On 23 June 2017, the Belgian “Sunshine Act” entered into force, requiring life sciences companies to disclose relationships with healthcare actors based in Belgium. Companies in both the pharmaceutical and medical devices sector must now report annually specific categories of premiums and benefits granted to healthcare professionals and organisations to the FAMHP through the ethical health platform Mdeon. The first publication under the statutory transparency regime will cover transfers of value for the year 2017 and take place on the website betransparent.be by 30 June 2018.
The Belgian Law of 18 December 2016 concerning various health-related matters (Health Law) for the first time introduced legally binding provisions on the disclosure of transfers of value to healthcare actors. Under the chapter entitled “Sunshine Act”, the Health Law established a legal basis for the (voluntary) self-regulatory transparency commitments that the Belgian life sciences sector implemented in June 2016 through the establishment of the platform betransparent.be.
On 23 June 2017, a first implementing Decree was published, marking the official entry into force of the Sunshine Act and defining the specific categories of premiums and benefits that must be disclosed. The Decree also confirmed that the first publication will cover transfers of value for the year 2017 and occur by 30 June 2018. On 22 August 2017, a second implementing Decree designated the ethical health platform Mdeon as the organisation that will handle the practical aspects of disclosure on behalf of the Federal Agency for Medicines and Health Products (FAMHP).
Analysis of the Belgian Transparency Requirements
Scope of application
Who is subject to the new requirements?
Life sciences companies – The Belgian “Sunshine Act” in essence requires all pharmaceutical and medical devices companies to annually notify the FAMHP of the premiums and benefits granted to a number of defined healthcare beneficiaries.
The Act specifies that the notification obligation more broadly applies to “all entities engaged in an economic activity, regardless of their legal status and the way in which they are financed.” This implies that (i) all marketing authorisation holders for medicinal products for human or veterinary use, (ii) all importers, manufacturers and distributors of medicinal products for human or veterinary use, (iii) all persons or entities trading or brokering medicinal products for human or veterinary use and (iv) all distributors, retailers and manufacturers of medical devices are subject to the notification obligation.
Importantly, the Act does not make a distinction between – and hence applies to – companies based in Belgium or abroad. Life sciences companies based outside the European Union will need to fulfil their reporting obligations through a subsidiary or legal representative based in the EU.
Health care beneficiaries – The notification obligation concerns benefits granted to all healthcare professionals (HCPs), healthcare organisations (HCOs) and patient associations having their principal activity or registered seat in Belgium. This includes in practice persons qualified to prescribe, issue or administer medicinal products (such as physicians, dentists, pharmacists, etc.), institutions involved in prescribing, dispensing or administering medicinal products (such as hospitals), and patient associations, which have their principal activity or registered seat in Belgium.
Which activities are subject to the new requirements?
All premiums and benefits – Life sciences companies have to notify the FAMHP of all “premiums and benefits” granted to these beneficiaries. The Act is particularly broad in this respect and specifies that it concerns all direct and indirect benefits, in money or in kind, received – from Belgium or elsewhere – by healthcare actors based in Belgium.
The total annual amount of the following categories of premiums and benefits need to be disclosed, depending on the healthcare beneficiary:
- Healthcare professionals:
- costs for participation in scientific events, such as registration fees and travel expenses;
- fees, payments and reimbursements of costs for services, including consultancy services.
- Healthcare organisations:
- costs for participation in scientific events, such as registration fees and travel expenses, and sponsoring contracts with healthcare organisations or third parties appointed by these organisations to organise scientific events;
- fees, payments and reimbursements of costs for services, including consultancy services;
- donations and grants that support healthcare.
- Patient associations:
- fees, payments and reimbursements of costs for services, including consultancy services;
- financial or other contributions.
In addition, the total annual amount of premiums and benefits concerning R&D related services (involving the aforementioned beneficiaries) must be disclosed on an aggregate basis.
Exceptions – The Sunshine Act provides a number of exceptions to this broad disclosure obligation. First, advantages and benefits of negligible value relating to the exercise of the medical, dental or pharmaceutical profession must not be disclosed. Guidance adopted in the context of the anti-gift statute clarifies that benefits are considered of negligible value provided they have a market value of up to EUR 50 (VAT included) per benefit or EUR 125 per year and per HCP. In addition, the Act excludes meals and drinks offered in the context of scientific events of an exclusively scientific nature. Finally, free samples as well as economic margins and price discounts that are part of usual purchase and sales transactions for medicinal products and medical devices are also excluded from the disclosure obligation.
Which information must be published?
Individual and nominative disclosure – The Sunshine Act provides for disclosure on an individual and nominative basis (i.e., per beneficiary) and stipulates that the notification to the FAMHP must include at least the following elements, with respect to:
- Premiums and benefits: the total amount in EUR – without VAT – per category of benefits (e.g. for donations and grants) provided throughout the relevant annual reporting period. It should be noted that premiums and benefits must be reported on the date the financial transaction occurred, not on the date the beneficiary actually received the benefit;
- Reporting life sciences companies: their business name and company/VAT number;
- the RIZIV/INAMI number (or the personal identification number in the absence thereof or in case of multiple RIZIV/INAMI numbers) as well as the name, first name, zip code, profession and specialty of the relevant HCPs;
- the name and company/VAT number of the relevant HCOs and patient associations.
Aggregate disclosure – However, the total amount of transfers of value for services in the context of clinical or non-clinical research and development must be disclosed on an aggregate, non-individual basis (i.e., without disclosing the identity of the beneficiary) annually.
Where must the information be published?
Mdeon – While the Sunshine Act requires that the notification is made to the FAMHP, the ethical health platform Mdeon – which already managed the voluntary transparency regime through the platform betransparent.be – was recently appointed (for an indefinite period) to handle and supervise the notification procedure on behalf of the FAMHP.
betransparant.be – The Sunshine Act stipulates that transfers of value will be made public on a Belgian transparency website accessible to the public, and it has been confirmed that such publication will occur on betransparant.be, the platform that was established to implement the self-regulatory transparency regime in June 2016. The disclosed information will be searchable per (i) reporting life sciences company, or (ii) healthcare actor (HCP, HCO, patient association).
When must the information be published?
By 30 June 2018 – Life sciences companies should submit a report of all transfers of value provided Belgian healthcare actors on an annual basis, at the latest on 31 May of the year following that of the relevant reporting period. Disclosure will occur at the latest on 30 June of the same year and the information will remain available for a period of three years after publication.
The first reporting period runs from 1 January to 31 December 2017 (except for companies marketing veterinary medicines which benefit from a grace period). Life sciences companies should therefore start collecting the necessary information about transfers of value to Belgian healthcare actors for the year 2017. The corresponding transfers of value must be notified to Mdeon by 31 May 2018 at the latest, and will be published on the betransparent.be platform by 30 June 2018.
Enforceability and sanctions
Criminal fines – Article 47 of the Sunshine Act provides that non-compliance with the transparency requirements may be sanctioned with criminal fines ranging from EUR 1.600 up to EUR 120.000.
While it remains to be seen to which extent the transparency obligations will be enforced in practice, and whether the sanctions imposed will effectively be applied or essentially serve as a deterrent mechanism, the new Sunshine Act is an important step towards a clear regulation of interactions between the life sciences industry and Belgian healthcare actors.