Belgium’s Sunshine Act Removes Consent Requirement For Government Reporting and Public Disclosures

Healthcare companies which previously were required to obtain informed consent for disclosure of personal data concerning transfers of value (e.g. benefits provided by practitioners) will no longer be required to obtain such consent, pursuant to new disclosure obligations in the Sunshine Act (“Act”); the Act creates a legal obligation to collect and report such personal data to the regulatory body (making it an exception for consent under the EU Data Protection Directive.)


Belgian Law of 18 December 2016 – The Sunshine Act – Relating to Various Health Matters

Background:

The Sunshine Act imposes a new transparency obligation on the pharmaceutical and medical devices industries. The Sunshine Act provides that medical device and pharmaceutical companies must provide the Federal Agency for Medicines and Health Products (“FAMHP”) with information concerning all pecuniary advantages or benefits in kind granted, directly or indirectly from Belgium or elsewhere, to a number of defined beneficiaries. These include healthcare professionals or healthcare professional organisations established in Belgium.

Obligation to disclose benefits to the FAMHP

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.”

And the text from “Moniteur Belge) (French) http://www.ejustice.just.fgov.be/… 

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