The pharmaceutical industry went into battle with the South African government at the Pretoria High Court on Monday, to fight for the right to defend its patents on medicines. The outcome could set a precedent for health care across the developing world.
A group representing about 40 pharmaceutical companies will try to overthrow a law that would enable the South Africa to import cheap generic medical drugs, without having to pay license fees to the companies holding the patents.
Ten percent of South Africa鈥檚 people are HIV positive, and the country has the highest infection rate in the world. The South African government says it cannot afford the high prices that Western drug companies charge, so the only way it can treat its people is to buy cheap versions of drugs produced in countries such as India and Brazil.
Advertisement
The Medicines and Related Substances Control Amendment Act would allow the South African government to import generic drugs when patented medicines are 鈥渦naffordable鈥� or when there is a 鈥渉ealth emergency鈥� such as AIDS.
鈥淓xcessive powers鈥�
But South Africa鈥檚 Pharmaceutical Manufacturer鈥檚 Association (PMA), representing the companies, argues that the law gives excessive powers to the health minister and is therefore unconstitutional. For example, it does not define what terms such as 鈥渦naffordable鈥� mean.
The PMA also claims the law would effectively scrap the recognition of patents on medicines, breaching international trade agreements including the Trade Related Intellectual Property Rights (TRIPS) agreement.
The South African government believes the legislation is consistent with TRIPS, which allows compulsory licences to be granted for non-commercial use by the government, or if there is 鈥渁 national emergency鈥�.
But the agreement also says that remuneration has to be paid to the patent holder. 鈥淚鈥檇 be very interested to ask the South African government whether they intend to pay remuneration,鈥� says Gordon Wright, an expert in pharmaceutical patents from patent firm Elkington and Fife in London.
鈥淒eadly precedent鈥�
Sophia Tickell, senior policy advisor for Oxfam, says whether or not the drug industry have a legal case, they do not have a moral case.
鈥淚f they win, this will set a deadly precedent for other poor countries,鈥� she says. 鈥淚t will also have a devastating effect within South Africa. It will make it much more difficult for the South African government to systematically obtain the cheapest possible drugs.鈥�
Tickell admits the South African government 鈥渉as not gone far or fast enough鈥� in dealing with the AIDS crisis, but she says the Act will help get drugs to the people who need them.
Infrastructure failure
Alan Chandler, spokesman for GlaxoSmithKline (GSK), says lack of infrastructure, not patenting, is to blame for the lack of availability of drugs in developing countries. 鈥淭he problem is that governments don鈥檛 have the infrastructure to distribute the drugs,鈥� he says.
He points out that 95 per cent of drugs on the World Health Organisation鈥檚 central drug list are not covered by patents. 鈥淏ut access to those medicines is still a problem.鈥�
Chandler adds that since 1997, GSK has been offering governments in Africa anti-AIDS drugs at an almost 90% discount. 鈥淚n some instances, that makes them cheaper than generic alternatives.鈥�
But South Africa has not shown interest in the offer. Some analysts say that this is because the condition that the pharmaceutical companies place on their offers is that the African governments may not then sell the discounted drugs back to the West at a profit.
The court case is expected to last seven days. By the end of that time, say Oxfam, 5000 South Africans will have died of AIDS.