Legal framework
The Ministry of Health, Welfare and Sport incorporates quality and safety requirements from European directives into the various laws. Three laws apply to organ and tissue donation.
Dutch legislation
Clear laws and rules apply to organ and tissue donation in the Netherlands. These laws ensure that donation and transplantation are conducted safely, carefully, and transparently.
Organ Donation Act (Wod)
The Wod regulates the fair distribution of donated organs and tissues, and the central registration of declarations of intent. The law ensures legal certainty for those involved and aims to prevent the trade in organs and tissues, including in living donation.
Human Body Material Safety and Quality Act (Wvkl)
This act concerns the safety and quality of human body material used for medical treatment.
Body Material Requirements Decree
The requirements decree contains additional rules regarding the safety and quality of human body material. This decree also regulates data protection and confidentiality.
Body Material Requirements Decree
In addition, the Personal Data Protection Act and the Medical Treatment Contracts Act apply.
View the laws atwetten.overheid.nl
Supervision of compliance with protocols
The Health and Youth Care Inspectorate (IGJ) supervises compliance. Some protocols are mandatory, such as the brain death protocol. In case of non-compliance with obligations, the IGJ can take measures, such as an order, instruction, or penalty payment.
European legislation
The European Union (EU) has legal guidelines for quality and safety in the field of donation and transplantation. Each EU country has competent authorities for implementation.