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Optingin vs opting out - Malaysian Thoracic Society

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. 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. 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
  3. 3. Content Introduction Transplant legal framework in Malaysia Opting in vs. opting out Conclusion Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
  4. 4. INTRODUCTION Definition | Why this is happening? | Why we need to fight? Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
  5. 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. 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. 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
  8. 8. Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
  9. 9. Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
  10. 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
  11. 11. Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
  12. 12. 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) Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang Source: 22nd Report of the Malaysian Dialysis and Transplantation Registry 2014
  13. 13. 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 Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang Source: National Transplant Resource Centre, National Renal Registry 2016
  14. 14. Transplant legal 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 Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
  15. 15. Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
  16. 16. Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
  17. 17. Opting in vs. opting out Definition | International perspectives | Malaysia’s perspectives Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
  18. 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. 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)
  20. 20. Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
  21. 21. 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)
  22. 22. 0.230 0.500 2.900 2.900 6.280 18.300 15.700 20.200 25.500 22.900 25.488 39.700 Phillipines Malaysia Thailand Saudi Arabia Turkey Australia Canada UK France Austria US Spain Deceased organ donation rates (per million population) by country, 2013 Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang Source: Global Observatory on Donation and Transplantation WHO 2013
  23. 23. 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
  24. 24. 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
  25. 25. Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
  26. 26. 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
  27. 27. Conclusion Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
  28. 28. 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
  29. 29. Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang
  30. 30. 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
  31. 31. Thank you hirmanmd@gmail.com | Twitter @DrHirman #MedTweetMy | www.about.me/hirmanismail Malaysian Thoracic Society Annual Congress (MTS 2016), 29 July 2016, Penang

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