A. Publication on an individual basis
All premiums and benefits are made public on an individual basis (on behalf of the recipient who received them directly or indirectly). In particular, each company subject to notification shall make public, for each beneficiary, the amounts of the premiums and benefits granted to that beneficiary during a calendar year.
These premiums and benefits are grouped by category (see below), so that a total amount per category and per beneficiary appears per calender year in the Transparency Register. The details of the publication shall be communicated by the company if the beneficiary concerned or the competent authority so requests.
The categories of premiums and benefits as referred to above are as follows:
- With regard to premiums and benefits granted directly or indirectly to healthcare professionals:
- The contributions to the costs of scientific manifestations, such as registration costs and travel and subsistence costs.
Offered meals are not to be made public, as this is already subject to several strict criteria and maximum amounts. However, where it is not possible to distinguish such costs into the total of the contribution to the costs, they can be made public (e.g. if they are part of a package).
- The fees, payment and reimbursement of costs for services and consultancy.
This can be a reasonable compensation for e.g. giving a scientific lecture, participation in an expert meeting, writing a scientific publication.
- With regard to premiums and benefits granted directly or indirectly to healthcare organisations:
- Contributions to the cost of scientific manifestations, such as registration and travel and subsistence costs, and sponsorship agreements with healthcare organisations or with third parties appointed by these organisations to organise the scientific event.
This concerns contributions from pharmaceutical and medical devices companies to hospitals or associations of healthcare providers to cover the costs of organising a scientific congress.
In the case of contributions to a patient organisation to organise a scientific event, publication takes place under category III, b (see below).
- Fees, payments and reimbursement of costs for services and consultancy.
This may include reasonable compensation, for e.g. to give a scientific lecture, to participate in a meeting of experts, to write a scientific publication, for which the compensation is being paid on the account of a healthcare organisation.
However, if the fees paid to the healthcare organisation are fully or partially transferred to one or more individual healthcare professionals, the publication will take place on behalf of the healthcare professionals concerned as they are the beneficiaries of the fees. In this case, the company publishes the total amount of the fees paid on behalf of the healthcare professionals concerned, unless the healthcare organisation has communicated, if applicable, to the company the distribution of fees between the healthcare organisation and the healthcare professional, in which case the company will publish the fees partly on behalf of the healthcare organisation and partly on behalf of the healthcare professional, according to the agreed key.
For premiums and benefits granted to a healthcare professional who acts as a company or who is part of a de facto association, see FAQ 5 below.
- Donations and grants that support healthcare.
This includes, among other things, the means that the industry puts at the disposal of healthcare organisations to support healthcare or scientific research. In no event shall these means be granted as a means of stimulating the recommendation, prescription, purchase, sale, delivery or administration of medicinal products or medical devices.
- With regard to premiums and benefits granted directly or indirectly to patient organisations:
- Fees, payments and reimbursement of expenses for services and consultancy:
This can be a reasonable fee granted to a patient organisation for its services as an expert or consultant, e.g. participation in a meeting with patient experts; speaker services; giving advice to a pharmaceutical or medical device company on priorities for patients in clinical trials or the relevance of specific research for patients.
- Financial or other support:
This includes amongst others financial support granted to a patient organisation for the organisation of a scientific event; to support disease awareness campaigns; to support the development of informative material for patients or a website for patients.
This may also involve non-financial support (in kind), such as the provision of manpower or space. For the purpose of disclosure, the company subject to notification needs to value the in kind granted premium or benefit on the basis of the normal market value, using the Belgian market as a reference. The company subject to notification must be able to demonstrate at all times how it was calculated.
The nature of the financial or other support may, if necessary, be further described by the company subject to notification in an “Explanatory Note” which can be consulted in the Transparency Register for every company subject to notification if it uploaded one.
A diverse framework of applicable legislation, deontological codes, and internal corporate policies is aimed at ensuring a transparent and honest cooperation that leads to medical progress in the interest of the patient. The transparency register therefore includes the support of pharmaceutical and medical device companies, but support from other bodies to patient organisations is beyond the scope of this register.
B. Publication on an aggregate basis
There is only one legal exception to the publication on an individual basis: premiums and benefits granted in the context of scientific research. These premiums and benefits are published in an aggregated, non-individual way, per company, without mentioning the identity of the beneficiaries (Article 42, §1, clause 3, Sunshine Act). Each company will therefore annually make public one total amount for scientific research in Belgium.
See below for a summary: