The arguments over affordable life-saving medicines for the developing world intensified late last month when it was revealed that Glaxo-Wellcome has blocked the importation of inexpensive generic knock-offs of its premier AIDS drug, Combivir, into Ghana (a small country in West Africa). The conflict is the latest skirmish in one of the most contentious issues emerging in sub-Saharan Africa, where 25 million people are infected with HIV, and only a tiny proportion have access to life-prolonging HIV drug cocktails.
In letters to a drug distributor in Ghana and a generic-drug maker based in India, Glaxo said sales of generic versions of Combivir (marketed as Duovir by the Indian generic company) in Ghana were illegal because they violated company patents. As a result, the Indian company, Cipla Ltd. of Bombay, has stopped selling its low-cost version in Ghana. Officials at the African agency (African Regional Industrial Property Organization, “ARIPO”) that issued the Glaxo patents in question, however, said that three of the patents are not valid in Ghana. (The fourth covers a specific formulation of Combivir, and Cipla claims that it does not pertain to their product.)
Combivir is a combination of two of the best-selling AIDS drugs, AZT and 3TC. Total world-wide sales of AZT, 3TC, and Combivir are expected to top $1.1 billion this year — up from about $775 million in 1997. Earlier this year, Glaxo had offered to sell Combivir in Senegal and Uganda for $2 a day — far less than the $16 a day retail price in the U.S. Miffed by this threat of generic importation, Glaxo officials now say they will make a similar offer to Ghana. Cipla’s generic version (Duovir) sells for about $1.74 a day ($620 a year) in Ghana.
The revelation came as South Africa announced it had reached an agreement with Pfizer over the provision of fluconazole to treat cryptococcal meningitis and, more recently, oral candidiasis. The threat of generic competition made Pfizer lift restrictions it wanted to impose on the fluconazole it is donating to South Africa. Initially the fluconazole was going to be provided for the treatment of cryptococcal meningitis only — and not for thrush — which affects more people. “The company was dictating how the drug was to be used,” said a spokesman for one of the activist groups there.
After South African activists began importing a cheaper version of the drug just months ago, Pfizer buckled under the threat of this discount competition and agreed to supply fluconazole for candidiasis as well as for meningitis.
The battle in Ghana is being watched closely elsewhere partly because it involves Cipla, one of the world’s major producers of generic AIDS medicines. Cipla’s stature, and its ability to market its drugs throughout Africa, may be why Glaxo has moved so aggressively in Ghana, according to industry analysts. Glaxo says it is simply protecting patents in a routine fashion.
Christopher Kiige, chief patent examiner of the African Regional Industrial Property Organization, said that if Glaxo took the case to court, “they would lose.” A Glaxo spokesman in London says the drug maker believes its drug is patent-protected in Ghana but declines to provide an explanation or legal documentation.
Glaxo is believed to be worried that if a small country such as Ghana violates patent protection, that could open a Pandora’s box of violations in larger markets, such as South Africa, Latin America, the Caribbean and parts of southeast Asia where a restive HIV-infected public is also said to be considering such measures. The pharmaceutical companies argue that without intellectual-property protection they would have no incentive to invest the millions required to discover and develop new drugs. As Glaxo spokesman Martin Sutton put it, “Ghana may represent only a fraction of our overall revenue, but where do you draw the line?”