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

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.


Disparities hinder passage of common East African AIDS drugs-access laws

By Zakumumpa Henry

Disparities between the views of East African community (EAC) member countries are complicating efforts to pass a common intellectual property law that would enable access to antiretrovirals to be scaled- up in the area, a regional meeting of East African Health rights NGOs was told last week (12 April 2012).

The three-day meeting held at the Imperial Botanical Beach hotel attracted participants from Kenya, Tanzania, Burundi, Rwanda and Uganda, the countries that make up the EAC.

Moses Mulumba, an intellectual property expert who conducted the study, said there were many disparities between the member states, which is making the passage of a common ‘TRIPS [trade related intellectual property rights] flexibilities’ compliant law difficult.

Currently, Kenya is regarded as a ‘developing’ country while the rest of the East African member states are regarded as ‘least developed countries’ or LDCs.

Mr Mulumba emphasized that this differention is complicating the making of uniform strategies and laws as developing countries are no longer permitted to manufacture generic antiretrovirals drugs whereas LDCs have a grace period running up to 2016 to do just that and also have the opportunity to reform their laws to permit them to continue manufacturing generic antiretrovirals.

In November 1999, the East African Community Treaty was signed by its member states. This means decisions taken at the EAC level, since they are legally-binding on all member states, supersede those taken at individual member country level. Currently, the proposed East African anti-counterfeit bill (2010) looks set to threaten access to essential medicines due to its intellectual property enforcement stance.

Mr Mulumba also revealed there were differences between government sector ministries in East Africa regarding enforcing intellectual property rights, with East African health ministries taking on a public health focus of enabling access to essential medicines while the trade ministries had a bias of enforcing the protection of business interests and private innovation rights.

Further illustrating the disparities, it was revealed that Kenya already has an act on anti counterfeiting while Uganda has a bill before parliament and Tanzania has regulations made under the trade marks law.

At the meeting, it was also revealed that the different East African countries preferred to move at different paces in reforming intellectual property-associated laws, with Tanzania preferring a slower and more cautious approach.

It was noted at the meeting that in regard to laws relating to intellectual property rights, there is widespread, erroneous mixing of the issue of quality and standards on the one hand and enforcing private rights of innovators and inventors on the other.

Jane Nalunga, Country Director of SEATINI-Uganda, an NGO that seeks to strengthen Africa’s world trade position, called on East African countries to negotiate for fairer international trade laws as an East African block as this gave them better leverage than as individual countries.

Ambassador Nathan Irumba of SEATINI said: ‘’Develop intellectual property laws that are based on your current level of development; ones that won’t strangle indigenous efforts. Japan and China did not hurry to enforce intellectual property rights of foreigners until they had reached a certain level of development themselves. How many East Africans have filed applications for patents?’’

The meeting was hosted by SEATINI-Uganda in partnership with Center for Health, Human Rights and Development (CEHURD) and HAI –Africa with funding from the Open Society Foundation.