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Transplantation FAQs

Frequently asked questions about transplantation.

General

When will the HTA regulate transplants and what are the handover arrangements with ULTRA?

The HTA will approve all living donor transplants from both related and unrelated donors from 1 September 2006. The Unrelated Live Transplant Regulatory Authority (ULTRA) will take applications for unrelated living transplants up until 31 August 2006 and will continue in existence for a longer period to deal with all applications received by them up until this point and any appeals made.

When will the The Human Organ Transplants Act (HOT Act) be repealed and does its repeal extend to Scotland?

The HOT Act 1989 and the Human Organ Transplants (Northern Ireland) Order 1989 (HOT NI Order) will be repealed and revoked, respectively, in England, Wales and Northern Ireland on 31 August 2006. There will be transitional arrangements to allow part of that Act and Order to continue for a period of 6 months after 1 September 2006.  This is to allow for applications made before 1 September 2006 to be dealt with and any appeals heard and determined.

The part of the HOT Act pertaining to section 32 of the HT Act (prohibiting commercial dealings), was repealed, and the equivalent part of the HOT NI Order, revoked from 20 September 2005.  The HOT Act will continue to apply to Scotland and the prohibition on commercial dealings has been made an offence in Scotland.

Role of the HTA

A recent paper shows there has been considerable success with paired donation in the US. How does it work and what is the role of the HTA?

Paired donation will be permitted once the relevant part of the HT Act is implemented on 1 September
2006. The term 'paired donation' relates to circumstances where a close relation, friend or partner is fit and able to donate an organ or part organ but is not biologically compatible with the potential recipient. That couple can be matched to another couple in a similar situation, so that both people in need of a transplant receive a matched organ or part organ. Pooled donation is where more than two pairs of donors and recipients are involved in the swap.

The HTA’s Code of Practice on Donation of organs, tissue and cells for transplantation gives more information on the procedures involved. The HTA will regulate this type of donation, but UKT will be responsible for establishing a national allocation system to facilitate this.

There is already a shortage of organs for donation – how will the HTA improve the situation?

A panel consisting of HTA members will approve paired / pooled transplants following assessment by an Independent Assessor (IA). We are working with UKT to ensure that systems, approvals processes, advice and training are in place for these and other forms of live transplants, to effect a smooth transition from the old to the new system.

What will be the role of Independent Assessor?

The IA are trained professionals who are usually, but not exclusively, based in hospitals with transplant units. Under the HT Act, IAs will provide assessment of all living solid organ donor-recipient pairs and recommend approval by the HTA, subject to the requirements of the HT Act being met. 

How many Independent Assessors will there be?

The HTA has trained and accredited over 100 IAs. The number per transplant unit and referring renal units varies between one and seven, and depends on the size of the unit and the workload of individuals.

From September, the HTA will regulate living donations. Will it improve uptake of live liver or lung donations?

We are a one-step-back regulator so our role is not to actively promote transplants. Our aim is to put the systems in place that increase the confidence of professionals and the public. The HTA will endeavour to regulate living liver and lung donation in such a way that the clinical needs of the donor and recipient are not compromised.

Would the HTA approve non-heart-beating organ donation? (This applies to liver, kidney, lungs and pancreas.)

This is a form of deceased donation, where the potential donor has died following cardio-respiratory arrest without being ventilated. The HT Act permits the taking of minimal steps, in order to preserve the organ’s viability for donation before consent has been obtained from the deceased person’s nominated representative or a person in a qualifying relationship. The HTA is currently working with the Academy of Medical Royal Colleges who are producing further guidance on the diagnosis and certification of death.

Consent

Currently 41% of relatives do not give consent for donation. How will the HTA improve the situation?

If a deceased person has expressed their wishes for organ donation in life, for example through the Organ Donor Register or a valid will, the HT Act 2004 allows organ donation to go ahead. If there is no record of consent this can be obtained from a person nominated by the deceased or a person in a qualifying relationship.

We are a one-step-back regulator so our role is not to actively promote transplants. Our aim is to put the systems in place that increase the confidence of professionals and the public. We hope that by doing this there will be a beneficial effect on healthcare including transplants in the long-term.

Does the handing over of regulation to the HTA mean there will be pressure to change consent for organ donation from ‘opt in’ to ‘opt out’ or presumed consent?

The option of presumed consent was debated extensively during the passage of both the HT Bill and HT (Scotland) Bill through Parliament. It was decided that the opt-in system should remain.
We have no capacity to change the law in this area. The HT Act has been signed into law and we are here to implement it. That said, the HT Act does open the doors for increasing the overall levels of organ transplantation through the various measures introduced.

Is it true that no consent is required to preserve transplant organs from the deceased?

In circumstances where people die suddenly in an Emergency Department the HT Act allows minimum steps to be taken to preserve organs, pending contact being made with the deceased’s nominated representative or qualifying person and consent being obtained. These steps involve placing tubes in the blood vessels of the groin, and running perfusion fluid in, to preserve the kidneys and in some cases, the liver.

The HT Act permits this whilst waiting for the nominated representative or qualifying person to be contacted and make a decision – if they consent then the donation will go ahead, but if not the tubes will be removed and all preservation processes stopped.

Will donation by children and mentally incapacitated adults be permitted?

We think that in certain and uncommon circumstances it may be appropriate for solid organ (including part of an organ) donation to be permitted by children and mentally incapacitated adults. Following discussions with the Department of Health, these forms of donation will go through our independent assessment process and will be subject to approval by an HTA panel. Prior approval from a court of law is also required in the case of mentally incapacitated adults and is good practice in the case of solid organ donation by a child.

In addition, donation of bone marrow and peripheral blood stem cells from these categories of individuals will be permitted. These forms of donation will also go through an HTA assessment process and will be subject to HTA approval. Prior court approval is required in the case of mentally incapacitated adults and may be required in the case of some child donors.

Does the wording on the organ donor register constitute consent?

UKT are amending the NHS Organ Donor Register registration forms to reflect the changes in legislation to English, Scottish, Wales and Northern Ireland.

Financial inducement, compensation, advertising, commercial trading, and import and export

What safeguards will there be to ensure donations are truly altruistic and not done for cash?

The buying or selling of human material for transplantation is prohibited, subject to exceptions. The HT Act makes it an offence to give or receive a reward for the supply, or offer of human material for transplantation.

All living donors will need to be assessed by an HTA trained and accredited IA, who is required to specifically look for evidence of coercion, payment and reward. The HTA must also be satisfied that there is no evidence of payment/reward and that consent has been given before it can approve the transplant.

Can donors be paid in any way for donating an organ?

The subject of reimbursement is covered in our Code of Practice on donation, of organs, tissue and cells for transplantation.
 
The HT Act makes it legal for the donor to receive reimbursement of expenses, such as travel costs and loss of earnings that are reasonably attributable to and directly result from an organ donation.
 
All such payments must be made by a proper authority, e.g., an NHS Trust or foundation hospital, or, in the case of a private patient, the hospital. Details on the levels of reimbursement are available on the Department of Health website.

Donors must not be reimbursed directly by the recipient or by their family or friends. The HTA requires that checks are made to ensure that no other payment any kind is made and that the donor does not make a profit from the donation.

Reimbursement has been permitted under the current Act, and this does not change under the new HT Act 2004.

What about the illegal trade of organs?

It remains illegal under the HT Act. Penalties are up to three years imprisonment, a fine or both.

Is commercial dealing in organs allowed?

No. The Department of Health commenced section 32 of the HT Act from 20 October 2005. In effect this prohibits commercial dealing in all human material for transplants, subject to certain exceptions. Most importantly it makes trafficking in tissue and cells for transplantation an offence for the first time and liable for a fine, imprisonment or both.

Does the HT Act prevent the import / export of organs for transplants?

No.  Numbers are small but there is a regular exchange of organs between European countries that meet similar standards to ours. UKT will continue to facilitate this on the occasions that it occurs.
Recent reports have highlighted the targeting of kidney patients by international websites. According to reports, a small number in the UK have gone abroad this year to receive a kidney, for example.

Patients seeking this route may find it difficult to assure themselves both of the quality and safety of the transplant and whether appropriate consent had been given.