Kenyan High Court set to make landmark decision on access to generic medicines

Posted on | maart 9, 2012 | No Comments

The Constitutional Division of the High Court will on Friday March 9, 2012 make a landmark judgment on the suspended Anti-Counterfeit Act of 2008. The outcome of this decision will directly affect access to affordable generic medicines in Kenya.

In 2009, three people living with HIV filed a law suit seeking a determination that the Kenya Anti-Counterfeit Act 2008 is unconstitutional and threatens access to life-saving generic medicines and thus infringes on their right to health. The right to health is now guaranteed by the Constitution of Kenya.

On the day of the ruling, over 100 people living with HIV, health advocacy groups and medical groups will gather outside the courtroom to hear the decision. “This will be a test of the strength of the right to health under the new constitution,” says Allan Maleche, a lawyer with the Kenya Ethical AIDS Legal Network (KELIN).

“The ruling is a matter of life and death for many people whose access to needed generic medicines will be determined by Lady Justice Ngugi’s decision. We hope she will act to uphold our new Constitution and protect access to generic medicines”.

The case is expected to set a precedent not only for Kenya, but other East African countries at a time they are considering a draft law and policy on anti-counterfeiting.

The Kenya Anti-Counterfeit Act, 2008was passed by the Kenyan parliament to deal with the problem of counterfeit products in the market. Among other products that the law seeks to regulate is medicines which has raised many problems and concerns.

Since April 2010, the High Court has ruled that the Act should not be interpreted in any way that may interfere with the importation of generic medicines until a constitutional case filed by three activists is fully heard and determined. The main issue is that this law confuses generic medicines with counterfeit medicines.

The civil society have raised a number issues regarding the way counterfeiting is addressed under the Kenya Anti-Counterfeit Act 2008.

They say definition of counterfeiting in the interpretation section is problematic. Even though a clause was added which specifically mentions “medicines”, it is still incomplete (for example, the clause does not include vaccines).

The CSOs say the two distinct issues of patent infringement and counterfeiting are confused even though these are separate and distinct issues. As a result, generic medicines have been confused with counterfeits.

The Act also recognizes intellectual property rights (IPRs) subsisting in other countries. This, say members of the CSOs imposes a duty on Kenyans to abide by IPRs of all other countries in the world even where these have not been registered and hence, recognized in Kenya. This places an undue burden on the Kenyan legal system to enforce and protect IP rights not registered in Kenya.

They say that since IP rights registered in other countries are enforceable in Kenya (even if not registered here), suspected counterfeit goods (including medicines) can be seized under section 34 of the Act.

The Act gives the Kenya Revenue Authority (KRA) broad powers on medicines rather than the Pharmacy and Poisons Board (PPB) which should be in charge of combating counterfeit medicines since it has the necessary technical expertise, unlike KRA.

AUTHOR: Henry Neondo
URL: http:// www.africasciencenews.org
E-MAIL: neondohenry [at] yahoo.com