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.
Health equity in economic and trade policies
In this brief, the Centre for Health Human Rights and Development (CEHURD) argues that anti-counterfeit measures are not an appropriate policy measure for curtailing the spread of substandard and falsified products, including medicines. The likely impact of the draft EAC Anti-Counterfeit Bill (2010) will be huge implementation costs through monitoring and settling international trade disputes. In addition, intellectual property rights (IPR) border controls and criminalising possession and trade in IPR infringing goods deters overall trade, in both IPR infringing goods and non-infringing goods. CEHURD notes that IPR-related “anticounterfeiting” action in the form of confiscated shipments of generic medicines reveals a pro-IPR bias and is being used to disrupt the flow of generics to developing countries instead of addressing more important issues of quality, safety and efficacy of generic medicines. The brief highlights the importance of distinguishing between generics, substandard medicines and counterfeit medicines. The TRIPS Agreement uses the term “counterfeit” only in the context of criminal trademark infringements that are wilful and on a commercial scale. CEHURD argues that there is a critical need to find legislative and policy approaches that would reduce the spread of such illicit, unregistered, and unsafe products without hindering access to good quality, safe and efficacious medicines - particularly legitimate and affordable generics of assured quality.
This article provides a local legal analysis of the ruling from the Kenyan High Court case in April 2012, where the judge found the Kenya Anti-Counterfeit Act was unconstitutional in hindering access to generic medicines, thereby undermining public health needs and the right to health of all Kenyans. The judge recommended the State reconsider and appropriately amend section 2 of the Anti-Counterfeit Act in a manner that ensures that the State fulfils its obligations to ensure that Kenyans have access to the highest attainable standard of health. The author of this article questions the usefulness of the Anti-Counterfeit law, arguing that the existing legal framework in Kenya was sufficient for enforcing intellectual property rights. He asks why Kenyan taxpayers should be paying for the implementation of this law as well as for the costs of running the Anti-Counterfeit Agency.
Uganda’s 2009 Industrial Property Bill needs to be reviewed before it is enacted into law, according to this brief by the Centre for Health Human Rights and Development (CEHURD). The review is needed to make full and maximum use of the flexibilities available in the TRIPS Agreement in order to guarantee public health, particularly access to essential medicines, for all Ugandans. CEHURD argues that, since Uganda is classified as a less-developed country, it is free to exploit all the flexibilities the TRIPS Agreement offers, and is required to adopt only the minimum levels of intellectual property rights (IPR) protection. The current bill contains unnecessary IPR protection over and above the minimum required by the TRIPS Agreement, and does not fully utilise flexibilities, CEHURD argues. A revised Industrial Property Act should promote Uganda’s public health interests by aiming to: develop the capacity at national level for production of generic medicines; allow the widest possible scope for parallel importation; adopt a simple and expeditious procedure for compulsory licensing and government use order; and allow extensive flexibility for scientific research and regulatory approval exceptions.
In this brief, the Centre for Health Human Rights and Development (CEHURD) outlines the current legislative environment affecting intellectual property (IP) rights in Uganda. The brief also considers the implications of the Industrial Properties Bill on the right to access essential medicines, a proposed piece of legislation that CEHURD argues will undermine efforts to manufacture generics in Uganda. It unnecessarily requires Government to consult the patent owner before producing generics for the public sector. It further requires applicants for a “compulsory license” to go through the lengthy court processes, yet procedures for granting such a licence should be simple and expeditious. Due to a lack of sufficient knowledge at the population level as well as Uganda’s weak negotiating position vis-à-vis other countries and negotiating blocs, CEHURD argues that the current laws and draft laws are not taking advantage of the TRIPS flexibilities, which would allow Uganda to fast track the supply essential medicines to the public sector.
There is a pressing need for Africa to bolster its pharmaceuticals industry, but it also requires the right policy framework, argues the author of this article. With limited initial capacity, countries need to be prudent about which drugs are developed. Different countries have different needs, and selection must be made through dialogue between government ministries, pharmaceutical companies, and local drug regulatory authorities. Good regulation is crucial, yet could prove most challenging. Many African states have patchy regulatory systems for quality assurance and little means to ensure drugs testing follows ethical guidelines. They will need to create and enforce watertight regulations to ensure that substandard or ineffective medicines don’t flood the market. But the development of a robust pharmaceutical industry in Africa can’t, and shouldn’t be, uniform, the author argues. States are extremely varied in their scientific ability, level of manufacturing regulation, and financial capacity to invest. She proposes that some countries could first set up a system to simply manufacture drugs based on existing formulations, before progressing to research and development. Others with more advanced biotech industries, such as South Africa, will have the know-how to innovate in drug development.
African ministers of mineral resources resolved, in a conference in Addis Ababa in December 2011, to move into action to reform Africa’s mining sector to benefit the African people. They set a brand new vision apparent in its action plan that includes these six points: Member States should reform the fiscal framework in order to optimise benefits from the mineral sector; Member States should explore the possibility of renegotiating existing contracts to secure a fair share of the rent; Member States should align their development strategies to their long term national development goals; Member States should ensure transparency in the collection and use of mining revenues; Governments could explore the use of equity participation in mineral ventures to capture a greater share of benefits; and Governments in collaboration with partners should build capacity of oversight bodies. Along with the action plan, the ministers reasserted the African Mining Vision (AMV) approved by the February 2009 African Union Summit. The AMV puts development outcomes at the heart of mineral regimes to stimulate the local economy and help prevent mines operating as enclave enterprises.
The fourth annual BRICS summit, held in March 2012 under the theme of "BRICS Partnership for Global Stability, Security and Prosperity", sought to strengthen ties between the five countries (Brazil, Russia, India, China and South Africa) in order to heighten bargaining power. And while the global media is focused on China in Africa, the author of this article argues that they are missing out on the story of trade between Africa and remaining partners Russia, India and Brazil. Outside of China, these countries remain some of the largest players in South-South relations and on the African continent. Trade between Brazil and Africa tripled from 2004-2010, totaling over $20 billion, while Indian trade with Africa reached $60 billion in 2011, with both countries expecting increased trade with the continent. And while Russian activity on the African continent remains low - at $7.3 billion in 2008 - it is also expected to grow.
Roughly a decade on from the launch of a new era of commercial and strategic alignment, China-Africa ties continue to mature, substantially altering the make-up of Africa’s political and economic milieu, according to this paper. The authors evaluate the current and potential scale of China’s position in Africa, and, in so doing, pose questions as to the role of Africa’s traditional Western partners in the continent’s ongoing economic progression. Bilateral trade in 2011 reached US$160 bn, up by 28% from the previous year, when China accounted for 18% of Africa’s trade (up from 10% in 2008). African exports to China increased by one-third in 2011, while Africa’s imports from China (23.7%) increased by 4%. Fluctuations in currency and domestic prices have little explanatory role in why China has undermined the position of developed nations in Africa, the authors argue. What counts is China’s foresighted engagement with Africa back at the start of the past decade, allowing Beijing to steal a march on Africa’s other partnerships. Importantly, China is well-positioned to be a significant player in Africa’s next phase of development.
The European Union (EU) has committed to concluding a new free trade agreement (FTA) with India, known formally as the Bilateral Trade and Investment Agreement (BITA), by the end of 2012, but the BITA may have significant adverse implications for India’s generic pharmaceutical industry that supplies much of the developing world’s antiretroviral (ARV) medications and other drugs. Critics argue that free trade agreements that may create new intellectual property obligations for India can increase ARV prices, impede the development of acceptable dosage forms, and delay access to new and better ARVs. They also state that by pressuring India and other developing countries to accept new intellectual property rules for pharmaceuticals, the EU threatens to undermine the Doha Declaration, a TRIPS-related agreement that is intended to ensure that low- and middle-income countries gain access to affordable medicines. The schedule for the next round of BITA negotiations in September 2012 has yet to be released and preparations are shrouded in secrecy. Neither party has sufficiently acknowledged the impact the FTA may have on millions of the world’s poorest people, who rely on India’s generic pharmaceutical industry to provide them with access to life-saving treatments.