The Netherlands: Treatment guidelines and influence by the pharmaceutical industry - legislation on its way

15 December 2009

Machteld Hiemstra

In the July 2009 edition of the Life Sciences update we reported on investigations by the Dutch Health Inspectorate in relation to marketing mechanisms used to influence health care practitioners, particularly the use of seeding trials to increase or initiate prescriptions. On 26 October 2009 another report by the Dutch Health Inspectorate was presented about investigations in relation to the involvement of pharmaceutical industry in the development of treatment guidelines.

Treatment guidelines present an important role in choices to be made by healthcare providers to prescribe certain medicinal products, either as first choice treatment or follow up treatment. Treatment guidelines also play an important role in determining best care practice and are used by large groups of healthcare providers.

The objective of this study was to give a better insight into mechanisms used by pharmaceutical companies to influence members of working groups responsible for establishing treatment guidelines and to provide better understanding of the ties between working group members and the industry. The Inspectorate selected six treatment guidelines and formularies which were considered to by highly susceptible to unwanted industry influences.

The Inspectorate concludes that creation of treatment standards is influenced by various mechanisms, most notably, by offering medicinal products at reduced prices but also via relationships between industry and working group members. Due to a lack of standardised systems for revealing these sorts of relationships the exact extent of relationships is not transparent. Use of a so-called "declaration of interest" is often not part of the selection procedure to qualify as a working group member. Also, no detailed questions are being asked about the nature of ties and financial implications. Even though, in the view of the Inspectorate, influencing treatment standards may be regarded as pharmaceutical advertising, the Inspectorate at the same time concludes that it has no enforcement power to prevent this type of advertising.

The Inspectorate conducted an expert meeting to challenge their findings against the opinions of representatives of patient groups, health care professionals and institutes of the industry. The Inspectorate reports that there is an overall consensus that agrees that ties between working group members and the industry should be fully transparent. The creation of a "guideline for creation of treatment guidelines" appears to be widely endorsed. The Inspectorate seems to recognise that the industry may play a part in the creation of treatment guidelines; however, such role should be limited to providing comments in a round of "field consultations" after adoption of a draft guideline by working groups.

In an earlier report of the Inspectorate in May 2007, suggestions to increase transparency of industry connections in relation to the development of treatment guidelines were presented. No actions were taken though. In reaction to the current report, the Minister of Health has announced that the window for the industry to optimise transparency by self regulation is closing and that he is preparing legislation which will impose the obligation on the industry to make their relations with health care providers and scientific institutes known.