There is an ongoing debate worldwide regarding permanent versus temporal deferral and receiving blood donations from persons with defined high risk behavior [1, 2], such as men who have sex with men (MSM) [3, 4]. The rationale and the benefits of such deferral/exclusion for MSM [5–10] have been questioned by lesbian, gay, bisexual, and transgender advocacy organizations seeking to change the current policy, in the light of technological advances in screening using Nucleic Acid Testing. This testing method enables a higher detection rate of contaminated blood by improving the tests sensitivity for the detection of causative agents of Transfusion Transmitted Infection (TTI) such as Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV) and by reducing the length of the Window Period, during which detection is impossible [11, 12]. Injection drug users (IDU) are additional persons with defined high risk behavior for TTI with those viruses [13, 14].

In addition the Israeli population is composed of immigrants from 142 countries, as well as work seekers, some originate from specific countries with a Generalized HIV Epidemic, like Ethiopia. Due to high prevalence and incidence of mostly HIV and HBV, they are currently not allowed to donate blood. Although this was changed in april 2016 shortly after this papers acceptance.

The main reason for considering liberalizing blood donation policy for MSM is a response to the lesbian, gay, bisexual, and transgender advocacy organizations. The reason is not demand driven, since blood supply shortages are almost non-existent and the expected addition contribution if all MSM were allowed to donate is only around 1.5% of the blood supply. Any shortages can be made up by blood drives in the general not at-risk population.

Throughout the years since HIV detection, most countries have imposed an indefinite deferral period on MSM. However, since the introduction of Nucleic Acid Testing, some countries have instituted a permanent 1 years’ deferral period for MSM who wish to donate blood, with Canada allowing donations after a 5 years period of abstinence [15]. In December 2015 the US Food and Drug Administration announced its revised recommendations that changed the donor deferral policy for MSM to a 1-year deferral from last sexual contact [16]. In countries where MSM are not permanently deferred the sexual risk is assessed during the individual interview, conducted by a physician or nurse, at the blood donation site [17].

The present permanent deferral policy of MSM since 1977, of the Ministry of Health in Israel, was based on the previous (now outdated) FDA standards, and is reflected in the Donor Health Questionnaire and the personal interview, which are part of the screening process to potential blood donors. The questionnaire gives potential donors an option to self-defer from donating blood if they practice high risk sexual behavior (including MSM or receiving payment for sex), intravenous and non-prescribed drug usage or originating from countries with high prevalence and incidence of HIV, since 1977. The current deferral is permanent since 1977.

Every blood donation in Israel is tested for the detection of HIV-1, HIV-2, HBV, HCV and HTLV by chemiluminescent Immunoassay assay (ChlIA third generation, Prism, Abbott) and by an Individual NAT testing for HIV-1, HBV and HCV (Procleix Ultrio Assay, Grifols). Blood donation criteria and guidelines are continuously reviewed by the Advisory Committee to the Ministry of Health for Transfusion Medicine.

The current article combines demographic, epidemiological and laboratory data on MSM (and IDU) in order to calculate their relative risks (RR) of being HIV positive in addition to modeling an estimate of the absolute risk of HIV TTI as a result of enabling them to donate blood. This work was presented as evidence to an ad hoc committee nominated by the Director General of the Ministry of Health in early 2014 to examine blood donor policies in Israel.

In view of the continuous pressure applied on decision makers in Israel to change the current indefinite deferral policy for MSM, we evaluated the additional risks of HIV TTI, using a self-built mathematical model based on inputs from the literature for scenarios where deferral for either a 5 or 1 year period after last sexual relation, or no- deferral is adopted.

Based on the epidemiological data in Israel, allowing MSM to donate blood, without any deferral period, will increase the number of HIV TTI cases by 4.99 from 1.03 to 6.02 cases over the next decade. Imposition of 1 and 5 year deferral rules will increase the number of HIV TTI cases among MSM by 0.10 (0.07–0.19) and 0.05 (0.03–0.08) cases respectively.

Unfortunately, it is impossible to predict future immigration patterns into Israel, whether from countries with high (e.g. Ethiopia) or low HIV prevalence (e.g. France) so our model made no attempt to adjust for future demographic changes among blood donors. Educational materials for donors and blood collection teams will be prepared ad-hoc, as required.

Changing to a temporal deferral policy may improve the reporting compliance of MSM who did not have sexual relations for the past 1 or 5 years, and by doing so, may in fact increase the safety of the blood donations. Many of the 68,000 MSM, not all of whom are high risk, would appreciate the change in policy and hence may be more likely to comply better with the new deferral policy.

By doing so, the safety of the national blood inventory might well increase. However one should notice that although the additional risk of TTI HIV among other people with risk behavior (i.e. about 20,000 IDU) is similar or even smaller (owing perhaps to their fewer numbers), no lobbies exist, to the best of our knowledge, whether in Israel or worldwide, for introducing changes in their permanent deferral policy.

While the AIDS-HIV registry enabled us to analyze relative risks for HIV by populations with risk behaviors, no such registries exist in Israel for HBV or HCV infections. Any change in policy needs to be accompanied by the establishment of a national monitoring program, to track rates of other infections (including other Transfusion-Transmitted Diseases) in the general population in order to assess risk factors in donors with HIV, HBV or HCV infections, and to study and evaluate these changes.

In deciding policy relating to blood donations one has to strike a balance between the safety of recipients, ensuring an adequate blood supply as well as societal/legal obligations to treat everyone fairly. Given that no transfusion is risk free, the question is what degree of risk is acceptable in order to meet the needs of recipients and society [32].

Lack of homogeneity of results of reported deferral periods caused us to just give a wide range of estimates for the effects of deferral periods on MSM. A Canadian study [24] reported that while the risk of implementing a 1 year deferral policy for MSM is very low, it can never be shown to be zero. They concluded that given today’s paradigm in blood safety, even a miniscule risk increment would be unjustified and undesirable. Another Canadian study reported that choosing a 1 year deferral period for MSM would almost certainly give rise to an incremental risk of TTI infection, and that such a policy would represent an unethical type of risk transfer from one social group to another, and would therefore be unacceptable [10]. Canada has since adapted a policy of allowing MSM to donate blood, after 5 years of abstinence, with a resultant worst-case estimate of one HIV contaminated unit every 1,072 years [33].

It should be noted that modeling studies indicate that adherence of potential blood donors to deferral policies is of major relevance, suggesting that good donor compliance may outweigh the negative effects on blood safety postulated for changing from permanent to temporary deferral periods for high risk sexual behaviors. The fact that a considerable percentage of donors are MSM - despite the permanent deferral policy [34] demonstrates the need to increase donor education and understanding [17]. It should be emphasized that our literature-based estimates of cases from MSM donors under a deferral system are based on a conservative estimate that does not take into account any possible gains resulting from less people giving false information about their MSM status as a consequence of instituting an MSM deferral period.

Whether or not to recommend the institution of a 1 year deferral period, as recommended lately by the FDA for the USA [16], or a 5 year period as in Canada [33] can be based on a value judgment as to whether or not 0.10 or 0.05 are subjectively acceptable increases in MSM TTI.

Based on the present model we recommend the institution of a 1 year deferral period for MSM to donate blood in Israel. However, we are aware of the fact that MSM are at a higher risk of other infections transmitted by blood (including Hepatitis B and C) than heterosexual men and women [13, 35, 36], so basing policy decisions solely on risks of TTI from just HIV in isolation is somewhat sub-optimal and inadequate. We therefore recommend that the suggested change in policy be accompanied by improving educational and other interventions with people with high risk behavior, upgrading the existing Nucleic Acid Testing and building a national hemo-vigilance and TTI monitoring system that will allow us to follow up the impact of such a policy change.

In addition, a recent publication from the USA showed that noncompliance with the MSM policy is evident and may be increasing compared to earlier data [37]. We join the authors’ recommendations that any change from the current policy requires close monitoring to determine whether it affects residual risk of HIV in the Israeli blood supply.

It should be also mentioned that there is an additional option of using an additional Nucleic Acid Test, 2 weeks post donation to the current Nucleic Acid Testing. If the additional Nucleic Acid Testing is negative then the Whole Blood unit which was held in quarantine can be released. However, this double- Nucleic Acid Testing protocol was considered to be unfeasible because of organizational constraints, stigmatization, loss of at least two major blood components and possible cost-effectiveness issues.

We note that the non-compliancy rate among MSM in Israel (i.e. MSM donate blood despite the restriction on accepting donations) is around 2.04% per annum, being of similar magnitude to that of 1.8% reported in Canada [38], 2.5% in the UK [39], 2.6% in the USA [37] and 4.5% in England [26]. Based on the UK and USA experiences, adoption of a 1 year deferral for donations from MSM is likely to reduce the non-compliancy rate by half [37, 39]. Furthermore, a non-compliancy rate as low as 0.2% has been attained in Australia [40], under a 1 year deferral regulation, by making the donors sign an extensive legal declaration that they are not MSM before donating.

A 1 year deferral period for blood donations from MSM in Israel is recommended.

We trust that recommendation that is based on hard data provides an appropriate balance to the public’s fear of allowing more high risk people to donate and the perception of activist groups that they are being discriminated against by the current lifetime MSM deferral.