Drug suppliers lobby Kenya Pharmaceutical Distributors Association (KPDA) has moved to court seeking to slam the brakes on a looming generic medicines ban.
This follows Anti-Counterfeit Agency (ACA) regulations that KPDA says criminalise the importation of generic medicines through implementation of the Intellectual Property Rights (IPR) recordation slated for January 1.
According to the lobby, the ban on the generic medicine trade will bar a majority of Kenyans from accessing affordable medicine and infringes on various constitutional rights.
ACA aims to create a database of intellectual property information for goods imported into the country for commercial purposes as a way of fighting illicit trade.
"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," says KPDA, which is the first petitioner.
"This means that a brand owner whose trademarks are already registered under the Trade Marks Act will be committing an offence by importing those same goods unless the brand has been recorded with the first respondent."
"This creates unnecessary bottlenecks which stifle trade, particularly in medicines and pharmaceutical products with the effect of violating the Petitioner's economic rights and consumer rights of the general public."
Parties named in the petition include KPDA Chairman Isaac Kamamia wa Murichu (second petitioner), ACA (first respondent), the Attorney General (second respondent) and Trade Cabinet Secretary (third respondent).
The Kenya Industrial Property Institute (KIPI) and the Pharmacy and Poisons Board are listed as interested parties. The implementation of the IPR had been scheduled for July this year but ACA extended the deadline by six more months.
KPDA expressed its reservations on the recording of its members who are licensed by the PPB to distribute medicines.
The lobby claims the exercise is intended to protect well-known brands that have intellectual rights.
It says ACA's move doesn't take into account that intellectual property rights of medicines have a shelf life, which is exhausted 20 years after the registration of the intellectual property rights "whereupon the exclusiveness of the patents cease to exist and other firms can go ahead and manufacture similar drugs."
KPDA says generics provide the same quality, safety and efficacy as the original branded products having been scrutinised and given market approval by PPB.