Cloudy Sunshine over Luxembourg
Most people involved in the life sciences or healthcare sector are aware, or at least have heard of, the “Sunshine Act”.
The “Sunshine Act”, now a familiar concept in the EU, is the abbreviated title of the 2010 US Physician Payments Sunshine Act, which was adopted as part of the Affordable Care Act (better known as Obamacare) with the goal of enabling consumers to have knowledge of potential conflicts of interest between pharmaceutical companies and healthcare professionals (HCPs).
European countries have started to adopt similar legislation, starting with France after the Mediator scandal. The idea behind any so-called “Sunshine Act” is to ensure transparency in the life sciences and healthcare sector by establishing a register where any advantage given to a HCP by a company is published and therefore may be freely searched on the internet.
In the Benelux, both Belgium and the Netherlands have adopted a transparency system making it mandatory for companies to disclose any advantage provided to a HCP. The notion of “advantage” is quite broad; it includes inter alia gifts, donations, sponsoring, invitations to scientific events, hospitality or remuneration in the context of paid services.
- In Belgium, the Sunshine Act of 18 December 2016 (Loi portant des dispositions diverses en matière de santé1) made it mandatory for companies to disclose the benefits or other advantages given to HCPs. No minimum threshold is set in regards to the value of said advantages. The Belgian “beTransparent” register may be consulted here.
- In The Netherlands, the self-regulated Dutch commission for pharmaceutical advertising (CGR) issued a code of conduct on the transparency of financial relationships between pharmaceutical companies and HCPs. On 1 January 2017, the pilot phase ended and the system was extended to the whole medical technology industry. Any financial relationship relating to services or sponsoring that amounts to more than € 500,- per calendar year must be disclosed in the public register.
In Luxembourg, the national association of the pharmaceutical industry adopted a Code of Ethics establishing some transparency rules. Forty pharmaceutical companies have endorsed this Code of Ethics. Yet, it must be noted that no transparency register has been established for Luxembourg and that disclosure is not mandatory. Thus, publications are made purely on a voluntary basis2. This has inevitably led to a low number of hard-to-find, decentralised and outdated disclosures made by a small number of companies3.
When it comes to transparency initiatives, peer-pressure is undoubtedly a powerful tool. However, when comparing the Luxembourg system to the Belgian or Dutch registers, it appears clear that the success of the latter two is due to their mandatory nature. While the sun may shine in Luxembourg, it does so through some clouds.
3 In the absence of any consolidated register, a list of the companies’ individual disclosures is available here: http://www.apl-pharma.lu/transparence.htm
Should you have queries, please contact Florence d’Ath, or your trusted Loyens & Loeff adviser.
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FlorenceD'AthAssociate Attorney at Law
Florence D'Ath, associate, is a member of the Litigation & Risk Management Practice Group in our Luxembourg office and of the Benelux Data Protection Team. She specialises in general commercial law, intellectual property, regulatory and ICT law, with a strong focus on data protection.T: +352 691 963 125 E: firstname.lastname@example.org