A scientific event organized by a third party may be organized by a separate company specializing in conference organization or by an organization in the healthcare sector. When such a scientific event is sponsored by industry, a visa (V2) is required in the following cases:

  • For events that take place over several consecutive calendar days;
  • And that 1) are organized by an association managed by a majority of healthcare professionals practicing in Belgium and/or 2) bring together a majority of healthcare professionals practicing in Belgium.

In this case, it is the responsibility of the scientific organizer of the event to submit the V2 visa application and to list all the meeting’s sponsors. The visa number obtained must then be included in all correspondence with the sponsors to inform them that the sponsorship proposal offered complies with legal and ethical provisions. In fact, the visa must be obtained before any funds are paid to the organizer. Sponsors are jointly and severally liable with the organizer for compliance with the visa requirement.

A company that additionally sponsors certain healthcare professionals to participate must submit a separate visa application (V1), independent of the organizer’s consolidated visa application for sponsorship. Under no circumstances may a company submit a V2 visa application on its own. Only when the organizer has already obtained a V2 visa but has not listed a specific company as a sponsor may that company join the application via a V2 visa application, as a substantial modification to the V2 visa already obtained.

The sponsoring of scientific events is permitted only if the sponsorship is clearly and exclusively used for the scientific component of the event.

What can be sponsored?

A company may contribute financially to the organization of a scientific event, for example by covering:

  • venue rental,
  • technical support (such as audiovisual and IT support),
  • speakers’ fees,
  • printing costs,
  • catering (provided it is limited to the scientific program).

What is not permitted?

Sponsorship of activities that do not meet the requirements of a scientific event, such as:

  • social activities,
  • recreational activities,
  • promotional activities (including booths: see below),
  • non-scientific presentations;
  • etc.

Furthermore, the sponsoring company may not exert any influence over:

  • the program content,
  • the selection of speakers,
  • the event’s target audience.

The sponsoring of scientific events is permitted only if the funds are clearly and exclusively used for the scientific component. The sponsoring company, the organizer, and any healthcare organizations share the responsibility for ensuring the proper, transparent, and verifiable use of the funds.

To prevent the funds referred to in Article 10 from being used for activities that do not meet the requirements of a scientific event, it must be clearly established in each case which costs specifically fall under the scientific component and how these are funded.

For this reason, there must always be a strict separation between activities with scientific content and those without (such as social, recreational, and promotional activities—including booths—non-scientific presentations, etc.). This separation must be demonstrable at all levels, particularly with regard to content, organization, facilities, programming, and funding, in order to prevent any confusion or undue influence.

The specific conditions for this separation are as follows:

  • The promotional or social component must be clearly separated from the scientific program and must not be part of it.
  • Social or recreational activities may not interrupt the scientific program or take place during it. They must occur exclusively before or after the scientific portion.
  • The non-scientific portion must not undermine the scientific character of the event.
  • There must be no confusion regarding the purpose or nature of the meeting; the scientific approach must remain central at all times.
  • Sponsorship by companies covered by Article 10 may only pertain to the scientific portion of the event.
  • No form of hospitality may be offered at company booths, with the exception of water, coffee, tea, non-alcoholic beverages, or other similar basic services.

The organizer remains fully responsible for the scientific independence and transparency of the event. In certain cases, a company’s contribution may help cover all or part of the participants’ registration fees or hospitality expenses, but this is permitted only to the extent that these costs relate exclusively to the scientific component of the event.

The organizer must at all times be able to demonstrate that the separation between the scientific program and other components is complete and verifiable. This means that financial flows must be clearly and unambiguously distinguishable, so that an audit can immediately determine which funds were specifically allocated to the scientific component. In this way, any confusion with social, recreational, or promotional components is ruled out. Revenue may therefore not be deposited into a single fund, as there is then a real risk that resources from companies covered by Article 10 could indirectly finance non-scientific activities, which is strictly prohibited.

It is strongly recommended that all parties involved retain detailed and verifiable supporting documentation that clearly identifies the funds received, their source, and the specific expenses for which they were used. The supporting documentation must unequivocally demonstrate that the funds were spent exclusively on the scientific component.

When a company contributes to the organization of an exclusively scientific event, it is recommended to have, prior to the granting of funding, the necessary documents certifying compliance with legal requirements. This includes, at a minimum:

  • the detailed scientific program;
  • the approved Mdeon V2 visa (if applicable);
  • a budget estimate received from the organizer, indicating the anticipated expenses for organizing the scientific event.

After the event, the organizer must have the following documents and be able to present them to the company:

  • invoices, proof of payment, and VAT receipts;
  • a detailed breakdown of expenses;
  • a comprehensive overview of income and expenses, clearly demonstrating that the funds received were not used for non-scientific, promotional, or social activities.

The financial report must include, at a minimum, the sections described in Annex A of the FAMHP guidelines. Expenses related to non-scientific activities must always be documented separately, with a clear indication of the party that covered these costs, so that, in the event of a control, it can be immediately determined how the funds were used.

Transparency and full traceability of financial flows are essential. All parties involved must keep documents available for inspection for 10 years.

! To avoid any confusion, it is recommended that financial flows be organized in such a way as to ensure a complete, clear, and traceable separation between the funds related to the scientific program and those related to the non-scientific component. Any contribution from other parties to the funding of the non-scientific component is permissible only if the contribution is organized and documented entirely separately from the scientific program, through separate and traceable financial flows, so that an inspection can unequivocally determine the origin and use of the funds. In any case, there must be no confusion whatsoever: the non-scientific component must under no circumstances be presented as being made possible, directly or indirectly, by the presence or support of pharmaceutical or medical device companies.

! The perception of healthcare professionals is also decisive: any impression that the non-scientific component is made possible, directly or indirectly, by the presence of pharmaceutical or medical device companies constitutes a prohibited indirect benefit. For this reason, the non-scientific component must under no circumstances be presented or communicated as being, even indirectly, linked to pharmaceutical companies or medical device companies.

Any funding provided by a company must be set forth in a single written contract between the sponsoring company and the organizer or healthcare organization. This contract must be clear and comprehensive and contain at least the following elements:

  • The purpose of the funding;
  • An estimate of the costs covered;
  • A clause regarding compliance with Article 10;
  • The obligation to provide supporting documentation following the event;
  • A provision regarding the handling of unused funds;
  • And, where applicable, the obligation to communicate Mdeon’s V2 approval to the sponsoring company and/or participants.

If the organizer is itself a beneficiary as provided for in Article 10, retaining the amount or a portion of the unused funds may constitute a violation of the law. In such cases, unused funds must always be refunded to the sponsors or used in accordance with the legal provisions. Beneficiaries are under no circumstances permitted to retain any remaining funds.

Payment by companies to an event organizer for a booth space is considered a purely commercial transaction. It constitutes compensation in exchange for a specific service or benefit provided by the organizer (for example, the provision of a booth space, technical support, logistical services, or visibility).

As long as the payment is limited to the commercial service provided by the organizer, it is not considered a premium or benefit within the meaning of Article 10.

It is, however, essential that the company pay a fair and market-based price, proportional to the nature and scope of the services provided. The remuneration must be transparent and based on objective criteria, such as the location, size, duration of use, technical assistance, and visibility of the booth. In principle, the same pricing terms should apply to all companies for the same services and facilities. These conditions and pricing agreements must be clearly set forth in a written contract between the organizer and the company.

Although payment for the booth space is in itself a permissible commercial transaction, this payment may under no circumstances—either directly or indirectly—be used to  grant an advantage to healthcare professionals.

Consequently, the payment made for a booth may not be used to cover the registration fees of healthcare professionals; travel or accommodation expenses (such as transportation, hotel, meals); any form of hospitality, whether at the company’s booth or elsewhere during the event; or the funding of conferences, presentations, or other non-scientific program elements that could be considered a benefit to healthcare professionals.

If the payment for the booth space is used in whole or in part to finance direct or indirect benefits for healthcare professionals, the transaction loses its commercial nature. In this case, it constitutes a prohibited benefit.

For a brief summary, click here.

6.9.1  The organizer of a scientific conference taking place in Belgium has a visa number for its sponsors. Do I need a separate visa number if my company invites professionals to the same conference?

Yes. This is in fact a different form of sponsorship, namely the sponsorship of “participants” (rather than the organizer), which requires a specific visa application using the “V1” visa application form titled “sponsorship of participants in a scientific conference.”

6.9.2  Is a visa required when a company sponsors the organizer of an event taking place abroad?

Yes, if the meeting is organized by an association (or on behalf of an association) led by a majority of healthcare professionals practicing in Belgium, or if the majority of participants are healthcare professionals practicing in Belgium.

6.9.3  What is a detailed budget?

A budget consists of at least two columns: revenue and expenses. Revenue includes registration fees for the meeting (a preliminary estimate), industry sponsorship, any grants, any equity capital, etc. The expenses column summarizes all meeting expenses, broken down by expense category and corresponding amounts. For a detailed budget template, click here.

If the sole source of revenue is industry sponsorship and the total amount is used by the organizer to cover all incurred costs, expenses related to hospitality (lunch, dinner, accommodation, etc.) must not exceed the maximum amounts specified in FAQ 8.1, and no social or cultural activities may be planned.

If it is a scientific event (such as a conference) that does not consist exclusively of scientific aspects (such as booths, social activities, non-scientific themes, etc.): see FAQ 6.3–6.5.

6.9.4  Does the budget have to be balanced?

Not necessarily. However, the organizer must state in the visa application that any profits generated will be refunded or used in accordance with Article 10 of the Law of March 25, 1964, on Medicines. Furthermore, by submitting the visa application, the organizer agrees to notify the Mdeon Secretariat via email of the amount and allocation of the final accounts within three months of the end of the scientific meeting.