Donor Behavioural Criteria
New Zealand Blood Service acknowledges that gender-based sexual activity rules, while necessary to ensure a safe blood supply in the past, have contributed to the stigma faced by men who have sex with men (MSM) in New Zealand.
We are committed to change and working towards introducing an individualised risk assessment when screening potential blood and plasma donors – one that is more inclusive and will enable those men in single-partner relationships with other men to donate.
The results from the Sex and Prevention of Transmission Study (SPOTS) represents a significant step on the pathway to change. As the largest survey of its kind in Aotearoa, we want to thank those who participated.
SPOTS has given us valuable insights into the safe sex practices of men who have sex with other men in Aotearoa, providing supportive evidence that moving to an individualised risk assessment in New Zealand will not compromise the safety and quality of the blood we supply to patients.
We’re excited to start the journey of change and about the prospect of being able to welcome more donors from the MSM community into our whānau of lifesavers in the future.
Next steps – what happens now
The results from SPOTS will be used by our clinical team alongside other peer-reviewed medical evidence from international blood services, against which NZBS benchmarks itself, to complete a detailed review and risk assessment.
It’s important to note there are several steps that need to occur before an individualised donor risk assessment can be implemented in New Zealand and that this process will take time.
This includes regulatory approval from Medsafe and an assessment by our plasma manufacturing partner (CSL Behring) to identify if any technical changes are required.
CSL Behring supports the global trends that are occurring in relation to donor eligibility criteria across a range of population groups, including men who have sex with men, which will improve equality by enabling a broader population to donate.
In order to enable these global changes, CSL Behring has identified that an updated testing regime, that aligns with global best practice, should be implemented, which will complement the individualised risk assessment recommended in New Zealand.
NZBS and CSL Behring have agreed that the testing changes to blood and plasma donations should be implemented now, to ensure that future changes to donor eligibility criteria can be supported.
NZBS and CSL Behring aim to achieve the earliest possible implementation timeline, however it is likely that achieving regulatory and technical approvals to implement the MSM donor deferral changes may not occur until 2025.
NZBS appreciate and thank you for your patience as we continue towards this goal.
Frequently Asked Questions
Other blood services have shown that a move to a more individualised donor risk assessment does not compromise the safety of blood and plasma. Why can’t you just follow in their footsteps and implement the change now?
It’s not as straightforward as that and there is a process that must be followed.
Firstly, our clinical team is required to complete a review and detailed risk assessment that is informed by data that is specific to New Zealand. The results from the Sex and Prevention of Transmission Study has provided the New Zealand-specific data that we can use in conjunction with other peer-reviewed medical evidence from other international blood service providers against which we benchmark ourselves to complete this work.
Regulatory approval from Medsafe and an assessment by our plasma manufacturing partner (CSL Behring) to identify if any technical changes are needed is also a requirement before any change to donor eligibility criteria.
What is the expected timeline? Does the change to testing need to happen before a submission recommending a change to the MSM criteria in New Zealand is made to Medsafe?
The Medsafe submission recommending a change to the MSM criteria in New Zealand will be made before the new testing regime is in place. Our plan is to make the submission while we put in place the changes needed to deliver the additional testing requirements.
Should Medsafe approve our submission, any change to this donor deferral won’t be able to be implemented until we have updated our testing programme. We anticipate the change to our testing will be implemented in 2025.
What is the change to testing?
The testing that we will put in place is an extension of our current nucleic acid testing (NAT) for viruses. We will be switching to a testing regime that has been used for a few years in commercial plasma processing called 5-NAT.
Expanding our testing regime will put us in a strong position to consider other changes to the plasma donor eligibility criteria in future.
Have other blood services who have moved towards an individualised risk assessment when screening donors had to do this?
Yes, blood services overseas that make plasma products using fractionation have already, or are in the process of, implementing this change to testing.
What is the current rule around men who have sex with men (MSM) and blood donation in New Zealand?
We currently ask men who have anal or oral sex (with or without a condom) with another man to wait three months from their last sexual encounter before donating blood, plasma and platelets.
This has been in place since late 2020, when the stand down period was reduced from 12 months.
What do you say to those who say your current rule is homophobic and has contributed to the stigma faced by men who have sex with other men?
New Zealand Blood Service does not discriminate against anyone on the basis of their gender, sexuality, race, or religion. Our primary responsibility is to ensure that blood and blood products supplied to patients in New Zealand are as safe as practicable.
Deferrals for sexual behaviour are based on what a person does or has done, not their sexual orientation.
The three-month stand down for men who engage in anal or oral sex (with or without a condom) with other men has been in place since late 2020 (reduced from one year) and reflects the higher incidence of HIV in New Zealand among men who have sex with men, compared to the general population.
A three-month stand down allows for a very high likelihood that any donation from a donor with recently-acquired HIV will be detected by our screening tests.
It’s important to note this stand down also applies to other groups at a heightened probability of an HIV infection. This includes:
- Women who have sex with men who have had anal or oral sex with another man.
- Men or women engaging in sex work (prostitution) or exchanging payment for sex.
- Men or women who have had sex with someone who lives in or comes from a country with high HIV prevalence.
- Men or women who have lived, and been sexually active, in a country with high HIV prevalence.
But if blood and plasma is tested, why does New Zealand Blood Service still have a rule that restricts men who have sex with men from donating?
Every donation is tested for a range of infectious disease such as HIV, hepatitis B and C using highly sensitive measures. While testing accuracy is good, there is a small (but not zero) chance that testing will not detect an infection that someone has recently acquired. That’s because in the early period following infection, even the most advanced tests are not able to detect it.
During that time a person’s blood may test negative but would be infectious to others if it was transfused. The relative risk of HIV transmission is much higher from a transfusion than from sexual intercourse.
As such, identifying those who are at a heightened probability of infection during the donor screening process and asking them to wait three months before donating is a precautionary measure to help further safeguard against this small risk.
Why are men ineligible if they have protected sex with men?
Condoms reduce that risk, but there is always a very small risk of transmission if the condom breaks or is not used properly.
Why do those taking HIV pre-exposure prophylaxis (PrEP) have to wait three months before donating?
PrEP minimises the risk of contracting HIV, but does not eliminate it. There is also a small probability that PrEP will mask a recently acquired infection from being detected by the testing used by NZBS.
What about undetectable equals untransmissible (U=U). Why can’t HIV+ people donate if they are on treatment and their viral load is undetectable?
Undetectable equals untransmissible only applies to sexual transmission of HIV. Unfortunately, even those who have an undetectable viral load may transmit the virus through blood transfusion due to the volume of a blood transfusion and therefore the amount of virus potentially present.
But I’m in a committed/monogamous relationship. Why can’t I donate?
We understand this restriction can be frustrating as there are different levels of risk among men who have sex with men. We are currently on the journey of shifting to an individualised risk assessment when screening potential blood and plasma donors – one that is more inclusive and will enable those men in single-partner relationships with other men to donate.
This process is going to take time, but we’re committed to making change.