Impending court battle between drug suppliers, government over imminent ban on generic medicine

Lobbyists from the Kenya Pharmaceutical Distributors Association (KPDA) under the Chairmanship of Isaac Kamamia wa Murichu, have filed a petition in court to prevent the Anti-Counterfeit Agency (ACA) from enacting regulations that would prohibit the importation of generic medications through the implementation of the Intellectual Property Rights (IPR) recordation.

The deadline for the move was originally set for July this year, but the ACA extended it by six more months until January 1, 2023.

KPDA, the first petitioner, claims in an affidavit that the ban on the trade of generic medications by ACA (first respondent), the Attorney General (second respondent), and the Trade Cabinet Secretary (third respondent) violates a number of constitutional rights and will prevent majority of Kenyans from accessing affordable medication.

“The petitioners aver that the first respondent’s directives criminalise the legitimate business of members of the first petitioner because it makes it an offence to import goods into Kenya, which bear brands that have not been recorded by the first respondent,” part of the KPDA petition reads.

The Pharmacy and Poisons Board (PPB) and the Kenya Industrial Property Institute (KIPI) have been mentioned as interested parties.

In order to combat illicit trade, ACA intends to create a database of intellectual property information for goods imported into the country for commercial purposes.

This means that if a brand owner whose trademarks are already registered under the Trade Marks Act imports those same goods without having the brand associated with them, they are breaking the law.

As it expressed its concerns about the recording of its members who are licensed by the PPB to distribute medicines, KPDA insisted that the move is likely to create unnecessary bottlenecks that stifle trade and protect well-known brands that have intellectual property rights, particularly in medicines and pharmaceutical products, with the effect of violating the ACA economic rights and consumer rights of the general public.

In their submissions, the move by ACA has been criticised by lobbyists as being irresponsible toward the intellectual property rights of medicines with a shelf life that expires 20 years after the registration of the intellectual property rights, despite the fact that generic versions of branded products offer the same level of quality, safety, and efficacy as the original products, which have undergone testing and received PPB market approval.

“Whereupon the exclusiveness of the patents ceases to exist and other firms can go ahead and manufacture similar drugs,” reads part of the affidavit.