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.
Medical products and health technologies are highly regulated by the National Regulatory Authority. The pharmacy and Poisons Board is anchored under the Pharmacy and Poisonous act cap 244.
Kenya is desirous of manufacturing Human vaccines it’s imperative to allow the country able to manufacture vaccines.
For export, the National Regulatory Authority system must reach WHO maturity levels three which means a stable and consistent regulatory environment.
The WHO assessed Kenya from June 24th to July 1st, 2022 and one of the issues that were raised is an 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 seek to create new offenses 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 make it an offense to the importation of goods into Kenya goods that 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 offense 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 of registration of IP and should force the second registration of brands by ACA.
The proposed changes will increase the cost of doing business and severely reduce the ease of doing business in Kenya.
ACA Violating IP ownership by subjecting registered IP to restrictions 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 record.
Prohibition of unbranded products Recordation rules seek to make the importation of unbranded goods illegal except for raw materials.
This is a curious and oppressive provision that 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 the importation of these medicines will seriously prejudice the citizens of Kenya. Not only will the rules prevent access to essential affordable medicine, but they will also 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 overlook 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 on anybody’s intellectual property rights and ought not to be banned.
Furthermore, some trademarks 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 RightsAll trademark rights is 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 manufactures a Land Cruiser and sells it 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 secondhand car. This is because Toyota exhausted its trademark rights when it sold the car in the first instance.
On the other hand, our trademark law is correct on this issue Trademarks Act Section 7(3)a. It provides that such an event is not an infringement.
The recordation period is impractical We are surprised that recordal 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 medicineConclusionOur view is that the 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 PharmacovigilanceThe risk for counterfeits in legitimate businesses is practically zero.
Counterfeits find their way into the country through unregulated contraband, which is Customs and Borders issue that should impact negatively legitimate trade in pharmaceutical products by regulated stakeholders.
The pharmaceutical industry should be exempted from the oppressive recordation rules.
