Kenyan law changed for cheaper drug imports

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The Kenyan President, Daniel Arap Moi, is reported to have signed the Industrial Property Bill, enacted by the Kenyan parliament last year, amid conflicting noises about his government's intentions for antiretroviral drugs.

The law that is now set to come into force includes a provision that should make it easier to import low-cost generic versions of antiretroviral drugs into Kenya, while bringing Kenyan law into compliance with World Trade Organization rules on intellectual property. A last-minute provision that was put in, requiring such importation to have the permission of any patent holder, has been removed following by lobbying Kenyan parliamentarians and a vigorous campaign by the Kenya Coalition for Access to Essential Medicines. However, it is not clear that the law will meet the hopes of some campaigners for early access to low-cost versions of antiretroviral drugs such as those produced by Indian companies such as Cipla.

A report in the Daily Nation by Jeff Otieno (here) quotes Attorney-General Amos Wako as saying that "The Bill has been assented to and licensed manufacturers can now import cheaper drugs" which seems to imply that any importation would be of the active component of a drug, to be formulated by local generic manufacturers in Kenya.

Glossary

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

compliance

An alternative term for ‘adherence’.

formulation

The physical form in which a drug is manufactured or administered. Examples of formulations include tablets, capsules, powders, and oral and injectable solutions. A drug may be available in multiple formulations.

This understanding of the aim of the law seems to be shared by the Health Minister, Sam Ongeri, reported in the East African Standard here as telling pharmaceutical companies that they would need to set up manufacturing operations in Kenya in order to import generic drugs.

If these reports are correct, they may suggest that it will take some time before the new law results in any cheaper drugs becoming available to people with HIV in Kenya. New formulations would still need to undergo an approval process before they could go on sale.