25 May Transparency requirements for all medicinal products and medical devices from 1 January 2017
Belgium has enacted “the Sunshine Act”, which introduces several substantial changes for medicinal products and medical devices.
What is in the Act?
The transparency obligation laid down in the Sunshine Act applies to:
- 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 Act covers benefits provided to healthcare professionals (“HCPs”) and organisations and any patient associations that carry out their main activity or registered seat in Belgium. In practice, this includes wholesalers, brokers, persons qualified to prescribe, issue or administer medicinal products, institutions involved in prescribing, dispensing or administering medicinal products and all patient associations which have their principal activity or registered seat in Belgium.
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.
Information on the benefits will be made public on a Belgian transparency website in due course, and will be available in French, Dutch and German.
Non-compliance can incur a fine of between €1,200 to €90,000.
What does it mean?
- All pharmaceutical and medical device companies are now subject to the disclosure requirements.
- HCPs will not have to provide consent to the company disclosing the information on benefits and will not be able to refuse the publication of their personal data.
- Collection of information is required from 1 January 2017.
What do you need to notify?
You need to send the following information to FAMHP:
- the name of the business name
- its VAT number
- the name and VAT number or RIZIV number of the beneficiaries;
- the total sum of the benefits provided throughout the relevant reporting period.