ABSTRACT
Lung transplant – opting in vs. opting out
Hirman Ismail MD (UKM) MPH (Nottingham)
Transplantation Unit, Medical Development Division
There are many strategies that have been widely discussed and implemented in many countries to increase donor pool and organ transplantation rate. These include among others strengthening central and local organisational structure, establish good transplant/ donor coordinator network, raising public awareness, addressing professional awareness and competencies, incentive (to donor, staff & medical institution), establish mechanism for potential deceased donor identification, ABO incompatible transplant, paired exchange programme, domino transplant, extended donor criteria and regional organ sharing. Legislation has been implicated to be as one of the many ways to improve organ and tissue donation rate in particular through the implementation of opting out system. Opting out system or also known as presumed consent is a system by which consent to donate organ and tissue is presumed unless a person has expressly indicated otherwise during his/her lifetime. Contrary to the opting out system, in opting in system however, consent to donate has to be explicit through verbal or written consent expressed by the donor when he/she was still alive. Legal and ethical barrier in implementing opting out system arises because of the fact that such system would exclude the next of kin from the decision making process when a donor passes away. In Malaysia, the law that governs the authorisation of removal of organ and tissue from a deceased is Human Tissues Act 1974 [Act 130]. Malaysia practices an opting in system as specified in subsection 2(1) of the Act 130 but the final decision to authorise the removal of organ and tissue of the deceased donor rest on the spouse or the next of kin, as specified in subsection 2(2). At the moment, the Ministry is in the process of drafting a new more comprehensive law on transplantation in which the option for possible implementation of opting out system was discussed. Even though it is thought that opting out system may increase donor pool as demonstrated in some countries, the challenges to its implementation is much more complex and shall be tailored to consider local sensitivity, level of awareness/ acceptance and also cultural/ religious values.
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Optingin vs opting out - Malaysian Thoracic Society
1. Lung Transplant –
Opting In vs. Opting Out
Hirman Ismail MD (UKM) MPH (Nottingham)
Head of Transplantation Unit, Medical Development Division &
Honorary Secretary to the Malaysian Society of Transplantation
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
2. Objective
Main objective of this presentation is discuss on
suitability of opting out system as an option in
authorisation for removal of human organ and tissue
in Malaysia.
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
4. INTRODUCTION
Definition | Why this is happening? | Why we need to fight?
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
5. Demand of organs in Malaysia
ORGAN NUMBER
Kidney 20,777
Liver 5
Heart 5
Lungs 2
Heart & lungs 6
TOTAL 20,795
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
Source: National Transplant Resource Centre, National Renal Registry 2016
6. 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
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
Source: National Transplant Resource Centre, National Renal Registry 2016
7. 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
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
Source: National Transplant Resource Centre, National Renal Registry 2016
10. 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
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
Source: 22nd Report of the Malaysian Dialysis and Transplantation Registry 2014
17. Opting in vs. opting out
Definition | International perspectives | Malaysia’s perspectives
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
18. Definition
Also known as “presumed consent” is “(t)he
system by which consent to donate is presumed
unless a person has expressly indicated
otherwise during his/her lifetime
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
Source: Jennifer Dolling. (2009)
19. Variant of opting out
system
“Soft” vs. “hard” opting out system
In “soft” system – family is still consulted and has
final say even though by law it is not required
In “hard” system – family is not consulted or not
even informed. Even if there is doubt, removal will
still take place
“Selective” opting out system
In 1987, Uniform Anatomical Gift Act (“UAGA”) in
the US allowed removal of cornea, pituitary gland
if the body under the custody of coroner
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
Source: Jennifer Dolling. (2009)
22. Opting out – increases donation
rate?
Shepherd, L et al (2014) reported “Deceased
donor rates (per-million population) were higher
in opt-out (M = 14.24) than opt-in consent
countries (M = 9.98; χ = -4.27, 95% confidence
interval (CI) = -8.08, -0.45, P = .029)”.
Kidney and liver transplantation rates (living and
deceased) are higher in opting out countries
No. of living donors is higher in opting in
countries
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
Source: Shepherd, L et al. (2014)
24. Opting out – ethical consideration
Autonomy – encroachment into personal
autonomy, ability to exercise opting out (esp. by
vulnerable groups)
Beneficence vs. non maleficence – psychological
effect to family members after the donation if
they don’t agree to it
Justice – ability to exercise exercise opting out
(esp. by vulnerable groups)
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
25. Opting out – in Malaysia?
Awareness and acceptance towards organ
donation is still low
Negative impression and perception need to be
carefully studied
Cultural consideration
Religious consideration
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
27. Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
Source: Medical Practice Division. (2013) Online Public Engagement on Proposed New Law on Organ
Transplantation. [Unpublished Report]. Ministry of Health Malaysia
28.90%
64.70%
6.38%
Agree
Disagre
e
Not
sure
In your opinion, should Malaysia practice opting out
system in authorisation for removal of human organs
and tissues?
N = 1,581
29. Conclusion
The option on opting out system has been widely
discussed in Malaysia
Opting out system is not the only way to improve
organ donation rates
Even though, transplantation rate is better in
countries with opting out system, cultural, ethical
and religious considerations shall be further
studied before it can be implemented in Malaysia
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
31. 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.
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
32. Thank you
hirmanmd@gmail.com | Twitter @DrHirman #MedTweetMy |
www.about.me/hirmanismail
Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
Editor's Notes
TOTAL Transplant Recipients (2005 – 2014) = 1,248
Overseas = 579 (46.40%)
Local = 649 (52.00%)
Total kidney transplant recipients has dropped in general
More significantly, overseas kidney transplant recipients has dropped significantly since 2007 – 2008 - ? Cause – ? China has consolidated their effort to curb transplant tourism especially since Olympic China 2008, ? Enforcement of law in China, IS policy by MOH Malaysia was implemented in 2012
More worrying is the number of locally performed has plateaued and dropped in 2014
TOTAL Transplant Recipients (2005 – 2014) = 1,248
Overseas = 579 (46.40%)
Local = 649 (52.00%)
Total kidney transplant recipients has dropped in general
More significantly, overseas kidney transplant recipients has dropped significantly since 2007 – 2008 - ? Cause – ? China has consolidated their effort to curb transplant tourism especially since Olympic China 2008, ? Enforcement of law in China, IS policy by MOH Malaysia was implemented in 2012
More worrying is the number of locally performed has plateaued and dropped in 2014
TOTAL Transplant Recipients (2005 – 2014) = 1,248
Overseas = 579 (46.40%)
Local = 649 (52.00%)
Total kidney transplant recipients has dropped in general
More significantly, overseas kidney transplant recipients has dropped significantly since 2007 – 2008 - ? Cause – ? China has consolidated their effort to curb transplant tourism especially since Olympic China 2008, ? Enforcement of law in China, IS policy by MOH Malaysia was implemented in 2012
More worrying is the number of locally performed has plateaued and dropped in 2014
What I would like to impress here apart from the reduction in overall overseas kidney transplantation recipients;
No. local kidney transplantation has not changed that much. It seems that cadaveric increasing a bit but the live donation programme has not improved much over the years.
It is important again to re emphasise that curbing commercial kidney transplant requires also efforts to ensure self sufficiency of organs locally, and therefore optimising the capacity of local programme shall always be our priority.
TOTAL Transplant Recipients (2005 – 2014) = 1,248
Overseas = 579 (46.40%)
Local = 649 (52.00%)
Total kidney transplant recipients has dropped in general
More significantly, overseas kidney transplant recipients has dropped significantly since 2007 – 2008 - ? Cause – ? China has consolidated their effort to curb transplant tourism especially since Olympic China 2008, ? Enforcement of law in China, IS policy by MOH Malaysia was implemented in 2012
More worrying is the number of locally performed has plateaued and dropped in 2014
TOTAL Transplant Recipients (2005 – 2014) = 1,248
Overseas = 579 (46.40%)
Local = 649 (52.00%)
Total kidney transplant recipients has dropped in general
More significantly, overseas kidney transplant recipients has dropped significantly since 2007 – 2008 - ? Cause – ? China has consolidated their effort to curb transplant tourism especially since Olympic China 2008, ? Enforcement of law in China, IS policy by MOH Malaysia was implemented in 2012
More worrying is the number of locally performed has plateaued and dropped in 2014
TOTAL Transplant Recipients (2005 – 2014) = 1,248
Overseas = 579 (46.40%)
Local = 649 (52.00%)
Total kidney transplant recipients has dropped in general
More significantly, overseas kidney transplant recipients has dropped significantly since 2007 – 2008 - ? Cause – ? China has consolidated their effort to curb transplant tourism especially since Olympic China 2008, ? Enforcement of law in China, IS policy by MOH Malaysia was implemented in 2012
More worrying is the number of locally performed has plateaued and dropped in 2014