Legislative and Ethical Framework of Organ Donation and Transplantation in Malaysia

Copyrights 2016 Hirman Ismail | www.about.me/hirmanismail | [email protected]

Legislative and ethical framework on organ donation and transplantation in Malaysia Hirman Ismail MD (UKM) MPH (Nottingham) Head of Transplantation Unit, Medical Development Division & Honorary Secretary to the Malaysian Society of Transplantation

IMAM 18TH Annual Scientific Conference, 20 August 2016, Seremban


Objective Main objective of this presentation is provide overview on how the practice of transplantation is regulated in Malaysia.


Content Introduction Why ethics is a main concern in transplant?Transplant legal and ethical framework in Malaysia Conclusion


INTRODUCTIONHistory & evolution | Situational analysis


No. of patients in the transplant national waiting list in Malaysia by organ (until April

2016)

ORGAN NUMBERKidney 20,777Liver 5Heart 5Lungs 2Heart & lungs 6

TOTAL 20,795

Source: National Transplant Resource Centre, National Renal Registry 2016

20002001200220032004200520062007200820092010201120122013201420150

10

20

30

40

50

60

70

80

16

2430

25

1613

25 25 26

39 38

4744 44

56

71

30 31

42

2932

42

29

45

3235

27

44 46

56

29 31

No. of Organ & Tissue Donor (Deceased vs. Living) in Malaysia, 2000 - 2015

Deceased LivingCopyrights 2016 Hirman Ismail | www.about.me/hirmanismail |

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Kidney Liver Heart Lungs Heart & lungs

0

200

400

600

800

1,000

1,200

1,400 1,292

69

511

64 26 6 4

No. of Organ Transplantation performed in Malaysia, 1975 – April 2016

Living DeceasedCopyrights 2016 Hirman Ismail | www.about.me/hirmanismail |

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2005 2006 2007 2008 2009 2010 2011 2012 2013 2014020406080

100120140160180200

No. of Kidney Transplant Recipients in Malaysia, performed locally (public &

private institutions) vs. overseas, 2005 - 2014

Total Overseas LocalCopyrights 2016 Hirman Ismail | www.about.me/hirmanismail |

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Source: 22nd Report of the Malaysian Dialysis and Transplantation Registry 2014

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014020406080

100120140

No. of Kidney Transplant Recipients in Malaysia, performed locally (live donor & cadaveric) vs. overseas, 2005 - 2014

Overseas (commercial) Local (live donors)Local (cadaveric)


Source: 22nd Report of the Malaysian Dialysis and Transplantation Registry 2014

Copyrights 2016 Hirman Ismail | www.about.me/hirmanismail |

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2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 201505,000

10,00015,00020,00025,00030,00035,00040,00045,00050,000

7,49210,081 8,885

12,24215,996 15,861

30,529

21,040 22,522

37,093

45,580

No. of Malaysians Pledged as Organ Donors, 2005 - 2015

Total Chinese Indian MalayCopyrights 2016 Hirman Ismail | www.about.me/hirmanismail |

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MyanmarViet NamMalaysia

Saudi ArabiaThailand

SingaporeTurkey

IranCanada

AustraliaUK

AustriaUSA

FranceSpain

0.020.330.54

2.332.36

4.445.09

8.6615.68

16.7820.07

24.4725.8326.02

35.29

Rate (p.m.p) of Deceased Organ Donor by Country, 2013


Source: Global Observatory on Donation and Transplantation, www.transplant-observatory.org, 2016

Situational analysisHuge gap demand and supply “Market force” has driven overseas commercial transplantsWe are placed among the lowest in the world in terms of deceased organ donation rateAwareness is improving especially among the Malay Muslim Racial discrepancy is still evident Living donation programme has not been optimised



Why ethics is a main concern in transplant?Huge disparity| Organ trading | Crime

19th Scientific Meeting of Malaysian Society of Transplantation, 27-28 May 2016, Penang


Transplant legal and ethical frameworkHuman Tissues Act 1974 [Act 130] | Anti-Trafficking in Person Act 2007 [Act 670] | Private Healthcare Facility and Services Act 1997 [Act 586] |Medical Act 1971 [Act 50\


LawTransplant legal and ethical framework


PolicyTransplant legal and ethical framework


Immunosuppressant policySince 2012, no free supply of IS to overseas transplant patients To discourage cross boundaries unethical practices, exploitation and crime Current patients are being informed about the policy


Unrelated living organ donation

Limiting related living organ donation to 2nd degree and below & legal spouse Unrelated living organ donation requires MOH approval Any cases involving foreigners requires approval as well


Proposed New LawTransplant legal and ethical framework


Organ and Tissue Transplantation Bill

A more comprehensive law to cover both living and deceased donation (unlike Human Tissue Act 1975)Covers a wide range of issues including ethics like certification of death, prohibition on organ trading and advertising, consent and authorisation, accreditation and credentialing, organ allocation Draft currently being reviewed by AG Chamber


Conclusion


Conclusion The potential of organ donation and transplantation has yet to be optimisedThe risk of unethical practices is present like in many other countries (due to shortage of organs) The control measures through law and policy exist but need to be enhanced through the new proposed law Ensuring self sufficiency of organ is everyone’s responsibility (increasing supply and reducing demand)

References Jennifer Dolling. (2009) Opting In To An Opt-Out System: Presumed Consent As A Valid Policy Choice For Ontario’s Cadaveric Organ Shortage [Unpublished thesis]. Graduate Department of the Faculty of Law University of Toronto. Available from : https://tspace.library.utoronto.ca/bitstream/1807/18276/1/Dolling_Jennifer_M_200911_LLM_thesis.pdf [Accessed 16 June 2016]Medical Practice Division. (2013) Online Public Engagement on Proposed New Law on Organ Transplantation. [Unpublished Report]. Ministry of Health Malaysia Shepherd et al. 2014. An international comparison of deceased and living organ donation/transplant rates in opt-in and opt-out systems: a panel study. BMC Medicine.12:131. Available from : http://www.biomedcentral.com/1741-7015/12/131 [Accessed 17 June 2016]Medical Development Division, 2007. National Organ Tissue and Cell Transplantation Policy. Putrajaya: Ministry of Health Malaysia. Medical Development Division, 2011. Unrelated Living Organ Donation: Policy and Procedures. Putrajaya: Ministry of Health Malaysia. Ministry of Health Malaysia, 2012. Policy on Unrelated Living Organ Donation. [Circular Letter by the Director General of Health], 4 January 2012, available at: http://www.moh.gov.my/attachments/1763 [accessed 6 February 2012]World Health Organization, 2010. WHO Guiding Principles on Human Cell, Tissue and Organ Transplantation. New York: WHO.



Thank you [email protected] | Twitter @DrHirman #MedTweetMy | www.about.me/hirmanismail

Legislative and Ethical Framework of Organ Donation and Transplantation in Malaysia

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