MedTech Europe and the end of direct sponsorship of healthcare professionals - Practical aspects from a Belgian perspective

In Belgium, the costs of healthcare professionals’ participation in scientific events (expert meetings, congresses, investigator meetings, medical training, lectures, etc.) may be borne by the pharmaceutical and medical devices industries subject to strict legal requirements.

Since 20041, the Belgian legislation regulates with great detail the provision of gifts, advantages or benefits to healthcare professionals.

Since 20072, the common ethical platform Mdeon establishes a framework by means of "visas" (prior authorisations), required for the participation of these professionals in scientific events taking place during several consecutive calendar days (including the hospitality related thereto), whereas the Federal Agency for Medicines and Health Products (FAMHP) ensures that the legislation is complied with and sanctions potential offences.

Months ago, MedTech Europe’s member companies have begun preparing themselves for the ban on direct sponsorship, ie the interdiction to select and sponsor directly, on an individual basis, healthcare professionals taking part to third party organised educational events. As of 2018, prior to any sponsoring request, funding will have to go through an umbrella healthcare organisation overseeing healthcare professionals and responsible of selecting the professionals benefitting from the sponsoring (indirect sponsorship).

Who is concerned by the ban?

On the one hand, members of MedTech Europe, the association representing the European medical technology industry. The rules enacted by this international non-profit organisation will be applicable as of 01 January 2018 to member companies which have joined the association on a voluntary basis, namely ca. 100 medical technologies companies. Other members of MedTech Europe, ie local medical technology industry associations (such as beMedTech in Belgium) will have to transpose these rules into their local ethics codes by 01 January 2020 at the latest.

On the other hand, healthcare professionals, defined as any individual (with a clinical or non-clinical role; whether a government official, or employee or representative of a government agency or other public or private sector organisation; including but not limited to, physicians, nurses, technicians, laboratory scientists, researchers, research co-ordinators or procurement professionals) that in the course of their professional activities may directly or indirectly purchase, lease, recommend, administer, use, supply, procure or determine the purchase or lease of, or who may prescribe medical technologies or related services.

What does the ban consist of?

As of 01 January 2018, member companies of MedTech Europe will no longer be able to finance directly the participation of healthcare professionals to third party organised educational events, regardless of whether the professionals are acting as speakers or merely as participants.

As a consequence, the selection of healthcare professionals and payments for their attendance costs in the context of educational events organised by third parties will necessarily have to be made through a healthcare organisation, to which healthcare professional(s) ultimately benefitting from the financial support relate.

MedTech Europe’s ban on direct sponsorship is not absolute and the following sponsoring options will remain possible after 01 January 2018:

• by way of exception, direct sponsoring of healthcare professionals for their attendance at third party organised procedure trainings - the focus of which is the safe and effective performance of one or more clinical procedures - may still occur
• the same applies to consultancy agreements contracted for scientific services with healthcare professionals
• member companies of MedTech Europe remain free to give grants directly to healthcare organisations - provided that their national legislation allows it, and
• member companies may also invite healthcare professionals directly to company events (ie events which they organise themselves, in compliance with the MedTech Europe Code as well as local laws and industry codes).

It is important to note that the above distinction between company events, third party organised procedure trainings and third party organised educational conferences has limited interest under Belgian law, which only provides for the concept of “scientific event”. The concept “includes all forms of scientific meetings such as congresses, gatherings, symposiums, scientific training courses, etc. which unite together healthcare professionals” (Mdeon Code of Ethics (article 3)). The title or qualification of the event is of little importance, it is the scientific content that matters.

What is the impact of this new regime for health sector stakeholders in Belgium?

The first group of stakeholders concerned are self-employed healthcare professionals who are practicing in a (semi-)individual configuration in Belgium, ie all those who are not part of a healthcare organisation (for instance, a healthcare establishment, a hospital, or a medical or scientific association). This group will no longer be able to enjoy direct financial support from MedTech Europe’s member companies in order to participate in trainings or other educational events organised by third parties.

The impact will be just as important for Belgian healthcare organisations and European healthcare organisations seated in Belgium or managed by a majority of healthcare professionals practicing in Belgium. As of 01 January 2018, it is expected that they will have to be able to introduce - jointly with MedTech Europe member companies - applications for Mdeon authorisations (visas) required for the participation of healthcare professionals in scientific events taking place over several consecutive calendar days. It is to be hoped that administrative staff within healthcare organisations will be trained on time in the joint visa application system set up by Mdeon, and that healthcare providers directly concerned by this new set of rules will be informed and educated about the main changes.

Member companies themselves will have to become accustomed to collaborating with the healthcare organisations referred to above. Mdeon requires that the draft joint visa application be completed by the healthcare organisation on the Mdeon website, in the name of the member company sponsoring the scientific event, before the request is sent to the member company, which is ultimately responsible for verifying, paying for and submitting the final application. Another underlying trick of this new configuration is the loss of control that the company sponsoring the scientific event used to have, especially when it comes to the effective use of the financial support by the organisation and the professional(s) in practice, whereas the same sponsoring company is at risk of sanctions of a criminal nature in case of a breach of the Belgian legislation regulating Mdeon visas.

In practice, therefore, it seems difficult to envisage that the current Belgian regulations - one of the most rigorous in Europe - may co-exist with the additional requirements imposed by the European medical device industry (MedTech Europe) summarised above.

Key takeaways

So far, the supply of gifts, advantages and benefits to healthcare professionals practicing in Belgium has been subject to strict substantive and formal requirements, which as a general rule provide an ex ante guarantee that interactions between the medical industry and healthcare professionals are of an ethical nature, notably through the Mdeon visa. The upcoming Royal Decree implementing the new Sunshine Act3 - expected in the coming weeks - will further allow an ex post monitoring by imposing transparency in such interactions.

As stated in Mdeon’s annual report for the year 2016, there is no evidence that direct sponsoring may be less or more ethical than direct sponsoring. This evolution should therefore be monitored with a view to examining how the new European rules will be understood and complied with by stakeholders in Belgium, not only at industry level but also with respect to healthcare organisations which will have to become familiar with the Mdeon visa application process.

This contribution is based on an article from the authors published in French language in the Belgian newspaper Le Spécialiste / De Specialist (n° 106).

1 Act of 16 December 2004 modifying the regulation of the fight against excessive promotion of medicinal products. 
2 See for example the Royal Decree of 25 February 2007 granting approval to the entities referred to in article 10, par. 3, of the Act of 25 March 1964 on medicinal products. Each approval has been renewed on a yearly basis since 2007. 
3 Articles 41 and seq. of the Act of 18 December 2016 on various health-related matters.