On 9 April 2009, the Healthcare Inspectorate sent a report to the Dutch Minister of Health regarding the use of Phase IV studies for marketing purposes. The Healthcare Inspectorate drafted a short list of aspects that may indicate the promotional nature of a Phase IV study:

  • the usefulness of the research is unclear;
  • the remuneration paid to the healthcare professional is too high compared to the work performed;
  • only minimal scientific data are collected;
  • there is no written service agreement; and
  • advertising is being made.

The Healthcare Inspectorate believes that if one of these circumstances applies, the research is likely to have a promotional purpose and it recommends that healthcare professionals then do not participate.

The Healthcare Inspectorate further recommends that:

  • the Minister of Health comes up with legislation or policy rules concerning Phase IV studies;
  • healthcare professionals draft professional guidelines concerning Phase IV studies; and
  • the self-regulatory body CGR introduces mandatory preventive testing of Phase IV studies.

In a first reply, the CGR pointed out that mandatory preventive testing does not provide an extra guarantee over the rules and testing mechanisms already in place. The Minister of Health responded that he indeed intends to come up with legislation regarding Phase IV studies, but that he intends to link that to the implementation, at a later moment, of the pharmacovigilance part of the EU Pharmaceutical Package, the European Commission's proposal of December 2008.