1. Sunshine Act: chapter 1 of title 3 of the Law of 18 December 2016 regarding various provisions on health, Belgian official Journal 27 December 2016.
  2. RD Sunshine Act: Royal Decree of 14 June 2017 executing the Sunshine Act, Belgian official Journal 23 June 2017.
  3. Company subject to notification: any entity that carries out an economic activity, irrespective of its legal form and the manner in which it is financed, as referred to in Title VII of the Treaty concerning the functioning of the European Union, in particular holders of Placing on the market of medicinal products for human or veterinary use, importers, manufacturers and distributors of medicinal products for human or veterinary use, persons engaged in the brokering of medicinal products for human or veterinary use, and distributors, retailers and manufacturers Medical devices (art. 41, §1, 1°, Sunshine Act). Both companies established in Belgium as abroad are included in the concept of “company subject to notification”.
    1. What if a company is part of a group with different entities?
      Companies that consist of different legal entities, whether or not in different countries, may choose to combine their disclosures in a single publication. In this case, the company subject to notification that performs the disclosure must explain in an explanatory note which legal entities (both Belgian and foreign) were exactly grouped in this single disclosure. This explanatory note can be consulted in the transparency register. In addition, the company concerned that has made the disclosure, must at all times and at the first request be able to provide all the details to the competent authority in the context of a control (the FAMHP) regarding the disclosed premiums and benefits (which entity has done exactly what for the benefit of whom).
    2. What about companies that also have other products in their portfolio?
      If, in addition to medicinal products and medical devices, companies also have other products on the market, e.g. food supplements and cosmetics, these other products also fall within the scope of the Sunshine Act, unless these other products are part of a separate legal entity with a separate company number.
    3. What about companies that are not based in the European Union?
      Companies subject to notification which are established outside the European Union must notify the notification by and in the name of an affiliated company within the meaning of Article 11 of the Company Code, which is established in the European Union, or, failing that, by a legal representative established in the European Union (Article 3, paragraph 1, 3°, RD Sunshine Act).
  4. Premiums and benefits: all that is made public, see FAQ 3.
  5. Premiums and benefits granted directly: premiums and benefits that are granted directly by a company subject to notification to a beneficiary.
  6. Premiums and benefits granted indirectly: premiums and benefits that are granted indirectly by a company subject to notification to a beneficiary, including premiums and benefits granted by or through an intermediary. In case of an indirect sponsorship of participation in a scientific event (also called “educational grant“) (see diagram in FAQ 5), the premium or benefit to be notified is the hospitality received by the final beneficiary (healthcare professional) (e.g. registration fee, hotel, transport) and not the “educational grant” previously transferred by the company subject to notification to the intervening healthcare organisation (see also definition of “reference year”).
  7. Beneficiary (art. 41, §1, 3°, Sunshine Act):
    • healthcare professional (see below)
    • healthcare organisation (see below)
    • patient organisation (see below).
  8. Healthcare professional: any natural person practicing medical, dental, pharmaceutical, veterinary or nursing art or who, in the course of his professional activities, may prescribe, purchase, deliver, recommend, lease, use or administer medicines or medical devices and whose practice is established in Belgium (Art. 1, 4°, RD Sunshine Act).
    Some examples: doctor, dentist, nurse, paramedic, veterinarian, hospital director, farmer, etc.
    Some examples that should not be considered as a healthcare professional: dental technician, secretary, etc.
  9. Healthcare organisation: any association or organisation with a seat or fixed place in Belgium active in health, medical or scientific care, whatever its legal or organisational form, as well as any legal entity through which one or more healthcare professionals provide services (Art. 41, §1, 2°, Sunshine Act).
    Some examples: hospital, medical practice, scientific association of doctors, organiser of scientific congress, wholesaler receiving a premium or benefit from a company subject to notification, PCO (Professional Congress Organiser) who organises a scientific event at its own initiative, etc.
    Some examples that should not be considered as healthcare organisation: industry associations (e.g. BRAS, APL, …), travel agencies, etc.
  10. Patient organisations: a healthcare organisation that is responsible for patient representation (Art. 1, 5°, AR Sunshine Act).
    This also includes organisations that act in the form of an “umbrella organisation” grouping different patient organisations, as well as patient support groups.
    A patient organisation that is composed of both patients and healthcare professionals should be considered as a patient organisation if it is composed mainly of patients and/or volunteer caregivers (non-professional) and if it supports and/or defends the interests of patients and/or volunteer caregivers (non-professional).
  11. Scientific research: the experiments as referred to in Article 2, 11°, of the Law of 7 May 2004 on experiments on human persons, non-clinical studies as defined in the OECD Principles on Good Laboratory Practice and clinical trials referred to in Article 6quinquies of the Law of 25 March 1964 on medicinal products (Art. 1, 3°, RD Sunshine Act and Art. 42, §1, paragraph 2, Sunshine Act):
    1. Non-clinical studies as defined in the OECD Principles on Good Laboratory Practice: “Non-clinical health and environmental safety study, henceforth referred to simply as “study”, means an experiment or set of experiments in which a test item is examined under laboratory conditions or in the environment to obtain data on its properties and/or its safety, intended for submission to appropriate regulatory authorities.”
    2. Experiments on the human person (as referred to in Article 2, 11°, of the Law of 7 May 2004 on experiments on human persons): any trial, study or investigation carried out on the human person whose objective is the development of knowledge specific to the exercise of the healthcare professions as referred to in Royal Decree No 78 of 10 November 1967 on the exercise of Healthcare professions.
      This definition covers experiments, with or without medicinal products, including -with respect to experiments witch medicinal products- clinical trials and prospective non-interventional studies.
      On the other hand, premiums and benefits that relate to non-interventional (observational) retrospective studies are made public individually. Where it is impossible for companies subject to notification to distinguish retrospective from prospective non-interventional studies, the amounts must be made public on an individual basis.
    3. Clinical trials as referred to in Article 6quinquies of the Law of 25 March 1964 on medicinal products: clinical trials with veterinary medicinal products.
  12. Reference year: the full calendar year in which the premiums and benefits were granted (Art. 42, §2, Sunshine Act).
    Example: premiums and benefits granted between 1 January 2017 and 31 December 2017
    • shall be communicated by the company subject to notification to betransparent.be no later than 31 May 2018,
    • shall be made public in the Transparency Register no later than 30 June 2018.

    The first reference year is 2017. As an exception however, an additional period is granted for premiums and benefits for medicinal products for veterinary use. Their first reference year is 2018, with a first publication in June 2019.

  13. Premiums and benefits in kind: premiums and benefits granted in kind are also subject to transparency requirements (Art. 41, §2, Sunshine Act).
    A few examples: the payment of the registration fee for participation in a congress to the congress organiser (no payment directly to the participating healthcare professional); organising a (e.g. in-house) product training by a company subject to notification whereby the participating healthcare professionals do not have to pay a registration fee or where the costs of the training are not fully covered by the registration fee.

    For the publication of these premiums and benefits in kind the company subject to notification must estimate the cost based on the normal market value, the Belgian market being taken as a reference. The company subject to notification must at all times be able to demonstrate how it calculated the cost of the benefit in kind.

    The date that determines the reference year in which a premium or benefit in kind was granted, is the date on which the premium or benefit concerned was granted by the company subject to notification and not the date on which the beneficiary actually benefited from it if it were to be different.