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UK Xenotransplantation Interim Regulatory Authority (UKXIRA)
Historical information

The United Kingdom Xenotransplantation Interim Regulatory Authority ceased to exist from 12 December 2006

This change follows a number of amendments to the statutory framework. Other Government Committees, Research Ethics Committees, and clinical governance arrangements are absorbing the functions.

New guidance on xenotransplantation has been developed to explain the DH policy position. It describes the different approval processes that apply in different circumstances, and it points to appropriate sources of expertise and advice for further information and support.

The guidance is available at:

Xenotransplantation guidance


 Back ground and terms of reference
 Membership as at December 2006
 Meetings and papers
 Publications

Back ground and terms of reference

Xenotransplantation is the transplantation of tissue and organs between different species, and in particular the transplantation of animal tissue into humans.

There is currently, and will continue to be, a shortage of human organs and tissue for transplantation. Much work is being done to increase public awareness of the organ donor programme and to maximise the numbers of organs donated. Initiatives to promote healthier lifestyles to minimise the need for transplantation are also underway. However, many conditions which lead to the need for transplants cannot be prevented simply through leading a healthier lifestyle. Furthermore, welcome reductions in the number of road traffic accidents and strokes mean that fewer organs are becoming available for transplant.

Xenotransplantation is a potential solution to this shortage. Recent scientific developments may mean that the problem of rejection of tissue transplanted between species can be overcome. This raises the possibility of increasing the supply of organs and tissue to meet medical demand. However, it also raises a number of complex ethical issues. Issues such as safety - both to the individual and the wider public; of the efficacy of such procedures; and considerations of animal welfare.

In late 1995, the Advisory Group on the Ethics of Xenotransplantation was formed under the Chairmanship of Professor Ian Kennedy. This commenced UK work on xenotransplantation and its implications. The Advisory Group's report to Government, Animal Tissue into Humans, was published in January 1997. Its main conclusion was that xenotransplantation could be acceptable provided that certain criteria were met. Amongst more than sixty detailed recommendations, was a recommendation for the establishment of a regulatory body to oversee the development of xenotransplantation in this country.

The United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA) was established in response to this report.

UKXIRA's terms of reference were:

"To advise the Secretaries of State for Health, Northern Ireland, Scotland and Wales on the action necessary to regulate xenotransplantation, taking into account the principles outlined in "Animal Tissues into Humans", and worldwide developments in xenotransplantation. In particular to advise:

(a) on safety, efficacy and considerations of animal welfare in liaison with the Home Office, and any other pre-conditions for xenotransplantation for human use, and whether these have been met;
(b) on research required to assess safety and efficacy factors in xenotransplantation procedures;
(c) on the acceptability of specific applications to proceed with xenotransplantation in humans; and
(d) to provide a focal point on xenotransplantation issues within Government."

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Membership as at December 2006

 Members
 Declaration of members' interests

Members

  • Dr Jeremy Wight (Chair) Director of Public Health - Sheffield PCT
  • Dr David Cook
    Fellow and Chaplain, Green College University of Oxford
  • Mr John Dark
    Consultant Cardiothoracic Surgeon, Director (Cardio-Pulm. Transplants) Freeman Hospital, Newcastle
  • Dr Maggy Jennings
    Head of Research Animals Department, RSPCA
  • Dr Jonathan Stoye
    National Institute of Medical Research
Declaration of interests

Members are asked to make a statement of any direct or indirect pecuniary interest they consider members of the public might reasonably think could influence the judgements they have to make as part of the United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA) activities.

The declarations will form a register of member's interests to be maintained by the UKXIRA Secretariat. Declarations will be updated on an annual basis, but Members should inform the Secretariat of any changes as they occur.

Declared interests
Dr Jeremy Wight None
Mr John Dark Member, Mycophenolate Advisory Board, Roche (F Hoffman-La Roche Ltd). Honorarium, approx £400, paid annually, for 2 meetings per year

Recipient of Support for Travel, Accommodation and registration at various meetings connected with transplantation medicine and surgery, from Novartis

Recipient of Support for Travel, Accommodation and registration at various meetings connected with transplantation medicine and surgery, from Roche (F Hoffman-La Roche Ltd)
Dr David Cook None
Dr Maggy Jennings None

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Meetings and papers

Discussion of matters involving commercial or patient confidence is not included

2006

2005

2004

  • Monday 16th February
  • Monday 17th May - Meeting cancelled
  • Monday 23rd August - Meeting cancelled
  • Friday 3rd December - Meeting cancelled

2003

2002

  • Monday 9th December
  • 25th September 2002
  • 11th February 2002
  • Tuesday 14th May - Meeting cancelled

2001

  • 4 December 2001 - Meeting cancelled
  • 10 September 2001
  • 14 May 2001
  • 7 February 2001
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Publications

Council of Europe

The Committee of Ministers of the Council of Europe has adopted a recommendation to its member states on xenotransplantation, underlining the need to keep patients fully informed and calling for the establishment of world-wide agreements and monitoring procedues.

For further information on the recommendation Rec(2003)10, visit the Council of Europe website on:
www.coe.int/T/E/Social_Cohesion/Health/Activities/Organ_transplantation

 

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copyright: © | last updated 12 December 2006
 

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