The general legal rules on the advertising of medicines for human use are provided by the Law on Medicinal Products of 25 March 1964 (the 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).
Furthermore, the Law of 18 December 2016 on “various provisions on health”, which entered into force on 23 June 2017 (the “Sunshine Act”) is also of high relevance 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").
In addition, four self-regulatory deontological codes provide specific provisions on pharmaceutical advertising. 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 FeBelGen, a professional association of Belgium-based generic medicine companies.
The focus of this chapter is 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 the Belgian innovative pharmaceutical companies) will be addressed if they add information or insights to further interpret or better understand the general legal framework, contain further material obligations for their members or install relevant a priori or a posteriori approval or control procedures regarding pharmaceutical advertising.
Lastly, the LMP and the RDAMP make a clear distinction between advertising medicinal products 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’s, 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 are binding (only) to the members of the relevant professional associations.
Article 9 LMP provides the following definition of advertising: “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”. Patient information leaflets, product labels and general information regarding health and disease areas with no direct or indirect reference to a medicinal product are however excluded from the definition of “advertising”.
Also not regarded as advertising is so-called “unsolicited” medical information about a particular drug product, given by a pharma company following a patient’s or healthcare professional’s specific request, as long as such information is strictly necessary to answer such particular request, and it does not contain unsolicited promotional content (for the distinction between information and advertising, see 2.2 Difference 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 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 a lot less 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 both types of communication is the question if the communication promotes or enhances or intends to promote or enhance the sale of a particular drug product.
The definition of advertising is commonly interpreted broadly by the supervising authorities, who will often be inclined to assume that any type of medical communication is promotional, unless clearly proven otherwise.
Article 9 of the LMP explicitly provides that general information regarding health and disease areas, with no reference (directly nor 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.
For borderline cases, pharmaceutical companies often apply the following rules of thumb to mitigate the risk of a re-qualification of “scientific information” into “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 case, comply with the general rules and requirements with regard to 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 to the General Public), no such press releases may be issued in the general media, unless it can be established that they are of a purely informative nature (see 2.2 Difference Between Information and Advertising).
Conversely, it is allowed 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 advertisement of unauthorised products or off-label indications is prohibited under Article 9 LMP (see 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications). Therefore, a press release with regard to such unauthorised products or off-label indications is only allowed if such press release is of a purely informative nature and is not to be considered promotional (see 2.2 Difference Between Information and Advertising).
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. Such press releases must, however, 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.
The requirements for legitimate comparative advertising are laid down in Article VI.17 of the Code of Economic Law. Comparative advertisements:
Moreover, pursuant to the pharma.be Code of Deontology, comparative advertisements must present the comparator product in a way that is fair, complete, scientifically accurate and based on the most recently available data.
In view of the general prohibition of advertising non-approved medicines or indications (see 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications), making comparative advertisements concerning a medicinal product that has not (yet) been authorised must be deemed illegal (ie, 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 it is of a purely informative nature, is scientifically validated (eg, on the basis of objective head-to-head clinical data) and is not to be considered promotional (see 2.2 Difference Between Information and Advertising),
Article 9 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 provide a patient/healthcare professional with specific information on unauthorised medicines or off-label indications if such information is provided at the specific, unsolicited request of a patient/healthcare professional, 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.
In addition, 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 pharma 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 are 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.
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 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 an advertisement and in breach of Article 9 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 of advertisement of unauthorised medicines (as set forth in 3.1 Restrictions on Provision of Information on Unauthorised Medicines and Indications) and is therefore, in principle, illegal.
A pharmaceutical company can however provide information on such early access programmes if such occurs at the specific, unsolicited request of a patient or a healthcare professional, such information does not contain any promotional content and is not aimed at encouraging the sale or prescription of a medicinal product, and such information is necessary to answer the patient’s or healthcare professional’s request.
Furthermore, it is acceptable that information on early access programmes are published in independent scientific (preferably peer reviewed and, in any case, non-commercial) magazines or journals (see 3.1 Restrictions on Provision of Information on Unauthorised Medicines and Indications).
Belgian law (Article 9 LMP) expressly prohibits the advertising of prescription-only medicines to the general public.
Advertising over-the-counter medicines is permitted, except when such advertisement:
Pursuant to Article 5 RDAMP, certain means for advertising medicinal products are prohibited (irrespective of the public to whom the advertisement is directed), eg, advertising by means of airplanes, billboards, telephone, text messages, fax, email, mailing, children’s magazines, leaflets, contests, software programs, etc. It is equally prohibited to promote medicinal products by promising, offering or granting any direct or indirect compensation in case 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.
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 the Product Characteristics (SmPC) and ensures a rational use of the medicinal product (Article 9 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 the generally accepted scientific knowledge and be backed by bibliographical data.
Specifically, in terms of advertising of over-the-counter medicines directed at the general public, Article 8 RDAMP requires that it should be designed in such a way that it is clear that the message is an advertisement and include the following minimum information:
There is no legal or deontological rule that requires that the price of the pharmaceutical product is mentioned in the advertisement.
Neither the LMP nor the RDAMP 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 LMP applies (see 8.1 General Anti-bribery Rules and 8.2 Legislative or Self-Regulatory Provisions). 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 6 of pharma.be’s Code of Deontology does contain rules on relations with patient organisations. Pharmaceutical companies may 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.
In addition, pharma.be requires its members to make the support it 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 the members of pharma.be.
As mentioned in 4.2 Information Contained in Advertising to the General Public, all advertisements 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 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 the generally accepted scientific knowledge and be backed by bibliographical data.
Specifically, for advertisements towards 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:
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 RDAMP (see 4.1 Main Restrictions on Advertising to the General Public) also apply to the 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 held in Novo Nordisk AS v Ravimiamet (C-249/09; 5 May 2011), it is generally accepted that the inclusion in advertisements directed to healthcare professionals of information, which is not part of the SmPC, 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 Provision of Information on Unauthorised Medicines or Indications), 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 the promotional claim is presented in an accurate, up to date, objective, sufficiently complete, truthful, verifiable and faithful manner.
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 therefore subject to those rules (including the prohibition of advertising on unauthorised products/off-label indications). Distribution by pharmaceutical companies will also be subject to the rules related to gifts to healthcare professionals (see below).
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. The MSL may hence only respond to unsolicited questions raised by healthcare professionals about unapproved products or off-label uses of approved products and not provide such information in a proactive manner. The MSL is, however, allowed to proactively exchange information on ongoing trials and 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 a prior approval (visa) from the Ministry of Health (Article 16, Section 1 RDAMP), which will base its decision on the advice from the Commission on the Supervision on Advertisement on Medicinal Products. This commission operates as an independent commission within the Federal Agency for Medicines and Health Products (FAMHP). The Ministry of Health must make a decision within 45 days as of the receipt of a complete request for approval (Article 17, Section 5 RDAMP).
All other forms of advertisement (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 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 applicable legal requirements. Both the visa and notification require the payment of a retribution by the company (EUR1,240 and EUR248, respectively) and are valid for a period of two years.
As regards advertising towards healthcare professionals, prior notification to or approval by the Ministry of Health is not required.
Pursuant to Article 13 RDAMP, every marketing authorisation-holding company must designate a qualified person (responsible for the information) who will 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 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 set out above, and in particular Article 9 of the LMP and the principles of the RDAMP, also apply to internet advertising.
Book XII of the Code of Economic Law, setting forth the rules on the digital economy, contains more specific rules on electronic advertising (on websites, by e-mail or through other electronic means). Pharma.be also issued guidelines on mandatory information to be included in internet advertising.
In a nutshell, advertisements on a website by pharmaceutical companies must comply with the following rules:
For the advertising on medicinal products on social media, see 7.1 Regulation of Advertising of Medicinal Products on the Internet.
No specific rules exist on the required website security for advertisements directed at healthcare professionals. Nevertheless, a company should take all security means 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 LMP.
The same applies to websites which contain scientific information regarding non-authorised medicines or off-label indications. A company should take all security means to prevent unrestricted access by the general public to such a website, as any provision of scientific information should generally occur on the basis of a specific unsolicited request (see 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications).
It is a common practice that pharmaceutical companies make certain parts of their website only accessible to healthcare professionals 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 Difference Between Information and Advertising, the provision of disease awareness information generally does not qualify as advertisement, as long as no direct or indirect reference is made to a specific medicinal product. Hence, 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.
Articles 504 bis and 504 ter of the Belgian Criminal Code provide the Belgian anti-bribery rules concerning the bribery of private legal entities and private individuals (ie, private bribery). These are the anti-bribery rules applicable to pharmaceutical companies.
Furthermore, Articles 246 to 252 of the Belgian Criminal Code provide the rules concerning the bribery of public legal entities and individuals of holding a public function (ie, public bribery). The rules on public bribery will apply to state-owned (university) hospitals, as well as healthcare professionals employed by such hospitals, since they are then considered to hold a public office.
Pursuant to Article 10 LMP, it is forbidden, within the framework of the supplying, prescribing or administering 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 LMP contains a broad prohibition to providing gifts 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”.
Strictly speaking, donations to healthcare organisations are not exempt from this prohibition. In practice, however, it is possible for the industry to provide donations (eg, money to organise an activity, research equipment) to healthcare organisations for educational, humanitarian or philanthropic purposes. The pharma.be Code of Deontology specifies further that these donations are allowed only if they are made available for the purpose of supporting healthcare or research. It also states if they do not constitute an inducement to recommend, prescribe, purchase, sell, supply or administer medicinal products.
A typical example of a permitted donation would be the support/sponsorship of a scientific congress organised by a healthcare organisation. However, as the scope of the exception to Article 10 LMP is not entirely clear, such events should 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.
The provision of free samples is possible, as long as the rules and obligations of Article 12 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 authorised to prescribe such a product at his 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. Additionally, each healthcare professional may receive no more than 600 samples, in total, per year.
Pharmaceutical companies may, in principle, both sponsor the attendance of healthcare professionals to continuing medical education (including hospitality) as the associations that organise such continuing medical education (see 9.1 Gifts to Healthcare Professional). Article 10 LMP, however, determines that this is only allowed if:
For events with an overnight stay, a prior visa must be obtained from Mdeon (see 1.1 Laws and Self-Regulatory Codes). Mdeon has provided additional guidelines regarding the hospitality that can be offered to healthcare professionals in the framework of a scientific event (eg the cost of an overnight stay is limited to EUR250, cost of lunch is limited to EUR40, cost of a dinner is limited to EUR80, 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.
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.
Article 10 LMP prohibits the provision of gifts to HCPs, with the exception of gifts having a limited value and being directly related to the medical profession (eg, medical/pharmaceutical scientific reference work, writing instruments, clinical material, professional use IT accessories, etc).
During the parliamentary discussions on the LMP it was acknowledged that EUR50 per gift per healthcare professional or organisation, with an absolute maximum of EUR125 per healthcare professional or organisation per year could be considered sufficiently limited. 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 of its members).
It is not possible to give cash money to healthcare professionals, as this cannot be considered “directly related to the medical profession”.
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, see above, or other very specific circumstances that will require expert regulatory assistance).
Paying healthcare professionals for the provision of services is possible if it concerns services of a scientific nature having a legitimate character. Such services could be, eg, speaker engagements, participation in advisory boards, consultancy, clinical trial services, etc.
Specific Mdeon guidelines prescribe that the healthcare professional’s compensation should be reasonable, proportionate, consistent, 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). 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 case of hospitality for HCP’s for scientific events with an overnight stay.
The provision of expert services by a healthcare professional may be subject to the explicit prior approval from such healthcare professional’s employer. In such cases, it is recommended to request a proof of such approval from the healthcare professional.
This requirement is set out in Chapter 1 of Title 3 of the Sunshine Act. This Act imposes on pharmaceutical (and medical devices) companies, whether Belgian or foreign, the legal obligation to document and annually disclose on the platform betransparent.be the premiums and benefits that they granted (in)directly to healthcare professionals, healthcare organisations or patient associations.
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.
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.
Multiple deontological organisations have co-created the Belgian Transparency Register (betransparent.be), which 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, eg through a healthcare organisation or corporation, the disclosure should still be made in the name of the healthcare professional.
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 FAHMP 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 be removed afterwards.
Prior to the entry into force of the Sunshine Act, the transparency obligation for pharmaceutical companies was based on self-regulation. Now that the transparency obligations have been anchored in legislation, these 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 subject to notification which are established outside the European Union 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, Section1, 1 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 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 susceptible to being imposed on their members following a breach of the applicable deontological code. The Committee for Deontology and Ethics in the Pharmaceutical Industry (DEP Committee) of pharma.be, for example, 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 Committee for Deontology and Ethics in the Pharmaceutical Industry). The DEP Committee shall 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 practices 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.
In addition, as breaches of the advertisement 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 Penalties for Violating Advertising Rules and Rules on Inducements to Prescribe).
Infringements of the rules governing the advertising of pharmaceutical products are sanctioned with fines ranging from EUR1,200 to EUR90,000 and imprisonment sanctions from one month to one year for individuals and with fines ranging from EUR3,000 to EUR180,000 for legal entities. Both the beneficiary of an inducement to prescribe (ie, generally a healthcare professional) as the pharmaceutical company providing such inducements 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 93 pharma.be Code of Deontology).
It is also possible 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). Of course, 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 LMP and the RDAMP).
There are no noteworthy developments in relation to the enforcement of the rules on pharmaceutical advertising.