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Three decades of MSM donor deferral policies. What have we learned?

Open AccessPublished:November 01, 2013DOI:https://doi.org/10.1016/j.ijid.2013.09.016

      Summary

      In the early 1980s, donor deferrals targeting men who have sex with men (MSM) and other high-risk groups were implemented in response to the outbreak of HIV/AIDS. It has now been three decades since the implementation of these deferrals. We review the international experience with developing these policies, which involves combining scientific evidence with ethical and moral concerns and the challenge of moving from precautionary to risk management policies as scientific knowledge and technology evolves. We provide key lessons that can guide blood policymakers as they confront potential new threats to the safety of the blood system and also provide lessons to the wider public health community on how best to incorporate precaution into the policymaking process.

      Keywords

      1. Introduction

      In the early 1980s, several countries were confronted with the tragedy of HIV-contaminated blood. Tens of thousands of individuals contracted HIV from blood transfusions, and in many jurisdictions there was a loss of confidence in the blood system's ability to protect the public from this and other risks.
      • Krever H.
      In response, many nations rethought how they would manage risk in their blood systems and new policies were implemented to protect the blood supply from future such events. In the case of HIV contamination, one such policy was the decision to defer donations from men who have sex with men (MSM). However, the implementation of this policy did not occur without controversy and sparked a backlash from the MSM community, many of whom believed the policy was discriminatory.
      • Somerville M.
      • Gilmore N.
      Blood Feuds: AIDS, blood, and the politics of medical disaster.
      Three decades have now passed since countries instituted these policies. These policies have evolved over time as new evidence on the risk of transfusion-transmitted HIV has become available, as well as new technologies for detecting this risk. We review the international experience with developing these policies, which involves combining scientific evidence with ethical and moral concerns, and discuss the challenge of adapting policy as scientific knowledge and technology evolves.

      2. Introduction of MSM policies/rationale at the time

      The first cases of what would become known as acquired immunodeficiency syndrome (AIDS) were characterized in homosexual men in mid-1981.
      US Centers for Disease Control and Prevention
      By early 1982, despite a viral etiology having not yet been identified, infection patterns had blood operators and key stakeholders such as hemophiliacs, concerned about the condition possibly being transfusion-transmissible. This suspicion was furthered as transmission patterns were beginning to resemble those of hepatitis B, i.e., transmission through sexual contact and the inoculation of blood and blood products.
      US Centers for Disease Control and Prevention
      By mid-1982, more than 350 people with the disease had been described.
      • Pindyck J.
      Transfusion-associated HIV infection: epidemiology, prevention and public policy.
      At that time, AIDS was predominantly being diagnosed in MSM, members of the Haitian community, non-medical intravenous drug users (IVDU), and hemophiliacs.
      • Peterman T.A.
      • Drotman D.P.
      • Curran J.W.
      Epidemiology of the acquired immunodeficiency syndrome (AIDS).
      In response, blood operators worldwide issued restrictions in the form of donor deferrals from these high-risk groups, including MSM, since there was no blood test available to detect the presence of the AIDS-causing agent at the time. In 1984, HIV was identified as the cause of AIDS.
      • Gallo R.C.
      • Salahuddin S.Z.
      • Popovic M.
      • Shearer G.M.
      • Kaplan M.
      • Haynes B.F.
      • et al.
      Frequent detection and isolation of cytopathic retroviruses (HTLV-III) 205 from patients with AIDS and at risk for AIDS.

      3. Evolution of policies

      The discovery of HIV and subsequent development of laboratory testing for blood products began to alleviate some of the scientific uncertainty surrounding the transfusion transmissibility and magnitude of the risk of the HIV virus to the blood supply.
      • Gallo R.C.
      • Salahuddin S.Z.
      • Popovic M.
      • Shearer G.M.
      • Kaplan M.
      • Haynes B.F.
      • et al.
      Frequent detection and isolation of cytopathic retroviruses (HTLV-III) 205 from patients with AIDS and at risk for AIDS.
      The introduction of nucleic acid testing (NAT), approximately 15 years after the implementation of the first MSM donor deferral policies, greatly increased the effectiveness of laboratory screening for transfusion-transmitted infections such as HIV, but also contributed to the complexity of policymaking. Many known transfusion-transmitted infections were now detectable at an early stage and thus the argument for the MSM deferral was not as compelling. However, the continued persistence of a narrow time window during which HIV could not be detected by NAT provided a scientific rationale for maintaining donor deferral policies.
      • Vamvakas E.
      Scientific background on the risk engendered by reducing the lifetime blood donation deferral period for men who have had sex with men.
      There was also theoretical concern about emerging transfusion-transmissible infections having a higher likelihood of developing amongst the MSM populations. While rates of sexually transmitted infections and transfusion-transmitted infections in this group are generally higher than in the rest of the population,
      • Vamvakas E.
      Scientific background on the risk engendered by reducing the lifetime blood donation deferral period for men who have had sex with men.
      emerging threats to the blood system, since the identification of AIDS, such as West Nile virus and variant Creutzfeldt–Jakob disease, have demonstrated other reservoirs for infection.

      4. From precaution to risk management

      Current MSM policies reflect modern testing methods and the attempt to balance the risks of contaminating the blood supply against the increasingly articulated social risks of marginalization through exclusion from participating in blood donation. The most restrictive is the lifetime deferral from blood donation for any male-to-male sexual contact. Slightly less restrictive is the lifetime deferral for any MSM activity after 1977. Intermediate approaches include donor deferrals for a fixed period after high-risk behavior, such as policies that defer donations for 6 months, 1, 5, or 10 years from those who have engaged in male-to-male sexual behavior (see Table 1). The least restrictive approach is to harmonize policies for MSM with those for individuals with a history of any risky sexual behavior regardless of orientation (as seen in Spain, Italy, Poland, and Russia).
      Table 1Current position of international MSM donor deferral policies
      CountryPolicyContributing reason for change from lifetime deferral
      South Africa6-month MSM donor deferralImplemented single sample NAT for HIV, HCV, HBV
      Argentina, Australia, UK, Hungary, Sweden, Czech Republic, Brazil12-month MSM donor deferralHarmonizing policy for risky sexual behavior
      New Zealand, Canada5-year MSM donor deferralNew Zealand: Implemented single sample NAT for HIV, HBV, HCV
      Canada: Risk analysis, and extensive consultation with scientific experts and with patient and community groups
      USA, Germany, Switzerland, the Netherlands, Norway, Hong Kong, Denmark, Finland, France, Mexico, Slovenia, and IcelandLifetime MSM donor deferralNot applicable
      Spain, Italy, Poland, RussiaNo specific MSM deferral policyDeferrals are now based on time period following the change of sexual partner, and assessment of risky sexual behavior – regardless of orientation
      MSM, men who have sex with men; NAT, nucleic acid testing; HCV, hepatitis C virus; HBV, hepatitis B virus.
      When the initial policies were introduced, there was considerable uncertainty concerning the risk posed for transfusion transmissibility of the emerging virus. Although they were perhaps not explicitly identified as such, the policies followed principles of precaution, introducing measures to protect against a theoretical risk. It is also apparent that the policies were necessary at the time.
      • Wilson K.
      • Ricketts M.N.
      The success of precaution? Managing the risk of transfusion transmission of variant Creutzfeldt–Jakob disease.
      As scientific evidence accumulated and the risk could be better quantified, MSM deferral policies migrated from precaution to risk management. This transition can be a difficult and lengthy process. The introduction of new technologies and the evolution of scientific consensus on both biological and social harm outpace policy changes in many instances. The process to change MSM deferral policies often involves many government and external consultations to address issues of the public's perception of risk and trust in the blood operators, as well as the evaluation of new risks created by changing existing policies.
      Pressure to liberalize MSM donor deferral policies has intensified in many countries. It is unlikely that public pressure from these groups will diminish without the issue being adequately evaluated in terms of acceptability and feasibility of various alternative screening approaches with both donor and advocacy groups.
      • Benjamin R.J.
      • Bianco C.
      • Goldman M.
      • Seed C.R.
      • Yang H.
      • Lee J.
      • et al.
      Deferral of males who had sex with other males.
      • Goldman M.
      • Yi Q.L.
      • Ye X.
      • Tessier L.
      • O’Brien S.F.
      Donor understanding and attitudes about current and potential deferral criteria for high-risk sexual behavior.
      It remains a challenge to strike a balance between prioritizing the safety of the blood supply and the rights of groups that are socially marginalized by the same protective policies. Nevertheless, the following key messages can be taken away from the experience with MSM donor deferral (Table 2).
      Table 2Evolution of MSM deferral policy in the USA, Canada, UK, South Africa, Australia, and New Zealand
      CountryPolicyChanges
      USA1983 – lifetime deferralNone
      Canada1983 – lifetime deferral suggestionResponse was criticized, withdrew deferral suggestion
      1985 – lifetime deferral mandated2012 – submission to regulator to change to 5-year deferral
      2013 – 5-year deferral2013 – Regulator approval for 5-year deferral
      UK (England, Wales, Scotland)1985 – lifetime deferral2011 – 12-month deferral
      South Africa2001 – 5-year deferral instituted by new national blood service2006 – 5-year deferral changed to 6-month deferral
      AustraliaIndividual states and territories all had their own version of an indefinite deferralRolling introduction of a 12-month deferral from 1996 to 2000
      New Zealand1998 – 10-year deferral2008 – 5-year deferral
      First, these policies were necessary at the time of implementation. Continuing to use a strong precautionary approach to protect the blood supply from emerging pathogens, and acting in advance of definitive evidence of risk, is necessary and essential to maintaining the safety of the blood supply in the future and the confidence of the public.
      Second, once instituted these policies are difficult to withdraw, even when risks become quantified and new technologies improve safety. Ease of removal is heavily influenced by the political and human consequences of the tragedy in each jurisdiction. A particularly tragic history can cast a shadow on the ability to alter the policy as new evidence becomes available. This can result in the maintenance of a policy even when it appears inconsistent with the weight of new evidence and scientific consensus.
      Third, there are invariably ethical and moral dimensions that must be considered when making decisions in this area. These aspects of policymaking must be considered in combination with the scientific evidence but should not preclude re-evaluation of policies in the face of changing scientific evidence.
      Fourth, those jurisdictions that have effectively transitioned policies have regular independent reviews of current policies and staged removals of policies when evidence suggests risk is decreased/eliminated.

      5. Evaluating the impact of policy changes

      It is too early to evaluate the impact of the different approaches to changing the MSM donor deferral policies. The lack of data collected before and after altering MSM deferral policies has previously been cited as a barrier to assessing the safety implications concerning policy change.
      • Leiss W.
      • Tyshenko M.
      • Krewski D.
      Men Having sex with men donor deferral risk assessment: an analysis using risk management principals.
      • Vamvakas E.C.
      Why are all men who have had sex with men even once since 1977 indefinitely deferred from donating blood?.
      • Sanchez A.M.
      • Schreiber G.B.
      • Nass C.C.
      • Glynn S.
      • Kessler D.
      • Hirschler N.
      • et al.
      The impact of male-to-male sexual experience on risk profiles of blood donors.
      • Seed C.R.
      • Kiely P.
      • Law M.
      • Keller A.J.
      No evidence of a significantly increased risk of transfusion-transmitted human immunodeficiency virus infection in Australia subsequent to implementing a 12-month deferral for men who have had sex with men.
      As jurisdictions have more experience with the new policies, several questions should be examined.
      Perhaps most important is whether relaxing the MSM deferral policies results in an increase in risk of transmission of HIV in the blood supply. Some initial studies have demonstrated this not to be the case and evidence is emerging to suggest that relaxing the deferral from lifetime can improve donor compliance, which may paradoxically reduce the risk of an HIV-positive donation entering the blood supply.
      • Seed C.R.
      • Kiely P.
      • Law M.
      • Keller A.J.
      No evidence of a significantly increased risk of transfusion-transmitted human immunodeficiency virus infection in Australia subsequent to implementing a 12-month deferral for men who have had sex with men.
      • Flanagan P.
      How should we assess risk behaviour when determining donor deferral?.
      • Davison K.L.
      • Conti S.
      • Brailsford S.R.
      The risk of transfusion-transmitted HIV from blood donations of men who have sex with men, 12 months after last sex with a man: 2005–2007 estimates from England and Wales.
      • Slowther A.
      • Watkins N.A.
      • Kelly D.
      Evidence-based policy and practice leads to changes in the criteria for MSM to donate blood.
      Blood systems also need to monitor future emerging transfusion-transmissible pathogens to determine if they did incubate in MSM and whether maintaining a restrictive MSM deferral could have protected the blood supply from these threats. To date, this appears not to have been the case.
      Another important question pertaining to changing the MSM policies is the potential impact on the donor pool. Models have suggested that if MSM deferrals are changed from lifetime, there would be an increase in eligible donors.
      • Germain M.
      • Remis R.S.
      • Delage G.
      The risks and benefits of accepting men who have had sex with men as blood donors.
      A gain of youth donors may also potentially be achieved by relaxing the deferral.
      • Saberton P.J.
      • Paez A.
      • Newbold K.B.
      • Heddle N.M.
      Geographical variations in the correlates of blood donor turnout rates: an investigation of Canadian metropolitan areas.
      • Bönig H.
      • Schmidt M.
      • Hourfar K.
      • Schüttrumpf J.
      • Seifried E.
      Sufficient blood, safe blood: can we have both?.
      • Go S.L.
      • Lam C.T.
      • Lin Y.T.
      • Wong D.J.
      • Lazo-Langner A.
      • Chin-Yee I.
      The attitude of Canadian university students toward a behavior-based blood donor health assessment questionnaire.
      Other areas that deserve examination include evaluating the impact of changing donor deferral policies on social stigmatization of the MSM population, as well as the public's perception of the safety of the blood supply.

      6. Conclusions

      Transfusion transmission of HIV and the subsequent response was transformative to public health. The protection of the blood supply from HIV and other transfusion-transmitted infections helped precipitate more widespread policies in public health where preventative actions were taken in advance of definitive evidence of risk.
      • Wilson K.
      The Krever Commission—10 years later.
      The MSM donor deferral story has also demonstrated the consequences of these policies on specific communities and has highlighted the challenges associated with moving from policies based on precaution to risk management policies – as new evidence quantifies risk and new technologies reduce the evidence for the policies’ existence. These lessons can inform blood systems as they address novel risks to the blood supply and are also useful to the wider public health communities as they determine how best to incorporate precaution into their policymaking process.

      Acknowledgements

      This commentary was based on work funded by the Canadian Institutes of Health Research, which was approved by the Ottawa Hospital Research Institute research ethics board. Dr Wilson is supported by a Public Health Policy Research Chair from the Ottawa Hospital, Department of Medicine and Ottawa Hospital Research Institute. We thank R. Ducharme for supporting this project.
      Conflict of interest: Dr Wilson is an unpaid member of the Canadian Blood Services Scientific Advisory Board. No other conflicts of interest to report.

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