Nairobi — The Constitutional Court in Kenya has barred the government from implementing the Anti-Counterfeit Act of 2008 as it applies to generic medicines until a verdict is delivered in a case filed by three people living with HIV.
Three petitioners in July 2009 filed a suit challenging sections two, 32 and 34 of the Anti-Counterfeit Act which they argued are unconstitutional.
It was argued that the act endangers the petitioners' lives as they will be arbitrarily denied access to affordable and essential generic medication. The act is also criticised as failing to uphold the provision on the right to life in section 70 and 71 of Kenya's constitution.
According to the petitioners, the act confuses quality and intellectual property rights (IPR) issues, thereby defining legitimate generic drugs as counterfeits.
The area of IPRs, including patents, trademarks, copyright and data protection, is clearly distinct from quality control issues when related to medicines. The act in its current form confuses these issues in such a manner that it is difficult to distinguish one from the other. As such, generic medicines may be erroneously interpreted as counterfeits, argued the petitioners' counsel, David Majanja.
Furthermore, the law contravenes sections of the Industrial Property Act of 2001, including section 58(2) providing for parallel importation and section 80 on government use, according to the AIDS Law Project, a non-governmental organisation defending access to adequate healthcare and treatment for people living with HIV and AIDS.
These sections have played an important role in the struggle to increase access to essential medicines in Kenya.
The World Trade Organisation's Doha Declaration confirmed the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement's allowance of parallel importation to address public health problems. Parallel importation involves the importation of non-pirated goods without the permission of the copyright holder.
Section 80 on government use allows the government or its agents to exploit a patent in the public interest.
Delivering the ruling today (Apr 23), Justice Roselyn Wendoh said that the petitioners had an arguable case and if the orders the petitioners wanted addressed were not met, they would suffer irreparable damage. "The petitioners have met the threshold, (therefore) the court issues a conservatory order as far as generics are concerned," she said.
The judge appreciated that the wording in the act was vague and would cause confusion between counterfeit and generic medicines. The judge looked at a number of provisions of the Intellectual Property Act and at international statutes on the right to life.
Justice Wendoh also noted that women and children would be the most affected if the act's provisions regarding generic medicine came into force. Section 9 of the Children's Act guarantees children the right to health.
The ruling suspends the Anti-Counterfeit Agency's powers to interfere with the importation and distribution of generic medicines in Kenya. Generic medicines make up 90 percent of medicines consumed in Kenya.
Reacting to the victory, one of the petitioners, Patricia Asero, said that the judge understood the agony they would undergo if the act was implemented: "We are happy that people living with HIV and AIDS will now have access to drugs while we await the main ruling."
Health Action International (HAI) Africa also welcomed the ruling. HAI Africa is a network of organisations and individuals involved in health and pharmaceutical issues that promote health as a fundamental human right.
"This ruling keeps the window of opportunity open for those in need of more affordable generic medicines. While the constitutional court case is yet to be fully determined, this ruling has reinforced people's call that public interest and human rights must be carefully considered before enacting and implementing any law," said Gichinga Ndirangu, regional coordinator at HAI Africa.
Rose Kaberia, coordinator of the International Treatment Preparedness Coalition in East Africa, said in a statement that the "ruling recognises the potential danger posed to public health by the anti-counterfeit legislation and is a significant step in the struggle for access to more affordable generic medicines for all Kenyans".
The act will still be applicable to other goods, such as soaps, detergents, food products, alcoholic beverages and dry cell batteries. The Anti-Counterfeit Act 2008 does not distinguish medicines from other goods.
Medicines are essential and life-saving and should be distinguished from non-essential goods such as DVDs and batteries, said Christa Chepuch, programmes director at HAI Africa. It is not known when the case will be heard and determined in full. The Constitutional Court will provide hearing dates in due course.