E-DRUG: GSK grants voluntary license for ARVs in Kenya
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[E-drug earlier reported that the Ministry of Trade refused to issue a compulsory / government use license, despite the fact that Ministry of Health had ordered the generic drugs to be produced.
The company has now resolved the deadlock by obtaining a voluntary license from GSK in a similar fashion as Aspen Pharmacare and Ranbaxy/Thembalami did in South Africa.
Cosmos' ARVs are not yet WHO prequalified, but it has applied for a WHO inspection.
Good news anyway for Kenyan AIDS patients (if the price is competitive).
Small correction: there are already more than 2 generic producers of ARVs in Africa! However, the majority does so without a voluntary license in their countries, probably because there are no valid patents.
Copied as fair use. WB]
from Kenya's Daily Nation (http://www.nationmedia.com/dailynation/)
Kenyan firm cleared to make HIV drugs
Published: 09/22/2004 By: DAGI KIMANI
Kenya's nearly 2 million HIV-positive people have reason to smile. Within a month, they will be able to get cheaper life-saving drugs manufactured locally.
This follows the green light given to a Kenyan company, Cosmos Limited, by British pharmaceutical giant GlaxoSmithKline, holders for the patents, to start manufacturing generics of three key drugs.
Cosmos will make the generics of lamivudine (brand named Epivir) and zidovudine (Retrovir), as well as the combination of the two, Combivir.
The patents for the three medicines give GSK the sole right to manufacture and distribute the drugs in Kenya.
Yesterday, the Cosmos chairman and chief executive, Dr Prakash Patel, termed the agreement between his firm and GSK, "historic", adding: "We are ready to commence production of the drugs immediately."
Production, Dr Patel said, would start as soon as the two companies agree on the brand names to be used locally.
GSK-Kenya managing director Andrew Bulloch could not be reached for comment.
One of the advantages of the local manufacture of the drugs is that the dosages and other instructions will be printed on medicine packs in both English and Kiswahili, helping to improve compliance.
"We greatly commend GSK for awarding us the voluntary licence to produce the two drugs locally," Dr Patel told the Daily Nation in Nairobi.
"This is a positive move given that while profits are important, the magnitude of the Aids problem in countries like Kenya calls for certain sacrifices. GSK has shown the way for other multinationals."
An announcement of the unprecedented agreement between Cosmos and the Kenyan subsidiary of the British multinational will be made at 11am today, at a function involving top officials of the two firms at GSK's Nairobi headquarters. It will be attended by the minister for Trade and Industry, Dr Mukhisa Kituyi.
During recent WTO negotiations, Dr Kituyi was instrumental in pushing for the rights of developing countries faced with the HIV/Aids pandemic to produce generic ARVs.
Under the World Trade Organisation's intellectual property law, a voluntary licence such as that granted by GSK to Cosmos can only be given by the patent holder of a drug to a third party.
The granting of the licences for the three ARVs to Cosmos will make Kenya the second country in sub-Saharan Africa, after South Africa, to manufacture generic ARVs.
Kenya will now join the likes of Brazil, Thailand and India in producing the generics of the "critical medicines", which the World Health Organisation (WHO) says are the key to expanding treatment to 3 million HIV-positive people around the world, by next year.
More importantly for people infected with HIV, local manufacture of generic ARVs could see prices fall from the current Sh3,000 for a month's dose. Government hospitals charge a subsidised fee of Sh1,500 for a month's treatment, which is about half the cost of the drugs.
Local manufacture will also result in a more reliable flow of the life-saving drugs from the factory to the patient, a leading HIV/Aids expert, Dr Ephantus Njagi, said yesterday.
"The current system where we depend on imported ARVs is subject to all manner of variables, including foreign exchange fluctuations and shipping disruptions," Dr Njagi said. "Manufacturing the drugs locally substantially shortens the supply chain."
Cosmos Limited, the manufacturer of such brands as Malaratab and Painotab, is one of the country's leading drug makers and has been agitating for licences and agreements to manufacture ARVs since early last year, when it said it had completed trial runs and quality control checks at its Nairobi Industrial Area factory.
Mid-last year, the company won a tender to supply generic ARVs to the Ministry of Health on the basis that it had the capacity to manufacture the drugs, but shelved the idea because of patent restrictions. Other local pharmaceutical companies that say they can make generic ARVs include Laboratory & Allied, and Universal Pharmaceuticals.
Yesterday, representatives of various organisations working with HIV/Aids expressed delight at the agreement between Cosmos and GSK.
"This is great news for all Kenyans," Mr Robert Dimba, the programme officer at The Association of People With Aids in Kenya (Tapwak), said. "We have tried to push for this for a long time, and this is definitely fantastic news."
Ms Christine Jamet, the head of mission for MSF-Belgium, which runs several treatment programmes using generics, added: "This is a good and necessary step for Kenya, but it is important that all parties involved ensure that the right quality standards are maintained."