Counterfeiting and piracy are long-standing problems which have been growing in scope and magnitude in recent years, and thus contributing negatively to economic development. In this respect, Parliament passed the Anti-counterfeit Act 2008, with the principal aim of prohibiting trade in counterfeit goods.
The act came into force on July 1 2009, where upon three HIV/AIDS patients petitioned the Constitutional Court(1) to declare the act illegal because it could deny them access to generic medicines. The patients also argued that:
• Section 2 of the act fails to provide a clear definition of 'counterfeit medicine';
• generic medicines may be misinterpreted to imply that they are counterfeits; and
• Sections 2, 32 and 34 of the act do not take into account Section 58(2) of the Industrial Property Act, which allows the importation of generic drugs.
The court ruled that intellectual property should not override the right to life, right to health and right to human dignity outlined in the Constitution 2010.
The law defines 'counterfeit goods' under Section 2 to mean goods that are the result of counterfeiting and include any means used for the purposes of counterfeiting. Although the definition is vague, it is apparent from an analysis of the act that 'counterfeiting' in relation to medicine is "[t]he 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" without the authority of the IP rights owner subsisting in Kenya or elsewhere in respect of protected goods.
Generic medicines are distinguishable from counterfeit medicines. The World Health Organisation (WHO) defines 'generic medicine' as:
"a pharmaceutical product, usually intended to be interchangeable with an innovator product, that is manufactured without a licence from the innovator company and marketed after the expiry date of the patent or other exclusive rights."
On the other hand, WHO defines 'counterfeit medicine' as medicine which is deliberately and fraudulently mislabelled with respect to its identity and source.
Generic medicines are made using similar or sufficiently active and correct ingredients as the innovator company's medicine. They are also sold under a brand which is different from the innovator company's brand for the particular medicine. Generic medicines are equivalent versions of the original and provide the same quality, safety and efficacy as the original brand name product, having undergone strict scrutiny before they are licensed and given market approval by the relevant national medicines authority.
They are legally manufactured and sold with or without descriptive representations regarding origin, authenticity or effectiveness. They are not counterfeit medicines.
It is crucial to properly define 'counterfeit' in the act and further to draw the distinction between 'generic' and 'counterfeit' medicine, as there is a tendency for the definitions to be used erroneously in an interchangeable and contradictory manner.
Arguably, there is no reason why a company manufacturing generic drugs may not continue to do so provided it ensures that there is no deliberate or fraudulent mislabelling of the generic drug with regards to its identity or source.
For further information on this topic please contact Ken Muchiri at Njoroge Regeru & Company by telephone (+254 20 271 8482), fax (+254 20 271 8485) or email (email@example.com).
(1) Ochieng v The Republic, High Court Civil Suit 409/2009.