and Theo Smart
After years of debate about the role of generic as against branded 'originator' versions of antiretroviral drugs (ARVs), the way that South Africa will manage drug costs as it moves towards comprehensive access for HIV positive people who need them is becoming apparent. Large scale local production, compulsory licenses, and not-for-profit procurement systems are all serious options. It is almost certain that most of the treatment that will be given to people with HIV in South Africa will be with generic products.
Aspen stavudine now available
This week, the South African generic manufacturer Aspen Pharmacare has launched its first generic ARV, Aspen stavudine (d4T), under a voluntary license from Bristol Myers Squibb. Aspen stavudine is now available in three doses of 40mg, 30mg and 20mg as a prescription drug from pharmacies, priced at 17 - 40% below the South African discounted price for the BMS version.
By the end of the year, subject in all cases to approval from the Medicines Control Council (MCC) of South Africa, Aspen will have launched generic versions of ddI, 3TC, AZT, Combivir (AZT+3TC), and nevirapine, licensed from BMS, GlaxoSmithKline and Boehringer Ingelheim. Aspen plans by the end of this year to offer a triple regimen for less than US $1 a day. Their manufacturing capacity is described as sufficient for "billions" of pills based on low-profit-margin high-volume operation, in line with government statements that 500,000 South Africans are currently in need of ARV treatment. They also plan to export to other African countries, subject to local licensing and patent laws.
Aspen is already the largest supplier of generic medicines to the South African government and has a 40% share of the domestic private sector market too. Beyond ARVs, it produces a number of other HIV/AIDS treatments including the anti-herpes drug aciclovir.
Strings and limitations
There are strings attached to the voluntary licenses that Aspen has been granted by the multinational companies which hold the South African patents. GSK in particular limits them to selling to the public sector, i.e. to the South African government. (Considering that the license involved no technology transfer, some might well view this as less than generous but at the same time a realistic model for what can expect to be achieved through compulsory licensing.) This means that other measures will need to be taken, to secure low-cost treatment access for those covered by managed care schemes in the private sector, which is currently the biggest ARV treatment provider in the country.
The South African government is concerned that public sector ARV provision should be additional to, and not a replacement for, existing ARV access through managed private sector care schemes. They have said they will require that such schemes offer, as a minimum, the same level of ARV access that is provided in the public sector. At the same time, they are moving towards a requirement that every employed person should be a member of such a scheme, paid for by their employer. For this to happen without bankrupting the schemes and/or the employers, it will be essential to control the cost of ARVs in that sector too.
Supporting international competition?
The Indian generic companies Cipla and Ranbaxy have each established a commercial presence in South Africa and have registered their versions of key ARVs with the MCC. Ranbaxy's joint-venture South African ARV company, Thembalami, is hoping to register a fixed dose triple combination as well as separate formulations of the drugs they produce in India. Clinical trials are planned in South Africa to demonstrate equivalence of such combinations to the drugs formulated separately.
Although some Indian generic formulations of ARVs have been approved by the MCC, they cannot be sold in South Africa since they infringe patents held by multinational companies. To get them onto the market would require either voluntary agreements or compulsory licenses, issued by the South African government. The South African government has now established a working party to advise them on how to make use of available legal means to reduce the cost of ARVs, and the most obvious application would be to find a way to issue such licenses to overseas generic companies.
Not-for-profit procurement - the world according to GARPP
While the majority of HIV positive South Africans who need ARV treatment will have to rely on government to set the pace for providing access, an expanding network of NGO projects has been pioneering some of the treatment strategies that will be needed. The project run by Medecins Sans Frontieres in partnership with the Treatment Action Campaign and the government of the Western Cape in Khayelitsha, Cape Town, is perhaps the best known example.
Such projects have often used either MCC-registered generic drugs or generic ARVs imported with special exemptions from registration granted by the MCC. Some drugs and formulations - especially paediatric versions such as syrups - remain unavailable in generic form although the generic manufacturers do claim to be working on them. The projects will therefore have to continue using some branded formulations.
In February 2003, 19 of these projects set up the Generic Anti-retroviral Procurement Project (GARPP), a non-profit company that procures ARVs for its member organisations, under contracts which require that they provide agreed minimum standards of treatment and care. It is anticipated that this network will expand to more than 30 projects and 4,000 people on treatment within the next year. As well as minimising drug purchase costs, GARPP will promote and enable exchanges of information and experience among the projects.
The honorary managing director, Wilbert Bannenberg, is a public health consultant and former WHO employee based in the Netherlands. In a presentation given at the South African AIDS Conference in Durban, he observed that the scheme may be overtaken by government provision for the impoverished communities currently served by most of these projects. However, until this actually happens, they will press on and are open to applications for membership by additional programmes.
Further information about GARPP is available from Wilbert Bannenberg: wilbertb @ wanadoo.nl; membership enquiries (from projects only) to colwynp@mweb.co.za.