Proposed Policy: Directed Donation South African Transplant Society 2010 Prepared by: Netcare Transplant Division Approved by: ____SATS______________ Approval date: _________________ Review date: ___________________ Version: 1 POLICY STATEMENT i. ii. To ensure that the South African Transplant Society and Transplant units are compliant with the National Health Act No 61 of 2003 and the Human Tissue Act 65 of 1983 with regards to transplantation Provide guidelines on the ethical concerns of solicitation for organs DIRECTED DONATION i. An organ that is directed to an identified recipient, either by a living donor or at the bequest of a donor family. THE LIVING RELATED / UNRELATED DIRECTED DONATION i. ii. Genetically related donor (usually a parent, sibling, son, daughter, aunt, uncle, nephew, niece, cousin) Emotionally related (usually spouse, friend or someone with whom they have a genuine close relationship) Donation of a kidney to a genetically related recipient is a well established in South Africa being regulated by the National Health Act No 61 of 2003. Donation of a kidney to an emotionally related recipient is ethically acceptable with Department of Health granting permission for the transplant in accordance to the National health Act No 61 of 2003. GENERAL PRINCIPLES FOR RELATED / UNRELATED LIVING DIRECTED DONATION i. ii. iii. iv. v. The donor must be over 21 years of age and be able to make an informed consent The donor must be altruistic, free from coercion The donor may withdraw at any time before the surgery without reason The safety and suitability of the donor and recipient must be complied with There should be follow up of the living donor SOLICITATION DEFINITION 1. “To plead or ask for something.” 2 2. ‘To ask somebody for something” 3. “To draw somebody into participation in illegal or immoral acts” Encarta Dictionary: English UK DIRECTED LIVING DONATION WITH SOLICITATION DEFINITION Public media advertising appealing for a potential living donor to come forward to donate an organ directly to the recipient. ETHICAL CONSIDERATIONS OF SOLICITED DIRECTED LIVING DONATION i. ii. iii. iv. Inappropriate transplant of unsuitable or less urgent recipients Recipients with greater resources and communication skills may have an advantage over less resources or educated recipients May be attempt to solicit a live donor rather then approach family or friends Potential for illegal payments or incentives to live donors even years later GENRAL PRINCIPLES OF LIVING DIRECTED DONATION WITHOUT SOLICITATION i. ii. Direct media and internet appeals to direct donation directly to the recipient are not ethically acceptable. Assistance with raising public awareness of organ donation in general is permitted. If a living altruistic donor should come forward, the Altruistic Donor” policy will be complied with. a. Currently the donor should be referred to a State hospital centre of excellence where all preliminary evaluations should occur b. Once the altruistic donor has been found competent to donate, cross matching can be undertaken c. Suitable recipients from the top of the cadaveric allocation system should be selected as potential candidates. This benefits many as everyone below shifts up a slot on the allocation system d. High risk recipients should not be considered as outcome of an altruistic donation is of great importance (MAC) e. The selected recipient’s insurer (State or Private sector) becomes responsible for all costs incurred in the donation process (CMS) f. The actual donation process may then occur in either health care sector g. For the donation to be truly altruistic, the donor should not request one recipient over another, and should this occur, the process should be halted 3 DECEASED DIRECTED DONATION DEFINITION The deceased donor family directs donor organs to a specific recipient where there is already an established relationship; family, friends or social community members known to the family e.g. church member. ETHICAL CONSIDERATIONS OF SOLICITED DECEASED DIRECTED DONATIONS i. ii. iii. iv. Violation of a fair cadaveric allocation system by allowing recipients to ‘jump’ the queue May allow donor families to direct donation based on conditional consent to specific groups only Inappropriate transplant of unsuitable or less urgent recipients Recipients with greater resources and communication skills may have an advantage over less resources or educated recipients GENERAL PRINCIPLES OF DECEASED DIRECTED DONATION i. ii. iii. iv. v. Donor autonomy should be balanced with the rights of those on the cadaver waiting list. The directed donation should only be to recipients with whom the donor family or donor have an emotional bond or a family member. If there is no emotional bond with the recipient, and the recipient is ‘known’ to the donor or family by media through raising awareness of organ donor, provided that the recipient has not made a specific appeal for organs to be directed to themselves, then this should be ethically allowed. The donor family must be made aware that the intended recipient must be medically suitable and matched before the transplant and if the recipient was not, that the organ would be allocated according to the cadaver waiting list. Other organs must be allocated according to the allocation system of the cadaver waiting list. LEGAL FRAMEWORK i. The National health Act 61 of 2003 and the Human tissue Act 65 of 1983 covers deceased donation to a specific institution or recipient. (The Human tissue act 65 of 1983 still remains enforce until the regulations of Chapter 8 of the National Health act 61 of 2003 have been published) 4 REFRENCES: 1. Human Tissue Act No 65 of 1983 - s 3(1) 2. National Health Act No 61 of 2004 – Ch 8 s 63 3. Hanto, D.W. 2007. Ethical Challenges Posed by the Solicitation of Deceased and Living Organ Donors. New England Journal of Medicine. 356:10. 10621066. 4. Truog, R.D. 2005. The Ethics of Organ Donation by Living Donors. New England Journal of Medicine. 353:5. 444- 446. 5. Department of Health, New South Wales. Policy Directive. Kidney Donation – Living (including Directed and Non- directed Donation). Available online: http://www.health.nsw.gov.au/policies/pd/2009/pdf/PD2009_013.pdf 6. Declaration of Istanbul on Organ Trafficking and transplant Tourism. Turkey 30 April – 2 May 2008. 7. Interm Report of the OPTN/UNOS Ethics Committee. Chicago. 7 December 2009. Available on line: http://www.unos.org/CommitteeReports/interim_main_EthicsCommittee_1_5_ 2010_9_18.pdf 8. World Health Organization. Sixty Second World Health Assembly. 26 March 2009. Guiding Principle 6. pg 10. Available at: http://apps.who.int/gb/ebwha/pdf_files/A62/A62_15-en.pdf 9. Statement on Directed Donation and Solicitation of Organs. American Society of Transplant Surgeons. 23 October 2006. Available at: http://www.asts.org/Tools/Download.aspx?fid=269 5