Health activists working in Kenya have welcomed the April 2012 decision by the Kenyan High Court, which ruled that that the country’s Anti-Counterfeit Act 2008 was ‘vague’ and could undermine access to affordable generic medicines. The ruling means that Parliament will now have to review the Act and amend sections that confuse generic medicines with counterfeits and remove ambiguities that may result in arbitrary seizures of generic medicines under the guise of fighting counterfeits. The organisations signing this joint statement have vowed to press for those changes to protect access to generic medicines. They hope this ruling will set a positive precedent for the East Africa region as other countries in the region are considering anti-counterfeiting laws that may threaten generics.
Health equity in economic and trade policies
An influential manufacturers’ lobbying group in Kenya is pushing the government to start enforcing an anti-counterfeiting law, despite fears from public health advocates that the new rules will impede access to generic drugs and set an unwanted precedent in East Africa. The Kenya Association of Manufacturers (KAM) says it wants the Anti-Counterfeit Act to be implemented as soon as possible and has been in talks with the government to make sure that happens. The law was passed last year but has not yet taken effect because of budgeting and procedural delays. The association claims that counterfeits cost companies 50 billion shillings (US$650 million) and the government 19 billion shillings (US$250 million) in taxes in 2008. Yet public health advocates argue that the Act’s definition of what constitutes a counterfeit product is too vague and could be used to block the import and local manufacture of generic drugs. Civil society organisations also want the two issues of counterfeiting and patent rights to remain separate.
Kenyan authorities are probing who in government may have been “compromised” by the pharmaceutical industry to try strip the African country of its right to produce medicines without patent-holder approval. There have been repeated efforts to delete parts of Section 80 of the Industrial Property Act, which was enacted in 2001. It enabled the government to issue compulsory licenses to local manufacturers to produce generic versions of pharmaceuticals, such as antiretrovirals for HIV/AIDS patients, without seeking approval from the drug company that holds the patent rights.
A landmark case has entered the Kenyan corridors of justice as a group of farmers and a human rights watchdog move to challenge the State over ongoing negotiations for a new trade agreement with Europe. Kenya Human Rights Commission (KHRC), a non-governmental organisation, and small-scale growers contend that though the process of the negotiations for a new Economic Partnership Agreements (EPAs) between Kenya and its key trade partner is of national concern, the State has failed to exhaustively involve all those who stand to be adversely affected by the pact.
Kenya, the third-biggest African market for Indian medicines, is planning a new legislation against ‘counterfeiting’ that could seriously jeopardise India’s medicine exports to that country. Domestic industry fears that other African nations may follow suit. The Anti-Counterfeit Bill, 2008, placed before the Kenyan parliament recently, indicates that copies or generic versions of all products having patent protection in Kenya or elsewhere can be considered ‘counterfeit’ in case of an intellectual property dispute. Since a majority of medicines manufactured by Indian companies are under patent protection in some country or the other (though they do not enjoy patent protection in India or Kenya), the definition, in its current form, can be misused to delay or prevent supply of low-cost generic medicines to Kenya, industry experts fear.
Kenya is facing a nationwide shortage of anti-retroviral (ARV) drugs after a court case held up the purchase of the life-prolonging medication. The High Court in the capital, Nairobi, barred the Ministry of Health from procuring ARVs after a consortium of drug suppliers challenged the tender process earlier this month. According to James Ole Kiyapi, permanent secretary in the Ministry of Public Health, unless the court allows the government to purchase ARVs, there is a real risk that people who depend on government hospitals for their medication could go without. ‘We have very little medicine left and there is nothing we can do to get the drugs because we have to abide by the court order; we can do very little at the moment unless the court reverses the order,’ he said. Earlier this year, the Public Procurement Review Board (PPRB) – responsible for monitoring the government's purchases – issued an order forcing the Kenya Medical Supply Agency (KEMSA) to accept tender documents by an Indian company, Hetero Drugs Limited, and start the tender process afresh. KEMSA had rejected the company's tender documents because they allegedly did not comply with procurement rules. The consortium that originally won the controversial tenders has now gone to court to reverse the order of the PPRB.
The United Nations has been enjoined in a court case in Kenya case challenging a potential threat to supply of generic drugs for HIV and AIDS. It claimed enforcement of the Anti-Counterfeit Act 2008 would endanger the lives of people infected. The High Court in Nairobi heard those affected would not access affordable and essential drugs. The UN Special Rapporteur indicated his wish to intervene as an interested party to support the constitutional principles of access to essential medicines, according to advocate Ombati Omwanza. Justice Daniel Musinga allowed Anand Grover to represent the UN in the suit. The court allowed importation of generic anti-retrovirals, pending the hearing and determination of this case. The interim order issued in April 2010 was aimed at saving the lives of those living with the virus. The judge’s interim order stopped the implementation of three sections of the new Anti-Counterfeit Act.
The United Nations (UN) has been enjoined in a case that claims that enforcement of the Anti-Counterfeit Act 2008 would endanger lives due to limits to access to affordable and essential drugs. The Special Rapporteur from the UN, Mr Anand Grover, intervened in the suit as an interested party to support the constitutional principles of access to essential medicines. The court allowed the importation of generic anti-retrovirals (ARVs), pending the hearing and determination of this case. The interim order issued in April 2010 was aimed at saving the lives of those living with the virus by stopping implementation of three sections of the new Anti-Counterfeit Act, which was enacted by Parliament in 2008. While the objective of the Act was to prohibit trade in counterfeit goods, advocate Omwanza told the court if implemented the clauses would deny people using ARVs access to affordable and essential medication necessary for their fulfillment of the right to life, as enshrined in the Constitution. Although generic drugs for the treatment of HIV and AIDS are available and affordable, the advocate argued that if implemented the clauses would force government to buy more expensive branded medicines.
The High Court of Kenya has ruled that the country’s 2008 Anti-Counterfeit Act was too ‘broad’ and could interfere with the flow of legal generic medicines to patients. The landmark ruling stated that ‘the Act is vague and could undermine access to affordable generic medicines since the Act had failed to clearly distinguish between counterfeit and generic medicines.’ High Court Judge Mumbi Ngugi called on Kenya’s Parliament to review the Act and remove ambiguities that could result in arbitrary seizures of generic medicines under the pretext of fighting counterfeit drugs. She also said that intellectual property rights should not override the right to life and health. She specifically found that Section 2 (definition of counterfeiting), section 32 (offenses) and Section 34 (Powers of the Commissioner to seize suspected counterfeit Goods) could severely limit or threaten access to affordable and essential drugs including generic medicines for HIV and AIDS and therefore infringed the right to life, dignity and health of the three Petitioners (all people living with HIV/AIDS) under the Constitution of Kenya, 2010.
A group of university students under the group The Journey and Haven Entertainment organised a conscious hip hop festival to oppose the proposed Economic Partnership Agreements (EPAs) between the European Union and Africa. This effort is part of a wider campaign by citizens, farmers' unions, civil society, and religious groups to stop the government from signing the proposed agreement which, according to economists and experts in international trade, are potentially detrimental to the development agenda and may exacerbate poverty in Kenya and other developing countries.