[e-drug] HAI Africa update on the Kenyan Anti-Counterfeit Bill

E-DRUG: HAI Africa Kenya update: amended Anti-Counterfeit Bill to be passed into law
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Dear all

Last week, Kenya's parliament agreed to pass the Anti-Counterfeit Bill 2008
into law. The Bill is now awaiting the final reading in parliament before
its assent by the President. This is likely to happen before the year ends;
Kenya's parliament adjourns for the holidays tomorrow.

If the Bill becomes law (which is imminent), then Kenya's definition of
counterfeiting will be as follows:

*< ... "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*

*a) the manufacture, production, packaging, re-packaging, labelling or
making, whether in Kenya or elsewhere, of any goods whereby those protected
goods are imitated in such manner and to such a degree that those other
goods are identical or substantially similar copies of the protected goods;*

*b) the manufacture, production or making, whether in Kenya or
elsewhere, the subject matter of that intellectual property, or a colourable imitation thereof so that the other goods are calculated to be confused with or to be taken as being the protected goods of the said owner or any goods manufactured, produced or made under his licence;*

*c) the manufacturing, producing or making of copies, in Kenya or
elsewhere, in violation of an author's rights or related rights;*

*d) in relation to medicine, the deliberate and fraudulent mislabeling
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: *

*Provided that nothing in this paragraph shall derogate from the existing
provisions under the Industrial Property Act." ... > *

The Bill as approved by parliament incorporates some of the amendments for
which civil society has been pushing. For example, (d) is
an amendment intended to protect access to medicines. Another
important amendment is one which ensures the national medicines regulatory
authority (the Pharmacy and Poisons Board) is recognized in its role
to combat counterfeit medicines, both in terms of surveillance as well as
representation in the Board of the Anti-Counterfeiting Agency, a new body to be established under the Bill.

However, some problematic text remains, notably (a) (b) and (c) which
confuses counterfeiting and patent infringement as we have noted in
our previous posts. We believe the problematic text is TRIPS Plus.
Another potential area of concern is that although the term "medicines" in WHO language appears to include diagnostics and vaccines, in Kenya law the term "medicines" does not include diagnostics and vaccines and thus, technically, these amendments do not protect diagnostics and vaccines from the danger of confounding counterfeiting with patent infringement.

Neighbouring countries often study Kenya's legislation as a model. Similar
anti-counterfeit legislations have been presented before parliaments in
Tanzania and Uganda. Presently, the civil society is monitoring the
legislative process in those countries.

Any comments you may have on the Kenya text as approved by parliament are
sincerely welcome.

kind regards
Peter Munyi, Christa Cepuch
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Health Action International (HAI) Africa
Africa Regional Office
www.haiafrica.org
christa@haiafrica.org

HAI is an independent, global network working to increase access to
essential medicines and improve their rational use through research
excellence and evidence-based advocacy