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1. Background
1 Hereafter, “HIV.”
2 Hereafter, “the Constitution.”
3 Hereafter, “AIDS.”
4 UNAIDS (2015) Global Statistics Fact Sheet. Available at
http://www.unaids.org/sites/default/files/media_asset/20150901_FactSheet_2015_en.pdf; last
accessed May 6, 2016.
5 Hereafter, “ART.” WHO (2015) HIV/AIDS: Online Q&A. Available at
In 2006, the CDC released its Revised Recommendations for HIV Testing of
Adults, Adolescents, and Pregnant Women in Health-Care Settings. 11 These
revised recommendations update previous recommendations for HIV testing in
healthcare settings and for screening of pregnant women. Providers in healthcare
settings are advised to:
1. Adopt a policy of routine HIV testing for everyone between the ages of 13-
64 and all pregnant women
2. Use opt-out screening for HIV—meaning that HIV tests will be done
routinely unless a patient explicitly refuses to take an HIV test
3. Eliminate the requirements for pre- and post-test counseling, 12 and
informed consent13
8 Center for Disease Control and Prevention (2015) Opportunistic Infections. Available at
http://www.cdc.gov/hiv/basics/livingwithhiv/opportunisticinfections.html; Last accessed May 6,
2016.
9 WHO (2011) Guidelines for intensified TB case-finding and isoniazid preventive therapy for TB.
for inpatients and outpatients in acute-care hospital settings. MMWR 1993;42[No. RR-2]:1--10;
CDC. Revised guidelines for HIV counseling, testing, and referral. MMWR 2001;50[No. RR-19]:1-
-62; and CDC. Revised recommendations for HIV screening of pregnant women. MMWR
2001;50[No. RR-19]:63--85). Available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm; Last accessed May 6, 2016.
12 Prevention counseling should not be required with HIV diagnostic testing or as part of HIV
not be required; general consent for medical care should be considered sufficient to encompass
consent for HIV testing.
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These recommendations are intended for all health-care providers in the public
and private sectors. The recommendations address HIV testing in health-care
settings only and do not modify existing guidelines concerning HIV counseling,
testing, and referral for persons at high risk for HIV who seek or receive HIV
testing in non-clinical settings (e.g., community-based organizations, outreach
settings, or mobile vans).14 The objectives of these recommendations are to:
2. Issues
a. What are the legal and ethical implications of HIV “opt-out” screening
and/or testing?
b. What are the potential conflicts, if any, with Philippine constitutional
provisions, national and local laws, jurisprudence, and/or various codes of
ethic, and how may these conflicts be mitigated and/or eliminated?
3. Summary of Findings
Where there is a generalized HIV epidemic, opt-out HIV testing and counseling
has been the leading recommendation for all individuals attending healthcare
facilities, irrespective of the presence of symptoms or the patient’s reasons for
accessing healthcare.16 In settings where HIV prevalence is low, or if focused on
particular groups within the population, then WHO/UNAIDS recommends that
opt-out testing should be offered to patients with symptoms suggestive of HIV
infection, as well as to individuals accessing pregnancy, tuberculosis and sexual
health services.17 Table 1 shows selected countries or states that have adopted opt-
out screening policies.
14 Ibid.
15 Ibid.
16 WHO (2011) Bulletin of the World Health Organization, Volume 89: 2011 Volume 89, Number
care hospital settings. MMWR 1993;42[No. RR-2]:1--10; CDC. Revised guidelines for HIV
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The Revised CDC Guidelines requiring opt-out screening for HIV, notably
without written patient consent, implies that even in the United States, HIV-
associated laws in conflict with this approach should be amended. 18 This
implication is applicable in the Philippine setting.
counseling, testing, and referral. MMWR 2001;50[No. RR-19]:1--62; and CDC. Revised
recommendations for HIV screening of pregnant women. MMWR 2001;50[No. RR-19]:63--85).
Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm; Last accessed May 6,
2016.
18 Ibid.
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The foregoing potential legal and regulatory conflicts may be mitigated in the
Philippines, however, by implementing opt-out testing methods that satisfy
patient testing protocols that include the legal definition of informed consent,
ensure confidentiality, and provide better test training for providers. Inclusion of
the WHO/UNAIDS testing guidelines 20 which recommend ensuring opt-out
testing remain voluntary, confidential, consensual, and supported by strong
counseling and access to services may be one way forward to overcome the
potential legal obstacles listed in Table 2.
19 Catherine Hanssens (2007) Legal and Ethical Implications of Opt-Out HIV Testing. Presented
in part: Opportunities for Improving HIV Diagnosis, Prevention & Access to Care in the U.S.,
Washington, D.C., 29–30 November 2006. Available at
http://cid.oxfordjournals.org/content/45/Supplement_4/S232.full; Last accessed May 10, 2016.
20 WHO/UNAIDS (2007) Guidance on Provider-Initiated HIV Testing and Counselling in Health
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Table 2 –Potential legal and regulatory conflicts; Mitigating proposals
Measures CDC Recommendations Potential legal and regulatory conflicts Proposals
Routine opt- All patients aged 13-64 years RA 8504 and its IRR require an opt-in approach, where Opt-out testing does not mean that
out screening voluntary, written informed consent shall be obtained prior an HIV test is mandatory. However,
coverage Exception: Screening should be testing. The law and its IRR make it clear that compulsory the current wording of the Revised
initated unless prevalence of HIV testing is prohibited. CDC Guidelines may make this
undiagnosed HIV infection in principle unclear. To advocate opt-
their patients has been The CDC recommendations do not recommend compulsory out testing the the Philippines, it
documented to be <0.1%. In the testing, and reiterates that HIV screening “should be should be recognized that whether
absence of existing data for HIV voluntary and undertaken only with the patient's patients “opt-in” or “opt-out”, the
prevalence, health-care providers knowledge and understanding that HIV testing is planned.” end result should be the same: an
should initiate voluntary HIV However, the CDC’s use of the term “routine testing” is informed decision by the patient to
screening until they establish vague and, thus, may give an impression that the kind of accept or decline the health care
that the diagnostic yield is <1 per testing recommended runs afoul of human rights and civil provider’s recommendation of an
1,000 patients screened, at which liberties protections. The term “routine testing” is vague HIV test. Hence, avoiding the
point such screening is no longer because: divisive term “opt-out” and
warranted. replacing it with “routine provider
1. A lack of definition and agreement about what is meant initiated HIV testing and
by routine testing, whether in Philippine legislation or counseling” will make it clear that
elsewhere; and the informed right of the patient to
2. The term “routine testing” may appear on its face more decline the recommendation of an
coercive, as it implies that all patients in a given setting HIV test is incorporated.22
or circumstance are tested without the requisite
consent. Conversely, the “routine offer of testing”
implies that patients in a given setting or circumstance
are routinely offered an HIV test, and the test is
conducted unless the patient rejects the offer.
22See WHO/UNAIDS (2007) Guidance on Provider-Initiated HIV Testing and Counselling in Health Facilities. Available at
http://www.unicef.org/aids/files/PITCGuidance2007_Eng.pdf; Last accessed May 19, 2016.
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21 See WHO/UNAIDS (2007) Guidance on Provider-Initiated HIV Testing and Counselling in Health Facilities. Available at
http://www.unicef.org/aids/files/PITCGuidance2007_Eng.pdf; Last accessed May 19, 2016. WHO (2011) Bulletin of the World Health Organization, Volume
89: 2011 Volume 89, Number 5, 317-392. Available at http://www.who.int/bulletin/volumes/89/5/10-084442/en/; Last accessed May 6, 2016.
23 Available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2730828/
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24 Open Society Foundation (2007). Increasing Access to HIV Testing and Counseling while Respecting Human Rights: Background Paper. Available at
https://www.opensocietyfoundations.org/sites/default/files/increasing_20070907.pdf; Last accessed May 19, 2016.
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25 Ibid.
26 WHO/UNAIDS (2007) Guidance on Provider-Initiated HIV Testing and Counselling in Health Facilities. Available at
http://www.unicef.org/aids/files/PITCGuidance2007_Eng.pdf; Last accessed May 19, 2016.
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27 Open Society Foundation (2007). Increasing Access to HIV Testing and Counseling while Respecting Human Rights: Background Paper. Available at
https://www.opensocietyfoundations.org/sites/default/files/increasing_20070907.pdf; Last accessed May 19, 2016.
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