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01 April 1997

Dear Colleague

PAYMENTS FOR DONORS

In July last year the Authority announced its decision to phase out payments to donors. It was stressed at that time that the implementation of the policy still needed to be developed.

As you know, the Authority is concerned about the impact that a sudden withdrawal of payment may have on the supply of donors. That is why the Authority has set up a Working Group to consider the implications of its decision.

I am aware that the Authority's announcement has led to fears that the withdrawal of payments to donors is imminent. I am also aware that the Authority has been criticised for a lack of communication on this issue. These points were made at a meeting arranged by the Working Group last December to which representatives from a number of professional and patient organisations were invited.

As a result of these concerns, I should like to take this opportunity to emphasise that:

• no implementation will take place without clinics first being consulted, and
• sufficient time will be given to clinics to prepare for any changes.

As you know, while the Authority can not take an active role in recruiting donors, it does not want its actions to jeopardise the provision of DI in this country. I enclose a document which explains the background to the Authority's decision. This was prepared in direct response to requests from clinics that more explanation of the Authority's policy be given. I hope you find it helpful. If you have any responses or comments on any of these issues please contact Beatrice Heales at the Authority.

Yours faithfully

Mrs Ruth Deech
Chairman

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HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY
PAYMENTS TO GAMETE DONORS

Introduction

In its 1996 Annual Report the HFEA announced that, in due course, all payments to gamete donors, other than reasonable expenses, would be disallowed. The procedure by which this decision will be implemented, and the programme for implementation, remain to be determined. This paper sets out:

• the background to the Authority's decision;
• the Authority's current approach on implementing its decision; and,
• the need for further constructive debate on these issues.

Although the Authority has established that payments to gamete donors should be phased out, no decision has yet been reached about how, and over what period, the transition should take place. The Authority will take the time required to consider both these matters. In the meantime, there is no change to current practice.

Background

The HFEA was established by the 1990 Human Fertilisation and Embryology Act to regulate embryo research and all fertility treatments involving the creation of human embryos outside the body or donated gametes. It is answerable to Parliament. As a regulatory body, the Authority has a responsibility to promote good practice and establish guidelines that protect all those who are involved in these treatments. This means patients, donors, any children born or affected and clinics. In general, the regulation of this area of fertility treatment in the UK is acknowledged to be beneficial to all these parties and to society at large. When making policy decisions the Authority considers how best it can fulfil its full role and responsibilities.

One of the areas the Authority is required to regulate is payments to gamete donors by licensed clinics. Under the Act payments to donors may only be made if authorised by the Authority in Directions.

The Authority currently authorises some payments to gamete donors. This situation was established when the Authority began operating in August 1991. At that time the HFEA set a level of payment that reflected what was then current practice, namely a maximum of £15 per donation plus reasonable expenses. The Authority did not wish to encourage higher levels of payment, so any clinic paying less than £15 per donation on 31 July 1991 was not allowed to increase its payments to £15 and new clinics were not allowed to make any payments at all. This has continued until the present day.

The intention was always for the Authority to consider the whole issue in more depth at a later date. Therefore, the current situation was, from the outset, only an interim measure. This position was reinforced in the HFEA's 1993 Annual Report where the Authority announced that it intended in the longer term to phase out payments to donors.

The desirability of reaching a conclusion about payments to donors increased with the development and spread of new clinical practices such as egg donation and egg-sharing. Moreover, because payments were frozen at levels operating in 1991, allowable payments vary from £0 to £15 between clinics. This variation is confusing for donors. New sperm banks, which are not allowed to make any payment, might also see themselves at a disadvantage in the present situation. For these reasons a resolution of the Authority's policy was necessary.

The Authority began its consideration of the issue in earnest in 1993 when it commissioned two pieces of research: a survey of the clinics' views of semen donation and a survey into the motivations and attitudes of semen donors(1). In the second study male donors reported that both a wish to help others and the offer of payment influenced their decision to donate. Donors and non-donors were also asked about the personal and social aspects of donating sperm. For donors the most common concerns were that they would be contacted by offspring or that changes in the law would result in offspring being able to identify them. The second study also included a comparison with egg donors. The women surveyed were almost all motivated by a wish to help others rather than by payment. They were more concerned than their male counterparts about the possible existence of children they would never know. This research indicated that there were clear differences in the attitudes of sperm and egg donors, but did not distinguish whether these differences were related to gender, to the different historical and cultural contexts of each type of donation, or to a combination of both these factors.

Once the report of the survey of donors had been received, a working group of Authority Members was set up in 1994 to consider the practical, social and ethical issues related to the payment of sperm and egg donors. The working group reported its findings to the Authority in November 1994, and it was agreed that a conference on payment for donors should be held to allow wider consideration of the issues.

That conference took place on 1 June 1995 at St Anne's College, Oxford. About 80 delegates attended from a variety of backgrounds including, lawyers, scientists, fertility practitioners, sociologists and experts in bioethics.

Several significant points emerged including that:

? HFEA policy on payment should strive for equity and justice between all parties;
? supplies of donated gametes should not diminish;
? potential donors should not be subject to pressure or excessive inducement;
? compensation for inconvenience should be considered; and
? a tariff system should be considered.

Interest was expressed in further research into how unpaid donors might be recruited, and there was widespread support for a co-ordinated effort to raise public awareness of the value and need for egg and semen donation.

A significant point to emerge for the Authority from the discussions was that the public perception of donation is an important influence on both the number and type of donors. For the supply of donors to be maintained in the absence of payment a change in culture would be needed. Public attitudes evolve over time and this process might be helped by raising awareness of the need for, and value of, donation. The HFEA felt that an important role in changing the culture of donation should be played by clinics, professional and patient organisations, with support from the Authority.

After the Oxford conference the Authority considered in detail the views and opinions that had been expressed by delegates. The Members of the Authority looked at the pros and cons of the arguments presented in favour and against payment and made comparisons with other forms of donation (such as blood, tissue and organs), adoption, surrogacy and policies in other countries. Additional consideration was given to the role the Authority could have, if any, in recruiting unpaid donors. This process took nearly a year, and it was during this time that the HFEA's policy took shape.

Development of HFEA policy

As the HFE Act was drafted with a clear presumption of non-payment, the Authority felt that, if payments to gamete donors were to be authorised in the long-term, then it would have to provide reasons why payment was allowable. In considering this the Authority distinguished between two quite distinct issues: an issue of principle and an issue of practice. The issue of principle concerned whether payment ought to be given to donors in exchange for their gametes. The issue of practice concerned the practical consequences of paying donors. The Authority decided to resolve the issue of principle first as this would determine its objective, and then consider the issue of practice as this would determine how it might best reach its goal.

In considering whether donors should receive payment in principle, the HFEA took into account how payment might affect the values associated with a donation, for example, whether donated gametes should be perceived as a gift or a commodity and whether payment could affect this perception. The Authority also considered whether payment might be given for other aspects of the donation rather than for the gametes themselves, and whether payment for these different things could be clearly separated. In addition, the Authority was concerned about how the values attributed to donated gametes might affect the social context in which DI children were born.

In reaching its decision, two major principles emerged. These were that:

• fully informed consent, free from any inducement and pressure, was fundamental to gamete donation; and,
• the potential for human life inherent in a donation made with the specific intent of producing children should be respected.

The Members of the Authority were concerned that payments to sperm or egg donors could jeopardise these principles. Members concluded that it was possible for a donor to be financially induced. If this were the case, the inducement might compromise the ability of the donor to consider fully the implications of the donation. Of gravest concern was that a donor would regret their decision to donate later. Whilst Members of the Authority accepted that payment did not necessarily or inevitably mean that donors had been induced financially, they did agree that the risk of financial inducement was not acceptable. It therefore appeared to the Authority that, in order to promote best practice and protect the interests of donors involved, a system of non-payment was most desirable.

In the UK blood and organ donors do not receive payment, and payments for children who are being adopted are forbidden. In this context, the Authority felt that payments to gamete donors was contrary to the accepted ethos in this country. Further, the Authority agreed that gamete donation had more serious consequences than blood or organ donation as gamete donation may result in the creation of new life. Payment might generate the perception that any resulting children were commodities and that the donors themselves were being exploited.

This general conclusion is supported by the Nuffield Council on Bioethics in its report "Human Tissue: Ethical and Legal Issues"(2). This report, which included sperm, ova and embryos in its definition of tissue, recommended that the altruistic nature of donors should be encouraged rather than eroded. In reaching its conclusions on the commercial procurement of human tissue the report noted that securing genuine consent might be threatened if donors were receiving payment. The report also questioned whether there were other means of improving the supply of urgently needed tissues that would not threaten the "gift relationship".

The Authority also took into account the draft Convention on human rights and biomedicine which has since been formally adopted by the Committee of Ministers of the Council of Europe. The Convention states at Chapter VII "that the human body and its parts must not, as such, give rise to financial gain".

The Authority considered the payment of compensation to donors on the basis of the risks or discomfort undergone in making a donation. This included consideration of a tariff system which has been suggested elsewhere as a possible way forward(3). The Authority felt that the tariff system used for medical trials was not an appropriate model for a number of reasons. This included the fact that volunteers in medical trials were involved in advancing medical science in a general sense rather than in giving their genetic material for the treatment of others. The context in which payment was made therefore appeared to the Authority to be very different. In addition, a recommendation made by a Royal College of Physicians Working Group(4), that payments in clinical trials should not be associated with any level of risk, seemed to make payment for egg donation, where there were clear risks, unacceptable. Members also had difficulty in establishing a sound basis for calculating compensation for inconvenience that did not involve risk. The discomfort associated with a donation seemed even harder to quantify because of the range of individual responses. An additional problem that was identified with the payment of compensation was that the payment would be known about in advance of the donation. As a result, even if the payment were intended to compensate for inconvenience experienced it would be impossible in practice to introduce such a system that did not also have the potential to act as a financial inducement.

The Authority also considered the recipients of the donated gametes and the resulting children and the effect of payment upon them. The Authority acknowledged that the evidence that is available suggested that the majority of couples who receive DI treatment did not tell their children, or did not intend to tell their children, of their reproductive origins. Couples may deny the fact of their treatment because of the stigma of male subfertility and/or DI. However, it has also been suggested that paying donors may encourage patients and clinics to marginalise the role of the donor in DI treatment. The Members of the Authority felt that, if payment were to be abolished, this might be the first step towards greater public acceptance and awareness of sperm donation. This in turn might encourage recipients to be more open about their treatment.

In relation to the children who result from DI treatment, the 'gift' nature of a donation appeared to be even more important where the child has been told of their reproductive origins. Although the initial concerns about payment focused on the donors themselves, the Authority took a view that paying donors did not encourage couples to be open about their treatment and that this was an additional consideration that favoured the non-payment of donors.

The Authority was clear, however, that the donors should not lose financially by donating. It wished a system of expenses payments to be put in place which was financially neutral for the donor.

The Authority concluded that a donation should be a gift, freely and voluntarily given with informed consent, and therefore that payments to donors should be phased out. In addition donors were to be reimbursed only for verified, necessary and consequential expenses incurred directly as a result of making the donation. This conclusion seemed to take into account in the best way possible the various interests of donors, patients and children conceived through the use of donated gametes.

The Authority also considered the giving of benefits in kind in exchange for donation. Having reached the conclusion that there should be a move away from payment, the Authority compared benefits in kind with payment to see whether any clear distinctions could be made between the two. It was felt that benefits in kind would be seen as payment in a different form, and that therefore the same conclusion should be reached. This means that in future an arrangement, such as an egg-sharing scheme, where the couple receive treatment at a reduced charge in exchange for donating eggs, should also be phased out.

Implementation of the policy

The Authority announced its decision of principle in its 1996 Annual Report. A Chairman's statement was sent to all clinics at the same time to draw their attention to the issue.

The Authority also set up a Working Group to consider how its long-term policy objective should be implemented. In setting up the Working Group the Authority was aware that the means of implementation could affect the availability of services. Therefore the Working Group has been asked to advise the Authority on :

• the effects of withdrawing payments to donors and benefits in kind
• how any adverse effects could be countered 
• the role of the Authority
• timetable for the removal of payments to donors

The Working Group comprises, Martin Johnson (Chairman), Jane Denton, Liz Forgan, Brian Lieberman and Angela Mays. Preliminary consideration has been given to various issues, including:

• alternative methods of recruiting donors;
• the evidence in the published literature on the possible effects of disallowing payments;
• the relationship between payment and anonymous donation;
• donation programmes overseas;
• the factors that influence successful DI treatment;
• the expenses that may be paid; and
• the systems in place for donation of other body tissues.

In addition, a bibliography relating to donation has been compiled by the Working Group and represents the published evidence that has been considered by the Group to date.

In December 1996 the Working Group invited twelve(5) relevant organisations to a meeting at the Authority to discuss practical issues of implementation. That meeting provided an opportunity for those attending to raise issues of concern to them, and for the Working Group to hear a variety of views. Following that meeting each represented organisation was invited to submit a written report to the Working Group summarising:

i.  what that organisation might do to facilitate the implementation of the agreed policy that payments to donors cease, and;
ii. what the HFEA might do to facilitate the implementation of its agreed policy.

In making their submissions, the organisations were asked to bear in mind the statutory limitations on the HFEA's role. The Authority may provide advice and information to clinics, donors and recipients, but cannot become directly involved in promoting gamete donation as this would conflict with its regulatory role.

The Working Group expects to report to the Authority later this year. There will be further opportunities for consultation after the Authority has considered the Working Group's report.

Human Fertilisation &
Embryology Authority
April 1997

(1) Susan Golombok and Rachel Cook. A survey of semen donation: Phase I - the view of UK licensed centres. Hum. Reprod., 9, 882-888
Rachel Cook and Susan Golombok. A survey of semen donation: Phase II - the view of the donors, Hum. Reprod., 10,951-959.
(2) Nuffield Council on Bioethics. Human Tissue: Ethical and Legal Issues. April 1995.
(3) Donald Evans, Procuring gametes for research and therapy, Journal of Medical Ethics, 21, 261-264.
(4) Report of a Royal College of Physicians Working Group. Research on health volunteers, 1986.
(5) RCN, CHILD, BICA, RCOG, ACE, BAS, PROGAR, DI NETWORK, BFS, NEEDS, ISSUE, PROGRESS

Page last updated: 14 April 2009

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