Changes to blood donation rules explained
By Kat Smithson, Director of Policy
Today the Government announced rule changes that will allow more gay and bisexual men to donate blood in the UK. These changes affect the assessment that donors complete when they give blood.
Read on for more details about how these changes came about and what they mean in practice.
What process led to these changes?
NHS Blood and Transplant (NHSBT) led a steering group called FAIR (For the Assessment of Individualised Risk). It was set up to consider how risk could be assessed on a more individual basis when people go to donate blood. Public Health England and the University of Nottingham were also involved along with charities from the LGBT+ and HIV sectors, including National AIDS Trust. FAIR made recommendations to SaBTO (Advisory Committee on the Safety of Blood, Tissues and Organs) which in turn made recommendations to the Government.
Why do they ask questions about sexual behaviour when someone goes to donate blood?
Blood-borne viruses (BBVs), such as HIV, hepatitis B and hepatitis C, can be transmitted via donated blood products if present but not identified. The UK today has one of the safest blood supplies in the world. All donated blood in the UK is screened for BBVs. However, all screening tests have what’s called a ‘window period’. This is a period of time after someone acquires a BBV where the test won't show as positive yet. Screening of blood will pick up BBVs as long as the infection was acquired more than three months ago (much earlier for HIV). Therefore, blood donation services want to minimise any risk that someone could have acquired a BBV within the past three months. To do this, questions are asked to potential donors about behaviours where risk of transmission is high enough that this could increase the chances of an undetected BBV being present in the blood. Epidemiological data is used to assess this possible risk.
Tests used in screening have improved in sensitivity over time, meaning it's much easier to detect viruses tin the blood earlier than it used to be. Because of this, organisations like National AIDS Trust have called for the deferral periods to be decreased to reflect this so that people are not unnecessarily excluded from donating.
Gay and bisexual men, along with other groups, are disproportionately impacted by HIV. This is a significant health inequality that needs to be tackled. The rules around blood donation have also disproportionately affected this group.
What were the rules for gay and bisexual men before these new changes, and how have they changed over the years?
Currently, until the new rules are implemented, a man who reports that he has had sex with another man in the past three months is not eligible to give blood. This therefore includes gay and bisexual men in ongoing sexual relationships with one other person. These current rules replaced previous rules for a 12-month deferral period. Prior to that men could not donate blood if they reported they had ever had sex with another man, regardless of when the sex was. This was rightly challenged as being discriminatory by National AIDS Trust and many others; it excluded a lot of men from giving blood when there was no risk of any BBV having been acquired that wouldn’t be picked up in screening.
What are the new rules FAIR recommended?
The new donor questions will no longer consider the gender of the person donating or that of their sexual partners. Instead, they will consider the sexual behaviour itself to assess whether there is a risk of a recent blood-borne infection that won’t be picked up in post-donation screening (all blood in the UK is screened for blood-borne viruses).
Under the new rules someone will be asked to defer their donation if they report anal sex with a new or multiple partners in the past three months. Anal sex with one partner in the past three months, when that is not a new sexual partner (i.e. the sexual relationship pre-dates three months), will not exclude a person from donating blood. This means gay and bisexual men in long-term relationships will be able to give blood when that person is the only person they have had anal sex within the three months prior to donating.
Why does this specify anal sex?
The evidence shows there is a higher risk of transmission of blood-borne viruses such as HIV from condomless anal sex than vaginal, oral or other types of sex. The likelihood of an undiagnosed infection from recent anal sex is therefore higher.
What about condoms?
The question doesn’t ask about condom use. This means that even if condoms are used, anal sex with new or multiple partners in the past three months will result in a deferral. In making the recommendations, FAIR considered acceptability of the questions to donors and the ability of donors to reliably recall behaviours. This is viewed as being diminished when it comes to reporting of regular and consistent condom use; condoms may also break or fail without a person being aware. However, condoms are very effective at preventing the transmission of sexually transmitted infections. This should be kept under review to ensure that condom use is taken into account fully in the development of the risk assessment.
Why three months?
All donated blood in the UK is screened for BBVs like HIV, hepatitis B and hepatitis C. Most BBV tests look for antibodies that the body produces in response to the viruses and so there has to be enough time for these to be produced. However, after three months, screening will pick up any of these BBVs. Very recent infections (particularly hepatitis B) may not be picked up in this screening because the body has not yet fully developed antibodies that will be detected in screening. The aim of the rules should be to reduce the chances of a donor having a BBV that will not be identified through screening. Therefore, if someone has potentially been at risk of acquiring a BBV within the past three months, they are not able to donate.
Are these the only questions about sexual behaviour asked?
No. This is a step towards an individualised risk assessment, but there are still some broader exclusions related to sexual behaviour and who a person has sex with. Currently donors are asked to defer if in the past three months they have:
- had sex with anyone who has had syphilis or anyone who is HIV positive
- been given money or drugs for sex
- had sex with anyone who has ever been given money or drugs for sex
- had sex with anyone who has ever injected drugs
- had sex with anyone who may ever have had sex in parts of the world where HIV is very common (this includes most countries in Africa)
- taken Pre-Exposure Prophylaxis (PrEP) / Truvada for prevention of HIV or have taken or been prescribed Post-Exposure Prophylaxis (PEP) for prevention of HIV
Few changes have been proposed to these under the current review (see below). However, it's accepted more needs to be done to assess these and there may be further recommendations made in the near future. It's our view the above need to be reviewed urgently to ensure they are asking questions that successfully identify higher risk without unnecessarily excluding people or groups. There is also a lifetime exclusion for anyone who has ever injected drugs (more below) which must be ended.
What if a sexual partner is living with HIV but is on treatment?
FAIR did recommend that when a person reports sex with a person living with HIV, the treatment status of the person should be considered. The vast majority of people with diagnosed HIV in the UK are on treatment with an undetectable viral load and cannot pass it on. Following this review, this question is therefore likely to be reworded to reflect this and donors will be asked to clarify that their partner has been on treatment for more than six months and has an undetectable viral load. It’s important, however, that this is reviewed to ensure that the six month requirement is necessary (for example if most people achieve an undetectable viral load in a shorter period of time) or even if an alternate approach of asking if the person has had sex with someone living with HIV who is not on treatment would be sufficient.
Why is there a three-month deferral if someone takes PrEP or PEP?
The three-month deferral for someone taking PrEP or PEP is described as precautionary, because there is limited data currently available on the impact on testing. There is a concern that the use of antivirals (PEP and PrEP are antiviral medications) when or soon after an infection is acquired, may affect the ability of current tests to detect very low levels of virus when a blood donation is screened. There is also a concern that production of antibodies – which is also part of routine screening of blood donation – may be delayed and give atypical results. This would only be an issue in an extremely rare circumstance where a person was taking PrEP having unknowingly acquired HIV shortly before. In the NHS HIV testing is routine prior to commencing PrEP. More data is being collated in the USA on donation testing and the BHIVA / BASHH PrEP guidelines here in the UK are under a review which will look at the data on HIV testing where HIV could have been acquired while taking PrEP (very rare and only reported in cases where PrEP was not adhered to). The effectiveness of PrEP at preventing HIV transmission is not under question. It should also be remembered that those reporting PrEP use will also be subject to other eligibility criteria. It’s our view that taking PrEP only decreases the risk of any onward infection as the person is likely to have been protected from HIV for longer and to have been regularly tested. Therefore, we’d like to see the rationale reviewed for this as soon as more evidence emerges.
What about chemsex?
FAIR is recommending a three-month deferral for those reporting using specific drugs to enhance or stimulate prolonged sexual behaviour. Key to this will be whether the drug could alter decision making or recall of sexual experiences. The list of drugs is not yet available, but it will not include poppers and Viagra.
What more needs to be done?
As well as reviewing the rules that apply as three-month deferral (see above), there's currently a lifetime exclusion for anyone who has ever injected drugs, regardless of when this took place. This is clearly an unnecessary exclusion affecting anyone with historical use of injecting drugs. This rule is in part dictated by EU Directive. However, there is precedent for deviating from directives when they are unnecessarily exclusionary and there is evidential basis for doing so. We would therefore like to see an urgent review of this, with changes made to the law if necessary.
When will the changes announced today be put in place?
There is not yet an implementation date and it may be that the four UK blood services follow slightly different processes and timelines. There is some concern that COVID-19 and the added pressure it has placed on blood services will also slow down implementation. NHSBT will need to consider piloting the new questions and implementing any feedback swiftly. There will also need to be staff training and wider communications. We hope the changes will be rolled out throughout 2021.
Kat Smithson is Director of Policy at National AIDS Trust. Follow her on Twitter here: @KatSmithson