By Paul Garwood
Kenya’s Parliament has rejected a proposal to revoke the government’s powers to issue compulsory licenses to manufacture products such as generic medicines without patent holder approval, a move welcomed Friday by supporters of universal access to pharmaceuticals.

The decision, made late Wednesday, protects Kenya’s ability to acquire affordable generic medicines, such as antiretroviral treatments for HIV/AIDS patients, without seeking permission from pharmaceutical firms who hold the drug patent rights, Tom Mboya Okeyo, Kenya’s deputy permanent representative to the United Nations in Geneva, told Intellectual Property Watch.

“It means Kenya can continue to buy medicines from the cheapest source and make them widely available for patients without being told we must adhere to patent rights,” said James Kamau, coordinator of the Kenya Treatment Action Movement, who witnessed the Parliament vote.

Governments can issue compulsory licenses to produce medicines more cheaply than prices offered by drug companies without seeking patent holder consent under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS allows countries, particularly in the developing world, to make drugs to safeguard public health in national emergencies or for non-commercial purposes.

Section 80 of Kenya’s Industrial Property Act 2001 enshrined the compulsory licensing provisions in national law. There have been repeated efforts to delete these provisions, initially by the state-run Kenya Industrial Property Institute, apparently because it offered no compensation to pharmaceutical firms whose products could be produced, under compulsory license, by state-approved companies, lawyers have said.

Wednesday’s attempt to amend the act was defeated when parliamentarians rejected a proposal to delete Section 80, which was among multiple amendments in the omnibus Miscellaneous Amendments Bill. The same bill was expected to go before Parliament in 2006 but was withdrawn at the last minute (IPW, Public Health, 21 December 2006).

“This means Kenya will continue to exploit the flexibilities of the TRIPS provisions to access to affordable medicines for the protection of public health,” Okeyo said.

Ellen ‘t Hoen of Médecins Sans Frontières said the organisation was relieved that the flexibilities in the Industrial Property Act had been protected. “Our ability to provide AIDS medicines to over 10,000 people in Kenya depends on the availability of affordable generic medicines,” she said. “This would have been in jeopardy if the amendments had gone through.”

Prominent Kenyan IP lawyer Peter Munyi said Parliament’s decision helped ensure the availability to medicines but also enabled access in other areas such as technology and security.

It was unclear who proposed the latest attempt to scrap the compulsory licensing powers, Okeyo said. The closest ministries to the compulsory licensing issue – health and trade – have denied seeking the amendments. “The government will continue to be vigilant,” Okeyo said of future attempts to scrap Kenya’s compulsory licensing powers.

Opponents of the amendments demanded the government reveal who is trying to nullify the compulsory licensing provisions and discover the motives for the proposed amendments. Kamau was unsure if pharmaceutical companies were involved, but claims they would gain most from the government losing its powers to produce cheap generic versions of the patented medicines.

“Ever since the Industrial Property Act was passed, there have been fights over its provisions,” Kamau told Intellectual Property Watch. “Who keeps sponsoring this bill? We need to find out how it keeps being raised.”

Ratifying the amendment would have resulted in the government relinquishing its power to issue compulsory licenses to local manufacturers to produce drugs for public health emergencies. It, in turn, would have compelled authorities to negotiate directly with the big pharmaceutical firms that hold the patents to obtain medicines.

In Kenya, between 270,000 and 300,000 people living with HIV need treatment, of which some 150,000 receive antiretroviral therapy, according to Kamau. Most medicines are generic versions of patented medicines and are obtained through parallel importation, mainly from India, which is a prime source of low cost, high quality pharmaceuticals. Kenya has never issued a compulsory license, but came close to in 2004 before German pharmaceutical major Boehringer Ingelheim agreed to enter into a voluntary license agreement with Kenyan drug firm Cosmos to produce generic versions of its patented anti-AIDS drug nevirapine.

Paul Garwood may be reached at pgarwood@ip-watch.ch.