Tuesday 6 April 2010

Darren Olivier

Kenyan anti-counterfeit legislation debate

My earlier post concerning the Anti-Counterfeiting Act challenge in Kenya here, has lead a number of useful responses. The first is copied below as the writer wishes to be anonymous:

"The Kenya Anti-Counterfeiting Act says “counterfeiting means taking the following actions without the authority of the owner of intellectual property right subsisting in Kenya or elsewhere in respect of protected goods – (d) in relation to medicine, the deliberate and fraudulent mislabelling of medicine with respect to identity or source, whether or not such products have correct ingredients, wrong ingredients, have sufficient active ingredients or have fake packaging” (my emphasis). Do you interpret this definition of counterfeit medicine as including legitimate generics? [Darren Olivier - no I do not] Again, the definition in the Act is almost identical to the official WHO definition counterfeit medicines.
From my basic understanding of the Act, I believe that the definition is fine, and that the real potential problem is that the Kenyan Revenue Authority (and other inspectors under this Act)will need training and established procedures to be able to quickly and efficiently tell the difference between legitimate drugs (both branded and generic) and counterfeits. Delay in releasing legitimate generic or branded drugs may occur if the KRA is unable to quickly identify legitimates from counterfeits. From what I’ve heard, the Kenyan Government is aware of this need for training and procedures. It seems that the activists – rather than trying to obfuscate the issue by claiming that the Act is “vague” – should be calling for the Govt of Kenya to put in place adequate resources and systems to ensure that their inspectors are able to implement the Act properly."
Further comment would be appreciated. Paul, David?

Darren Olivier

Darren Olivier

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Asiimwe Paul
6 April 2010 at 12:35 delete

Darren, I agree with you entirely. My view is that there has been a pursuit of extreme positions from both sides of the coin which is needless.

There is need to establish some kind of inter institutional committee that will guide application of the new law in the first 2-3 years, as procedures are better understood. This would cover staff in the standards authority, KIPI as well as the revenue authority. This mechanism should be quick and efficient to reduce any bottlenecks in the interpretation of the law and regulations.

In the very last resort, local manufacturers can always invoke the compulsory licensing provisions available under the Kenyan Industrial Property Act and the TRIPS agreement.

Graham Dutfield
6 April 2010 at 14:20 delete

I think the definition is horrible and am with the activists on this. I don’t see any obfuscation on their part; obfuscation is there for all to see in the statute. According to this law, "counterfeiting" means taking certain defined actions without the authority of the owner of an IP right subsisting in Kenya or elsewhere in respect of protected goods - in this case medicines (and excuse me, aren’t IP rights normally territorial?). So the authorities are supposed to determine whether or not a drug is counterfeit on the basis of whether there are trade-marks or other IP rights somewhere in the world which control identity and source of the drug. The main obfuscation lies in this phrase: “… without the authority of the owner of intellectual property right subsisting in Kenya or elsewhere in respect of protected goods”. It seems to me bad policy to make being a counterfeit depend in the first instance on the authority of a private right owner. It’s a matter of public safety.

By tying the legislation to IP, a number of acts will not be covered, apparently. The most negligent failing of the law is not to cover a generic drug that is fake or adulterated but does not violate any IP rights. Since such a product is not captured by the first part of the definition (ie the text prior to the subordinate point (d)), one may interpret the law as indicating that such a drug is not a counterfeit under the definition.

What about the issue of originator and authorised firms selling poor quality versions of their own drugs? I have heard this can happen. And what about a company making a false claim to have IP rights in relation to the identity and origin of a drug in a country, especially one where it would be difficult to verify the veracity of the claim? (Fraudulent claims to IP ownership may be covered by another part of the law, though I’m doubtful it is.) And so far I’ve said nothing about whether this definition could be construed to include patent protection…

8 April 2010 at 11:07 delete

My two cents about this discussion on the Act and its position on generics:
I disagree with the above two positions, and Darrens', as far as they say generics are not counterfeits as captured by the Act's definition, thought I am inclined to agree that IP enforcement ought to fall within the mandate of IP bodies such as KIPI.The solution to the counterfeit problem therefore lies in the Anti-Counterfeiting Agency working with these institutions (Its probably a good start that KIPI and this Agency both fall under the Ministry of Industrialisation).

I have been musing over it for a bit, and I think the definition of counterfeiting under the Act does encompass most 'legitimate' generics.
Many generics drugs are manufactured without authorisation of the owner of the IP made use of
in such manufacture. This, I think, makes such generics to fall squarely within the definition of counterfeiting. The only instance I
can think of where generic drugs are not counterfeits as provided
under the Act is when they do not infringe on existing IP rights ie

1. When, for example, the term of the patent for the drugs or their process has expired, or otherwise invalidated;
2. When the generics have been manufactured with the consent of the
owner of the IPR involved, say by a licensing agreement.

Still musing....