On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act “) was adopted by the Belgian Ministry for Public Health. The Sunshine Act introduces several substantial changes to the current Belgian legal and regulatory framework for medicinal products and medical devices.
The Sunshine Act imposes a new transparency obligation on the pharmaceutical and medical devices industries. The Sunshine Act provides that medical device and pharmaceutical companies must provide the Federal Agency for Medicines and Health Products (“FAMHP”) with information concerning all pecuniary advantages or benefits in kind granted, directly or indirectly from Belgium or elsewhere, to a number of defined beneficiaries. These include healthcare professionals or healthcare professional organisations established in Belgium.
Obligation to disclose benefits to the FAMHP
The transparency obligation laid down in the Sunshine Act applies to all entities engaged in an economic activity, regardless of their legal status and the way in which they are financed. The obligation applies:
- 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.
As regards beneficiaries, the transparency obligation laid down in the Sunshine Act covers benefits provided to all healthcare professionals (“HCPs”), healthcare organisations (“HCOs”) and patient associations having their principal 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:
- meals and drinks offered in the context of scientific events that are of an exclusively scientific nature, provided that:
- the provision of meals and drinks is in connection to the scientific event;
- the location, date and length of the scientific event do not create confusion as regards the scientific nature of the event;
- the provision of meals and drinks is strictly limited to the official length of the event;
- the provision of meals and drinks is limited to HCPs and HCOs.
- advantages and benefits of negligible value that relate to the exercise of the medical, dental or pharmaceutical profession or that relate to veterinary medicinal products;
- the economic margins and price discounts which are part of usual purchase and sales transactions for medicinal products and medical devices conducted by a company subject to the notification obligation or between such a company and beneficiaries;
- free samples.
Content of the notification to the FAMHP
The Sunshine Act provides that the notification to the FAMHP must include the following elements:
- the business name and company VAT number of the pharmaceutical or medical device company;
- the name and VAT number or RIZIV number of the beneficiaries;
- the total sum of the benefits provided throughout the relevant reporting period.
It is expected that Mdeon will be appointed by the authorities in the course of 2017 to perform the functions and tasks relating to the new disclosure obligation on behalf of the FAMHP. Mdeon is an ethical platform made up of associations of physicians, pharmacists, veterinarians, dentists, nurses, and of the pharmaceutical and medical devices industry. The role of Mdeon is to assess whether the hospitality and sponsorship offered by pharmaceutical and medical device companies to Belgian HCPs at scientific and educational events is acceptable on the basis of Article 10 of the Sunshine Act on medicinal products.
In light of the above, companies will be required to submit to Mdeon information concerning transfers of value granted to Belgian HCPs, HCOs and patient organisations. A report of all transfers of value provided by a company to individual HCPs or HCOs must be submitted to the Mdeon on an annual basis, at the latest on 31 May of the year following that of the relevant reporting period. The Sunshine Act specifies that where transfers of value in money or in kind are provided to a HCP or a HCO for work which falls within the category of clinical or non-clinical research and development, the transfers of value must exceptionally be disclosed as an aggregated sum.
Publication of disclosed information
The Sunshine Act provides that transfers of value will be made public on a Belgian transparency website accessible by the public. It is understood that publication of transfer of value will be made on Mdeon’s BeTransparent.be website. Publication will occur in French, Dutch and German.
This publication will occur at the latest on 30 June of the year following that of the relevant reporting period.
Entry into force of the disclosure obligation
Before the law can enter into force, several implementing Decrees must be published. Two Royal Decrees are reported in preparation, for adoption in late March 2017. One Royal Decree will specify:
- the types of transfers of value that are subject to the disclosure obligation;
- the practical and technical arrangements for both the notification and publication of transfers of value;
- the date of entry into force of the Sunshine Act.
The second Royal Decree is expected to appoint Mdeon, as an accredited organisation, to perform the functions and tasks relating to the new disclosure obligation on behalf of the FAMHP.
The date of adoption of the above Royal Decrees will determine the date of entry into force of the Sunshine Act. It has been reported that the Sunshine Act will enter into force at the latest in April 2017. It has also been reported that the disclosure obligation will apply to transfers of value granted to Belgian HCPs, HCOs and patient organisations in the course of 2017.
In light of the above, the first reference period prior to disclosure is likely to be from 1 January 2017 to 31 December 2017, with the first related publication required by 31 May 2018 at the latest.
Consequences for medical devices and pharmaceutical companies
The new disclosure obligation will have several practical consequences for pharmaceutical and medical device companies.
- All pharmaceutical and medical device companies are now subject to the disclosure requirements: Pharmaceutical companies that are members of pharma.be, the General Association for the Pharmaceutical Industry, are already required to collect and disclose information, including personal data, concerning transfers of value granted to Belgian HCPs, HCOs and patient organisations. Disclosure is based on the consent of the beneficiaries. Similarly, medical devices companies that are members of beMedtech.be, the Association for the Medical Technology Industry, and members of FeBelGen, the Association that represents companies that market generic medicinal products and biosimilars, must collect and disclose this information. Again disclosure is based on the consent of the beneficiaries. From the date of application of the Sunshine Act, however, all pharmaceutical and medical device companies, whether or not member of the above organisations, would be subject to the disclosure requirements.
- Informed consent from healthcare professionals for disclosure is no longer required: In accordance with the transparency rules established by pharma.be, BeMedtech.be and FeBelGen, member companies of these organisations must comply with data protection requirements related to the collection, processing and disclosure of transfers of value. As a result, HCPs can refuse to have their personal data publically disclosed on the website betransparent.be. As a result of the new Sunshine Act, companies would no longer be required to seek the informed consent of HCPs before disclosing information concerning transfer of value. HCPs would also no longer be able to refuse the publication of their personal data. In accordance with the EU Data Protection Directive and the related national Belgian implementing provisions, processing of personal data without the need for additional safeguards such as an informed consent is permitted where such processing activities is necessary for compliance with a legal obligation. In light of the fact that the Sunshine Act now imposes a legal obligation of collection, processing and disclosure of personal data concerning transfers of value, this data may be collected without the related informed consent of HCPS. From the date of entry into force of the Sunshine Act, companies will no longer be required to seek the consent of the concerned HCPs, HCOs and patient organisations for the collection and disclosure information concerning the transfers of value granted to them.
- Collection of information is required now: The Sunshine Act imposes on companies an obligation to trace and report transfers of value provided to HCPs, HCOs and patient organisations established in Belgium. This disclosure obligation already applies to all transfers of value provided from 1 January 2017 to 31 December 2017. Related notification of these transfers of value, anticipated to be to Mdeon, must be made by 31 May 2018 at the latest. A record of the information submitted for notification and all relevant supporting documents must be kept by companies for a period of ten (10) years from the date of publication.
The Sunshine Act provides that non-compliance with the disclosure obligation will be punished by fines ranging from €1,200 to €90,000.