Life Science Compliance Update

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October 10, 2017

Belgian Sunshine Act Decrees Issued, Providing Guidance

Belgiumparliament

On June 23, 2017, the Belgian “Sunshine Act” became law, requiring life science companies to disclose relationships with healthcare actors in the country. The Decree confirmed that the first publication of data under the statutory transparency regime will cover transfers of value for the year 2017 and will be published on betransparent.be by June 30, 2018.

The June 23 Decree notes that the provisions of the Sunshine Act apply to “premiums and benefits granted during calendar year 2017 to healthcare professionals, healthcare organizations and/or patient organizations.”

A second Decree was issued on August 22, 2017, which designated the ethical health platform Mdeon as the organization that will handle the practical aspects of disclosure on behalf of the Federal Agency for Medicines and Health Products (FAMHP). Mdeon will be managing theh publicly accessible website that will disclose the premiums and benefits that pharmaceutical and medical device companies grant to healthcare professionals and organizations, as well as patient organizations, annually.

It is unclear whether this determination causes the Sunshine Act to have retroactive effect in that it would require firms to notify and publish the transfers of value that occurred during all of 2017.

There are, however, certain benefits and premiums granted to these beneficiaries that do not have to be notified. These exceptions are (i) premiums and benefits of limited value that concern the practice of medicine, dentistry, pharmacy or veterinary medicine; (ii) meals and drinks supplied during scientific events; (iii) premiums and benefits that are part of ordinary-course purchases and sales of medicinal products or medical devices by and between a pharmaceutical or medical devices company and the beneficiary; and (iv) samples of medicines.

Before the implementation of the Sunshine Act, only industrial codes of conduct were adopted in order to enhance the transparency of transfers of value from pharmaceutical and medical devices companies to HCPs and HCIs. The transparency obligations were only mandatory for companies that were members of an association that had a code of conduct in place. 

The transparency obligations are now mandatory for all companies under the Sunshine Act. Considering the scope of the definition of “notifiers”, this practically covers all companies in the healthcare sector. Therefore, the scope of the notification obligation is very broad.

Sometime in September 2017, betransparent.be plans to organize an information session for the industry to explain – in detail – the new legal framework, including the differences with the current transparency in self-regulation.

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