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Activating Law and Human Rights to End Tuberculosis: An Empirical Assessment of Ten Countries' Fulfillment of United Nations Commitments

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The United Nations General Assembly held the first-ever High-Level Meeting on Tuberculosis in 2018 (the TB UNLHM). In the Political Declaration that followed, Heads of State made ambitious pledges to end TB and drug resistant TB by 2030. Among these were pioneering legal and human rights commitments on the right to health, non-discrimination, and access to medicines. In 2020 and 2023, the UN Secretary-General and World Health Organization released reports examining countries’ progress toward the UN pledges. The reports discuss some human rights initiatives and contain data for key targets, such as reductions in TB incidence and deaths, but they do not empirically evaluate progress toward the legal and human rights commitments. This paper fills this gap by reviewing law and policy in ten countries with high burdens of drug-resistant TB. It develops the TB UNHLM Legal Rights Index modeled on the Human Development Index, comprising quantitative indicators for the legal and human rights pledges. Using this empirical framework, this paper evaluates over 150 legal instruments from the ten countries and finds that each has failed to meet all three commitments. The results nonetheless demonstrate significant variation among the countries and highlight challenges and opportunities as they work to fulfill their pledges in the new Political Declaration from the second TB UNHLM held in September 2023.
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Indiana Health Law Review
Volume XXI 2024 Number 1
ARTICLES
ACTIVATING LAW AND HUMAN RIGHTS TO END
TUBERCULOSIS: AN EMPIRICAL ASSESSMENT OF
TEN COUNTRIES FULFILLMENT OF
UNITED NATIONS COMMITMENTS
BRIAN CITRO*
ABSTRACT
The United Nations General Assembly held the first-ever High-Level
Meeting on Tuberculosis in 2018 (the TB UNLHM). In the Political Declaration
that followed, Heads of State made ambitious pledges to end TB and drug-
resistant TB by 2030. Among these were pioneering legal and human rights
commitments on the right to health, non-discrimination, and access to
medicines. In 2020 and 2023, the UN Secretary-General and World Health
Organization released reports examining countries’ progress toward the UN
pledges. The reports discuss some human rights initiatives and contain data for
key targets, such as reductions in TB incidence and deaths, but they do not
empirically evaluate progress toward the legal and human rights commitments.
This paper fills this gap by reviewing law and policy in ten countries with high
burdens of drug-resistant TB. It develops the TB UNHLM Legal Rights Index
modeled on the Human Development Index, comprising quantitative indicators
for the legal and human rights pledges. Using this empirical framework, this
paper evaluates over 150 legal instruments from the ten countries and finds that
each has failed to meet all three commitments. The results nonetheless
demonstrate significant variation among the countries and highlight challenges
and opportunities as they work to fulfill their pledges in the new Political
Declaration from the second TB UNHLM held in September 2023.
—————————————————————————————
* Independent researcher and Lecturer at the University of Chicago; JD, University of
Chicago Law School; BM, Northern Illinois University. Thanks to the Global Drug-Resistant TB
Initiative for supporting this research, especially Fuad Mirzayev, Medea Gegia, Fraser Wares,
Ignacio Monedero, and Sarabjit Singh Chadha, and thanks to Kate Sagers De La Cruz for her
research assistance.
INDIANA HEALTH LAW REVIEW [Vol. 21:1
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TABLE OF CONTENTS
I. INTRODUCTION
II. GLOBAL CONTEXT
A. Drug-Resistant Tuberculosis
III. ASSESSMENT SCOPE, METHODOLOGY, AND LIMITATIONS
A. Scope
1. TB UNHLM Commitments
2. Legal Jurisdictions
3. Sources of Law
B. Methodology: TB UNHLM Legal Rights Index
1. Right to Health Indicator
2. Non-Discrimination Indicator
3. Access to Medicines Indicator
C. Limitations
IV. ASSESSMENT RESULTS: FULFILLING TB UNHLM LEGAL AND HUMAN
RIGHTS COMMITMENTS
A. TB UNHLM Legal Rights Index
B. Right to Health
C. Non-Discrimination
D. Access to Medicines
V. CONCLUSION
APPENDIX
I. INTRODUCTION
In September 2018, the United Nations (UN) General Assembly held the
first-ever High-Level Meeting on the Fight against Tuberculosis (the TB
UNHLM).
1
The theme was: “United to end tuberculosis: an urgent global
response to a global epidemic.”
2
During the meeting, the heads of UN Member
States acknowledged that tuberculosis (TB) was the top infectious disease killer
at the time and a major cause of death related to antimicrobial resistance. They
agreed to accelerate efforts to end TB and reach all affected people with
prevention, diagnosis, treatment, and care.
The TB UNHLM produced a Political Declaration on the Fight against
Tuberculosis in the form of a UN General Assembly resolution.
3
In the
Declaration, UN Member States affirmed that:
tuberculosis, including its drug-resistant forms, is a critical challenge
—————————————————————————————
1
. United Nations High-Level Meeting on the Fight to End Tuberculosis, GEN. ASSEMB. OF
THE UNITED NATIONS, (Sept. 26, 2018), https://www.un.org/pga/73/event/fight-to-end-
tuberculosis [https://perma.cc/X284-JLPE].
2
. Id.
3
. G.A. Res. 73/3 (Oct. 18, 2018).
2024] ACTIVATING LAW AND HUMAN RIGHTS 3
TO END TUBERCULOSIS
and the leading cause of death from infectious disease, the most
common form of antimicrobial resistance globally and the leading cause
of death of people living with HIV, and that poverty, gender inequality,
vulnerability, discrimination and marginalization exacerbate the risks
of contracting tuberculosis and its devastating impacts, including
stigma and discrimination at all ages . . .
4
Member States committed to meeting ambitious targets in the four years
from 2019 to 2022, during which the Political Declaration runs. These targets
include reaching forty-million people with TB treatment, including 1.5 million
with drug-resistant TB (DR-TB) and thirty million with preventive treatment.
5
In addition to public health targets, countries made three pioneering legal and
human rights commitments to “protect and promote” the right to health,
“promote and support an end to stigma and . . . discrimination” against people
affected by TB, and “[promote] access to affordable medicines.”
6
Member
States also requested the UN Secretary-General to submit a report in 2020 and
conduct a “comprehensive review” in 2023 with the World Health
Organization’s (WHO) support on “the progress and implementation of the
[Political Declaration] towards agreed tuberculosis goals at the national,
regional and global levels.”
7
In 2020, the UN Secretary-General and WHO released reports highlighting
global progress toward the TB UNHLM targets and documents containing data
on TB funding pledges and public health targets, such as reductions in TB
incidence and deaths and increases in treatment access.
8
However, the 2020
progress reports do not empirically evaluate progress toward fulfilling the three
legal and human rights commitments. Instead, the Secretary-General’s report
discusses a few human rights initiatives, noting that legislators in some “high-
burden countries have been working . . . to promote laws that protect the rights
of people with TB.”
9
In their recommendations, the reports call on Member
States to “[r]eview and update laws, policies and programmers to combat
inequalities and eliminate stigma and discriminatory practices in the TB
response, working together with civil society and affected communities.”
10
In 2023, the UN Secretary-General and WHO released their final,
—————————————————————————————
4
. Id. at 1.
5
. Id. ¶¶ 24-25.
6
. Id. ¶ ¶ 19, 37.
7
. Id. ¶ 53.
8
. U.N. Secretary-General, Progress Towards the Achievement of Global Tuberculosis
Targets and Implementation of the Political Declaration of the High-Level Meeting of the General
Assembly on the Fight Against Tuberculosis, A/75/236 (Sept. 16, 2020); World Health Org.,
Overview: Progress Towards Achieving Global Tuberculosis Targets and Implementation of the
UN Political Declaration on Tuberculosis (Sept. 23, 2020).
9
. U.N. Secretary-General, id. ¶ 62(b).
10
. Id. ¶ 103(a); World Health Org., supra note 8, at 5.
INDIANA HEALTH LAW REVIEW [Vol. 21:1
4
comprehensive review of global progress towards the TB UNHLM targets.
11
The 2023 reviews contain detailed analyses of global progress in meeting public
health targets, including reductions in TB incidence and mortality and the
number of people treated for TB.
12
The reviews also contain socio-economic
indicators, such as the number of people with TB who experienced financial
hardship because of the disease and global funding levels for TB services.
13
However, like the 2020 reports, the 2023 reviews do not empirically evaluate
progress toward the TB UNHLM legal and human rights commitments. The
Secretary-General’s report includes a section titled “Transforming the
tuberculosis response with a focus on human rights, equity, multisectoral
engagement and accountability,” but it only briefly mentions some human
rights-related initiatives and highlights the engagement of civil society and
affected communities in the TB response.
14
The report also includes a
recommendation calling on Member States to “Enforce laws, policies and
programmes that protect human rights, and eliminate inequalities, stigma and
discriminatory practices in the TB response.”
15
Notably, neither the 2020 nor 2023 progress reports discuss intellectual
property or patent policy, despite Member States’ commitment in the Political
Declaration to use so-called “flexibilities” from the World Trade Organization’s
TRIPS Agreement to address intellectual property and patent-related barriers to
TB drugs.
16
Instead, the Secretary-General’s 2020 report highlights global
mechanisms and claims that “[b]ilateral and multilateral agreements are helping
to make new drugs and diagnostics more affordable.”
17
The document only
refers to intellectual property barriers in relation to research and development,
noting that the “complexity and variability of regulatory processes related to
sharing scientific data, patent information, the review of new health products
and research protocols also constrain the pace of research” for TB.
18
The
Secretary-General’s 2023 report does not mention intellectual property and only
refers to patents once in a sentence asserting that “[e]asily accessible databases
on research and development investment, patents and the pricing of medicines
can help ensure that investments in innovation lead to equitable access.”
19
The
Secretary-General’s 2023 report does not mention intellectual property and only
—————————————————————————————
11
. U.N. Secretary-General, Comprehensive review of progress towards the achievement of
global tuberculosis targets and implementation of the political declaration of the United Nations
high-level meeting of the General Assembly on the fight against tuberculosis, A/78/88 (May 18,
2023); World Health Org. Status Update: Reaching the Targets in the Political Declaration of the
United Nations General Assembly High-Level Meeting on the Fight Against Tuberculosis (Sept.
2023).
12
. U.N. Secretary-General, id. ¶¶ 8-15, 18-21; World Health Org., id. at 3.
13
. U.N. Secretary-General, id. ¶¶ 16-17, 25-30; World Health Org., id. at 5.
14
. U.N. Secretary-General, id. ¶¶ 58-68.
15
. Id. ¶ 106(a).
16
. General Assembly, supra note 3, ¶ 19. 3
17
. U.N. Secretary-General, supra note 8, ¶¶ 45-46.
18
. Id. ¶ 79.
19
. U.N. Secretary-General, supra note 1, ¶ 80.
2024] ACTIVATING LAW AND HUMAN RIGHTS 5
TO END TUBERCULOSIS
refers to patents once in a sentence asserting that “[e]asily accessible databases
on research and development investment, patents and the pricing of medicines
can help ensure that investments in innovation lead to equitable access.”
20
Notwithstanding the failure to consider patent-related barriers to TB medicines,
both Secretary-General reports acknowledge that “achieving equitable access to
new TB medicines and technologies remains a major challenge.”
21
In September 2023, the UN General Assembly held the second TB
UNHLM.
22
The meeting’s theme was “Advancing science, finance and
innovation, and their benefits, to urgently end the global tuberculosis epidemic,
in particular, by ensuring equitable access to prevention, testing, treatment and
care.”
23
Member States reviewed the progress they made in meeting the targets
set in 2018 Political Declaration, and they adopted a new declaration, aiming to
end the TB epidemic by 2030.
24
A thorough analysis of the 2023 Political
Declaration is beyond the scope of this paper. Notably, the declaration
recommits Member States to protecting and promoting the right to health,
increasing access to affordable medicines, and eliminating all forms of TB-
related stigma and discrimination.
25
This paper empirically evaluates the fulfillment of Member States’ legal and
human rights commitments in the 2018 TB UNHLM Political Declaration by
examining law and policy in ten countries with high DR-TB burdens. The paper
develops the TB UNHLM Legal Rights Index, a novel assessment framework
modeled on the Human Development Index, comprising the TB UNHLM Legal
Rights Indicator (LRI) and quantitative indicators for the three legal and human
rights pledges. Using this empirical framework, this paper evaluates more than
150 legal instruments from the ten countries and finds that each nation has failed
to meet all three commitments. The assessment nonetheless demonstrates
significant variation among the countries and highlights challenges and
opportunities for Member States as they work to fulfill their pledges in the 2023
Political Declaration.
This paper proceeds as follows. Section II sets the global context, focusing
on DR-TB. Section III details the assessment’s scope, methodology, and
limitations, introducing the TB UNHLM Legal Rights Index. Section IV
presents the assessment results and discussion. Finally, section V concludes and
shares reflections on fulfilling the TB UNHLM legal and human rights
commitments.
—————————————————————————————
20
. U.N. Secretary-General, supra note 11, ¶ 80.
21
. Id. ¶ 57; U.N. Secretary-General, supra note 8, ¶ 82.
22
. United Nations High-Level Meeting on the Fight to End Tuberculosis, GEN. ASSEMB. OF
THE UNITED NATIONS, (Sept. 22, 2023), https://www.who.int/activities/preparing-for-the-un-high-
level-meeting-on-the-fight-against-tuberculosis--2023 [https://perma.cc/EN45-HQNA].
23
. Id.
24
. G.A. Res. 78/5 (Oct. 16, 2023).
25
. Id. ¶¶ 39, 70, 77.
INDIANA HEALTH LAW REVIEW [Vol. 21:1
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II. GLOBAL CONTEXT
TB is preventable and curable, yet it remains one of the leading causes of
death worldwide.
26
In 2022, 10.6 million people fell ill with TB, and 1.3 million
diedmore than 3,500 people a day.
27
About 3% of the people who got sick
with TBmore than three million overall—were “missed by national TB
programs.
28
Some of the “missing millions” may have obtained testing and
treatment in the private sector, but many likely went undiagnosed and untreated,
further contributing to the spread of the disease.
The COVID-19 pandemic had a terrible impact on the TB response. Key
global indicators moved in the wrong direction in 2020 for the first time in more
than a decade and continued doing so in 2021, placing hard-earned gains at
stake.
29
In its 2021 Global Tuberculosis Report, WHO reported that while TB
incidence remained essentially the same as the year before, the number of people
newly diagnosed with TB and registered by their national health systems fell
from 7.1 million to 5.8 million.
30
WHO also reported an increase in TB deaths
in 2020 and 2021 for the first time in fifteen years, erasing more than a decade
of progress.
31
In 2023, WHO reported “a major global recovery in the number
of people diagnosed with TB and treated” during 2022 following these two years
of disruptions caused by the COVID-19 pandemic.
32
Notwithstanding this
notable recovery, WHO also reports that “COVID-related disruptions” are
estimated to have caused about half a million more TB deaths from 2020 to 2022
as compared with the number that would have likely occurred if pre-pandemic
trends in TB mortality had continued.
33
A. Drug-Resistant Tuberculosis
Drug-resistant TB (DR-TB) is TB that is resistant to at least one of the main
drugs used to treat the disease. DR-TB is one of the most common forms of
antimicrobial resistance,
34
which WHO has declared to be one of the top “global
—————————————————————————————
26
. Taghreed Adam et al., Global Tuberculosis Report 2023, WORLD HEALTH ORG., at 1
(2023).
27
. Id. at 2.
28
. Id. The first figure is calculated by dividing the total number of people reported as newly
diagnosed with TB (7.5 million) by the global number of people estimated to have developed TB
(10.6 million) in 2022. The second figure is calculated by subtracting the number of newly
diagnosed from the number of people who fell ill.
29
. Tereza Kasaeva, Global Tuberculosis Report 2021, WORLD HEALTH ORG., at v (2021).
30
. Id. at 1, 4.
31
. Annabel Baddeley et al., Global Tuberculosis Report 2022, WORLD HEALTH ORG., at 2
(2022).
32
. Global Tuberculosis Report 2023, supra note 25, at 2.
33
. Id.
34
. Global Burden of Bacterial Antimicrobial Resistance in 2019: A Systematic Analysis,
ANTIMICROBIAL RESISTANCE COLLABORATORS 399 Lancet 629 (2022).
2024] ACTIVATING LAW AND HUMAN RIGHTS 7
TO END TUBERCULOSIS
public health threats facing humanity.”
35
There are several types of DR-TB.
Multidrug-resistant TB (MDR-TB) is resistant to two of the most effective TB
drugsrifampicin and isoniazid.
36
Rifampicin-resistant TB (RR-TB) is
resistant to rifampicin.
37
Extensively drug-resistant TB (XDR-TB) is resistant
to rifampicin (and possibly isoniazid), at least one fluoroquinolone
(levofloxacin or moxifloxacin), and bedaquiline, linezolid, or both.
38
Pre-
extensively drug-resistant TB (pre-XDR-TB) is resistant to rifampicin (and
possibly isoniazid) and at least one fluoroquinolone (levofloxacin or
moxifloxacin).
39
More than 400,000 people fell ill with MDR- or RR-TB in 2022.
40
However,
only 175,650 of those were diagnosed and started on treatment, about two in
five people and still below the number diagnosed and treated for DR-TB in 2019
before the pandemic (181,533).
41
Diagnosing DR-TB requires bacteriological
confirmation of TB plus testing for drug resistance using advanced diagnostics,
such as rapid molecular tests, culture methods, or sequencing technologies.
42
In
2022, only 47% of people newly diagnosed with TB were tested with WHO-
recommended advanced diagnostics that detect drug resistance.
43
To explain the
gaps in DR-TB incidence and the number of people tested and treated for the
disease, experts emphasize the “[p]rohibitive pricing and lack of transparency”
around the cost of production of a leading rapid, molecular diagnostic for TB
the GeneXpert MTB/RIF Assay, a cartridge-based nucleic acid amplification
test.
44
The company that manufactures the diagnostic received more than USD
250 million in public funding, primarily from the US government, to develop
the technology.
45
Yet, the diagnostic is prohibitively costly, limiting access to
the tests in low-and middle-income countries. A 2019 study modeled the
necessary investments required for twenty-four high-burden countries to use the
GeneXpert to meet the TB UNHLM target of diagnosing and treating forty-
—————————————————————————————
35
. World Health Org., Global Antimicrobial Resistance and Use Surveillance System
(GLASS) Report 2021, at 2 (2021).
36
. World Health Org., WHO Consolidated Guidelines on Tuberculosis, Module 4:
Treatment, Drug-Resistant Tuberculosis Treatment, 2022 Update, at xi (2022).
37
. Id. at xii.
38
. Id. at xi.
39
. Id. at xii.
40
. Global Tuberculosis Report 2023, supra note 25, at 2.
41
. Id.
42
. Id. at 28.
43
. Summary of Tuberculosis Data: Tuberculosis in the World, WORLD HEALTH ORG.,
https://worldhealthorg.shinyapps.io/TBrief/?_inputs_&group_code=%22global%22&entity_typ
e=%22group%22&sidebarCollapsed=true&sidebarItemExpanded=null (last visited Jan. 12,
2024).
44
. David Branigan, Realizing Returns on U.S. Government Investments in GeneXpert
Diagnostic Technologies, TREATMENT ACTION GROUP AND MÉDECINS SANS FRONTIÈRES (Sept.
2021), https://www.treatmentactiongroup.org/wp-content/uploads/2021/09/realizing_returns_
govt_investments_geneXpert.pdf. [https://perma.cc/6N8H-8873]
45
. Dzintars Gotham et al., Public Investments in the Development of GeneXpert Molecular
Diagnostic Technology, 16 PLOS ONE (2021).
INDIANA HEALTH LAW REVIEW [Vol. 21:1
8
million people by 2023. The analysis revealed that it would require an additional
USD one billion in investmentsfive times the amount invested at the time
to meet the UNHLM target.
46
In September 2023, under global pressure from
advocates, GeneXpert’s manufacturer reduced the cost of a key component of
the diagnostic by 20%.
47
Médecins Sans Frontières (Doctors Without Borders)
called the reduction a “significant step in the right direction” but noted that the
test for the most severe form of TB (XDR-TB) remains prohibitively priced.
48
The success rate for MDR-TB treatment is only 63% globally, compared
with 88% for drug-sensitive TB treatment.
49
Until recently, the standard DR-TB
treatment comprised a regimen of multiple second-line drugs for at least nine
and as long as twenty months.
50
This regimen has potentially severe side effects,
including cardiac toxicity, depression, liver dysfunction, neuropathy, and
hearing loss.
51
But after more than forty-years during which no new TB drugs
were approved, three newer drugs are now available for DR-TB: bedaquiline,
delamanid, and pretomanid. The new drugs have led to shorter, more tolerable
DR-TB treatments. These include a six-month treatment for MDR/RR-TB and
pre-XDR-TB called BPaL(M) and a nine-month, all-oral MDR/RR-TB
treatment that eliminates the need for painful injections used in older treatments
that can lead to hearing loss.
52
However, globally, only 30% of people with DR-TB receive these new,
shorter treatments.
53
WHO acknowledges there are “major economic and
financial barriers to accessing and completing TB treatment.”
54
Experts point to
intellectual property protections and pricing as major barriers to accessing the
new DR-TB drugs.
55
The primary patent on the basic compound in the drug
delamanid expired in October 2023, but the manufacturer, Otsuka, still holds
—————————————————————————————
46
. Amy S. Piatek et al., Realizing the “40 by 2022” Commitment from the United Nations
High-Level Meeting on the Fight to End Tuberculosis: What Will It Take to Meet Rapid
Diagnostic Testing Needs?, 7 GLOBAL HEALTH: SCIENCE AND PRACTICE 551 (2019).
47
. Médecins Sans Frontières, Technical Brief: Access to TB Testing and Treatments:
GeneXpert and Delamanid, at 3 (Nov. 2023), https://msfaccess.org/sites/default/files/2023-
11/MSF-AC_TB_GeneXpert%2BDlm_Final.pdf.
48
. Id.
49
. Global Tuberculosis Report 2023, supra note 25, at 2.
50
. Global Tuberculosis Report 2021, supra note 28, at 19.
51
. Christoph Lange et al., Management of Drug-Resistant Tuberculosis, 394 THE LANCET
953 (2019); Francesca Conradie et al., BedaquilinePretomanidLinezolid Regimens for Drug-
Resistant Tuberculosis, 387 NEW ENG. J. MED. 810 (2022).
52
. WHO Consolidated Guidelines on Tuberculosis, supra note 35, at xvi.
53
. Summary of Tuberculosis Data, supra note 42.
54
. Global Tuberculosis Report 2023, supra note 25, at 2.
55
. See Eskild Petersen et al., End of the Bedaquiline patent a crucial development for
moving forward affordable drugs, diagnostics, and vaccines for infectious diseases in low- and
middle-income countries, 131 Int’l J. Infectious Disease 180 (2023); Lindsay McKenna, An
Activist’s Guide to Shorter Treatment for Drug-Resistant Tuberculosis, TREATMENT ACTION
GROUP (Nov. 2023), https://www.treatmentactiongroup.org/wp-content/uploads/2023/11/
activists_guide_shorter_tx_dr_tb_2023.pdf; Médecins Sans Frontières, DR-TB Drugs Under the
Microscope 2022: Pricing and patent landscape of medicines for adults and children, 8th ed. (Nov.
2022), https://msfaccess.org/dr-tb-drugs-under-microscope-8th-edition.
2024] ACTIVATING LAW AND HUMAN RIGHTS 9
TO END TUBERCULOSIS
secondary patents and further patent applications pending.
56
In September 2023,
Otsuka reduced the price of delamanid for countries buying through the Stop
TB Partnership’s bulk purchasing mechanism, the Global Drug Facility.
57
But
at $1,700 per six-month treatment course, delamanid remains prohibitively
expensive for countries that need it.
58
In 2017, researchers estimated that
manufacturers could produce and sell delamanid for a profit at $30 to $96 per
six-month treatment.
59
The drug bedaquiline, manufactured by Johnson &
Johnson, was on patent and priced prohibitively high until its primary patent
expired in July 2023,
60
and the company, under mounting pressure from a
decades-long global advocacy campaign, announced its intention in September
2023 not to enforce its remaining patents on the drug.
61
In March 2023, the
Indian Controller of Patents also rejected Johnson & Johnson’s application to
extend its patent on bedaquiline in the country, opening the door to Indian
generic manufacturers to produce the drug for domestic use and global export.
62
The TB Alliance, a non-profit partnership funded entirely by governments and
philanthropies, sponsored the development of the drug pretomanid.
63
The TB
Alliance has signed non-exclusive licensing agreements with several generic
manufacturers to produce pretomanid.
64
However, experts note that the price of
the drug is still high, constituting over 50% of the cost of the BPaL(M) regimen,
though prices may fall as the other producers enter the market and volumes
increase.
65
—————————————————————————————
56
. Medicines Patent Pool, MedsPaL Medicines Patents and Licenses Database: Delamanid
50mg, https://www.medspal.org/?product%5B%5D=Delamanid+50+mg&page=1.
57
. Médecins Sans Frontières, supra note 46.
58
. Id. at 4.
59
. Dzintars Gotham et al., Estimated generic prices for novel treatments for drug-resistant
tuberculosis, 72 J. Antimicrobial Chemotherapy 1243 (2017).
60
. Medicines Patent Pool, MedsPaL Medicines Patents and Licenses Database: Bedaquiline 100mg,
https://www.medspal.org/?product%5B%5D=Bedaquiline+100+mg&page=1.
61
. Médecins Sans Frontières, supra note 47; Johnson & Johnson, Johnson & Johnson
Confirms Intent Not to Enforce Patents for SIRTURO® (bedaquiline) for the Treatment of
Multidrug-Resistant Tuberculosis in 134 Low- and Middle-Income Countries (Sept. 29, 2023),
https://www.jnj.com/johnson-johnson-confirms-intent-not-to-enforce-patents-for-sirturo-
bedaquiline-for-the-treatment-of-multidrug-resistant-tuberculosis-in-134-low-and-middle-
income-countries.
62
. In the matter of Patent Application No. 1220/MUMNP/2009 by Janssen Pharmaceutica
and In the matter representation by way of opposition by Network of Maharashtra people living
with HIV, Nandita Venkatesan, and Phumeza Tisile (Mar. 23, 2023), available at
https://www.patentoppositions.org/en/drugs/bedaquiline/patent_office_decisions/641c1136d270
8f00050ab275; see also Sankalp Yadav, Gautam Rawal, and Madhan Jeyaraman, India’s
Decision to Deny an Extension of Patent for Bedaquiline: A Public Health Imperative, 15 Cureus
e49542.
63
. TB Alliance, The Pathway to Potential New TB Treatments, https://www.tballiance.org/
pathway-potential-new-tb-treatments (last visited Jan. 12, 2023).
64
. TB Alliance, Realizing our “Triple-A Mandate” (Aug. 14, 2023), https://www.tballiance.
org/ news/realizing-our-triple-mandate.
65
. McKenna, supra note 54, at 13.
INDIANA HEALTH LAW REVIEW [Vol. 21:1
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III. ASSESSMENT SCOPE, METHODOLOGY, AND LIMITATIONS
This section lays out the scope, methodology, and limitations of this paper’s
empirical assessment framework.
A. Scope
The scope of this assessment involves three parameters: (1) TB UNHLM
commitments, (2) legal jurisdictions (i.e., countries), and (3) sources of law.
1. TB UNHLM Commitments
UN Member States made three distinct legal and human rights commitments
in the 2018 Political Declaration from the TB UNHLM. They are commitments
concerning the right to health, non-discrimination, and access to medicines. The
right to health pledge comes primarily from paragraph thirty-seven of the
Political Declaration, in which countries:
Commit to protect and promote the right to the enjoyment of the highest
attainable standard of physical and mental health, in order to advance
towards universal access to quality, affordable and equitable
prevention, diagnosis, treatment, care and education related to
tuberculosis and multidrug-resistant tuberculosis . . . .
66
The right to health is also mentioned in paragraph thirteen, in which States:
Note with concern that the protection and promotion of the right to the
enjoyment of the highest attainable standard of physical and mental health,
. . . remains challenging, especially in developing countries . . . .
67
The non-discrimination commitment also comes primarily from paragraph
thirty-seven of the Political Declaration, in which countries:
Commit to . . . promote and support an end to stigma and all forms of
discrimination, including by removing discriminatory laws, policies
and programmes against people with tuberculosis . . . .
68
The preamble to the Political Declaration also mentions discrimination.
—————————————————————————————
66
. G.A. Res. A/RES/73/3 (Oct. 18, 2018). (The “right to the enjoyment of the highest
attainable standard of physical and mental health” is the full term for the “right to health” as
enshrined in article 12 of the International Covenant on Economic, Social and Cultural Rights.
G.A. Res. 2200A (XXI), ¶ 37 (Dec. 16, 1966)).
67
. G.A. Res. 2200A (XXI), ¶ 13 (Dec. 16, 1966).
68
. Id. ¶ 37.
2024] ACTIVATING LAW AND HUMAN RIGHTS 11
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States affirm that “poverty, gender inequality, vulnerability, discrimination and
marginalization exacerbate the risks of contracting tuberculosis and its
devastating impacts, including stigma and discrimination . . . .”
69
Countries raise
“serious concerns” about the “enormous costs” people affected by TB incur
from stigma and discrimination in paragraph seven.
70
And countries make
further commitments to reducing discrimination and ensuring the non-
discriminatory “involvement of communities and civil society” in the disease
response in paragraphs fourteen and seventeen, respectively.
71
The access to
medicines pledge comes primarily from paragraph nineteen, in which States:
Commit to promoting access to affordable medicines, including
generics, for scaling up access to affordable tuberculosis treatment,
including the treatment of multidrug-resistant and extensively drug-
resistant tuberculosis, reaffirming the World Trade Organization
Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPS Agreement), as amended, and also reaffirming the 2001 World
Trade Organization Doha Declaration on the TRIPS Agreement and
Public Health, which recognizes that intellectual property rights should
be interpreted and implemented in a manner supportive of the right of
Member States to protect public health and, in particular, to promote
access to medicines for all, and notes the need for appropriate incentives
in the development of new health products.
72
Countries raise further concerns about the lack of access to affordable TB
medicines and diagnostics in paragraphs six and thirteen. They underscore the
importance of affordable drugs and diagnostics, including new technologies, to
the global disease response in paragraphs nine and forty-five.
73
2. Legal Jurisdictions
The ten legal jurisdictions in this assessment are from WHO’s 20212025
list of countries with the highest DR-TB incidence rates, one of three “global
lists of [TB] high-burden countries.”
74
They are:
China, Democratic Republic of the Congo (DRC), India, Indonesia,
Myanmar, Nigeria, Pakistan, Philippines, Russian Federation, and
Vietnam.
Combined, these ten nations also accounted for almost 80% of the global DR-
—————————————————————————————
69
. Id. at 1.
70
. Id. ¶ 7.
71
. Id. ¶¶ 14, 17.
72
. Id. ¶¶ 19.
73
. Id. ¶¶ 6, 9, 13, 45.
74
. Global Tuberculosis Report 2022, supra note 30. The full list contains 30 countries: 20
with the highest MDR/RR-TB incidence rates in absolute numbers plus the 10 (not already in the
top 20) with the highest number of new cases per 100,000 people worldwide.
INDIANA HEALTH LAW REVIEW [Vol. 21:1
12
TB treatment gap in 2019, the first year of the TB UNHLM Political
Declaration.
75
In other words, at that time, approximately 80% of people with
DR-TB worldwide who could not access treatment resided in these ten
countries.
3. Sources of Law
This assessment examines three sources of law at the national level in each
countryconstitutions, legislation, and executive branch materials. The review
does not consider sources of law from subnational jurisdictions, such as states,
provenances, districts, or cities. Constitutions comprise each State’s national
constitution. Legislation encompasses laws and statutes enacted by legislatures,
including health, intellectual property, disability, labor, and other laws. The
specific subject matter of the legislation examined is described below in the
three commitment indicators. Executive branch sources comprise directives
promulgated by ministries of health and labor, including regulations, policies,
strategic plans, and other decrees. This assessment reviews each source of law
using the three indicators developed for the TB UNHLM legal and human rights
pledges, as detailed in the next section.
B. Methodology: TB UNHLM Legal Rights Index
This assessment’s methodology is modeled on the UN Human Development
Index (HDI).
76
The HDI measures the “average achievement in key dimensions
of human development,” calculated from the geometric mean of normalized
indices for three dimensionshealth, education, and standard of living.
77
Similarly, the TB UNHLM Legal Rights Index measures UN Member States’
fulfillment of the three legal and human rights commitments in the TB UNHLM
Political Declaration. The TB UNHLM Legal Rights Indicator (LRI) is a
country’s overall score between zero and one calculated from the arithmetic
mean of its three UNHLM commitment indicator scores (right to health (RtH),
non-discrimination (ND), and access to medicines (A2M)):
LRI = (IRtH + IND + IA2M) / 3
A country’s LRI represents its progress in fulfilling the three TB UNHLM legal
and human rights pledges. The TB UNHLM Legal Rights Index lists the ten
assessment countries ranked by their LRI scores. This assessment also produces
indices for the three commitment indicatorsthe Right to Health Index, Non-
—————————————————————————————
75
.Annabel Baddeley et al., Global Tuberculosis Report 2020, WORLD HEALTH ORG., at xvii
(2020).
76
. Human Development Index (HDI), UNITED NATIONS DEVELOPMENT PROGRAM,
[https://perma.cc/H52X-can7] (last visited January 31, 2023).
77
. Id.
2024] ACTIVATING LAW AND HUMAN RIGHTS 13
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Discrimination Index, and Access to Medicines Index. Like the TB UNHLM
Legal Rights Index, they comprise lists of the assessment countries ranked by
their indicator scores.
This assessment uses the arithmetic mean to calculate the LRI rather than
the geometric mean, as in the HDI, for three reasons. First, the TB UNHLM
Index inputsthe three commitment indicescomprise scaled data sets with
scores between zero and one. Second, the commitment indices zero to one scale
means no large, outlier numbers skew the arithmetic mean. Third, the
commitment indices’ data sets contain zeros. Using the geometric mean would
require an imperfect workaround because geometric means always produce a
zero when there is a zero in the data set.
78
1. Right to Health Indicator
As explained above, the right to health commitment indicator stems from
paragraph 37 of the TB UNHLM Political Declaration and is formulated as:
Explicit recognition and commitment to the right to health.
A country’s right to health indicator score is calculated as follows:
—————————————————————————————
78
. See Roberto de la Cruz & Jan-Ulrich Kreft, Geometric Mean Extension for Data Sets
with Zeros, CORNELL, https://arxiv.org/pdf/1806.06403.pdf [https://perma.cc/3KYX-MGUH]
(last visited January 31, 2023).
INDIANA HEALTH LAW REVIEW [Vol. 21:1
14
Figure 2: Right to Health Indicator
Source of law
Score
Constitutional recognition
Full recognition
1.0
Judicial
0.75
State
commitment
0.50
Legislative recognition
Health or human rights law
0.50
HIV law
0.15
Executive branch recognition
0.25
Constitutional recognition means the establishment of a right to health in
the national constitution. Full recognition requires explicit, unambiguous
language establishing an individual right to health (1.0). In the absence of an
explicit right to health in the text of the constitution, partial recognition includes
either judicial recognition of a constitutional right to health in case law (0.75)
or a State commitment in the constitution to protect or promote individual or
public health that falls short of establishing an individual right (0.50).
Legislative recognition means the explicit, unambiguous establishment of a
right to health in health or human rights legislation (0.50)
79
or HIV legislation
(0.15).
80
Executive branch recognition means the explicit recognition of the
right to health in an executive branch decree from the ministry of health (0.25).
The right to health indicator score has a minimum value of zero and a
maximum value of 1.0 and represents a nation’s progress in fulfilling the TB
UNHLM right to health commitment. The score is partly additive. Partial
constitutional recognition is added with legislative recognition or executive
branch recognition. Legislative recognition and executive branch recognition
are also added together. The two elements of partial constitutional recognition
judicial recognition and State commitment to protect or promote healthare
mutually exclusive; a country may only receive points for one or the other. Any
sum above 1.0 is reduced to the maximum value of 1.0.
2. Non-discrimination Indicator
As explained above, the non-discrimination commitment indicator stems
from paragraph thirty-seven of the TB UNHLM Political Declaration and is
formulated as:
—————————————————————————————
79
. This assessment only considers human rights legislation that establishes enforceable,
statutory human rights. It does not include laws that solely establish National Human Rights
Commissions or equivalent bodies.
80
. This assessment includes HIV legislation because TB is the leading killer of people living
with HIV, closely connecting the diseases, and many people are co-infected with both.
2024] ACTIVATING LAW AND HUMAN RIGHTS 15
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Explicit prohibition of discrimination against people affected by TB.
81
A country’s non-discrimination indicator score is calculated as follows:
Figure 3: Non-Discrimination Indicator
Source of law
Score
Constitutional
recognition
Health status
0.50
Other status, catch-all
0.25
Legislative
recognition
Health or human
rights law
TB, infectious
disease
1.0
Health status
0.50
Disability law
TB, infectious
disease
0.75
Labor law
TB, infectious
disease
0.50
Health status
0.25
HIV law
HIV status
0.10
Executive branch recognition
0.25
Constitutional recognition means the explicit prohibition of discrimination
or establishment of the right to be free from discrimination in the national
constitution on the basis of health status (0.50), or “other” status or another
inclusive, catch-all category (0.25). Legislative recognition means the explicit
prohibition of discrimination or establishment of a statutory right to be free from
discrimination in health or human rights legislation
82
on the basis of TB or
infectious, contagious, or communicable disease (1.0) or health status (0.50); or
in disability legislation on the basis of disability wherein “disability” is
explicitly defined to include TB or infectious, contagious, or communicable
—————————————————————————————
81
. United Nations High-Level Meeting on the Fight to End Tuberculosis, supra note 1.
(Countries further commit in paragraph 37 to “removing discriminatory laws, policies and
programmes.” However, this assessment only considers whether countries have affirmatively
prohibited discrimination against people affected by TB for two main reasons. First, as with other
kinds of discrimination, such racial, ethnic, or gender discrimination, ending discrimination
against people affected by TB requires targeted legal prohibitions, not only the elimination of
discriminatory policies. Second, from a methodological perspective, it is prohibitively difficult to
identify laws, policies, or programs that have been removed and are no longer in effect.).
82
. As noted above for the right to health indicator, this assessment only considers human
rights legislation that establish enforceable, statutory human rights. It does not include laws that
solely establish National Human Rights Commissions or equivalent bodies.
INDIANA HEALTH LAW REVIEW [Vol. 21:1
16
disease (0.75); or in employment or labor legislation on the basis of TB or
infectious, contagious, or communicable disease (0.50) or health status (0.25);
or in HIV legislation on the basis of HIV status (0.10).
83
Executive branch
recognition means an explicit prohibition of discrimination, the establishment
of the right to be free from discrimination, or a specific commitment to non-
discrimination on the basis of TB in health care, employment, education, social
protection, housing, or other areas in an executive branch decree from the
ministries of health or labor (0.25).
The non-discrimination indicator score has a minimum value of 0 and a
maximum value of 1.0 and represents a nation’s progress in fulfilling the TB
UNHLM non-discrimination commitment. The score is partly additive.
Constitutional recognition for health status or “other” status or catch-all
category are mutually exclusivea country may only receive points for health
status recognition or “other” status or a catch-all category recognition.
Constitutional recognition is added with legislative recognition. Legislative
recognition in health or human rights legislation, disability legislation, labor
legislation, or HIV legislation are all added together. Constitutional recognition
and legislative recognition are both added with executive branch recognition.
Any sum above 1.0 is reduced to the maximum value of 1.0.
3. Access to Medicines Indicator
As explained above, the access to medicines commitment indicator stems
from paragraph nineteen of the TB UNHLM Political Declaration and is
formulated as:
Commitment to promoting access to affordable medicines through
intellectual property law and policy in line with the World Trade
Organization’s Agreement on Trade-Related Aspects of Intellectual
Property Rights (TRIPS Agreement) and its Doha Declaration.
A country’s access to medicines indicator score is calculated as follows:
—————————————————————————————
83
. As noted above for the right to health indicator, this assessment includes HIV legislation
because TB is a leading killer of people living with HIV, so the diseases are closely connected,
and many people are co-infected with both. However, legislative recognition of the non-
discrimination commitment in HIV legislation (0.10) receives less points than legislative
recognition of the right to health in HIV legislation (0.15) because discrimination prohibitions
protecting people living with HIV are unlikely to apply to all people affected by TB. By contrast,
recognition of the right to health in any kind of health-related legislation may have a broader
impact across diseases.
2024] ACTIVATING LAW AND HUMAN RIGHTS 17
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Figure 4: Access to Medicines Indicator
Source of law
Score
Constitutional
recognition
Access to medicines or health goods,
products, or technologies
0.25
Legislative or
executive branch
recognition
IP/Patent
law or
regulation
6 TRIPS flexibilities
1.0
5 TRIPS flexibilities
0.75
3-4 TRIPS flexibilities
0.50
1-2 TRIPS flexibility
0.25
Textual commitment
0.10
Health law
or regulation
Institutional commitment
0.20
Textual commitment
0.10
Constitutional recognition means an explicit State commitment to
promoting access to medicines or health goods, products, or technologies in the
national constitution (0.25). Legislative or executive branch recognition means
recognition of TRIPS flexibilities (6 = 1.0; 5 = 0.75; 3-4 = 0.50; 1-2 = 0.25) or
an explicit, textual commitment to promote access to medicines (0.10) in
legislation or executive branch decree on intellectual property or patents; or an
explicit, textual commitment (0.10) or concrete institutional commitment
84
i.e., the establishment of institutional structures, procedures, mandates or
authority(0.20) to promote access to medicines in legislation or executive
branch decree on health.
85
According to the World Trade Organization (WTO), World Intellectual
Property Organization (WIPO), and WHO, TRIPS flexibilities comprise a “wide
range of policy options and flexibilities” built into the global intellectual
property regime that “can be used to pursue public health objectives.”
86
Relatedly, in the Doha Declaration on the TRIPS Agreement, WTO members
—————————————————————————————
84
. For institutional and textual commitments in health legislation or executive branch
decree, this assessment considers any kind of explicit commitment to ensuring access to
medicines, not only those related to intellectual property or patents. However, it does not include
guarantees for access to health care or health services, more broadly.
85
. This assessment does not consider TB national strategic plans for executive branch
recognition of the access to medicines commitment. Tuberculosis national strategic plans do not
possess the same level of legal authority as legislation or other executive branch decrees, such as
directives, orders, or regulations, that legally mandate certain actions as opposed to setting forth
an overarching, often aspirational strategy.
86
. WORLD TRADE ORG. ET AL., PROMOTING ACCESS TO MEDICAL TECHNOLOGIES AND
INNOVATION: INTERSECTIONS BETWEEN PUBLIC HEALTH, INTELLECTUAL PROPERTY AND TRADE 21
(2d ed. 2020).
INDIANA HEALTH LAW REVIEW [Vol. 21:1
18
emphasized the importance of implementing the agreement “in a manner
supportive of public health, by promoting both access to existing medicines and
research and development into new medicines.”
87
This assessment considers six
flexibilities:
88
1. Compulsory licensing or government useallows
governments to grant non-voluntary licenses to third parties to
manufacture and sell medicines without the consent of the
patent holder or to produce and use the invention themselves
for public, non-commercial uses, both subject to payment of
adequate remuneration (i.e., a royalty) to the patent holder.
2. Parallel importation and the international exhaustion
principleallows drugs legally placed on the market in one
country to be imported by another country for sale based on the
principle that the patent holder’s exclusive marketing rights
were exhausted when it placed the drug on the foreign country’s
market.
3. Limited exceptions to patent rights for research and
experimental use and “early working” or Bolar exceptions for
regulatory reviewallow third parties to use patented
medicines for research and experimental purposes and to
prepare for regulatory review for generic drugs.
4. Heightened patentability criteriaallows governments to set
their own legal standards for what constitutes an invention
eligible for a patent, including defining “novelty,” “inventive
step,” and “industrial application,” and precluding certain
things from being patented, such as plants and animals.
5. Patent opposition or revocation proceduresallow interested
parties other than a patent-holder to challenge drug patents
before (opposition) and after (revocation) they are granted.
6. Transition period for least developed countries (LDCs)
allows LDCs to refrain from granting or enforcing patent
protections for medicines until January 1, 2033, or a later date
as agreed upon by WTO members.
89
The access to medicines indicator score has a minimum value of 0 and a
—————————————————————————————
87
. World Trade Organization, Ministerial Declaration of 14 November 2001, WTO Doc.
WT/MIN(01)/DEC/1, 17 (2001).
88
. For TRIPS flexibilities, Report of the United Nations Secretary-General’s High-Level
Panel on Access to Medicines: Promoting Innovation and Access to Health Technologies, (Sept.
2016). For patent opposition and revocation procedures, see generally Opposition Systems,
WORLD INTELL. PROP. ORG., http://www.wipo.int/scp/en/revocation_mechanisms/opposition/
index.html [https://perma.cc/LC58-AARF] (last visited Jan. 31, 2023).
89
. There are currently forty-six LDCs on the United Nations list; thirty-five of them are
members of the World Trade Organization, including the DRC. Understanding the WTO: The
Organization: Least-developed Countries, WORLD TRADE ORG., http://www.wto.org/english/
thewto_e/whatis_e/tif_e/org7_e.htm [https://perma.cc/4HKD-LRFA] (last visited Jan. 31, 2023).
2024] ACTIVATING LAW AND HUMAN RIGHTS 19
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maximum value of 1.0 and represents a nation’s progress in fulfilling the TB
UNHLM access to medicines commitment. The score is partly additive.
Constitutional recognition is added with legislative or executive branch
recognition. Recognition in intellectual property or patent legislation or
executive branch decree of 1-6 TRIPS flexibilities are added with textual
commitments to promote access to medicines in intellectual property or patent
legislation or executive branch decree and textual or institutional commitments
in health legislation or executive branch decree. If both textual and institutional
commitments occur in the same legislation or executive branch decree, points
are only awarded for institutional commitment; if they appear in separate
instruments, they are added together. Any sum above 1.0 is reduced to the
maximum value of 1.0.
C. Limitations
This assessment has two main limitations. First, it does not assess the
implementation or enforcement of the sources of law it examines. Legal and
policy commitments on paper are necessary to fulfill the TB UNHLM legal and
human rights pledges. But laws and policies must be implemented and enforced
to achieve their intended results. Notwithstanding this concern, evaluating the
implementation and enforcement of more than 150 laws and policies in ten
countries would be highly challenging from logistical, financial, and
epistemological standpoints.
Second, due to challenges in identifying, obtaining, and analyzing
documents containing the sources of law, the TB UNHLM Legal Rights Index
may reflect gaps in the underlying research. The challenges included identifying
and obtaining documents not available online, searching primarily in English to
identify sources of law in other languages, and using unofficial machine
translations for documents in non-English languages. To mitigate their impact,
the author sent letters to government authorities requesting their assistance in
obtaining documents and confirming aspects of the research. The author also
engaged lawyers and civil society in the assessment countries to the same ends.
The author received further assistance obtaining policy documents from the
Stop TB Partnership Country and Community Support for Impact (CCS4i) team
that works directly with National TB Programs and civil society in the
assessment countries. To reduce language barriers in the assessment, the author
conducted keyword searches in the original languages for non-English language
sources of law. For example, the author searched for the word “discrimination”
in Bahasa, Burmese, Chinese, French, Russian, and Vietnamese while
reviewing sources of law for the non-discrimination commitment.
INDIANA HEALTH LAW REVIEW [Vol. 21:1
20
IV. ASSESSMENT RESULTS: FULFILLING TB UNHLM LEGAL AND
HUMAN RIGHTS COMMITMENTS
This section presents the assessment results of ten high DR-TB-burden
countries’ progress in fulfilling their legal and human rights commitments in the
TB UNHLM Political Declaration. The subsections contain the four indices,
basic quantitative analyses of the results, tabulations of the underlying research
and scoring, and brief discussions.
A. TB UNHLM Legal Rights Index
The TB UNHLM Legal Rights Index below displays the overall
assessment results, with the ten countries ranked in order of their TB UNHLM
Legal Rights Indicator (LRI) scores.
Table 1: TB UNHLM Legal Rights Index
TB UNHLM Commitment Indicators
Right to
Health
Non-
Discrimination
Access to
Medicines
LRI
1
Russia
1.0
1.0
0.90
0.97
2
Vietnam
1.0
1.0
0.70
0.90
3
China
1.0
0.75
0.80
0.85
4
Indonesia
1.0
0.50
0.90
0.80
5
Philippines
1.0
0.35
1.0
0.78
6
DRC
1.0
0.25
0.60
0.62
7
India
0.75
0.10
0.95
0.60
8
Myanmar
1.0
0.25
0.50
0.58
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TB UNHLM Commitment Indicators
Right to
Health
Non-
Discrimination
Access to
Medicines
LRI
9
Nigeria
0.75
0.35
0.55
0.55
10
Pakistan
0
0
0.50
0.17
The TB UNHLM Legal Rights Index has a range of 0.80 from 0.17 to 0.97.
The mean LRI score is 0.682, with a standard deviation of approximately 0.232.
The median score is 0.70, and there is no mode.
B. Right to Health
The Right to Health Index below displays the ten assessment countries
ranked by their right to health indicator scores.
Table 2: Right to Health Index
Right to
Health
1
China
1.0
2
DRC
1.0
3
Indonesia
1.0
4
Myanmar
1.0
5
Philippines
1.0
6
Russia
1.0
7
Vietnam
1.0
8
India
0.75
INDIANA HEALTH LAW REVIEW [Vol. 21:1
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Right to
Health
9
Nigeria
0.75
10
Pakistan
0
The Right to Health Index has a range of 1.0 from 0 to 1.0. The mean right
to health indicator score is 0.85, with a standard deviation of 0.30. The median
and mode scores are both 1.0.
The research and scoring underlying the Right to Health Index are tabulated
here. The table contains the sources of law assessed for each country. As
explained above, the assessment evaluated the national constitution of each
nation to determine constitutional recognition. Countries that received the
maximum value (1.0) for full constitutional recognition were not assessed for
legislative or executive branch recognition, represented by “n/a” in the table.
Sources of law for legislative and executive branch recognition listed with
specific provisions above an ellipsis contribute to a country’s right to health
indicator score. Sources of law without specific provisions do not meet the
definitions for legislative or executive branch recognition of the right to health
commitment. Where necessary, scoring designations and information about the
author’s ability to obtain sources of law are in brackets and footnotes,
respectively.
Table 3: Right to Health Index Scoring and Sources of Law
Constitutional
recognition
Legislative
recognition
Executive
branch
recognition
Score
China
0.50
0.50
0
1.0
Arts. 21, 45
[state
commitment]
Law on Basic
Healthcare and
Health Promotion
(2020) arts. 4-5
Law on the
Prevention and
Treatment of
Infectious Diseases
(1989, rev. 2013)
Implementing
Measures for
the Law on the
Prevention and
Treatment of
Infectious
Diseases (1991)
Healthy China
2030 Blueprint
(2016)
Opinions of the
State Council
on
Implementing
the Healthy
2024] ACTIVATING LAW AND HUMAN RIGHTS 23
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Constitutional
recognition
Legislative
recognition
Executive
branch
recognition
Score
China Action
Plan (2019)
Healthy China
Action (2019
2030) (2019)
DRC
1.0
1.0
Art. 47
n/a
n/a
Indonesia
1.0
1.0
Art. 28H
n/a
n/a
Myanmar
1.0
1.0
Art. 367
n/a
n/a
Philippines
1.0
1.0
Art. II, § 15
n/a
n/a
Russia
1.0
1.0
Art. 41
n/a
n/a
Vietnam
1.0
1.0
Art. 38
n/a
n/a
India
0.75
0
0
0.75
Arts. 21, 39, 47
[judicial
recognition]
Consumer
Education &
Research Centre
v. Union of
Epidemic Diseases
Act (1897)
The Human
Immunodeficiency
Virus and Acquired
Immune Deficiency
Syndrome
(Prevention and
Control) Act (2017)
National Health
Policy 2017
(2017)
National
Strategic Plan
for
Tuberculosis:
201725,
Elimination by
INDIANA HEALTH LAW REVIEW [Vol. 21:1
24
Constitutional
recognition
Legislative
recognition
Executive
branch
recognition
Score
India (1995) 3
SCC 42 (India)
State of Punjab
v. Mohinder
Singh Chawla
(1997) 2 SCC
83 (India)
Epidemic Diseases
(Amendment) Act
(2020)
2025 (2017)
Nigeria
0
0.50
0.25
0.75
African Charter on
Human and
Peoples’ Rights
(Ratification and
Enforcement) Act
(1983) art. 16
National Health Act
(2014) § 1(1)(d, e)
HIV and AIDS
(Anti-
Discrimination) Act
(2014)
National Health
Policy 2016
(2016) §§ 3.4.1,
5.3
National
Strategic Plan
for Tuberculosis
Control 2021
2025 (2021)
Human Rights
and Gender
Action Plan for
Tuberculosis
Care and
Prevention in
Nigeria 2021
2025 (2021)90
Pakistan
0
0
0
0
Public Health
(Emergency
Provision)
Ordinance (1944)
West Pakistan
Epidemic Diseases
Act (1958)
Epidemic Diseases
(Amendment) Act
(2011)
National Health
Vision, 2016
2025 (2016)
National
Strategic Plan
for Tuberculosis
Control, 2020
2023 (2020)
—————————————————————————————
90
. Surprisingly, the Human Rights and Gender Action Plan for Tuberculosis Care and
Prevention in Nigeria 20212025 does not recognize the right to health. However, the plan does
assert that “the right to health is not guaranteed for most Nigerians due to poverty [and]
inaccessibility of . . . health care services,” among other things (see page 7).
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Six of the ten assessment countries score full constitutional recognition (1.0)
by enshrining the right to health in their national constitutions. For example, the
Constitution of the Democratic Republic of the Congo states that the “right to
health and to [a] secure food supply is guaranteed.”
91
The Constitution of
Indonesia provides that every “person has a right to a life of well-being in body
and mind . . . and to receive medical care.”
92
By contrast, the Constitution of the People’s Republic of China contains a
state commitment to “protect the people’s health” through the State’s
development of health services and promotion of sanitation.
93
China nonetheless
scores the maximum value 1.0 because its 2019 Law of the People’s Republic
of China on Basic Healthcare and Health Promotion establishes that the State
shall “respect and protect citizens’ right to health,” including the “right to
receive basic medical and healthcare services.”
94
The Supreme Court of India has judicially recognized a constitutional right
to health through the right to life and health-related “directive principles of state
policy” enshrined in the Constitution of India.
95
In doing so, the court
established a justiciable, individual right to health even though the Constitution
of India does not explicitly recognize the right. India scores 0.75 as a result,
despite not recognizing the right to health through legislation or executive
branch decree.
Similarly, Chapter II of the Constitution of the Federal Republic of Nigeria
sets forth a series of State objectives for socioeconomic policy. The objectives
include pledges to ensure the “health, safety and welfare of all persons in
employment” and “adequate medical and health facilities for all persons.”
96
However, an earlier provision in the constitution makes these sections
nonjusticiable, meaning they are not enforceable in court.
97
And unlike India,
Nigerian courts have not interpreted a justiciable constitutional right to health
through the right to life. Some courts have nonetheless enforced a statutory right
to health in legislation domesticating the regional African Charter on Human
and People’s Rights.
98
The National Health Act also commits to protect,
promote and fulfil the rights of the people of Nigeria to . . . access . . . health
—————————————————————————————
91
. CONST. (2005), art. 47. (Dem. Rep. Congo).
92
. UNDANG-UNDANG DASAR NEGARA REPUBLIK INDONESIA [CONSTITUTION] art. 28H(1)
(1945) (Indon.).
93
. XIANFA art. 21, § 1 [CONSTITUTION] (1982) (China).
94
. Law of the People’s Republic of China on Basic Healthcare and Health Promotion, arts.
4-5 (2020) (China).
95
. INDIA CONST. art. 21, 39, 47; see also Consumer Educ. & Rsch. Ctr. v. Union of India,
Judgment, 1995 3 SCC 42 (India) (Jan. 27); State of Punjab v. Mohinder Singh Chawla, Judgment,
1997 2 SCC 83 (India) (Dec. 17).
96
. CONSTITUTION OF NIGERIA (1999), § 17(3).
97
. Id. § 6(6)(c).
98
. African Charter on Human and Peoples’ Rights (Ratification and Enforcement) Act
(1983) L.F.N. 1990, Cap. 10 (Nigeria); Odafe. v. Attorney General, Judgment, 2004
FHC/PH/CS/680/2003 (Nigeria) (Feb. 23) and Georgina Ahamefule v. Imperial Med. Ctr.,
Judgment, 2012 ID/1627/2000 (Nigeria) (Sept. 27).
INDIANA HEALTH LAW REVIEW [Vol. 21:1
26
care.”
99
The National Health Policy further asserts that the right to health is a
fundamental right and a “guiding principle” for the policy.
100
The policy also
calls for a “review of the Constitution . . . to make health an enforceable right in
Nigeria.”
101
Nigeria thus obtains a score of 0.75 and is the only nation that
recognizes the right to health through executive branch decree.
The Constitution of Pakistan does not contain a right to health. But like in
India, courts have sometimes given wide meaning to the constitutional right to
life. For example, in 1994, the Supreme Court of Pakistan held that
environmental hazards threatening human health implicate the constitutional
rights to life and dignity.
102
More recently, in a 2020 case about the government
response to COVID-19, the court affirmed the “fundamental right . . . to life,
under which [the] Government of Pakistan is required to provide . . . safe and
healthy living conditions.”
103
However, in both cases, the court stopped short of
declaring a constitutional right to health and has not done so in other rulings.
Pakistan also does not recognize the right to health through legislation or
executive branch decree and therefore scores 0 for the right to health indicator.
C. Non-Discrimination
The Non-Discrimination Index below displays the ten assessment countries
ranked by their non-discrimination indicator scores.
—————————————————————————————
99
. National Health Act (2014), Cap. (A139), §1(1)(e) (Nigeria).
100
. National Health Policy (2016), § 3.4.1 (Nigeria).
101
. Id. § 5.3.
102
. Ms. Shehla Zia v. WAPDA, (1994) 1994 PLD (SC) 693 (Pak.).
103
. Suo Moto Action Regarding Combating the Pandemic of Corona Virus (COVID-19),
2020 SCMR (SC) 1006 (Pak.), https://www.supremecourt.gov.pk/downloads_judgements/
s.m.c._1_2020_19052020.pdf [https:// perma.cc/TMB4-247A].
2024] ACTIVATING LAW AND HUMAN RIGHTS 27
TO END TUBERCULOSIS
Table 4: Non-Discrimination Index
Non-
Discrimination
1
Russia
1.0
2
Vietnam
1.0
3
China
0.75
4
Indonesia
0.50
5
Nigeria
0.35
6
Philippines
0.35
7
DRC
0.25
8
Myanmar
0.25
9
India
0.10
10
Pakistan
0
The Non-Discrimination Index has a range of 1.0 from 0 to 1.0. The mean
non-discrimination indicator score is 0.455, with a standard deviation of 0.335.
The median score is 0.35, and the modes are 1.0, 0.35, and 0.25.
The research and scoring underlying the Non-Discrimination Index are
tabulated here. The table contains the sources of law assessed for each kind of
recognition for each country. The constitutional recognition column contains
the equality and non-discrimination provisions evaluated in each national
constitution. Sources of law for legislative and executive branch recognition
listed with specific provisions above an ellipsis contribute to a country’s non-
discrimination indicator score. Sources of law without specific provisions do
not meet the definitions for legislative or executive branch recognition of the
non-discrimination commitment. Information about the author’s assessment or
ability to obtain or review sources of law is in footnotes where necessary.
INDIANA HEALTH LAW REVIEW [Vol. 21:1
28
Table 5: Non-Discrimination Index Scoring and Sources of Law
Constitutional
recognition
Legislative
recognition
Executive branch
recognition
Score
Russia
0.25
1.0
0
1.0
Art. 19(2)
Law on the
Basics of
Health
Protection of
Citizens in the
Russian
Federation
(2011) art. 5(3)
Law on Social
Protection of
the Disabled
(1995)
Law on the
Sanitary and
Epidemiologica
l Welfare of the
Population
(1999)
Labor Code
(2001)
Law on
Preventing the
Spread of
Tuberculosis
(2001)
Law on the
Circulation of
Medicines
(2010)
State Strategy for the
Elimination of
Tuberculosis in the
Russian Federation
until 2025 and Beyond
(2018)
Strategy for the
Development of
Healthcare in the
Russian Federation for
the Period until 2025
(2019)
Vietnam
0.25
1.10
0.25
1.0
Art. 16(2)
Law on
Prevention and
Control of
Infectious
Disease (2007)
art. 8(5)
Law on
Vietnam National
Tuberculosis Program
Draft National
Strategic Plan 2021
2025 (2020) §§
3.1.1.4, 3.3.5.4
2024] ACTIVATING LAW AND HUMAN RIGHTS 29
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Constitutional
recognition
Legislative
recognition
Executive branch
recognition
Score
HIV/AIDS
Prevention and
Control (2006,
rev. 2020), arts.
3(4), 8, 10(7)
Law on Persons
with
Disabilities
(2010)
Labor Code
(2012)
Plan for People’s
Health Protection,
Care and Promotion
20162020 (2016)
China
0
0.75
0
0.75
Art. 4
Law on the
Prevention and
Treatment of
Infectious
Diseases (1989,
rev. 2013) art.
16
Employment
Promotion Law
(2007, rev.
2015) arts. 25,
26, 30
Law on the
Protection of
Persons with
Disabilities
(2008, rev.
2018)
Law on Basic
Healthcare and
Health
Promotion
(2020)
Implementing
Measures for the Law
on the Prevention and
Treatment of
Infectious Diseases
(1991)
Administrative
Measures for the
Prevention and
Treatment of
Tuberculosis (2013)
Healthy China 2030
Blueprint (2016)
Healthy China Action
(20192030) (2019)
Opinions of the State
Council on
Implementing the
Healthy China Action
Plan (2019)
Indonesia
0.25
0
0.25
0.50
INDIANA HEALTH LAW REVIEW [Vol. 21:1
30
—————————————————————————————
104
. The preamble of Indonesia’s Labor Law (Undang-undang tentang Ketenagakerjaan
[Labor Law], No. 13 of 2003) establishes the objective “to secure the implementation of equal
opportunity and equal treatment without discrimination on whatever basis.” Chapter III, entitled
“Equal Opportunities,” provides in article 5 that “[e]very person available for a job shall have the
same opportunity to get a job without discrimination,” and in article 6 that “[e]very
worker/labourer has the right to receive equal treatment without discrimination from their
employer.” But the law does not explicitly prohibit discrimination based on TB, infectious
disease, or health status.
105
. The author was unable to obtain a copy of and thus could not assess the Ministry of
Health Circular Letter HK.03.03/D1 III.I/951/2016 on Increasing TB Case Findings.
Constitutional
recognition
Legislative
recognition
Executive branch
recognition
Score
Art. 28I
Health
Principles Law
(1960)
Outbreaks of
Infectious
Diseases Law
(1984)
Human Rights
Law (1999)
Labor Law
(2003)104
Medical
Practice Law
(2004)
Heath Law
(2009)
Hospital Law
(2009)
Law on Persons
with
Disabilities
(2016)
Omnibus Law
on Job Creation
Law (2020)
Presidential
Regulation 67/2021 on
Tuberculosis
Management
(2021) arts. 12(8),
24(3), 29(2)
National Strategy of
Tuberculosis Care and
Prevention in
Indonesia 20202024
(2020) §§ 4.5.2, 4.5.3,
5.1.5
Ministry of Health
Regulation 67/2016 on
Tuberculosis
Treatment arts. 7(4),
25(1, 3)
Ministry of Health
Decree
1278/Menkes/SK/XII/2
009 on Guidelines for
Implementing
Collaborative TB and
HIV Control
Ministry of Health
Circular Letter
HK.03.03/D1
III.I/951/2016 on
Increasing TB Case
Findings105
2024] ACTIVATING LAW AND HUMAN RIGHTS 31
TO END TUBERCULOSIS
Constitutional
recognition
Legislative
recognition
Executive branch
recognition
Score
Ministry of Health
Regulation 39/2016 on
Guidelines for
Implementing the
Healthy Indonesia
Program with a
Family Approach
Ministry of Health
Regulation 43/2016 on
Minimum Health
Service Standards
Ministry of Health
Strategic Plan 2020
2024 (2020)
Nigeria
0
0.10
0.25
0.35
Art. 15
HIV and AIDS
(Anti-
Discrimination)
Act (2014) Part
II
Labour Act
(1971)
African Charter
on Human and
Peoples’ Rights
(Ratification
and
Enforcement)
Act (1983)
National Health
Act (2014)
Discrimination
Against
Persons with
Disabilities
(Prohibition)
Act (2018)
National Strategic
Plan for Tuberculosis
Control, 20212025
(2021) §§ 2.2, 2.2.1.2,
4.2.6.2
Human Rights and
Gender Action Plan
for Tuberculosis Care
and Prevention in
Nigeria 20212025
(2021) §§ 5, 8, 11
National Health Policy
2016 (2016)
Philippines
0
0.10
0.25
0.35
Art. III, § 1
Philippine HIV
and AIDS
Policy Act
(2018) art. VII
Guidelines for the
Implementation of
Policy and Program
on Tuberculosis (TB)
INDIANA HEALTH LAW REVIEW [Vol. 21:1
32
Constitutional
recognition
Legislative
recognition
Executive branch
recognition
Score
Labor Code of
the Philippines
(1974)
Magna Carta
for Disabled
Persons (1992)
Universally
Accessible
Cheaper and
Quality
Medicines Act
of 2008 (2008)
Comprehensive
Tuberculosis
Elimination
Plan Act (2016)
Universal
Health Care
Act (2019)
Prevention and
Control in the
Workplace (2005) §
4.1
National Tuberculosis
Control Program
Manual of Procedures
6th ed. (2020) Ch. 1,
3-4
The Philippine Health
Agenda 20162022
(2016)
Implementing Rules
and Regulations of the
Comprehensive
Tuberculosis
Elimination Plan Act
(2017)
Strategic Framework
and Implementing
Guidelines for
FOURmula One Plus
for Health (F1+)
(2018)
Implementing Rules
and Regulations of
Universal Health Care
Act (2019)
National TB Control
Program Adaptive
Plan for the COVID-
19 Pandemic (2020)
Updated Philippine
Strategic TB
Elimination Plan,
Phase 1: 2020-2023
(2020)
DRC
0
0
0.25
0.25
2024] ACTIVATING LAW AND HUMAN RIGHTS 33
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—————————————————————————————
106
. Article 16 of the DRC’s Public Health Law (Loi n° 18/035 du 13 décembre 2018 fixant
les principes fondamentaux relatifs à l'organisation de la Santé publique [Public Health Law],
Dec. 13, 2018) protects against discrimination in accessing health care, but the law does not
prohibit discrimination on grounds of TB, infectious disease, or health status.
107
. The author was unable to obtain an English language version of the

 [Public Health Law], 1972. The Burmese language version he obtained
was not searchable in Burmese and google translate did not produce a coherent English language
machine translation of the Burmese language document. As a result, the author did not assess this
law.
Constitutional
recognition
Legislative
recognition
Executive branch
recognition
Score
Art. 13
Labor Code
(2002)
Law for the
Protection of
the Rights of
People Living
with HIV/AIDS
and Affected
Persons (2008)
Public Health
Law (2018)106
Law on the
Protection and
Promotion of
the Rights of
Persons with
Disabilities
(2022)
National Strategic
Plan for the Fight
Against Tuberculosis
2021-2022 (2023)
(2019) §§ 2.2.7,
6.5.4.7
National Health
Development Plan
2019-2022: Towards
Universal Health
Coverage (2018)
Myanmar
0
0
0.25
0.25
Art. 348
Public Health
Law (1972)107
Prevention and
Control of
Infectious
Diseases Law
(1995)
Amendment of
Prevention and
Control of
Infectious
Diseases Law
(2011)
Employment
and Skill
Development
National Strategic
Plan 2021-2025:
National TB
Programme (2020) §§
3.2.3, 3.3
Myanmar National
Health Plan 2017
2021 (2016)
INDIANA HEALTH LAW REVIEW [Vol. 21:1
34
—————————————————————————————
108
. Ministry of Health with Fam. Welfare, Nat’l Strategic Plan for Tuberculosis: 2017–25,
Elimination by 2025 at 86, 87, and 120 (Mar. 2017) mentions discrimination but does not
explicitly prohibit discrimination, establish the right to be free from discrimination, or commit to
non-discrimination of people affected by tuberculosis.
Constitutional
recognition
Legislative
recognition
Executive branch
recognition
Score
Law (2013)
The Minimum
Wage Law
(2013)
Rights of
Persons with
Disabilities
Law (2015)
Payment of
Wages Law
(2016)
Shops and
Workplaces
Law (2016)
Myanmar
Companies Law
(2017)
India
0
0.10
0
0.10
Arts. 14, 15,
16
The Human
Immunodeficien
cy Virus and
Acquired
Immune
Deficiency
Syndrome
(Prevention and
Control) Act
(2017) § 3
Epidemic
Diseases Act
(1897)
Rights of
Persons with
Disabilities Act
(2016)
Code on Wages
(2019)
National Health Policy
2017 (2017)
National Strategic
Plan for Tuberculosis:
201725, Elimination
by 2025 (2017)108
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Constitutional
recognition
Legislative
recognition
Executive branch
recognition
Score
Epidemic
Diseases
(Amendment)
Act (2020)
Industrial
Relations Code
(2020)
Occupational
Safety, Health
and Working
Conditions
Code (2020)
Pakistan
0
0
0
0
Arts. 25, 26,
27
Factories Act
(1934)
Public Health
(Emergency
Provision)
Ordinance
(1944)
West Pakistan
Epidemic
Diseases Act
(1958)
West Pakistan
Industrial and
Commercial
Employment
(Standing
Orders)
Ordinance
(1968)
West Pakistan
Shops and
Establishments
Ordinance
(1969)
Disabled
Persons
(Employment
and
Rehabilitation)
Ordinance
(1981)
National Health
Vision: Pakistan
20162025 (2016)
National Strategic
Plan for Tuberculosis
Control, 20202023
(2020)
INDIANA HEALTH LAW REVIEW [Vol. 21:1
36
Russia and Vietnam both receive maximum scores of 1.0 by prohibiting
discrimination based on disease in legislation. Russia “guarantees citizens
protection against any form of discrimination due to the presence of any
disease.”
109
Vietnam prohibits “[d]iscriminating against and publishing negative
images of and information on persons suffering from an infectious disease.”
110
Russia and Vietnam, along with Indonesia, are also the only countries that
include inclusive, catch-all categories in their constitutional prohibitions against
discrimination. Indonesia’s constitution enshrines the right to be free from
discrimination “based upon any grounds whatsoever.”
111
Vietnam’s constitution
prohibits discrimination in “political, civic, economic, cultural, and social life,”
and Russia’s constitution “guarantees the equality of human and civil rights and
freedoms regardless” of ten listed categories and any “other circumstances.”
112
China’s score of 0.75 results from points awarded for non-discrimination
provisions in infectious disease and employment legislation. Article 16 of the
Law on the Prevention and Treatment of Infectious Diseases prohibits
discrimination against people with infectious diseases.
113
Article 30 of the
Employment Promotion Law prohibits employers from refusing to hire people
because they have an infectious disease.
114
However, both provisions also bar
people affected by TB from jobs prohibited by “laws, administrative
regulations, or the health administration department under the State Council.”
115
The Chinese Regulations on Hygiene Management in Public Places prohibit
—————————————————————————————
109
. Об основах охраны здоровья граждан в Российской Федерации [Law on the Basics
of Health Protection of Citizens in the Russian Federation], 2011, no. 323-FZ, art. 5(3), 2
(Russ.).
110
. Lut Phòng, chng bnh truyn nhim [Law on Prevention and Control of Infectious
Disease], No. QH12, art. 8(5).
111
. UNDANG-UNDANG DASAR NEGARA REPUBLIK INDONESIA TAHUN [UUD 1945]
[CONSTITUTION] art. 28I (Indon.).
112
. HIẾN PHÁP NƯỚC CNG HÒA XÃ HI CH NGHĨA VIT NAM [HIN PHÁP] [CONSTITUTION]
1992 art. 50 (Viet.); KONSTITUTSIIA ROSSIĬSKOĬ FEDERATSII [KONST. RF] [CONSTITUTION] art. 19
(Russ.).
113
. Law of the People's Republic of China on the Prevention and Treatment of Infectious
Diseases (promulgated by Order No. 17 of the President of the People’s Republic of China., Aug.
28, 2004), art. 16 (China).
114
. Employment Promotion Law of the People's Republic of China (promulgated by
Standing Committee of the National People's Congress of China., June 29, 2007, effective Jan. 1,
2008), art. 30 (China).
115
. Id.; Law of the People's Republic of China on the Prevention and Treatment of
Infectious Diseases, supra note 112.
Constitutional
recognition
Legislative
recognition
Executive branch
recognition
Score
Epidemic
Diseases
(Amendment)
Act (2011)
2024] ACTIVATING LAW AND HUMAN RIGHTS 37
TO END TUBERCULOSIS
people with pulmonary TB from “direct customer service work until they are
cured,” and the General Standard for Medical Examination for Civil Servants
(Trial) disqualifies people affected by TB from civil service until one to two
years after they are cured.
116
People with TB are usually no longer contagious after two weeks of the
standard 6-month treatment.
117
People who successfully complete TB treatment
are considered disease-free and are no longer contagious. Therefore, China
receives 0.50 rather than 1.0 points for its infectious disease law and 0.25 rather
than 0.50 points for its employment law because both laws are subject to overly
broad administrative regulations at odds with the non-discrimination
commitment in unnecessarily restricting people affected by TB’s employment
opportunities.
India, Nigeria, the Philippines, and Vietnam prohibit discrimination based
on HIV status in HIV legislation, reflecting the proliferation of HIV laws during
past decades.
118
By contrast, only two countries have enacted TB lawsRussia
and the Philippinesneither of which prohibits discrimination against people
affected by TB. The DRC has an HIV law, but it does not prohibit discrimination
against people living with HIV. In 2006, China’s State Council promulgated the
“Regulations on AIDS Prevention and Treatment.”
119
The decree prohibits
discrimination against people living with HIV. But the State Council is an
executive branch body, so the regulations do not constitute legislation and do
not contribute to China’s non-discrimination indicator score.
120
Nine countries have strategic plans or implementation guidelines for their
national TB programs but only six address discrimination. For example, the
DRC’s plan includes a section on reducing “stigma and discrimination in TB
prevention and care” with ten subsections outlining a detailed approach.
121
Myanmar’s plan commits to combatting stigma and discrimination through
“community engagement” as an “essential intervention” and highlights the need
—————————————————————————————
116
. Regulations on Hygiene Management in Public Places (promulgated by Decree of the
State Council of the People’s Republic of China., 1987) No. 24 art. 7 (China)
[https://perma.cc/URF5-Q74X]; General Standards for Medical Examination for Civil Servants
(Trial) (promulgated by Circular of the Ministry of Personnel and the Ministry of Health., 2005),
No. 1, art. 4 (China) [https://perma.cc/W4Z2-7LFM].
117
. Division of Tuberculosis Elimination, CORE CURRICULUM ON TUBERCULOSIS: WHAT
THE CLINICIAN SHOULD KNOW, 139 (Centers for Disease Control and Prevention, 7th ed. 2021).
118
. See The Lancet HIV, Time to End Discriminatory Laws Against People with HIV, 8
THE LANCET HIV e729 (2021); Matthew M. Kavanagh et al., Law, Criminalisation and HIV in
the World: Have Countries That Criminalise Achieved More or Less Successful Pandemic
Response? 6 BMJ GLOBAL HEALTH (Aug. 2, 2021).
119
. Regulations on AIDS Prevention and Treatment 2006 (Decree No. 457) (promulgated
by the State Council of the People’s Republic of China, Jan. 18, 2006) §§ 3, 10 (China).
120
. State Structure of the People's Republic of China: The State Council, THE NATL
PEOPLES CONG. OF THE PEOPLES REPUBLIC OF CHINA, www.npc.gov.cn/zgrdw/englishnpc/state
Structure/2007-12/06/content_1382098.htm (last visited Jan. 31, 2023) [https://perma.cc/G4DJ-
FRS5].
121
. National Strategic Plan for the Fight Against Tuberculosis 2021-2022 (2023) § 2.2.7
WORLD HEALTH ORG. DEM. REP. CONGO (2019) [https://perma.cc/9MZW-J5FX ].
INDIANA HEALTH LAW REVIEW [Vol. 21:1
38
to reduce TB-based discrimination in the workplace.
122
By contrast, Pakistan’s
100-page plan does not mention discrimination and only refers once to TB
stigma in the summary of a sub-national jurisdiction’s plan.
123
D. Access to Medicines
The Access to Medicines Index below displays the ten assessment countries
ranked by their access to medicines indicator scores.
Table 6: Access to Medicines Index
Access to
Medicines
1
Philippines
1.0
2
India
0.95
3
Indonesia
0.90
4
Russia
0.90
5
China
0.80
6
Vietnam
0.70
7
DRC
0.60
8
Nigeria
0.55
9
Myanmar
0.50
10
Pakistan
0.50
The Access to Medicines Index has a range of 0.50 from 0.50 to 1.0. The mean
access to medicines indicator score is 0.74, with a standard deviation of
approximately 0.184. The median score is also 0.74, and the modes are 0.90 and
—————————————————————————————
122
. Ministry of Health and Sports, National Strategic Plan, 2021-2025: National TB
Programme § 3.2.3, 3.3 WORLD HEALTH ORG. MYAN. (Mar. 2020).
123
. Ministry of National Health Services, National Strategic Plan for Tuberculosis Control,
2020-2023 § 4 WORLD HEALTH ORG. PAK. (2019).
2024] ACTIVATING LAW AND HUMAN RIGHTS 39
TO END TUBERCULOSIS
0.50.
The research and scoring underlying the Access to Medicines Index are
tabulated here. The table contains the sources of law assessed for each kind of
recognition for each country. The constitutional recognition column contains
the relevant provisions evaluated in each national constitution when such
provisions exist. Sources of law for legislative and executive branch recognition
listed with specific provisions above an ellipsis contribute points to a country’s
access to medicines indicator score. Sources of law without specific provisions
do not meet the definitions for legislative or executive branch recognition of the
access to medicines commitment. Information in brackets designates the TRIPS
flexibilities and textual and institutional commitments in the sources of law
contributing to the indicator scores.
Table 7: Access to Medicines Index Scoring and Sources of Law
Constitutional
recognition
Legislative and executive branch
recognition
Score
Philippines
0.25
1.40
1.0
Art. XIII, § 11
Intellectual Property Code (1998, 2015
ed.) § 22.1 [heightened patentability
criteria], 72.1 [parallel importation, int’l
exhaustion], 72.3 [limited exceptions
research, experimental use], 72.4 [limited
exceptionsBolar], 74 [government use],
93 [compulsory licensing]
Universally Accessible Cheaper and
Quality Medicines Act of 2008 (2008)
[institutional, textual commitments]
Implementing Rules and Regulations of the
Comprehensive Tuberculosis Elimination
Plan Act (2017) § 5.2 [institutional
commitment]
Implementing Rules and Regulations of
Universal Health Care Act (2019) § 28
[institutional commitment]
Universal Health Care Act (2019) § 3(b),
28 [institutional, textual commitments]
INDIANA HEALTH LAW REVIEW [Vol. 21:1
40
Constitutional
recognition
Legislative and executive branch
recognition
Score
Comprehensive Tuberculosis Elimination
Plan Act (2016)
India
0
0.95
0.95
The Patents (Amendment) Act (2005) §
3(d) [heightened patentability criteria], 25
[opposition procedures], 64 [revocation
procedures], 84, 92, 92A [compulsory
licensing, government use], 107A(a)
[limited exceptionsBolar], 107A(b)
[parallel importation, int’l exhaustion]
National Health Policy 2017 (2017) §§
3.3.3, 14.4, 14.7, 17 [institutional
commitment]
Drugs and Cosmetics Act (1940)
Indonesia
0
0.90
0.90
Law on Patents (2016) arts. 19(3) [limited
exceptions research, experimental use],
93, 109, 111 [compulsory licensing,
government use], 132 [revocation
procedures], 167 [parallel importation, int’l
exhaustion]
Ministry of Law and Human Rights
Regulation 30/2019 on Procedures for
Granting Compulsory Patent Licenses
[compulsory licensing, government use]
art. 33(1, 2) [textual commitment]
Presidential Regulation 77/ 2020 on
Procedures of Patent Implementation by
the Government [compulsory licensing,
government use] art. 13 [textual
commitment]
Health Law (2009) arts. 36-41
[institutional, textual commitments]
Omnibus Law on Job Creation Law (2020)
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—————————————————————————————
124
. Part 4 of the Omnibus Law on Job Creation (2020) amends the compulsory licensing
articles of the Law on Patents (2016) allowing compulsory licenses for patents that have been
“exercised by the patent holder . . . [in] a way that detracts from the interests of the community.”
Indonesia passed a new version of the Omnibus Job Creation law in 2023, repealing the 2020 law.
However, this paper’s assessment covers the inclusive four year period 2019-2022 during which
the 2018 TB UNHLM Political Declaration was in effect. The new 2023 law is outside this
timeframe.
Constitutional
recognition
Legislative and executive branch
recognition
Score
art. 107 [compulsory licensing].124
Presidential Regulation 67/2021 on
Tuberculosis Management
Ministry of Health Decree 67/2016 on
Tuberculosis Treatment
Russia
0
0.90
0.90
Civil Code, Part IV, § VII, Rights in the
Results of Intellectual Activities and Means
of Individualization (2006) arts. 1359(2)
[limited exceptions research,
experimental use], 1360, 1362 [compulsory
licensing, government use], 1398
[revocation procedures]
Law on Preventing the Spread of
Tuberculosis (2001) art. 14(4) [textual
commitment]
Law on the Circulation of Medicines
(2010) art. 9.3, Ch. 12 (arts 60-63)
[institutional commitment]
Law on the Basics of Health Protection of
Citizens in the Russian Federation (2011)
art. 18(2) [textual commitment]
Law on Amendments to Article 60 of the
Federal Law ‘On the Circulation of
Medicines’ and Article 38 of the Federal
Law ‘On the Basics of Protecting the
Health of Citizens in the Russian
Federation’ (2020) [institutional
INDIANA HEALTH LAW REVIEW [Vol. 21:1
42
—————————————————————————————
125
. The institutional commitment in the Law on Amendments to Article 60 of the Federal
Law ‘On the Circulation of Medicines’ and Article 38 of the Federal Law ‘On the Basics of
Protecting the Health of Citizens in the Russian Federation’ (2020) is not aggregated with the
institutional commitment in the Law on Circulation of Medicines (2010) because, as amending
legislation, it is technically part of the Law on Circulation of Medicines.
126
. The relevant articles in Lut ca Quc hi: Lut S Hu Trí Tu [Law on Intellectual
Property], No. 11/VBHN-VPQH, July 8, 2022 are amended but not meaningfully modified by
Lut ca Quc hi: Lut sửa đổi, b sung mt s điu ca Lut s hu trí tu [Law Amending and
Supplementing a Number of Articles of the Intellectual Property Law], No. 07/2022/QH15, June
16, 2022.
Constitutional
recognition
Legislative and executive branch
recognition
Score
commitment].125
China
0
0.80
0.80
Patent Law (1984, rev. 2020) arts. 54-55
[compulsory licensing], 75(1) [parallel
importation, int’l exhaustion], 75(5)
[limited exceptionsBolar]
Implementing Rules of the Patent Law
(2010) Ch. 5 [compulsory licensing]
Measures for the Compulsory Licensing of
Patent Implementation (2012) [compulsory
licensing]
Drug Administration Law (2019) art. 3
[textual commitment]
Law on Basic Healthcare and Health
Promotion (2020) arts. 58-59 [institutional
commitment]
Implementing Measures for the Law on the
Prevention and Treatment of Infectious
Diseases (1991)
Measures for the Administration of Drug
Registration (2020)
Regulations for the Implementation of the
Drug Administration Law (2020)
Vietnam
0
0.70
0.70
Law on Intellectual Property (2022)126 arts.
125(2)(a) [limited exceptionsresearch,
Bolar], 125(2)(b) [parallel importation,
2024] ACTIVATING LAW AND HUMAN RIGHTS 43
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Constitutional
recognition
Legislative and executive branch
recognition
Score
int’l exhaustion], 133-133a [government
use], § 3 (arts 145-147) [compulsory
licensing]
Plan for People’s Health Protection, Care
and Promotion 20162020 (2016) §§ 2.2
[textual commitment], 4.7 [institutional
commitment]
Law on Prevention and Control of
Infectious Disease (2007)
Guidance the Confidential Protection of
Trial Data in Drug Registration (2010)
DRC
0
0.60
0.60
Industrial Property Law (1982) arts. 49
[limited exceptionsresearch], 79-82
[compulsory licensing, government use],
149 [revocation procedures]
National Health Development Plan 2019-
2022: Towards Universal Health Coverage
(2018) art. 5.2.5 [textual commitment]
Nigeria
0
0.55
0.55
Patents and Designs Act (1971) first sch
[compulsory licensing, government use]
National Health Act (2014) §§ 2(l) [textual
commitment], 11(3)(b) [institutional
commitment]
National Health Policy 2016 (2016) § 4.2.5
[textual commitment]
Myanmar
0
0.50
0.50
Patent Law (2019) §§ 14(b) [LDCs
transition period], 33-35 [opposition
procedures], 54(b) [limited exceptions
research, experimental use], 65-73
[compulsory licensing], 77 [revocation
procedures]
INDIANA HEALTH LAW REVIEW [Vol. 21:1
44
The Philippines is the only nation to score the maximum value of 1.0 and
obtain points for constitutional, legislative, and executive branch recognition.
The Philippines has established four TRIPS flexibilities in intellectual property
legislation and made both textual and institutional commitments in law and
—————————————————————————————
127
. See supra note 113. The author was unable to obtain an English language version of the
Public Health Law (1972). The Burmese language version he obtained was not searchable in
Burmese. And Google Translate did not produce a coherent English language machine translation
of the Burmese language document. As a result, the author did not assess this law.
128
. PAK., PATENTS ORDINANCE, Ch. 8, § 30(5)(a) (2000), does not mention importation in
the statute. Additionally, importation is generally prohibited in 30(a, b) for patented products and
processes. However, § 30(5)(a) clearly establishes the international principle of exhaustion of
patent rights as an exception to the rights of patent holders, establishing that “rights under patent
shall not extend” to articles in Pakistan that “have been put on the market anywhere in the world.”
Constitutional
recognition
Legislative and executive branch
recognition
Score
Public Health Law (1972)127
Prevention and Control of Infectious
Diseases Law (1995)
Amendment of Prevention and Control of
Infectious Diseases Law (2011)
Myanmar National Health Plan 20172021
(2016)
Pakistan
0
0.50
0.50
Patents Ordinance (2000) § 23 [opposition
procedures], § 30(5)(a) [parallel
importation, int’l exhaustion],128 § 30(5)(c,
e, f) [limited exceptionsresearch, Bolar],
§ 46-49 [revocation procedures], § 58
[compulsory licensing, government use]
The Patent Rules (2003) § 18 [opposition
procedures], § 26 [revocation procedures],
§ 44 [compulsory licensing]
Public Health (Emergency Provision)
Ordinance (1944)
West Pakistan Epidemic Diseases Act
(1958)
Epidemic Diseases (Amendment) Act
(2011)
National Health Vision: Pakistan 2016
2025 (2016)
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TO END TUBERCULOSIS
executive branch decrees. The Constitution of the Philippines commits the
country to adopting an “approach to health development which shall endeavor
to make essential goods, health and other social services available . . . at
affordable cost.”
129
The intellectual property law is also remarkable for
explicitly addressing access to medicines in the TRIPS flexibilities provisions.
For example, section 72.1 establishes limitations on patent rights, including
allowing parallel importation of medicines based on the international exhaustion
principle. The provision states that “with regard to drugs and medicines, the
limitation on patent rights shall apply after a drug or medicine has been
introduced in the Philippines or anywhere else in the world by the patent owner,
or by any party authorized to use the invention.”
130
Section 93 sets forth the legal
grounds for compulsory licensing, including when “the demand for patented
drugs and medicines is not being met to an adequate extent and on reasonable
terms.”
131
India enacted The Patents (Amendment) Act in 2005 to comply with the
TRIPS Agreement.
132
The law contains five of this assessment’s TRIPS
flexibilities, including a provision heightening patentability criteria for
medicines. The provision excludes from the statutory definition of “inventions”
the “mere discovery of a new form of a known substance which does not result
in the enhancement of [its] known efficacy.”
133
In 2015, the Supreme Court of
India upheld the provision declaring that it requires new patents for existing
chemical substances used in medicine to enhance a drug’s “therapeutic
efficacy.”
134
The court acknowledged that drug patents might “put[] life-saving
medicines beyond the reach” of people who need them.
135
And it discussed
India’s history of protecting process rather than product patents for medicines
that fostered the development of the country’s generic pharmaceutical
industry.
136
The Philippines’ Intellectual Property Code contains an article
modeled on the Indian provision with the same language requiring the
“enhancement of the known efficacy” of new forms of known substances used
in medicines.
137
India’s patent legislation is also noteworthy because it is the only
intellectual property law in this assessment that mentions TB. Section 92 sets
forth special procedures for granting compulsory licenses during national
—————————————————————————————
129
. CONST. (1987), art. XIII, § 11 (Phil.).
130
. INTELL. PROP. CODE, § 72.1, Rep. Act 8293, as amended (Phil.).
131
. Id. at § 93.6.
132
. See Shamnad Basheer, India’s Tryst with TRIPS: The Patents (Amendment) Act, 1
Indian J. of L. & Tech. 15, 42 (2005).
133
. The Patents (Amendment) Act, 2005, § 3(d) (India).
134
. Novartis AG v. Union of India, (2013) 13 S.C.R. 148, 180 (India).
135
. Id.; see Understanding the WTO: The Organization: Least-developed Countries supra
note 88.
136
. Id. ¶ 47-59.
137
. INTELL. PROP. CODE, §§ 22.1, 26.2., Rep. Act 8293, as amended (Phil.).
INDIANA HEALTH LAW REVIEW [Vol. 21:1
46
emergencies or “circumstances of extreme urgency.”
138
The procedures
supersede the normal statutory requirements and allow the government to
expedite the process for granting a compulsory license. The circumstances
warranting this expedited process include “public health crises[] relating to . . .
tuberculosis.”
139
Indonesia’s patent legislation and regulations notably include community
concerns and drug prices as considerations for challenges and limitations on
intellectual property rights. The Law on Patents empowers individual parties
who “represent the national interest” to file suit to revoke a patent “for the
benefit of the community.”
140
A 2019 regulation on compulsory licensing
designates “difficulty . . . accessing drugs in the community” as an “emergency”
for which the Minister of Law and Human Rights may grant a compulsory
license.
141
A 2020 presidential regulation on public, non-commercial use
authorizes the government to make use of a patent to address “expensive prices”
of medicines and other biotechnologies needed to combat a deadly disease.
142
Russia is the only country that has committed in legislation to providing free
medicines to people with TB.
143
Russia also makes an institutional commitment
to access to medicines in its Law on the Circulation of Medicines which
authorizes State price controls of drugs on its essential medicines list.
144
A 2020
amendment of the law expands the program to allow price controls of drugs not
included in the essential medicines list to confront “extraordinary situations” or
emerging infectious diseases.
145
V. CONCLUSION
In 2018, the UN General Assembly’s High-Level Meeting on TB prompted
countries worldwide to make ambitious commitments to end TB and DR-TB by
2030. These included groundbreaking legal and human rights commitments on
—————————————————————————————
138
. The Patents (Amendment) Act, 2005, § 92(1) (India).
139
. Id. § 92(3).
140
. Law on Patents, No. 13 of 2016, art. 132(4) (Indon.); Explanation of the Law on Patents,
No. 13 of 2016, § II (132(4)) (Indon.).
141
. Regulation of the Minister of Law and Human Rights, No. 30 of 2019 on Procedures
for Granting a Patent's Mandatory License, art. 33(2) (Indon.).
142
. Regulation of the President of the Republic of Indonesia, No. 77 of 2020 on Government
Procedures for Implementing Patents, art. 13(a) (Indon.).
143
. Федеральный закон предупреждении распространения туберкулеза в
Российской Федерации" [Federal Law on Preventing the Spread of Tuberculosis], No. 77-FZ,
June 18, 2001, art. 14(4) (Russ.).
144
. Федеральный закон "Об обращении лекарственных средств" [Federal Law on the
Circulation of Medicines], No. 61-FZ, Apr. 12, 2010, as amended, arts. 9.3, 60-63 (Russ.).
145
. Федеральный закон "О внесении изменений в статью 60 Федерального закона "Об
обращении лекарственных средств" и статью 38 Федерального закона "Об основах охраны
здоровья граждан в Российской Федерации" [Federal Law on Amendments to Article 60 of the
Federal Law “On the Circulation of Medicines” and Article 38 of the Federal Law “On the Basics
of Protecting the Health of Citizens in the Russian Federation”], No. 67-FZ, Mar. 26, 2020, art. 1
(Russ.).
2024] ACTIVATING LAW AND HUMAN RIGHTS 47
TO END TUBERCULOSIS
the right to health, non-discrimination, and access to medicines. This paper
represents the first effort to empirically measure countries’ progress in fulfilling
these pledges.
This paper developed and applied a novel empirical framework modeled on
the UN Human Development Index to assess ten countries with high DR-TB
burdens. The results show that none of the countries has fulfilled all three legal
and human rights pledges. Nonetheless, several nations have fulfilled one
commitment, and two have fulfilled two commitments, as illustrated in the TB
UNHLM Legal Rights Index above. The laws and policies in these countries
provide concrete examples of legal instruments that satisfy the legal and human
rights pledges as nations work to fulfill their commitments in the new Political
Declaration from the second TB UNHLM held in September 2023. However,
as noted in the limitations discussed above, this paper’s assessment does not
evaluate the implementation or enforcement of these laws and policies.
Countries must full implement their laws and policies to achieve their intended
impact. As a result, even the countries receiving maximum scores (1.0) in this
assessment must implement and enforce their laws and policies to fully realize
the TB UNHLM legal and human rights commitments.
To this end, countries whose national constitutions do not fully recognize
the right to health should consider amending their constitutions to establish an
individual right to health. All nations should consider amending relevant
legislation to explicitly prohibit TB-based discrimination. And all countries
should consider enshrining the full set of TRIPS flexibilities in intellectual
property legislation and regulations while making clear textual and institutional
commitments to ensuring access to medicines in patent and health law and
policy.
INDIANA HEALTH LAW REVIEW [Vol. 21:1
48
APPENDIX
This appendix contains citations for the legal instruments evaluated in this
paper’s assessment listed by country and source of law.
China
Constitutional
XIANFA [CONSTITUTION] (1982).
Legislative
Zhuānlì fǎ (利法) [Patent Law] (promulgated by the Standing Comm. Nat’l
People’s Cong., Mar. 12, 1984, effective Apr. 1, 1985).
Chuánrǎn bìng fángzhì (染病防治法) [Law on the Prevention and
Treatment of Infectious Diseases] (promulgated by the Standing Comm. Nat’l
People’s Cong., Feb. 21, 1989, effective Sept. 1, 1989).
Jiùyè cùjìn () [Employment Promotion Law] (promulgated by
the Standing Comm. Nat’l People’s Cong., Aug. 30, 2007, effective Jan. 1,
2008).
Cánjí rén bǎozhàng fǎ (残疾人保障法) [Law on the Protection of Persons with
Disabilities] (promulgated by the Standing Comm. Nat’l People’s Cong., Apr.
24, 2008, effective July 1, 2008).
Yàopǐn guǎnlǐ (品管理法)[Drug Administration Law] (promulgated by the
Standing Comm. Nat’l People’s Cong., Sept. 20, 1984, effective July 1, 1985).
Jīběn yīliáo jiànkāng cùjìn (基本医和健康促) [Law on Basic
Healthcare and Health Promotion] (promulgated by the Standing Comm. Nat’l
People’s Cong., Dec. 28, 2019, effective June 1, 2020).
Executive branch
Chuánrǎn bìng fángzhì shíshī bànfǎ (染病防治法)
[Implementing Measures for the Law on the Prevention and Treatment of
Infectious Diseases] (implemented by the State Council Letter [1991] 66 on Oct.
4, 1991).
2024] ACTIVATING LAW AND HUMAN RIGHTS 49
TO END TUBERCULOSIS
Zhuānlì shíshī qiángzhì xǔkě nfǎ () [Measures for
the Compulsory Licensing of Patent Implementation] (promulgated by the State
Intellectual Property Office, Mar. 15, 2012, effective May 1, 2012).
Jiéhébìng fángzhì guǎnlǐ bànfǎ (核病防治管理) [Administrative
Measures for the Prevention and Treatment of Tuberculosis] (promulgated by
the Ministry of Health, Jan. 9, 2013, effective Mar. 24, 2013).
Zhuānlì shíshī xìzé (利法细则) [Implementing Rules of the Patent
Law] (promulgated by the State Council of the People's Republic of China, June
15, 2001, effective July 1, 2001, rev. Jan. 9, 2010).
“Jiànkāng zhōngguó 2030” guīhuà gāngyào (“健康中国2030”)
[Healthy China 2030 Blueprint] (promulgated by the Central Comm. of the
Communist Party of China and the State Council of the People’s Republic of
China, Oct. 25, 2016).
Jiànkāng zhōngguó xíngdòng (2019—2030 nián) (健康中国行 (20192030
) [Healthy China Action (20192030)] (promulgated by the Healthy China
Action Promotion Comm., July 9, 2019).
Guówùyuàn guānyú shíshī jiànkāng zhōngguó xíngdòng de yìjiàn (院关于
施健康中国行的意) [Opinions of the State Council on Implementing
the Healthy China Action Plan] (promulgated by the State Council of the
People’s Republic of China, July 15, 2019).
Yàopǐn zhùcè guǎnlǐ bànfǎ (品注册管理) [Measures for the
Administration of Drug Registration] (promulgated by the State Admin. Market
Regul., Jan. 15, 2020, effective July 1, 2020).
Yàopǐn guǎnlǐ shíshī tiáolì (品管理法施条例) [Regulations for the
Implementation of the Drug Administration Law] (promulgated by the State
Council of the People's Republic of China, Aug. 4, 2002, effective Sept. 15,
2002).
INDIANA HEALTH LAW REVIEW [Vol. 21:1
50
Democratic Republic of the Congo
Constitutional
CONSTITUTION DE LA RÉPUBLIQUE DÉMOCRATIQUE DU CONGO
[CONSTITUTION] (2005).
Legislative
Loi n° 82/001 du 7 janvier 1982 sur la Propriété industrielle [Industrial Property
Law] (Jan. 7, 1982).
Loi n° 015/2002 du 16 octobre 2002 portant Code du Travail [Labor Code] (Oct.
16, 2022).
Loi 08/011 du 14 juillet 2008 portant protection des droits des personnes
vivant avec le VIH/SIDA et des personnes affectées [Law for the Protection of
the Rights of People Living with HIV/AIDS and Affected Persons] (July 14,
2008).
Loi n° 18/035 du 13 décembre 2018 fixant les principes fondamentaux relatifs
à l'organisation de la santé publique [Public Health Law] (Dec. 13, 2018).
Loi organique 22/003 du 3 mai 2022 portant protection et promotion des
droits des personnes vivant avec handicap [Law on the Protection and
Promotion of the Rights of Persons with Disabilities] (May 3, 2022).
Executive branch
Ministry of Public Health, Plan Strategique National de Lutte Contre la
Tuberculose 2021-2022 (2023) [National Strategic Plan for the Fight Against
Tuberculosis 2021-2022 (2023)] (Dec. 2019).
Ministry of Public Health, Plan National de Développement Sanitaire recadré
pour la période 2019-2022: Vers la couverture sanitaire universelle [National
Health Development Plan 2019-2022: Towards Universal Health Coverage]
(Sept. 2018).
India
Constitutional
CONST. OF INDIA (1950).
Consumer Educ. & Rsch. Ctr. v. Union of India, (1995) 3 SCC 42.
2024] ACTIVATING LAW AND HUMAN RIGHTS 51
TO END TUBERCULOSIS
State of Punjab v. Mohinder Singh Chawla, (1997) 2 SCC 83.
Legislative
The Epidemic Diseases Act, 1897.
The Drugs and Cosmetics Act, 1940.
The Patents (Amendment) Act, 2005.
The Rights of Persons with Disabilities Act, 2016.
The Human Immunodeficiency Virus and Acquired Immune Deficiency
Syndrome (Prevention and Control) Act, 2017.
The Code on Wages, 2019.
The Epidemic Diseases (Amendment) Ordinance, 2020.
The Industrial Relations Code, 2020.
The Occupational Safety, Health and Working Conditions Code, 2020.
Executive branch
Ministry of Health with Family Welfare, National Health Policy 2017 (2017).
Ministry of Health with Family Welfare, National Strategic Plan for
Tuberculosis: 20172025 Elimination by 2025 (Mar. 2017).
Indonesia
Constitutional
UNDANG-UNDANG DASAR NEGARA REPUBLIK INDONESIA [CONSTITUTION]
(1945).
Legislative
Undang-Undang Tentang Pokok-Pokok Kesehatan [Health Principles Law],
No. 9 of 1960.
INDIANA HEALTH LAW REVIEW [Vol. 21:1
52
Undang-Undang Tentang Wabah Penyakit Menular [Outbreaks of Infectious
Diseases Law], No. 4 of 1984.
Undang-Undang Tentang Hak Asasi Manusia [Human Rights Law], No. 39 of
1999.
Undang-Undang Tentang Ketenagakerjaan [Labor Law], No. 13 of 2003.
Undang-Undang Tentang Praktik Kedokteran [Medical Practice Law], No. 29
of 2004.
Undang-Undang Tentang Kesehatan [Health Law], No. 36 of 2009.
Undang-Undang Tentang Rumah Sakit [Hospital Law], No. 44 of 2009.
Undang-Undang Tentang Paten [Patents Law], No. 13 of 2016).
Undang-Undang Tentang Penyandang Disabilitas [Law on Persons with
Disabilities], No. 8 of 2016.
Undang-Undang Tentang Cipta Kerja [Omnibus Law on Job Creation Law], No.
11 of 2020.
Executive branch
Keputusan Menteri Kesehatan Tentang Pedoman Pelaksanaan Kolaborasi
Pengendalian Penyakit TB dan HIV [Ministry of Health Decree on Guidelines
for Implementing Collaborative TB and HIV Control], No.
1278/Menkes/SK/XII/2009.
Surat Edaran Menteri Kesehatan Tentang Peningkatan Penemuan Kasus
Tuberkulosis [Ministry of Health Circular Letter on Increasing TB Case
Findings], No. HK.03.03/D1 III.I/951/2016.
Peraturan Menteri Kesehatan Tentang Pedoman Penyelenggaraan Program
Indonesia Sehat Dengan Pendekatan Keluarga [Ministry of Health Regulation
on Guidelines for Implementing the Healthy Indonesia Program], No. 39 of
2016.
Peraturan Menteri Kesehatan Tentang Standar Pelayanan Minimal Bidang
Kesehatan [Ministry of Health Regulation on Minimum Health Service
Standards], No. 43 of 2016.
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TO END TUBERCULOSIS
Peraturan Menteri Kesehatan Tentang Penanggulangan Tuberkulosis [Ministry
of Health Regulation on Tuberculosis Treatment], No. 67 of 2016.
Peraturan Menteri Hukum Dan Hak Asasi Manusia Tentang Tata Cara
Pemberian Lisensi-Wajib Paten [Ministry of Law and Human Rights Regulation
on Procedures for Granting Compulsory Patent Licenses], No. 30 of 2019.
Rencana Strategis Kementerian Kesehatan Tahun 2020-2024 [Ministry of
Health Strategic Plan 20202024] (2020).
Ministry of Health, National Strategy of Tuberculosis Care and Prevention in
Indonesia 20202024 (2020).
Peraturan Presiden Tentang Tata Cara Pelaksanaan Paten Oleh Pemerintah
[Presidential Regulation on Procedures of Patent Implementation by the
Government], No. 77 of 2020.
Peraturan Presiden Tentang Penanggulangan Tuberkulosis [Presidential
Regulation on Tuberculosis Management], No. 67 of 2021.
Myanmar
Constitutional
 [CONSTITUTION]
(2008).
Legislative

 [Public Health Law], 1972.
  
[Prevention and Control of
Infectious Diseases Law], No. 1 of 1995.
  
[Amendment of Prevention and Control of Communicable Diseases Law], No.
16 of 2011.
   [Employment and Skill
Development Law], No. 29 of 2013.
INDIANA HEALTH LAW REVIEW [Vol. 21:1
54
   [The Minimum Wage Law], No. 7 of
2013.
  [Rights of Persons with Disabilities Law],
No. 30 of 2015.
  [Payment of Wages Law], No. 17 of
2016.
    [Shops and Workplaces Law], No.
18 of 2016.
 [Myanmar Companies Law], No. 29 of 2017.
 [Patent Law], No. 7 of 2019.
Executive branch
Ministry of Health and Sports, Myanmar National Health Plan 20172021
(Dec. 2016).
Ministry of Health and Sports, National Strategic Plan 2021-2025: National TB
Programme (Mar. 2020).
Nigeria
Constitutional
CONST. OF NIGERIA (1999).
Legislative
Labour Act (1971) L.F.N. 1990, Cap. (198).
Patents and Designs Act (1971) L.F.N. 1990, Cap. (344).
African Charter on Human and Peoples’ Rights (Ratification and Enforcement)
Act (1983) L.F.N. 1990, Cap. (10).
HIV and AIDS (Anti-Discrimination) Act (2014) O.G., A123.
2024] ACTIVATING LAW AND HUMAN RIGHTS 55
TO END TUBERCULOSIS
National Health Act (2014) O.G., A139.
Discrimination Against Persons with Disabilities (Prohibition) Act (2018) O.G.,
A97 (2019).
Executive branch
Federal Ministry of Health, National Health Policy 2016 (Sept. 2016).
Department of Public Health, Human Rights and Gender Action Plan for
Tuberculosis Care and Prevention in Nigeria 20212025 (2021).
Federal Ministry of Health, National Strategic Plan for Tuberculosis Control,
20212025 (2021).
Pakistan
Constitutional
CONST. OF PAKISTAN (1973).
Legislative
Factories Act, No. XXV of 1934.
Public Health (Emergency Provision) Ordinance, No. XXI of 1944.
West Pakistan Epidemic Diseases Act, No. XXXVI of 1958.
West Pakistan Industrial and Commercial Employment (Standing Orders)
Ordinance, No. VI of 1968).
West Pakistan Shops and Establishments Ordinance, No. VIII 1969.
Disabled Persons (Employment and Rehabilitation) Ordinance, No. XL of 1981.
Patents Ordinance, No. LXI of 2000, amended by Patents (Amendment)
Ordinance, No. XCV of 2002.
Epidemic Diseases (Amendment) Act, No. XX of 2011.
INDIANA HEALTH LAW REVIEW [Vol. 21:1
56
Executive branch
The Patent Rules, S.R.O.1142 (i)/2003, THE GAZETTE OF PAKISTAN
EXTRAORDINARY, Dec. 31, 2003.
Ministry of National Health Services Regulations and Coordination, National
Health Vision: Pakistan 20162025 (2016).
Ministry of National Health Services, Regulations and Coordination, National
Strategic Plan for Tuberculosis Control, 20202023 (2020).
Philippines
Constitutional
CONST. OF THE PHILIPPINES (1987).
Legislative
LABOR CODE, Pres. Dec. No. 442, as amended.
Magna Carta for Disabled Persons, Rep. Act No. 7277 (Mar. 24, 1992).
INTELLECTUAL PROPERTY CODE, Rep. Act No. 8293, as amended.
Universally Accessible Cheaper and Quality Medicines Act of 2008, Rep. Act
No. 9502 (June 6, 2008).
Comprehensive Tuberculosis Elimination Plan Act, Rep. Act No. 10767 (Apr.
26, 2016).
Philippine HIV and AIDS Policy Act, Rep. Act No. 11166 (Dec. 20, 2018).
Universal Health Care Act, Rep. Act No. 11223 (Feb. 20, 2019).
Executive branch
Dept. of Labor and Employent, Guidelines for the Implementation of Policy and
Program on Tuberculosis (TB) Prevention and Control in the Workplace, Dept.
Ord. No. 73-05 (2005).
Office of the Secretary, The Philippine Health Agenda 20162022, Admin. Ord.
No. 2016-0038 (Oct. 26, 2016).
2024] ACTIVATING LAW AND HUMAN RIGHTS 57
TO END TUBERCULOSIS
Office of the Secretary of Health, Implementing Rules and Regulations of the
Comprehensive Tuberculosis Elimination Plan Act, Mem. Circ. No. 2017-0014
(May 2, 2017).
Office of the Secretary of Health, Strategic Framework and Implementing
Guidelines for FOURmula One Plus for Health (F1+), Admin. Ord. No. 2018-
0014 (May 30, 2018).
Office of the Secretary of Health, Implementing Rules and Regulations of
Universal Health Care Act (July 23, 2018).
Office of the Secretary of Health, National TB Control Program Adaptive Plan
for the COVID-19 Pandemic, Admin. Ord. No. 2020-0056 (Nov. 9, 2020).
Department of Health, National Tuberculosis Control Program Manual of
Procedures 6th edition (2020).
Department of Health, Updated Philippine Strategic TB Elimination Plan,
Phase 1: 2020-2023 (2020).
Russian Federation
Constitutional
KONSTITUTSIIA ROSSIĬSKOĬ FEDERATSII [CONSTITUTION] (1993)
Legislative
Федеральный закон социальной защите инвалидов в Российской
Федерации" [Federal Law on Social Protection of Disabled People], No. 181-
FZ, Nov. 24, 1995, as amended.
Федеральный закон санитарно-эпидемиологическом благополучии
населения" [Federal Law on the Sanitary and Epidemiological Welfare of the
Population], No. 52-FZ, Mar. 30, 1999.
ТРУДОВОЙ КОДЕКС РОССИЙСКОЙ ФЕДЕРАЦИИ [LABOR CODE], No. 197-FZ,
Dec. 30, 2001.
Федеральный закон предупреждении распространения туберкулеза в
Российской Федерации" [Federal Law on Preventing the Spread of
Tuberculosis], No. 77-FZ, June 18, 2001, as amended.
INDIANA HEALTH LAW REVIEW [Vol. 21:1
58
ГРАЖДАНСКИЙ КОДЕКС РОССИЙСКОЙ ФЕДЕРАЦИИ [CIVIL CODE], Part IV, §
VII, No. 230-FZ, Dec. 18, 2006, as amended.
Федеральный закон "Об обращении лекарственных средств" [Federal Law
on the Circulation of Medicines], No. 61-FZ, Apr. 12, 2010, as amended.
Федеральный закон "Об основах охраны здоровья граждан в Российской
Федерации" [Federal Law on the Basics of Health Protection of Citizens in the
Russian Federation], No. 323-FZ, Nov. 21, 2011.
Федеральный закон внесении изменений в статью 60 Федерального
закона "Об обращении лекарственных средств" и статью 38 Федерального
закона "Об основах охраны здоровья граждан в Российской Федерации"
[Federal Law on Amendments to Article 60 of the Federal Law “On the
Circulation of Medicines” and Article 38 of the Federal Law “On the Basics of
Protecting the Health of Citizens in the Russian Federation”], No. 67-FZ, Mar.
26, 2020.
Executive branch
Государственная стратегия ликвидации туберкулеза в Российской
Федерации до 2025 года и дальнейшую перспективу [State Strategy for the
Elimination of Tuberculosis in the Russian Federation until 2025 and Beyond],
2018.
Указ Президента РФ “О Стратегии развития здравоохранения в
Российской Федерации на период до 2025 года” [Decree of the President of
the Russian Federation “On the Strategy for the Development of Healthcare in
the Russian Federation for the Period until 2025”], No. 254, June 6, 2019.
Vietnam
Constitutional
HIN PHÁP CNG HÒA XÃ HI CH NGHĨA VIT NAM [CONSTITUTION] (1992).
Legislative
Lut ca Quc hi: Lut Phòng, chng nhim vi rút gây ra hi chng suy gim
min dch mc phi người (HIV/AIDS) [Law on HIV/AIDS Prevention and
Control], No. 64/2006/QH11, June 29, 2006, as amended.
Lut ca Quc hi: Lut Phòng, Chng Bnh Truyn Nhim [Law on Prevention
and Control of Infectious Disease], No. 03/2007/QH12, Nov. 21, 2007
2024] ACTIVATING LAW AND HUMAN RIGHTS 59
TO END TUBERCULOSIS
Lut ca Quc hi: Luật Người Khuyết Tt [Law on Persons with Disabilities],
No. 51/2010/QH12, June 17, 2010.
LUT CA QUC HI: B LUT LAO ĐNG [LABOR CODE], No.
10/2012/QH13, June 18, 2012.
Lut ca Quc hi: Lut S Hu Trí Tu [Law on Intellectual Property], No.
11/VBHN-VPQH, July 8, 2022.
Executive branch
Ministry of Health, ng dn bo mt d liu th nghiệm trong đăng ký thuốc
[Guidelines for the Security of Testing Data in Drug Registration], No:
05/2010/TT-BYT, Mar. 1, 2010.
Ministry of Health, Plan for People’s Health Protection, Care and Promotion
20162020 (Mar. 2016).
Ministry of Health, Vietnam National Tuberculosis Program Draft National
Strategic Plan 20212025 (May 2020).
ResearchGate has not been able to resolve any citations for this publication.
Measures for the Administration of Drug Registration] (promulgated by the State Admin
Yàopǐn zhùcè guǎnlǐ bànfǎ (药品注册管理办法) [Measures for the Administration of Drug Registration] (promulgated by the State Admin. Market Regul., Jan. 15, 2020, effective July 1, 2020).
Plan National de Développement Sanitaire recadré pour la période 2019-2022: Vers la couverture sanitaire universelle [National Health Development Plan 2019-2022: Towards Universal Health Coverage
Ministry of Public Health, Plan National de Développement Sanitaire recadré pour la période 2019-2022: Vers la couverture sanitaire universelle [National Health Development Plan 2019-2022: Towards Universal Health Coverage] (Sept. 2018). India Constitutional CONST. OF INDIA (1950).
Tentang Hak Asasi Manusia
  • Undang-Undang
Undang-Undang Tentang Hak Asasi Manusia [Human Rights Law], No. 39 of 1999.
Tentang Praktik Kedokteran
  • Undang-Undang
Undang-Undang Tentang Praktik Kedokteran [Medical Practice Law], No. 29 of 2004.
Executive branch Federal Ministry of Health
Executive branch Federal Ministry of Health, National Health Policy 2016 (Sept. 2016).
Standing Orders) Ordinance, No. VI of
West Pakistan Industrial and Commercial Employment (Standing Orders) Ordinance, No. VI of 1968).
Epidemic Diseases (Amendment) Act, No. XX of
Epidemic Diseases (Amendment) Act, No. XX of 2011. INDIANA HEALTH LAW REVIEW [Vol. 21:1
Ministry of National Health Services Regulations and Coordination, National Health Vision
  • S R O The Patent Rules
The Patent Rules, S.R.O.1142 (i)/2003, THE GAZETTE OF PAKISTAN EXTRAORDINARY, Dec. 31, 2003. Ministry of National Health Services Regulations and Coordination, National Health Vision: Pakistan 2016-2025 (2016).
Ministry of National Health Services, Regulations and Coordination, National Strategic Plan for Tuberculosis Control
Ministry of National Health Services, Regulations and Coordination, National Strategic Plan for Tuberculosis Control, 2020-2023 (2020). Philippines Constitutional CONST. OF THE PHILIPPINES (1987).
Magna Carta for Disabled Persons
Magna Carta for Disabled Persons, Rep. Act No. 7277 (Mar. 24, 1992).