"The Emphasis On Consent In The Human Tissue Bill 2004 Is To Be Welcomed By All. It Represents The Most Appropriate Way Of Regulating The Use Of Human Tissue. However, The Bill Fails To Address The Shortfall In The Supply Of Organs. Alternative Methods

The use of human tissue is currently regulated by a combination of the common law and the Human Organ Transplant Act 1989 for live donation and by the Human Tissue Act 1961 for dead donors. Call for reform of the loosely worded legislation was amplified after the Alder Hey and Bristol scandals in which large numbers of organs from dead children were removed and retained at a Liverpool hospital without proper permission and without parents' knowledge. Despite the admirable aims of the Human Tissue Bill 2004 in its emphasis on express consent it is doubtful whether the bill is the most appropriate way of regulating use of human tissue particularly in its ability to solve the problem of organ shortage and it may even exacerbate the problem. The bill has not addressed other methods of satisfying the demand for organs but it is debatable practically and ethically whether these should be incorporated into the bill. Ultimately it is vital to assess the underlying views of society on organ donation to determine the success of any scheme or laws the government devises.

Under the Human Tissue Act 1961 "the person in lawful possession of the body... may authorise the removal of any part from the body... if having made such reasonable inquiry as is practicable, he has no reason to believe" that the deceased had expressed an objection during his life or that any surviving relative objects. It is unclear as to what constitutes "reasonable inquiry" - whether it includes contacting every surviving relative or whether an estranged relative should have the power to veto organ donation. Such ambiguities in legislation, lack of criminal sanction and inadequate monitoring of organ and tissue retention has created the perfect setting for the Alder Hey and Bristol scandals.

Outrage at these scandals has lead to the Human Tissue Bill (2004) that establishes 'appropriate consent' as the cornerstone principle for the storage and use of any human tissue, from a live human or cadaver. Consent is needed for the storage and use, including transplantation and research, of any material taken from the body of a person - removal of tissue from a living person is already covered by common law. The new bill proposes criminal sanctions making it an offence to remove, store or use any tissue from a dead person's body without appropriate consent, either from that person prior to death, or from someone representing them. The Bill establishes a new organisation, the Human Tissue Authority, to guide the medical profession in use of human tissue. Any person or organisation involved in removing, storing or using tissue from a dead person, or in storing human tissue from a living person will now require a licence from the Authority.

However the Bill has been described as complicated and unclear. The same ambiguities as in existing legislation remain - the scope and detail of what constitutes "appropriate consent" is left undefined. This will be left up to the Authority to define which will have huge implications on how medical research and organ donations can proceed. The Bill has admirable aims and provides a much stricter approach to consent putting in place such safeguards as to prevent any misuse of any form of human tissue. Yet perhaps this is a disproportionate reaction to the threat posed. The Bill threatens doctors who remove organs from dead bodies without the prior consent of the deceased person or their next of kin with up to three years' imprisonment and unlimited fines. The scandal at Alder Hey was a horrific situation where criminal sanction is apt but it seems inappropriate to apply the criminal law in the area of medical research. It is an extremely heavy worry to impose on those in the medical profession who handle human tissue samples every day. The requirement of licences and regular inspections from the HTA for any establishment that stores any human material at all will lead to a huge increase in bureaucracy and expenditure.

The biggest criticism of the Bill is its impact on research and organ donation. Dr Evan Harris, Chairman of the All Party Parliamentary Kidney Group, feels the real "tragedy" of current legislation lies in its failure to address the problem for the hundreds of patients dying while waiting for organs. Yet the proposed moves to tighten the regulation of how human tissue and organs can be used do not appear to address the problem of organ shortages. Furthermore Dr M.Walport states that "The bill is a confusing mix of contradictions and ambiguities which could result in an unworkable, bureaucratic system that stifles legitimate research" .

Ten years ago about 30 percent of relatives refused to allow the deceased's organs to be donated but this has increased to 50 percent. At the end of December 2003, there were 7278 people on the transplant waiting list in the UK whilst 400 people died waiting for a transplant . There is much debate on how to increase the number or organs yet most critics agree that "the government is wasting an opportunity here by not including provision for presumed consent for organ donation in the proposed legislation" .

Cadaveric transplants are the type where reform may have the greatest chance of increasing organ donations. A system of presumed consent is an "opting-out" scheme which would assume that every patient would want to be a donor unless they had registered an objection and would downgrade the role of relatives. In its purest form doctors may automatically remove organs where the deceased has not expressed an objection in his lifetime and the views of relatives are not taken into account, as is the system in Austria. It is widely thought that presumed consent will increase the number of organ donations but assuming this is true it is important to assess whether such a system is ethically permissible.

Respect for persons is a vital part of ethics in that it requires us to acknowledge the value and dignity of others, not, as deontologists would argue, just as a means to another's ends. Autonomy is a key principle in medical law thus one should have a right to do as they wish with their bodily tissue. The Retained Organs Commission emphasises the principle of informed consent which is an element of respect for persons in that it is through consenting to things that affect us that we exercise our autonomy and determine our own actions and values. Thus perhaps a system of presumed consent is inconsistent with our must fundamental values.

Brazier argues that in life the law accords ultimate respect to autonomy leaving us free to act in whatever way we choose even if the consequences are dire thus our autonomy should be equally respected in death. Most importantly Brazier feels that "deeply held cultural and religious beliefs" and interests of the bereaved should