Last Thursday, we were very pleased to welcome Mieke Goossens amongst us at our first Healthcare Compliance Workshop, for a discussion with Christel Brion. Mieke Goossens is a member of the Management Committee of betransparent.be.
Along with representatives from the pharma and medtech sectors, we had a discussion with Mieke about the transparency obligation in the healthcare sector.
The emergence of a legal obligation
Mieke clarified that transparency obligations were first assumed on a voluntary basis by the pharma industry (self-regulation). In 2018, however, the Act pertaining to several health provisions of 18 Dec 2016 (Belgian Sunshine Act) entered into force, making transparency in healthcare relationships a legal obligation (1).
Mieke explained how every company, holding an authorization to market, import, manufacture or distribute medicinal products (pharmaceutical companies) and every distributor, retailer and manufac-turer of medical devices (medical device companies), has an obligation to annually notify to betransparent.be certain premiums and benefits which it grants to healthcare organisations (HCOs), healthcare professionals (HCPs) and patient organisations (POs) who have a (corporate) seat in Belgium. Both companies established in Belgium as abroad are subject to this notification obligation.
The betransparant.be platform makes this information public in a central transparency register, which documents and discloses the premiums and benefits that pharmaceutical and medical device companies have granted to HCPs, HCOs and POs as of 1 Jan 2017.
The transparency register is up and running
Why this legal obligation
Mieke emphasized what this obligation to attain. In a word, that is, trust. The transparency obligation seeks to foster trust amongst actors in the field, but also between pharmaceutical companies and, for instance, patients and governments.
For indeed, imposing a general obligation on pharmaceutical or medical device companies seeks to avoid the semblance of improper relationships between, for instance, such companies and healthcare professionals. The legislator explained it as follows. As in every economic sector, it is normal that the pharmaceutical industry maintains relationships with actors in the field. However, society rightfully expects transparency in this regard. (2) Moreover, such transparency contributes to better ensuring patients' safety.
The Belgian Sunshine Act seeks to foster trust,
bolstering the independence and integrity of healthcare professionals.
Which transfers trigger the obligation
Some transfers of value must be disclosed in full, on a nominative basis (disclosing the identity of the beneficiary):
- fees, payments and reimbursements of costs for services and consultancy granted to HCOs, HCPs and POs;
- contribution to the costs of the organisation of or participation to scientific events (such as registration costs and travel and subsistence costs) granted to HCOs, HCPs or POs;
- donations and grants that support healthcare granted to HCOs; or
- financial or other support granted to POs.
There is no need for consent from the healthcare professionals concerned to disclose their data. However, under the GDPR rules, they must be informed beforehand by the companies about the processing of their data.
Other transfers can be disclosed in an aggregate form, thus without mentioning the identity of the HCP or HCO concerned and without further details. More particularly, premiums and benefits granted in the framework of scientific research, including these granted in the framework of clinical trials, must only be disclosed at this aggregated level.
The law, finally, makes room for some exceptions to this reporting duty. First, small gifts of negligible value and which are related to the exercise of medicine, pharmacy or dentistry are exempt from the reporting duty (3). Second, benefits granted in the framework of a scientific event (including hospitality) are exempt if the event is clearly organized for strictly scientific purposes and the hospitality benefits are strictly aligned with the scientific goals (4). Third, economically justified (price) reductions and rebates are exempted. Finally, samples of medicine are also exempted.
In a later blog, we will expound upon this obligation in more detail. More particularly, we will deal with the risks involved, and how such risks can be offset or mitigated. We will also clarify what exactly must be disclosed by pharmaceutical and medical device companies.
Afterwards, we will deal with the other presentation that was provided by Jens Mosselmans on 21 March 2019 on tender legislation in life sciences.
Hence, we undertake to keep you continually updated on recent developments and discussions amongst important stakeholders in the healthcare sector.
1) Artt. 41 et seq. W. 18 december 106 houdende diverse bepalingen inzake gezondheid, BS 27 december 2016 ; Loi 18 décembre 2016 portant des dispositions diverses en matière de santé, MB 27 décembre 2016.
2) "Zoals dit geldt voor iedere economische sector, is het normaal dat ook de farmaceutische industrie relaties onderhoudt met de actoren uit haar omgeving. Maar terecht verwacht de maatschappij dat de farmaceutische industrie hier transparant over is" / "Comme cela s'applique pour chaque secteur économique, il est normal que l'industrie pharmaceutique entretienne également des relations avec les acteur de son environnement. La société attend toutefois à juste titre que l'industrie pharmaceutique fasse preuve de transparence dans ce domaine" (Parl. Doc. Chamber 2016-17, No 2154/1, p 24).
3) Art 41, § 3, 1° of the aforementioned 18 Dec 2016 Act, read in conjunction with Art 10, § 2 (1) 1° of the 25 March 1964 Act on Medicine, BSG 17 April 1964.
4) For a more detailed list of the conditions imposed, see Art 10, § 2, (1) 2° of the 25 March 1964 Act on Medicine, BSG 17 April 1964.