Source: https://iclg.com/practice-areas/pharmaceutical-advertising-laws-and-regulations/belgium
Timestamp: 2019-04-20 20:58:03+00:00

Document:
The advertising of medicinal products (for human use) is governed by (i) the Law on Medicinal Products of 25 March 1964 (“LMP”) (in particular by articles 9 and 10), and (ii) the Royal Decree regarding information and advertising of medicinal products for human use of 7 April 1995 (“RDAMP”). The LMP and the RDAMP set forth the general legal rules applicable to the advertising of medicinal products in Belgium.
This contribution also devotes particular attention to the new Law of 18 December 2016 regarding various provisions on health, which entered into force on 23 June 2017 (the “Sunshine Act”). The Sunshine Act imposes a legal transparency obligation on pharmaceutical companies to document and annually disclose premiums and benefits granted to healthcare professionals, healthcare organisations or patient organisations (see below under question 7.2).
The LMP and RDAMP are supplemented by four main self-regulatory deontological codes issued by the following professional associations (i) pharma.be, a professional association of Belgium-based innovative pharma/EFPIA companies, (ii) BACHI (the Belgian Association for the Consumer Healthcare Industry) which focuses on over-the-counter medicines and healthcare products sold in pharmacies, (iii) Mdeon, a common platform between several professional associations and healthcare professionals/ organisations, and (iv) FeBelGen, a professional association of Belgium-based generic drug companies. These self-regulatory codes are only binding on the members of the relevant professional association.
This contribution focuses on the general legal framework for the advertising of medicinal products (including the Sunshine Act) that applies to all pharmaceutical companies in Belgium. The abovementioned self-regulatory deontological codes (notably the pharma.be Code of Deontology, which is applicable to 90% of the Belgian innovative pharmaceutical companies) will be addressed if such deontological codes (i) provide additional input or insights to further interpret or better understand the general legal framework, (ii) include additional material obligations for their members, or (iii) organise relevant a priori or a posteriori approval or control procedures on pharmaceutical advertising.
Finally, please note that the LMP and the RDAMP make a clear distinction between the advertising of medicinal products towards the “general public” and towards “healthcare professionals”. Within the scope of the LMP and the RDAMP, only medical doctors, dentists and pharmacists are considered “healthcare professionals”. This means that nursing personnel are regarded as part of the general public. However, please note that under the Sunshine Act, also nurses, paramedics and hospital directors fall under the definition of “healthcare professional”.
Article 9 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”. 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, not regarded as “advertising”. The same applies to so-called “solicited” medical information about a particular drug product that is given by a pharma company further to a specific request from a patient or a healthcare professional, as long as such information is strictly necessary to answer said particular request and does not contain unsolicited promotional content.
The abovementioned definition and exclusions provided in Article 9 of the LMP are the same as in Article 86 of Directive 2001/83/EC of 6 November 2001 on the Community Code relating to Medicinal Products for Human Use.
The definition is further supplemented by article 2, §2 RDAMP, in which specific examples of advertising are named, such as the provision of samples, visits to healthcare professionals, sponsorships of scientific conferences and incitements to deliver or prescribe medicines by providing financial or in-kind benefits.
The distinction between “medical information” (which is subject to less restrictions and rules) and “advertising” is often difficult to draw. The litmus test that is generally used to differentiate both types of communication is the question whether or not such communication intends to promote or enhance sales of a particular drug product.
Supervising authorities usually broadly interpret the definition of “advertising” and seem inclined to assume that any type of medical communication is of promotional nature unless clearly proven otherwise.
Pharmaceutical companies that are confronted with borderline cases and decide to consider a communication as “scientific information” (as opposed to “advertising”) often apply the following rules of thumb to mitigate the risk of a so-called “requalification” by the supervising authorities: (i) ensure that this communication emanates from its medical affairs department (and not from a member of its sales team); (ii) limit this communication to strictly scientific data; and (iii) keep a written file that can demonstrate (if needed) the clear non-promotional intent of said communication (and the assessment made by the company prior to its launch). The mere implementation of these rules of thumb can of course never entirely eliminate the risk of such requalification.
Certain communications to the general public on over-the-counter (“OTC”) drugs should be notified to or receive the prior approval from the Ministry of Health (see question 1.5 below).
Information and advertisements to healthcare professionals and the general public should always be ratified in advance by the qualified person (responsible for the information) designated by the company (see question 1.4 below).
Pharmaceutical companies are required to adequately train sales reps who visit healthcare professionals (including the scientific aspects of the medicinal products).
According to Article 13 RDAMP, any 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 by said company. The qualified person should be a pharmacist or physician and registered with the Ministry of Health.
There are no relevant legal or code requirements to have specific SOPs in place to cover advertising activities.
With regards to advertisements towards the general public, the applicable approval and notification procedure depends on the medium that is used for such advertisement.
If the advertisement is made on the radio and/or television, the company should obtain a prior approval (visa) from the Ministry of Health (article 16, §1 RDAMP). The decision regarding this prior approval will be made on the basis of advice from the Commission on the Supervision on Advertisement on Medicinal Products, which operates as an independent commission within the Federal Agency for Medicines and Health Products (“FAMHP”). The Ministry of Health has 45 days to make a decision (article 17, §5 RDAMP).
All other forms of advertisement of medicinal products 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). Please note that the Ministry of Health may require the company to provide additional documents in the framework of such notification which could potentially postpone the notified advertisement. The Ministry of Health may also prevent any (intended) advertising if it is not in line with applicable legal requirements (see also below under question 1.6). Both the visa and notification require the payment of a retribution by the company (EUR 1,240 for the visa, EUR 248 for the notification) and are valid for a period of two years.
Prior notification to or approval by the Ministry of Health is not required for advertising towards healthcare professionals.
According to Article 24 RDAMP, the Minister of Health has various options and powers to stop the publication or broadcasting of an advertisement that is not in line with the LMD and/or the RDAMD (e.g., revocation of a granted visa, immediate order to terminate the advertising, issuing of a corrective statement). If the advertisement is made on the radio and/or television, the decision to stop will be made in consultation with the Commission on the Supervision on Advertisement on Medicinal Products.
Before a decision is made by the Minister of Health, the company must receive the right to be heard and to defend its case. The company can appeal the decision of the Minister of Health at the highest Belgian administrative court (Conseil d’Etat/Raad van State).
The deontological codes include similar measures. The so-called DEP Committee of pharma.be may, for instance, oblige pharma.be members to take corrective actions in case of breach of applicable deontological rules (correction of the material, corrective communication towards healthcare professionals, etc.).
Under Belgian law, breaches of the rules governing the advertising of medicinal products are penalised with criminal sanctions (fines and imprisonment). The public prosecution should first open (generally on request of the FAMHP) a file against the allegedly infringing company and a judge should convict said company before a penalty can be imposed. The FAMHP may, however, propose a settlement with the company instead of requesting the public prosecution to open a file. There is, partly as a consequence of the latter but also due to the fact that pharmaceutical professional associations have their own mechanisms to take corrective measures intra muros, very little case law available on the subject.
A criminal prosecution against a company can also be initiated by the public prosecution further to a complaint by a competitor. And, although direct actions by competitors before the court are not expressly organised under the rules governing the advertising of medicines, competitors can also initiate proceedings under general torts law or for breaches of the Code of Economic Law of 23 February 2013 (the “CEL”) that includes general market practices principles, e.g., if they believe that a company’s advertising is misleading or creates unfair competition (see also below question 1.9).
The pharmaceutical professional associations also have a separate set of penalties which can be imposed on their members in case of a breach of the applicable deontological code. The Committee for Deontology and Ethics in the Pharmaceutical Industry (DEP Committee) of pharma.be may, for instance, impose various corrective, supervisory and financial sanctions on its members. Please note that it is also possible for individuals (e.g., 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, which shall rule on such complaints. An appeal can be brought before pharma.be’s Chamber of Appeal.
The self-regulatory deontological codes should be considered as independent rules and means of enforcement. Notwithstanding the foregoing, 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 has already been conducted (in the past) before another competent authority. If a procedure is initiated before the deontological bodies of pharma.be and, during such procedure, a separate procedure is initiated before another competent authority, 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). It is, on the other hand, 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). Regulatory authorities, courts or the public prosecution will only be competent to decide on a breach of a deontological code to the extent such also constitutes a breach of the applicable legal framework (notably the LMP and the RDAMP).
Pursuant to the CEL (that includes general principles on market practices), pharmaceutical companies can initiate various actions to counter unfair competition. Possibilities include cease and desist procedures and the request for compensation for damages on the grounds of unfair competition.
In principle, any entity that suffered harm from an alleged unfair competition has legal standing to initiate any such proceedings.
All advertising (including to healthcare professionals) of (i) medicines that are not yet authorised, or (ii) off-label indications, is expressly forbidden by article 9 LMP. This prohibition, however, only applies to advertisements and not to medical information (for the difference between both concepts, see above under question 1.2). Pharma companies may therefore in general provide information on non-authorised medicines or off-label indications to a healthcare professional to the extent that such information was requested by said healthcare professional.
It is also generally accepted that scientific information on non-authorised medicines or off-label indications (such as results of clinical studies) may be presented to healthcare professionals during scientific meetings, as long as such presentation is strictly scientific and is not (blatantly) intended to promote the relevant drug product. Such intention will be more difficult to disprove if the meeting is (materially) sponsored by the product owner and it is always preferable to have such presentations brought by an independent expert faculty.
Information on non-authorised medicines or off-label indications can be published in independent scientific (and non-commercial) magazines or journals (preferably peer reviewed). Such publication can, however, never be used as promotional material by a pharma company (e.g., by extending copies of said journal to a healthcare professional).
All other publications of non-authorised medicines or off-label indications will in principle be deemed promotional and therefore illegal.
Pharmaceutical companies should be very cautious with issuing press releases that refer to unauthorised products or off-label indications (e.g., by circulating updates on ongoing clinical trials or approvals outside the EMA) and as such, releases will likely be considered to have promotional intent in breach of article 9 LMP (regardless of the target audience).
The pharma.be guidelines are even stricter and consider that such press releases are only possible if they are made by journalists independently of any input of the pharmaceutical company (e.g., when the journalist has received the information during a scientific event organised by a third party).
See above under question 2.1. Information on non-authorised medicines or off-label indications may in principle only be sent to healthcare professionals upon their request.
Article 9 LMP contains an explicit exception for the provision of price lists that contain no information about the medicinal product (except for the name). This exception was already included in article 9 LMP before the decision in the Ludwigs case.
As set forth in question 2.1, such information to healthcare professionals is likely to be considered an advertisement on unauthorised medicines or indications in breach of article 9 LMP, unless this information was expressly solicited by said healthcare professionals.
This is possible, provided that (i) the rules regarding consultancy services by healthcare professionals are respected (see below under question 5.4), and (ii) the applicable consultancy agreement was not solely entered into as an “excuse” to transfer information on unauthorised products or indications to healthcare professionals.
Generally, all advertisements (to both the general public and healthcare professionals) must present the characteristics of the medicinal product in such a way that it (i) is compatible with the summary of the product characteristics (SmPC), and (ii) ensures a rational use thereof (Article 9 LMP). In addition, the applicable legal framework and deontological codes provide that the presentation of a drug 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 dossier, (ii) reflect the generally accepted scientific knowledge, and (iii) be backed up by bibliographical data.
Article 9 of the RDAMP further specifies that an advertisement in the press directed at healthcare professionals should contain the following essential data which should cover at least 50% of the total advertisement space: (i) the name of the product, its qualitative and quantitative composition in terms of active substances, as well as its pharmaceutical form; (ii) all information regarding indications, posology, contraindications and side-effects contained in the SmPC; (iii) the package leaflet or the labelling in case of a homeopathic medicinal product; and (iv) the (trade) name of the marketing authorisation holder as well as the number of the marketing authorisation or product registration. It must also contain the applicable retail price per approved formulation/pack size. Such price must appear in bold, on a contrasting background in the upper right-hand corner of the advertisement and should at least cover 0.5% of the print advertisement. Finally, the advertisement must explicitly mention the date of its creation or the date of its last revision.
For the sake of completeness, please note that pursuant to article 5 RDAMP certain means for the advertising of medicinal products (to both the general public and healthcare professionals) are prohibited, such as advertising by means of airplanes, billboards, telephone, SMS, fax, email, mailing, children’s magazines, leaflets, contests, software programs, etc. Moreover, it is prohibited to promote medicinal products by promising, offering or granting any direct or indirect compensation if the patient is not satisfied with the product. Note that advertising by email, fax or mailing to healthcare professionals is not prohibited if said professionals have given their prior consent.
Pursuant to the LMP, all information included in an advertisement for medicinal products must comply with the information set out in the SmPC. Further to the European Court of Justice decision held in the Novo Nordisk AS v. Ravimiamet case (C-249/09; 5 May 2011), 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.
Endorsements by healthcare professionals in promotional materials to other healthcare professionals are not expressly prohibited.
(iii) the information included in the endorsement must be objective, truthful, and backed up by verifiable data.
Companies should therefore be cautious to include any endorsements in advertisements to healthcare professionals, as it will always be difficult to demonstrate that such endorsement is “objective” and “verifiable by data”. The validity of such endorsements should therefore be checked on a case-by-case basis and should, in any event, be strictly limited to statements by key opinion leaders in the relevant therapeutic area who have conducted or were involved in scientific research concerning the relevant drug product.
Article 7 RDAMP, however, does prohibit the inclusion in advertisements to the general public of any recommendation by scientists, healthcare professionals or other persons who, because of their status, could encourage the consumption of medicinal products.
Under Belgian law, there is no such specific requirement. The general rules on comparative advertisement (as set forth below under question 3.5 below) should, however, be complied with. This means, inter alia, a comparative claim must be fair and may not be misleading.
should not represent the products as being an imitation or counterfeit of products with a protected brand or trade name.
In addition, the pharma.be Code of Deontology states that comparative advertisements, if necessary or useful, must present the comparator product in a manner that is fair, complete, and based on the most recently available data.
Given the general prohibition of advertising of non-approved medicines or indications (as set forth above under question 3.1), comparisons with a medicinal product that has not been authorised should be deemed illegal per se (even if these are in line with the above requirements).
As set forth above under question 2.2, the distribution to healthcare professionals by a pharmaceutical company of scientific papers (or proceedings of congresses) that refer directly or indirectly to a drug product of said company will generally be considered as advertising and be subject to the same rules set out herein. Note that such distribution by pharmaceutical companies will also be subject to the rules related to gifts to healthcare professionals (see question 4.2 below).
Pharmaceutical companies should also avoid scientific papers (or proceedings of congresses) that refer directly or indirectly to a drug product of said company are distributed on a congress sponsored by the company, as this may also be considered as (indirect) advertising by the company.
Teaser advertisements that directly or indirectly refer to upcoming data about a drug product will be considered as advertising and be subject to the same rules set out herein (including the general prohibition to promote unauthorised products or indications).
Yes. The provision of free samples is possible, provided that the rules and obligations of article 12 LMP and the Royal Decree of 11 January 1993 regarding medical samples are complied with. Further clarifications concerning these provisions are set out in Circular no. 503 of the FAMHP.
As a general principle, samples can only be provided to an HCP authorised to prescribe such product on his specific request, on the condition that for such medicinal products a marketing authorisation has been obtained in Belgium. The provision of samples is limited to 8 samples per product (in its smallest available pack size) per treating physician per year. Furthermore, each HCP may receive no more than 600 samples, in total, per year.
Article 10 LMP contains a prohibition to provide gifts to HCPs, with the exception of gifts which have a limited value, and which are directly related to the medical profession (e.g., medical/pharmaceutical scientific reference work, scientific CD-Rom, writing instruments, clinical material, IT accessories for professional use, etc.).
During the parliamentary discussions on the LMP it was acknowledged that EUR 50 per gift per healthcare professional/healthcare organisation and a maximum of EUR 125 per healthcare professional/healthcare organisation per year would be considered as “limited value”. Although these thresholds were eventually not explicitly provided for in the LMP, these amounts are considered as the standard within the entire sector (e.g., pharma.be also 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 as “directly related to the medical profession”.
Article 10 LMP contains a broad prohibition to provide 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 give donations (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 specifies 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. A typical example of a permitted donation is the support/sponsorship of a scientific congress organised by a healthcare organisation. As the scope of this exception is not entirely clear, it should be assessed on a case-by-case basis. Donations which relate 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 and treated with appropriate restraint.
No. It is not possible for the industry to give any advantages that may lead to a change in prescribing patterns as a direct result thereof.
Discounts (including volume-related discounts) are permitted if they are in line with the (general) principles of economic law (in particular those included in the CEL) 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, not possible to offer free authorised medicinal products (except in the case of samples).
The provision of additional services and of so-called “package deals” is to be considered an advantage that is related to the purchase of medicinal products, which are, in principle, prohibited by article 10, §1 LMP. However, depending on the circumstances (e.g. in the case an apparatus for administration of the medicine is offered), such advantages may arguably be considered as gifts of limited value which are directly related to the medical profession. As set forth under question 4.2, such advantages are exempt from the prohibition in article 10, §1 LMP.
These refund schemes are explicitly prohibited by article 5 §1, 10 RDAMP. The prohibition of “not-satisfied, money back” practices applies both to prescription medicines and OTC medicines.
the coverage of the costs are strictly limited to healthcare professionals concerned by the event.
For events with an overnight stay, a prior visa should be obtained from Mdeon. Mdeon has also drafted additional guidelines regarding the hospitality that can be offered to healthcare professionals in the framework of a scientific event (e.g., cost of an overnight stay is limited to EUR 250, cost of lunch is limited to EUR 40, cost of a dinner is limited to EUR 80, travel within Europe should always be in economy class, etc.).
Under Belgian Law, the rules on anti-bribery applicable to companies (private bribery) are provided in article 504bis and 504ter of the Belgian Criminal Code of 8 June 1867. The Central Anti-Corruption Department (a department of the federal police) is responsible for the detection of bribery/corruption crimes. This department can investigate breaches of the anti-bribery legislation independently from the pharmaceutical authorities.
As mentioned above under question 4.8, the provision of hospitality is governed by article 10 LMP (hospitality is only possible for scientific events) and the interpretation and implementation of this article by Mdeon. These rules apply to hospitality offered to Belgian healthcare professionals or healthcare professionals exercising their profession in Belgium, for scientific events both in Belgium and abroad. As set forth under question 4.8, the cost of a meal provided to a healthcare professional is limited to EUR 40 for lunch and EUR 80 for dinner.
Except for the provision of hospitality (registration fees, travel costs, accommodation), it is not possible to pay the healthcare professional as long as she/he does not perform any scientific services (see below under question 5.4). It is not possible to pay for the time of the healthcare professional if this time is not used for the provision of scientific services.
Although this is not explicitly provided for in article 9 LMP and the RDAMP, pharmaceutical companies may be held responsible for the contents distributed on scientific meetings organised by the company and/or sponsored by the company. For instance, if off-label information regarding a medicinal product of a company is distributed during a congress organised or sponsored by such company, it will be difficult to disprove that this off-label information is non-promotional. This is confirmed by the applicable pharma.be guidelines.
The above does not apply to information (including possible advertising) that is distributed during a scientific meeting attended by a healthcare professional to whom hospitality was provided but which is not sponsored or organised by the pharmaceutical company.
Yes. The services to be provided by healthcare professionals should be of a scientific nature and have a legitimate character. Possible services may include speaker engagements, participation in advisory boards, consultancy, clinical trial services, etc. Specific Mdeon guidelines provide that the compensation for the healthcare professionals should be (i) reasonable, (ii) proportional, (iii) consistent, (iv) a reflexion of the “fair market value of the services, and (v) be in accordance with the scope and duration of the services (e.g., in function of the complexity, level of experience of the healthcare professional, degree of urgency). The prescription behaviour of the healthcare professional should not be a factor for determining the applicable compensation. The provision of services by a healthcare professional can never be used as a means to provide (prohibited) advantages to healthcare professionals.
This is possible if the post-marketing surveillance studies have a scientific nature and legitimate character (see above under question 5.4).
This is possible if the post-marketing surveillance studies have a scientific nature and legitimate character (see question 5.4 above). As promotional materials are involved, it is advised to clearly describe the scientific nature of the services before these services are provided by the healthcare professional.
Yes, unless such advertisement: (i) gives the impression that a medical consultation or surgical operation is unnecessary; (ii) suggests that the effects of taking the medicinal product are guaranteed or that there are no side effects; (iii) suggests that the health of the patient can be enhanced by taking the medicinal product or affected by not taking the medicine; (iv) is directed exclusively or principally at children; (v) refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing, but who – because of their status – could encourage the consumption of medicinal products; (vi) suggests that the medicinal product is a foodstuff, cosmetic or other consumer product; (vii) suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural; (viii) could lead to erroneous self-diagnosis; and (ix) uses improper, alarming or misleading terms or pictorial representations (see article 7 RDAMP).
the (trade) name of the marketing authorisation holder.
Finally, please note that the principles and restrictions of article 9 LMP and article 5 RDAMP, as set forth above under question 3.1 are also applicable to advertisements of non-prescription medicinal products to the general public.
No, this is expressly prohibited under Belgian law.
Yes. If such disease awareness campaign makes no direct or indirect reference to any medicinal product, it is considered “information”, which falls outside the definition of “advertising of medicinal products” pursuant to the LMP (see also above under question 1.2).
As set forth above under question 2.3, press releases that refer, directly or indirectly, to medicinal products, will in principle be considered as an advertisement. Press releases concerning prescription-only medicines directed to non-scientific journals are therefore prohibited.
Since this material will be available to the general public, the general rules on advertisements set forth herein should be complied with.
The LMP and RDAMP do not contain provisions on relations with patient organisations. A patient organisation that has a healthcare professional among its members should, however, be treated as a healthcare organisation to which article 10 LMP applies (see questions 4.2 to 4.4 above). Pharmaceutical companies should also be careful that their public interaction with patient organisations within a specific therapeutic area does not qualify as advertisement to the general public in respect of their related drug products.
Chapter 6 of the pharma.be Code of Deontology contains rules applicable to 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 aimed at the support of healthcare or research, or (iii) sponsor events organised by patient organisations to the extent that such support is covered by a written agreement.
Pharma.be requires its members to make the support it has attributed to patient organisations available to the public on a yearly basis. As set forth under question 7.2 below, this transparency obligation has been legally anchored into the Sunshine Act, making it incumbent on all companies (and not only those who are members of pharma.be).
Advertisements through the provision of items (e.g., donation of a free scarf when buying cough syrup) is not possible, since article 5,6° RDAMP prohibits advertising through means destined to be used totally or partially for another purpose than the communication of information. It may, however, be possible to provide items to the benefit of patients, as long as this cannot be considered (directly or indirectly) as an advertisement for a specific pharmaceutical product. It might, for instance, be possible to provide a ballpoint (only) containing the name of the pharmaceutical company during a meeting with a representative (non-healthcare professional) of a patient organisation.
Notwithstanding the above, there is growing consensus that providing items for free for the benefit of a patient’s health within the framework of patient support programmes (e.g., starter-kits, education regarding the administration of the product, home care and follow-up apps) is acceptable. Currently, the FAMHP, the Minister of Health and pharma.be are drawing up guidelines relating to this practice (see also below under question 9.3).
Besides the general European regulatory requirements for disclosure of the details of clinical trials to the regulatory authorities (e.g., to the “end of trial declaration”), there are no general obligations for pharmaceutical companies to disclose the results of a clinical trial to the general public.
Yes. This requirement is set out in chapter 1 of title 3 of the Sunshine Act.
The Sunshine Act imposes the legal obligation on pharmaceutical (and medical devices) companies, whether Belgian or foreign, to document and annually disclose on the platform betransparent.be the premiums and benefits that they granted directly or indirectly to healthcare professionals, healthcare organisations or patient associations as from 1 January 2017.
Before the entry into force of the Sunshine Act, the transparency obligation for pharmaceutical companies was based on self-regulation and was hence only incumbent on companies which were bound by a self-regulatory code including such transparency obligations (such as the pharma.be Code). 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.
The transparency obligation applies to (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 based in Belgium, or (c) patient organisations based in Belgium. Please note that within the scope of the Sunshine Act, “healthcare professionals” are defined as any natural person practicing medical, dental, pharmaceutical, veterinary or nursing art or who, in the course of her/his professional activities, may prescribe, purchase, deliver, recommend, lease, use or administer medicines or medical devices and whose practice is established in Belgium. Hence, for the scope of application of the Sunshine Act, also nursing personnel are regarded as “healthcare professionals”.
The provision of such 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 notification must make public, for each beneficiary, the amounts of the premiums and benefits granted to that beneficiary during a calendar year (also, see below under question 7.3).
Yes. See above under question 7.2. Multiple deontological organisations have together created the Belgian Transparency Register of betransparent.be, which is now used for all disclosures under the new Sunshine Act. As a general principle, the companies have an obligation 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) all transfers of value to healthcare professionals, healthcare organisations and patient organisations on an individual basis (note, however, the exception set out below under question 7.4). Please note that when a premium or benefit is granted to a healthcare professional indirectly, e.g. through a healthcare organisation or corporation, the disclosure should be made on the name of the healthcare professional.
the total amount of the attributed premiums and benefits in respect of the relevant calendar year.
The Sunshine Act is, for the first time, applicable on premiums and benefits granted in the calendar year 2017. At the end of June 2018, these premiums and benefits will be made public on the betransparent.be platform. The published data remains public for three years and will be removed afterwards.
Since the publication of the transfer of value (including the healthcare professional’s personal data) takes place according to a legal basis in the Sunshine Act, an individual healthcare professional cannot object to the publication of the data mentioned in the law. Companies subject to notification should therefore not obtain prior consent to be able to publish this data in the Transparency Register. However, they must first inform the beneficiary of this publication in accordance with applicable privacy laws. This information is often provided by a clause in the contract between the company and the beneficiary.
The aforementioned general rules for pharmaceutical advertising, particularly Article 9 LMP and the principles of the RDAMP, also apply to internet advertising. The Law on Certain Legal Aspects of Services in the Information Society of 11 March 2003 (the “E-Commerce Law”) contains further specific rules on electronic advertising (on a website, by e-mail or through any other electronic means). Pharma.be also issued guidelines regarding the mandatory information to be included in internet advertising.
In general, advertisements on a website by a pharmaceutical company must comply with the following rules: (i) the advertising must contain a clearly visible, legible and unambiguous statement that it is an advertisement; and (ii) the pharmaceutical company to which the advertisement relates, must be identifiable.
As indicated above under question 6.2, it is prohibited to advertise prescription medicines to the general public. It follows that it is also prohibited to promote prescription medicines via social media, such as Facebook, Twitter, etc.
Compliance with these rules is being controlled in the same way as compliance with the general rules on pharmaceutical advertising.
There are no specific rules concerning the required website security for advertisements directed at healthcare professionals. A company should take all security means to prevent access by the general public to a website that contains prescription-only medicinal products. Lack of adequate measures will constitute a violation of article 9 LMP.
For instance, 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.
There are no specific advertising rules on links to and from websites. The acceptability of such links should therefore be assessed using the general principles applicable to pharmaceutical advertising.
Under normal circumstances, linking to independent websites is permissible as long as the inclusion of said link is not intended to circumvent the rules on pharmaceutical advertising (e.g., by referring to a website that clearly contains promotional content on the company’s drug products). As the content of such independent website can change over time, pharma companies are generally advised to include a clear disclaimer that the information on the linked webpage is outside its control and responsibility.
A company is not responsible for reverse linking undertaken by an independent party.
(iv) if the website contains a summary of the company’s specialties and refers to patient information or scientific leaflets of these products, those leaflets should be the official leaflets approved by the government.
Finally, as regards the mandatory information to be included in advertising of medicinal products to the general public (see above under section 6), the FAMHP has issued specific guidelines for internet advertising.
There are no specific rules concerning the use of social media by companies in Belgium.
The most significant development has been the enactment of the Sunshine Act, which, has entered into force on 23 June 2017 (see above under question 7.2).
Now the Sunshine Act has entered into force, all companies within the pharmaceutical sector are bound by transparency obligations and healthcare professionals will no longer be able to refuse the disclosure of transfers of values based on legal restrictions (e.g., data privacy). As mentioned under question 7.3 above, the Sunshine Act is for the first time applicable on premiums and benefits granted in the calendar year 2017. At the end of June 2018, these premiums and benefits will be made public for the first time on the betransparent.be platform.
We have noticed an increasing interest in patient support programmes financed by the pharmaceutical industry, both from the pharmaceutical industry itself and the government (as a means of limiting the healthcare budget). At this moment, the Ministry of Health, FAMHP and pharma.be are drafting a set of guidelines concerning these specific patient support programmes and their compatibility with the Belgian regulatory and compliance framework (advertising and inducement, data privacy, pharmacovigilance, etc.).

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