In brief, the Petitioners filed a Petition on 8 July 2009, seeking declarations that their fundamental rights under Sections 70 and 71 of the Constitution were likely to be infringed by the implementation of Kenya'a Anti Counterfeit Act (ACA) of 2008. They objected that it limited access to affordable and essential drugs, including generic medicines, for HIV/AIDS and that enforcement of the Act would infringe their right to life. They sought a stay of the coming into force of Sections 2, 32 and 34 of the ACA pending the hearing of the Petition, plus orders that the Anti Counterfeit (AC) Agency be restrained from enforcing those sections in so far as they related to generic drugs and medication as well as the importation of generic drugs and medicines.
This action was premised both on the notion that enforcement of the disputed provisions of the ACA would deny the Petitioners and others infected with HIV the right to access affordable and essential drugs and medication, thus jeopardizing the availability of generic drugs and medication and on the ground that Section 2 of the ACA failed to provide a clear definition of what a counterfeit is -- the problem being that generic medicines used by HIV sufferers can be misinterpreted to mean counterfeits. Additionally, it was maintained that the disputed sections of the ACA had taken no account of Section 58(2) of the Industrial Property Act, which allows importation of generic drugs.
7. The Judge noted that the Petitioners had submitted evidence that generic drugs for HIV, bound for Brazil, were being seized in the Netherlands, and that other drugs manufactured in India bound for Vanuatu were being seized in Germany. He said that Sections 58(2) and 37 of the IPA and Section 2 of the ACA were inconsistent. The law, he noted, was that if an existing statutory provision is inconsistent with a latter statute, then the latter (Section of the ACA) will take precedence (over section 58 of IPA).
The Judge held, without giving reasons for his belief, that Section 2 of the ACA did not appear to distinguish medicines from other goods and that one needs to consider the right to life as enshrined in Section 71 of the Constitution. Taking into account that women and children are said to be most vulnerable to HIV and AIDS, the ACA has to be read in conjunction with the Children’s Act and other international instruments on the rights of the child and women.
Further, the Judge found that failure to get access to affordable ARV drugs and medicines will obviously affect adversely those infected with HIV and AIDS and many risk loosing their lives.
In conclusion, after finding that the Petitioners had sufficiently demonstrated that the Petition was not frivolous but disclosed an arguable case with a chance of success, he granted an injunction staying Section 2, 32 and 34 of the ACA as relates to the importation of generic drugs and medication and an injunction in the interim restraining the AC Agency from enforcing those sections as relates to importation of generic drugs and medication.
This decision has been criticised for its failure to analyze Section 2 properly and, more specifically, to discuss the issue of mislabelling visa-vis ARV drugs, which are generics. The issue would be whether, under Section 2, all legitimate generic medicines would be deemed counterfeits. At present it is a fact that one can find counterfeit generics circulating in a market which has legitimate generics.