Community advocates meet with Indian generic companies: 2nd World CAB meeting

Bob Huff, HIV i-Base and GMHC

An unprecedented meeting took place in Mumbai, India in January between four manufacturers of affordable generic antiretroviral medicines and advocates for HIV treatment access drawn from every region of the world.

The companies were Cipla, the pioneer manufacturer of low-cost antiretroviral (ARV) drugs; Hetero, a large supplier of the bulk drug substance to many other generic drug makers; Strides, a small supplier of ARVs with historical ties to the African market; and Ranbaxy, an emerging powerhouse with ambitions of joining the ranks of the multinational, research-based pharmaceutical industry.

Thirty advocates from Africa, South America, the Caribbean, Eastern Europe, Southeast Asia, as well as from India and Nepal, met to press for lower prices and assurances of quality products. The meeting was organised by HIV i-Base in London and GMHC in New York on behalf of the International Treatment Preparedness Coalition (ITPC). ITPC is an email-connected network of over 300 advocates from over 100 countries.

Within the span of three years competition from the Indian generic drug industry has caused the price of ARVs to fall from over $8,000 per year, offered by the multinational originator companies, to under $200 per year. This lower price is dependent on economies of scale demand from large-scale treatment programmes. It makes plans for treating millions of people throughout the developing world feasible. But if lowered prices have brought plans to the table, the realities of actually providing therapy to so many have proven formidable and many problems remain.

The meeting in Mumbai was intended to explore some of the problems that the generics industry can address, including the need for pediatric formulations of generic ARVs; the need for equally affordable second-line therapy for when side-effects, treatment failure or drug interactions require an alternative; and the need to address sometimes radical disparities in pricing that occur from country to country.

A key topic of discussion was the recent withdrawal of several important ARVs from a quality assurance list maintained by the World Health Organisation (WHO) that many governments rely upon when purchasing large quantities of drugs. At issue was the performance of several clinical studies designed to show that the generic drugs are absorbed into the bloodstream as well as the brand name versions. Inspectors from WHO uncovered certain irregularities with the conduct and reporting of several of these bioequivalence studies, which called into question results from all such studies performed by the Indian drug makers.

This was a delicate issue for the generic companies, and while no consistent explanation for the problems uncovered by WHO were obtained, the affected companies all pledged a rapid return to the critical WHO list.

The future of low-cost generic ARVs also came under discussion. New patent rules going into effect in India may change the way the industry does business. Low-cost generic drugs for an extensive range of other indications including HIV have been possible because Indian patent law does not protect the final drug product, only the process of making the product. This means the generic makers have been free to copy expensive Western-developed drugs by coming up with a new manufacturing process. When patients expire, generic companies also provide Western markets with more affordable drugs. Fifty percent of Ranbaxy’s market is in the US.

Under the new rules, patent protection will be granted to final products first known after 1995, which means that newer ARV drugs, like tenofovir and atazanavir may never become available at the kind of prices the generic makers are able to deliver. Products known before 1995 will not be affected.

All of the implications of the new patent laws are not clear, but Dr. Hamied of Cipla, the only of the four companies serving the private ARV market within the country, thinks the outcome will hurt India by introducing monopoly patents, “It’s going to be a disastrous situation for India ten years down the line.”

HIV-positive advocates from India pressed the manufacturers on one of the most vexing contradictions they face, “Why are drugs made in India cheaper in Africa than at home?” Each company added its piece to the puzzle, variously blaming import duties on raw materials, reduced taxes for the export market and an indifferent Indian government. But all agreed that the key barrier to achieving lower prices, whether in India or Nigeria, is the lack of a consistent, growing commercial demand for their production.

Despite widely announced plans for scaling-up treatment to reach three million people by the end of 2005, last year, one maker said, only 40,000 new patients were added to the treatment roles. Yet with Cipla now claiming an average price of $160 per year for a Fixed Dose Combination of d4T/3TC/nevirapine, it may be that drug cost is no longer the limiting factor. Until the barriers of inadequate healthcare infrastructure, training and finance are removed, many fear that attainment of the kind of large-scale orders than can bring ARV costs below $100 per year will remain unlikely.

A full report from this World CAB meeting will be produced and distributed with HTB.

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