Independent report

Review of existing gamete donation guidance and further recommendations

Published 16 November 2023

Executive summary

The current assisted conception regulations stipulate that gamete donors must be screened for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), among other microbiological agents. Those who test positive are deemed unsuitable to donate gametes as they carry risk of transmitting HIV, HBV or HCV to the recipient.

The established scientific evidence has changed since those regulatory stipulations were made. Most people living with HIV in the UK have an undetectable viral load in blood and so cannot transmit HIV sexually. HIV can only be transmitted if people have a detectable level of virus (defined in the relevant studies as more than 200 copies per ml (millilitre)).

This means that people living with HIV who are on effective treatment and have an undetectable viral load in blood are unable to transmit the virus through donation of their gametes. This removes any justification for excluding them from eligibility to be gamete donors. Maintaining this position can be construed as discrimination against this group and deprive them of the opportunity to use their gametes for reproduction.

Summary of the working group’s recommendations

The working group proposes the following recommendations (note that the recommendations only apply to known gamete donors and not anonymous gamete donations).

HIV

Working group recommendation: that the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) recommends to UK ministers of health that they consider amendments to the law to allow gamete donation to occur from individuals living with HIV and have undetectable levels of the virus, to known recipients. 

Additional recommendations were made to change UK legislation.

For donors with HBV

Working group recommendation: to allow gamete donation where the donor is HBV surface antigen negative and anti-HB core positive and has undetectable levels of plasma HBV DNA.

For donors with HCV

Working group recommendation: to indicate that HCV screening for gamete donors should incorporate both anti-HCV and HCV ribonucleic acid (RNA) testing. Only those potential gamete donors who are shown to be HCV RNA positive should be deferred from donation.

Screening requirements for female same-sex couples

Working group recommendation: to remove additional screening requirements for female same-sex couples in an intimate relationship as there is no microbiological reason for this.

Further details of these recommendations are provided in the section ‘Working group recommendations’.

Role of the working group

The Gamete Working Group was established in November 2022 to review current Human Fertilisation and Embryology Act 2008 (HFEA) guidance in place for gamete donors in a known donor relationship, living with either HIV, HBV or HCV. The group has focused on the following 4 areas:

• surrogacy and HIV, HBV, HCV positive gamete donors
• shared motherhood arrangement with an HIV, HBV, HCV positive donor
• ‘known donor’ arrangements, with an HIV, HBV, HCV positive known donor
• screening requirement for female same-sex couples

The remit of this group does not consider anonymous donations.

The group is chaired by Yacoub Khalaf. The full membership and terms of reference for the group are in Annex A.

Background

Under existing HFEA guidance, those who test positive for any of these infections (HIV, HBV, HCV) are unable to donate gametes. In addition to this, guidance on what is classified as an ‘intimate relationship’ within gamete donation is currently restricted to heterosexual relationships between a man and a woman. Couples in same-sex relationships are not covered by current guidance.

Established scientific evidence has evolved since the above regulatory stipulations were included in the Human Fertilisation and Embryology Act 1990 (‘1990 Act’) and antiviral therapy has become very much more effective in treating these chronic viral infections. Almost all people living with HIV and receiving effective antiviral therapy in the UK have an undetectable viral load in blood and current evidence has demonstrated that they do not transmit HIV sexually. HCV infection is now almost always curable with antiviral therapy.

This paper outlines the:

• remit of the working group
• current HFEA guidelines on gamete donation for those with HIV, HBV and HCV
• screening requirements for female same-sex couples
• updated transmission risks
• working group’s proposed recommendations to SaBTO

Current HFEA guidance

The 1990 Act established the legal framework that governs infertility treatment, medical services ancillary to infertility treatment and all human embryological research performed in the UK.

Paragraph 7 of Schedule 3A of the 1990 Act spells out that requirements for screening must be complied with. The only exception to this is for ‘partner donated’ gametes (donation between a man and a woman, not between 2 women).

Fertility clinics need to apply to HFEA for licensing to provide fertility treatments, store eggs, sperm and embryos and carry out embryo testing. Section T52 of the licensing conditions states that centres must comply with selection criteria for donors and requirements for testing, including that donors must be negative for:

• HIV1 and 2: anti-HIV-1,2
• HBV: HBsAg and anti-HBc
• HCV: anti-HCV-Ab

Section T53 notes that if the blood sample taken at the time of sperm donation is tested using nucleic acid amplification testing (NAT) for HIV, HBV and HCV, donor sperm must be quarantined for a minimum of 3 months, after which a further blood sample should be taken and subjected to repeat serological and NAT testing. See details of full licencing conditions (PDF, 202KB).

‘Known donor relationship’ arrangements with an HIV, HBV or HCV positive known donor

In a known donation arrangement, ‘known donors’ are either family members or close friends who donate gametes for use in fertility treatment. Currently couples are legally prohibited to use gametes from HIV, HBV (including HBsAg negative but anti-HBc positive individuals), or HCV (currently defined as anti-HCV positive) positive known donors.

Surrogacy and HIV positive gamete donors

HIV testing rules apply to both heterosexual and same-sex couples. Same-sex couples living with HIV are currently prohibited from gamete donation with a named or known surrogate. HIV testing is required by law for both heterosexual and same-sex couples, except in cases of ‘partner donation’ (a man and a woman in an intimate physical relationship). Clinics are required to screen both men and women providing gametes in surrogacy arrangements as if they were gamete donors as the surrogate is not in an intimate physical relationship with the gamete providers and will therefore need to be screened in the same way as a donor. 

Shared motherhood arrangement with an HIV positive donor

Shared motherhood is where a female same-sex couple wish to have IVF treatment where embryos are created using eggs from partner one and donor sperm, and partner 2 would carry the pregnancy. This is a scenario that clinics have been increasingly encountering, as a growing number of same-sex couples are accessing fertility treatment and wishing to share motherhood while alive and posthumously.

A shared motherhood arrangement, where partner one is HIV, HBV or HCV positive and wishes to use her eggs (with donated sperm) to transfer the embryo into partner 2, is not permitted. Where partner one is HIV, HBV, or HCV positive and wishes to use her own eggs with donor sperm in her own treatment, then she would not require further screening. Only the donor sperm in this scenario would be screened.

Screening requirements for female same-sex couples

Egg donation between female same-sex couples is currently subject to additional screening. In the 1990 Act, sperm is to be treated as partner donated sperm if the donor of the sperm and the recipient of the sperm declare that they have an intimate physical relationship. There is no similar provision for partner-donated eggs or embryos created with the partner’s eggs.

Therefore, as the law currently stands, it is a legal requirement that same-sex couples sharing eggs are screened as non-partner donors. Despite this they can, however, now be registered with HFEA as partners. HFEA has no discretion to waive compliance with the law and clinics must continue to screen in line with the requirements of the second directive.

Current epidemiology and transmission risk

Established scientific evidence has changed since the above regulatory stipulations were made. Current epidemiology and transmission risks for HIV, HBV and HCV are outlined below.

HIV

Current evidence demonstrates that someone with HIV who is on antiretroviral therapy (ART) and has an undetectable HIV viral load will not transmit HIV sexually.

Both HPTN 052 and the PARTNER studies demonstrated the efficacy of suppressive ART at preventing HIV transmission through condom-less sex for heterosexuals and men who have sex with men (MSM) when HIV levels are undetectable^{[footnote 1]},^{[footnote 2]},^{[footnote 3]}.

A large randomised controlled trial of 1,763 men assigned to either early or delayed ART (HPTN 052)^{[footnote 1]} showed that ART yielded a 96% reduction in transmission to HIV-negative partners and zero transmissions when the partner living with HIV had an undetectable viral load. Ninety-seven percent of couples participating in HPTN 052 were heterosexual, but the landmark PARTNER studies^{[footnote 2]},^{[footnote 3]} found that people living with HIV on effective treatment with an undetectable level of virus in their blood (defined as an HIV viral load on a blood test of less than 200 copies per ml) do not transmit the virus sexually, regardless of the type of sex – including sex between men. These studies looked at 135,000 instances of sex without condoms where one partner was living with HIV and the other was not. When the partner living with HIV was on effective treatment^{[footnote 1]},^{[footnote 2]} and HIV RNA was undetectable, the risk of transmission was zero. A further smaller prospective cohort study (Opposites Attract)^{[footnote 4]} demonstrated similar findings.

The evidence that suppressive ART is not associated with a risk of onward sexual transmission has led to the ‘undetectable=untransmissible’ (U=U) and ‘can’t pass it on’ statements; these are actively discussed and explained to people living with HIV receiving care. These statements have been endorsed by the British HIV Association (BHIVA), the European AIDS Clinical Society (EACS), the Centers for Disease Control and Prevention (CDC) in the USA and more than 240 HIV organisations across the world.

Evidence also shows that women living with HIV, when on effective HIV treatment that suppresses the HIV virus to undetectable levels, can give birth without transmitting HIV to their baby^{[footnote 5]}.

HIV where viral load is not suppressed

For conception or gamete donation, we strongly recommend that the person living with HIV should be taking ART and have a sustained undetectable level of virus on polymerase chain reaction (PCR) blood testing.

In the unusual situation where someone is unable or unwilling to take ART medicines or has a detectable virus but wishes to conceive with an informed consenting partner, risk reduction advice may be given, including timed unprotected sexual intercourse, sperm washing (as and where available) and the use of pre and/or post exposure prophylaxis. While there is limited evidence for some of these approaches, this was recommended practice in BHIVA and BASHH guidelines (PDF, 1.21MB) and also NICE fertility guidelines (PDF, 754KB), to reduce HIV transmission risk prior to the availability of full evidence supporting U=U.

Such cases should be managed on a case-by-case basis and with involvement of a multidisciplinary team in a specialist unit with expertise in the management of HIV and pregnancy. In addition to the fertility wishes of those involved, the safety of both the HIV negative person and the potential child will be of paramount importance.

HBV

Current legislation stipulates that donors must be tested and found negative for the presence of hepatitis B surface antigen (HBsAg) and antibodies to hepatitis B core protein (anti-HBc). Deferment of donors found to be HBsAg positive is clearly appropriate – such individuals would not be accepted as blood donors. However, the management of donors found to be HBsAg negative and anti-HBc positive is more difficult. Anti-HBc positivity is a marker of past infection with HBV. It is not possible to determine the presence or absence of current HBV infection (and infectiousness) in individuals who are HBsAg negative solely by testing for anti-HBc. The true marker of infectivity for HBV is the presence of HBV DNA. It is now accepted that some individuals with past HBV infection (those who are anti-HBc positive) who have cleared HBsAg from their peripheral blood may nevertheless be HBV DNA positive in peripheral blood and/or liver – this is so-called ‘occult’ HBV infection.

This raises 3 possibilities for management of HBsAg negative and anti-HBc positive donors.

Option 1: all such donors should be deferred from gamete donation.

Option 2: donation from all such donors should be accepted.

Option 3: these donors should be tested for HBV DNA; if negative at the time (or close to the time) of donation, then donation is acceptable.

Option 1 is the current status quo. While minimising the risk of transmission of HBV infection, there are several drawbacks to this, including:

• the vast majority of anti-HBc positive and HBsAg negative individuals carry no infectious risk at all. Following the introduction of anti-HBc screening of blood donors in 2022, NHSBT has so far found detectable HBV DNA in 2 of 391 (0.5%) samples from confirmed anti-HBc positive donors. Therefore, this option can be seen as being over-zealously risk averse, denying fertility treatment to many individuals who pose no risk of infection
• anti-HBc assays are prone to false positivity. Using data between 31 May 2022 and 31 December 2022, only 44% of 889 anti-HBc repeat reactive samples from blood donors with anti-HBs levels less than 100 international units per litre (IU/l) were confirmed as true positives (data from NHSBT). So, this option runs the risk of excluding individuals who have never had an HBV infection

In terms of option 2, HBV DNA levels in peripheral blood in occult infected individuals are usually very low (less than 200 international units per millilitre (IU/ml)) – in 138 occult HBV infection (OBI) carriers, the median viral load was 11 IU/ml^{[footnote 6]}. There is very little robust evidence on HBV DNA levels in seminal fluid, especially from individuals who have undetectable levels of HBV DNA in their peripheral blood, but the levels of seminal HBV DNA are likely to be correspondingly low. However, there is no doubt that HBV infection is sexually transmitted, so this option may be associated with a low residual risk, albeit the risk may be reduced even further by the preparation of spermatozoa for fertility work, but may not be zero.

Option 3 adds an additional level of safety to option 2 by demonstration of the absence of HBV DNA in peripheral blood. The natural history of occult infection is not well defined, but there is emerging evidence that HBV DNAemia may be intermittent and therefore this recommendation is qualified by the need for the DNA test to be taken within a certain timeframe in relation to the donation. It would be possible to add further measures to the risk assessment such as stratifying risk according to anti-HBs titre – high anti-HBs levels are known to reduce the risk of transfusion-transmitted occult HBV^{[footnote 7]}. So, only anti-HBcore positive HBV DNA negative donors with levels of anti-HBs (more than 100 IU/l) could be allowed to donate.

The evidence base for recommending any of the above options is sparse. The latest guidelines from the American Association for the Study of Liver Disease (AASLD)^{[footnote 8]} states:

Persons who are anti-HBc positive without HBsAg are not at risk of transmission of HBV, either sexually or to close personal contacts

but gives no references to support that statement. This may simply reflect the difficulty inherent in proving a negative.

Extensive reviews of occult HBV infection acknowledge the risk of transmission by transfusion of blood or blood products, or by liver organ donation, but make no reference to the risk of sexual transmission^{[footnote 9]}. For anti-HBc positive HBV DNA positive blood donors:

the risk of transmission of the infection depends on many factors, such as the amount of plasma transfused, the immune status of the recipient and the HBV serological status of both donor and recipient^{[footnote 9]}.

So, not all HBV DNA positive transfusions transmit HBV infection – estimates vary from 8% to 29% of recipients of blood products from donors with OBI becoming HBV-infected^{[footnote 10]},^{[footnote 11]}.

In making recommendations, the working group considered the following facts:

• the receptor for HBV is a bile acid transporter (NTCP) found only on hepatocytes and viral replication is only within hepatocytes. Therefore, it is reasonable to assume that the viral load in seminal, or other bodily fluid will reflect that found in plasma and not exceed it
• the volume of bodily fluid associated with gamete donation is at least one, if not 2 logs less than the volume of blood or product transfused and will therefore contain correspondingly less HBV DNA

• for couples seeking fertility treatment, the recipient may:

  • already be infected with HBV (for example, through sexual transmission) in which case appropriate steps will be taken to minimise the risk of mother-to-baby transmission
  • have had previous HBV infection and cleared virus from peripheral blood, in which case she will have anti-HBs protection against infection
  • have no evidence of prior HBV infection, in which case he or she can be counselled and advised to receive a course of HBV immunisation in advance of any fertility treatment. Over 80% of adults immunised with currently available vaccines will generate protective levels of anti-HBs

Donors who are HBsAg positive but on anti-viral therapy

The working group also considered the scenario of individuals who are HBsAg positive but on anti-viral therapy with an undetectable HBV DNA in peripheral blood. This is analogous to those HIV-infected donors whose viral load is therapeutically suppressed. For the latter group, with extensive evidence of U=U, the working group is recommending a change in the testing regulations. However, in the case of HBV-infected patients, the working group does not recommend any change in eligibility criteria relating to donors who are HBsAg positive.

One reason for this is that in contrast to the situation with HIV, there is no clinical trial data where couples discordant for HBsAg, with the positive partner on antiviral suppressive therapy, have been followed to assess transmission risk.

Secondly, there are good reasons for believing that in the case of HBV, ‘undetectable’ will not be equal to ‘untransmissible’. HBsAg positive individuals will be virologically suppressed while on nucleos(t)ide analogue (NA) therapy and HBV DNA may well be undetectable. However, there is a huge body of literature indicating that such individuals may have circulated pre-genomic HBV RNA (see example review)^{[footnote 12]}. This will be encapsulated in immature viral particles which may be enveloped and have HBsAg on their surface. While there is no in vivo data proving that such particles are infectious, it is highly likely that they will be, and once the immature RNA-containing particle has entered a recipient hepatocyte, it is entirely possible that reverse transcription to HBV DNA may occur (as the recipient will not be taking suppressive levels of nucleos(t)ide analogues and HBV infection will ensue).

HCV

Current legislation stipulates that donors must be tested and found negative for the presence of anti-HCV antibodies (anti-HCV). Anti-HCV is a marker of exposure of the patient’s immune system to HCV, so it is not possible to determine the presence or absence of current HCV infection (and infectiousness) solely by testing for anti-HCV. The marker of current infection is the presence of HCV RNA as shown by NAT. It has been stated, in the context of defining risk for HCV transmission by organ transplantation, that:

It is now consensus, that HCV-positive status, should be defined as the presence of HCV NAT viraemia, which conveys risk of transmission. Therefore, it is essential that chronic infection is defined based on detection of HCV NAT^{[footnote 13]}.

Screening of gamete donors by anti-HCV testing only is inappropriate for 2 reasons:

• individuals recently infected with HCV may be anti-HCV negative but HCV RNA positive (and therefore infectious). Such donors with acute infection would be missed if screening was limited to anti-HCV testing alone
• individuals who have cleared HCV RNA from their peripheral blood, either spontaneously or following antiviral therapy, are indeed cured of their HCV infection, and therefore no longer represent an infectious risk (see below)

Furthermore, HCV antibody assays have a false reactive rate given data and, thereby exclude those who have not ever suffered from HCV infection.

The absence of HCV RNA and hence infectiousness, in patients who are anti-HCV positive (and have therefore suffered a past infection with HCV) is best illustrated by a study of 26 kidney transplant recipients who were followed for a median of 10.5 years after HCV elimination while on haemodialysis. This heavily immunosuppressed patient population would be considered as having the highest risk in whom HCV ‘reactivation’, if it exists, would most likely occur. All patients had undetectable HCV RNA as ascertained by several tests. At the last follow-up visit, no residual HCV RNA was detected in 5 liver biopsies, 26 plasma samples, or in 37 non-stimulated and 24 stimulated peripheral blood mononuclear cell preparations tested with an ultrasensitive RT-NAT assay with a detection limit of 2 IU/ml. No biochemical or virological relapse was seen during follow-up, all of which suggests the complete eradication of HCV by therapy^{[footnote 14]}.

The European Association for the Study of the Liver, in their recommendations for the treatment of HCV infection^{[footnote 15]}, state that:

The goal of therapy is to cure HCV infection in order to: prevent the complications of HCV-related liver and extrahepatic diseases; improve quality of life and remove stigma; prevent onward transmission of HCV (treatment as prevention or ‘TasP’).

Further, they state that:

The endpoint of HCV therapy is a sustained virological response (SVR), defined by undetectable HCV RNA in serum or plasma 12 weeks (SVR12) or 24 weeks (SVR24) after the end of therapy, as assessed by a sensitive molecular method.

Long-term follow-up studies have shown that an SVR corresponds to a definitive cure of HCV infection in the vast majority of cases. Swain and others^{[footnote 16]} followed 1,343 patients post-SVR. They reported that:

most patients (99.1%) who achieved an SVR had undetectable levels of HCV RNA in serum samples throughout the follow-up period. Serum samples from 0.9% of the patients contained HCV RNA, a mean of 1.8 years (range, 1.1 to 2.9 years) after treatment ended. It is not clear if these patients were re-infected or experienced a relapse^{[footnote 16]}.

Sarrazin and others ^{[footnote 17]} followed 3,004 patients treated in clinical trials of directly acting antiviral therapy who achieved SVR12. Only 12 such patients had detectable HCV RNA having achieved an SVR12, all of which occurred within 24 weeks of follow-up. Phylogenetic analysis showed that 7 out of 12 patients had suffered a re-infection, with the remaining 5 suffering a late relapse^{[footnote 17]}.

The concept of ‘cure’ for HCV infection, either achieved spontaneously or with antiviral therapy, is now well-embedded in the literature^{[footnote 18]} and in clinical practice, as non-cirrhotic HCV RNA negative patients are discharged from specialist care^{[footnote 18]}.

Perhaps the most convincing evidence that non-viraemic patients do not represent an infection risk is that derived from studies of organ transplantation from anti-HCV positive HCV RNA negative donors to anti-HCV negative recipients. In a study of 32 kidney recipients from anti-HCV positive HCV RNA negative donors (none of whom received antiviral therapy), “all 32 patients were HCV RNA negative at one and 3 months post-transplant and 27 and 8 patients tested at 6 and 12 months post-transplant, respectively, remain HCV RNA negative.”^{[footnote 19]}

Similarly, a study from Spain in which 7 patients, none of whom received antiviral therapy, received kidney grafts from anti-HCV positive HCV NAT negative donors, reported that none of the recipients exhibited HCV NAT positivity during at least 6 months follow-up^{[footnote 20]}. The same group later reported a larger cohort (n = 34) of kidney recipients from anti-HCV positive but non-viraemic donors. Post-transplant viraemia was not detected in any recipient over the following 6 months^{[footnote 21]}. In a cohort of 14 heart transplant recipients from anti-HCV positive NAT negative donors in 2017, with a median follow-up of 256 days, none had a detectable HCV viral load during prospective monitoring at any time^{[footnote 22]}.

Working group recommendations

As outlined, these recommendations only apply to known donors and not anonymous donors. The working group recommends that future work is undertaken with HFEA on the applicability and implications of these recommendations for anonymous donors.

HIV

The working group proposes that SaBTO recommends to UK ministers of health that the law is amended to allow gamete donation to occur from individuals living with HIV to known recipients.

We recommend gamete donation from people with HIV (PWH) is allowed without restriction to a known recipient where the U=U criteria are met. This means that a person living with HIV should have an undetectable plasma HIV viral load (less than 200 copies/ml) determined by PCR testing and have been receiving ART for 6 months or more.

We recommend that in the rare and unusual situation where a person with HIV cannot achieve an undetectable viral load and conception is desired, gamete donation to a known, counselled, informed, consenting recipient may be permitted, in a specialist unit with expertise in managing HIV and pregnancy and providing tried and tested safety approaches are followed (see section ‘HIV where viral load is not suppressed’).

HBV

The working group recommends that SaBTO should recommend to UK ministers of health that the law should be amended so that gamete donation should be permitted where the donor is anti-HBcore positive and has undetectable levels of plasma HBV DNA in a sample taken within 30 days of donation and in an assay which can detect down to 10 IU/ml and is donating to a known recipient (option 3 in section ‘Current epidemiology and transmission risk’, above).

The recipient of such a donation should be counselled about the potential risk and advised to be fully immunised against HBV (if not already immune) before fertility treatment is undertaken.

HCV

The working group recommends that SaBTO proposes to UK ministers of health that the law should be amended to indicate that HCV screening for gamete donors should incorporate both anti-HCV and HCV RNA testing; the HCV RNA assay used should be able to detect down to 12 IU/ml. Only those gamete donors who are shown to be HCV RNA positive should be deferred from donation.

For donors who have undetectable levels of the virus following antiviral therapy, we recommend that a sample taken 6 months after the end of therapy should be tested to mitigate against the small risk of late relapse.

For all donors, the timing of HCV RNA testing should take place within a limited timeframe in relation to the date of gamete donation, to mitigate against the risk of re-infection between testing and donation.

Screening requirements for female same-sex couples

The working group recommends that additional screening requirements for female same-sex couples in an intimate relationship are removed as there is no microbiological reason for this. Removal would also create parity with opposite-sex couples.

Benefits of the recommendations

Should they be approved by SaBTO members, the recommendations may bring several benefits, including:

• improved access to fertility treatment, including through surrogacy, for people living with HIV, HBV and HCV, their partners and other people in their lives, increasing opportunities to have a family

• increase mental wellbeing for people previously unable to access gamete donation

• reduce the stigma associated with HIV, HCV and HBV

Costs

The working group has not undertaken a full costing exercise as the group believes any costings from additional testing will be small and can be balanced against savings such as the removal of testing of HIV for gamete donors in intimate or known donor relationships.

Annex A

SaBTO Gamete Donation Working Group terms of reference

The working group will be set up to review the current gamete donor selection criteria and guidelines in place.

The group will begin reviewing the guidance in place for gamete donors living with HBV and HCV.

The working group will consider epidemiology, transmission risk, current legislation and regulations in place.

The working group will aim to produce guidance for SaBTO. If necessary, the working group will make recommendations for change in practice. The final report and any necessary recommendations, are to be agreed by members at the wider committee meeting and published online.

The remit of the subcommittee and its workstreams includes the following:

• to review the current relevant guidance regarding gamete donation, including guidance on:
  • surrogacy and HIV, HBV or HCV positive gamete donors
  • shared motherhood arrangement with a HIV, HBV or HCV positive donor
  • ‘known donor’ arrangements, with a HIV, HBV and HCV positive known donor
  • screening requirement for female same-sex couples
• to review relevant policies, legislation and regulation
• to review current scientific evidence on HIV, HBV and HCV transmission risks
• to assess potential risk reduction measures in terms of transmission to recipients and harm to donor and recipients and where possible, the cost-effectiveness of such interventions
• to ensure that recommendations, if made, are in line with current legislation and relevant regulations
• to consider and, where possible, evaluate the operational impact of any recommendations
• to make recommendations on any work required to inform future guidance
• to make recommendations for dissemination of the outcome of the review
• to take full account of the potential benefits to gamete donors and surrogates, with regards to mitigation of harm and improved outcomes
• to consider the impact of its advice on all stakeholders, including but not exclusively donors, surrogates, patients, the wider NHS and the public
• to take account of views of interested parties on areas of concern, including concerns regarding discrimination and address these as far as possible
• to be ultimately accountable to SaBTO

Membership

Chair: Professor Yacoub Khalaf (consultant gynaecologist and reproductive medicine specialist, Guy’s and St Thomas’ Hospital).

Members:

• Professor James Neuberger (SaBTO Chair)
• Professor Will Irving (member of SaBTO, Professor of Virology, University of Nottingham)
• Dr Gary Mallinson (SaBTO secretariat, JPAC and NHS Blood and Transplant (NHSBT))
• Dr Tristan Barber (consultant in HIV Medicine, Royal Free Hospital, London. Honorary Secretary, British HIV Association. Representing the British Association of Sexual Health and HIV (BASHH))
• Dr Nicky Mackie (Consultant in HIV, Imperial College Healthcare NHS Trust, and Vice-Chair of the British HIV Association (BHIVA). Representing BHIVA)
• Sharon Fensome-Rimmer (Human Fertilisation and Embryology Authority)
• Niamh Marren (Human Fertilisation and Embryology Authority)
• Danielle Hamm (Nuffield Council on Bioethics)
• Ranveig Svenning Berg (Nuffield Council on Bioethics)

Secretariat:

• Amelia Worley (DHSC)
• Hannah Kempson (DHSC)
• Stephen Milner (DHSC)

The working group’s membership can adjust over time, with new members added, reflecting specific workstreams where necessary.

Members are subject to the wider SaBTO terms of reference.

Travelling expenses are payable for attendance at necessary face-to-face meetings in line with DHSC rates for individuals who serve on committees.

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