Legal Issue regarding Living Donor Organ Transplants Lim Heng Seng lhslh-ag

1. Legal Issue regarding Living Donor Organ Transplants Lim Heng Seng lhs@lh-ag.com

2. Background Lifestyle-related diseases among causes leading to rise in the incidence of end stage organ failures Organ transplant the only option in saving lives. Increase in demand for organs: Harvesting organs from cadavers alone clearly insufficient. Thus issue of living donors

3. LEGAL PERSPECITVES AND ISSUES

4. Scope of paper Legal regime for organ donation The position of living organ donation Consent Commercialization of transplantation and commoditization of body organs by their sale and purchase Risks to living donors

5. The Law Governing Organ Transplantation Currently no Malaysian legislation governing living donor organ transplants The Human Tissues Act 1974 [HTA 1974] governs only cadaveric transplants HTA 1974: An Act to make provision with respect to the use of parts of human bodies of deceased persons for therapeutic purposes and for purposes of medical education and research. With regards living donors, there are only guidelines and policies in place

6. a) Guidelines for Organ Transplantation from Living Donor Guidelines for Organ Transplantation from Living Donor 006/2006: Issued by the Malaysian Medical Council Consent: Clauses 6.1 (a) and (f) provides that an individual willing to donate organ must: i) be an adult legally able to give consent ii) have not receive any coercion Altruism: Clause 6.6 provides that: ‘No financial transactions are permitted except payment for expenses incurred by the donor, payable to a third party’

7. b) National Organ, Tissue and Cell Transplantation Policy The ‘National Organ, Tissue and Cell Transplantation Policy’ is introduced by the Medical Development Division, Ministry of Health Malaysia (June 2007) Policy acts as a guide to all those involved in working towards attaining the highest professional and ethical standards in the field of transplantation. Twin principles of informed consent and altruism are fundamental in national policy.

8. Aims of Policy One of the main aims of the policy is to ensure that the rights and welfare of living donors are looked after, in cases where live donations are necessary. Clause 3.2 prohibits the commercialization of organ, tissue and cell transplantation and any act that may indirectly promote or lead to commercial transaction. Clause 3.4 protects the welfare of living donors where it states that all living organ donors shall be followed up for life.

9. Free consent without commercial inducement Clause 6.1: organs and tissues shall be procured preferably from cadaveric donors. However where appropriate, organs and tissues from living donors may be used. Clause 6.2: Guidelines for organ and tissue procurement from living donors. Clause 6.2.1: 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.

10. Prior authorization and criteria Clause 6.2.3: Prior authorization from the Unrelated Transplant Approval Committee (UTAC) shall be obtained before any unrelated live organ donation. Such donation must fulfill the following criteria except in the case of regenerative tissues: a) No available cadaveric donor; b) No compatible donor from genetically-related or emotionally related family members, and c) No other alternative treatment.

11. Minors, prisoners and mentally disabled persons Clause 6.2.2: 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. Clause 6.2.5: Death row prisoners and mentally disable persons prohibited from live donation [However with regard to prisoners, exception for life saving circumstances]

12. Cross-border organ recipients Clause 11.1: Prohibits the allocation of organs/tissue from donors in Malaysia to recipients in another country unless: there is no suitable recipient locally, and there is a prior agreement on organ/tissue sharing between such two countries. Clause 11.2: importation of tissues from other countries shall be made through institutions recognized by the Ministry of Health and in accordance with the Guidelines on Importation and Exportation of Human Tissues and/or any Body Part.

13. Enforceability of Policy and Guidelines Policy is not law May be subject of disciplinary sanction under relevant legislation governing medical profession Living organ donation therefore comes under general law Need for comprehensive legislation

14. Consent Organ donation involves removal of organs which is technically “grievous injury” under common law and Penal Code [Sec 320] Whether defence under Sec 87 [Act not intended and not likely to cause death or grievous hurt done by consent] applies Whether defence under Sec 88 [Act not intended to cause death done by consent in good faith for benefit of a person] applies Consent usually relevant to therapeutic operations but even more so to altruistic living organ donation here the donor’s own benefit is less apparent. Position in England clarified: non-therapeutic operation valid so long as consequential injury not against public interest Malaysian position under Penal Code unclear

15. Meaning of consent Consent nevertheless subject to authorization of Unrelated Transplant Approval Committee MOH 2007 Policy does not elaborate on the requirements for free consent MMC Guideline for Organ Transplantation from living donors specifies: (a) Adult legally able to give consent (b) Aware of all risks that can occur (c) Physically and mentally fit (d) Fully aware of decision being made (e) Able to evaluate and understand all information given (g) Not coerced; had not received advice or opinions from sources other than institution planning transplantation.

16. Commercialization of transplantation

17. Commoditization of organsEmergence of a Black Market Demand by desperate patients exceeds supply Leads to organ trafficking with attendant risks of poor outcomes Organs have now become a commodity we can buy and sell WHO: transplants can be arranged by brokers at rates between USD 100,000 and USD200,000 Donors who are usually impoverished and ill-educated receive as little as US$ 1000 for a kidney Unverified reports: 600 Malaysians to India and China [executed prisoners] for kidney purchase and transplants

18. Singapore Human Organ Transplant Act 1987 (HOTA 1987) Section 14(1) prohibits contract or arrangement for sale or supply of any human organs or blood for any valuable consideration transaction and renders such transaction as void Section 14(2) criminalizes such contracts or arrangement; offender is guilty of an offence and shall be liable to a fine not exceeding $10,000 or to imprisonment not exceeding 12 months or both Note: To be read with other general Penal Code provisions

19. HOTA 1987 offences Section 14(2A) (a) and (b) prohibits giving or offering and receiving of valuable consideration for supply of organs Section 14(2A) (c) prohibits offers to sell or supply organs for valuable consideration Section 14(2A) (d) prohibits the initiation or negotiation for contract or for offer for organs

20. Prosecutions HOTA 1987: An insight into the organ trade: March 2008 Toni approached by Iwan to donate kidney Arrived in Singapore and met by Wang Introduced to Julaina Soh, intended recipient TEC approved transplant and successfully done Toni paid Rph 186,000,000 [S$29,000] Wang received S$8,000

21. ….May 2008 Ministry received information that blood samples sent to Singapore from foreigners for cross-matching against Singaporean Investigations revealed that Tang required kidney transplant Whang [Tang’s wife’s uncle] had recommended Wang to Tang; Tang engaged Wang for S$300,000 to source for kidney donor Sulaiman approached and agreed to donate

22. ….May 2008 Toni asked to act as liaison and to accompany Sulaiman from Indonesia and whilst in Singapore; Whang paid total of S$20,000; Toni paid Rph 150,000 [S$3,2000]; Wang agreed to pay Sulaiman Rph 150 [S$23,700] upon successful transplant operation Wang made arrangements for all medical examinations and appearance before TEC including affirmation in Statutory Declaration before COA.

23. Prosecutions under Singaporean HOTA 1987 PP v Tang Wee Sung [2008] SGDC 262 PP v Wang Chin Sing [2008] SGDC 268 PP v Sulaiman [2008] SGDC 175 Wang Chin Sing v PP [2009] 1 SLR(R) 870 Whang Sung Ling v PP [2010] SGHC 53

24. The primary transaction, the offence and the 3 accused persons Facts: Tang Wee Sung required a kidney transplant Tang entered into an arrangement for a kidney to be supplied to him. Tang engaged Wang Chin Sing to source for a donor who was willing to donate his for a fee. Tang agreed to pay Wang S$300,000 Sulaiman Damanik (Indonesian) approached and agreed to donate his kidney for 150 million rupiah (about S$23,700).

25. Held: 4 individuals were found guilty under the HOTA 1987 Wang sentenced to imprisonment for 14 months [Entering into arrangement for supply of kidney: Offence under Section 14(1) read with (2)] . Tang fined S$7000 in default 7 weeks imprisonment [Agreed for valuable consideration: Offence under Section 14(1) read with (2)]. Sulaiman was fined S$1000 in default 1 week imprisonment. Whang sentenced to 8 months imprisonment [Abetting 14(1) read with (2)] offence]

26. Wang appealed to High CourtWang Chin Sing v PP [2009] 1 SLR(R) 870 Wang had….”peddled in deceit, trafficked in organs and profiteered from misery” Primary sentencing consideration is general deterrence and not retribution To deter other individuals contemplating acing as middlemen in organ trading in Singapore Middleman’s role should as a matter of sentencing policy be accorded prominence Sentence of 14 months imprisonment sufficiently articulate unambiguous message that organ trafficking will not be tolerated in Singapore

27. Ethical issues and human dilemma: Prosecution in Tang’s case Exploitation of poor and disadvantaged in commercial trade in organs Recipient as culpable as donor: if no demand, no supply However, noted need to temper justice with mercy: PP recognizes desperate situation of accused, did not seek custodial sentence

28. Ethical issues and human dilemma raised prior to sentencing: Tang the intended recipient Desperation due to extreme ill-health No intention to exploit: Informed that donor will be very well-paid from 300,000 such that sum would be more that he can earn in a lifetime Played passive role: Approached and instigated by one Whang; did not actively seek to buy; as much a victim of organ trading as would be donor

29. Court’s consideration Clear that main disapproval (in applying retributive principle in sentencing) is focused on the middleman who profit from illicit organ trading and not the dying patient in need of transplant or the poor, s ocially disadvantaged donor Society’s disapproval directed at “middleman creaming off bulk of compensation which grateful patient is willing to offer” Need for retributive justice reserved for the middleman and not the desperately terminally ill.

30. Ancillary charges: Wang False written declaration Commissioner for Oaths that (a) no monetary payment and (b) family relationship with intended donor [Offence under Oaths and Declarations Act] False oral statement to Transplant Ethics Committee re distant relative of intended donor and non-payment of supply of kidney [Offence under HOT Regulations2004] Note: Similar ancillary charges preferred against Tang and Sulaiman

31. United Kingdom Like Singapore UK Human Tissue Act 2004 (HTA 2004) governs the area of organ transplants sourced from a cadaver as well as or living donor Section 32 prohibits all forms of commercial dealings of organs Section 33 provides for the restriction on transplants involving a live donor unless the conditions for the exception laid out in S.33(3) can be fulfilled

32. Exception S.33(3) provides that organ transplants sourced from a living person would be allowed where: a) The Human Tissue Authority is satisfied that - i) no reward has/is to be given for such transplant, and ii) such other conditions as are specified in the regulations are satisfied, and b)such other requirements as are specified in the regulations are complied with.

33. Payment of expenses etc permitted Section 14(3) of HOTA 1987 permits contracts or arrangements of reimbursement of expenses necessarily incurred; government scheme for granting benefits or privileges for blood or organ donations; cost of domestic help etc; loss of earnings reasonably attributable to person supplying organ from his body; short or long term medical care or insurance reasonably necessary as a consequence of supply of organ from body.

34. A contrarian view: Should altruism give way to free market for human organs? Extreme view that free market forces should determine the distribution of organs? Low proportion of the organs potentially available for donation as law prohibits economic incentives There is simply no financial gain in donating organs. Legalization of market would benefit many people . Ideology: A man must earn his right to purchase any consumer good, and this applies to human body parts as to all else. (See ‘Human Organ Transplantation: Economic and Legal Issues’; Walter Block Etc University of Central Arkansas) Iranian model: Government funded and regulated living-unrelated kidney donor renal transplantation program adopted (See ‘Iranian Model of Paid and Regulated Living-Unrelated Kidney Donation’; Ahad J. Ghods and Shoufeh Savaj American Journal of Nephrology) 2006

35. ISSUES of RISKS re LIVING DONORS

36. Risk of endangerment to health and life MMC Guidelines for Organ Transplantation from Living Donor: Issued by the Malaysian Medical Council 006/2006 highlights issue of risk Clause 5.1: Living organ donors engenders various risks to health [and also very minimally to life].

37. Inherent risk in living donor transplantation Existence of an inherent risk when harvesting from a living donor as opposed to cadaveric donation Issue of civil and even criminal negligence Case Example: Surender Singh S/O Jagdish Singh And Another (Administrators Of The Estate Of Narindar Kaur D/O Sarwan Singh, Deceased) V Li Man Kay And Others [2010] 1 SLR 428

38. Surender Singh’s Case Donation of left kidney to her husband who was suffering from end stage renal failure. Complications arose after surgery during the recuperation period where the deceased was not given proper medical care. slippage of “Hem-O-Lok” clips used to secure inter alia, the deceased’s left renal artery, left renal vein and surrounding blood vessels Acute intra-abdominal hemorrhage from the ultimately led to her death.

39. …Surender Singh’s Case The Plaintiffs thus brought an action against the 2 doctors (1st and 2nd Defendant) and the Hospital (the 3rd Defendant) for medical negligence. Held: The court dismissed the Plaintiff’s claim against the 2 doctors and stated that they were not negligent. However, the court found the Hospital liable for its failure to monitor/properly monitor the deceased in the ward.

40. LEGISLATION GOVERNING LIVING DONOR ORGAN TRANSPLANT IN MALAYSIA

41. Comprehensive legislation in the works? There is a need for a law governing living donor organ transplants in Malaysia to ensure commercialization of organs do not happen MOH 2007 Policy and MMC Guidelines translated into legislation Incorporate best practices from other jurisdictions The National Transplantation Act is being drafted to serve as a guideline on unrelated live organ donations. Source: http://www.malaysianbar.org.my/legal/general_news/new_law_on_live_organ_donation_proposed.html

42. Singapore Human Organ Transplant Act 1987 (HOTA 1987) Preamble to HOTA 1987: An Act to make provision for the removal of organs for transplantation, for prohibition of trading in organs and blood, and for purposes connected therewith. Governs removal of any organ from the body of a dead person into the body a living person Also between living persons; consent and authorization required [considerations to be prescribed by Director of Medical Services] Renders void and criminalizes trading in organs and blood.

43. Concluding Remarks