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| A woman waits for medicine at a pharmacy in the Cape Town township of Gugulethu, by Trevino on Flickr |
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South African Supreme Court Judge Edwin Cameron, who is HIV+ on living with HIV (4.1 Mb) CC BY-NC-ND 3.0
The story of access to medicine for South Africa, and anti-retroviral treatment in particular, has played itself out on two stages. On the one is the battle against big pharma for the rights to manufacture affordable anti-retroviral drugs. In this arena, South Africa along with Brazil and India have sent a clear message to the pharmaceutical companies, and are doing all they can to manufacture and/or import cheap generic drugs for treating people with HIV. In South Africa, this action against the restrictions of access to medication imposed by intellectual property and patent law had another effect. It brought the government and the non-profit sector together against pharmaceutical companies. This is unusual because the non-profit and activist sector in South Africa has always been highly critical of the government’s response to HIV, even going so far as to call for the resignation of the Minister of Health, because of her poor and belated response to the HIV crisis in the country, and her unscientific statements that a diet that includes African potatoes, garlic and lemons could be a cure for HIV.
In a country where an estimated five million people are infected with HIV, access to anti-retroviral treatment was always going to be the cornerstone of any significant governmental response to the disease. In the late 1990s, access to anti-retroviral treatment was the privilege of the wealthy, who were able to buy expensive, imported drugs and use then under the supervision of their personal doctors. However, for the vast majority of South Africans, ARV treatment was impossible – inhibited by the cost of the medicine, and the lack of access to a primary healthcare worker – most poor South Africans rely on clinics and local hospitals for healthcare, where monitoring and one-on-one treatment is rare.
For many years, the South African government maintained that the cost of anti-retroviral drugs made it impossible to provide access on a national level to all HIV positive South Africans. The attitude of the President of South Africa, Thabo Mbeki, who has often questioned the causal relationship between HIV and AIDS, and has aligned himself with the opinions of AIDS dissidents has also had an influence on the government’s response to the epidemic that killed over a million South Africans in 2001.
Big Pharma, Big Laws, Big Fights
TRIPS, the WTO’s agreement on Trade-Related Aspects of Intellectual Property Rights obliges all WTO member states to provide 20 years of patent protection for medicines, and prohibits the production of generic drugs during this period. This agreement may only be overridden in the case of a national emergency.
TRIPS does, however, allow for voluntary and compulsory licensing for the manufacture of medicines. Voluntary licensing means that the government grants a production licence to a third company to produce the generic drug with the consent of the patent holder. The patent holder usually receives a token royalty. For example, in April 2006, Enaleni Pharmaceuticals, a subsidiary of Indian generic drugs manufacturer Cipla, used such a licence to start manufacturing Triomune, a three-in-one ARV drug, which allows users to reduce the number of pills they have to take every day, and the frequency of the dosage. Triomune contains lamivudine (under license from Glaxo Group Ltd. and the Wellcome Foundation Ltd.); nevirapine (under license from the Boehringer Ingelheim group of companies) and stavudine, all three of which make up the recommended first-line treatment against HIV.
Compulsory licensing, the process whereby a production licence is granted without the consent of the patent holder, has yet to take place in South Africa, unlike in Brazil, where in 2007, President Luiz Inacio Lula da Silva issued a compulsory license to produce a lower-cost, generic version of Merck's anti-retroviral Efavirenz.
In 1997, Parliament passed the Medicines and Related Substances Control Amendment Act, No. 90 of 1997 (Medicines Act) which contained provisions that made medicines more affordable. The Act gives the government a legal framework to:
- Compel pharmacists to prescribe cheaper generic substitutes of medicines no longer under patent (generic substitution)
- Import cheaper brand-name medicines from countries where the product is sold for less (parallel importing)
- Issue compulsory licenses, under certain conditions, to local companies to produce generics of patented medicines (compulsory licensing) and
- Introduce a transparent pricing mechanism to make pharmaceutical companies justify the prices they charge
This was a vital piece of legislation for the provision of cheap anti-retroviral drugs in South Africa.
The South African Patents Act provides for compulsory licensing in the event that the patent holder can be shown to abuse the patent. In February 1998, a court action was instituted against the South African government by the Pharmaceutical Manufacturers Association (PMA) to defend the industry’s patent rights. The action was aimed specifically at Section 15c of the Medicines and Related Substances Control Amendment Act, which allows government to purchase drugs from other countries where prices are lower, therefore allowing for parallel trading of those drugs with the local equivalent as well as compulsory licensing. The case was withdrawn in April 2001 due to international political and public pressure.
This did not mean that South Africa was suddenly flooded with cheap anti-retroviral medicine, but did mean that access to these medications, via government roll-out programmes, would become easier for the majority of poor South Africans. It also meant that the South African government, and particularly the Ministry of Health no longer had the cost of medicines as an excuse to justify its reluctance to commit to a national roll-out. However, it wasn’t until 2003 that the Cabinet approved a strategic roll-out plan. By 2005, an estimated 104 000 South Africans were able to access anti-retroviral medicine, both in the public and private sector. This number stands in stark reality to the World Health organisation’s estimate that 837 000 South Africans are in need of access to anti-retroviral treatment.
Cost of Treatment
In 2000, in an effort to highlight the huge discrepancies between the cost of original and generic drugs, activist Zackie Achmat (then leader of the Treatment Action Campaign (TAC) a non-profit dedicated to campaigning for equal treatment for all HIV positive people in South Africa) smuggled 5 000 tablets of a drug called Biozole into South Africa. Biozole is used in treating some opportunistic infections associated with HIV, and is a generic version of the drug Fluconazole, which is manufactured by pharmaceutical giant Pfizer. At the time, Fluconazole was patent protected in South Africa, and the manufacture of generic versions was illegal. A single tablet of Fluconazole was selling for R124 (U$16.00) in South African pharmacies and government was paying R28.57 (U$ 3.71) for each tablet.
The generic tablets, bought in Thailand, cost R1.78 (U$0.23) each.
In 2005, the South African government awarded a tender to seven different pharmaceutical companies to supply the public healthcare system with anti-retroviral drugs. At the time, the tender was worth around R3.4 billion, or U$399 million. Aspen Pharamacare, a South African generics manufacturer was awarded the largest share of the tender, with international pharmaceutical companies included only when generics were not available. It is hard to imagine the cost of providing ARV treatment to all South Africans without generic drugs. In 2005, the cost of providing ARV treatment through the South African healthcare system was around R296-million (U$39.4 million). By 2007/8 it will cost an estimated R1.65 billion (U$ 219.6 million) as the number of people seeking treatment grows in correlation with the number of new infections. This is a huge amount of money, but when you break it down to the cost per person, it is, in fact, very cheap. In South Africa at the moment, ARV therapy costs between R97 (U$ 12.00) and R500 (U$ 65.00) per patient, depending on the individual’s specific needs. This is significantly cheaper than the R70 000
(U$ 9 124.00) that it cost ten years ago.
The impact of generic drugs on the cost of treating HIV positive South Africans cannot be denied. However, diseases such as TB, malaria and hepatitis still have a devastating impact on South Africans, and particularly the poor. Pharmaceutical companies, who are eager to be seen doing their bit in the "fight against HIV” are still making drugs that are prohibitively expensive for the majority of South Africans, under the protection of international treaties.
tags: johannesburg south africa policy-law local-context-global-commons access-to-medicine patent law trips drug-patents
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