Focus on local manufacture of anti-retroviral drugs

Pharmacist Sudhir Sathe stands by an idle production line. By now, he says, desperately needed antiretrovirals (ARVs) for 70,000 AIDS patients a month could be rolling off the gleaming conveyor belt. Bethlehem Pharmaceuticals – one of only two factories in Ethiopia licensed to produce the potentially life-saving ARVs – blames the static situation on international funding delays. "We do not need to state the urgency of getting these drugs out," said 51-year-old Sathe, who has worked in the pharmaceutical industry for 27 years. "We are frustrated." The Bethlehem Pharmaceuticals factory, sited in the outskirts of the capital, Addis Ababa, was awarded a licence to start producing the drugs in early August. The other factory so licensed is in northern Ethiopia. Ethiopia has 2 million people living with HIV. The virus has orphaned some 1 million children. Experts estimate that the virus kills around 600 people a day, while two-thirds of all deaths in Addis Ababa of people aged between 20 and 54 are AIDS-related. But, says Bethlehem's chief executive, Yordanos Tadese, despite promises by international organisations, no funds have been forthcoming. FACTORY READY TO START PRODUCTION The factory was opened by Trade Minister Girma Biru in a blaze of publicity last year. Now, Yordanos says, it is imperative that funds be found to make it possible for locally manufactured ARVs to be produced. He says he could produce them more cheaply than the cost of current generic imports, and has been ready to start production of the desperately needed medicines for the past six months. "We have got the capacity, we are ready to go, but we need international organisations to release funds to the country as soon as possible," said Yordanos, a former stockbroker based in the USA. "We could have started producing them as soon as we got the licence if we had had the financial support," he added. He went on to say that the initial cost of buying the raw materials needed for manufacturing the ARVs was too high for his firm to underwrite without additional funding and support. Meanwhile, banks in the country were unwilling to finance the production of ARVs drugs as they considered the enterprise too risky, Yordanos told PlusNews. The company, which is currently producing antimalarial drugs and antibiotics, is seeking funding through the World Health Organisation (WHO) under its 3 by 5 initiative. The US $350-million scheme, which was launched on World AIDS Day in December 2003, aims to treat 3 million people by the end of 2005. Ethiopia is one of the 20 countries to benefit from the programme. WHO experts visited the Bethlehem factory in this context in January. WHO estimates that 6 million people infected by HIV in the developing world need access to ARV therapy to survive, but only 400,000 so far have access. In Africa, where 70 percent of all people living with HIV/AIDS reside, drugs are available to just 100,000 people – a mere 2 percent of those in need, says WHO. WHO INITIATIVE At the launch of the 3 by 5 initiative, WHO Director-General Dr Lee Jong-wook said lack of access to ARV therapy posed a "global health emergency". Dr Peter Piot, the UNAIDS executive director, echoed his comments. "We firmly believe that we stand no chance of halting this epidemic unless we dramatically scale up access to HIV care," he said at the launch. "Treatment and prevention are the two pillars of a truly effective comprehensive AIDS strategy," he added. Bethlehem is also looking to the EU for support under an innovative plan to transfer manufacturing technology to Third World countries to enable them to fight AIDS, tuberculosis and malaria. Under the plan, developing countries were granted the right to produce generic drugs to fight health crises, overriding patents held by major pharmaceutical companies. The deal was struck as part of the 2001 Doha Declaration on Public Health. Peter Ungphakorn, a spokesman for the World Trade Organisation (WTO) said Ethiopia was under "no constraint" in the matter of producing its own ARVs. "It is up to Ethiopia to decide for itself whether its law should provide that protection," Ungphakorn told PlusNews from the WTO office in Geneva. Meanwhile, although Ethiopia is still awaiting WTO membership, new regulations mean that it has until 2016 before it has to apply pharmaceutical patents. The need for Ethiopia to start mass-producing ARVs has also been spelt out in stark terms by its health ministry. The ministry and the HIV/AIDS Prevention and Control Office have warned that fake drugs are being sold in the country as desperate people search for medical help. The danger is that those living with the virus may develop resistance to treatment if they use drugs that do not meet the correct standards or do not use them properly. ARVs STILL IN SHORT SUPPLY Ethiopia's efforts to support growing numbers of AIDS patients are still confronted by huge financial hurdles. The country began a limited distribution of ARVs late last year. The drugs – imported from India - are currently available at six clinics and cost around $50 for a month's supply. Bethlehem says it can produce the same quantity for $20. But even then, for many the drugs are simply unaffordable. According to health experts, at least 200,000 people in Ethiopia could qualify for the treatment, which is being made available on a first-come-first-served basis. However, the costs dwarf the country’s tiny health budget, which stands at $120 million a year - just under $2 per person. The government is examining two ways of ensuring a greater supply and reducing the cost - financial support from the Global Fund and through generic drugs. It has secured multi-million dollar funding, but the money has yet to be distributed in full. The health ministry has been allotted $425 million for the production of ARVs. Bethlehem has applied for $25 million of this amount to produce anti-AIDS drugs and expects an announcement later this month. Bethlehem is also working with a South African-based NGO called Initiative for Pharmaceutical Technology Transfer to help raise finances. Yordanos told PlusNews that he had personal experience of the HIV/AIDS pandemic, having lost members of his family to the virus. "We have a lot of Ethiopians who live with HIV/AIDS who do not have the capability to purchase these drugs," he said. "Our aim is to reach these people with a good quality, affordable medicine. We have to think of these people who are suffering with HIV/AIDS." The raw materials mainly come from India and China, according to Sathe, who will be in charge of producing the ARVs, and who was brought in by Bethlehem for his skills. "We have the means to do this and can do it to the standards of the rest of the world," he said. "As soon as we get the funds for the raw materials, we can start producing drugs."