Govt. of India's anntiretroviral treatment plan: Response of the AMTC

[Guest guest]

Dear all,

The Affordable Medicines and Treatment Campaign (AMTC), is a national campaign

in India, aiming to demand and create an environment that will ensure sustained

accessibility and affordability of medicines and treatment for every individual

in India, including access to affordable Anti-retroviral Therapy for persons

living with HIV/AIDS (PLHAs). As you know the Government of India has announced

a free ARV treatment plan in six high prevalence states to be rolled out on 1st

of April 2004. We take this opportunity to congratulate NACO for responding

positively to and accepting one of the long-standing demands of PLHAs for ARV

treatment. Such a paradigm shift from prevention focused strategies to an

approach that recognises the synergies between treatment and prevention is an

essential component of any rights based approach to the HIV/AIDS epidemic.

Having studied the " Programme Implementation Guidelines for a Phased Scale up of

Access to Antiretroviral Therapy (ART) for People Living with HIV/AIDS "

(accessible at http://www.naco.nic.in/nacp/arvimp.htm.), the AMTC, has come up

with a response to the government plan. We appreciate the fact that mass

provision of ART is a complex process and have attempted to raise some issues of

concern which are vital to the success of the programme and its implementation.

The same is pasted below and has also been submitted to NACO. We hope this

document may provide us all with an opportunity to address key concerns

regarding access to treatment. We invite comments, critiques and ideas on these

issues.

In solidarity,

For AMTC

Secretariat

Lawyers Collective HIV/AIDS Unit

2nd Floor, 7/10 Botawalla Building

Horniman Circle, Fort, Mumbai, India 400 023

Phone: +91 22 2267 6213/19, Fax: +91 22 70 2563

Email: aidslaw@..., E Group: amtc_india

___________________

AMTC Response to the Programme Implementation Guidelines for a Phased Scale up

of Access to Antiretroviral Therapy (ART) for People Living with HIV/AIDS (PLHA)

A recent development of significance has been the announcement made by Ms.

Sushma Swaraj, the Minister of Health & Family Welfare, Government of India on

the eve of World AIDS Day last year, of the government's intention to finally

provide ART through the National AIDS Control Program from 1st April 2004. This

is indeed a welcome decision. We are happy that the Government and NACO has

positively responded to and accepted one of the long-standing demands of people

living with HIV/AIDS, networks of PLHAs, human rights and public health NGOs,

activists, groups and campaigns such as the AMTC. It is clear that this has been

due to the sustained advocacy efforts by several individuals and organisations

including Networks of people living with HIV/AIDS, NGOs working on HIV/AIDS and

campaigns like the AMTC, which many of these networks and NGOs have created and

are a part of.

With this plan there is recognition that the HIV/AIDS epidemic has indeed

impacted a large number of people in India, many of whom are in urgent need of

treatment that they cannot afford. It is also a recognition that such treatment

can actually be provided. Further, it is a recognition that India has a relative

advantage, having a vibrant generic drug industry, an advantage that has not

thus far been used to its full potential. Most significantly, it is an attempt

to re-constitute HIV as a treatable condition and thus, to reduce the

stigma and fear that surround it, to encourage more voluntary testing and thus

to bring about the normalisation of HIV/AIDS. The government deserves to be

congratulated for the institution of the programme.

The document titled " Programme Implementation Guidelines for a Phased Scale up

of Access to Antiretroviral Therapy (ART) for People Living with HIV/AIDS

(PLHA) " shows a paradigm shift from a prevention focus to an approach where the

synergies between care/support and prevention are be put in action. While we

eagerly await the realization of the objectives of the program, we have some

concerns related to the manner in which the program is envisaged and suggestions

to improve the concept and implementation of the ART rollout.

The mass provision of ART is a complex process, which can backfire seriously if

not carried out properly. Sustainability and context sensitivity of such a

program is of prime importance. The risk of resistance to the drugs is high and,

as has been seen with the experience of the development of MDR TB. A careless

program could lead to a more complicated epidemic. Similarly, the high level of

toxicity and experiences of severe side effects make it necessary

that the mass provision of ART be a part of a more comprehensive program for the

provision of care and support. Further, the impending changes to patent laws

could soon drastically reduce the government's ability to actually procure these

drugs and new line regimens at affordable rates. As such, the program itself

needs to be one that is based on the experiences in and of the public health

system, the experiences of people providing and receiving ART in the Indian

context, and retaining as the base, a human rights approach to public

health.

Although feedback from civil society, on the rollout plan, has not yet been

widely solicited by the government, the AMTC is here presenting a preliminary

response to it. The following points have been articulated by members of the

campaign and other friends, over email and through discussions. These comments

are intended to be taken in the spirit of constructive suggestions.

Main points of concern:

Strategy to bring about an enabling environment – The inherent logic of the

program is that the provision of treatment will contribute towards the creation

of an enabling environment, whereby people have an incentive to voluntarily

access testing facilities and health care services. This establishes the

relationship between care/support and prevention. While such recognition is

positive, there remains some ambiguity in the document, where it refers to the

`identification' and `tracking' of people who may test positive. There is no

doubt that in order to receive treatment, people must first recognize themselves

as needing it. This implies large increases in testing and access to healthcare

services. The question here is, how is this increased testing envisaged? In this

regard, the plan identifies certain `entry points' for ART, including STD

clinics, PPTCT centers, Blood Banks, TB DOTS centers and government hospitals.

The ambiguity in the document lends space for mandatory screening of all those

who access these services. This may have the undesired impact of actually

decreasing access to these services, despite the promise of treatment for those

who need it. The present minimal amount of voluntary testing is indeed more

complicated – stigma around HIV/AIDS, in other words, is brought about by more

factors than the inaccessibility of treatment.

The document needs to clearly recognize the difference between creating an

enabling environment where people are encouraged to use the services of VCTCs

and tracking down people for the purposes of providing treatment. The NACP

identifies itself as being based on a `human rights approach'. This should

include addressing concerns such as the need for informed consent,

confidentiality and non-discrimination. The commitment to these principles needs

to be clearly stated. At the outset, it needs to be ensured that a promise of

treatment does not amount to a justification for doing away with

adherence to rights on these issues.

Maintaining confidentiality – Scaling up of ART requires a careful consideration

of how confidentiality will be maintained. This is more so when considering the

mandate of enabling adherence to the treatment. While the ocument does contain a

reference to the need for maintaining confidentiality, there is no clear

conceptualization of protocols and systems through which confidentiality will be

ensured. Where, for example, the document talks about providing identity cards

to persons on ART, there is no mention of how the

problems that such a system may pose to the maintenance of confidentiality will

be dealt with. This again, would impact the efficacy of the program. Hence, we

feel that confidentiality norm should not be compromised at any stage of the

treatment.

Funding and Sustainability - ART is not a one-off treatment but is meant to

continue for life. Interruption of the therapy has been seen to significantly

raise the risk of resistance to the drugs and a drastic decline in health. In

this context, sustainability of the treatment program is of central importance.

As of now, there is no reference in the plan to the budget which has been

allocated for purchase of ARVs, the estimated price of purchase, how much money

has been set aside, from what source, to buy medications at what price, and from

whom. Without this information what we basically have is a training manual for

ARV scaling up without an assurance of sustainability.

Some estimates place the expected cost for the treatment plan as Rs 500 Crore

per annum. Of the GFATM commitment of USD 140 million (Rs 700 Crore), spread

over a period of 5 years, only USD 100.08 million (Rs 500.40 Crore) is for

HIV/AIDS. Additionally, this commitment is geared towards ART programs being run

by NGOs. It is not clear whether the government plan is dependent on resources

from the GFATM. At the same time, the government does not seem to have moved the

Planning Commission or included the cost of the program in its

interim budget. As such, there is no hint of where the resources for the program

are expected to come from.

The document recognizes that India has an established `domestic drug

manufacturing base'. It also needs to recognise that this relative advantage may

not survive much longer if strategies such as pushing for a TRIPS review, and

building the capacity of public sector industry to provide drugs are not

simultaneously considered.

Procurement –While it has been mentioned that the procurement will be done by

NACO based on estimates provided by SACS the plan for the procurement of drugs,

facilities and services has not been fully spelt out. The constant reference to

`public – private partnerships', seen in conjunction with the impending

amendments to the Indian Patent Act, which will seriously harm the generic drug

industry implies that the government may soon be in a position where it could

be held to ransom by the multinational pharmaceutical industry and have to

depend on charity of the drug industry.

Further, there definitely need to be mechanisms to ensure transparency of the

process of procurement, a concern that needs to be addressed at the inception of

the program itself.

Who will get the treatment? The plan document does not specify how many people

will be given treatment when. It refers to providing treatment for 100,000

" starting on April 1st, 2004 " . The actual extent to which the rollout plan will

address treatment needs in the epidemic right now is ambiguous. It needs to be

noted here that the evaluation of number of people who need ART is to be carried

out by SACS, and that the deadline is very short.

At present the government plan limits the coverage of the program by identifying

certain categories of people as beneficiaries. At present, the only

beneficiaries identified are (i) sero-positive mothers who have participated in

the PPTCT programme; (ii) seropositive children below the age of 15 years; and

(iii) people with AIDS who seek treatment in government hospitals. It is

important to know, but to difficult to estimate, how many individuals such a

scheme would cover. There has been estimation of the number of pregnant women

who would be covered with this new scheme.

These estimates have been drawn on assumptions from National Sample Survey (NSS)

52nd round, National Family Health Survey 2 and NACO on the following

parameters: estimated number of women in age group 15-49 percent that seek

antenatal care, percent that visit government facilitates and estimate of HIV

prevalence among ANC attendees (assumed 1 percent prevalence). Based on these

assumptions, it was estimated that about 55, 000 pregnant mothers who were HIV

positive would seek care in government facilities. Of these about 8,000 pregnant

HIV positive women would be ART eligible in a year, and the target for the new

policy. NSS and other statistics indicates that a much lower percent of all

those who seek care –about 18 percent seek care in public facilities for their

illnesses. If the population who are ART eligible is taken at 7,50,000 then

about 1,35,000 individuals would be accessing public health facilities. This of

course includes the pregnant mothers as well. Even if all the pregnant mothers

were added here, we get 1,43,000 individuals who will be covered by the

new programme. Adding 13, 000 who are already being covered currently, we arrive

at 1, 56, 000 individuals who are going to be covered by ART. This still leaves

a gap of about 600000 individuals who are not covered by ART.

It needs to be emphasised that a miniscule number of women living with HIV/AIDS

have access to the PPTCT program. Many may not participate for a range of

complex reasons. In fact, in rural pockets in areas of high HIV prevalence most

deliveries are done at home, and a majority of the rural poor do not access

government hospitals for normal deliveries. Of those who do participate, not all

are in need of ART. Similarly, there is no explanation why only those who seek

treatment in government hospitals will be provided treatment, considering the

high rates of discrimination and refusal of treatment in the public sector in

many parts of the country. The problematic presumption here is that the public

health care system is already a functional site for treatment of PLWHA, one

which is repeatedly disproved by real life experiences.

Third, the document does not link up with the indicators for ART as identified

in the (draft) guidelines on ART published recently by NACO. These guidelines

lay out in detail the government's own prescription for when and in what

conditions ART is to be started. In the presence of these guidelines, the

reasons for using other indicators, such as participating in PPTCT programs, or

of qualifying as an `AIDS patient' are unclear. Identification of these sites

will limit the benefits of this programme to certain sections of the

population.

The experience of refusal of treatment and of discriminatory behaviour in health

care is magnified for marginalized populations. It was the lack of MSM friendly

services, for example, that justified focused `targeted interventions'. Basing

the treatment plan in government hospitals is thus a tacit exclusion of these

populations from the treatment program. There is no justification provided for

such exclusion. This plan would lead to a moralistic framework of " treat the

victim " , which has been demonstrated the world over as

an ineffective strategy in dealing with prevention or reducing stigma or

ensuring access to care – three key elements in HIV interventions

Role of PLHA Net Work, Civil Society Organisations and NGOs: Over the years many

NGOs are providing ARV treatment and developed expertise in the area. However,

the plan covers only government hospitals and gives only minimal role to NGOs

and civil society organisations such as home visits follow up of cases etc. The

plan should make use of the experience of these organisations. This is important

because studies show that the majority people do not depend on

government hospitals for health care. Moreover the GFATM proposal of the

government envisaged rendering ART to 15,000 PLHAs at four sites, of

which two are NGOs. It is not clear whether those are covered under the new

initiative. It is very clear from all success stories in ART ( and there a

number of them) that a continuum of care into which ART is embedded is the only

strategy that ensures early voluntary testing, greater degree of positive

living, destigmatisation, high level of access and good adherence. The role of

civil society and PLHA networks is much wider than just followup visits.

How and where will the treatment be provided? The document identifies three

phases of the rollout program. The first phase involves preparing 15 centres in

the six `high prevalence states' to provide treatment, the second extends this

to all government hospitals with medical colleges and the third to all district

level hospitals in these states. To this end, health care workers at these

various sites will be trained over a period of five days on a range of issues

relating to the provision of ART. Two main concerns need to be emphasised here.

First, the reasons for a focus on high prevalence states are unclear, especially

where the provision of care and support is being seen as related to a prevention

strategy.

Second, systemic and infrastructural issues of preparedness are not addressed

by the program, which presumes that five days of `training' will be sufficient

to enable an effective system of ART provision. It needs to be pointed out that

even sites of PPTCT are merely administering ART for mother to child

transmission, and do not have any experience or systems in place for treating

people with CD4 counts>200.

Finally, almost all the centers where the treatment will be provided are located

in cities, with a concentration in Chennai and Mumbai. It needs to be emphasized

here that if access to treatment is to be a reality, rather than simply a

populist measure, the centers must be closer to those who need the treatment,

must be PLWHA friendly, and must match patterns of health seeking behaviour in

the populations.

Nutrition – The rollout plan recognizes that nutrition is a requirement that

needs to be provided for alongside the rollout program. Unfortunately, it does

so in terms of provision of anabolic steroids, which by themselves are

controversial hormonal drugs that are to be used in very particular

circumstances. The provision of everyday low cost nutritious food in different

settings is not addressed.

Gaps in training of care providers – The plan has a detailed description of the

training workshops that will go towards building the capacity of the centers to

provide ART. Almost all the sessions are medical in nature, and the complex

socio-economic issues that need to be considered in the provision of ART have

been ignored. Given the hierarchical composition of medical teams, if the socio-

economic and gender issues are not highlighted in the training, they will

definitely not happen in practice. There has to be an equal role for civil

society and PLHA networks to ensure equity in access and support in adherence.

In a context where discrimination in healthcare continues to be a widespread

experience, creating `preparedness' will involve a more serious engagement with

these issues as well. Whereas there is a half-hour slot for discussion of `legal

and ethical issues', there is no scope for a focus on human rights issues and

protocols, in terms of attitude or actual systems through which confidentiality

and informed consent will be ensured. Further, there is minimal scope for

learning from people's experiences at the field level.

Testing facilities not addressed – The provision of ART requires not merely

ARVs, but requires as well accessible and affordable CD4 and may be Viral load

testing facilities. These again, are not addressed by the rollout plan, although

the NACO –WHO workshop on 28th-29th January 2004 did have presentations by

private corporations on their capacity to provide such testing facilities. Again

the growing dependence on private corporations needs to be regarded with

caution. With respect to such testing facilities in particular, the field level

experience in some parts of the country seems to be that

governmental facilities, however limited, are more reliable than those provided

by private companies. NACO should make efforts to establish at least one CD4

testing labs in every district and at least one PCR lab in every state.

Regimens being offered – The framework of the rollout plan envisages a

standardisation of drug regimens, based on WHO recommendation on a `public

health approach'. Unfortunately, this goes against experiences in clinical

practice. As such, the standardisation of regimens is an aspect that still needs

to be debated and cannot be taken for granted as the desirable strategy. How the

specific requirements of individuals are to be addressed is not envisaged in the

document. Further, there seem to be some problems with the

regimens prescribed in certain circumstances – for example, whereas it is

recognised that women receiving NVP as part of PPTCT programs may have developed

resistance to it, and thus, that the recommended first line regimen of

d4T/3TC/NVP may not be effective, the only alternative that is provided to them

is replacement of NVP with EVP. EVP as well, unfortunately, is not indicated in

pregnant women. In this context there other options available in western markets

that have not been suggested.

NVP was adopted as the strategy for PPTCT despite its rejection in healthcare

systems in Europe and the US due to the high risk of resistance, which could

impact on treatment options in the future. It is the effect of this decision

that we are now faced with where a certain segment of the population that needs

ART will not have effective options. This is an articulation of the implications

of the politics of health. The rollout plan does not recognize or address this.

Language and presumptions - Finally, a note needs to be made of the largely

insensitive language of the document, and the continuing use of phrases that

fuel stigma and discrimination against people living with HIV/AIDS. Terms such

as `HIV infected' and `indulging in " disinhibition " ' are scattered through the

document. If this document is to be the basis for training in the public health

system where stigma is a definite problem to be addressed, then a certain degree

of sensitivity needs to be incorporated into it. Second, the identification of

beneficial and adverse affects of ART have been made in a manner as to already

place the blame of any failure of the program on people living with HIV/AIDS,

for example, through the emphasis on the phenomenon of `disinhibition', which

thus far has only been identified in specific western contexts. Similarly,

concerns with respect to adherence in the document seem to be an exercise of the

political construction of the `third world patient'.

The fact that evidence that forms the basis of these concerns comes from

particular western experiences needs to be clearly stated.

In fact, studies are showing that while in the developed countries, there have

been reports of reduced responsibility in sexual behaviour, in developing

countries, access to ART has led to increased responsibility.

Since the document says " the document will be reviewed frequently so that it

keeps up with new regimes ………also reflects the backward and forward linkages

between programmes for treatment and interventions for prevention of HIV/AIDS

and care and support of people living with HIV?AIDS " . We hope that the above

suggestions would be incorporated in the coming days.

FOR AMTC: Anand Grover. Lawyers Collective HIV/AIDS Unit, Ashok Rau, Freedom

Foundation, Bangalore, Sanghamitra Iyengar, SAMRAKSHA, Bangalore, Dr. Jayasree,

FIRM, Trivandrum, D Noorie, South India Positive Network, Chennai, Dr. Tokugha

Yepthomi