The Kenyan Anti-Counterfeit Act adopted in December 2008 contained an excessively broad definition of what constitutes a ‘counterfeit’ product that had the potential to include legally-manufactured generics. As such, legally manufactured and/or imported generic medicines of approved quality may be erroneously interpreted as ‘counterfeits’ because of the provisions of this Act.
In 2009, three people living with HIV filed a constitutional challenge in the High Court of Nairobi (Patricia Asero Ochieng and 2 Others v. the Attorney General & Another) on the grounds that their fundamental right to life, human dignity and health are threatened by the enactment of the Anti-Counterfeit Act, 2008.
The decision has just been made public. The court has held, that three sections of the Kenya Anti-Counterfeit Act, 2008 are unconstitutional, infringing the petitioners right to life, dignity and health. These three sections are Section 2 (definition of counterfeiting), section 32 (offenses) and Section 34 (Powers of the Commissioner to seize suspected counterfeit Goods) of the Anti-Counterfeit Act, 2008.
The Judge observed –
On the definition of counterfeit in para 78:
“In my view, the definition of ‘counterfeit’ in section 2 of the Act is likely to be read as including generic medication. I would therefore agree with the Amicus that the definition ‘would encompass generic medicines produced in Kenya and elsewhere and thus is likely to adversely affect the manufacture, sale, and distribution of generic equivalents of patented drugs. This would affect the availability of the generic drugs and thus pose a real threat to the petitioners’ right to life, dignity and health under the Constitution.”
According to the decision, the Kenyan Government is required to reconsider the provisions of section 2 of the Anti-Counterfeit Act and make appropriate amendments to ensure that the rights of petitioners and others dependent on generic medicines are not put in jeopardy (See para 88).
The decision also highlights that the anti- counterfeiting law does not only pose a threat for access to generic medicines, but also diverts attention and much needed resources from where action is most needed to ensure patients receive quality drugs. According to the Judge – ” 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 what the respondents have submitted is the purpose behind the Act: the protection of the petitioners in particular and the general public from substandard medicine. Protection of consumers may have been a collateral issue in the minds of the drafters of the Act (see para 83).”
The decision is also important on the broader question of law – can the enforcement of IP rights constitute a legitimate limitation to fundamental rights? In the coming years, the decision will be an important legal precedent in developing countries as the court has clearly ruled that, “While such intellectual property rights should be protected, where there is the likelihood, as in this case, that their protection will put in jeopardy fundamental rights such as the right to life of others, I take the view that they (IP rights) must give way to the fundamental rights of citizens (para 86)”.
See the court decision here.