NKF Campaigns Zone:
Transplantation & Live Donors

Minutes of a Transplant Summit held at 1.00pm on Thursday 25 May 2006 in The Thatcher Room, Portcullis House

Present

• Dr Evan Harris MP (Chairman)
• Tim Statham,  NKF APPKG Secretariat

Observers

• Becky Purvis, Dr Harris Researcher

Authorities

Dr Simon Ball, ABO & Transplant; Prof J Andrew Bradley, Surgeon, Transplant Research; Simon Bramhall, Consultant Liver Surgeon; Lisa Burnapp, Consultant Nurse, Living Donors; Dr Philip Dyer, Transplantation Specialist; Veronica English, British Medical Association; Sue Falvey, UK Transplant; Prof John Feehally, Renal Association; Jayne Fisher, Chair, UK Transplant Coordinators; John Forsythe, President, British Transplantation Society; Prof Peter Friend, Vice President, British Transplantation Society; Dr Susan Fuggle, Oxford Transplant Centre; Dr Roger Greenwood, Chair, Kidney Alliance; Andrea Harmer, Blood & Transplant Service BSHI; Dr Robert Higgins, Consultant Nephrologist, Antibody Removal; Rachel Johnson, UK Transplant; Jane MacDonald, Lead Nurse, & Vice President BRS; Dr Susan Martin, BSHI; Adrian McNeil, Human Tissue Authority; Dr C G Newstead, Chair of Standards Committee BTS; Prof Michael Nicholson, Transplant Surgery, Leicester; Triona Norman, DOH; Dr Donal O’Donoghue, Renal Association; Dr Julian Pratt, Leeds University Hospital; John Richardson, Co-Chair UK Transplant Co-ordintaors; Keith Rigg, Consultant Surgeon & HTA; Chris Rudge, UK Transplant; Magdi Shehata, Consultant Surgeon, Living Donation; Dr Paul James Sinnot, Head of Clinical Transplantation Laboratory; Maurice Slapak CBE, Transplant Sports Assn of Gt Britain; Anthony Warrens, British Transplantation Society; Hugh Whittall, DOH.

Industry

Anju Balla, Astellas; Joanna Bright, Workhouse; Melanie Edwards, Astellas; Catherine Gribbon, Genzyme; Katherine Horton, Roche; Mary Lynn Manning, Novartis; Ros Meek, Wyeth; Jenny Rowlands, Wyeth; George Stanley, Novartis; Jay Vaja, Genzyme; Tim Wheelan, Roche; James Woodhouse, Roche.

NKF

Jean Aplin, Jenny Bartlam; Ian Cundell; Judith Dear; Robert Dunn; Deborah Duval; David MacDonald; Ray Mackey; Margaret Parkin; Stephen Rowe; Robert Smith.

1. Apologies for absence (14)

Ian Taylor MP, Joan Cummings MP, Bill Etherington MP, John Randall MP, Lord Davies of Coity, John McDonagh MP, Elwin Clwyd MP, Bill Etherington MP, Rt Hon Tony Blair MP, Baroness Fookes of Plymouth DBE DL, Michael Hill, NKF.

2. Presentation by UK Transplant (Chris Rudge)

Chris Rudge presented the results from the recent and first ‘potential donor audit from deceased donors in the UK’.

Points of note:

Figures from first 30 months of audit.

Criteria for organ donation occurs after death. Death is diagnosed by tests of the brain stem (‘brain stem death) or after cardiac and respiratory arrest. Under current legislation the consent of the relatives is needed.

Brain stem & Cardiac death explained.

Possible reasons for donor shortage –

• Fall/low death rates from road traffic accidents
• Fall in death rates from strokes
• Lack of ICU beds
• Change in clinical practice
• Failure to convert possible donors into actual donors:–
• Clinical practice within ICU
• Non-referral from ICU
• No approach to the donor’s relatives
• Relatives refusal of consent

Potential for HB donation:

Results 1

Results 2

Solid organ donation with relatives consent for HB solid organ donation:

Reasons for lack of consent from relatives:

Refusal rates by patient demographics:

Patient age group does not influence

Patient sex does not influence

Patient ethnicity significantly influences = White 35% non-white 69%

Potential for NHB donation results:

Consent for NHB donation:

Reasons for lack of consent to NHB donation:

Non Heart Beating refusal rates by patient demographics:

Patient age group – insignificant

Patient sex - insignificant

Summary:

Many patients are not tested by the brain stem death criteria.

There is no record that relatives are approached for 15% of potential heart beating donors.

There are not enough non-heart beating donor programmes.

The relative refusal rate is high.

Brain stem death – patient on ventilator: Brain stem accepted as death of patient. All organs that can be transplanted can be removed from brain stem dead patients.

Cardiac death: organs removed from NHBD can survive for a relatively limited time – 45 minutes maximum. Most surgeons would want to remove in less than this time.

Livers from NHBD: Results not quite as good as with an ideal liver transplant but good enough. This is now established in all the liver transplants units in UK. 5 lung transplants from NHBD – 4 successful.

Possible shortage of donor organs: There is also a failure to convert possible donors to actual donors.

Potential to try to identify which of this possibilities is related.

Evan Harris. 5072 (brain stem death possible diagnosis) may be too high because it cannot be guaranteed that all patients had brain stem death test performed as in 514 cases relatives had not been approached.

Chris Rudge. We know when patients who meet BST criteria that relatives refusal rate is higher than western European countries where the rate is 20-30%. In the UK it is 40% to 46%.

Data collected by donor transplant coordinators. This data was collected pre-donation from outside ICU. It is about as valid as it can be.

3. Questions

John Feehally. What proportion of units do not have NHBD programmes in place?

Chris Rudge: 2 kidney transplant units do not have NHBD programmes.

The percentage of ICU beds – only 60-70 ICUs have NHBD programmes, out of over 300 ICUs in the UK. It is not known what percentage of UK ICU beds are in this limited number of ICUs..

The problem is that the referral team is tied up whilst waiting for people to die following withdrawal of treatment. Organ donation ceases to be possible after 2-3 hours. Someone has to be there and an operating theatre available.

Peter Friend. Logistically, NHBD has to be right in the middle of National organ planning and should be part of the national service.

John Forsythe. The nub of the problem seems to be the refusal rate. Donor rates vary significantly around Europe but do we know how much the refusal rate various around Europe, in particular Spain?

Chris Rudge. Relative refusal in Spain has been 20-25% over last 15 years. the most recent 24%. Australia - 50%. USA was about 45%. Europe better. Comparable data in the UK from 1990-2 showed relative refusal rate was 30%.

Evan Harris. Any proposal to do a like for like study in Europe?

Chris Rudge. A number of projects under way at the moment including Member Council of Europe studies and Eurodonor project. There are a lot of discussions going on to look at comparable data.

Simon Bramhall. How does the organ donation rate in UK compare to USA? Is there any evidence that the ICU problem is any different to USA.

Chris Rudge. UK Organ donation rate is one of the lowest in European developed countries. ICU problem – difficult to find comparisons per head of population. There are 3 times more ICU beds pro rata in Spain than UK. Does not know about intensive care clinicians in other countries.

Bramhall. There is very little difference. He was asked to provide evidence so we can ask DOH.

Chas Newstead. In Portsmouth they only have a 20% relative refusal rate. Do we know how they are so successful?

Chris Rudge. No we do not know the secret to what they are doing differently. Although we have looked in detail.

Donal O’Donoghue. Is there a national comparison on refusal rates by ethnicity?

Chris Rudge. There is no data separately on refusal rates in different parts of the country by ethnicity. No international data on refusal rates on ethnicity

Maurice Slapak. Do you have any comparative data on relative refusal with a transplant co-ordinators to ICU

Chris Rudge. Not known by individuals. It is known that the relative refusal rate is lower when an organ donor coordinator is in discussion with the family but organ donor coordinators are often only called in when the family has already agreed.

Jayne Fisher, Transplant Coordinator, Leeds. Donor coordinators are not being called into a unit. A lot of members report this is a problem and there should be some way of involving them before the family is approached for donation. This should be more of a planned request in accordance with family needs. Some families are not making a fully informed consent because they do not have all information available.

Roger Greenwood. It will be interesting to explore ethnicity further because renal failure is so common in the ethnic population. There should be sub analysis of reasons given why they refuse within ethnic groups. Suggest revising the form to try to work out more answers.

Evan Harris. Asked who UKT were consulting.

Chris Rudge. Donor advisory group, intensive care clinicians and nurses and donor coordinators giving advice.

Sue Falvey. Researchers have tried to interview families who refused consent for donation in more depth but few families volunteer themselves. In the most recent study, which has just been published, researchers at Southampton University only had 26 families who volunteered to be interviewed. Disappointingly of those 26 almost a quarter said that they refused donation despite knowing that it was their relatives wish to be a donor and that they themselves had previously supported this decision. The decision not to donate was not one, they said, they later regretted. Clearly something happened at the point of death to change their mind.

Veronica English. Suggested plans should be modified. Was it known whether they were brain stem dead and whether they were tested. It is the relatives decision as to whether donation goes ahead.

Chris Rudge. We are modifying the questionnaire to identify where the gaps are and to find out more about why these relatives refuse and to take account of HTA. We wanted to keep this open ended because it is advantageous and because the numbers are as big as they are but we have to continue to audit. This is important.

Evan Harris. Are you consulting outside UK Transplant on any changes to design of form?

Chris Rudge. We have no plans to consult outside. We consult transplant units and in house.

Phil Dyer. Donor audit can influence the outcome. It looks like no significant change over time. Some units have done well and some not so. Can audit be split to show whether some are doing better than others.

Chris Rudge. We have no evidence either way. It is something we can look at.

Ethnicity

Evan Harris. There is a differential and cross matching issues.

Maurice Slapak. What about the island affect? The affect of an homogenous population stimulus of knowing everyone, such as Cyprus, Sardinia, Canary Islands. Organ donation is way over the rate of other countries. In USA where there is an ethnic situation in various parts they have appointed ethnic coordinators.

Prof Feehally. In Leicester in the 1980’s consent from ethnic minority families for cadaveric organ donation was close to 0%. Therefore the current national figures, although showing lower consent rates in ethnic minorities, may actually represent an improvement on the past. In the past we did a lot of work within our ethnic minority communities trying to provide information and reassurance, especially about perceived religious objections to donation

Evan Harris. On living donation there is no ethnic differential. There is no fundamental reason.

Sue Falvey. One donor co-ordinator team working in an area with a large non-white population are planning a pilot study to see whether or not there is an effect on refusal rates if the request for donation is made by someone from the same ethnic group as the family. People from various ethnic groups will be trained to discuss donation with the families of potential donors.

Anthony Warrens. They have looked at attitudes to ethnic donation within all the major religions. Some have objection to organ donation but we found there was an education issue. We need to gain the confidence of people we are trying to survey. Publications such as the American Journal of Transplantation all attribute objection to organ donation by Afro-Caribbeans to suspicion of white middle class doctors.

Rob Higgins. Thinks media makes a big difference such as the TV advertising campaign that featured a donor family of black ethnicity. Is it appropriate to target the different ethnic groups and how successful is it.

Evan Harris. Do people who are making the approach on donation match the ethnicity of the population they serve.

S Falvey. It is also important to understand culture and we have recently done some work in this area and will be publishing a booklet for donor transplant co-ordinators.

Simon Ball. Many West Birmingham GPs are Asian and are around 50-60 years of age. They are now experiencing renal failure themselves so taking more interest in transplantation and organ donation and are a good group to tap into because they are expressing a desire to get involved.

Chris Rudge. Targeted advertising. Two campaigns were established on South Asian and black Afro Caribbean two and a half years ago. Unable to answer how successful they were as they and can only measure by how many have put names on organ donor register. There has been an increase in Afro-Caribbeans, but not dramatic.

Evan Harris. Is there a differential recruitment on ethnic minorities.

Chris Rudge. ODR does not record ratio of ethnicity.

S Falvey. Some people from minority ethnic groups question why there has to be different literature for them, in fact some even say they find it somewhat offensive.

Evan Harris. When ODR is checked before approaching families. 3 years ago we were told that some coordinators did not think it was appropriate to check ODR before approaching families. Is this being done and is there an ethnic minority breakdown? Is this being captured?

Chris Rudge. Yes. There have been 937 checks to the register in the last 3 months. This is going up. We do not record ethnicity.

Evan Harris. Donation rate staying constant but transplant rates going up. Is there less enthusiasm for the ODR.

Chris Rudge. Is there less enthusiasm for the ODR. The ODR is a vehicle for publicity about organ donation. What is more important is that they have talked to their family about it.

It will become a more important vehicle after 1 September.

Not certain that it is checked on every occasion but is becoming more routine practice for donor transplant coordinators.

Jayne Fisher. All families should be approached whether the person is on the ODR or not. One would hope there will be some improvement after 1 September.

Chris Rudge. After 1 September, relatives will NOT be able to veto the donor’s wish to donate so these cases should be eliminated except where feelings are so high.

Donal O’Donoghue. Can people record if they do not want to be donors on the ODR and if not is this worth considering?

Chris Rudge. No. You could make registration mandatory on all criteria but running it would be dependent on resources.

Adrian McNeil. Up to now it has been common practice that there is a lack of objection forms completed but when an approach is made to a family after 1 September the culture will have changed. There will be a change of attitude. We think we need to find ways of training that is different between what is now and then.

Sue Falvey. It is not quite as black and white to say that if the deceased is on the ODR there is no need to get consent for donation from the family. There are several things that we do need to obtain consent for, for instance the storage of tissue typing samples; virology screening, because the family have to agree to be notified of any results that may have a health implication for them. We also have to complete an extensive health assessment of the donor to ensure that it is safe for them to donate and for this we need cooperation from the family.

It is also important to be aware that for many intensive care unit staff the most important thing is that the family make the right decision for them as a family and they tell the family that they want the family to leave the ICU having made the decision that they are most comfortable with, whatever that decision may be.

Judith Dear, NKF. When people are approached to put their name on the register most will now do so but there does not seem to be a campaign to get everyone to put their name on the ODR in the way of putting ODR forms in voting papers. Wondered if there could be an initiative to encourage councils to send forms to everyone to encourage them to put name on ODR.

Chris Rudge. This was done and was very successful but was deemed to be illegal so was stopped. We have a department which looks at better ways to get people to sign up.

Judith Dear. What about Council tax forms?

Evan Harris. Ministers recognise that things are getting better.

John Forsythe. Relative refusal ratio. If we get a change to the way it was a number of years ago we would have a major impact on waiting lists. We have not looked at why the refusal rate is changed. There needs to be more done about it.

We need to do something high profile such as a major TV campaign which includes celebrity status including from ethnic minority groups.

Evan Harris. Should a different approach be tried such as presumed consent.

John Forsythe. Thinks there has been a loss of trust. We should influence this by major TV campaign.

Evan Harris. Why does transplant not get the same coverage as blood?

Keith Rigg. We need to work with the Intensive Care community on training and education.

Bramhall. There was approximately 460 refusals each year. If we achieve 25% improvement this would be 12-14 pmp.

800 patients per year which do not have Brain stem test and who are not referred. This is the biggest group of patients which are being ignored. It is ITU clinicians fault that these people are not appproached. The test should be done and the family should then be given the right to consider organ donation.

S Falvey. National Guidelines do recommend that if a patient is thought to be brain stem dead then their death should be confirmed by brain stem testing but in reality brain stem testing is often only done if the patient is going to be an organ donor. It is much easier, for a variety of reasons, to withdraw treatment on patients.

Guidance is clear that individuals should be certified dead by the appropriate means for them and therefore if they are brain stem dead they should be certified dead by brain stem testing regardless of what is going to happen to them after death.

Simon Bramhall. In USA this is done through legislation requiring the test and required request. This has changed the donor rate from 8 – 20 pmp. In USA hospitals are penalised if someone is found not to have referred. They have a financial incentive for requesting.

R Greenwood. PBR is interceding and if there is a certain tariff would it not be possible to have PBR for organ donation?

Friend. If Required Request was not done with the complete approval of ITU it could be sabotaged. What we should be working towards is a change of culture that it is normal to donate. If it requires legislation for a culture change then so be it.

M Slapak. How do you influence public opinion? Logistics improved and a public relations drive around the regions.

RESOURCES

Bramhall. Heart beating would have enough resources. Separate from NHBD. We have been talking about change of culture over 10 years but a change may mean a move towards legislation.

514 confirmed brain stem dead and not considered for organ donation is terrible.

Evan Harris. Does anyone know of an organ not used because of lack of space.

Chris Rudge. There are cases where an organ is not used in one place because of shortages but is then used elsewhere. Virtually no organs are “wasted” for lack of resources nationally.

Evan Harris. Are there any constraints?

J Forsythe. Does not know of any major instance of this type where an organ is not used at all. It may not be used on a particular site. The beauty of transplantation is that it is cost effective compared with dialysis so find it easier to gain resource than colleagues in other areas. Majority of constrains to organ donation is lack of donors.

Evan Harris. Do we have capacity to respond if there was an increase in donors?

J Forsythe. If it happened over night then I think the service would struggle. If it was a gradual increase then I think units would adapt, particularly kidney transplant units. It would be more difficult for liver and pancreas to adapt if time is short, but we need to put efforts into improving the donor rate.

Andrea Harman. There are lots of things behind the scenes which do not get built into funding. If numbers increase we would not sufficient resources to do the tests to support transplants.

P Friend. Resource would be likely to follow the workload. NHS is carrying the capacity to expand and could respond over a number of months.

Simon Ball. The main issues are if renal patients on the transplant waiting list could get cardiac work done. Some patients are waiting 6 – 10 months before listed and there is no reason why this should be the case. Outcomes would be better the sooner you get people transplanted.

You need to get a live donor rapidly worked up. This is where resources should be a priority.

Evan Harris. Kidney transplant waiting is 5722 names. Why are there so many people in ESRF and dialysis and aren’t on the list. Is this because there is no incentive to put them on the list or because of resource limitations in doing the work up?

J Feehally. There is a significant resource shortfall, especially for cardiovascular investigations, when trying to get people worked up and get them on the list. It is frustrating for nephrologists not be able to get people on the list, especially when we know the advantages of early transplant, ideally pre-emptively before dialysis is needed

J Forsythe. There is definitely inequality of access. We wanted to try to compare units in terms of cardiac waiting problems and whether these could be ironed out. Have not done this because of lack of resource. There is inequity of access to the list.

Bramhall. If the number of organ donors could be doubled it would release a large resource to NHS. It is expensive to die and many patients have in-hospital time.

R Greenwood. Are there enough trainees coming through to this speciality?

Chris Rudge. Statistics from UK Activity report for calendar year 2005:

• 293 who were on kidney transplant waiting list died on the list.
• -412 patients removed from list because they have become too unhealthy for a transplant.

Susan Martin. A resource issue in relation to patients on list. Nobody thinks of healthcare scientists. Patients have to be regularly monitored so increasing pressure on laboratories and this is forgotten but it is important to remember that this is important if you increase the number of donors.

J Forsythe. Crisis in recruitment of transplant surgeons - Radio 4. There were a number of measures introduced. Transplant surgeons being involved in transplant and research fellowships to enhance careers of transplant surgeons so junior trainees club is quite healthy and there are a number of trainees wishing to do transplant surgery but it requires attention. There are changes to training and it requires transplant surgeons to be involved at the highest level. It is very much better but needs attention for the future.

Most would want multi organ rather than renal transplant alone. Trainees looking at manpower planning what is the need and does it match the numbers in the club.

Evan Harris. Vacancies in line with CCITs rather than in vacancies for consultants post.

Friend. We have to create jobs which are attractive to fill such as hybrid jobs.

Judy Dear. Are there differences as to whether you belong to a big transplant hospital or a smaller centre. She waited 5 years for her transplant but when switched hospitals received one immediately.

Evan Harris. Overall figures do not show this.

Keith Rigg. The national Workforce Review Team had undertaken to look at workforce planning for transplant surgeons within the current year’s work programme.

Rob Higgins. 8 or 9 years ago Morris report had structure by transplant units and suggested a reduction and that did not happen. There is a situation where we are not sure what the optimal number of transplant units are in the country and this leads to instability and a lot of trainees in transplant surgery want to do multi-disciplinary surgery.

L Burnapp. Transplantation is profitable and a proper infrastructure would free up other areas on the way creating donors. We have to remember what goes along with caring for patients both in and out of hospital and it should be remembered resource should be available to all groups including nursing groups.

Evan Harris. Equity. Can you say how the new scheme is progressing?

Chris Rudge. There has been inequity of access to transplant. The new scheme was introduced on 3 April 2006. General principles are that all patients are equal and should have an equal chance of getting a transplant. It will take a number of years to achieve that. It is working it is making changes is to identify the number of patients waiting a long time on the list and have not been transplanted and many patients who have waiting a long lime have now been transplanted.

Allocation System

CR It is having some immediate beneficial changes to some patients but it will take several years before we see real effect of the system but generally feel content.

NHBD/Cadaveric

Evan Harris. What is the potential capacity of NHBD? What are constraints on this? Why can not more be done? What is the realistic limit?

C Rudge. What percentage of ITU beds are on 13 schemes funded. Majority of NHBD came from 35-40 ITU units.

Evan Harris. What percentage of ITU beds are covered by a scheme. Is it 10%, 30%.

Chris Rudge Units vary in size. Will provide figures at a later date.

Friend. Can speak on experts. 3,000,000 around Oxford. Not quite half cadaveric kidney transplant operations out of about half of ICUs in region. 3 or 4 ICUs.

NHBD has got to capacity and double potential over cadaveric. Implication was that ICUs not geared up.

There are constraints and it is important nationally that we operate a scheme for every unit in the country. We have to work on a national organ retrieval service.

Evan Harris. In some areas they have the surgeons but they cannot retrieve a kidney because they do not have the expertise.

Friend. Most surgeons will feel unwilling to operate on an infrequent basis.

Evan Harris. If organ donation increased they would be doing quite a few. Average on call is 1 in 6, 1 in 8 1 in 10 but they would not want to do on call more frequently.

Friend. We do not have constraints in practice where we have not had 2 NHBD at the same time but if all units got busy it could happen and we would have to have the ability to run two teams or have agreement with a neighbour to cross cover.

J Forsythe. Constraints on retrieval is based mostly on liver transplant centres. HBD the potential is that there is a liver, pancreas, kidney next day and retrieval takes place in the hours around midnight. With the change in junior training there is less and less involvement with juniors in retrieval and on top of that to build up a NHBD programme it is important it is done properly. This requires planning for an organ retrieval team for the whole of the UK.

P Friend. We have a workable system for HB donors but it is not a perfect service for NHBD and this requires a more active response time.

It requires national planning to divide the country to areas of responsibility and back up arrangements and draw up contracts for HB and NHBD.

C Rudge. There are signs of movement in the last 2 to 4 weeks. NHBD is around kidneys is local. At a recent meeting it was felt that NHBD should be considered as multi organ donors because all liver centres have carried out NHBD transplants. NHBD liver is not as good as HB liver but good enough. If NHBD are going to be multi organ donors and done through liver units you have the beginnings of national framework if all units are properly funded.

Bramhall. Been running retrieval on HB donors. NHB incurred between 3 to 16 medical staff, and 4 – 8 coordinators.

Andrew Bradley. Only half of NHBD will be liver. There will be more kidney donors so how do you manage ones who are going to be multi organ donors.

Evan Harris. Who should be doing what? That is the problem.

P Friend. It is not easy. It is a case of hospital there are major geographical gaps in the country. There should be a much more open view as to what an organ retrieval service should look like. We should look at response times etc and then progress.

EH. Who would take the lead on taking up options.

Friend. Either DOH or UKT.

K Rigg. Chairs the UK Transplant Organ Retrieval Working Group, but with other commitments this had not progressed as quickly as anticipated. Aspects of donation had moved on since the group was set up. When they started with work on NHBD not as common Further work is needed to develop a strategy and funding will be needed to aupport a national retrieval programme. Retrieval teams needs to be self-sufficient but they do need to be adequately resourced.

J Forsythe. Should not be decided at this meeting. Thinks the Organ Retrieval Working Group needs to be enlivened to take this on. Needs multi-disciplinary input and all involved. It is requiring planning for HBD and NHBD and input from BTS and efforts on multi disciplinary team on retrieval.

Friend service should be reimbursed for organ retrieval.

Newstead. It is possible in a big centre to go to PCT and commissioners and successfully seek funding. The managerial time commitment should not be underestimated.

What is the scale on NHB and how far – they do 25 - 30 NHB last year but they think they could do double this.

Evan Harris

Sum Up.

1. Is the interest of the donor would not wanted pick up because I do not live in a large catchment area.
2. Would want to see a nationally organised scheme/s.
3. If there is potential thinks we should be moving as fast as possible to maximise. This is an urgent issue.
4. Lobbying by APPKG to ministers to make sure a time scale is agreed.

TS Thinks needs a multi disciplinary team to cope with larger numbers background team would not cope.

Evan Harris. APPKG had Baroness Hayman to speak to it on codes of practice and contribution was well received. There may well be a number of issues in respect of live donation.

Adrian MacNeill. Codes of practice on website in draft form. Statistics very recently been improved from the one on website approved by Dept of Health ministers and before parliament for approval. And will be published around beginning of July.

Code 2 on solid organs. Code 6 approved by ministers

Code on donation of solid organs. A lot has been said about changes but we started a new system of living donation on 1 September. That system under ULTRA will still continue to 31 August and take on any appeals for 6 months after.

Very shortly new codes will be worked up but cannot be approved to 1 September. We have written to directors of transplant units outlining the new system. There has been one significant change on system of approval on which it has been decided that the HTA executive would approve local donations. This has changed because ministers decided that legislation required the Human Tissue Authority to be satisfied that the requirements of the Human Tissue Act had been met before donation should proceed.

Recommendations on donation have to go from HTA.

New systems of approval are paired and pooled donation from live donors and non altruistic donors and in these situations independent assessors would assess and make recommendations for final consideration by HTA.

I do not have an idea how many additional donations there will be from altruistic donors but hopeful that we well get 50 or so a year from paired and pooled donations.

Magdi Shehata. Why was time wasted going to ministers and then back to HTA. We now have to put application for approval for related living donors as well as unrelated donors. This is extra work.

Evan Harris. There could be as much coercion with related as unrelated so it is not legal to split. There was no parliamentary opposition.

A McNeil. Accepts this is regulation where there was no regulation before but they want to apply as light a touch as possible but HTA must be satisfied that there has been no coercion. HTA will turn round cases in 5 working days.

HTA needs the assessors to take all the hard work out of it. We are hoping to produce a pro-forma which independent assessors could use to help speed up approvals process.

John Forsythe. Transplant community are supportive of new legislation especially on living donation but there is significant disquiet about this new change. No question with unrelated. At present a father gives to his son and if local officials are happy it goes ahead. With new legislation there will be an extra level of scrutiny to check this off which will make it heavily bureaucratic.

Very good legislation might be tainted, delay may cause problems for what may be 700 transplants. There is a significant disquiet with this most recent change .

Newstead. Does this mean that these regulators take a responsibility for transplant. Unreasonable to regulate without accepting some of the accountability.

Evan Harris. Guidelines about relatives felt this might be an issue.

Lisa Burnapp. In an area when donation is evolving living donor transplants may increase. It would be difficult to predict what activity might be. At present we can now drop in another pair if one falls out but this would be a challenge with the new system. This new constraint may need to be monitored to ensure they do not have an impact.

Andrew Bradley. ULTRA had low staffing levels and he hope this level of staffing will not appertain to HTA.

Evan Harris. There will be a one and a half hour debate on all codes in June and there is very rarely vetoes on things like this and there will be a debate in Lords also.

Hugh Whittal. Codes of practice laid before parliament will not be statutory instrument but will follow similar procedures. If voted against there will be a debate and if vetoed they would fail. They cannot then be sent for amendment.

Shehata.. Living donation - 60% at some of transplant units. One of the major problems is that it is not financed properly.

Living donor should be taken back before assessor and have national recognition for units who do living donor programmes and should have money given directly from DOH.

Living Donor programmes. ABO compatible and desensitisation would increase living donor transplants by 10 – 15%. It will be expensive but we need someone to do this. We need PCTs to count 10 years ahead on how much money it will save them on living donation.

Rob Higgins. Purchasers in West Midlands have supported antibody incompatible transplantation but this is the only development in any renal services they are contemplating funding. All PCTs have paid for patients from other parts of the country to come for desensitisation (antibody incompatible transplantation.

Simon Ball. 2 to 3 years waiting for ABO transplantation. Only recently assessments finalised. They say there is no gain to be had because one patient just replaces another.

Shehata. How do we get into the heads of PCTs that they should count long term saving.

Friend. Does purchasing have to be centralised or could there be guidelines to purchasers on how it should be done?

C Rudge. Department initiated a review of Commissioners of specialised services. Carter report now written and comes back to Lord Warner by Summer. The responsible bodies on specialised services should be the commissioner.

It will set out a framework on how it should be done.

Renal services do not fall into Payment by Results but living donation will fall in to PBR and live donor follow up and once this falls in this system this will give the potential for main transplant units to get the funding.

Lisa Burnapp. Money should also be put into nurses contract. It is equally important that we recognise the contribution of these nurses are making to transplant units.

Rob Higgins. Living donor coordinator must also be funded, currently one trust in the West Midlands has UKT funding and has doubled the transplant rate, but will probably lose the post when central funding comes to an end, as a dialysis only centre their management do not see a priority in transplantation occurring elsewhere.

Newstead. There is a precedent for local PCTs providing additional case by case funding in the example of reimbursement out of pocket expenses for live donors and this could be used as a model for antibody testing and desensitisation protocols.

R Greenwood. Warner report is in keeping with what the Kidney Alliance wanted. Believes this are going to get easier in the New Year.

Living Donation

Evan Harris. Is there a lot more to come from living donation? Is there a sustained increase in living donation or has it plateaued?

C Rudge. Living kidney donation transplant numbers have increased year on year for the last 5 years. Last year 599 about an 8-9% increase.

Feehally. Some units, such as his own, now have living donor transplants up to 50% of the total transplants done per year. But there is still much variation with a number of units considerably less than this, suggesting there is room for growth.

Shehata. We need to discourage people from buying organs from India and Pakistan because they come back with all sorts of diseases.

UKT Does not have reliable data on transplants done overseas. It is an offence to pay for living donation. If it is being organised in UK they are breaking the law.

Lisa Burnapp. Some units are finding difficulty in trying to get overseas living donors into the UK due to immigration laws which do not allow reimbursement of expenses. It would be good if in some way this could be addressed (immigration codes fore reimbursement. Lisa Burnapp to provide information to TS)

Rob Higgins. Medical outcomes from illegally purchased kidneys are not good.

Living donor transplant rate will plateau at close to 1000 per year if all units transplant at the rate of the most successful.

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Summary/Manifesto

What we are seeking to do is:

1. Extract a wish list where there is broad agreement where something has to happen. Or where there is good evidence that something is not being done right and could be.
2. What we can say to Ministers. Eg after 5 years where we want to be and do we have to have a fundamental if things have not improved.
3. list of things that could be done. Pressure on guidelines for purchasers.
4. Parliamentary Questions or letters to Minister. Responsible minister come to APPKG and to be questions to her. Everyone will be invited to the meeting.
5. Action points attached. Send by email. We will ask questions about these. We will write to minister about this. We will seek data about this from Chris Rudge. What other questions are to be asked.

Thanked TS and colleagues for setting up meeting. Thanked everyone for coming

We could rearrange in a years time to see how things are improving.

There being no further business the meeting closed at 4.55pm.

“Bullet point” comments made from the floor during the Transplant Summit held on 25th May 2006 in Portcullis House - Palace of Westminster

• Only 2 transplant units don’t have non-heart beating programme.
• Logistics – NHBD must be at the heart of national planning
• Variation in refusal rates around Europe – Spain, Europe 20% range; America similar to UK
• Number of European Studies
• How do organ donation rates compare
• 3 times ICU beds pro rata in Spain compared to UK
• Portsmouth high success rate in low relative refusal
• Ethnic Refusal Rate – Is it geographical?
• Data on transplant co-ordinators per ICU
• Transplant Co-ordinators to be involved before relatives are approached.
• Sub-analysis of reasons for ethnic refusal
• Two studies Southampton
• Data forms being amended and design of audit
• Design of audit is UKT
• Island Affect
• Living Donation – Ethnic no difference
• Major religions – some cultures do have an issue with donation or there is confusion (article in Journal of Public Health)
• Media – should publicity be targeting ethnic groups
• West Midlands Group – tap into ethnic GPs
• ODR does not register ethnicity
• Is the ODR always consulted before approaching relatives – answer not always
• An analysis of ethnic responses is needed
• 23% of population registered on ODR
• Registration after September 1^st. The ODR becomes more important after this date. Relatives will not be able to veto the donor’s wishes
• Mandatory register currently not sought
• 1^st September should result in a change of culture, by those who approach relative
• All coordinators being trained about the HTA over the next 3 months
• Is the high relative refusal rate due to a lack of trust
• Major TV campaign to raise awareness
• Intensive care clinicians are responsible for missing the largest group of potential cadaveric donors
• Require requests
• Could PPR be introduced for donation and transplantation
• The UK needs a culture change towards donation
• PR drive around regions

RESOURCES

• Would transplantation be able to cope with a large increase in donors
• Laboratory constraints
• Renal Units want dialysis patients to get on to the transplant list. It is a resource issue
• Unfairness in the way patient gets to the list
• Resources would be released if organ donation could be doubled
• In 2003 - 293 patients died whilst on the list
• 412 permanently removed due to becoming too ill
• Shortage of transplant surgeons – was known three years ago
• Situation has improved but it needs to continue
• Transplant needs are being monitored
• A need to show transplant jobs are sustainable
• Transplant units are uncertain as to their future viability
• Resource needs to be available across all groups to do with transplantation
• New allocation scheme should improve equity of access

ALLOCATION

• New scheme has shown some immediate results – but it will be several years before full results are seen
• NHBD - 35 to 40 ICU units throughout UK where they come from

POTENTIAL & CONSTRAINTS

• Provide a scheme all units can work to
• Need of a national organ retrieval scheme
• Local retrieval not realistic
• No present constraint but it is envisaged – two transplant teams to operate
• Retrieval currently based on liver units
• Divide country up into sections of responsibility and provide teams for retrieval
• Multi organ NHBD programme run through liver units
• Point above disputed
• Self sufficient team – multi disciplinary
• DoH should lead
• Nationally organised scheme for donor
• NHBD programme urgent issue

LIVE DONATION

• Living donation 1^st September new system
• Paired, Pooled and Non=directed altruistic
• System contains additional bureaucracy and approvals
• HTA - 5 day turnaround on decisions
• Disquiet at the need for HTA to consider each of these living donations. The legislation is unnecessarily cumbersome.
• HTA needs to be sufficiently resourced
• De-sensitisation programmes could increase live donation by 20-30%
• The cost of transplantation is advantageous compared with ten years of dialysis
• Living donor to fall into payment by results
• There may be an argument for guidelines for commissioners
• Warner report encouraging
• Living donation has not reached a plateau
• Potential donors from abroad are discouraged by immigration considerations from coming to Britain

MANIFESTO

• Extract wish list
• Good evidence something is not being done right and put it right
• List of things to be done
• Parliamentary questions

Further News (as at 21st August 2006)

The NKF has been told today (21st August 2006) that following the Transplant Summit (and ahead of the impending All Party Parliamentary Kidney Group Transplant manifesto ). Rosie Winterton MP (Health Minister) and Sir Liam Donaldson are setting up a review of Transplantation with an identical agenda to the original NKF inspired summit. The NKF will have representation on it. Work begins shortly.

A Transplant Manifesto, More Transplants - Saving more lives, Report (14 October 2006)

... has now been launched and is available on this website by clicking here ( , 22 pages, 160 Kb)