Healthcare is one of the most regulated sectors in Belgium, particularly when it comes to the promotion of medicinal products and medical devices to healthcare professionals (such as doctors and pharmacists) and healthcare organisations (such as hospitals). Article 10 of the Medicines Act of 25 March 1964 provides for a general prohibition on the offer or acceptance of any kind of benefit, financial or otherwise, in the context of the supply, prescription, dispensing or administration of medicinal products or medical devices. However, some exceptions, such as invitations to scientific events and premiums and benefits of negligible value, are allowed. Despite the existence of extensive literature on the subject and the publication of guidelines by Mdeon, Article 10 is still considered very much a grey area on both ends of the healthcare supply chain. This blog provides a short practical guide for compliance with Article 10.
Article 10 of the Medicines Act is intended to prevent the exertion of undue influence or pressure on healthcare professionals involved in prescribing, administering, supplying or dispensing medicinal products and/or medical devices. In accordance with Article 10, it is therefore not allowed, in the context of the supply, prescription, delivery or administration of a medicinal product or medical device, to offer or promise any premium or benefit, directly or indirectly, in cash or in kind, to wholesalers, brokers, persons responsible for prescribing (doctors), dispensing (pharmacists) or administering (nurses) medicines or to institutions where medicines are prescribed, dispensed or administered (such as hospitals). This general prohibition applies to the entire pharmaceutical supply chain, from pharmaceutical companies to healthcare professionals, as well as to any relationship of supply and demand between healthcare professionals or institutions. It is important to note that Article 10 also implies a general prohibition on the acceptance of premiums or benefits throughout the pharmaceutical supply chain. Violations are punishable by substantial criminal sanctions.
Article 10 was intended to curb excessive benefits and undue influence, not to suffocate the pharmaceutical and medical devices industry. To this end, a number of exceptions are provided for by Article 10 to allow the promotion of products in a fair and equitable way.
Premiums and benefits of negligible value
Gifts of negligible value may be offered to healthcare professionals, as long as there is a link to the practice of medicine, veterinary care, dentistry or pharmacy. Negligible value is understood as a market value of up to EUR 50 per gift or EUR 125 per year and per healthcare professional. The importance of the link between the gift and the beneficiary's professional practice cannot be overstated. Mdeon clarifies that gifts intended for purely personal use, related to private or personal events (weddings, birthdays etc.), or which, in their normal and current use, do not serve a purpose in the exercise of the profession are unacceptable. In other words, while calendars, diaries, subscriptions to medical or pharmaceutical journals, small clinical items such as surgical gloves and computer accessories for professional use, etc. are all acceptable gifts, wine, gift vouchers, iPads, watches, bottles of wine, etc. are most definitely not.
Pharmaceutical or medical devices companies may invite healthcare professionals to attend or participate in scientific events, such as seminars, conventions and scientific training courses which are sponsored, organised or otherwise supported by them. The scientific nature of the event is of paramount importance to qualify for this exception. There can be no confusion that the event, as well as the attendance of the beneficiary, is for scientific purposes. In this light, the invitation cannot be extended to other persons accompanying the invitee, such as a spouse or family member. Any hospitality offered must be reasonable and limited to meals, lodging and registration fees for the event, during its official duration. For events taking place over multiple consecutive calendar days a prior "permit" (visa) must be obtained by the organiser or sponsor from Mdeon, which will verify that the event and the hospitality offered comply with the statutory requirements. If a visa is not obtained, any benefits offered in the context of the event will be deemed to violate Article 10.
Fees for legitimate scientific services
Reasonable remuneration for legitimate scientific services carried out by healthcare professionals for pharmaceutical or medical device companies is allowed under Article 10. The scientific services designated by this exception include in particular involvement in clinical trials as well as the presentation of scientific papers at seminars or attending expert or advisory board meetings. The legitimate nature of the services is evaluated based on whether they satisfy a real need of the company and are effectively performed by a qualified consultant with the necessary expertise. The compensation must be in accordance with fair market value, consistent and proportional to the services performed. The services as well as the fees must be outlined in a written agreement.
Donations to healthcare organisations to support healthcare or scientific research
Donations and grants from the pharma and medical devices industry to healthcare organisations in order to support healthcare or scientific research (such as a grant to a hospital to support a university chair, the sponsorship of a scientific prize, a grant for humanitarian purposes) are not expressly mentioned in the law as an exception to the general prohibition of Article 10 but can be allowed on a case-by-case basis. Under no circumstances can such donations be used to stimulate or encourage the recommendation, prescription, purchase, sale, delivery or administration of medicinal products or medical devices. Nor can they be provided to individual healthcare professionals.
Rebates are not expressly mentioned in the law as an exception to the general prohibition of Article 10 but are generally tolerated by the Federal Agency for Medicinal and Health Products provided the price reduction is punctual or periodic (e.g. volume discounts on an invoice based on quantities or an annual discount dependent on a certain sales volume over a certain period) and that the same conditions are offered to parties in an identical situation (since the contrary would be tantamount to an actual “benefit” within the meaning of Article 10). Free medicinal products cannot be provided under the scope of this exception. For the sake of completeness it should be noted that stricter conditions apply to the veterinary sector. The compliance of rebates will be discussed in an upcoming newsletter.
When in doubt
The applicability of and compliance with Article 10 are assessed on a case-by-case basis. Each actor in the pharmaceutical or medical devices supply chain is obliged to ensure compliance with Article 10. While the article itself mostly adopts the perspective of the offering party, the potential beneficiary of a gift or other benefit should exercise adequate due diligence before accepting it. Mdeon's practical guidelines and ethics code, in which many potential scenarios are explained, are useful tools to help determine whether a given scenario complies with Article 10. NautaDutilh's compliance team would be happy to advise you on this subject and to assist you in achieving your compliance goals.