The cornerstone of India’s AIDS treatment programme—thanks to strong leadership from the National AIDS Control Organisation (Naco), public health experts and civil society—is the implementation of a policy that mandates the provision of antiretroviral (ARV) drugs that fight HIV itself, to all people living with HIV/AIDS (PLHIV).
Barely five years after India started treating HIV/AIDS at only a few select centres in government hospitals, it has the largest growing programme in the world today.
Photograph: Adrees Latif / Reuters
Two hundred and twenty thousand PLHIV access treatment from 190 ARV therapy centres across the country. Treatment includes access to doctors, diagnostics, counselling, essential medicines including ARVs and those that treat opportunistic infections—all free of cost.
The dramatic scale-up of India’s treatment programme was enabled in large part by the domestic production of affordable three-in-one fixed-dose combinations of first-line ARV drugs by generics companies—made possible by India’s refusal to grant product patents on pharmaceuticals until 2005. The treatment is proving effective even for those with advanced disease. With treatment, PLHIV are living longer, healthier lives.
Yet, all this success is now at risk. HIV/AIDS is a lifelong disease. Over the years, people on HIV treatment will inevitably develop resistance to their first-line combination of ARVs. When this drug resistance develops, increasing numbers of patients will need to switch to newer-generation, second-line ARVs. This is something that “established” AIDS treatment programmes in other developing countries such as Brazil, Thailand and South Africa have faced.
The need for access to newer combinations of ARVs has been evident from the beginning of the government treatment programme. Yet, the government held back from introducing second-line ARVs in the national AIDS treatment programme on concerns about the spiralling prices of second-line ARVs. With the product patent regime having been introduced in India in 2005, domestic generics production that had so successfully brought down prices for first-line treatment was unlikely to be replicated.
People living with AIDS, or PLHA, networks and public interest groups also saw the danger of the possible patenting of these newer medicines, and of the high prices that multinational pharmaceutical companies were likely to be able to set. In order to ensure access to these life-saving drugs, they launched a legal struggle to safeguard domestic generics production for second-line ARVs. Starting from 2006, several oppositions to the grant of patents on second-line ARVs have been filed before the Indian patent offices—on tenofovir, abacavir, atazanavir and lopinavir/ritonavir, for example.
Encouraged by such moves, Indian generics companies followed up with the generics production of second-line ARVs—at prices substantially lower than those of multinational pharmaceutical companies. Competition between multiple generics producers has further brought down these prices over the last four years.
In 2008, at last assured of sustainable generics production of newer-generation ARVs at affordable prices, India started to address the needs of PLHIV who had developed drug resistance to first-line ARV regimens. Ten ARV therapy centres across the country have begun providing second-line ARVs.
Under the criteria prescribed by Naco for accessing second-line ARV treatment, the priority given to widows and children living with HIV will narrow the disparities they face in accessing healthcare.
But this does not mean the battle has been won. PLHIV show that these same criteria also restrict the access of those who most need the treatment. A key criterion restricts access to second-line treatment to those living “below the poverty line”. Another restricts access to those PLHIV who have been on the government treatment programme for two years.
This leaves out patients whose conditions have already so deteriorated that they are unable to wait for government-provided second-line ARVs and are forced to seek treatment in the private sector. Others who are already failing first-line but have been under treatment for less than two years in ARV therapy centres are also ineligible.
Excluding PLHIV from second-line treatment based on these conditions means driving them to the unregulated private medical sector, where the prescription of irrational ARV regimens is common—a concern Naco itself has often expressed.
The refusal to treat spells immense hardship for PLHIV and their families, who are forced to purchase second-line ARVs themselves from pharmacies at prices significantly higher than those obtained by the government through bulk purchases directly from the generics producers. Many will not be able to sustain this expensive treatment, leading inevitably to further drug resistance, continuous ill health, AIDS, and death.
If India is not to reverse the advances it has made in the past five years in increasing access to ARV therapy, the concerns of PLHIV unable to access second-line ARVs must be addressed urgently.
The battle to start providing ARV therapy in India has been won. The battle to provide lifelong treatment to all is just beginning.
Loon Gangte is president of the Delhi Network of Positive People, and Leena Menghaney is projects manager, India, Campaign for Access to Essential Medicines, Medecins Sans Frontieres. Comment at firstname.lastname@example.org