Select Committee on European Union Minutes of Evidence


Memorandum by the Human Tissue Authority

INTRODUCTION

  1.  The Human Tissue Authority (HTA) welcomes the opportunity to contribute to the Select Committee on the European Union's Inquiry into the EU Commission's Communication on organ donation and transplantation: policy actions at EU level.

  2.  The HTA's evidence covers topics raised within the Commission's Communication and other relevant issues which relate to the work and remit of the organisation.

  3.  We would of course be happy to provide further oral or written evidence to the Inquiry.

THE HUMAN TISSUE AUTHORITY

  4.  The Human Tissue Authority was established in April 2005 to implement the Human Tissue Act 2004. The Authority's remit covers the removal, storage, use and disposal of human bodies, organs and tissue for a number of purposes including transplantation. The Act and the Authority's remit apply to England, Wales and Northern Ireland.

  5.  The Authority regulates the donation by living people of solid organs, bone marrow and stem cells. It is responsible for approving all organ transplants from living donors; and this latter role is also extended to Scotland.

  6.  The Authority is also one of two UK Competent Authorities for the implementation of the European Tissues and Cells Directive.

CONSENT

  7.  Underpinning the provisions of the Human Tissue Act 2004 is the need to obtain appropriate consent for the removal, storage, use and disposal of human tissue, organs or cells for transplantation—and for other purposes specified in the Act. Consent is therefore a mandatory first step in removing, storing and using human tissue for transplantation. The Human Tissue Authority has taken the view that the giving of consent is a positive act; that the absence of refusal is not evidence of consent; and that consent should where appropriate be generic and enduring. We have stated this in our published statutory guidance.

  8.  The Human Tissue Act 2004 specifies whose consent is needed, but is generally silent on defining what form appropriate consent should take, or how it should be sought or recorded. The Human Tissue Authority is charged through its remit to consider these ethical and practical matters, and has published guidance on them in its code of practice on consent. The HTA has also issued a code of practice on the donation of organs for transplantation, which provides guidance on the donation process and sets the standards practitioners are expected to meet.

LIVING DONORS

  9.  The Human Tissue Authority replaced and extended the role of the erstwhile Unrelated Live Transplant Regulatory Authority (ULTRA). Before the Authority was established, organ donations from living people could only be made to genetic relatives and to people with a close personal relationship. The Human Tissue Act 2004 has now widened the scope of living donation to include altruistic and paired cases (covered in more detail below).

  10.  Under the provisions of the Act, which came into force on 1 September 2006, the Human Tissue Authority is responsible for approving all organ transplants from living donors. All donors and recipients have to be individually assessed by a local independent assessor, who is trained and accredited by the Authority to act on behalf of the donor. The independent assessor ensures that the donor and recipient have an appropriate relationship; that the donor fully understands the risks which donation involves; that s/he is not under any pressure to donate; and that consent has been given freely and voluntarily. The independent assessor then submits an on-line report making a recommendation on approval to the HTA.

  11.  The HTA will make a decision on each individual transplant case based on the report provided by the independent assessor, subject to the requirements of the Human Tissue Act 2004 and the Authority's guidance. Most HTA decisions are made by a dedicated transplant approvals team. Decisions on complex cases including altruistic and paired donations are made by a panel of Authority members. The average turn-round time for approval by the HTA for straightforward genetically or emotionally related living donor cases is two working days.

  12.  Since the Act came into force in September 2006, we have approved almost 900 living donor transplants, mainly involving kidneys.

  13.  We note the EU Commission's Communication states that "exploring the promotion of altruistic donations from volunteer living donors, on the basis of appropriate safeguards for the donors and the prevention of trafficking, could be important in expanding the organ pool." The HTA has already introduced systems to enable more flexibility in who can donate to whom, by allowing both non-directed altruistic donation and paired donation. Non-directed altruistic donation involves a donation by a person who does not have a relationship with the recipient. In such cases a psychiatric assessment of the donor is required. Paired donation is where a related donor and recipient whose blood groups or tissue types are mismatched (or incompatible) are paired with another donor and recipient in the same situation.

  14.  These new means of finding suitable organ donors are expected to increase transplant numbers. Two altruistic and two paired donations have already taken place since the Act came into force. Altruistic donations are probably never likely to be numerous, but enthusiasm on the part of the transplant community and the wide national publicity that accompanied the first paired donation suggests that the number of paired donations is likely to increase substantially, perhaps to as many as fifty per year.

ORGAN DONATION FROM THE DECEASED

  15.  The Human Tissue Act 2004 makes it lawful for organ donation from a deceased person to take place provided that consent was given by the person prior to their death. In the absence of the known wishes of the deceased, consent may be obtained from the person nominated by the deceased person to act on his or her behalf or, if there is no-one so nominated, from a person in a qualifying relationship—such as a spouse, partner or other relative or friend.

  16.  Under the Act the wishes of the deceased person are paramount and take precedence over the views of the family.

  17.  The Human Tissue Authority's code of practice on donation of organs for transplantation advises that if the family or those close to the deceased person object to the donation, even though the deceased person (or his/her nominated representative) has explicitly consented, clinicians should seek to discuss the matter sensitively with them. The family should be encouraged to accept the deceased person's wishes and it should be made clear that they do not have the legal right to veto or overrule the wishes of the deceased person.

  18.  Currently all deceased organ donation in the UK is non-directed: organs are allocated according to clinical need rather than according to any specific wishes of the donor communicated while they were alive or of their family. In the past year the Authority has been made aware of a number of cases which might merit consideration as exceptions to that general rule. We are examining these with other members of the transplant community at the moment.

"PRESUMED CONSENT"

  19.  As we have explained, the underpinning principle of the Human Tissue Act 2004 is that consent must be obtained to use human organs and tissue for transplantation, whether from the living or after death. The option of presumed consent was debated extensively during the passage of the Act through Parliament. It was decided then that the opt-in system should remain.

  20.  Any move to a system of presumed consent within the UK would thus require a change in the law. There would need to be extensive consultation and debate before that happened. The Human Tissue Authority would favour as much transparency as possible in shaping and conducting that debate.

  21.  Provisions for appropriate consent have only recently been established through the Act, and the Authority would see an argument for giving the current legislation more time to take effect before considering whether to change the nature of what constitutes appropriate consent for deceased donation of organs for transplantation.

  22.  Furthermore, the HTA would want to be reassured about the impact that a system of presumed consent for organ transplantation would have on the current provisions in the Human Tissue Act 2004 for fully informed consent for other purposes, such as body donation for medical science or removal of tissue at autopsies.

ETHICAL ISSUES RELATING TO ORGAN DONATION

  23.  A number of ethical principles inform the Human Tissue Act 2004 and its provisions for organ donation and transplantation: these include the need for consent and for freedom from coercion, for equity and justice in assessing individual need, and for respect to be accorded to bonds of kinship in directing donations.

  24.  These principles have been central to our development of both the HTA codes of practice and the systems for regulating living and deceased donation.

ILLEGAL TRAFFICKING

  25.  We share the view of the European Commission Communication that organ trafficking is an issue of serious political and ethical concern.

  26.  The Human Tissue Act 2004 makes it an offence to give or receive a reward for the supply or offer of human material for transplantation. The offences relating to the prohibition of commercial dealings in human material came into force on 20 October 2005.

  27.  The Act does not however prevent import or export of organs for transplants. Numbers are small but there is a regular exchange of organs between European countries that meet similar quality and safety standards to ours. The UK Transplant wing of the NHS Blood and Transplant Authority facilitates this on the occasions that it occurs.

EUROPEAN ACTION IN THE FIELD

  28.  The European Commission Communication examines the scope for a European directive setting standards for the quality and safety for organs.

  29.  The Authority has experience of implementing a European directive. We are one of the two Competent Authorities for the implementation of the EU Tissues and Cells Directive in the UK: that Directive is intended to create a common framework for ensuring consistent standards across the EU community.

  30.  This has required the HTA to set up and regulate two systems of licensing, one under the Human Tissue Act 2004 and another under the regulations which transposed the European Directive into UK law.

  31.  Implementing this dual approach has created significant challenges for the Authority in keeping the resulting regulatory burden within the confines of Better Regulation expectations.

  32.  From our experience of implementing the European Tissue and Cells Directive, we would strongly suggest that any directive for the quality and safety of organ donation should be flexible and practicable in approach: one way to encourage this would be to involve stake-holders directly from the beginning in the drafting of the proposals to ensure that unintended consequences are minimised. We believe that this involvement should be in addition to consulting stake-holders after the work is done. We would also suggest that any directive should endorse the principle of subsidiarity among member states: for example, different legislative models for consent should be allowed to co-exist; and any wider system should be organised in such a way to enable these different models to work as intended.

CONCLUSION

  33.  The Human Tissue Authority's role under the Human Tissue Act 2004 in regulating living and deceased donation for transplantation has given it experience and insights into a number of the issues under consideration by the Inquiry.

  34.  In implementing the provisions of the Act, the Authority has had the opportunity to consider the practical and ethical aspects of both living and deceased donation.

  35.  And our experiences of implementing the European Directive on tissues and cells points to the benefits of a flexible and practical approach to developing any European directive on organ donation.

  36.  The Authority would be happy to provide the Committee with further evidence on any of these points.

30 October 2007



 
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