Kenyan HIV activists say a ruling by the High Court that the definition of "anti-counterfeit" in the 2008 Anti-Counterfeit Act is too broad will save millions of lives and protect the right to life of citizens.
The case filed by three people living with HIV in July 2009 argued that sections 2, 32 and 34 of the Act contained ambiguities, which, if misinterpreted or abused, would be detrimental to Kenyans' access to essential generic medicines.
High Court Judge Mumbi Ngugi found that the Act failed to clearly distinguish between counterfeit and generic medicines. She called on parliament to review these ambiguities that could result in the arbitrary seizure of generic medicines under the pretext of fighting counterfeit drugs.
Like many low- and middle-income countries, more than 80 percent of the drugs used by Kenyans are generic and largely manufactured in India. The judgement also ensures that government agencies cannot interfere with the importation and distribution of generic medicines.
"The right to life, dignity and health of people like the petitioners, who are infected with the HIV virus, cannot be secured by a vague proviso in a situation where those charged with the responsibility of enforcement of the law may not have a clear understanding of the difference between generic and counterfeit medicine," she said in her judgement.
"As an interested party, this judgement was a victory for us because the judge specified that protecting intellectual property rights cannot override the interests and rights of the individual - it's a powerful message," Jacinta Nyachae, executive director of local NGO, the AIDS Law Project (ALP), told IRIN/PlusNews. "She [Judge Ngugi] found that the wording of the Act was unconstitutional and a threat to the right to life, dignity and health."
With advice of the Attorney General, the minister concerned will be expected to amend the Act to reflect the judgment.
UNAIDS executive director Michel Sidibé welcomed the decision. "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," he said. "This decision will set an important precedent for ensuring access to life-saving drugs around the world."
Kenya has not had a case where patients were denied access to generic drugs as a result of the Act, but ALP's Nyachae noted that generic drugs bound for Africa had been held in Europe in the past, which formed the basis for the case. In 2009 a shipment of drugs headed to Nigeria was held at The Netherlands' Schipol Airport on the grounds that they violated patent rights.
Uganda and Tanzania currently have draft anti-counterfeit bills. "We are working to ensure that the text of the law is not as vague as that of the Kenyan Act," Nyachae noted.
James Kamau, coordinator of the Kenya Treatment Access Movement, said the judgement is historic and protects not just Kenya, but the entire eastern African region.
"Uganda, Rwanda, Burundi, and so on - all the countries that depend on Kenyan ports to import their drugs - have now been shielded from the threat of being denied access to vital generics as a result of the ruling," he told IRIN/PlusNews. "We hope to see a ripple effect, where countries will pick up on this ruling and adapt it to protect their own citizens."
"Even in Kenya this judgement is not just important for people living with HIV, but to all 42 million Kenyans, who depend on generics to treat all kinds of illnesses,” Kamau said. “It extends well beyond ARVs [antiretrovirals] and to drugs for opportunistic infections and all other diseases."
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The case filed by three people living with HIV in July 2009 argued that sections 2, 32 and 34 of the Act contained ambiguities, which, if misinterpreted or abused, would be detrimental to Kenyans' access to essential generic medicines.
High Court Judge Mumbi Ngugi found that the Act failed to clearly distinguish between counterfeit and generic medicines. She called on parliament to review these ambiguities that could result in the arbitrary seizure of generic medicines under the pretext of fighting counterfeit drugs.
Like many low- and middle-income countries, more than 80 percent of the drugs used by Kenyans are generic and largely manufactured in India. The judgement also ensures that government agencies cannot interfere with the importation and distribution of generic medicines.
"The right to life, dignity and health of people like the petitioners, who are infected with the HIV virus, cannot be secured by a vague proviso in a situation where those charged with the responsibility of enforcement of the law may not have a clear understanding of the difference between generic and counterfeit medicine," she said in her judgement.
"As an interested party, this judgement was a victory for us because the judge specified that protecting intellectual property rights cannot override the interests and rights of the individual - it's a powerful message," Jacinta Nyachae, executive director of local NGO, the AIDS Law Project (ALP), told IRIN/PlusNews. "She [Judge Ngugi] found that the wording of the Act was unconstitutional and a threat to the right to life, dignity and health."
With advice of the Attorney General, the minister concerned will be expected to amend the Act to reflect the judgment.
UNAIDS executive director Michel Sidibé welcomed the decision. "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," he said. "This decision will set an important precedent for ensuring access to life-saving drugs around the world."
Kenya has not had a case where patients were denied access to generic drugs as a result of the Act, but ALP's Nyachae noted that generic drugs bound for Africa had been held in Europe in the past, which formed the basis for the case. In 2009 a shipment of drugs headed to Nigeria was held at The Netherlands' Schipol Airport on the grounds that they violated patent rights.
Uganda and Tanzania currently have draft anti-counterfeit bills. "We are working to ensure that the text of the law is not as vague as that of the Kenyan Act," Nyachae noted.
 We hope to see a ripple effect, where countries will pick up on this ruling and adapt it to protect their own citizens |
"Uganda, Rwanda, Burundi, and so on - all the countries that depend on Kenyan ports to import their drugs - have now been shielded from the threat of being denied access to vital generics as a result of the ruling," he told IRIN/PlusNews. "We hope to see a ripple effect, where countries will pick up on this ruling and adapt it to protect their own citizens."
"Even in Kenya this judgement is not just important for people living with HIV, but to all 42 million Kenyans, who depend on generics to treat all kinds of illnesses,” Kamau said. “It extends well beyond ARVs [antiretrovirals] and to drugs for opportunistic infections and all other diseases."
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This article was produced by IRIN News while it was part of the United Nations Office for the Coordination of Humanitarian Affairs. Please send queries on copyright or liability to the UN. For more information: https://shop.un.org/rights-permissions
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