The chapter entitled “Sunshine Act” of the “Law on various health-related matters” (Health Law) that was published in the Official Journal on 27 December 2016 establishes a legal basis for the transparency obligations that the Belgian healthcare sector introduced in June 2016 through the self-regulatory betransparent.be platform.
The Health Law requires that a large category of life science companies notify the Federal Agency for Medicines and Health Products (FAMHP) of the premiums and benefits, in cash or in kind, which they granted, directly or indirectly, to certain beneficiaries including healthcare professionals, healthcare organisations and patient associations that are established in Belgium. A number of categories of benefits (for example, those that are exempted from the “anti-gift” statute in Article 10 of the Medicines Law) do not have to be declared.
The requested information must be submitted on an annual basis, before 31 May of each year for the previous calendar year. The information must include the name or identification of each individual beneficiary and the total amount of the premiums and benefits granted (with the exception of research and development grants which are disclosed on an aggregate, non-individual basis). The FAMHP will then publish the information on the website betransparent.be by 30 June of each year.
According to the Health Law, all entities engaged in an economic activity concerning pharmaceutical and medical device products are subject to the transparency obligations, regardless of their legal status and the way in which they are financed. The obligations therefore apply to, inter alia, marketing authorisation holders of medicinal products (for human or veterinary use) and medical devices manufacturers, and also importers, manufacturers, distributors, retailers, and brokers of such products. In addition, “all entities”, as currently interpreted, will likely include healthcare organisations (patient associations is less clear), but further clarification may be given in the implementing decrees or guidance to come.
However, before the transparency obligations can be enforced, several implementing decrees must be published for example, to determine the categories of premiums and benefits subject to the obligation. Reportedly, two royal decrees are in preparation for adoption in late March 2017. If this timeline is met, the first reference period subject to the transparency obligation will likely be from 1 January 2017 to 31 December 2017, with the corresponding information being published by 30 June 2018.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, February 2017 Issue (Thomson Reuters).