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MEMORANDUM

FROM: Patricia Miranda

RE: Legal and ethical implications of HIV “opt-out” screening


and/or testing

DATE: May 20, 2016

This memorandum discusses the legal and ethical implications of human


immunodeficiency virus 1 “opt-out” screening and/or testing. Aside from
reviewing potential conflicts with the range of the provisions 1987 Constitution of
the Republic of the Philippines, 2 national and local laws, jurisprudence, and/or
various codes of ethics, this memorandum further assesses various strategies to
best implement “opt-out” recommendations within the current Philippine legal
framework.

1. Background

HIV infection and acquired immunodeficiency syndrome3 remain leading causes


of illness and death globally.4 While there is still no cure for HIV, the progression
of HIV in the body can be slowed with continued and effective adherence to
antiretroviral therapy. 5 However, the high cost of the medicines, weak or
inadequate health care infrastructure, and lack of financing prevented wide use of
ART, particularly in low- and middle-income countries. 6 In the Philippines,
antiretroviral therapy coverage among people with advanced HIV infection was
estimated to be 31% in 2015.7

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

http://www.who.int/features/qa/71/en/; last accessed May 6, 2016.


6 Ibid.
7 WHO (2015) World Health Statistics.
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The most common life-threatening opportunistic infection affecting people living


with HIV/AIDS is tuberculosis.8 A number of core health care strategies that are
critical to prevent and manage TB infection among people living with HIV include:
(a) intensified case finding for active TB; (b) isoniazid preventive treatment; (c);
and (d) early initiation of ART.9 In the Philippine setting, scholars have made the
case for intensified case finding for HIV through opt-out screening procedures.10

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.

Available at http://apps.who.int/iris/bitstream/10665/44472/1/9789241500708_eng.pdf; Last


accessed May 6, 2016.
10 Edsel Maurice Tanghal Salvana (2010) HIV in the Philippines: A Prime Target for Elimination

through Test-and-Treat. Institute of Molecular Biology and Biotechnology, National Institutes of


Health, University of the Philippines Manila. Available at
http://actamedicaphilippina.com.ph/sites/default/files/HIV-Elimination.pdf; Last accessed May 6,
2016.
11 Hereafter, “CDC Revised Guidelines.” CDC (2006) Recommendations for HIV testing services

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

screening programs in health-care settings; Prevention counseling is strongly encouraged for


persons at high risk for HIV in settings in which risk behaviors are assessed routinely (e.g., STD
clinics) but should not have to be linked to HIV testing. Available at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm; Last accessed May 6, 2016.
13 Ibid. According to the Revised CDC Guidelines, separate written consent for HIV testing should

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:

1. increase HIV screening of patients, including pregnant women, in health-


care settings;
2. foster earlier detection of HIV infection;
3. identify and counsel persons with unrecognized HIV infection and link
them to clinical and prevention services; and
4. further reduce perinatal transmission of HIV.15

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

5, 317-392. Available at http://www.who.int/bulletin/volumes/89/5/10-084442/en/; Last accessed


May 6, 2016.
17 CDC (2006) Recommendations for HIV testing services for inpatients and outpatients in acute-

care hospital settings. MMWR 1993;42[No. RR-2]:1--10; CDC. Revised guidelines for HIV

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Table 1 –Selected Countries or States with Opt-Out Screening Policies


Low Income Lower middle Upper middle High Income
Malawi Kenya Botswana United Kingdom
Uganda Zambia Bulgaria Czech Republic
Zimbabwe Ghana Belarus* Estonia
Moldova* Germany**
Malta
The Netherlands
Norway
Portugal
Russian Federation*
Slovak Republic
Spain**
United States
(Tennessee,
Alabama, Colorado)
*legally mandatory testing for migrants and asylum seekers
**no opt-out testing in other facilities (e.g., prisons, STI facilities), including surgery
[NOTE: country income classification based on World Bank 2015 data]
SOURCES: J Nyuzaghl et al. (2011) “Acceptability of Routine Offer of HIV Testing (Opt-Out
Approach) among Pregnant Women in the Wa Municipality” in Ghana Med J., 45(1): 10–15.
Available at: <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3090094/> Last accessed: April
25, 2016; S. Mounier-Jack et al. (2008) “HIV testing strategies across European countries” in
HIV Medicine, 9 (Suppl. 2), 13–19. Available at:
<http://www.ncbi.nlm.nih.gov/pubmed/18557864> Last accessed: April 25, 2016. CDC (2016)
“An Opt-Out Approach to HIV Screening” in HIV/AIDS. Available at:
<http://www.cdc.gov/hiv/group/gender/pregnantwomen/opt-out.html> Last accessed: April
25, 2016. Michael Carter (2007) “WHO/UNAIDS endorse opt-out HIV testing” in Aidsmap News.
Available at: < http://www.aidsmap.com/WHOUNAIDS-endorse-opt-out-HIV-
testing/page/1427409/> Last accessed: April 25, 2016.

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.

In the Philippines, implementing these guidelines will necessitate an amendment


of the Philippine AIDS Law (Republic Act 8504), which requires opt-in testing

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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founded on voluntary, written informed consent during the testing process.


Moreover, a whole sale or across the board implementation of the CDC Guidelines
may run afoul of constitutional rights, which may include the rights to
nondiscrimination and bodily integrity, the right to be free from violence, and the
right to the highest attainable standard of health, particularly since certain
recommendations lessen the currently confidential nature of such tests and the
weakening of counseling methods. It has likewise been suggested elsewhere that
the rigid application of the new CDC guidelines may trigger legal claims,
especially if there is no link to care for persons with a positive test result, no proof
of informed consent, or inadequate counseling.19

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

Facilities. Available at http://www.unicef.org/aids/files/PITCGuidance2007_Eng.pdf; Last


accessed May 19, 2016.

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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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The rights under threat from coercive approaches to


screening are said to include the rights to nondiscrimination
and bodily integrity, the right to be free from violence, and
the right to the highest attainable standard of health. It
should be noted that the Revised CDC Guidelines go further
than those of WHO and UNAIDS (see below), because
among other things they envisage opt-out testing in all
health care settings, not only “where there is a high HIV
prevalence.”21
All patients initiating treatment It has been argued that the
for TB requirement of informed consent
has been raised to an unjustifiably
high level for HIV care under the
principle of "AIDS
exceptionalism."23 Hence,
amendments to Republic Act 8504
and other regulations governing
HIV/AIDS should be justified that
informed consent has been relaxed
for other communicable diseases,
including tuberculosis.
All patients initiating treatment
for STDs during each visit for a
new complaint
All pregnant women as early as
possible during each pregnancy

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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Newborn as soon as possible


after birth
Repeat ANNUAL: All persons likely to be From a human rights perspective, routine testing also Under international law, any public
screening at high risk for HIV: carries the risks of becoming a war on "vulnerable groups." health action by the state that
timelines and  injection-drug users and Given the current stigma in the Philippines for drug-users, limits human rights must be
coverage their sex partners sex workers, and MSMs, these groups can be deterred from justified by demonstrating that it:
 persons who exchange seeking health services by the fear of forced HIV testing and 1. is rationally connected to
sex for money or drugs prejudicial treatment by health workers. achieving a pressing objective;
 sex partners of HIV- 2. infringes upon human rights as
infected persons little as possible; and
 MSM or heterosexual 3. ensures that the benefits
persons who themselves achieved are proportional to
or whose sex partners the harm done to individual
have had more than one human rights.24
sex partner since their
most recent HIV test
BEFORE SEXUAL RELATIONSHIP
INITIATION: patients and their
prospective sex partners*
CLINICAL JUDGMENT: persons
not likely to be at high risk for
HIV
TIME OF EXPOSURE: any person
whose blood or body fluid is the
source of an occupational
exposure for a health-care
provider

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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Exception: unless recent HIV test


results are immediately available
Consent and Screening should be voluntary Oral means of informing patients may trigger legal claims, The Revised CDC Guidelines
pretest and undertaken only with the especially if there is no proof that the missed opportunity requiring opt-out screening for HIV,
information patient's knowledge and for pre- and post-test counseling will impact negatively on a notably without written patient
understanding that HIV testing is person's coping ability as well their prospects for adherence consent, implies that even in the
planned to ART. United States, HIV-associated laws
Patients should be informed in conflict with this approach
orally or in writing that HIV should be amended.25 This
testing will be performed unless implication is applicable in the
they decline (opt-out screening): Philippine Setting. In the
 screening should be Philippines, implementing these
incorporated into the guidelines will necessitate an
patient's general informed amendment of the Philippine AIDS
consent for medical care on Law (Republic Act 8504), which
the same basis as are other requires opt-in testing founded on
screening or diagnostic tests voluntary, written informed
 separate consent form for HIV consent during the testing process.
testing is not recommended
Easily understood informational Section 20 of RA 8504 requires pre- and post-test Amendments should include of the
materials should be made counseling. This portion of law must be amended: WHO/UNAIDS testing guidelines26
available in the languages of the which recommend ensuring opt-
commonly encountered Section 20. Pre-test and post-test counselling. – All out testing remain voluntary,
populations within the service testing centers, clinics, or laboratories which confidential, consensual, and
area perform any HIV test shall be required to provide supported by strong counseling and
and conduct free pre-test counselling and post-test access to services.
counselling for persons who avail of their HIV/AIDS
testing services. However, such counselling services

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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must be provided only by persons who meet the


standards set by the DOH.
Patient’s decision to “opt out”
should be documented in the
medical record
Diagnostic All patients with signs or
testing for symptoms consistent with HIV
HIV infection infection or an opportunistic
illness characteristic of AIDS
should be tested for HIV
Clinicians should maintain a high
level of suspicion for acute HIV
infection in all patients who have
a compatible clinical syndrome
and who report recent high-risk
behavior
Sufficiency of Patients or persons responsible Continued emphasis on counseling as the gateway to
patient's for the patient's care should be informed consent necessitates training community health
general notified orally that: workers in counseling that is sensitive to human rights and
consent via 1. testing is planned; ethics in the practice of medicine. It also requires that the
oral 2. advised of the indication for state play a much greater role in making health information
notification testing; available in order to increase treatment literacy and
3. the implications of positive understanding of HIV.27
and negative test results; and
4. offered an opportunity to ask
questions and to decline
testing.
With such notification, the
patient's general consent for

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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medical care is considered


sufficient for diagnostic HIV
testing

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