WGBO - Medical Treatment Agreement Act

The most relevant law determining the treatment of patients in the Netherlands is the Wet Geneeskundige Behandelingsovereenkomst (WGBO). The WGBO concerns the contractual relation (either implicit or explicit) between caregivers and patients. The caregiver has the obligation to deliver good quality of care. In order to do so, he or she is obliged to keep a file on a patient and the treatment of the patient. The WGBO indicates that information about a patient and his or her treatment can be shared between those who are directly involved in the treatment of the patient. Sharing data with “others” outside the direct treatment, including professional caregivers is only allowed when the patient has consented to this sharing. This consent should be distinguished from the informed consent that is prerequisite before a patient can be treated.

Concerning scientific research, the WGBO prescribes that patients should be able to object to having data concerning them being made available for scientific research. This should be considered a generic opt-out: the objection concerns all requests. This objection includes the caregiver who intends to use data for his or her own research. The WGBO allows to use patient data without asking for consent if asking consent is practically impossible (address not known for instance or too many patients to approach one by one) and when informing would have adverse consequences for the patient. Additional constraints for these exceptions are that the research needs to serve a public interest (backed by a law), the data are necessary for being able to do the research and the patient has not explicitly objected against using his or her data for research purposes.