a healthcare organisation or corporation, the disclosure should still be made in the name of the healthcare professional.

The disclosure should provide the following details:

(i) the name and company number of the company subject to notification;

(ii) the name and company number/RIZIV-INAMI number of the beneficiary or any other number that allows the FAMHP to identify the beneficiary; and

(iii) the total amount of the attributed premiums and benefits in respect of the relevant calendar year.

These 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.

According to article 3, section 1,3° of the RD Sunshine Act, companies subject to notification which are established outside the European Union must make the notification (a) by and in the name of an affiliated company established in the European Union or (b) 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° Sunshine Act). Companies that do not yet have a marketing authorisation are hence not subject to the notification obligation

The general rules for pharmaceutical advertising are also applicable to internet advertisement. Book XII of the Code of Economic Law sets forth specific rules on electronic advertising (on a website, by e-mail or through any other electronic means). Pharma.be also provided guidelines concerning the mandatory information to be included in internet advertising.

Generally, advertisements on a website by a pharmaceutical company must abide by the following rules:

(i) The advertising must have a clearly visible, legible and unambiguous statement that it is an advertisement; and

(ii) The pharmaceutical company to which the advertisement relates, has to be identifiable.

Following from the prohibition to advertise prescription medicines to the general public, it is prohibited to promote prescription medicines via social media, such as Facebook, Twitter, etc.

The Belgian Criminal Code provides for the anti-bribery rules concerning the bribery of private legal entities and private individuals (article 504bis and 504ter) and the bribery of public legal entities and individuals holding a public function (article 246 to 252).

It is prohibited to offer, supply or promise (in)direct benefits to healthcare professionals and healthcare organisations (For exceptions, see question 12).

The Public prosecutor and the criminal courts are primarily responsible for the enforcement of the pharmaceutical advertising rules (the AMP, RDAMP and the Belgian Criminal Code).

In addition, the pharmaceutical professional associations can also impose a separate set of penalties on their members following a breach of the applicable deontological code.

Under general rules governing fair market practices, competitors can act against pharmaceutical companies allegedly violating advertising rules. Under such rules, remedies include cease and desist procedures, injunctive relief and claims for damages.

Violating the rules governing advertisement of pharmaceutical products may give rise to sanctions, such as fines (from EUR 1 600 to EUR 120 000) and imprisonment (from 1 month to 1 year) for individuals and with fines ranging from EUR 4 000 to EUR 240 000 for legal entities.

The self-regulatory deontological codes are independent rules and means of enforcement. Nonetheless, 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 pharma.be Code).

It is also a possibility that a deontological organisation notifies a breach by one of its members to the regulatory authorities or the public prosecution (this is, for instance, explicitly provided for in the pharma.be Code of Deontology).

Regulatory authorities, courts or the public prosecution will only be competent to decide on a breach of a deontological code if it also constitutes a breach of the applicable legal framework (notably the AMP and the RDAMP).

Recently, there has been public criticism and scrutiny of submissions to the BeTransparent Register under the Sunshine Act, as investigations showed that information provided therein was often incomplete or incorrect. We may see additional legislation creating broader transparency obligations, as well as stricter enforcement by authorities in the coming period.