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Focus on Regulation

Dutch Sunshine Act: Financial relations between pharmaceutical companies and healthcare professionals will be made public in the Netherlands in April

As of 10 April 2013, the transparency register regarding financial relations between pharmaceutical companies and healthcare professionals in the Netherlands will go live.  Through the register, anybody from patients and journalists to competitors will be able to search per healthcare professional or per organization of healthcare professionals for financial relations with pharmaceutical industry.

 The self-regulatory Dutch commission for pharmaceutical advertising (CGR) issued a code of conduct on transparency of financial relations between pharmaceutical companies and healthcare professionals.  The rules were drafted after the Dutch Minister of Health had in 2009 urged the CGR to do so in order to come up with a Dutch equivalent of the US Sunshine Act.  These rules entered into force on 1 January 2012.  The first disclosure of information through the public register (“Transparantieregister Zorg“, www.transparantieregister.nl) is expected in April and will relate to financial relations that existed in 2012.

 The transparency rules apply to (1) service agreements between pharmaceutical companies and healthcare professionals and (2) sponsoring agreements between pharmaceutical companies and organizations in which healthcare professionals cooperate or work, such as hospitals, general practitioners practices and scientific associations.  Hospitality such as meals, travel, hotels, provided to individual healthcare professionals does not need to be disclosed, nor do gifts or product samples.

 Any financial relation relating to services or sponsoring that amounts to more than € 500,- per calendar year must be disclosed in the public register.  This also applies to indirect payments that are made on the pharmaceutical company’s behalf.  In summary, the following information must be disclosed: (i) name and address of the pharmaceutical company, (ii) name and address of the sponsoree or service providing healthcare professional (iii) type of agreement according to a CGR selection table (for example speaker services, advisory board services or sponsoring of a scientific conference) and (iv) amount of money paid.  Disclosure must be done once a year within three months after the previous calendar year concerning relations that existed in that previous calendar year.  The information will remain published in the central register for a period of three years after which period the data will be removed.  If the financial relation exists with a pharmaceutical company established in the Netherlands, the pharmaceutical company should take care of reporting the information to the public register.  If a financial relation exists with a pharmaceutical company established outside the Netherlands, the healthcare professional or organization should report the information, although in practice multinational pharmaceutical companies may have arranged for their Dutch affiliate to take care of the reporting of any financial relations with healthcare professionals who practice in the Netherlands.

 Sponsoring or service arrangements must be laid down in a written agreement.  The agreement must contain a specific clause regarding transparency, arranging for the disclosure into the public register.  The pharmaceutical company shall provide each healthcare professional or organization of healthcare professionals with which it has a financial relation, with a yearly overview of the data that will be disclosed.

 There are still quite some questions in respect of the disclosure, for example: There is a number of exceptions to the transparency requirements, not all of which are clear-cut.  When a company provides sponsoring in kind, for example by offering patient support programs or medical technology, it is often difficult how to determine the value that has to be disclosed.  Long-term agreements that were agreed before the transparency rules entered into force may need to be amended.  It is not always clear which legal entity should be mentioned as the beneficiary of sponsoring.

 Apart from the US and the Netherlands, similar transparency initiatives are taken in a number of countries.  The Netherlands however seems to be the first country in the world where financial relations will be disclosed through a publicly accessible register.  Of course, many companies wonder what the responses will be after disclosure in April.  Will the media and/or politicians pick this up?  What will patients ask their doctors when they learn about their doctor’s relations?  And what reactions can pharmaceutical companies expect from healthcare professionals, patients and competitors?