Recent Changes to the Medical Law - Essay Example

School: MEDICAL LAW Lecturer: ‘The law addressing transplantation has undergone considerable change over thelast few years. Nonetheless, the shortage of human organs continues to cause otherwise preventable death and suffering.’ (Pattinson, 2006) Critically evaluate the changes to the law that have taken place in recent years and consider possible alternative responses, which may increase the supply of human organs for transplantation. Introduction The law addressing transplantation of human organs is one that has continued to receive a lot of attention and come up for public debate and discourse. Debates surrounding the law have been noted to have come from two major perspectives, the first of which is a legal and professional perspective, and the second being humanity and ethical perspective.1 It has been said that the controversies surrounding the laws have always arisen from a perspective where people have looked at the law from a human and ethical perspective rather than from a legal and professional perspective.2 The reason much controversy is said to arise when the law is viewed from humanity and ethical perspective is that it gives way for people to judge the law mainly from how wrong and dehumanising it is to take organs from a dead person, especially when the person did not leave any living proof of consent.3 Meanwhile, there is the legal and professional perspective which also looks at the impact of a refusal to engage in the supply of human organs for transplantation on the living. For example, the right to live has been argued to apply to the living rather than the dead and so it is important that as far as there is a professional medical intervention that can save a living person rather than a dead person, that intervention must be applied4. In this paper, the writer combines both sides of the argument and critically evaluates recent changes to the law, while giving alternative responses that can help increase the supply of human organs for transplantation. Overview of the Law on Transplantation The Human Tissue Act 2004 is the current set of laws regulating the supply of human tissue for transplantation in the U.K. The Human Tissue Act 2004 is generally in place to regulate the activities bordering on the removal, storage, use and disposal of human tissue5. The laws were established by the Human Tissue Authority, which currently puts emphasis on consent. By consent, reference is being made to the need for a person, whiles alive to agree that once he or she dies, there can be a supply of part of his or her tissue for issues of medical purposes prescribed under the Act. There are also consent requirements binding the removal, storage and use of body parts, organs and tissue from a living person6. Because of the differences in consent requirements, the Human Tissue Act 2004 has a list of purposes that applies in each case. These purposes are referred to as scheduled purposes. Either though the issue of consent exists in other jurisdictions such as with Human Transplantation (Wales) Act 2013, what makes the U.K case different is that consent is from an opt-in approach. By an opt-in approach, people are required to state emphatically by agreeing to the scheduled purposes that they would be part of a supply once the need arises; whether they are dead or alive. Apart from the uniqueness of the opt-in approach, the Human Tissue Act 2004 has three major points that regulates it. The first is that the Act should be responsible for all legal interpretations regarding the removal, storage and use of human tissue. In this instance, the term human tissue is defined to be any material coming from the human body and consisting of a human cell as its least component7. In the second place, there is the creation of a new offence known as DNA theft, which comprises the intentional analysis of a DNA in an unlawful manner without the consent of the person from whom the tissue was taken8. By creating an offence with DNA theft, it means that the Act spells out clear punishments that must be carried out in the case of breaches. Lastly, the Act makes provisions for minimum steps to be taken on the preservation of human organs of a deceased person for the purpose of future transplantation, once the necessary consent has been sought from the deceased or a qualified relation9. Offences under the Human Tissue Act 2004 and their Implications One of the ways by which the enforcement of laws are said to be very effective is by having offences defined to accompany their enactment.10 In this sense, having offences under the Human Tissue Act 2004 is a step in the right direction. As part of this, the removal, usage and storage of human tissue for scheduled purposes without following the due process in seeking consent becomes an offence.11 The implication here is that any form of transfer of human tissue without opt-in consent is not permissible. In the same way, the usage of donated human tissue for scheduled purpose for any purpose other than the purpose for which it is intended for becomes offence. This implies that consent is not conclusive in its self but must be accompanied by a commitment for the consent to be used for purposes for which they are defined. What is more, the trafficking of human tissue for the purpose of transplantation is considered an offence. This means that at any point in time, the law puts premium on the source of human tissue rather than the purpose for which the tissue is made to serve.12 Again, licensing activities carried without a license is an offence, as well as engagement in DNA analysis without prior consent of the owner of the DNA.13 Significant change to the Law from Previous Laws The current Human Tissue Act 2004 is the creation of series of changes to what used to be existing laws in England and Wales and corresponding Orders in Northern Ireland. There are three major acts that the current law has come to replace, which are the Human Tissue Act 1961, the Anatomy Act 1984, and the Human Organ Transplants Act 1989.14 Unlike what exists in the current law, the previous laws were noted to be more flexible and allowed the free flow of human tissues for professional purposes15. But even though the laws clearly spelled out sanctions in the cases of prohibition of commercial dealings in human organs and restriction on transplants between not genetically related, there were several lapses and abuses with the whole issue of tissue supply.16 It was the lapses that lead to the current changes. The most significant changes that have taken place have therefore being in line with the need to curtailing the lapses. For example, as part of new laws, the Human Tissue Act 2004 emphasis is placed on consent in an opt-in approach, when the previous laws did not emphasise on opt-in. Due to the changes, a person must now express consent by opting that his or her tissue can be used for any of the purposes prescribed under the new law once he or she is deceased. Impact of the existing changes The changes that have taken place in the law addressing transplanting have had two major impacts. In the first place, the changes have brought about much emphasis on the ethical and humanity perspective of the whole public debate and discourse.17 As a result, people have started reasoning from a perspective where the dead is seen as an entity deserving a greater level of care, respect and the protection of dignity. This has also created an impact where the basic rights of people are transferred to their moments of dead. There continues to be some legal experts who question this situation and argue that rights of people are not transferrable18. In the opinion of these people, as much as the dead deserve respect and dignity that ought to be accorded them, this should not be equated to the total transfer of their rights as the new situation seems be portray. Once there is emphasis on the ethical and humanity perspective, it means that a lot more people are becoming concerned about the need for them to also experience the level of dignity and respect being advocated in public discourse. There is another component of impact that looks at the fact that there has been reported professional shortage of human tissues in most health facilities.19 The reason this is so is that there is being apathy towards the contribution of human tissues. It will be noted that under the new law, people must consent by opting in. What this means is that unless a person gives a formal consent that upon being deceased, his or her tissue could be used for transplantation purposes as defined in the Tissue Act 2004, medical professionals cannot use the tissue of the person for any purpose. Meanwhile, the popularity of the ethical and humanity perspective is making more and more people withdrawn from the need to consent. Due to this, the need for there to be sufficient supply of human organs for genuine medical operations on the living is suffering greater lapses, leading to reported cases of preventable deaths and suffering.20 This is however not to deny the fact that there has been better sanity when it comes to the approach to using human tissues. This is because most cases of unlawful use of human tissue, especially for cases of unwarranted DNA tests have been avoided. Alternative Response to increase supply of Human Organs for Transplantation Based on documented evidence from medical experts and researchers of shortages in human organs, leading to avoidable deaths and other forms of fatalities,21 it is important that alternative responses will be taken to increase supply of human organs for transplantation22. The alternative response must be based on the direct weaknesses found with the existing law, for which reason it has not been able to serve the purpose of human organ availability very well. With this said, it will be accepted that the opt-in approach to consent currently being used is the major hindrance to the law23. With an opt-in approach, people who become deceased whiles being silent on their state of supply of human tissue become automatically exempted from a possible organ donation, unless otherwise overturned by a person in an authorised relationship24. As an alternative therefore, it is recommended that an opt-out approach to consent be taken as exists with the Human Transplantation (Wales) Act 2013. This is because under the mentioned alternative, all people who are 18 years and above who die without opting out are presumed to be naturally consenting to the usage of their tissues for the purpose of transplanting.25 Implications of Alternative Response The alternative response that has been suggested is clearly one that will favour the legal and professional perspective of the argument. Once this side of the argument is favoured, the implication is that there will be sufficient supply of human organ for professional use. Luckily, this perspective does not undermine the need for the legal implications of supplying human organs to be considered. This means that the necessary legal arrangements that ought to be made before such supplies take place will be considered. By and large, the alternative response will give much credence to the need to preserve the living, whiles making the dead be useful to the living26. This does not also mean that there will be an undue advantage taken over the dead and that the dead will not be respected in any way as argued from the ethical and humanity perspective. This is because with an opt-out approach, people will have the right to still exempt themselves from such donations if they have a feeling that it will be dehumanising to their bodies once they are dead. Another implication of the alternative response is that people will be responsible for what happens to them once they die. This will just be like leaving a will before a person dies. Imperatively, silence over one’s dead body will mean consent to human transplant. Caution in the Practice of Alternative Responses As much as the alternative response will have some solutions to prevailing situations on the shortage of human organs for transplantation purposes, it is important that all necessary caution be taken to avoid any form of abuses and disregard for the legal observation of the law. For example, it is important that undue advantage will not be taken by medical professionals in the supply and usage of human organs. Caution must be taken in ensuring that all due processes will be followed, including consultation with family and the payment of any compensation where necessary. It will also be important to keep most parts of the defined offences that currently guide the Human Tissue Act 2004. Specifically, offences defined for DNA theft, scheduled purposes, and trafficking must all be in place to ensure that any forms of professional breaches are avoided. What is more, as the alternative response takes presumed consent approach, it is important that once people are 18 years and registered under the National Health Service, various approaches will be taken to them to make their consent clearly known so that there will not be the need for controversies in time of untimely or sudden deaths. Conclusion From the discussions so far, the need to emphasise on both the humanity and ethical perspective and legal and professional perspective of the laws on the supply of human tissue has been stressed. This is because there are highly valid justifications in both sides of the argument. However, given the present need for there to be more supply of human tissue for professional purposes, which are aimed at saving lives for the living, it is important that existing laws will be revisited in a manner that makes it more flexible for supplies to take place. Once this is done, it means that the legal and professional perspective would have to overshadow the ethical and humanity perspective. However, it is important not to totally disregard the valid basis of the latter.27 It is for this reason that the possible negative effects of the alternative response which touches on an opt-out approach has been elaborated in the paper. In conclusion, it would be said that it is high time the living started benefiting from the dead but in a much respected and legalised manner. It is also time for the living to take responsibility for what happens to them once they are dead so that the legal interpretations of human tissue supply will not be met with the level of current controversy it receives. References Regulations and Laws Human Tissue Act 2004 Case Laws Yearworth v North Bristol NHS Trust [2009] EWCA Civ 37 Books Emily Jackson, Medical Law: Text, Cases and Materials (3rd edition) (Oxford University Press 2013) - Chapter 11: ‘Organ Transplantation’ Veatch Robert M. Transplantation ethics. (Washington, DC: Georgetown University Press, 2000) 171 E Catherine and F Quinn, English Legal System (9th ed.). (Pearson Longman 2008). Journals Ungoed Thomas J. ““Dead” organ donors may still feel pain” (2010) 232 Sunday Times 204 McDonagh Samuel. “Organ Donation (Presumed Consent and Safeguards) Bill” (2004) 417 House of Commons official report (Hansard) 645 V English and A Sommerville. “Presumed consent for transplantation: a dead issue after Alder Hey?” (2003) 291 J Med Ethics 152 M Brazier, “Retained Organs: Ethics and Humanity” (2002) 22 Legal Studies 550 M Brazier, “Organ retention and return; problems of consent” (2003) 29 Journal of Medical Ethics 30 M Brazier and S McGuinness, “Respecting the Dead means Respecting the Living too?” (2008) 28 Oxford Journal of Legal Studies 297 Heather Saul "Opt-out scheme for organ donation given go-ahead in Wales". (2013) 231 The Independent 43 J Harris, Organ procurement: dead interests, living needs (2003) 29 Journal of Medical Ethics 130-4. K Liddell & A Hall, Beyond Bristol and Alder Hey: the future regulation of human tissue (2005) 13 Medical Law Review170 D Price, ‘The Human Tissue Act 2004’ (2005) 68 Modern Law Review 798-821 D L Manninen and R W. Evans “Public attitudes and behaviour regarding organ donation” (2013) 43 JAMA 3115 D Price, End of Life Treatment of Potential Organ Donors: Paradigm Shifts in Intensive and Emergency Care (2011) 19(1)Medical Law Review 8 Steven Morris. "Opt-out organ donation bill reaches Welsh assembly". (2012) 332 The Guardian 23 T Wilkinson, “Individual and family consent to organ and tissue donation: is the current position coherent?” (2005) 31 Journal of Medical Ethics 587 Websites The National Archives, ‘Human Organ Transplants Act 1989’ (2009). accessed 16 April, 2014 Department of Health: Human Bodies, Human Choices: The law on human organs and tissues in England and Wales (A summary consultation report) (2002) located at: accessed 18 April, 2014 HTA, ‘Human Tissue Act 2004’ (2010) accessed 17 April, 2014 Read More