This document discusses legal and ethical issues related to organ transplantation. It covers topics such as definitions of live and cadaveric organ donors, principles of biomedical ethics applied to live donation, criteria for live donation, and guidelines for obtaining consent from donors and families. The national policy in Malaysia is also summarized, which follows an opt-in approach, only allows living donation between family, and prohibits organ commercialization.

1. ORGAN TRANSPLANTATION-
LEGAL ISSUES
GROUP 1B

2. NAME MATRIX NUMBER
Devarubiin A/L Denamany QIUP-201810-002627
Emmanuel David Arul A/L Koilpitchai QIUP-201810-002629
Ngu Kue Ming QIUP-201810-002600
Sarvina A/P Ravi QIUP-201810-0022709
Seah Wei Sheng QIUP-201810-002736
Syedali Fakhrudeen Mushthak QIUP-201810-002791
Hanan Kunhammad QIUP- 201810-002790
Ealanthi Asna Nazreen QIUP-201810-002792
Nur Wajihah Binti Khalipsa QIUP-201809-002580
GROUP MEMBERS

3. LEARNING OUTCOMES
Organ transplantation:
• Background
• Definition
• Ethical issues of Live organ donation
• Ethical issues of Cadaveric organ donation
• Organ allocation
• National organ transplantation policy
• General guideline for organ donation

5. ● Organ transplantation is the replacement of diseased and damaged
organs.
● It isan established treatment for end stage organ failure.
● Organ donors can be classified as live or cadaveic
● Live donors can come from family members when they are known as “live
related” donors (LRD) or from close friends, relatives or spouses, when
they are known as “emotionally related” donors (ERD).
● There are also donors who sell body parts, and they are called
“commercial” donors.
ORGAN TRANSPLANTATION

6. Organs and Tissues that can be donated

7. The ethical issues of live organ donation should be considered in the light of
the four basic principles of biomedical ethics:
● Respect for autonomy
● Non-maleficence
● Beneficence
● Justice
Ethical Issues in Live Donors

8. ● Competent adult living persons can donate organ and/or tissue but they shall
preferably be related to the recipients and donor consent must be given freely and
altruistically without coercion or any commercial inducement.
● No organ and/or tissue shall be removed from the body of a living minor for the
purpose of transplantation except in the case of regenerative tissues.
● Prior authorisation from the Unrelated Transplant Approval Committee (UTAC) shall
be obtained before any unrelated live organ donation. Such donation must fulfil
the following criteria except in the case of regenerative tissues;
 No available cadaveric donor
 No compatible donor from genetically related or emotionally related family
members
 No other alternative treatment.
Organ and Tissue procurement from live donors

9. ● In the case of organ donation, all living donors shall be counselled by donor
advocates regarding the risks, benefits and possible consequences. Donor
advocates shall be independent of the organ procurement and transplantation
team.
● Prisoners awaiting execution and mentally disabled person shall be prohibited
from live donation.
● Under life saving circumstances, live donation of organs from prisoners may be
considered for immediate relatives subjected to approval from relevant
authorities.
● Organ and tissue procurement and transplantation from living donors shall only
be performed in accredited centres by credentialed personnel.
● Accredited centres performing organ procurement from related and unrelated
living donors shall have written guidelines and standard operating procedures.
These shall include the following:
○ Criteria for eligibility to be a donor.
○ Detailed donor evaluation including psychosocial and medical assessment.
○ Plan for life-long donor follow-up.

10. ❖ Consent for organ donation following death is usually given in two ways. In
the “opting in” system presently practised in this country a person states his
intention to donate his organs when he is alive and this is recorded in a
document.
❖ In another system of giving consent, “the presumed consent” or “the opting
out system”are considered. In “presumed consent”, a person is deemed to
have consented if he had not clearly stated that he did not wish to donate his
organs.
❖ Such a system is practised in many countries including Singapore and a
number of European countries and has led to improvements in organ
donation rates.
Ethical issues in cadaveric donations

11. Organ and Tissue procurement from
cadaveric donors
 There shall be a dedicated unit at the national level to manage and coordinate all aspects
of organ and tissue procurement from cadaveric donors. This unit shall be known as
Transplantation Procurement Management Unit (TPMU). The responsibilities of this unit
include:
 To coordinate organ and tissue procurement in any part of the country with the local hospital
unit managing the donor.
 To liaise with organ and tissue transplantation teams.
 To organise efficient and safe transport of organ and tissue from donor hospital to recipient
hospital.
 To develop guidelines, standard operating procedures and standard criteria for donor
referral, donor management, organ and tissue procurement, storage and transport as well as
disposal of any unused organ and tissue.
 To conduct public education and promotion of organ and tissue donation.
 To provide regular data on organ and tissue donation activities.

12. ❖ At each identified hospital there shall be a Tissue Organ Procurement (TOP) Team consisting of
trained personnel who shall be responsible for the identification and management of the potential
donor including getting consent from the next of kin, evaluation for donation, organising the
procurement, storage and transport of the organs and tissues and speedy return of the donor’s remains
to the next of kin.
❖ All potential cases for cadaveric donations shall be made known to the local Tissue Organ
Procurement (TOP) Team.
❖ All deaths shall be considered for possible tissue donations.The TOP Team shall provide support and
follow-up care to the family of the donor for an appropriate duration.
❖ Death certification for potential cadaveric donors shall be carried out by registered medical
practitioners who are independent of the organs and/or tissues transplantation teams.
❖ In cases where potential cadaveric donors’ remains are being held under the Criminal Procedure Code
for post-mortem or coronal inquest, prior written consent from the magistrate has to be obtained before
any organ and/or tissue procurement is carried out, in accordance with the existing legislation.
❖ Consent for donation can be obtained either from the deceased’s expressed wish made through
the organ and/or tissue donor pledge card and/or from the next of kin.
Organ and Tissue procurement from
cadaveric donors

13. •The numbers of organs have never been sufficient to meet the demands and
the waiting time for patients to receive organs continue to grow. In heart
and liver failure, transplantation is life saving.
•The ethical principles utilized in allocating organs include utilitarian,
justice and autonomy.
Ethical Issues in Organ Donation

14. ❖ The next of kin shall be informed by the TOP Team if the organs and/or
tissues are not used and the next of kin shall be consulted on the method of
disposal.
❖ It is mandatory to obtain consent from the next of kin if the organs and/or
tissues are to be used for purposes other than transplantation.
❖ Any incidence of unused organ and/or tissue shall be investigated and
reported to the NTTC.
❖ Any unused organ and/or tissue which are not claimed by the next of kin shall
be disposed with dignity in accordance with the guidelines on disposal of
human materials.
Unused Organs and Tissues

15. National Organ Transplantation Policy
 National Organ, Tissue and Cell Transplantation policy
is developed to guide practitioners in the field and all
other stakeholders to further develop this therapeutic
option to treat end stage organ failure states.
 It has taken into consideration the development of
transplantation in this country so far, issues and
concerns, resources required and their shortfall.
The National Organ Tissue and Cell Transplantation
Policy, Ministry of Health Malaysia, 2007

16. National Organ Transplantation Policy
 Opt-in law
 No organ and/or tissue shall be removed from the body of a living minor for
the purpose of transplantation except in the case of regenerative tissues.
 Living organ donation only allowed between family members.
 Unrelated living organ donation requires approval from the Unrelated
Transplant Approval Committee (MoH).
 Organ commercialisation and trafficking is prohibited.

17. General Guidelines for Organ Donation by Living Donors
An individual willing to donate organ must be :
• An adult legally able to give consent
• Aware of all risks that can occur
• Physically and mentally fit
• Fully aware of the decision he/she is making
• Able to fully evaluate and understand all information given to him/her
• Not have received any coercion or any advice or opinions from sources other then the
institution.
Guideline Of The Malaysian Medical Council
Organ Transplantation

18. Information which the potential donor must understand include:
• The choice of treatment for the patient.
• The types of tests which need to be carried out, and the risks and complications
of such tests.
• The short term and long term risks.
• The success rate of the transplantation in general and the success rate of the
institution performing the transplantation.
• The need for follow-up treatment.
Guideline Of The Malaysian Medical Council
Organ Transplantation

19. Organ Donation By Living
Related Donor
• The donation of organ by a
living related donor must
follow the general guidelines
for living donors.
• It is the responsibility of the
institution performing the
transplant to ensure that all
guidelines are followed
Organ Donation By Living
Unrelated Donor
• Organ donation from unrelated
donors is primarily not
accepted unless in special
circumstances.
• Application should be made
for approval from the
Unrelated Transplant Approval
Committee (UTAC)
Organ Transplantation

21. References
● The National Organ Tissue and Cell Transplantation Policy, Ministry of Health Malaysia, 2007.
Retrieved from http://www.mst.org.my/articles/malaysia%20transplant%20policy.pdf
● Malaysian Medical Council 2006 November 14; 23 p. [Online]. Accessed:
http://mmc.gov.my/v1/index.php?option=com_content&task=view&id=47&Itemid=77 [2010 May
14]
● https://emedicine.medscape.com/article/1680082-overview