The paper, commissioned by Indian Network for People Living with HIV/AIDS, argues vigorously for the introduction of an affordable second line ART regimen in India and makes recommendations for the programme’s effective functioning.

NACO’s Strategy and Implementation Plan, November 2006, for the third phase of the National Aids Control Programme, did not plan for the introduction of second-line antiretroviral therapy (ART), despite acknowledging the fact that development of drug resistance is inevitable. While the strategy planned to delay drug resistance, no commitment was made to initiate second-line regimens, apart from the key activity - “Negotiate with government agencies and industry regarding generic second line drugs which are affordable and finalise a policy on second line drugs for the treatment of AIDS”. However, mounting pressure on NACO (National Aids Control Programme) over the last two years to introduce second-line regimens has resulted in the recent introduction of second-line regimens at a few centres in the country. NACO envisages that nearly 3,000 patients, who have become resistant to first-line therapy, will be put on second-line by December 2008.

Various concerns regarding the introduction of second-line regimens have been raised, especially as the issues with the ART roll-out so far have still not been ironed out. Most of these concerns are expressed in the Discussion Paper ‘India and second line ART: March 2007’ authored by Priti Radhakrishnan, Initiative for Medicines, Access & Knowledge. The paper was commissioned by Indian Network for People Living with HIV/AIDS (INP+) with the support of DFID, prior to NACO’s decision to introduce second-line ART and addresses the feasibility of introducing second-line ART into NACO’s public-sector treatment programme.

The paper advocates for the rapid introduction of second-line regimens into the public-sector treatment programme and supports NACO in its endeavor to ensure that second-line ART is introduced. The paper has tried to fill the gaps in evidence - accurate estimation of numbers of patients requiring second line treatment, the factors contributing to the cost barriers of second-line ART, the impact on the NACO programme if these drugs are patented, and the gaps plaguing the utilisation of funding to procure these drugs - in order to more effectively advocate for second-line ART.

While India’s efforts in the area of prevention are recognised globally, in the care, support and treatment of those who are actually living with HIV/AIDS, India is lagging woefully behind, with fewer than 10% of those who require ART receiving treatment. This state of affairs exists, ironically, in a country where the pharmaceutical sector continues to be the world’s leading producer of generic ART.

This discussion paper is likely to have contributed to NACO’s recent decision to introduce second-line drugs, as it presents arguments to show that NACO’s 2006 decision against introducing free second-line ART is not convincing. After giving the background and current scenario of the ART programme in India, it goes on to discuss the cost implications and the measures that can be taken by NACO to reduce the cost of second-line ART. The paper also highlights the impact of the new patent law on second-line ART, procurement concerns, strategies that NACO can adopt to best promote access to medicines while staying in compliance with Indian and international laws, and related clinical, operational and ethical issues.

For the ART programme to function more effectively, the paper recommends an evaluation of and transparency in, the supply system, a check on the ongoing interruptions in the drug supply for first-line ART, improved pharmaco-vigilance, involvement of civil society in efforts to improve procurement mechanisms, addressing infrastructural concerns, emphasising treatment literacy, and understanding the causes of non-adherence. The paper says that there is value in studying India’s Revised National Tuberculosis Control Programme (RNTCP) when considering the introduction of second-line ART into India’s HIV programme. The latter can draw on the institutional mechanisms that proved constructive in the fight against TB. The discussion paper concludes with a set of recommendations, showing that all the issues discussed - cost, patents, funding, adherence – are capable of resolution.

It remains to be seen how many of these issues are being and will be addressed in the roll-out of second-line regimens. With second-line ART having been initiated in only a few centres in the country, there is adequate scope to incorporate the concerns expressed in this discussion paper, and pre-empt difficulties in ensuring treatment adherence, drug procurement and addressing infrastructural issues.

Click here to read the full discussion paper 
www.law.fsu.edu/gpc2007/materials/18%20FINAL_INP_March20.pdf

InfoChange News & Features, April 2008