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Oct-Dec2004-12(4)
RESPONSE
Challenges confronting the
WHO/UNAIDS 3x5 Initiative
Ruth
Macklin
Efforts such as the World Health Organization's 3x5
Initiative bring with them new challenges, along with the hope and promise of
expanding access to antiretroviral treatment (ART) in developing countries. Some
challenges are practical or technical: Will a sufficient number of volunteers
undergo HIV tests to determine their eligibility for treatment? Will there be
enough rapid test kits available for all the people who will have to be tested?
Equally challenging are questions of ethics and equity.
The editorial in the July-September 2004 issue of
the Journal (1) describes some of the ethical challenges this initiative faces
in India. This includes the ongoing discrimination against people living with
HIV/AIDS in both public and private sectors, the injustice evident in the
selection of the sites where free access to ART will be offered, and the
potential for corruption due to bribery in rejecting or selecting patients for
free treatment. Although these and other ethical challenges are not unique to
India, they are based on evidence from current and past discriminatory practices
and unjust distribution of health care resources.
The editorial asks, 'How can the selection process
be impartial and objective if the profession that is supposed to implement it
has shown discriminatory behaviour?' The only way to accomplish this is to
adhere to procedural fairness while selecting both the sites where free ART will
be available and the individuals who will be eligible to receive the treatment.
Elements necessary for achieving procedural fairness are discussed
below.
Community
involvement
Involvement of communities is a prerequisite for procedural fairness.
Involvement of communities is a prerequisite for procedural fairness.
Transparency
Groups involved in setting priorities must use democratically developed, unambiguous criteria in taking decisions about the individuals or groups that will receive treatment. 'Public accountability in the form of open, democratic processes is a fundamental requirement of justice because people must understand what principles and reasoning are used in choices that affect their basic well-being(2).'
Groups involved in setting priorities must use democratically developed, unambiguous criteria in taking decisions about the individuals or groups that will receive treatment. 'Public accountability in the form of open, democratic processes is a fundamental requirement of justice because people must understand what principles and reasoning are used in choices that affect their basic well-being(2).'
Decisions about which categories or groups should
have access to ART and the rationale for these decisions should be 'reasonable'
in that it should appeal to reasons and principles that are accepted as relevant
by the stakeholders. Such decisions must be publicly accessible(3).
Inclusiveness
Those involved in the decision-making process at all levels should include a wide range of individuals and groups. Policy-makers and members of advisory boards should include persons with HIV infection and their family members, people from different backgrounds-language, cultural, educational and class.
Those involved in the decision-making process at all levels should include a wide range of individuals and groups. Policy-makers and members of advisory boards should include persons with HIV infection and their family members, people from different backgrounds-language, cultural, educational and class.
Impartiality
This criterion is required to avoid conflicts of interest. For example, stakeholders should not be involved in the decision-making process which sets priorities for their own group to receive ART.
This criterion is required to avoid conflicts of interest. For example, stakeholders should not be involved in the decision-making process which sets priorities for their own group to receive ART.
Due process
There should be a mechanism for challenge and revision of the chosen scheme, including the opportunity for revising decisions about priorities in the light of further evidence and changing circumstances (3).
There should be a mechanism for challenge and revision of the chosen scheme, including the opportunity for revising decisions about priorities in the light of further evidence and changing circumstances (3).
Accountability
There should be some form of accountable regulation of the process to ensure that the above conditions are met (3). In addition to embodying elements of procedural fairness, implementation of the 3x5 Initiative must also respect human rights and adhere to substantive principles of ethics and equity. Although adherence to human rights provisions in scaling up treatment programmes is essential, none of the various human rights treaties or declarations provide specific criteria for setting priorities or choosing among potentially relevant principles of equity. As treatment programmes are rolled out, it will not be possible for every eligible person to be treated at once. What criteria should decision-makers use to set priorities for access? Are there ethically acceptable grounds for choosing special groups, such as health care workers, to ensure effective implementation of treatment programmes? Can giving preference to children or pregnant women be ethically justified? There is no clear and uncontroversial way of determining which groups in a population should be given the priority when all cannot be treated at the outset.
There should be some form of accountable regulation of the process to ensure that the above conditions are met (3). In addition to embodying elements of procedural fairness, implementation of the 3x5 Initiative must also respect human rights and adhere to substantive principles of ethics and equity. Although adherence to human rights provisions in scaling up treatment programmes is essential, none of the various human rights treaties or declarations provide specific criteria for setting priorities or choosing among potentially relevant principles of equity. As treatment programmes are rolled out, it will not be possible for every eligible person to be treated at once. What criteria should decision-makers use to set priorities for access? Are there ethically acceptable grounds for choosing special groups, such as health care workers, to ensure effective implementation of treatment programmes? Can giving preference to children or pregnant women be ethically justified? There is no clear and uncontroversial way of determining which groups in a population should be given the priority when all cannot be treated at the outset.
Ideally, the 3x5 Initiative should provide ART free
of charge through public health care institutions. This would ensure not only
that the poor will not be excluded from the scaling up of ART, but also that
priority will be given to the large number of people in developing countries for
whom existing treatments have not been affordable and who would continue to be
excluded if they had to pay out-of-pocket. Moreover, practically, evidence from
existing programmes in which people in developing countries have had to pay for
some or all the cost of antiretroviral drugs reveals an array of negative
medical and social consequences, including interruption of therapy,
deterioration of health status, poor adherence, and development of drug
resistance.
An argument in favour of giving priority to the
poor is supported by a leading ethical principle: concern for the worst off or
the least advantaged. In the context of health care delivery, this is usually
understood to refer to those who are worst off in terms of health status, but it
could also apply to the poorest members of society; the lowest socioeconomic
class; the most vulnerable (for example, children, especially orphans); or
groups that are marginalised or most discriminated against. The principle that
favours the least advantaged and the most vulnerable groups does not, however,
call for giving strict priority to these groups.
Other ethical principles are potentially relevant
and can provide justifications for choosing one or the other scheme for access
to ART. The utilitarian principle, applied specifically to health policy, aims
at maximising health benefits for society as a whole. For example, treating
health care personnel or teachers would have the additional benefit of ensuring
that needed personnel are available for providing treatment and for health
promotion, which produces additional health benefits for society. Similarly,
treating factory workers rather than children or unemployed people produces
economic benefits for the country which, in turn, could be used to increase
treatment access. However, giving priority to the more productive members of
society would perpetuate the exclusion of individuals and groups who have
historically lacked access to health care.
An egalitarian principle of equity in this context
would call for distributing resources equally among persons, or distributing
health care services equally among different groups. This principle is the basis
for schemes that emphasise health equity over health maximisation. There is thus
a conflict with the utilitarian approach. The goal is to reduce disparities in
health status among different groups or strata in society: the poor, women,
people living in rural areas, ethnic or racial minorities, and others.
The three principles described here point to
criteria or concerns that must be considered, but the principles can lead to
conflict, and it then becomes necessary to balance competing concerns. There is
no unique, correct way of achieving this balance. For this reason, leading
commentators have urged that the emphasis has to be on fair processes (4). The
aforementioned principles can serve to justify the decisions to the extent that
decision-makers in each country can agree on principled ways to set priorities
for equitable access among those eligible for ART.
A different option for setting priorities could
focus initially on applying principles of equity to institutions that provide
health care services to individuals and groups likely to be HIV-infected. These
would include both urban and rural health facilities, general public hospitals,
and specialised clinics or facilities. Whichever approach is chosen, the use of
the fair procedures described earlier remains necessary, since equity demands
adherence to both substantive and procedural aspects of ethics.
This article is adapted from a background paper
prepared for a WHO consultation on Ethics and Equity in the 3x5 Initiative,
Geneva, Switzerland, January 26-27, 2004. The background paper, Ethics and
Equity in Access to HIV Treatment-3 by 5 Initiative, can be accessed athttp://www.who.int/ethics/en/background-macklin.pdf.
References
1. Jesani A, Kalantri SP, Thomas G, Srinivasan S. Government-funded anti-retroviral therapy for HIV/AIDS: new ethical challenges. Indian Journal of Medical Ethics 2004;1:70-1.
2. Daniels N, Light DW, Caplan RL. Benchmarks of fairness for health care reform, New York: Oxford University Press, 1996:57.
3. Last chance therapies and managed care: Pluralism, fair procedures, and legitimacy, The Hastings Center Report. 1998;28:27-41. (Based on criteria for legitimacy and fairness specified in Daniels N, Sabin JE.
4. Daniels N. How to achieve fair distribution of ARTs in 3 by 5: fair process and legitimacy in patient selection, prepared for the WHO consultation on Ethics and Equity in the 3x5 Initiative, Geneva, Switzerland, January 26-27, 2004. Available from URL: http://www.who.int/ethics/en/background-daniels.pdf
Ruth Macklin, Department of
Epidemiology and Population Health, Albert Einstein College of Medicine, 1300
Morris Park Avenue, Bronx, New York 10461, USA. email:macklin@aecom.yu.edu 1. Jesani A, Kalantri SP, Thomas G, Srinivasan S. Government-funded anti-retroviral therapy for HIV/AIDS: new ethical challenges. Indian Journal of Medical Ethics 2004;1:70-1.
2. Daniels N, Light DW, Caplan RL. Benchmarks of fairness for health care reform, New York: Oxford University Press, 1996:57.
3. Last chance therapies and managed care: Pluralism, fair procedures, and legitimacy, The Hastings Center Report. 1998;28:27-41. (Based on criteria for legitimacy and fairness specified in Daniels N, Sabin JE.
4. Daniels N. How to achieve fair distribution of ARTs in 3 by 5: fair process and legitimacy in patient selection, prepared for the WHO consultation on Ethics and Equity in the 3x5 Initiative, Geneva, Switzerland, January 26-27, 2004. Available from URL: http://www.who.int/ethics/en/background-daniels.pdf