Pharmaceutical Advertising 2019

Last Updated June 11, 2019

Belgium

Law and Practice

Authors



QUINZ The firm is based in Brussels and has a strong focus on life sciences, with a 12-strong team assisting the global, regional (EMEA, LATAM, APAC) and local (Belgian, Luxembourg and the Netherlands) legal departments of pharmaceutical companies on a broad array of strategic, operational, licensing and M&A transactions throughout the life cycle of a life sciences product. Quinz has also developed sound expertise in regional and local regulatory work (including pricing and reimbursement, clinical trials, data transparency, marketing authorisation procedures, cGMP) and compliance matters (including transfers of value, promotion of drug products, antitrust compliance questions and patient directed programmes).

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 (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
  • organise 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. 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 professional'.

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 (in)direct 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 the information provided is strictly necessary to answer said particular request, and it does not contain unsolicited promotional content (for the distinction between information and advertising, please see 2.2 Difference Between Information and Advertising).

The definition and exclusions that Article 9 of the LMP provides 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, §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 intends to promote or enhance sales 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 to a medicinal product, is not regarded as advertising. Therefore, disease awareness campaigns would typically not qualify as advertising.

For borderline cases pharmaceutical companies often apply the following rules of thumb to mitigate the risk of a requalification 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 requalification 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 also 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:

  • 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.

Moreover, pursuant to the pharma.be deontological code, comparative advertisements must present the comparator product in a way that is fair, complete, 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 per se (ie, even if such comparison is in line with the above requirements).

Article 9 LMP explicitly forbids all advertising of medicines that are not yet authorised or off-label indications. However, this prohibition applies only to advertisements and not to medical information (see 2.1 Definition of Advertising). Note also, as indicated in 2.1 Definition of Advertising, that the provision of 'unsolicited' medical information does not constitute an advertisement of a pharmaceutical product, regardless of who requests such information. 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. Such publications, however, 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 such information was shared upon the unsolicited request of said relevant third party.

Such information to healthcare institutions is likely to be considered an advertisement on unauthorised medicines or indications in breach of Article 9 LMP, unless said healthcare institutions expressly requested this information.

Belgian law expressly prohibits the advertising of prescription-only medicines to the general public.

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

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

Pursuant to Article 5 RDAMP, certain means for the advertising of 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 (in)direct compensation should the patient be 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.

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 (Article 9 LMP). Moreover, the applicable legal framework and deontological codes rule 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 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:

  • 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 the case of radio advertisements, such an invitation must be explicit and clearly audible; and
  • the (trade) name of the product’s marketing authorisation-holder.

There is no legal or deontological rule that requires 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, below). 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 contains 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 can now also be found in the Sunshine Act, making it incumbent on all companies (and not only the members of pharma.be).

As regards advertising to the general public, Article 7 RDAMP expressly prohibits the inclusion of endorsements by healthcare professionals. Such advertisements may not refer 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.

As set forth 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 (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:

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

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.

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). Such distribution by pharmaceutical companies will also be subject to the rules related to gifts to healthcare professionals (see 6.1 Requirements for Prior Notification/Authorisation).

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 postpone 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:

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

For the advertising on medicinal products on social media, the same rules apply as set forth above in 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 prescription-only medicinal products, as a lack of adequate measures will constitute a violation of Article 9 LMP.

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).

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

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, which are set forth in 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 deontological code 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 Professionals). Article 10 LMP, however, determines that this is only allowed if:

  • the event is by its nature exclusively scientific;
  • the hospitality is strictly limited to the scientific objective of the event;
  • the location, date and duration of the event do not create confusion about the scientific nature of the event;
  • the financial contribution to the participation (including the offered hospitality) is strictly limited to the official duration of the event; and
  • the coverage of the costs 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 (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 9.2 Limitations on Providing Samples to Healthcare Professionals, or other very specific circumstances that will require expert regulatory assistance).

This 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 31 May 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 remain 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, Section 1, 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 also 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 EUR 180,000 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).

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. Since pharmaceutical professional associations have their own mechanisms to take corrective measures intra muros and since very often a confidential settlement is reached before an infringement is brought before court there is very little case law available on the subject.

The 'Implant Files' have however created public awareness of the fact that certain premiums and benefits to healthcare professionals and donations to healthcare organisations could be used to enhance or maintain a certain prescription behaviour. It is not unlikely that the authorities will increase their scrutiny in this respect.

QUINZ

Business & Mediapark
Medialaan 28B
1800 Vilvoorde
Belgium

+32 (0)2 255 73 80

+32 (0)2 253 42 19

info@quinz.be www.quinz.be/node/38
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Trends and Developments


Online medicines advertising: Key considerations

Digitalisation and advertising for medicines: It is a complex marriage. On the one hand, online communications have clear advantages, as they allow, among other things, real-time access to, greater volumes of and faster dissemination of information. On the other hand, online communications also create challenges, especially in the medicines advertising sphere. Precisely because of its impact, volume and speediness, online content is typically harder to control than offline content – regulators sometimes struggle to apply the medicines advertising rules to online content.

So how do the medicines advertising rules apply to online content? This brief contribution reiterates the key principle under EU law, namely that the rules that apply in an offline context also apply online (Section I). It then focuses on how the “traditional” concepts of pharma advertising apply in the online sphere, zooming in on one concrete example, namely disease-awareness websites (Section II). Finally, we discuss the difficult jurisdictional questions that multi-country websites can raise (Section III).

I.       The mantra: What applies offline applies online

In the EU, most regulators take the view that what applies “offline” also applies “online”, meaning that the medicines advertising principles that apply to, say, a physical brochure, also apply in an online context.

The key principles that (also) apply to websites and that are discussed in this guide, include the following: First, various countries (including all EU countries) prohibit direct-to-consumer (“D2C”) promotion of prescription-only medicines. When using social media, companies therefore need adequate processes to establish and target the appropriate audience. While in the US, the Food and Drug Administration (FDA) allows the promotion of prescription drugs through social media, like Facebook, that is not possible in the EU. Second, pre-approval promotion is unlawful in most large jurisdictions, such as the EU and the US, regardless of whether the target audience are healthcare professionals (“HCPs”) or patients. Websites that promote investigational products not already placed on the market are therefore prohibited. Conversely, websites that provide non-promotional information on certain investigational compounds could be permissible, but the line is very thin. Third, online promotion for medicines needs to provide certain specific information on the medicine, which again varies depending on the target audience. Finally, depending on the country, certain pre-vetting requirements could apply and prior authorisation could be required by local authorities for online advertising.

II.       Application of offline principles to the online sphere: “advertising” v information and disease-awareness websites

Where does information stop and “advertising” begin?

Under EU law (and a similar logic applies in the US), non-promotional information does not constitute “advertising.”

Pursuant to EU Directive 2001/83 (the “Medicines Directive”) advertising for medicines is any information “designed to promote the prescription, supply, sale or consumption of medicinal products” (Article 86). The Court of Justice of the European Union case-law has further explained that the (perceived) intention to promote is key (See MSD Case, CJEU C-316/09).

Information about medicines that is not intended to promote the product is, therefore, not “advertising” under the Medicines Directive, which contains certain express carve-outs from the scope of “advertising”, such as “factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists” or disease-awareness information. In practice, information may not fit under any of these express carve-outs. The question then often becomes whether the information forms part of a genuinely non-promotional message, sometimes referred to as forming part of a “scientific exchange.”

In the EU, the doctrine of a “scientific exchange” is not particularly well-defined as there is no express carve-out from the concept of advertising. Some national laws and self-regulatory codes do confirm; however, that their rules do not restrict or regulate scientific exchanges. For example, in the UK, the exception for scientific exchange is quite explicit: The UK Association of the British Pharmaceutical Industry Code, for instance, provides that “the legitimate exchange of medical and scientific information during the development of a medicine is not prohibited provided that any such information or activity does not constitute promotion.”

Thus, when determining whether online information on medicines is allowed, companies should never lose sight of the very basic question: Does this website/post/campaign/email constitute advertising or not? If not, then the advertising rules will not apply. The line between “advertising” and non-promotional information is often thin and depends on a variety of factors, such as the content and purpose of the message, its target audience, the role of the person disseminating the message, the scale and a reactive v proactive context, etc.

Specific example: Disease-awareness campaigns

“Disease-awareness campaigns” are an example of online communications that companies use more and more often. They illustrate just how nuanced and fact based the analysis can be under EU advertising rules.

Pursuant to Article 86(2) of the Medicines Directive, “information relating to human health or diseases” is carved out from the scope of the “advertising” rules, “provided that there is no reference, even indirect, to medicinal products.”

As a result, a website that constitutes a true “disease-awareness campaign”, which does not refer (even indirectly) to medicines, is not subject to the EU rules on advertising.

Let us apply this to a hypothetical example of a website, hosted by company X, which discusses five different treatment options for disease A. The treatment options vary depending on the mode of action. Company X has produced three medicines that correspond to three out of the five discussed modes of action. Some, but not all, of these products are approved in the EU.

To fall outside the medicines advertising rules, the disease-awareness website may not refer “even indirectly” to specific medicine(s). How strictly this applies varies between EU countries. France, for instance, is known to take a very strict stance on this. If, in our example, company X is the only company that has developed (a) product(s) with the relevant mode of action, the website may well be deemed to refer indirectly to the product. In that case, some regulators may well take the view that the website identifies a particular product and apply the advertising rules to the website.

•       If the website is patient-facing:

First, as mentioned, EU law prohibits D2C promotion for prescription-only medicines. Nonetheless, EU law permits the use of patient-facing websites that intend to provide information on a particular disease but do not seek to promote a particular product, even if the disease in question is only treatable with prescription medicines. Thus, depending on the specifics of the website regarding disease A, this website could be permissible.

The key factor is what the (perceived) aim is of the website. Disease awareness is traditionally where one raises the profile of a disease and its symptoms and is, not by law but in practice, often a consumer-facing concept. In such cases, the website should not be overly sophisticated, so that it can be understood by patients. If the website goes into great scientific detail on different modes of action, for instance, regulators may question whether the purpose of the website is indeed to provide easily digestible information on a disease or, instead, to raise the profile of certain therapies with that particular mode of action – raise patients’ interest in those particular therapies.

Second, another factor is whether the product(s) is (are) identifiable, as explained above.

•       If the website is HCP-facing:

First, as mentioned, EU law prohibits pre-approval promotion (regardless of target audience). Nonetheless, EU law permits HCP-facing websites that intend to educate HCPs on a particular disease but do not seek to promote a particular product, even if (some of) the treatment options are still investigational.

If the information on the various modes of action is indeed factual, balanced, accurate and does not highlight the strengths of medicines that have a particular mode of action, the information may well be considered to constitute non-promotional information. Depending on the country and the applicable rules (eg, France v UK; regulatory guidance v self-regulatory codes), the website could qualify as “health education information”, “disease-awareness information” or a form of “scientific exchange”. The terminology is not set in stone.

Second, another factor is whether the product(s) is (are) identifiable, as explained above.

Whether or not the website is HCP- or patient-facing depends primarily on the content of the messaging, but other techniques such as access blocking, HCP identification banners, language in terms and conditions, etc, may have a bearing on this. In some EU countries, access blocking or other means of HCP identification is mandatory. In other EU countries, access blocking is only one aspect in determining the target audience and/or permissibility of the website.

III.       Cross-country websites: What law applies?

A website rarely stops at a country's borders. This not only adds an additional layer of complexity to online medicines advertising but also creates opportunities, as it opens the door for jurisdictional strategies. Such strategies require, however, thorough analysis and reflection. We provide some thoughts below.

Rather than take a country-by-country approach, pharmaceutical companies often use international (ie, “above country”) websites to streamline the way they present information to a global intended audience. They sometimes do this to bring the website within (or outside) reach of regulators in one particular country.

Establishing the law/regulatory code that governs a particular website and tailoring content accordingly are indeed key when creating online content on medicines. In the EU, a medicines regulatory authority will typically only seek to exert jurisdiction against a website if that site is established in that country (“country of origin”) or if it targets consumers in that particular country (“country of destination”). Satisfying either of these criteria is often sufficient for regulators to take enforcement action against the pharmaceutical company responsible for a non-compliant website.

Some regulators focus on the “country of destination” rather than “country of origin” principle. For that reason, some companies choose to “root” their website to a jurisdiction with a relatively flexible approach to medicines advertising and communications. Another “tool” consists of clauses regarding the governing law and intended audience in the terms of use, sometimes coupled with explicit disclaimers.

Having an above-country website does not eliminate the risk that regulators in a particular country, inside or outside of the website’s intended audience, determine that it is within their jurisdiction. One should therefore not readily assume that placing information on an international website brings it outside a particular regulator’s reach. Depending on how that regulator applies the “country of origin” v “country of destination” principles, authorities may well decide to examine the content of the website, for instance, against local advertising codes.

Companies that host product-specific websites targeting HCPs, for instance, may be faced with similar but slightly divergent requirements between EU countries (eg, what product-specific information must that website contain, must the price be mentioned, etc). Certain companies in the market have decided to work with EU-level product websites, in conforming with EU law and the European Federation of Pharmaceutical Industries and Associations rules. While this is a sensible approach in many respects, the difficulty is that by stating that the target audience is the “EU”, some regulators could conclude that this website targets visitors in each and every EU member state. While complying with the principles of the EFPIA code might be sufficient for some authorities, it might not be where national rules are more stringent than EFPIA’s or have very specific requirements.

As a general rule, an international website should be clear as to its intended audience, contain content that is appropriate for that audience and provide factual and balanced information. Applying that rule, however, often proves to be a tricky balancing exercise.

Covington & Burling LLP

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QUINZ The firm is based in Brussels and has a strong focus on life sciences, with a 12-strong team assisting the global, regional (EMEA, LATAM, APAC) and local (Belgian, Luxembourg and the Netherlands) legal departments of pharmaceutical companies on a broad array of strategic, operational, licensing and M&A transactions throughout the life cycle of a life sciences product. Quinz has also developed sound expertise in regional and local regulatory work (including pricing and reimbursement, clinical trials, data transparency, marketing authorisation procedures, cGMP) and compliance matters (including transfers of value, promotion of drug products, antitrust compliance questions and patient directed programmes).

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Covington & Burling LLP offers one of the largest and most comprehensive life sciences industry-focused practices in the world. Our clients, spanning all industry sectors and ranging from start-up ventures to multinational corporations and trade associations, trust us with their most challenging business problems. They know that they can rely on Covington for practical, efficient solutions rooted in a sophisticated knowledge of their business that only comes from deep immersion in the industry and decades of dedicated service.

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