 Hello, welcome to Health Law Primers. This module has to do with law surrounding organ donation. I'm Jennifer Chandler. I'm an Associate Professor of Law at the University of Ottawa. And if you have questions on this, feel free to email me at the email address indicated here. A quick note on the outline for this module. We'll start off talking very briefly about which laws are applicable before moving to the dead donor rule, the definition of death, the law surrounding consent to donation, both posthumous and living donation, and finally briefly touch upon the purchase and sale of organs, which is illegal in Canada and legal in only one country in the world, Iran, although a black market does exist in some parts of the world. First, a quick point about the law. A variety of laws are applicable to organ donation and transplantation in Canada because Canada as a federal state, power to make legislation is split between the provinces and the federal government. For this reason, we have to look at both the laws of the province, where the practitioner is located, as well as any applicable federal laws. As we shall see, the criminal code is applicable. This is a federal legislation, as well as provincial laws having to do with tissue gift, well I should say tissue gift acts, as well as more general legislation having to do with advance directives and substitute decision making in health care generally. One important note for those of you practicing in Nova Scotia is that in 2010, the Nova Scotia government passed a new statute governing organ and tissue donation. It is not yet in force, but it should be declared in force soon. Until then, the old law continues to apply. This new law will bring substantial changes, and so I will try to point out to you in this module where some of the major changes will lie, but you should be aware about this, the possibility that some of the rules described in this module may end up changing when this law comes into effect in Nova Scotia. The first topic is the dead donor rule. This is a familiar principle of biomedical ethics, and it's also enshrined in the law. It essentially means that the removal of an organ or tissue cannot be the cause of the donor's death. Or to put it another way, if organ or tissue removal would kill the donor, that's not allowed. Living donation of a non-vital organ is permissible. This dead donor rule is enshrined in the criminal code of Canada, which would clearly contemplate as a form of murder the act of removing vital organs and thus bringing about a person's death. An important point for you also is that the criminal code makes it clear that a person cannot provide valid consent to have death inflicted upon him. So it doesn't really matter if someone agrees to have organs removed. If it brings about death, that still constitutes murder, and that's very clear law on this point. So why have this dead donor rule? Well, two main types of reason. One, it reflects a strongly held moral position against killing in general and specifically in this context. And also it promotes public trust in the organ donation system because one of the often cited fears of people unwilling to register for posthumous donation is that organs may be removed inadvertently before they're dead. Despite the firm adherence to this dead donor rule, not everyone agrees that it is a good idea or that it makes sense. One example for you is this cited article by Cochrane and Bianchi who suggests that it ought to be permissible in an advanced directive for someone to instruct their surrogate decision makers and healthcare providers to disregard the rule if a decision has been made to withdraw life-sustaining treatment from them. They suggest that people should be able to remove organs while they are under general anesthetic. This would be a way of allowing, in their view, people who really wish to donate organs to do so in conditions where brain death is not a possibility and also where donation after cardiac death is unlikely to be successful. So for now and for the foreseeable future, the law is quite clear that dead donor rule applies and the removal of organs cannot cause death. So given this important rule, the definition of death becomes extremely important as well. So let's turn to that now. Before we talk about what the law says about it, one or two observations about how organ donation has put pressure on the ethics and law applicable to this topic. Some suggest that the invention of brain death as a concept in the late 1960s was driven by the need or the desire to remove organs from people who had irreversible loss of brain function but whose hearts were still beating because they were sustained on ventilators. It's obviously important that organs continue to be perfused with oxygen and that they will deteriorate swiftly after that stops. Therefore, it was very useful to be able to declare this class of patients to be dead so that organs could be removed in a well oxygenated state. Another form of pressure that's being put on the definition of death is the more recent move to donation after cardiac death in North America. In this context, it's very important to remove organs swiftly after cardiac arrest and the issue is how long does one have to wait before organs can be removed. There's a certain amount of uncertainty about that now because of wondering about auto resuscitation but also about the ambiguity in a situation where a person could in theory be resuscitated but where a decision has been made not to do so. Does that count as irreversible cessation of cardiac or cardiorespiratory function? A couple of points about why it's so difficult to define death from a legal perspective is that there's a number of somewhat arbitrary and one might say metaphysical questions to address in trying to define death. Does it pertain to the organism as a whole or only to specific functions or parts? Brain death obviously contemplates that a specific function or part is enough to define death. Another question is does function have to be irreversibly lost in order for someone to be declared dead and if so, what does irreversible mean in an era of improving technologies of resuscitation and life support? So let's switch now to the legal definition of death and in fact the approach varies subtly from province to province and I direct you to this article for detailed information on this point but for our purposes now I'll just point out that some jurisdictions such as Manitoba have fairly precise definitions so in Manitoba the legislation states that the death of a person takes place at the time at which irreversible cessation of all that person's brain function occurs. In other places such as Nova Scotia this level of detail is not included so from the existing organ donation legislation the Human Tissue Gift Act we see that in Nova Scotia for the purposes of organ donation the fact of death is to be determined by at least two physicians in accordance with accepted medical practice. That practice is unspecified in the act. Note that there are certain procedural constraints placed on death determination in the organ donation context for example as you see in this point on this slide two physicians are required to certify death where it's proposed that organ donation take place. There are other constraints also put on and we see them here. They're meant to avoid conflict of interest in the context of organ donation and transplantation or the appearance of conflict. So there's a firm separation made between physicians who determine death and those who have association with the proposed transplant recipient of the organs or those who participate in the transplant procedures. Note that the old act which is currently in a force makes an exception for the removal of eyes for cornea transplants. Let us turn now to the topic of consent to organ donation. We'll divide this into post-mortem donation and then living donation on a subsequent slide. Essentially consent is required for removal of organs. Whether in the context of living or post-mortem donation. The provincial laws specify how this is to be done again in both cases post-mortem or living donation. In Nova Scotia for example the existing law states that any person who has attained the age of majority can consent in a signed document at any time or orally in the presence of at least two witnesses during their last illness. Note this person must be capable of giving consent and as stated above the age of majority. However, it's frequent that people will not have consented in this way and families are often turned to to give substitute consent. I would also note that even where there is an expressed consent by the decedent families are nonetheless often consulted and this is both out of a desire not to upset the family but also to verify that the decedent's consent was not later withdrawn. If there is no expressed consent from the decedent then one turns to the hierarchy of people set out in the legislation who are empowered to give substitute consent. Again, this substitute decision-maker must be competent to play this role. There is one complication in this area with the move to donation after cardiac death and that is that while the person is still alive and sustained on ventilation it is sometimes the case that there are pre-mortem interventions meant to facilitate the later removal of organs and this includes the administration of drugs such as heparin as well as cannulation of femoral vessels. There are different considerations that apply when interventions are made on a living person even if they are soon to pass away and this has led to uncertainty and discomfort about whether those pre-mortem interventions can really be said to be for the best interests of that living patient. Now, there are major changes afoot in Nova Scotia including rules that will help to solve this kind of problem and in particular the new legislation when it's in force provides extensive information requirements about those pre-mortem interventions that must be given to the substitute decision-maker and also clarifies that that substitute decision-maker should decide in accordance with what they believe to be in the wishes, values, etc. of the decedent. In other words, the thorny question of whether or not those interventions is in the medical best interest of that dying patient is not the central criterion that's applied in that context instead it is to try to decide in accordance with the wishes of that individual if that individual had been able to make that decision. Now, this point about extensive information requirements for valid consent is actually broader than what I've just described to you in the new Nova Scotia legislation. In fact, this extensive information will be required for valid consent by the I should say by first-person consent so a person expressing their willingness to donate after their own death their consent will only be valid if they've been given extensive information and similarly substitute decision-makers consenting for a family member who has passed away will also be required to receive extensive information set out in the new act for their substitute consent to be valid. As for living donation if we look at the existing rule in Nova Scotia we see that a person who has attained the age of majority is mentally competent to consent and can make a free and informed decision can do so but it must be in writing. It must also be given shortly before the donation because the law says consent is to removal forthwith of donated tissue and this implies that the consent has to be given relatively close in time to the actual donation. The new law, which is not as I mentioned not yet in fact will bring changes to this. It will allow for living donation to be specified in advance directive so that consent can be given for that living donation sometime in the future when one is actually incapable. It also provides for living donation by people who never expressed a capable wish in an advance directive but in these cases consent has to be or consent will be verified through by the courts and a court order is required for living donation by incapable people. We'll finish off with a quick word about incentives for donation. It's unfortunately the case that there's not enough organs available to meet the demand and many Canadians die while waiting for donation or suffer greatly reduced quality of life. So there's a lot of eagerness to increase donation and the availability of organs especially with an eye to the future of an aging population which may well have a higher demand for transplants. From time to time the idea of paying people to donate one kidney is raised as a way to increase donation. As I mentioned at the outset, so far only Iran has created a system of paid donation of a kidneys and this has reduced the gap between demand and supply but it has also raised ethical problems because it tends to be the poor who end up providing the kidneys. The purchase and sale of organs is illegal in many parts of the world including Canada but there is a thriving black market operating in numerous countries. I've cited for you a recent article from August 2014 in the New York Times about thriving illegal or black market in kidneys in Costa Rica. However in Canadian jurisdictions it is an offense punishable by fines and imprisonment to buy or sell body parts or tissues in Nova Scotia an exception is made for blood or blood constituents. The new Nova Scotia law when it comes into effect will clarify that reimbursement of reasonable expenses for living donors is nonetheless legal. So I'll close on that now. I hope this was informative and interesting for you and I wish you best of luck with your studies in future.