International Donation and Transplantation Legislative and Policy Forum: Methods and Purpose

Area of Science:

• Transplantation Medicine
• Health Policy
• Bioethics

Background:

• Organ and tissue donation and transplantation (OTDT) legislation and policies exhibit significant global variability.
• This variability contributes to disparities in the performance of OTDT systems worldwide.
• There is a need for harmonized guidance to improve OTDT system effectiveness.

Purpose of the Study:

• To convene an international forum to achieve consensus on recommendations for key legal and policy attributes of an ideal OTDT system.
• To provide guidance for legislators, regulators, and stakeholders involved in creating or reforming OTDT legislation and policy.
• To address discrepancies in OTDT system performance stemming from policy variations.

Main Methods:

• An international forum was organized, cohosted by Transplant Québec and the Canadian Donation and Transplantation Program.
• Seven domains were established: Ethical Principles, Legal Foundations, Consent, Donation System Architecture, Living Donation, Tissue Donation, and Research/Innovation.
• Consensus on 94 recommendations was achieved through virtual meetings using the nominal group technique, involving 61 participants from 13 countries and patient/family partners.

Main Results:

• Ninety-four consensus recommendations were developed across seven key domains of organ and tissue donation and transplantation.
• An ethical framework for evaluating new OTDT policies was created.
• Recommendations were presented at a hybrid forum in Montreal, Canada, with accompanying articles detailing justifications.

Conclusions:

• The developed recommendations offer guidance for establishing or reforming OTDT legislation and policy globally.
• While acknowledging global diversity, the recommendations aim for broad applicability.
• The consensus-driven approach ensures recommendations are grounded in ethical and legal principles.