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Are global health policies good for public health in developing countries?

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Title: Are global health policies good for public health in developing countries?


1
Are global health policies good for public health
in developing countries?
  • Amar Jesani
  • Indian Journal of Medical Ethics (www.ijme.in)
  • Centre for Studies in Ethics and Rights
    (www.cser.in)
  • Mumbai, India

2
Conflict of interest
  • Bioethics as health activism
  • I have taken public position on the case around
    which this presentation is structured
  • I was also a member of the advisory committee of
    the project for a brief while after the data of
    the formative research came in, and participated
    in the committee to discuss draft report.
    However, soon after I resigned from the committee.

3
Outline
  • Framework
  • About India
  • A case study of HPV vaccine demonstration project
  • Learning from the case
  • (a) Science and evidence
  • (b) Coming together of global policy makers
  • (c) Promotion of techno-managerial solutions in
    public health
  • (d) Nation state What is the right balance
    between facilitation and regulation?
  • (e) Global health governance Is there a balance
    between facilitation and regulations?
  • To conclude

4
Framework
  • The global health policies are increasingly
    shaped by
  • (a) global trade relations giving priority to the
    interests of global Corporate business,
  • (b) World banks involvement in the field of
    health and
  • (c) Private philanthropic foundations
  • The inter-governmental agency, the WHO, has
    considerably ceded its powers in the global
    governance to the above players
  • Global health policies are paying only lip
    service to strengthening of the national public
    health system

5
Framework
  • Dominant disease centric vertical approach is
    often found to weaken the existing health systems
    in many developing countries
  • The non-state players dominate in setting the
    agenda and priorities, and they often co-opt the
    national elites in the process
  • The international community must learn from the
    experiences of the global health policies in the
    field
  • Policies without robust global and national
    governance systems would not provide expected
    results

6
Context About India - General
  • High economic growth of last two decades
  • Booming business including private for- profit
    pharmaceutical and hospital service sectors
  • Massive export of drugs, and country opened to
    Medical tourism and Clinical trials to sustain
    health care business
  • At the same time
  • Increased inequities - Substantial proportion of
    population below poverty line, illiterate or
    semi-literate, and discrimination in accessing
    health care
  • Government spends only ONE percent of GDP on
    health care, which is one fifth or sixth of total
    health care expenditure

7
Context About India Health care
  • No universal access to health care
  • 80 of health services in for-profit private
    sector
  • 10-20 covered under voluntary health insurance
  • High cost of health care over two third of
    health care financed by out of pocket expenditure
    by patients
  • Cost of health care a major cause of poverty
  • Recent report for universal access system
  • Health care regulations
  • Dominant for-profit private health sector covered
    under grossly inadequate regulations .
  • Existing weak regulations hardly implemented

8
Understanding the issues from a case
  • Instead of putting together evidence from the
    review of scientific literature, this
    presentation takes up a case and tries to unravel
    the effect of the global health policies at the
    ground level in India.
  • It argues that the complexities should not deter
    us from understanding something very simple that
    emerges from the analysis of practice

9
Case study Research on cervical cancer and HPV
vaccine in India
  • Cervical cancer - a major cause of deaths of
    women due to cancer. Also has a history of
    unethical research in India
  • Screening program
  • 1976 to 1990 A long term observational study of
    1163 women with cervical dysplasia to understand
    causative factors and biological behaviour of
    dysplasia.
  • Rationale scarce resources could be saved if
    dysplasias that need intervention are identified
  • This research was completely supported from
    Indian sources and Indian medical scientists and
    institutions were involved
  • The end point of the study was carcinoma in situ
    (CIS) when appropriate treatment was offered.

10
Case study Research on cervical cancer and HPV
vaccine in India
  • In 1986, the results of the study were
    extensively used in planning National Cancer
    Control Program for control of cervical cancer.
  • However, the screening program could never be
    universalised due to low investment and weak
    public health system
  • So the very purpose with which over a thousand
    women were exposed to risks without offering
    treatment was never achieved
  • Controversy in 1997

11
Case study Research on cervical cancer and HPV
vaccine in India
  • HPV vaccine
  • 2006-07 Phase IIIb marketing approval clinical
    trials of the HPV vaccines to test its
    immunogenicity in 100 to 200 subjects
  • 2008 Marketing approval by Indian drugs
    regulator
  • 2009 Market launch of vaccine
  • HPV vaccine demonstration project
  • 2007 PATH, in collaboration with Indian Council
    of Medical Research (ICMR) and two state
    governments (Andhra Pradesh and Gujarat) launched
    the project funded by the Gates Foundation
  • Objective generating evidence the would enable
    policy makers to decide on possible public sector
    introduction of the HPV vaccine in the countrys
    immunisation program

12
Case study Research on cervical cancer and HPV
vaccine in India
  • HPV vaccine demonstration project
  • 2008 Completion of formative research in one
    district each of two states
  • 2009 Launch of demonstration project with two
    components
  • (a) An observational study of post-licensure HPV
    vaccination (a Phase IV clinical research on a
    vaccine)
  • (b) Evaluation of Implementation of HPV
    vaccination though operational research in terms
    of coverage, acceptability, feasibility and
    costs.
  • Of the five primary outcome measures, four were
    assessment of serious and non-serious adverse
    events and the timeliness of their reporting
  • The Companies, the producers of the vaccines,
    provided vaccine free for the study (costing over
    5 million)

13
Case study Research on cervical cancer and HPV
vaccine in India
  • 2010 After 23,428 girls in the age group 10 to
    14 years were vaccinated, in March it was
    suspended following an investigation report by
    womens health organisation, Sama, Delhi, on the
    death of seven girls (5 in AP, and 2 in Gujarat)
  • 2010, April Govt appointed an Investigation
    Committee
  • Committee submitted its final report on February
    15, 2011
  • The report is still not in public domain, but its
    interim report released on Nov 10, 2010 is in
    public domain
  • The report points to several concerns which are
    important for their human rights and public
    health dimensions so also for the Global Health
    Policies

14
Case study Research on cervical cancer and HPV
vaccine in India
  • Some of the findings of the committee
  • The project, though used the national
    immunisation services, was never put up for
    appraisal by the National Technical Advisory
    Group on Immunisation
  • A quarter of participants were drawn from tribal
    communities
  • In the predominantly tribal blocks it was known
    that the immunisation system was not in robust
    shape, with extremely inadequate reporting and
    management of the Adverse Event Following
    Immunisation (AEFI)
  • And yet the project relied on it without
    enhancing its capacity, or creating additional
    support structure from the project.

15
Case study Research on cervical cancer and HPV
vaccine in India
  • As a consequence, non-serious adverse events
    hardly got recorded (0.29 to 1.37), and there
    were long delays in reporting of serious adverse
    events
  • In AP, the deaths of girls who died in July, Sept
    and Oct 2009, were not taken cognizance until Jan
    29, 2010.
  • In the process, the project also blurred the
    distinction between regular work of the national
    immunisation program and the research project
  • Gave a wrong impression to people that the HPV
    vaccine was a part of the national program

16
Case study Research on cervical cancer and HPV
vaccine in India
  • Deficiencies in Informed consent
  • (a) In AP, 20 parents gave thumb impression,
  • (b) In Gujarat, 37 parents gave thumb impression
  • (c) The AP tribal department issued an
    administrative order giving authority to hostel
    warden/head masters of schools to provide consent
    on behalf of girls - nearly one-third of forms
    were signed by them
  • (d) a sample study of the forms found most of the
    forms deficient in information, many names not
    matching with the signatures,

17
Case study Research on cervical cancer and HPV
vaccine in India
  • (e) assent of girls not documented, though as per
    the ICMR guidelines, it is mandatory to do so
  • (f) at no time the participants were provided
    information that the HPV is a sexually
    transmitted infection and not told about other
    preventive measures available
  • No insurance for participants obtained, though
    insurance for PATH and its researchers was
    purchased.
  • Since project did not have its own follow up
    mechanism, no appropriate data on causality of
    girls death were available, but indirect
    evidence suggested that deaths were not related
    to the vaccine. No compensation paid.

18
  • What do we learn from this case?

19
(a) Science and evidence
  • Prima facie, the researchers involved in the
    project believed that once a good tool is
    developed by the science, the only thing
    remaining for its use is to show that it can be
    delivered nothing else mattered
  • Evidence is not evidence without a proof from
    experiment a wholesale application of the
    natural science paradigm to the social reality
  • Under development of developing societies
    converted into disease emergencies
  • In the war on terror, the doubters are
    unpatriotic in the war on disease, they are
    against science!

20
(a) Science and evidence
  • Societies and communities are emerging as a vast
    terrain for experimentation the experiments are
    getting converted into experimentality.
  • Social experiments are good when they are needed,
    if
  • Undertaken with some credible consent of
    communities and individuals involved, and
    protection of their safety
  • And there is economic feasibility and political
    will to implement their findings.
  • At present, social and public health experiments
    are global trends, involving researchers from all
    types of nations
  • And yet, we do not have ethical framework and
    guidelines in place for protection of
    participants human rights

21
(b) Coming together of global health policy makers
  • The project brought together most of the key
    players of the global health
  • An international foundation set up for
    philanthropy
  • An international NGO established to do research
    on technologies - an NGO that acted more like a
    Contract Research Organisation
  • The pharmaceutical companies that donated over 5
    million dollar worth vaccines with an eye on a
    massive captive market
  • A willing national scientific establishment that
    was more interested in experiment than the
    feasibility of providing universal access to the
    benefits of its findings to the people
  • And interestingly, the WHO Bulletin was the first
    to publish the findings of operation research
    without any mention of what happened in that
    research in India

22
(b) Coming together of global health policy makers
  • This, indeed, was a big global collaborative
    research taken with an obvious objective of
    impacting a nations public health system.
  • Yet, the investigation committee or the research
    ethics committees that reviewed the project, were
    not provided any information on
  • Total cost involved
  • Terms of agreements and contracts signed by all
    participating parties
  • All parties invoked trade secret clause of
    Indias Right to Information Law when they were
    formally requested by the civil society
    organisation to reveal those agreements and
    research protocol used

23
(b) Coming together of global health policy makers
  • Thus, the operation of the international and
    national health policy makers is shrouded in
    complete secrecy
  • The formal release and public discussion of the
    investigation committee report are stalled, as
    government has taken no action on its findings
  • Not just hard-core biomedical research for
    commercial product development, but also the
    social research with potential to affect lives of
    millions of people, is a part of the trade
    policies, and secrets that surround them
  • A section of scientific, bureaucratic, corporate
    and political elite at national level is always
    implicated to ensure that if anything went wrong,
    there will be the least repercussion

24
(b) Coming together of global health policy makers
  • Lastly, something about the involvement of
    philanthropic organisations in international and
    national health policies
  • What should be the role of such foundations?
  • Should their dominant actions be such that
    consistently and progressively the health moves
    from the realm of market and philanthropy to
    human rights?
  • Should they narrowly concentrate on the task of
    plugging the market failures so that the rest of
    business and trade could go on unhindered?
  • There is a need to engage with private players,
    but the engagement ought to be for pulling them
    in towards the right to health

25
(c) Promotion of techno-managerial solutions in
public health systems
  • There is no doubt that the public health systems
    of many developing countries are deprived of
    basic technologies and suffer from inefficient
    and sometimes corrupt management practices
  • The building of universal access public health
    system with adequate technology and strong,
    transparent and accountable management system
    ought to be a top priority on the agenda of the
    global health policies
  • Social and public health research, therefore,
    need to be evaluated from the perspective of
    whether it would build a good health system or
    break the existing one, howsoever deficient it
    may be the responsiveness requirement of ethics
    thus has a massive added dimension in such
    research

26
(c) Promotion of techno-managerial solutions in
public health systems
  • For this project, from the health system building
    perspective, there were two important questions
  • It is known that HPV vaccine will not provide
    protection to a significant number of people
    (over two fifth of them).
  • Would the research be done in communities where
    the screening and treatment program is in place?
  • Would the introduction of universal screening and
    treatment program go hand-in-hand with the
    introduction of universal vaccination of girls?
  • How would the weak public health system
    accommodate the task of universal immunisation
    with one more vaccine?
  • And above all, how cost-effective would that be
    as compared to universal screening program that
    would build basic laboratory and medical services?

27
(c) Promotion of techno-managerial solutions in
public health systems
  • Social and public health experiments are often
    done with an intention to keep multiple solutions
    ready for the system as and when it is able to
    absorb their findings or, if the system cannot
    absorb them in foreseeable future, then at least
    some can avail of it from the market
  • When system is not ready, the use of its
    infra-structure for experimentation, more so if
    that would disrupt its normal functioning, must
    be critically examined
  • There is some lack of ethical responsiveness when
    experiments are done on the poor who are unlikely
    to afford when their findings are scaled up in
    the market

28
(c) Promotion of techno-managerial solutions in
public health systems
  • The clinical trials outsourced in developing
    countries, with research participants drawn from
    the poor communities lacking access to health
    care, have shown phenomenal lack of ethical
    responsiveness
  • The social and public health intervention
    research going in the same direction ought to
    worry all of us
  • Lastly, the international polio eradication
    program another techno-managerial solution that
    disrupted regular health services for long - and
    with India declared free of polio cases, has
    raised concerns about the disease eradication
    strategies, and about the Non Polio Flaccid
    Paralysis cases getting neglected in the health
    system

29
(d) The nation state What is the right balance
between facilitation and regulation?
  • The HPV vaccine project would not have been
    possible within the public health system without
    the helping hand of the state
  • The reach of the global health players was such
    that they could obtain from the state an
    administrative order compromising rights of the
    participants
  • On May 8, 2012 the Parliament Standing Committee
    in its report noted that the stated mission of
    the Indian drugs regulator is to meet the
    aspirations... demands and requirements of the
    pharmaceutical industry, without any reference
    to protection of consumers and research
    participants.

30
(d) The nation state What is the right balance
between facilitation and regulation?
  • Report provides numerous instances of drugs
    approved for marketing without adequate research
    and the industry drafting and obtaining support
    from doctors on identical letters of
    recommendation to get drugs approved
  • Regulatory agencies are grossly under-staffed,
    poorly trained in inspection and monitoring and
    lack competence to scientifically evaluate
    research findings
  • If a similar investigation is done of research
    ethics committees - the frontline regulators of
    clinical health research going on in over 4000
    hospitals and research institutions in India
    its findings would be similar

31
(d) The nation state What is the right balance
between facilitation and regulation?
  • Capture of regulators by the regulated is not new
    but the concern is that the national and
    international health policies are the least
    committed to change the situation
  • There is inadequate material and human investment
    and capacity building for regulations
  • Good governance is not possible without
    independent, transparent and accountable
    regulators
  • The physical independence of regulators may have
    to go hand-in-hand with the political and
    ideological liberation from the deep rooted
    convictions of theirs that limit their actions to
    facilitation without effective protection of
    users of services and research participants

32
(e) Global health governance is there a balance
between facilitation and regulation?
  • The situation in the global health governance in
    some ways mirror the situation at the national
    level in some developing countries
  • The dominant players in the global policies on
    trade, services and research in health are
    effectively allowed to decide the system of
    governance themselves.
  • The inter-governmental agency, the WHO as a UN
    body is reduced to a technical organisation
    without power in the global governance

33
(e) Global health governance is there a balance
between facilitation and regulation?
  • A huge proportion (nearly 80) of funding of the
    WHO comes from the partnerships it forges with
    the global health players aid funds of member
    states, corporate sector, philanthropic
    foundations and the banking institutions
  • Such funding is conditional, short-term
    extra-budgetary funds
  • This compromises its constitutional mandate as
    against the specific interests and priorities of
    individual donors
  • Unlike the WTO, the WHO has no mandate to work
    for compulsory dispute settlement and enforcement

34
To conclude
  • We may get carried away by the complexities of
    global health policies, and conclude that there
    are no easy solutions
  • Or we may take a view that complexities should
    not deter us from finding the basic political
    trends that become easily visible when the
    complex policies are seen from what is happening
    at the ground level
  • To make global health policies useful for
    developing countries and to establish and
    strengthen universal access health care systems,
    we need to evolve independent, transparent and
    accountable governance, globally as well as
    nationally.

35
Resources used
  • Marchal Bruno et al, Global health actors claim
    to support health system strengthening Is this
    reality or rhetoric? PLoS, 2009, 6(4)
  • Sarojini NB et al, HPV vaccine science, ethics
    regulation, 2010, EPW, 45(27) 27-34. Sarojini
    NB et al, Undeniable violations, unidentifiable
    violators, 2011, EPW, 46(24) 17-19)
  • Amit Sengupta, Global governance of health a
    minefield of contradictions and sectional
    interests, Ind Jn of Med Ethics, 8(2) 86-90
    (www.ijme.in)
  • Reports of Global Health Watch, 2005, 2008, 2011
  • Report of the High Level Committee on Universal
    Health Coverage, Planning Commission, India, 2011

36
  • Final report of the committee appointed by Govt
    of India to enquire into alleged irregularities
    in the conduct of studies using HPV vaccine by
    PATH in India, Feb 15, 2011
  • 59th Report of the department related
    Parliamentary Standing Committee on functioning
    of the Central Drugs Standard Control
    Organisation, Government of India, May 2012
  • Neetu Vashisth, Jacob Puliyel, Polio program
    Let us declare victory and move on, Indian
    Journal of Medical Ethics, Vol IX, No. 2
    April-June 2012, pages 114-117

37
Thank you
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