Men who have sex with men blood donor controversy

The men who have sex with men blood donor controversy is the dispute over prohibitions on donations of blood or tissue for organ transplants from men who have sex with men (MSM), a classification of men who engage (or have engaged in the past) in sex with other men, regardless of whether they identify themselves as bisexual, gay, or otherwise. Opposition to the prohibition is frequently addressed in terms of bisexual and gay men. Restrictions on donors are sometimes called "deferrals", since blood donors who are found ineligible may be found eligible at a later date. Many deferrals are indefinite, however, meaning that these blood donors may or may not be accepted at any point in the future. The restrictions vary from country to country, and in many cases, men are deferred even though they always have protected sex or have not had sex with men for many years. The restrictions affect these men, and, in some cases, any female sex partners. They do not otherwise affect other women, including women who have sex with women. Opponents of many of the deferrals point out that these policies are not supported by medical science.[1]

Many LGBT organizations view the restrictions on donation as based on homophobia and not based on valid medical concern since donations are rigorously tested to rule out donors that are infected with known viruses such as HIV, Hepatitis B, and Hepatitis C. They state the deferrals are based on stereotypes.[1] Proponents of the lifetime restriction defend it because of the risk of false negative test results[2] and because the MSM population in developed countries tends to have a relatively high prevalence of HIV/AIDS infection.[3] The UK government advisory committee, SABTO, states that the risk of transfusion of HIV infected blood would increase if MSM were allowed to donate blood.[4] Opponents of prohibitions against MSM point out that screening of donors should focus on sexual behavior as well as safe sex practices since many MSM may always have protected sex, be monogamous, or be in other low risk categories.[1][4] Some groups in favor of lifting the restrictions support a waiting period after the blood is donated when the donor is considered to have had behavior considered higher risk, and before it is used, to match the blood bank's window of testing methods.[1] Depending on the testing method used, the window to detect HIV can be as short as 7 to 21 days (RNA testing), or as long as three months (serology testing method). However, there is a small percentage of the population at 3% who still will not test positive after 3 months with serology testing.[5]

HIV/AIDS

In many developed countries HIV is more prevalent among men who have sex with men (MSM) than among the general population.[3]

In the United States in 2005, MSM, African Americans, and persons engaging in high-risk heterosexual behavior accounted for respectively 49%, 49%, and 32% of new HIV diagnoses.[6] In 2009 in the United States, African Americans accounted for 47.9% of new HIV diagnoses reported that year, but represented approximately only 12% of the population.[7]

Current situation

List of countries with their stand on MSM blood donors

Blood donation policies for men who have sex with men
  Men who have sex with men may donate blood; No deferral
  Men who have sex with men may donate blood; Temporary deferral
  Men who have sex with men may not donate blood; Permanent deferral1
  No Data / Unknown
1No restriction in Israel and the United States of America if last MSM activity was before 1977.
Blood donation policies for female sex partners of men who have sex with men
  Female sex partners of men who have sex with men may donate blood; No deferral
  Female sex partners of men who have sex with men may donate blood; Temporary deferral
  No Data

This list shows countries that had restrictions on blood donors.[8][9] Most national standards require direct questioning regarding a man's sexual history, but the length of deferral varies.

Country Deferral for MSM Deferral for female
sex partners of MSM 		Ref(s)
 Algeria Indefinite
 Argentina No deferral No deferral [10][11][12]
 Australia 1 year 1 year [13]
 Austria Indefinite [14]
 Belgium Indefinite [15]
 Bhutan No deferral No deferral [16]
 Brazil 1 year 1 year [17]
 Bulgaria No deferral
 Canada 5 years 1 year [18]
 Chile No deferral No deferral [19]
 China Indefinite [20]
 Colombia No deferral No deferral [21]
 Costa Rica No deferral [22]
 Croatia Indefinite [23]
 Czech Republic 1 year 1 year [24]
 Denmark Indefinite [25]
 Estonia Indefinite [26]
 Finland 1 year [27]
 France Indefinite A [28]
 Germany Indefinite [29]
 Greece Indefinite
 Hong Kong Indefinite [30]
 Hungary 1 year [8]
 Iceland Indefinite
 India Indefinite Indefinite
 Ireland Indefinite
 Israel Indefinite B No deferral [31]
 Italy No deferral No deferral [8] [32]
 Japan 1 year [8]
 Latvia No deferral B No deferral B [33]
 Lithuania Indefinite [34]
 Malta Indefinite [35]
 Mexico No deferral No deferral [36]
 Netherlands 1 year 1 year [37][38]
 New Zealand 1 year 1 year [39]
 Northern Ireland Indefinite 1 year [40]
 Norway No deferral [41][42][43]
 Peru No deferral No deferral [44][45]
 Philippines Indefinite
 Poland No deferral B No deferral B [8][46][47][48]
 Portugal No deferral No deferral [49]
 Russia No deferral No deferral [50][51]
 Serbia 1 year
 South Africa No deferral No deferral [52]
 South Korea No deferral No deferral
 Slovakia 1 year
 Slovenia Indefinite [53]
 Spain No deferral No deferral [8]
 Sweden 1 year 1 year [54][55]
  Switzerland Indefinite
 Thailand No deferral No deferral [56]
 Turkey Indefinite
 United Kingdom (excluding Northern Ireland) 1 year 1 year [57][58]
 United States 1 year 1 year [59]
 Uruguay No deferral No deferral [8]
 Venezuela Indefinite No deferral

Notes

United States

In the US, the current guidance from the U.S. Food and Drug Administration (FDA) is to indefinitely defer any male donor who has had sex with another man (MSM), in the period from 1977 to the present day.[60] As of July 2015, the U.S. Food and Drug Administration was proposing to change the policy by replacing the indefinite deferral with a 1-year deferral.[61][62]

Female sexual partners of MSM are deferred for one year since the last exposure. This is the same policy used for any sexual partner of someone in a high risk group.[63] The argument used to follow these policies is that blood should be collected from a population that is at low risk for disease, since the tests are not perfect and human error may lead to infected units not being properly discarded, and these population groups would be considered a high risk. The policy was first put in place in 1983 by the FDA, which regulates blood donations to profit and non-profit organizations.[64]

Donors of what the FDA calls "HCT/P's", a category that includes transplants (other than organs) and some reproductive tissue, notably anonymous semen donations, are ineligible for five years after the most recent contact.[65] UNOS policies for Organ donation require the hospital receiving the organ to be notified if the donor was an MSM within the past 5 years.[66] The organs are generally used unless there is a clear positive test for a disease. The one year deferral was approved by the FDA on December 21, 2015, replacing a lifetime ban on donations from MSM.[67]

History of calls to change the policy

European Union

The UK (excluding Northern Ireland) lifted its lifetime ban on MSM blood donation in September 2011,[57] and changed the policy to simply restrict men who have had sex with another man within the previous 12 months.[76] The Advisory Committee on the Safety of Blood, Tissues and Organs recommended the policy change after a study concluded that a total ban may breach equality legislation and that the risk of HIV reaching the blood supply would only increase by approximately 2%.[77]

A similar policy exists in the rest of the European Union and is the prevailing interpretation of the European Union Directive 2004/33/EC article 2.1 on donor deferrals.[78] The policy, however, is not very specific and refers to "high risk sexual contact." The UK interprets the directive to include all forms of homosexual sex as falling within 2.2.2 of Annex III to the directive "Persons whose behaviour or activity places them at risk of acquiring infectious diseases that may be transmitted by blood." requiring a deferral based on the window period for the diseases involved, and sets this at 12 months, despite the Annex suggesting 6 months for risk of exposure to Hepatitis B. Bulgaria, Italy, Latvia, Poland, and Spain all regard sex between men as not being high risk. Hélder Trindade, President of the Portuguese Institute of Blood and Transplantation (IPST), stated in 2015 that sexually abstinent homosexuals may give blood, but that MSM is definitely seen as a risk factor.[79] Protected or unprotected oral sex is less likely to transmit HIV or Hepatitis B than unprotected penis in vaginal sex.

In Finland, the parliamentary ombudsman launched an investigation on the possible unconstitutionality of the lifetime ban in January 2006. In June 2008, it was concluded that the ban was not unlawful in Finland as it is based on "appropriately reasoned epidemiological information" and because it is related to sexual behaviour rather than sexual orientation. The ombudsman added that people over the age of 65 and people who lived in Britain during the bovine spongiform encephalopathy (mad cow disease) outbreak are also screened out during blood donor interviews. In December 2013, the Finnish Red Cross blood service announced it was lifting the ban and introducing a one-year deferral instead.

France announced plans in 2015 to lift its ban on blood donation by MSM beginning in 2016, though a 12 month deferral will be put in place[80]

Australia

Australia's individual states and territories each had their own policies on blood donations by MSM. Most previously had some form of the indefinite deferral, and they all changed to a 12-month deferral at different times between 1996 (SA) and 2000 (ACT, NSW).[8]

A comparison of confirmed HIV positive blood donations before and after the change did not see a statistically significant difference, though the number of HIV positive blood donations during the period with a 12-month deferral was greater. In all of the cases of HIV positive donations associated with MSM after the 12-month deferral, the donors had lied about their medical history and would not have been eligible under either criterion.[8]

New Zealand

Since 2009, the New Zealand Blood Service (NZBS) had deferred males who have had oral or anal intercourse, with or without protection, with another male for five years. From the formation of the NZBS in 1998 to 2009, the deferral period had been ten years, but reduced to five years following an independent review of blood donation criteria in 2007-8 which found no significant difference in risk to the blood supply for deferral periods of five years compared to ten years.[81]

In 2014, the NZBS dropped the ban period from 5 years to one year following the recommendation of Medsafe.[82] Their decision was mainly caused by recently gained facts about HIV transmission in Australia [83] which already had a one-year deferral. The new 12-month deferral has been in effect since 15 December 2014.

The one year deferral period for MSM is on par with the one year deferral period for persons engaging in prostitution outside of New Zealand and people who have resided in a country which has a high (1% or more) HIV prevalence. Females who engage in sexual intercourse with a male who has had sex with another male are also deferred for twelve months.[84]

Reasoning for the restrictions

Blood services first and foremost must ensure that all blood received for donation is safe for transfusion purposes. This is achieved by screening potential donors for high risk behaviors through questionnaires and interviews before blood is taken, and subsequent laboratory testing on samples of donated blood.

Blood services commonly justify their bans against MSM using the statistically higher prevalence of HIV and hepatitis of MSM in population studies.

In the earliest years of the AIDS epidemic, there were no reliable tests for the virus, which justified blanket bans on blood donations from groups at high risk of acquiring or having HIV, including MSM. These restrictions are similar to present-day restrictions in most countries on people residing in the United Kingdom during the BSE ("mad cow disease") epidemic of the 1980s and early-to-mid 1990s, due to the absence of a test for its human form, variant Creutzfeldt–Jakob disease (vCJD).

In 1985, early tests using the ELISA method looked for antibodies, which are the immune system's response to the virus. However, there is a window period when using this method in which a person who has been infected with HIV is able to spread the disease but may test negative for the virus. This window period can be as long as three to six months,[85] with an average of 22 days.[86] Tests using the ELISA methods are often still used in developed countries because they are highly sensitive. In developing countries, these tests are often the only method used to screen donated blood for HIV. To cover the window period resultant from the use of these tests, donors are also screened for high risk behaviors, one of which is a history of same-sex sexual activity among male potential donors. Other groups with similar restrictions include commercial sex workers, injecting drug users, and people resident in countries with a high HIV prevalence (such as sub-Saharan Africa). Newer tests look for the virus itself, such as the p24 antigen test, which looks for a part on the surface of the virus, and Nucleic acid tests (NAT), which look for the genetic material of the virus. With these tests, the window period is shorter, with an average duration of 12 days.[86] Fourth generation combination HIV tests are conclusive at 3 months, and Hepatitis B tests are conclusive at 6 months.

Risks are also associated with a regular donor testing positive for HIV, which can have major implications as the donor's last donation could have been given within the window period for testing and could have entered the blood supply, potentially infecting blood product recipients. An incident in 2003 in New Zealand saw a regular donor testing positive for HIV and subsequently all blood products made with the donor's last blood donation had to be recalled. This included NZ$4 million worth of Factor VIII, a blood clotting factor used to treat haemophiliacs which is manufactured from large pools of donated plasma, and subsequently led to a natiowide shortage of Factor VIII and the deferral of non-emergency surgery on haemophiliac patients, costing the health sector millions of dollars more.[81] Screening out those at high risk of bloodborne diseases, including MSM, reduces the potential frequency and impact of such incidents.

Criticism of the restrictions

Objections to the restrictions, including those from the American Medical Association and Red Cross, are generally based on the idea that improvements in testing and other safeguards have reduced the risk from transfusion transmitted HIV to an acceptable level. Blood shortages are common, and opponents of the policies point out that excluding healthy donors only makes the problem worse. "Ideal" inventories are at least a three-day supply, but many blood centers struggle to meet this demand.

Further opposition stems from the fact that the ban is a blanket ban encompassing all men who have had sex with another man, even with protection and even if the HIV status of these men's partners is shown beyond doubt to be negative. Opponents point out that a promiscuous straight male is a higher-risk donor than a gay or bisexual man in a monogamous relationship, but the former will usually be allowed to donate blood. Furthermore, other high-risk activities such as having sexual contact with anyone who has used needles to take drugs not prescribed by their doctor have a set deferral period before the donor is allowed to donate blood, whereas in some countries MSM donors are deferred indefinitely. Female donors who have sexual contact with MSM are sometimes deferred temporarily.

Protests and boycotts

Canada

United States

Throughout the 2000s, several boycotts have been held on college campuses across the United States against blood drives. For example, in 2003, a blood drive at the University of Vermont was cancelled to protest the MSM donor policy.[88] In 2007, an Iowa State University student group sparked controversy when they pulled their support for a blood drive.[89] In 2008, a faculty member at Sonoma State University proposed a ban on blood drives on campus,[90] and at San Jose State University President Don Kassing suspended all blood drives on campus.[91] In 2010, students from Keene State College protested blood drives on their campus.[92] On 14 April 2011, The Queens College Academic Senate of The City University of New York recommended that all blood drives on campus should cease.[93] The recommendation was adopted by Queens College President James Muyskens but reversed in June 2011 when the CUNY chancellory expressed its disapproval.[94] A student organization at the University of Michigan, Blood Drives United, has been holding awareness drives in conjunction with their annual blood drive competitions as a means of productively addressing the policy while still collecting blood.[95][96] These "sponsor" drives allow individuals ineligible to donate because of the policy to bring eligible individuals to donate on their behalf, visually demonstrating that twice as much blood could potentially be collected.[97]

United Kingdom

France

See also

References

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  8. 1 2 3 4 5 6 7 8 9 Clive R. Seed, Philip Kiely, Mathew Law, and Anthony J. Keller (December 2010). "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 (AABB) 50: 2722–2730. doi:10.1111/j.1537-2995.2010.02793.x.
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  86. 1 2 FDA Approves First Nucleic Acid Test (Nat) System To Screen Whole Blood Donors For Infections With Human Immunodeficiency Virus (Hiv) And Hepatitis C Virus (Hcv) Archived 21 February 2008 at the Wayback Machine
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