The Sunshine Act [available for consultation here] and its implementing royal decree [available for consultation here] require pharmaceutical and medical devices companies to document and disclose annually on the beTransparent platform [available here] premiums and benefits granted, as from 1 January 2017, directly or indirectly to healthcare professionals (HCPs), healthcare organisations (HCOs) and patient organisations (POs).
There is now a legal basis in Belgium for transparency in healthcare relationships. The so-called Sunshine Act and its implementing royal decree provide for mandatory annual reporting via the central platform beTransparent (www.betransparent.be). This obligation is applicable to both pharmaceutical and medical devices companies located in Belgium or abroad. The information to be reported pertains to premiums and benefits (financial or in kind), granted directly or indirectly to HCPs with a practice in Belgium, HCOs with a fixed establishment or headquarters in Belgium, and POs with their headquarters or a fixed establishment in Belgium. In the event of noncompliance with this obligation, civil fines ranging from EUR 1,600 to EUR 120,000 can be imposed.
It should be noted that the reporting obligation is quite broad and applies to:
- all pharmaceutical and medical device companies;
- established in Belgium or abroad;
- even if they have no product on the Belgian market and
- even if no premium or benefit was actually granted during the reference period to a Belgian HCP, HCO or PO; the company must still register on beTransparent and indicate that no premiums or benefits were granted during the reference period.
The main categories of premiums and benefits are:
- fees, payments and reimbursements of expenses for services and consultancy (to HCPs, HCOs or POs);
- contributions to HCPs to participate in scientific events and contributions to HCOs to organise scientific events;
- donations and grants that support healthcare, made to HCOs;
- financial or other support on behalf of a PO;
- fees granted in the context of scientific research (to HCPs, HCOs or POs);
The reporting obligation does not apply to:
- inexpensive gifts which are relevant to the practice of medicine;
- meals and drinks offered in the framework of scientific events;
- economic margins and discounts which are customary in the purchase and sale of medicinal products or medical devices; and
- samples.
Notifications must be made annually, by 31 May of the year following the calendar year in which the advantages and benefits were granted (i.e. the reference year). Publication shall occur by 30 June of the year following the reference year. The information shall remain online for a period of three years.
This means that premiums and benefits granted in 2017 must be reported by 31 May 2018 and will be posted on beTransparent no later than 30 June 2018.
Companies are required to keep substantiating documents and receipts relating to a notification for a period of 10 years.
It should be noted that in principle notifications must be made on a nominative basis. This means that information allowing identification of the beneficiaries must be provided (such as the name, company number or RIZIV number), as well as the full amount of the benefits and advantages granted. It is thus no longer required to ask an HCP for consent to disclose this information as disclosure is required by law. Pursuant to the privacy legislation, however, companies are still required to duly inform HCPs of the fact that in order to comply with the requirements of the Sunshine Act certain information will be disclosed and posted on beTransparent for 3 years and kept by the company for 10 years.
An important exception to the general rule of no anonymity is made for premiums and benefits granted in the framework of scientific research, which may be reported on a non-individual, aggregate basis without mentioning the identity of the beneficiaries.
Finally, the Sunshine Act requires beneficiaries to cooperate, subject to the imposition of civil sanctions. This entails for instance an obligation to provide the sponsoring company with their national, RIZIV or company number. In the event of indirect sponsorship of participation by HCPs in scientific events (i.e., the HCPs receive the premium through an HCO) the HCO must cooperate by providing the sponsoring company in a timely manner with a list of HCPs sent to the event.
More information can be found at www.betransparent.be, including a Q&A and an explanatory document which medical representatives can provide to beneficiaries.
