New Mdeon rules applicable as from 1 January 2023

Introduction

Mdeon, the legally recognised Belgian ethical platform for healthcare professionals and the pharmaceutical industry, announced several new ethics rules applying from 1 January 2023. The present blog post discusses their practical importance for the broader healthcare community, and particularly (i) several new ethic rules in light of the ascendant trend of virtual and hybrid scientific events, and (ii) new maximum hospitality amounts that can be offered to healthcare professionals.

Background

The Mdeon Code of Ethics (the “Code”) does not have the status of a law or executive order, but nevertheless contains a set of essential rules that flesh out the legal criteria pertaining to inter alia the participation of healthcare professionals in scientific events. The Code must be read in light of Article 10 of the Act of 25 March 1964 on medicines (the “Medicines Act”), the latter constituting the basic legal framework with respect to the promotion of medicinal products and medical devices towards healthcare professionals.

Article 10, §1 of the Medicines Act principally prohibits – in the context of supplying, prescribing, dispensing or administering medicinal products – to promise, offer or grant, directly or indirectly, premiums or benefits in cash or in kind to a broad category of healthcare professionals. This prohibition should shield those professionals from being unduly influenced in their choice of medicine. Article 10, §2 of the Medicines Act provides for a number of exceptions to this general prohibition, including the invitation and the payment of participation costs in a scientific event (including hospitality costs) of healthcare professionals.

Recognition of virtual and hybrid scientific events

The rise of virtual and hybrid scientific events since the COVID-19 pandemic has prompted a change of the Code in this regard.

Article 1.4, 2° of the Code now clearly states that a ‘scientific event’ can refer to a physical, virtual or hybrid event. The latter two are defined by the revised Article 3.2 of the Code, particularly as “a scientific event in which the healthcare professional participates individually and virtually, from anywhere, by logging in via a PC, laptop or any other medium”, respectively “a scientific event in which the health professional can choose between a physical or virtual participation”.

In the framework of a hybrid event, the participant’s choice to attend physically or virtually affects the applicable legal regime. Physical participation means that the rules for physical events will apply, while virtual participation triggers the slightly different rules for virtual events. Reference can be made to the following differences:

• Mdeon’s practical guidelines concerning Article 4 of the Code prescribe that at least six hours per day must be devoted to scientific activities during normal office hours to safeguard the predominant scientific nature of the event. This rule does not apply to exclusively virtual scientific events, which do not require a minimum number of hours of scientific activities.

• Also, the hospitality offered to healthcare professionals within the framework of a virtual scientific event is limited to the event’s registration fee (Article 5.1, 2^nd section of the Code). The virtual nature of the event makes the offering of meals or other hospitality redundant.

• Lastly, Mdeon’s practical guidelines concerning Article 16 of the Code state that a virtual scientific event of which the registration fee is paid and takes place over several consecutive days, is still subject to a visa obligation. This is not the case for ‘on-demand’ virtual scientific modules. Sponsoring the registration fee for the latter is considered as a gift which does not fall under the prohibition of Article 10, §1 of the Medicines Act if it does not surpass the maximum amount of 50 EUR per Mdeon’s guidelines on Article 2 of the Code.

Hospitality amounts are increased

As mentioned above, the invitation and payment for participation in a scientific event (including the hospitality) of a healthcare professional are exempted from the prohibition of Article 10, §1 of the Medicines Act. Hospitality refers to the costs that enable a healthcare professional to attend a scientific event. Examples include transport, meals and/or lodging. Article 5.1. of the Code clearly states that such hospitality “must always be reasonable and remain secondary to the scientific aims of the event”.

Mdeon has taken into account the rising costs of living and has increased the cost-ceiling for hospitality. There is now a maximum of 45 EUR for a lunch (including drinks), 90 EUR for a dinner (including drinks) and 23 EUR for a coffee break. Nevertheless, a maximum of 135 EUR per day comprising at least six full hours of scientific activities must be respected. In case the threshold of six hours is not reached, a maximum of 23 EUR per full hour of scientific activity may be spent on meals. For overnight stays, the maximum price per night is elevated to 250 EUR (breakfast and taxes included). An exception applies to destinations where, according to the Ministerial Decree of 2 July 2018, the maximum subsistence allowance exceeds the amount of 250 EUR.

Conclusion

As already mentioned, the new Mdeon rules have started applying from 1 January 2023 onwards, and  compliance with Mdeon’s revised Code and all its associated guidelines is therefore advised in order to continue to benefit from the exception laid down in Article 10, §2, 2° of the Medicines Act.

Should you have questions in this regard, Kirian Claeyé or Bart Junior Bollen will be happy to help you.

Written by

• Kirian Claeyé

  Partner

• Bart Junior Bollen

  Associate