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  • Brussels blog
  • June 03, 2019

In our first blog, we started to discuss the transparency obligations incumbent upon pharma and medtech companies when certain transfers of value take place between these companies and medical professionals, such as healthcare organizations (HCOs), healthcare professionals (HCPs) and patient organisations (POs).

We explained how transparency grew out of a commitment by the industry into a full-fledged legal obligation, which aims to foster trust in medical professionals.  We there explored which precise transfers of value trigger the transparency obligations.

After having briefly discussed the new Hospital Law in our second blog, in this third blog, we will delve deeper into the transparency obligation. First, we will further elaborate on what exactly must be disclosed. We already explained that while most transfers of value must be disclosed on a nominative basis, some - particularly pertaining to scientific researchmust only be disclosed at an aggregate level (without disclosing the identity of the beneficiaries). Here, we will further specify what this implies. Next to that, we will deal with the risks associated with non-compliance with the transparency obligation. 

The information to be disclosed

The law(1) requires that the following elements be disclosed:
    
1. The name and the company number of the medtech or pharma company.
        
For companies consisting of several legal entities, it is possible to group the information and to submit a single disclosure. In that case, an explanatory note must be added, which shall be published in the transparency register. At all times, moreover, the company must be able to provide all the specific details to any monitoring authority (i.e. which entity has done exactly what for the benefit of whom).

If, in addition to medicinal products and medical devices, a company also has other products on the market, e.g. food supplements and cosmetics, these other products also fall within the scope of the Sunshine Act, unless they are part of a separate legal entity with a separate company number.

Any pharma company having cosmetics, food supplements or biocidal products in its portfolio, and which does not wish to publish value trans-fers pertaining to these products, could consider corporate restructuring.

2. The name and the company number or RIZIV / INAMI (2) identification number of the beneficiary.
        
The beneficiaries of premiums and benefits are under a legal obligation to provide the pharma and medtech companies with the aforementioned information (3). Hence, if not all beneficiary information is available for the pharma and medtech companies, they should gather it in time for submission.
    
The premiums must be made public on behalf of the direct or indirect beneficiary of the granted benefit, taking into account that

  • as to fees, payments and reimbursement of costs for services and consultancy to HCO: the beneficiary is the HCO, unless the services are provided by a HCP acting as a company or who is part of a de facto association;
  • as to contributions to the costs of participating in scientific events: the beneficiary is the HCP, even if the HCO intervened by receiving the premium or benefit first;
  • as to contributions to the costs of organizing scientific events: the beneficiary is the HCO or PO.

On the FAQ section of betransparent.be (sub 5), a useful diagram provides more information as to the particular transactions involved.

3. The total amount of the qualified premiums and benefits for the reference year.
        
The benefits and premiums include these granted indirectly, for instance through indirect sponsorship in scientific events (the so-called "educational grant"). In the latter case, it is the hospitality (eg registration fee, hotel, transport) received by the final beneficiary (HCP) which must be notified, and not the transfer to the intervening HCO. 

For the purposes of determining the reference year, the determining date will be the date of the financial transaction and not the date on which the beneficiary actually benefited. The amounts should be provided without VAT (4).

The following premiums and benefits are disclosed on a nominative basis: 
 

HCPs

HCOs

POs

Contributions to the costs of participation to scientific events (eg registration fees, travel and accommodation)

Contributions to the cost of scientific events (eg registration fees, travel and accommodation) and sponsoring contracts with HCOs or with third-party organizers of scientific events

Fee payments and reimbursement of expenses for services and consultancy

 

Consultancy and service fees or reimbursements of expenses

Consultancy and service fees or reimbursements of expenses

Financial or other support

 

Donations and grants that support healthcare

 

Scientific research is disclosed on an aggregate basis. This encompasses non-clinical studies, experiments on the human person, clinical trials, prospective non-interventional studies and veterinary clinical trials.

The information must be disclosed by 31 May of the year following the reference year (5), using the file which is made available on the website . The documentation which attests to the value transfers must be kept by the pharma and medtech companies for 10 years (6).

This information, except the unique identifiers (7), is made public through the betransparent.be transparency register. Pharma and medtech companies can freely add explanatory notes to explain certain transactions or to provide context. However, given that these notes become public alongside the legally required information for three years (8), it is advisable to double check that the activities which are disclosed in these notes are indeed compliant under the applicable legislation (in particular Article 10 of the Act on medicinal products). 

Non-compliance risks

Pharma and medtech companies that do not comply with the Belgian Sunshine Act obligation, risk a criminal fine between EUR 1,600 and 120,000 (9). 

So far, we are unaware of any company having been fined already. However, the Federal Agency for Medicines and Health products (FAMHP) is legally tasked to conduct inspections and audits. More audits have been announced in order to check compliance with the transparency obligation. Especially after the implant files, sanctions and more thorough monitoring is expected. More thorough enforcement measures are also to be expected, should complaints be filed with the FAMHP. 

Non-compliant companies face an increasing risk of sanctions.

Hereby, we want to emphasize that fulfilling the transparency obligations does not make these transfers of value compliant with other legal obligations. In that regard, we for instance refer to our newsletter on Article 10 of the Act on medicinal products

Further

Our Healthcare compliance seminar also dealt with public procurement (tender) obligations). We touched upon this issue already at the end of our second blog. In our next and final blog, we will revisit the presentation provided by Jens Mosselmans on this issue.

In the meantime, should you have any questions, please do not hesitate to contact Christel Brion (christel.brion@nautadutilh.com) or Jens Mosselmans (jens.mosselmans@nautadutilh.com).

On 21 March 2019, we were very pleased to welcome Mieke Goossens amongst us at our first Healthcare Compliance Workshop. Mieke, member of the Management Committee of betransparent.be, had a discussion with Christel Brion on the transparency obligations in the pharma and medtech sector.


1) Article 42, § 1 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 (hereinafter: "Belgian Sunshine Act").
2) The RIZIV ("Rijksinstituut voor ziekte- en invaliditeitsverzekering") / INAMI ("Institut national d'assurance maladie-invalidité") grants a unique identification number to all Belgian healthcare professionals (art. 218, § 2 14 July 1994 Act on the compulsory health insurance and allocations).
3) Article 42, § 3 Belgian Sunshine Act. If, for instance, no RIZIV/INAMI identification number is available, the national identity number must be provided (Article 3, 5°, c) of the 14 June 2017 Royal Decree executing the Sunshine Act (KB 12 juni 2017 tot uitvoering van de Sunshine Act/ A.R. 14 juin 2017 portant execution du Sunshine Act, BS / MB 23 juni / juin 2017) (hereinafter: "RD 2017").
4) Article 3, 2°, d) RD 2017.
5) Article 42, § 2 Belgian Sushine Act.
6) Article 43, § 2 Belgian Sunshine Act.
7) That is: the RIZIV/INAMI identification number. See further Article 5 RD 2017. 
8) Article 6 RD 2017.
9) The numbers in the law (200 to 15.000 euros) must be multiplied by the legal "opdeciemen" (Article 1 of the 5 Mar 1952 Act on criminal opdeciemen).

 

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