Kenya Pharmaceuticals Distributors Association is faulting the Anti Counterfeit authority for usurping powers that will see it regulate the importation of medicine and other essential medical products.
The medical products and health technologies are highly regulated under the National Regulatory Authority.
The pharmacy and Poisons Board is anchored under the Pharmacy and Poisons act cap 244.
Kenya is desirous of manufacturing Human vaccines it’s imperative to allow the country to be able to manufacture vaccines. For export the National Regulatory Authority system must reach WHO maturity level three which means a stable and consistent regulatory environment. The WHO assessed Kenya in June 24th to July 1st 2022 and one of the issues that was raised is overlay of authority between government agencies.
“We have been informed that the Anti-counterfeit Authority will require distributors of medicine to buy excise stamps or something similar and affix them to all medicines imported into Kenya, this is a particularly cruel way to treat the sick and the dying by charging them a sin tax.Anti-counterfeit Act 34(13)The Anti-counterfeit Authority wants “to start implementation of these rules with the pharmaceutical industry as a priority”BackgroundThe Recordation rules seeks to create new offences that will not only hurt business (including e-commerce) but also criminalize doing legitimate business. It also creates another layer of registration of intellectual property rights which is totally unnecessary in light of existing laws.
Challenges criminalization of legitimate business The recordation rules makes it an offence to import goods into Kenya goods which bear brands that have not been recorded by the ACA. This means, for instance, 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 ACA.Usurpation of KIPI mandateACA has taken over the role of KIPI as the only statutory body mandated by law and equipped with resources to examine and register brands.
ACA should only ask for evidence registration of IP and should force a second registration of brands by ACA. The proposed changes will increase cost of doing business and severely reduce the ease of doing business in Kenya.ACA Violating IP ownership by subjecting registered IP to restrictionsThe Recordation requirements overlook the fact that based on international conventions to which Kenya is a party, the enjoyment of copyright cannot be subjected to any form of restrictions such as the proposed recordal.Prohibition of unbranded products.
The Recordation rules seeks to make the importation of unbranded goods illegal except for raw materials. This is a curious and oppressive provision which is going to stifle business in many goods that are generally imported and sold unbranded such as shoes, clothes, utensils, ornaments, etc. Unbranded non-proprietary medicines are at the core of the supply of affordable medicines to the republic of Kenya and the blanket prohibition of importation of these medicines will seriously prejudice the citizens of Kenya. Not only will the rules prevent access to essential affordable medicine, they will cause an astronomical increase in the price of those medicines which will be available. This is in complete violation of the people’s constitutional right to the highest attainable standard of health as contemplated by article 34(a)1 of the constitution of Kenya 2010.
The recordal rules also overlooks the fact that intellectual property rights are private rights and no one can be forced to use or register a brand in order to trade in any kind of goods. Additionally Unbranded medicines do not infringe anybody’s intellectual property rights and ought not to be banned. Furthermore, some trade marks may have expired or may simply be unregistrable for any number of reasons. Copyright may also have fallen into the public domain and become unprotectable. It is therefore not sensible to require all goods to bear registered brands in order to be imported into Kenya.Exhaustion of IP Rights.
All trademark rights are deemed to be exhausted once products are placed on the market. The recordation rules propose to enforce non-existent intellectual property rights even after they have been exhausted. For example when Toyota Japan manufacturers a Land Cruiser and sells to someone in Japan, that buyer from Japan should not be prevented by recordation rules from selling the same car to a Kenyan citizen as a second hand car. This is because Toyota exhausted their trade mark rights when they sold the car in first instance. On the other hand our trademarks law is correct on this issue – Trademarks Act Section 7(3)a. It provides that such an event is not an infringement. Recordation period is impractical
We are surprised that recorded last only for 12 months and brand owners are required to repeat the entire process every year for all their brands. This is not only tedious but very expensive for the importation of medicine Conclusion Our view is that Ministry of Health, through PPB has put in place adequate measures to prevent counterfeits including. No further intervention is required for the pharmaceutical industry.
The measures are as follows1) GMP Inspection of manufactures – USD 80002) Technical evaluation of products –USD 1000 (now USD 5000)3) Annual Retention – USD 300 pa4) Proactive Pharmacovigilance The risk for counterfeits in legitimate businesses is practically zero. Counterfeits find their way into the country through unregulated contraband, that is is Customs and Borders issue which should impact negatively on legitimate trade in pharmaceutical products by regulated stakeholders. The pharmaceutical industry should exempted from the oppressive recordation rules.