The 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
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