The Belgian Sunshine Act set out in Title III, ch. 1 of the Law of 18 December 2016 containing various provisions on health (the Sunshine Act) came into force on 23 June 2017 and was enacted by the Royal Decree of 14 June 2017 (published in the Belgian State Gazette on 23 June 2017).
By virtue of the Belgian Sunshine Act, pharmaceutical companies (making medicines for human and animal use) and medical technology companies (jointly the “Pharma/medtech companies”) are obliged to notify the Federal Agency for Medicine and Health Products (“Agence fédérale des médicaments et produits de santé/AFMPS” / “Federale agentschap voor geneesmiddelen en gezondheidsproducten/FAGG”; the “FAHMP”) of any incentives and advantages, in cash or in kind, granted directly or indirectly, from Belgium or anywhere else, to a “beneficiary” as further described below.
Previously, this system already existed on a voluntary basis, whereby Pharma/medtech companies could make notifications on the « Be Transparent » platform. The Belgian Sunshine Act now makes this system mandatory for all entities falling under its scope.
The new obligations of the Belgian Sunshine Act should be read together with the existing legislative framework (amongst others, article 10 of the Law of 25 March 1964 on medication) which already restricts the circumstances in which incentives and advantages can be awarded to healthcare professionals, in particular when organising scientific events that are subject to an approval visa from the Ministry of Health.
How does it work and who is concerned?
The notification by the Pharma/medtech companies will need to take place on an annual basis and will be published on an online platform accessible to the public.
The publications will be available in the three Belgian national languages (French, Dutch and German) and will contain a list of all incentives and advantages given by a Pharma/medtech company to the relevant beneficiaries. The publications can be accessed through a search engine allowing for name searches. Only the data relating to incentives and advantages provided for scientific experimentations on human beings within the framework of non-clinical studies (as defined in the OECD Principles on Good Laboratory Practice) or clinical trials on veterinary products will be presented in an anonymous and aggregated manner.
The notifying companies falling under the scope of the Belgian Sunshine Act are all entities having an economic activity and – regardless of their means of financing – that hold a marketing authorisation for medicines of human or veterinary use and/or of medical devices, including importers, manufacturers, distributors, brokers and retailers.
Pharma/medtech companies registered and operating in the EU can proceed to the notification themselves. Companies registered outside of the EU must designate an affiliated company or a legal representative based in the EU, which will be liable for such notification.
The “beneficiaries” of the incentives and advantages must have their practice or their registered or operational office in Belgium. These are classified in different categories:
- The “Healthcare Professionals”: wholesale dealers or their brokers; individuals authorised to prescribe, deliver or administer medication; and the institution in which this medication is prescribed, delivered or administered;
- The “Healthcare Organisations”: defined as any association or organisation active in the healthcare, medicine or scientific sectors, regardless of their legal or organisational form, and any legal entity through which one or more healthcare professionals provide services to the public;
- “Patient Organisations”.
Incentives and advantages to be notified
The following incentives and advantages must be included in the annual notifications, pursuant to the Belgian Sunshine Act :
- Fees, payments and reimbursements of fees for services and consultancy provided to all types of beneficiaries;
- For Healthcare Professionals and Healthcare Organisations, any contributions to costs of (authorised) scientific events (such as registration fees, travel and accommodation expenses, and sponsorship agreements relating to such events and executed with healthcare organisations or third party organisers);
- Donations and subsidies made to Healthcare Organisations;
- Any form of financial incentives given to Patient Organisations.
Incentives and advantages falling beyond the scope of the Sunshine Act
The FAHMP does not need to be notified of the following incentives and advantages:
- Incentives and advantages of insignificant value and relating to the exercise of medicine, dentistry, pharmacy or veterinary science;
- Meals and drinks given to/made available to/provided for the attendees of (authorised) scientific events;
- The margins and rebates schemes in use in current transactions between a beneficiary and a Pharma/medtech company;
- Promotional samples given to a beneficiary.
Investigatory powers from the FAHMP and sanctions
If a Pharma/medtech company is suspected of infringing the Belgian Sunshine Act, the FAHMP can carry out inspections and audits or require actions in order to ensure compliance with the law.
Moreover, failure to make the notification, or issuing an incomplete notification, can lead to criminal fines ranging between EUR 1,600 – 120,000.
What should businesses do next?
- As the Belgian Sunshine Act came into force on 23 June 2017, the first year of reference for advantages and incentives provided to beneficiaries is the calendar year 2017. The (first) notification relating to calendar year 2017 must be filed before 31 May 2018
- Further annual notifications will have to be filed before 31 May of the calendar year following the calendar year during which the incentive(s) or advantage(s) were provided
- It remains to be seen how the notification will work in practice (e.g. payment of a notification fee, dedicated website) and which entity will be responsible for receiving and compiling the information (since the FAHMP is authorised to delegate its powers under the Sunshine Act).
- In the meantime, Pharma/medtech companies need to ensure that they have an internal compliance process in place allowing for the recording, collection and storage of all necessary information relating to advantages or incentives provided to beneficiaries during the year 2017, including the category of such advantages and incentives and the identity (and other required identification details) of the beneficiaries. Internal processes should be compliant with applicable data protection rules, including in view of the GDPR, which will be applicable as from 25 May 2018.
- Finally, companies should check whether their current anti-bribery policies are in line with the principles laid down by the Belgian Sunshine Act.
Please contact one of our experts should you have any queries in relation to the Belgian Sunshine Act.