Stavudine

The health department has called for bids for the next AIDS-drug tender, a move keenly awaited by local pharmaceutical firms that invested heavily in developing capacity to make generic copies of patented antiretroviral medicines. SA has the worlds biggest caseload of HIV patients, with about 5,4-million people infected with the virus that causes AIDS.

he first generic antiretroviral drug that can be sold without its manufacturer being sued will be on the shelves in South Africa shortly. Aspen Pharmacare, the country's largest generics company, is awaiting finalisation on details from the Medicine Control Council for Stavudine. Precious Matsoso, the registrar of medicines at the Medicine Control Council, confirmed this week that Stavudine, which trades as Zerit in the Bristol-Myers Squibb stable, has been registered. Generics need to overcome two hurdles in this country: they need to be registered by the council and obtain the go-ahead by the multinational should a patent still exist. Multinationals generally have 20-year patent protection of drugs in their stable. Bristol-Myers Squibb waived its rights to Stavudine, saying it would not sue Aspen if it manufactured the drug and sold it to about 43 countries in Africa. Aspen subsequently developed the generic version and has been awaiting approval from the council. Stavudine is one of three drugs necessary in a package comprising Stavudine, Limivudine and Nevirapine. A year's worth of Zerit (recently significantly discounted by Bristol-Myers) costs R554.64 including VAT in sub-Saharan AfricaLinda Philip, chief executive of Aspen Pharmacare Southern Africa, says the company will go to market at a lower price than the originator. Aspen also has voluntary licences from GlaxoSmithKline to develop generics of AZT and 3TC and Combivir (a combination of the two), as well as avoluntary licence from Boehringer Ingelheim to make a Nevirapine generic. These drugs are awaiting registration from the council. Philip says the event is symbolically important. We're hopeful it's close to market and that we'll have the first legal South African registered generic to market. Philip says that as more generics come to market, they could replace other components of Aids cocktail drugs, making the whole package cheaper. The drug will trade as Aspen Stavudine. The impact on Aspen's profitability will be through additional volumes, improving economies of scale. Other generic antiretrovirals have been registered in South Africa, but cannot be sold legally as this would override patent protection, a cornerstone of world trade law. Activist groups such as the Treatment Action Campaign are trying to push the government to issue compulsory licences, which would enable businesses in this country to produce the drugs, on the basis of a national emergency. They say loopholes exist in legislation that allow for violation of patent protection on this basis. German company Boehringer Ingelheim said recently it would not interfere with countries that issued compulsory licences. (Source: http://www.sundaytimes.co.za/2003/07/06/business/news

Bristol-Myers Squibb's Southern Africa general manager, Ian Strachan, said the company's two antiretroviral drugs, Zerit and Videx - would be made available at the combined price of $1 a day (about R8 a day) to both the private and public healthcare sectors, starting from Thursday.

Now that pharmaceutical court action has stopped, act can be promulgated. Health department drug experts have spent the past two days drawing up proposed regulations for the Medicines and Related Substances Control Amendment Act of 1997 so that it can be promulgated and put to work as soon as possible. High on the list are proposed regulations to deal with parallel importation such as who would be licensed to do the importing, whether and how imported medicines would be registered and how this would be monitored, according to one of the health department's advisers on drug issues, James Love, of the Consumer Project on Technology, a Ralph Nader group. In the armoury of provisions hoped to have the effect of dropping prices are a fixed single exit price for medicines that will not be varied by discounts; increased use of generic copies in prescriptions; and the ability to import brand name drugs available at lower prices outside SA than in it. (Source: Business Day, 26 April 2001)

This week, US drug giant Bristol-Myers Squibb announced that it is slashing the prices of its HIV/AIDS drugs Zerit and Videx for Africa, and added that it will not object to South Africa licensing imports or producing generic copies of the two drugs, also known as stavudine and didanosine. Makers of generics will have to compete with the below-cost prices Bristol-Myers Squibb said it would now offer all African countries $0,15 a day for Zerit and $0,85 a day for Videx. Zerit costs a patient about $100 a day in the US. Cipla has offered to sell it for $0,20 a day. The Bristol-Myers Squibb offer was greeted coolly by Zackie Achmat of the Treatment Action Campaign (TAC), the group which lobbies for greater access to medicines by people with HIV/AIDS. Bristol-Myers Squibb should be held accountable for the millions of dollars it had already earned from people with HIV/AIDS, said Achmat. The company had not invented the drugs and had spent almost nothing on their development. He said the TAC was applying for a compulsory licence for the drugs and wondered if this, or a row with Yale University in the US, had forced the firm's hand. There have also been further international developments with other pharmaceutical companies. Most, if not all, pharmaceutical companies involved in the United Nations access initiative on HIV/AIDS medicines have reduced the prices of their drugs significantly recently. The moves by Boehringer Ingelheim, GlaxoSmithKline, Merck and, yesterday, Bristol-Myers Squibb remove price as the largest obstacle in the way of providing the antiretroviral drugs needed for the treatment of HIV/AIDS. Roche, which was involved in the programme, has not announced new moves on access to its product used in HIV/AIDS. (Source: Simon Barber, Business Times, 15 March 2001 and Pat Sidley: Business Day, 15 March 2001)