Kenya: Access to Generic Drugs Prevails in High Court Ruling on Anti-Counterfeit Law

27 April 2012

This Bridges Weekly article examines the Kenyan High Court ruling last Friday, when the suspension of the country's anti-counterfeiting legislation was reaffirmed. The piece highlights the issues of health security that could arise due to trade impediments linked to an unclear distinction in the act between counterfeited and generic drugs.

Bridges Weekly - In a landmark decision last Friday, Kenya's High Court ruled that the country's anti-counterfeiting legislation could potentially undermine access to life-saving generic medicines. Lawmakers will now have to reconsider the relevant sections of the bill to eliminate ambiguities between generic and counterfeit drugs.

The 2008 Anti-Counterfeit Act was approved by the Kenyan Parliament with the intent of prohibiting trade in counterfeit goods and establishing an Anti-Counterfeiting Agency. (See Bridges Review, June 2009) The legal challenge to the act began in 2009 with a lawsuit filed by three petitioners with HIV/AIDS.

High Court Judge Mumbi Ngugi found that the act fails to clearly distinguish between counterfeited drugs and generic medicines. The ruling affirms that this legislative misstep may lead to confusion, which in turn could hinder access to life-saving medicines, particularly for people living with HIV.

"The right to life, dignity, and health of people like the petitioners who are infected with the HIV virus cannot be secured by a vague provison in a situation where those charged with the responsibility of enforcement of the law may not have a clear understanding of the difference between generic and counterfeit medicine," Judge Mumbi Ngugi stated in the ruling.

"The Anti-Counterfeit Act has, in my view, prioritised enforcement of intellectual property rights in dealing with the problem of counterfeit medicine. It has not taken an approach focused on quality and standards which would achieve ... the protection of the petitioners in particular and the general public from substandard medicine," Ngugi added.

Following doubts in July 2010 over the act's consistency with the Kenyan Constitution on the right to life and the right to the highest standard of health, the High Court suspended implementation of the act's provisions on counterfeited drugs until a decision on the case could be taken.

Last Friday's ruling reaffirmed the suspension, underscoring that "there can be no room for ambiguity where the right to health and life of the petitioners and the many other Kenyans who are affected by HIV/AIDS are at stake."

Health activists welcome decision

After the ruling, UNAIDS Executive Director Michel Sidibé declared that "the High Court of Kenya has upheld a fundamental element of the right to health."

According to UNAIDS, 1.6 million people in Kenya live with HIV/AIDS; an estimated 743,000 Kenyans are eligible for antiretroviral treatment, of whom 539,000 are currently receiving it. Generic drugs are the most widely used medicines in Kenya.

"We must have both generic drugs and strong anti-counterfeit laws. Generic drugs give more people access to life-saving treatment - while anti-counterfeit laws keep people safe," Sidibé added.

Several health advocacy groups similarly applauded the decision.  AIDS Law Project Executive Director Jacinta Nyachae - in a joint statement issued by Médecins Sans Frontières, Health Action International Africa, and the Kenya Ethical and Legal Issues Network on HIV and AIDS - welcomed the High Court ruling and underlined the possible ripple effect the decision could have on Kenya's neighbours.

"Kenya is leading the way in protecting access to medicines and public health and we are watching the actions of the East African Community member states to see if they follow suit," Nyachae concluded.

ICTSD reporting; "Kenyan court ruling upholds access to generic drugs," REUTERS AFRICA, 20 April 2012.

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