New Belgian Sunshine Requirements applicable to all pharmaceutical and medical devices from 1 January 2017

On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act “) was adopted by the Belgian Ministry for Public Health.
The Sunshine Act introduces several substantial changes to the current Belgian legal and regulatory framework for medicinal products and medical devices.

The transparency obligation laid down in the Sunshine Act applies to all entities engaged in an economic activity, regardless of their legal status and the way in which they are financed. The obligation applies:

• to marketing authorisation holders for medicinal products for human or veterinary use;
• to importers, manufacturers and distributors of medicinal products for human or veterinary use;
• to persons or entities trading or brokering medicinal products for human or veterinary use;
• to distributors, retailers and manufacturers of medical devices.

The Sunshine Act provides that any transfer of value in money or in kind must be notified to the FAMHP. The Law also lists a number of exceptions to this transparency requirement:

• meals and drinks offered in the context of scientific events that are of an exclusively scientific nature
• advantages and benefits of negligible value that relate to the exercise of the medical, dental or pharmaceutical profession or that relate to veterinary medicinal products;
• the economic margins and price discounts which are part of usual purchase and sales transactions for medicinal products and medical devices
• free samples.

The Sunshine Act provides that transfers of value will be made public on a Belgian transparency website accessible by the public. It is understood that publication of transfer of value will be made on Mdeon’s BeTransparent.be website. Publication will occur in French, Dutch and German.

In light of the above, the first reference period prior to disclosure is likely to be from 1 January 2017 to 31 December 2017, with the first related publication required by 31 May 2018 at the latest.

To read the full article by Elisabethann Wright, Fabien Roy and Elinor Pecsteen