Legal framework
The Ministry of Health, Welfare and Sport incorporates quality and safety requirements from European directives into various laws. There are three laws applicable to organ and tissue donation.
Dutch legislation
There are clear laws and rules in place for 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 cases of living donation.
Safety and Quality of Human Body Material Act (Wvkl)
This law concerns the safety and quality of human body material used for medical treatment.
Body Material Requirements Decree
The requirements decree contains additional requirements 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 are applicable.
View the laws atwetten.overheid.nl
Supervision of protocol compliance
The Health and Youth Care Inspectorate (IGJ) monitors compliance. Some protocols are mandatory, such as the brain death protocol. In the event 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.