A landmark judgement and a victory for patient activist groups but how will pharma MNCs react?
UNAIDS, Médecins Sans Frontières, Health Action International Africa, and the Kenya Legal and Ethical Issues Network on HIV and AIDS have issued statements praising the decision and hoping that other East African nations who were contemplating similar anti-counterfeiting laws follow Kenya’s lead.
Considering that Indian generic companies are major suppliers of generic HIV medication to many East African nations, there is no doubt that this judgement will be hailed as a positive step forward.
At the heart of the legal tussle is the interpretation of the terms ‘generic’ and ‘counterfeit’ and the fact that they are used interchangeably, resulting in the seizure of shipments of generic drugs while in transit. The petitioners cited examples like the December 2008 episode where authorities in the Netherlands seized shipments of generic drugs for HIV destined for Brazil.
Anand Grover, the United Nations Special Rapporteur for Health, who joined as an Interested Party in the case, made the point that the definition of ‘counterfeiting’ within the Kenya Anti-Counterfeit Act, 2008 “effectively conflates generic medicines with medicines which are produced in violations of private intellectual property rights, and this conflation of legitimately produced generic medicines with those that possibly violate intellectual property rights is likely to have a serious adverse impact on the availability, affordability and accessibility of low-cost, high-quality medicines.”
The Judge conceded that while intellectual property rights should be protected, where there is the likelihood that their protection will put in jeopardy the right to life of others, they must give way to the fundamental rights of citizens like the petitioners.
The Judge agreed with the petitioners that the definition of ‘counterfeit’ in section 2 of the Act is likely to be read as including generic medication and therefore ruled that the Kenyan state authorities have to “reconsider” these provisions “alongside its constitutional obligation to ensure that its citizens have access to the highest attainable standard of health and make appropriate amendments to ensure that the rights of petitioners and others dependent on generic medicines are not put in jeopardy.”
But the battle is far from over. While the activists have vowed to pressurise the Kenyan government to make the necessary changes in the Act, there will no doubt be other interest groups pulling the government in the opposite direction. Will there ever be a win-win solution to this legal conundrum?
Viveka Roychowdhury
Editor