International Journal of Infectious Diseases 18 (2014) 1–3
Contents lists available at ScienceDirect
International Journal of Infectious Diseases journal homepage: www.elsevier.com/locate/ijid
Perspective
Three decades of MSM donor deferral policies. What have we learned?§ Kumanan Wilson a,b,*, Katherine Atkinson b, Jennifer Keelan c a Departments of Medicine and of Epidemiology and Community Medicine, University of Ottawa, The Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Administrative Services Building, Room 1009, Box 684, Ottawa, ON, K1Y 4E9, Canada b Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada c Dalla Lana School of Public Health, University of Toronto, Toronto, Canada
A R T I C L E I N F O
S U M M A R Y
Article history: Received 8 August 2013 Received in revised form 17 September 2013 Accepted 20 September 2013
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. ß 2013 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. All rights reserved.
Corresponding Editor: Eskild Petersen, Aarhus, Denmark Keywords: HIV Blood transfusion Blood donors Prevention of transfusion-transmitted infections Men who have sex with men Precautionary principle
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.1 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.2 Three decades have now passed since countries instituted these policies. These policies have evolved over time as new evidence on
§ This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-No Derivative Works License, which permits non-commercial use, distribution, and reproduction in any medium, provided the original author and source are credited. * Corresponding author. E-mail address: [email protected] (K. Wilson).
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-1981.3 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.3 By mid1982, more than 350 people with the disease had been described.4 At that time, AIDS was predominantly being diagnosed in MSM, members of the Haitian community, non-medical intravenous drug users (IVDU), and hemophiliacs.5 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
1201-9712/$36.00 – see front matter ß 2013 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. All rights reserved. http://dx.doi.org/10.1016/j.ijid.2013.09.016
K. Wilson et al. / International Journal of Infectious Diseases 18 (2014) 1–3
2
test available to detect the presence of the AIDS-causing agent at the time. In 1984, HIV was identified as the cause of AIDS.6 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.6 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 transfusiontransmitted 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.7 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,7 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). 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.8 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.9,10 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). 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
Table 1 Current position of international MSM donor deferral policies Country
Policy
Contributing reason for change from lifetime deferral
South Africa Argentina, Australia, UK, Hungary, Sweden, Czech Republic, Brazil New Zealand, Canada
6-month MSM donor deferral 12-month MSM donor deferral 5-year MSM donor deferral
USA, Germany, Switzerland, the Netherlands, Norway, Hong Kong, Denmark, Finland, France, Mexico, Slovenia, and Iceland Spain, Italy, Poland, Russia
Lifetime MSM donor deferral
Implemented single sample NAT for HIV, HCV, HBV Harmonizing policy for risky sexual behavior New Zealand: Implemented single sample NAT for HIV, HBV, HCV Canada: Risk analysis, and extensive consultation with scientific experts and with patient and community groups Not applicable
No specific MSM deferral policy
MSM, men who have sex with men; NAT, nucleic acid testing; HCV, hepatitis C virus; HBV, hepatitis B virus.
Deferrals are now based on time period following the change of sexual partner, and assessment of risky sexual behavior – regardless of orientation
K. Wilson et al. / International Journal of Infectious Diseases 18 (2014) 1–3
3
Table 2 Evolution of MSM deferral policy in the USA, Canada, UK, South Africa, Australia, and New Zealand Country
Policy
Changes
USA Canada
1983 – lifetime deferral 1983 – lifetime deferral suggestion 1985 – lifetime deferral mandated 2013 – 5-year deferral 1985 – lifetime deferral 2001 – 5-year deferral instituted by new national blood service Individual states and territories all had their own version of an indefinite deferral 1998 – 10-year deferral
None Response was criticized, withdrew deferral suggestion 2012 – submission to regulator to change to 5-year deferral 2013 – Regulator approval for 5-year deferral 2011 – 12-month deferral 2006 – 5-year deferral changed to 6-month deferral
UK (England, Wales, Scotland) South Africa Australia New Zealand
policy change.11–14 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.14–17 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.18 A gain of youth donors may also potentially be achieved by relaxing the deferral.19–21 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.22 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.
Rolling introduction of a 12-month deferral from 1996 to 2000 2008 – 5-year deferral
References 1. Krever H. Commission of inquiry on the blood system in Canada Final report, Vol. 3. Canadian Government Publishing; 1997. 2. Somerville M, Gilmore N. Blood Feuds: AIDS, blood, and the politics of medical disaster. In: Feldman E, Bayer R, editors. From Trust to Tragedy: HIV/AIDS and the Canadian Blood System, New York: Oxford University Press; 1999. p. 127–59. 3. US Centers for Disease Control and Prevention. In: Acquired immunodeficiency syndrome (AIDS): precautions for health-care workers and allied professionals. MMWR Morb Mortal Wkly Rep 1983;32:450–1. 4. Pindyck J. Transfusion-associated HIV infection: epidemiology, prevention and public policy. AIDS 1988;2:239–48. 5. Peterman TA, Drotman DP, Curran JW. Epidemiology of the acquired immunodeficiency syndrome (AIDS). Epidemiol Rev 1985;7:1–21. 6. Gallo RC, Salahuddin SZ, Popovic M, Shearer GM, Kaplan M, Haynes BF, et al. Frequent detection and isolation of cytopathic retroviruses (HTLV-III) 205 from patients with AIDS and at risk for AIDS. Science 1984;224:500–3. 7. Vamvakas E. Scientific background on the risk engendered by reducing the lifetime blood donation deferral period for men who have had sex with men. Transfus Med Rev 2009;23:85–102. 8. Wilson K, Ricketts MN. The success of precaution? Managing the risk of transfusion transmission of variant Creutzfeldt–Jakob disease. Transfusion 2004;44:1475–8. http://dx.doi.org/10.1111/j.1537-2995.2004.04116.x. 9. Benjamin RJ, Bianco C, Goldman M, Seed CR, Yang H, Lee J, et al. Deferral of males who had sex with other males. Vox Sang 2011;101(4):339–67. 10. Goldman M, Yi QL, Ye X, Tessier L, O’Brien SF. Donor understanding and attitudes about current and potential deferral criteria for high-risk sexual behavior. Transfusion 2011;51:1829–34. http://dx.doi.org/10.1111/j.15372995.2011.03078.x. 11. Leiss W, Tyshenko M, Krewski D. Men Having sex with men donor deferral risk assessment: an analysis using risk management principals. Transfus Med Rev 2008;22:35–57. 12. Vamvakas EC. Why are all men who have had sex with men even once since 1977 indefinitely deferred from donating blood? Transfusion 2009;49:1037–42. http://dx.doi.org/10.1111/j.1537-2995.2009.02175.x. 13. Sanchez AM, Schreiber GB, Nass CC, Glynn S, Kessler D, Hirschler N, et al. The impact of male-to-male sexual experience on risk profiles of blood donors. Transfusion 2005;45:404–13. 14. Seed CR, Kiely P, Law M, Keller AJ. 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. Transfusion 2010;50:2722–30. http://dx.doi.org/10.1111/j.15372995.2010.02793.x. 15. Flanagan P. How should we assess risk behaviour when determining donor deferral? Reflections on the MSM deferral Biologicals 2012;40:173–5. http:// dx.doi.org/10.1016/j.biologicals.2011.10.009. 16. Davison KL, Conti S, Brailsford SR. 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. Vox Sang 2013;105:85–8. http://dx.doi.org/10.1111/vox.12024. 17. Slowther A, Watkins NA, Kelly D. Evidence-based policy and practice leads to changes in the criteria for MSM to donate blood. Transfus Med Hemother 2013;40:155–8. http://dx.doi.org/10.1159/000351770. 18. Germain M, Remis RS, Delage G. The risks and benefits of accepting men who have had sex with men as blood donors. Transfusion 2003;43:25–33. 19. Saberton PJ, Paez A, Newbold KB, Heddle NM. Geographical variations in the correlates of blood donor turnout rates: an investigation of Canadian metropolitan areas. Int J Health Geogr 2009;8:56. http://dx.doi.org/10.1186/1476072X-8-56. 20. Bo¨nig H, Schmidt M, Hourfar K, Schu¨ttrumpf J, Seifried E. Sufficient blood, safe blood: can we have both? BMC Med 2012;10:29. 21. Go SL, Lam CT, Lin YT, Wong DJ, Lazo-Langner A, Chin-Yee I. The attitude of Canadian university students toward a behavior-based blood donor health assessment questionnaire. Transfusion 2011;51:742–52. 22. Wilson K. The Krever Commission—10 years later. CMAJ 2007;177:1387–9. http://dx.doi.org/10.1503/cmaj.071333.
Contents lists available at ScienceDirect
International Journal of Infectious Diseases journal homepage: www.elsevier.com/locate/ijid
Perspective
Three decades of MSM donor deferral policies. What have we learned?§ Kumanan Wilson a,b,*, Katherine Atkinson b, Jennifer Keelan c a Departments of Medicine and of Epidemiology and Community Medicine, University of Ottawa, The Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Administrative Services Building, Room 1009, Box 684, Ottawa, ON, K1Y 4E9, Canada b Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada c Dalla Lana School of Public Health, University of Toronto, Toronto, Canada
A R T I C L E I N F O
S U M M A R Y
Article history: Received 8 August 2013 Received in revised form 17 September 2013 Accepted 20 September 2013
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. ß 2013 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. All rights reserved.
Corresponding Editor: Eskild Petersen, Aarhus, Denmark Keywords: HIV Blood transfusion Blood donors Prevention of transfusion-transmitted infections Men who have sex with men Precautionary principle
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.1 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.2 Three decades have now passed since countries instituted these policies. These policies have evolved over time as new evidence on
§ This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-No Derivative Works License, which permits non-commercial use, distribution, and reproduction in any medium, provided the original author and source are credited. * Corresponding author. E-mail address: [email protected] (K. Wilson).
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-1981.3 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.3 By mid1982, more than 350 people with the disease had been described.4 At that time, AIDS was predominantly being diagnosed in MSM, members of the Haitian community, non-medical intravenous drug users (IVDU), and hemophiliacs.5 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
1201-9712/$36.00 – see front matter ß 2013 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. All rights reserved. http://dx.doi.org/10.1016/j.ijid.2013.09.016
K. Wilson et al. / International Journal of Infectious Diseases 18 (2014) 1–3
2
test available to detect the presence of the AIDS-causing agent at the time. In 1984, HIV was identified as the cause of AIDS.6 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.6 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 transfusiontransmitted 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.7 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,7 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). 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.8 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.9,10 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). 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
Table 1 Current position of international MSM donor deferral policies Country
Policy
Contributing reason for change from lifetime deferral
South Africa Argentina, Australia, UK, Hungary, Sweden, Czech Republic, Brazil New Zealand, Canada
6-month MSM donor deferral 12-month MSM donor deferral 5-year MSM donor deferral
USA, Germany, Switzerland, the Netherlands, Norway, Hong Kong, Denmark, Finland, France, Mexico, Slovenia, and Iceland Spain, Italy, Poland, Russia
Lifetime MSM donor deferral
Implemented single sample NAT for HIV, HCV, HBV Harmonizing policy for risky sexual behavior New Zealand: Implemented single sample NAT for HIV, HBV, HCV Canada: Risk analysis, and extensive consultation with scientific experts and with patient and community groups Not applicable
No specific MSM deferral policy
MSM, men who have sex with men; NAT, nucleic acid testing; HCV, hepatitis C virus; HBV, hepatitis B virus.
Deferrals are now based on time period following the change of sexual partner, and assessment of risky sexual behavior – regardless of orientation
K. Wilson et al. / International Journal of Infectious Diseases 18 (2014) 1–3
3
Table 2 Evolution of MSM deferral policy in the USA, Canada, UK, South Africa, Australia, and New Zealand Country
Policy
Changes
USA Canada
1983 – lifetime deferral 1983 – lifetime deferral suggestion 1985 – lifetime deferral mandated 2013 – 5-year deferral 1985 – lifetime deferral 2001 – 5-year deferral instituted by new national blood service Individual states and territories all had their own version of an indefinite deferral 1998 – 10-year deferral
None Response was criticized, withdrew deferral suggestion 2012 – submission to regulator to change to 5-year deferral 2013 – Regulator approval for 5-year deferral 2011 – 12-month deferral 2006 – 5-year deferral changed to 6-month deferral
UK (England, Wales, Scotland) South Africa Australia New Zealand
policy change.11–14 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.14–17 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.18 A gain of youth donors may also potentially be achieved by relaxing the deferral.19–21 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.22 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.
Rolling introduction of a 12-month deferral from 1996 to 2000 2008 – 5-year deferral
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