12/20/2018 1 Comment
Is the opt-out system the answer to filling the gaps between demand and supply of human organs?
The gap between the demand and the supply of human organs for transplantation in Malaysia is on the rise, despite the efforts of the government to promote donor registration. The supply of organs in Malaysia suffers from a persistent chronic dearth, which results in many people who need organs suffering and dying while on waiting lists.
Several countries have opted for a change in legislation and introduced an opt-out system, whereby cadaveric organ procurement is based on the principle of presumed consent to increase the number of donations. Cadaveric organ donation is the donation of organs after the death of an individual. Such individual is classified as a potential donor in the absence of explicit opposition to donation during the individual’s lifetime. It is interesting to note that the English government recently announced its plans to change the law on consent for organ donation. The new opt-out system, known as Max’s law, seeks to be in place by 2020 in England, if Parliament grants approval.
Malaysia is now practising the opt-in system, that is, only those who have given explicit consent to organ donation will be donors. In light of organ dearth in Malaysia, it has been suggested to the government to adopt the opt-out system. Nevertheless, Datuk Dr Noor Hisham Abdullah, the Director-General of the Health Ministry, responded that Malaysia has no plans in the near future to change the current organ donation scheme due to the unsatisfactory level of public readiness. This article seeks to discuss the possible ethical and practical repercussions of an opt-out organ donation law in Malaysia. The author briefly looks into the Spanish and Singaporean positions of law on cadaveric organ donation to determine whether it is time for Malaysia to move to an opt-out donation law or whether such law is too flawed to adopt.
II. CADAVERIC ORGAN DONATION LAW IN MALAYSIA
The availability and use of cadaveric organs and tissue are closely connected to the ability and willingness of the deceased (prior to death) or surviving relatives to veto their removal. Traditionally, there are two ideal systems in the acquisition of cadaveric material: opt-in and opt-out. An opt-in system is one permitting organs to be posthumously removed for transplantation only with the appropriate consent and is sometimes referred to as a "contracting in" system. An opt-out system, on the other hand, is one permitting organs to be posthumously removed unless an appropriate objection is made and is sometimes referred to as a “contracting out” system.
In Malaysia, transplantation of cadaveric organs is allowed for therapeutic, medical education, and research purposes under the Human Tissues Act 1974 (HTA). There are two conditions imposed by the HTA before removal of organs from the deceased is permitted. Firstly, there must be an express request of the donor either in writing or orally in the presence of two witnesses under S.2(1) of the HTA. Secondly, there must be no objection from the deceased and the surviving spouse or surviving next-of-kin under S.2(2). Doctors are under a duty to take all reasonable steps to find out if the deceased had any objection and to obtain consent from the next-of-kin.
It can be seen that Malaysia presently adopts an opt-in system whereby an individual’s intention to donate organ(s) when he is alive is recorded in some form, as provided in the HTA. Upon his death and in circumstances where it is confirmed that organ retrieval is possible, the doctors may, after consulting his immediate relatives, remove his organs for the purpose of transplantation.
The author wishes to emphasise that the views of surviving relatives in Malaysia are treated as a determinant in deciding for or against donation, and the deceased’s view can unfortunately be countermanded. This is referred to as family veto which enables family members to prevent organ donation — even if the deceased person registered as an organ donor — for almost any reason, even if the reason is influenced by emotions, or religious or philosophical notions with which the deceased would not have agreed. If the objection is unlikely to be resolved or the prospect of organ donation is causing significant distress to close family members, the process of donation in practice will be abandoned, despite the previous consent of the deceased.
Regrettably, the cadaveric organ donation rate of Malaysia is among the lowest in the world with the current rate standing at 0.6 donors per million people in the population (pmp) — a standard way of measuring the rate of donation in a country, which is very low compared to the 46.7, 7, 9.95 and 4.3 deceased donors pmp in Spain, Turkey, Korea and Thailand respectively. Negeri Sembilan Health Director Dr Abdul Rahim states that the number of people who signed up as donors only represented 1% out of 30 million Malaysians. What makes the matter worse is that at the moment, more than 20,000 patients are on the waiting list for organ transplants, including those suffering from kidney, liver, heart and lung failures.
Consequently, there are calls made for the introduction of opt-out legislation in our country on the assumption that this approach will increase the rate of organ donation. It is therefore vital for us to evaluate the scheme with reference to countries adopting the opt-out system.
III. OPT-OUT ORGAN DONATION: A VIABLE SOLUTION IN SPAIN AND SINGAPORE?
A. Spain’s Success: Too Good to be True
Spain is a country that leads the world in organ donation with a considerable margin. Figures published reveal that 2183 people in Spain became organ donors after they died in 2017. This amount is equivalent to 46.7 per million people in the population, which is by far the world’s highest rate of organ donation from deceased donors.
Hence, the Spanish model of organ donation is internationally recognised as the best model worldwide. Interestingly, Spain’s opt-out system for cadaveric organ donation is commonly associated with the country’s accomplishments. Nevertheless, upon meticulous examination, its national success is not necessarily linked to the opt-out regime.
1. A Successful Opt-out Regime?
Spain introduced opt-out legislation for organ donation in 1979 but there was no measurable impact on transplant rates until after 1989, when Spain created and implemented a strong network of highly trained transplant coordinator trams in donor hospitals. Although this leading light for cadaveric organ donation has an opt-out system, it has no opt-out register for those who do not wish to become organ donors. Its opt-out system is dormant and non-publicised, with no financial incentive ever spent to record objections by Spanish citizens.
Spanish law establishes that the absence of explicit refusal automatically renders the patient a potential donor. However, the Spanish module is one that is described as the “soft opt-out” system, where doctors can retrieve organs due to presumed consent subject to the requirement of seeking a patient's possible refusal to donate. It can be done by checking their backgrounds, beliefs and belongings, and by consulting proxy decision makers. Since most patients have not registered as donors and do not carry donor cards, family members are always consulted for consent with their wishes are always final.
In short, organ procurement will not be undertaken in practice if the grieving family refuses the donation. Therefore, the author is of the opinion that the outstanding rate of cadaveric organ donations in Spain cannot be solely attributed to its opt-out laws. Spanish law theoretically imposes an opt-out system, but in practice, the system is opt-in. The substantial increase in the rate of organ donation in Spain that implements the opt-out system suggests that additional factors are at work.
2. Spanish Scheme: A Roadmap for the Rest of the World
The sufficiency of medical resources and universal access to health care, including organ transplant, is one cornerstone in the Spanish model that contributes to the Spanish nationals’ positive attitudes towards organ donation. Spanish health-care professionals who play a role in organ donation are trained to maximise donations through donor detection, brain-death diagnosis, donor management, family approach, communication of bad news and management of refusals.
The presence of transplant coordinators is another salient feature of the Spanish Model, with at least one team of transplant coordinators appointed in every hospital — even ones with potentially low rates of deceased donors — that has an intensive-care unit (ICU) or acute beds. Their roles include identifying and evaluating donors, supporting the maintenance of potential donors in the ICU and interviewing donor families. Since these coordinators are part of the in-house staff of the hospital and are mostly ICU doctors who work part-time as in-hospital transplant coordinators, their familiarity, access and authority in the ICU forestall the loss of donors due to non-detection, or untrained or undertrained staff members’ reluctance in approaching grieving families. When transplant coordinators are also ICU doctors who have participated in the treatment of the patients, an opportunity is presented to the coordinators to promote family satisfaction with the treatment received and the trust in the doctor, further facilitating a request for a donation. Flowing from that, Spain has one of the lowest rates of family refusal of organ donation in the world with an amazing percentage of merely 16.4% of the patients’ next-of-kin refusing to donate.
The author wishes to stress that what Spain has shown is that opt-out law is only a peripheral feature of its success, if not an unnecessary one, and their highest level of organ donation is obtained by other innovative and effective methods. The rest of the transplant world must continue to look to the Spanish model for these methods for addressing the organ shortage. For instance, Italy and Croatia have adapted the Spanish model with excellent results.
We can hence conclude that the Spanish scheme can be partially or totally adapted to other countries if basic conditions are met. Although a successful adoption of the Spanish scheme may be hindered by the sociological and political differences between Malaysia and Spain, having regard to locality and national coordination, such a scheme must be put on the pedestal.
B. Singaporean Policy: Not a Magic Bullet
Malaysian policy has always been compared to that of its close neighbour, Singapore, with which it shares a close political, social, historical and cultural relationship. One would think that Singapore surpasses Malaysia in most areas, including the organ donation scheme, especially when Singapore already adopted an opt-out scheme for a few decades. The author intends to look into the Singaporean regime to determine whether such opt-out law is a magic bullet for the common issue of organ scarcity.
1. Enactment of Presumed-Consent Law: Human Organ Transplant Act 1987
Singapore stands out among Asian countries; it is not only garlanded as one with the best healthcare systems rendering it the envy of the West, but it has also since 1987 legislated an opt-out model in its national organ donation scheme. Singapore passed the Human Organ Transplant Act 1987 (HOTA) to address the severe organ shortage in the country.
Organ donation rates under the old opt-in scheme of Singapore, the Medical (Therapy, Education and Research) Act 1972 (MTERA), were poor despite door-to-door canvassing and continuing transplant awareness education through information booklets posted to citizens throughout the 1970s and 1980s. The citizens and permanent residents of Singapore became quite blasé with the media publicity to pledge their organs for the purpose of transplant after their deaths. Consequently, the low take-up rates prompted the introduction of the opt-out system under the HOTA in 1987. It is to be noted that the MTERA remains in force as an alternative opt-in scheme where a person above 18 and of any nationality can donate his or her organs for transplant and treatment, or for medical education and research purposes in Singapore.
Under the HOTA, Singapore adopted the ‘hard opt-out’ systems where those who have not opted out are presumed to have consented to organ donation regardless of their families’ wishes. Hospitals are empowered by S.5 of the HOTA to remove any organ from the body of a person who has died in the hospital for the purpose of organ transplantation. A citizen or permanent resident above 21 years old is presumed to have given his or her consent to the removal of specified organs for the purpose of transplantation upon death, unless he formally opted out of organ donation where the objection form (HOTA opt-out form) was actively filled to indicate an objection to the removal of some or all specified organs.
In other words, Singaporeans could choose to opt out of being an organ donor, but if they do nothing, they would be legally viewed as having given their consent to be organ donors. Family members have no legal right of objection, although in practice, organ retrieval is carried out with due regard to families.
2. Progress of Organ Transplantation in Singapore after HOTA: Static
The momentous enactment of the HOTA in 1987 led many transplant quarters to believe that the slow but sure progress in actual organ transplantation is bound to happen. Opt-outs are rare in Singapore where only around 2%–3% of Singaporeans opted out of donating organs after death, which means that opt-out law had effectively increased the pool of donors to 97% of the Singapore population. However, the reality was much less encouraging. The number of deceased donors actualised per year remained low and has not risen accordingly. There are already critics mauling that introducing the HOTA is nugatory if it is merely for the sake of having a high percentage of potential instead of increasing the number of actual donors among the population.
It is generally acknowledged that it has been a failure when it comes to the real measure of whether the number of donations is raised. Donald Low, a former professor from the National University of Singapore, reasoned that the source of the problem is that the current Singaporean system represents a weak form of consent where emergency ward doctors have been reluctant to insist on organ donation. When grieving family members object to organ retrieval by presumed consent to donation, in the face of uncertainty about the wishes of the deceased, it is extremely difficult, sometimes inhumane, for the doctors to press on the issue, despite the opt-out law and the finding that the deceased is suitable to be a donor object.
Since families, although lacking a legal right to stop the retrieval of organs, are appropriately given due concern for their bereavement, doctors are often left high and dry, and are solely dependent on organ pledges made by the patients. However, voluntary organ pledges in Singapore are considerably rare due to many personal factors, such as apathy and inertia, fear of death, and reluctance to discuss death and feelings of uncertainty about transferring organs into the bodies of strangers. The hard opt-out system is hence not as cut and dried as everyone thinks when family veto overrides its legal position.
There are calls to promote express consent, even with the presumed consent in organ donation. Prof Voo Teck Chuan advocates in encouraging and nudging Singaporeans to pledge their organs for transplant under the METRA along with the tacit agreement with the HOTA. However, the author, with due respect, is of the view that if the HOTA was enacted for the Singaporean government to automatically enrol citizens and set participation by default in the organ donation scheme, whilst still maintaining the alternative for the Singaporeans to opt out, only to rely again on voluntary organ pledges in the previous opt-in law, it is, ipso facto, stultified and rendered superfluous.
Hence, although an opt-out system with presumed consent to organ donation has been in existence in Singapore for the past 31 years, the shift from a consent-based opt-in system has not yielded the expected increase in organ donors. In view of the static progress of organ transplantation, the author concludes that opt-out law is not a feasible solution in the Singaporean context.
IV. TIME TO MOVE TO PRESUMED CONSENT IN MALAYSIA?
A. A Matter of Consent
The general perception is that it is wrong to take someone’s organs without their consent. The present opt-in system can hence ensure that organs are only harvested when the donor has given a clear sign of his consent, such as signing up on the donor register and carrying a donor card. Hence, it is commonly argued that an opt-out system may compromise vital ethical values by failing to respect one of the sacrosanct principles of medical ethics, namely, personal autonomy. Autonomous individual action must be in line with an individual’s wishes, and such wishes must be based on adequate — rather than insufficient, incomplete or one-sided — presumed consent. In circumstances where an individual’s preferences toward organ donation are fluid rather than fixed, it is also ethically questionable whether the government can use policy to shape people’s attitudes, behaviours and choices.
Some individuals who do not wish to register as donors might be ignorant of the option to opt-out. It would be ethically improper to categorise them as donors by default. It is to be noted that it is practically impossible to ensure that every citizen of the country is sufficiently well-informed and have the opportunity to opt-out during their lifetime. Professor Puteri Nemie suggests that an opt-out system can only be fair if every person in the community is given notice of the law and understands its implications, and there must also exist a simple and effective way of registering objections. She then observes that in a country such as Malaysia with a fairly large rural population, not to mention the various religious and cultural sensitivities, an opt-out system does not seem viable.
Professor Shad Saleem Faruqi comments that the opt-out system contravenes basic human rights principles. His reason is that one’s body is his own property and the State has no right to the body, unless one expressly surrenders his right to his body after death. Professor Shad Saleem disagrees with the argument that silence means consent, and instead opines that expressed consent should be required. Singapore’s current presumed-consent law may provide some useful lessons for Malaysia. In several highly-publicised Singaporean cases, family members have opposed the donation of their deceased relative’s organs, claiming that the patient had not been aware of the law and condemned the position of default consent as invalid and violated of their deceased relative’s will. In short, the opt-out system with presumed consent, to a large extent, violates the autonomy of an individual, and is hence ethically flawed.
B. Family Veto vs Personal Consent
However, the author wishes to remind the readers that in fact, the opt-in system also faces difficulties in guaranteeing a donor's consent or the refusal to donate. Under the current opt-in system in Malaysia, there is no way to ensure that one’s organs are not donated, as it is the family that has the final say to donate the deceased’s organs, even if one has not given consent. Similarly, there is also no way to ensure that one’s organs are donated, even if one has opted in, due to the existence of family veto. The opt-in system is not without defects in terms of respecting one’s autonomy and consent.
There is hence an argument that an opt-out system would allow the minority of the public who are strongly averse to organ donation to record this on a register. Thus, one’s autonomy towards one body can be safeguarded and an opt-out system will be the optimum model to showcase one’s consent (or refusal) effectively. However, this argument, in the author’s viewpoint, is not strong enough to prevail over the ethical concern that the majority's silence is simply displaced as tacit consent.
There are contentions that if individuals have registered their wishes to donate organs, it is a violation of their autonomy if the family vetoed that wishes after the individuals’ death. However, some suggest that such family veto should be allowed and should not be seen as a deficiency of the opt-in system. The issue is more complicated than a simple confrontation between respecting individual autonomy and respecting the family. Dr Fan and Dr Chan of the City University of Hong Kong propose that autonomy is the capacity not only to set one’s own goals to direct one’s action, but also to refrain from acting on impulses if they are incompatible with their goals, especially when one has an impulse without being sufficiently well-informed in the first place. Sometimes, an individual may merely want to indicate his or her preference and will not be so minded to have it modified or even overridden by the decision of other family members.
The author opines that in Malaysia we adopt the typical Asian family-oriented culture where our families normally assists our capacity to exercise autonomy. A shared decisional authority by both the individual and the family is normally acknowledged, and the natural and useful engagement of immediate family members in a person’s biomedical decisions is often appreciated. Professor Shad Saleem has also highlighted that an individual does not exist as an individual alone, as he is a member of a family and it is disrespectful to disregard the rights of the family.
Therefore, the author is of the view that family’s opinion is to facilitate, rather than to obstruct, the deceased’s autonomy. The family will be in a much better position to decide whether the decision made by the deceased is still valid, whether it has been withdrawn or is otherwise inconsistent with the deceased's long-standing life goals. This may be why our HTA in S.2(2) requires the consent of the next-of-kin before the organ transplantation can be carried out, even if the deceased has already expressed his consent to such procurement. Family veto is hence not unjustifiable.
C. Opt-in vs Opt-out: The Elephant in the Room?
Having regard to the comparison between the opt-out system of Spain and Singapore earlier, the conclusion reached is that an increase in the total number of organs transplanted when switching to such a system is inconclusive. It is too simplistic and naïve to assume that the introduction of an opt-out law will increase cadaveric organ donation rates. The author is therefore of the view that such a change would not be helpful towards the organ dearth in our country.
It is true that an opt-out system is likely to bridge the gap between Malaysians' intention and their behaviour by removing the need, if not the inconvenience, to undertake an action in order for one to become a donor. However, it can be witnessed that Spain’s opt-out policy did not produce a positive result for almost 10 years, not until the country implemented some crucial and thorough organisational changes. In the meantime, maintaining the status quo in Malaysia would not be of great assistance to the problem of organ scarcity.
The author argues that whether to adopt an opt-out or an opt-in system is not the question at all. Since family veto has to be respected in Malaysia, what should be addressed to improve the rate is the reduction of the next-of-kin refusal rate. The Spanish model recognises that to maximise organ donation, medical professionals need to learn the best practices for obtaining consent from each potential organ donor family. Hence, transplant coordinators are designated in each hospital and specifically trained in the methods for maximising the likelihood of a positive consent when approaching families. Skilled coordinators should be sensitive to the needs of family in bereavement and assist them to seek solace in the beneficent act of organ donation. A respectful, supportive and reverent atmosphere should be built and sustained for the family to have adequate grieving and reflection for the healthcare to establish trust with the potential donor’s family.
Time taken to certify brain death has to be reduced too. The unfamiliarity and variability in the conduct of brain death certification often lead to delays in confirming brain death, either through unnecessary checking and correction of biochemical parameters or from unnecessary ordering of supplementary tests. These delays often result in anger and frustration among families of potential donors who may already be lukewarm or openly hostile to organ donation. Some may even at this juncture withdraw their consent to donation and request for withdrawal of cardiopulmonary support.
Up-to-par healthcare system, trustworthy medical professionals and transparent guidelines and protocols on organ donation should be developed to address misplaced fears concerning the donation, and to enhance family trust in the doctors and medical system so as to facilitate the request of donation. Besides, an increase in the number of hospital beds may potentially improve donor care. Shortage of intensive care unit beds can influence the ability of critically injured patients to be admitted and thus, prevent them from becoming potential donors.
One may also consider China and Taiwan’s recent policy that incorporates legal decisions that will prioritise a donor’s family members for organ distribution. With that, deceased organ donors are honoured and their relatives are given a higher priority on any transplant waiting list. Similarly, Israel in 2010 has legislated the principle of priority by signalling to people that the allocation of transplant organs in situations of equal medical need would give priority to living donors, families of deceased donors and those who long been on the donor register. Their results are promising, showing a significant increase in both deceased and living organ donation. Chile and Singapore also have such priority system. Offering registered donors priority for receiving organ transplants may be one effort that could boost organ donation.
It is obvious that there are no quick fixes to this issue, but at least we are certain that opt-out legislation is not the answer. The possible institutional reforms are plentiful and non-exhaustive, and stakeholders should study the efforts made by other countries to address the low organ procurement rates in Malaysia.
The shortage of organ and tissue suitable for donation is a profound crisis in the Malaysian healthcare system. This crisis is, however, not without a cure. The success of the Spanish scheme suggests that the increase of the donation rate is attributable to infrastructure improvements rather than the opt-out system. The author opines that the enactment of an opt-out law alone is not sufficient to boost cadaveric organ donation. Although it did unleash more potential organ donors, these donations cannot be realised if the systems are not improved to accommodate them, or if next-of-kins continue to be unwilling to refuse donation. Opt-out law is indeed too presumptuous after all and will not be the silver bullet to the organ shortage in Malaysia. In terms of medical ethics, it is more flawed when compared to the current opt-in model.
The author, thus, suggests maintaining the present scheme. There is no need to switch to an opt-out model. Meanwhile, it is timely for the government to improve the underpinning infrastructure for transplantation in order to increase wealth and investment in health care and to shift the social stigma, coupled with religious and cultural beliefs that are plaguing the members of the public. As long as the mindsets are changed through the dissemination of knowledge and the promotion of communitarian ethics, altruism and social compact, the author is optimistic that in the near future the issue of low rate cadaveric organ transplants in Malaysia can be resolved.
Written by Benjamin Kho Jia Yuan, a third year law student of the Faculty of Law, University of Malaya. Edited by Kenny Chia Wen Kok.
Disclaimer: The opinions expressed in this article are those of the author and do not necessarily reflect the views of the University of Malaya Law Review, and the institution it is affiliated with.
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