Legislative and Ethical Framework of Organ Donation and Transplantation in Malaysia

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
Copyrights 2016 Hirman Ismail | www.about.me/hirmanismail | hirmanmd@gmail.com
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

INTRODUCTION
History & evolution | Situational analysis

No. of patients in the transplant national waiting list in
Malaysia by organ (until April 2016)
ORGAN NUMBER
Kidney 20,777
Liver 5
Heart 5
Lungs 2
Heart & lungs 6
TOTAL 20,795
Source: National Transplant Resource Centre, National Renal Registry 2016

16
24
30
25
16
13
25 25 26
39 38
47
44 44
56
71
30 31
42
29
32
42
29
45
32
35
27
44
46
56
29
31
0
10
20
30
40
50
60
70
80
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
No. of Organ & Tissue Donor (Deceased vs.
Living) in Malaysia, 2000 - 2015
Deceased Living

1,292
69
511
64
26 6 4
0
200
400
600
800
1,000
1,200
1,400
Kidney Liver Heart Lungs Heart & lungs
No. of Organ Transplantation performed in
Malaysia, 1975 – April 2016
Living Deceased

0
20
40
60
80
100
120
140
160
180
200
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
No. of Kidney Transplant Recipients in Malaysia,
performed locally (public & private institutions)
vs. overseas, 2005 - 2014
Total Overseas Local
Source: 22nd Report of the Malaysian Dialysis and Transplantation Registry 2014

0
20
40
60
80
100
120
140
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
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
| hirmanmd@gmail.com

7,492
10,081
8,885
12,242
15,996 15,861
30,529
21,040
22,522
37,093
45,580
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
45,000
50,000
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
No. of Malaysians Pledged as Organ Donors,
2005 - 2015
Total Chinese Indian Malay

0.02
0.33
0.54
2.33
2.36
4.44
5.09
8.66
15.68
16.78
20.07
24.47
25.83
26.02
35.29
Myanmar
Viet Nam
Malaysia
Saudi Arabia
Thailand
Singapore
Turkey
Iran
Canada
Australia
UK
Austria
USA
France
Spain
Rate (p.m.p) of Deceased Organ Donor by
Country, 2013
Source: Global Observatory on Donation and Transplantation, www.transplant-observatory.org, 2016

Situational analysis
Huge gap demand and supply
“Market force” has driven overseas commercial
transplants
We are placed among the lowest in the world in terms
of deceased organ donation rate
Awareness 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
framework
Human 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

Law
framework
Copyrights 2016 Hirman Ismail | www.about.me/hirmanismail |
hirmanmd@gmail.com

Policy
framework
hirmanmd@gmail.com

Immunosuppressant policy
Since 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
Law
framework
hirmanmd@gmail.com

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 optimised
The 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
hirmanmd@gmail.com | Twitter @DrHirman #MedTweetMy |
www.about.me/hirmanismail

Legislative and Ethical Framework of Organ Donation and Transplantation in Malaysia

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Legislative and Ethical Framework of Organ Donation and Transplantation in Malaysia

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