According to UNAids, the United Nations programme on HIV/Aids, 17m people received treatment for HIV infection with antiretroviral drugs (ARVs) in 2016. Of these, 13.9m lived in low and middle-income countries (LMICs). Fifteen generic manufacturers supply more than 95 per cent of ARVs to LMICs, of which four supply the bulk — 83 per cent. In 2014, those four suppliers each provided about 20 per cent of the total volume, but since 2015, with new procurement policies among the main buyers, one company, Mylan, supplied more than 50 per cent, and three others, Hetero, Cipla and Aurobindo, provided 32-35 per cent between them. The remaining 11 each supply 2 per cent or less. Reliance on so few suppliers for continuing treatment for millions of people is dangerous because, unlike other diseases, there are no alternatives to ARVs for the treatment of HIV. This dependence creates serious risks. Today, the risk of supply interruption is at a worrying level. Last year, a key plant owned by Mylan in Nashik, India, was inspected by the US Food and Drug Administration. Several deficiencies were found that could lead to suspension of production of its ARVs. Mylan produces over half of all ARVs for LMICs. If its production were to be suspended, up to 7m patients might not receive drugs. Emerging markets guest forum beyondbrics is a forum on emerging markets for contributors from the worlds of business, finance, politics, academia and the third sector. All views expressed are those of the author(s) and should not be taken as reflecting the views of the Financial Times. Hetero and the other manufacturers are presently unable to meet such volumes. Hetero, due to its externally contracted research operation, was reproved by regulators last year and is waiting for the green light from the FDA and the World Health Organization to restart production. The danger of supply interruptions will increase as the world moves towards meeting the UNAids target of “90-90-90”, which requires treating 30m people by 2030. This is not a trivial problem: when treatment stops, many patients will have disease progression and die, and even more will develop resistant viruses, the rise of which is already a serious concern. Procurement of Aids drugs in LMICs is controlled by just three major buyers: the US President’s Emergency Plan for Aids Relief (PEPFAR), the Global Fund, and South Africa, who together purchase 80 per cent of all LMIC requirements. This arrangement has enabled the rapid expansion of treatment for HIV infection and ensures the high quality of the drugs in use to treat HIV today. However, it also implies the responsibility of those major buyers for the continuity of treatment, so that people can live, drug resistance can be limited, and new and better treatment options in the pipeline can be introduced. To ensure treatment for 30m people by 2030, the major buyers must become much less dependent on so few suppliers. They must allocate their purchases to all manufacturers that meet quality standards, and allow excluded or limited suppliers the opportunity to quickly increase their volumes. PEPFAR procures ARVs through annual tenders and offers producers more opportunity to stay engaged but the other buyers purchase from a few manufacturers under three-year supply contracts, which may be extended to the exclusion of other manufacturers. The generic manufacturers of ARVs that have supplied PEPFAR and the Global Fund have gained international acceptance and credibility. If they are not able to supply ARVs, they now have alternative and lucrative options for the deployment of their production facilities. Meanwhile, the buyers and those who depend on them remain vulnerable to supply interruption. The major buyers must take immediate steps to ensure that, in the event of interruptions at Mylan and other producers, credible and sustainable arrangements are in place to secure the continued supply of ARVs to people living with HIV and Aids who have no other treatment options. Brian Elliott is chief executive of Procela Consultants, which advises governments, international agencies and pharmaceutical companies on access to medicines in low and middle-income countries. @beyondbrics
Fifteen drug manufacturers supply more than 90 % of antiretroviral drugs ( ARVs ) , crucial treatments for HIV and AIDS , to low and middle - income countries , according to the aids Nations programme on HIV / AIDS . Of these firms , just four supply a staggering 83 % of the drugs , which prevents the growth of the AIDS virus . Therefore , these disruptions could have serious implications for millions of people . Last year , an Indian factory owned by major supplier companies was found to have deficiencies that could lead to the suspension of production of ARVs .