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Legislation Netherlands

Donation:

  • Since 1998 a law concerning organ donation exists.
    In 2003 a new law was implemented which concerns quality and safety of all organs and tissues.
  • According to the new law Tissue Banks process the eye tissue and are responsible for quality and safety, which includes all processes from donor to patient. They may delegate certain tasks to third parties. In case of the Cornea Bank this means tissue is collected, allocated and distributed by the Organ Centre Bio Implant Services Foundation (BIS), serology testing is performed by a specialized institute.
  • Organ donation is a mixture of an opting in and opting out system: everyone above the age of 17 is asked to express his will (permission, objection, decision to the next of kin); in case no will is available in the national register, permission can be asked from the next of kin.

Cornea banking:

  • An accreditation by the Ministry of Health as the competent authority is required.
  • Inspection of eye banks occurs by the Inspector of Medical Technology of the Ministry of Health.
    A certified Quality Management System is required.
  • The National Normalization Institute is defining more detailed criteria for tissue.
  • The Netherlands Association of Tissue Banks exists since 2002.

 

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