Legal frame and Code of Ethics

Article 10 of the law of March 25, 1964 on Medicinal products for human use (also applicable to medical devices) includes the general prohibition on offering or granting advantages or benefits of any kind or even pecuniary to healthcare professionals and healthcare organizations, either directly or indirectly, in the context of prescribing, issuing and supplying medicinal products or medical devices.

This prohibition comes from a European Directive which is already implemented in several member states (the Netherlands and France have also developed a prior visa procedure).

One exception in this regard is inviting healthcare professionals to a scientific meeting and covering their participation costs, including hospitality, provided that this event meets the cumulative conditions set out in Article 10.

That’s why as from January 1^st, 2007 each producer or supplier of medicinal products or medical devices wishing to invite a healthcare professional to take part in a scientific event which takes place during several consecutive calendar days, is required to have a prior visa.

The visa procedure makes it possible to assess the program and whether the hospitality offered as part of a scientific event complies with the cumulative conditions set out in Article 10 of the law on medicinal products.

For companies that manufacture veterinary drugs, the legal basis is Section 47(5) of the Veterinary Drugs Act of May 5, 2022.

The visa procedure is based on the Mdeon Code of Ethics and applies the legal criteria described in article 10 of the Law on Medicines.

The Code of Ethics is presented in two columns. The column on the left contains the articles of the Code. The one on the right contains Practical Guidelines, our User’s Manuals and an article-by-article reference to the corresponding FAQs.

To whom does the above-mentioned prohibition on offering premiums and advantages apply?

The prohibition set out in Article 10 has a very broad scope and covers all natural and legal persons – both in Belgium and abroad – involved in activities carried out in the context of the prescribing, dispensing, administering or use of medicinal products and/or medical devices. This includes, among others:

• manufacturers, importers and distributors of medicinal products for human use;
• intermediaries in medicinal products;
• holders of a marketing authorization or registration for medicinal products;
• companies that manufacture, import, supply or distribute medical devices or their accessories.

The law does not contain an exhaustive list: other actors — such as associations of healthcare professionals — may also fall within its scope if their activities are related to the acts described in Article 10.

As soon as there is a link with the supply, dispensing or administration of medicinal products or medical devices, Article 10 applies — regardless of the other activities of the company. A mixed portfolio within a company may not lead to a circumvention of Article 10 of the Law on Medicinal Products for Human Use.
Example: a company that distributes both medicinal products and food supplements falls under Article 10, even if the majority of its activities fall outside the scope of the law.

To whom does the above-mentioned prohibition on accepting premiums and advantages apply?

Natural and legal persons

Article 10 of the Law on Medicinal Products for Human Use applies to natural and legal persons authorized to exercise their professional activity in Belgium or having a place of practice, business establishment or registered office in Belgium. Only persons who no longer hold a visa as provided for in Article 10 of the Law of 22 April 2019 on the quality of healthcare practice, nor an INAMI/RIZIV/NIHDI number, fall outside the scope.

The following persons may not, in the context of their professional activities and within their legal competences, request or accept premiums or advantages when these are contrary to Article 10 of the Law on Medicinal Products for Human Use.

With regard to medicinal products:

• Wholesalers and intermediaries
• Prescribers (healthcare professionals): physicians (all specialties, including general practitioners and specialists), dentists, midwives and veterinarians, each within their respective scope of practice (although veterinarians are not included in the Law of 10 May 2015, they are considered prescribers under medicines legislation within their own scope of competence)
• Dispensers (healthcare professionals): pharmacists (in community pharmacies open to the public or in hospital pharmacies) and pharmaceutical-technical assistants, each within their respective scope of practice
• Administrators (healthcare professionals): in addition to those authorized to prescribe or dispense medicinal products, this includes, among others, nurses, care assistants, paramedics, …

With regard to medical devices and IVDs:

• Wholesalers and intermediaries
• Healthcare professionals authorized to prescribe, dispense, administer, use or rent medical devices

Healthcare organizations

Institutions are also subject to Article 10 and may not request or receive premiums or advantages that are contrary to the legal provisions. This includes hospitals, nursing and care homes, private clinics, rehabilitation centres, home care services and similar healthcare institutions.

Not only the institutions themselves fall within the scope, but also all persons involved within them in the prescribing, dispensing, administering or use of medicinal products and/or medical devices, such as hospital directors, hospital technicians, purchasing committees, …

Associations, organizations or civil partnerships of healthcare professionals (such as general practice groups, associations and other structures through which one or more healthcare professionals organize their professional activities) also fall within the scope of Article 10 of the Law on Medicinal Products for Human Use. This applies regardless of their legal form, organizational structure or the way in which they organize their activities.
Where such entities act as organizer, intermediary or contracting party in a context where medicinal products or medical devices are prescribed, dispensed, used or administered (e.g. scientific events, continuing education), they are subject to the same prohibition on requesting or receiving premiums or advantages as individual professionals.

Although professional associations are not directly targeted, care must be taken to ensure that no (direct or indirect) premiums or advantages are granted to healthcare professionals via such associations. This must always be assessed on a case-by-case basis.

Patients or patient organizations are not targeted as beneficiaries. However, premiums and advantages granted to patient organizations in which healthcare professionals are also active may not benefit those professionals (e.g. participation of healthcare professionals in an event), but must be used exclusively for the activities of the organization that benefit patients (e.g. purchase of a wheelchair, organization of patient activities, …). However, it should be noted that, for the purposes of the Sunshine Act, patient organizations are considered beneficiaries.

Which premiums and benefits fall under the prohibition?

The concept of “premiums and advantages” is interpreted broadly and covers any form of financial, material or immaterial benefit that directly or indirectly provides an advantage to the healthcare professional or organization concerned. The assessment is based on the economic value and the potential impact on professional independence.

Examples (non-exhaustive):

• Financial advantages (funding of participation in scientific events, monetary rewards, discounts that are not market-conform or not objectively justified, reimbursement of costs by companies without a legal or contractual basis)
• Benefits in kind or material advantages (e.g. gifts or gadgets that do not meet the conditions of “very low value”, making goods, equipment or instruments available free of charge or at non-market-conform conditions, free or underpriced services that are normally paid for)
• Services and performances without invoicing or at non-market-conform conditions (such as free or non-market-conform maintenance, repairs or loan of medical devices where such services are not demonstrably included in the total price and do not fall under the low-value rules, presence of company staff in the operating theatre or other clinical environment, unless such services are included in the total price or separately remunerated at market value)

In these cases, the advantages are considered indirect, as the company bears costs or burdens that would otherwise fall on the healthcare professional or institution.