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Kenya: Court Orders Parliament to Review Law Threatening Access to Generic Medicine

(Apr. 25, 2012) On April 20, 2012, Kenya's High Court ordered the revision of the Anti-Counterfeit Act of 2008 on the grounds that in its current form the Act threatens access to affordable generic medicine. (Kenya Ruling Upholds Access to Generic Drugs, ANGOP (Apr. 21, 2012).) The ruling follows an April 2010 order that had temporarily suspended the implementation of the Act, which had come into effect in July 2009, with respect to generic medicine. (Kenya Court Set to Deliver Ruling on Anti-Counterfeit Law, THE PHARMALETTER (Jan. 27, 2012).)

At issue in the case was the definition of the term “counterfeiting” in the Act. Petitioners in the case, three people living with HIV, contended that the Act was unconstitutional because it violated their right to life by putting in danger their access to life-saving, affordable generic medicine. (Susan Anyangu-Amu, Anti-Counterfeit Law “Violates Right to Life and Health,” IPS (Dec. 21, 2009).) The petitioners submitted that the Act did that by adopting a broad definition of the term “counterfeiting” that lumps together generic and fake medicine. (ANGOP, supra.) According to the Act, counterfeiting, among other things, includes:

…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…(Act No. 13 of 2008 – Anti-Counterfeit Act, § 2, Cap. 13, Kenya Law Reports website [conduct search for Anti-Counterfeit Act in Laws of Kenya database].)

The Court sided with the petitioners. In her ruling, Judge Mumbi Ngugi wrote that the Act “is vague and could undermine access to affordable generic medicines,” and called on the Parliament to “remove ambiguities that could result in arbitrary seizures of generic medicines under the pretext of fighting counterfeit drugs.” (Kenyan High Court's Overturning of Anti-Counterfeit Law Hailed, INTELLECTUAL PROPERTY WATCH (Apr. 21, 2012).) The Court further observed that intellectual property rights should not prevail over the right to life and health. (Phil Taylor, Kenya Set to Repeal Controversial Anti-Counterfeit Law, SECURING PHARMA (Apr. 23, 2012).)

The Joint United Nations Programme on HIV/AIDS (UNAIDS) praised the decision. In a statement it issued on the same day the ruling was handed down, UNAIDS commended the Court for a step “that will safeguard access to affordable and quality life-saving generic medicines.” (Press Statement, UNAIDS, UNAIDS Welcomes Kenya High Court Judgment on Anti-Counterfeit Law (Apr. 20, 2012).) The Programme's Executive Director, Michel Sidibé, stated that “[a] vast majority of people in Kenya rely on quality generic drugs for their daily survival. Through this important ruling, the High Court of Kenya has upheld a fundamental element of the right to health.” (Id.)

Of Kenya's some 40 million people, 1.5 million are said to be living with HIV, and only one-third of them have access to antiretroviral medications, most of which is generic. (ANGOP, supra.) Over 80% of the antiretroviral treatment that 6.6 million people in low- and middle-income countries depend on comes from generic manufacturers. (UNAIDS, supra.)