The Human Tissues Act 2004 and Presumed Consent - Essay Example

Critically evaluate the changes to transplantation law that have taken place in recent years and consider possible alternative responses, which may increase the supply of human organs for transplantation. Introduction Organ transplantation is not a new concept for UK. As early as in 1955, the Yorkshire Regional Tissue bank was established in UK. The Oswestry and the North Wales Tissue Bank was established in 1991, and skin banks were established both in London and Sheffield (Gaum et al.,2012:143). NHSBT TISSUE SERVICE is the single largest tissue bank in UK, which deals with retrieval, consent, processing, storage and dispatches of donated tissue. Tissue donation may take many forms like donor only as in the case of eye –only donors, multi-tissue donors like bone, eye and skin donors or solid organ and tissue donors (Doad 2010:3).A clinic in Harley Street in 1980s was involved in buying kidneys from downtrodden Turkish immigrants and transplanted them to wealthy patients who were ailing with end-stage renal disease. There was a large-scale public outcry against these practices and due to this, the Human Organ Transplants Act was introduced in 1989 (Johnston & Bradbury: 150). There are about 2500 eye donors and 450 multi-tissue donors on annual basis in UK. There were about 3564 corneas’ transplantation took place in 2010-2011 in UK. Organ transplantation could be lifesaving whereas tissue transplantation may have a dramatic impact on a donee’s quality of life. (“Gaum et al 2012”). In UK, law relating to scientific and medical usage of the dead human body has chiefly originated from statute law. Under the Murder Act 1752, the dead bodies of murderers who had been executed were used for dissection purposes (Eder 2004:133).Under the Anatomy Act 1832, it was lawful to use unclaimed corpses, if there had been provisions for licensed anatomists and consented donations (Lawrence 1998:37).Corneal transplantation can be traced back to the Human Tissues Act 1952. These customary laws dealt with the use and removal of organs and tissue taken from deceased bodies(Dworkin1970:353).Under the Human Tissues Act 1961, it was legal to use tissue immediately after death for education, treatment or for research purposes if there is no objection from the close relatives of the deceased. (Nwabueze 2013:133). This researh essay will make an attempt to disparagingly assess the changes to organ transplantation law that has been introduced of late in UK and will try to find out alternate methods and ways and means , which may escalate the supply of human organs for transplantation in UK within provisions of the existing laws of UK. The Human Tissues Act 2004- An Analysis The Human Tissues Act 2004 is not without any ambiguity. As Skegg (1984), as per section 1 (1), a person can be in lawful possession of a human organ where the donor could accord approval for carrying out the post-mortem of his body after his death (Klaiman 2005:475). However, the 2004 Act failed to offer a definition as regards to who would be in possession of the deceased body. As per Lanham (1971), if a person died in a hospital, it is generally assumed that the hospital would be in lawful possession (Skegg 1976:193). Further, the 1971 Act never provided the details of sanctions for non-compliance. Hence, as per Kennedy (1989), there is no clarification as regards to whether non-compliance would be dealt by the civil or criminal court. As per Miola (2007), medical scandals involving Harold Shipman who was a general practitioner and a serial killer who murdered hundreds of his patients and this had traumatised the public confidence in the medical profession (Herring 2012:508). As per Bristol Inquiry (2007) on paediatric death, it was established that organs were removed from patients even without their knowledge and consent (Westaby et al., 2007:759).As per Liverpool Children’s Inquiry (2001), organs from children were removed without their knowledge or without the parent’s consent. Due to these widespread malpractices in the medical field in UK, a Retained Organ Commission was created to supervise the return of retained tissue and also to suggest new law and guidance for the prevention of these malpractices in the future (Leith 2007:1023). Under this background and with large-scale consultations that introduced the Human Tissue Bill, which finally became the Human Tissue Act, 2004. Thus, the birth of Human Tissue Act 2004 was mainly because of legal and ethical failure to control the medical profession in UK. (Lenk 2011:81). The UKs present Human Tissues Act 2004 is concerned with the use, removal and storage of organs from corpse and parts of the corpses for transplantation. The Human Tissues Act 2004 control the use, storage and the removal of human tissues and has defined tissue as a material that emanates from a human body and includes or consists of human cells. The Human Tissues Act 2004 has replaced the earlier legislations like the. Human Tissues Act 1961, the Human Organ Transplanting Act 1989, and the Anatomy Act 1984. Further, the Human Tissues Act 2004 has consolidated the law on the donation of organ, revoked earlier laws on the subject, and came into effect on 1 September 2006 (Miola 2011:79) . The 2004 Act established the HTA (Human Tissue Authority) to manage the activities pertaining to the storage, removal, use, and disposal of human tissue. Further, free consent is the basic principle of the law, and it buttresses the legal removal, usage and storage of body organs, parts and tissues. The Human Tissue Authority has prescribed six main codes of practice, which offer direction on matters relating to organ donation, consent, and investigation of a body after death (Brazier 2006:26). “The mainstream of live human organ gifts are between relatives.” Further, all probable living organ donations should be evaluated by an independent assessor who has rich experience to investigate whether all the conditions of the Act have been complied with. Assessor will have an exhaustive discussion with both the donee and donor to make sure that consent is valid , has been given without any coercion and the parties are aware of the risks associated with organ transplantation and to make sure that the donor is not receiving any financial compensation.(Bernan 2008:145). Thus, under 2004 Act, live organ donation is feasible even between strangers provided the donor has the ability to give consent and there is no element of coercion ,which includes financial compensation (Johnston & Bradbury 2008:150). Further, 2004 Act makes the DNA theft as an offence. Thus, it is now illegal to have DNA with an aim of its being analysed without consent of the person from whom it is taken. As per Consultation by Human Genetics Commission (2000), non-consensual DNA analysis should be criminalised. (Stanley 2014 :32). Further, the 2004 Act makes it legal to initiate some basic steps to safeguard the organs of a dead person, mainly to use in the transplantation of the same with the consent of the dead or consent of his close relative. The Human Tissues Act 2004 makes the following as offences: Without obtaining consent from donors, using, storing and removing human tissue for scheduled purposes. Using the DNA for some other purposes instead of using it for originally consented purpose by the donor Engaging in trafficking in human tissues, which is originally donated for transplantation purposes Without holding license from HTA, indulging in licensed activities; and failing to present records to HTA or hindering the HTA officials from exercising their authority or power. Using human tissues like gametes, hair and nail or cells linked with the sexual reproduction without consent from the legal owners.(Herring 2011:184). As per the Human Tissue Act 2004, anything from a dead body or living thing, and if it contains human cells, then, it will be called as “relevant material.” Under Coroners (Amendment) Rules 2005, a duty is vested with the Coroner to inform the relatives of the dead about the retention of the organ or body of the deceased. Further, relatives are having the right to select either to donate the organ or body or refuse the same. (Price 2005:798). Case Laws on Organ Transplantation Moore v. Regents of the University of California1- This case concerned with the issue of rights of the property in own body parts. In this landmark case, a case was filed by John Moore in Supreme Court of California against Golde, a physician who treated Moore for leukaemia at UCLA Medical Centre of the Regents of the University of California. Moore was treated for hairy cell leukaemia, and Moore’s cancer was transformed into a cell line that was later commercialised without his knowledge. It was held that Moore had no privilege to any percentage of profits generated from the sale of anything created from his abandoned body parts. Nonetheless, the court found that the defendant did have a moral duty to divulge his financial interest in the materials removed from Moore and Moore had the right to raise a claim for any injury that he suffered due to the failure of the physician to divulge those commercial interests. (Gold 1996:156). Yearworth v North Bristol NHS Trust2, Yearworth was given treatment for cancer, and the defendant performed a chemotherapy test on him. Later, due to the effect of chemotherapy treatment, the plaintiff had the chance of becoming infertile and the defendant informed the plaintiff that they would undertake to warehouse the samples of his semen, which will be kept in a frozen condition and accordingly , it was later warehoused by the defendant. However, the defendant’s fertility unit infringed a specific promise to the plaintiff that his sperm would be warehoused at minus 196o C. Due to this, the sperm became useless. The Court of Appeal in this case viewed that defendant became gratuitous Bailee of the sperm and was accountable for the plaintiff for infringement of his duty under the bailment. (Chitty 2012:316). Another significant issue in this case is that whether or not the sperm’s loss amounted to damage to the men’s property. The court was of the opinion that despite the Human Tissue Act 2004 restricted the capability of donor to give direction for the usage of their stored sperm, but they had property in it. Further, the 2004 Act acknowledges that men have fundamental feature of owning sperm and at any juncture, they can demand the destruction of stored sperm. Hence, the court viewed that the defendant was accountable for losses under tort also. (Murphy & Witting 2012:290). “Organ Donation and Religion” Backing for presumed consent appears to have some fundamentals in religious culture as majority of Catholic nations are in favour of presumed consent as opposed to Protestant nations. This may mirror a more utilitarian footing of Roman law. (Lawson 2008:117). Jewish law advocates presumed consent where in the absence of any explicit direction from the deceased, the organs can be always used for transplantation for saving some other life. In Judaism, it is an obligatory moral duty to donate an organ. The organ donation is an act of charity as per the Roman Catholic Church. As per Quran, organ donation is an act of merit and in some scenarios, it can be regarded as an obligation. In Singapore, Muslims have been given exception to the presumed consent, mainly on religious grounds (Lawson 2008:117). “Wales and Presumed Consent From December 2015 onwards, Wales’s citizens will be assumed to have given their consent for use of their organs for any living individuals after their death unless people have specifically refused the same. Transplantation offers hopes for those who are terminally ill who may be badly in need of a transplant. Under section 43, it is a lawful action by hospital authorities to initiate steps for safeguarding the part of the body for the use for transplantation and to preserve the body for that objective. In a study made by Veatch, only 7% of the respondents answered that they may vent their objection even though they are not divergent to organ donation. The present efforts as regards to consent in the UK orbit around preferences to opt-out and mandated preferences. In a scenario, where the patient is not in decision making capacity, all features of the patient’s best interest shall have to be taken into account.(Carr 2013:156). The Human Tissues Act 2004 and Presumed Consent In UK, if someone in UK is diagnosed with blood cancer like leukaemia and then, they have to undergo a blood stem-cell transplant, which is the only treatment available for leukaemia. At present, about 1600 people in the UK, who are in need of a blood stem-cell transplant, which is their last chance for their survival. As about 70% of the patients may not have a matching donor from their family itself, and they have to solely rely on the outside donors only (Bates 2012). In the year ending 31 March 2007, about 440 people died in UK for want of human organs. If there is an increase in the organ donor’s numbers, NHS is likely to save £ 50m per annum towards expenses on supportive care of the patients. About eight thousand patients are presently waiting for organ donation in UK, and this gives the concept of “presumed consent” more prominence. As per UK transplant survey, 90% of respondents answered that they are extending their support for organ donation, but they fail to carry with them the donor cards and just only23percentage of them registered for organ donation. As per Barber (2006), in 40% of the cases, close relatives have refused to donate the organ of the dead, as they were unaware about the consent of the deceased. As per Bell (2006) , there has been a strong demand for change the law to introduce “ presumed consent” but the opponents argued that it does not take into account one of the basic ethical cannons namely respect for autonomy as it is one of four main principles of medical ethics(Labadie & Gay 2006:600). Presumed consent is considered as the best solution available for organ donation when there is a shortfall in the supply of human organs. Abadie and Gay made a research on a panel of 22 nations over a decade and discovered that cadaveric donations’ rates soar by about 25 to 30% in nations where presumed consent was in existence. Nonetheless, if the presumed consent is subject to a multiple regression analysis, the impact of presumed consent is still statistically important as compared to be other contributing factors of organ donation that have to be taken into consideration (Labadie & Gay 2006:600). The hospitals in UK are now legally empowered to initiate steps to “preserve the part for transplantation” under section 43 of the Human Tissue Act. This section gives more concerns as to how the cannon that the patient’s best interest can be reconciled with the employment of preservation techniques like cold perfusion. (Lawson 2008:117). “Findings and Recommendations “ Organ transplantation could be lifesaving whereas tissue transplantation may have a dramatic impact on a donee’s quality of life. , The birth of Human Tissue Act 2004 was mainly because of legal and ethical failure to control the medical profession as regards to handling of human organ and tissues in UK. Under 2004 Act, live organ donation is feasible even between strangers provided the donor has the ability to give consent and there is no element of coercion, which includes financial compensation. Further, 2004 Act makes the DNA theft as an offence. At present, about 1600 people in the UK who are in need of a blood stem-cell transplant, which is their last chance for their survival. As about 70% of the patients may not have a matching donor from their family itself, and they have to solely rely on the outside donors only. In the year ending 31 March 2007, about 440 people died in UK for want of human organs. If there is an increase in the organ donor’s numbers, NHS is likely to save £ 50m per annum towards expenses on supportive care of patients. About eight thousand patients are presently waiting for organ donation in UK, and this gives the concept of “presumed consent” more prominence. Abadie and Gay made a research on a panel of 22 nations over a decade and discovered that cadaveric donations’ rates climbed up by about 25 to 30% in nations where presumed consent is in existence. From December 2015 onwards, Wales’s citizens will be assumed to have given their consent for use of their organs for any living individuals after their death unless people have specifically refused the same. Hence, it is strongly recommended that UK should follow the footsteps of Wales by making presumed consent as a mandatory provision so that many lives can be saved in UK . List of References Barber K, Falvey S, Hamilton C et al. (2006). Potential for Organ Donation in the United Kingdom. BMJ 332, 1124-27. 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