Recently, the Dutch Code of Conduct for Pharmaceutical Advertising underwent some changes in order to align it further with European rules in this area. These changes mainly relate to rules regarding provision of hospitality and research not subject to so-called WMO.
Provision of hospitality – reasonable meal costs
The Code of Conduct for Pharmaceutical Advertising already sets out rules regarding maximum amounts that pharmaceutical companies may compensate for provision of hospitality at meetings and manifestations. On January 1, 2015 the Code of Conduct was amended to introduce a maximum amount for reasonable meal expenses in the Netherlands. This amount is set at € 75 and is in addition to the applicable maximum amounts for provision of hospitality at meetings and manifestations that may include food. If the meal is provided outside of the Netherlands, then the maximum amounts set out in self-regulation of that specific country are applicable.
Provision of hospitality – agreement in writing
Pharmaceutical companies and professionals are required to be transparent about their relationships. Currently, the Code of Conduct requires that service and sponsorship agreements must be set out in writing and must be disclosed in the Transparency Register (Transparantieregister Zorg) if the total amount exceeds € 500 a year. As of January 1, 2015 these obligations will also apply to agreements regarding provision of hospitality. The written form requirement does not apply to instances where the hospitality provided by the pharmaceutical company is limited to provision of a meal.
Another change concerns implementation of transparency rules of the European Federation of Pharmaceutical Industry Associations (EFPIA). Per January 1, 2015 pharmaceutical companies and healthcare professionals must disclose the reimbursement of expenses for services and sponsoring in the Transparency Register. The obligation to disclose fees paid to groupings of healthcare professionals and/or entities in which they participate has disappeared under the condition that these fees have been disclosed under the name of the healthcare professional that performed the services.
Research not subject to WMO
Until 2015 research with medicinal products by pharmaceutical companies which was not subject to so-called WMO (the Dutch Medical Research involving Human Subjects Act, Wet medisch-wetenschappelijk onderzoek) was assessed by CGR (the Dutch Foundation for the Code for Pharmaceutical Advertising) for compliance with the Code of Conduct. As of January 1, 2015 the CGR will apply the so-called “Toetsingskader niet-WMO-plichtig onderzoek” when assessing advice requests for such research. During the first six months of 2015, the CGR will receive requests for advice, but will no longer subject these to substantive assessment. Such assessment will be conducted by a Medical Ethics Review Committee (METC). The Code Commission of CGR will only assess the part relating to inducements. As of July 1, 2015, the obligation to have research not subject to WMO be approved by the CGR will cease to exist.