In this essay, the author considers the impact of the India-Brazil-SouthAfrica (IBSA) and the Brazil-Russia-India-China (BRIC) summits on South-South co-operation and development. In terms of the health sector, the author argues that IBSA and BRIC offer synergies among the countries in the alliances. As regards HIV/AIDS, for instance, the interests of the three countries are quite convergent. India has the second largest number of HIV-positive people (2.4 million) and also the largest generic drugs industry. Brazil has developed role-model public policies in fighting AIDS and exports its know-how to several African, Asian and Latin American countries. South Africa has a high demand in this regard, since it has the largest number of HIV-positive people (5.7 million) and faces severe constraints in democratising public health services regarding the epidemic. In recent years the IBSA countries have been prominent in the G-21 lobby that succeeded in lessening the negative effects of the Trade-Related Aspects Of Intellectual Property Rights agreement (TRIPS). Flexibilities in TRIPS permit governments to issue licenses for generic drug production for the domestic market in the interests of public health, without the consent of the patent owner, to help bring down the high costs for patented drugs in developing countries. India is one of the world’s leading producers of generic medicines. While a trilateral trade agreement has been alluded to on numerous occasions, the author alleges it is unlikely to materialise between India, Brazil and South Africa, which are technically bound to regional trade blocs.
Health equity in economic and trade policies
According to this article, China has become one of Africa's leading trading partners, with trade totaling US$106.8 billion in 2008, up 45 per cent from the previous year. China's increasing demand for raw materials to fuel its domestic growth has resulted in agreements on access to and extraction of minerals and oil from resource-rich African countries. China has also become an emerging player in providing financial assistance for infrastructure development in Africa, helping African countries address their infrastructure needs such as railways, hydropower and roads. China has sought to provide concessional financing for infrastructure and construction projects through its Export-Import Bank, often using Chinese companies to carry out the projects. Since 200, China's foreign policy in the region has been directed through the Forum on China-Africa Co-operation (FOCAC), which is the main vehicle for China's activities in Africa, providing a multilateral platform for dialogue with a view to reaching mutually agreeable goals. A number of action plans have emerged from FOCAC, which outline commitments to Africa by the Chinese government, such as the 2009 Sharm El Sheikh Action Plan, in which the Chinese government commits itself to finance the training of African nurses, as well as contribute to malaria health services by supplying equipment and anti-malaria drugs.
A decade ago, the anti-malaria drug artemisin – available only from the sweet wormwood plant, Artemisia annua – was scarce and expensive. But by 2007, the market was wallowing in a surfeit of the drug as farmers flocked to grow the crop. Now, as a US$343-million initiative starts to battle malaria through hugely subsidised medicines, suppliers are again worried that there will not be enough artemisinin to go around, while farmers, plant breeders and synthetic biologists are hoping that they can snap the drug out of its roller-coaster supply cycle. Farmers and scientists are struggling to keep up with needs of ambitious medicine-subsidy programme, the article notes. The authors observe that artemisin yields could be improved by planting new Artemisia strains. On average, one kilogram of its dried leaves yields some 8 grams of artemisinin. Researchers have used selective breeding to create hybrid plants that produce up to 24 grams, according to a British Artemisia breeding consortium. These plants are now being grown and harvested commercially in Madagascar, and trialled in South Africa, Uganda, Zimbabwe and the United States, as well as in Britain.
The author of this paper argues for public-private partnerships to help deliver locally produced generics in Africa, and against protectionism in favour of open market access. He points to promising developments, such as experienced Indian and Western pharmaceutical firms undertaking original research and development and partnering with firms in African countries. He believes this investment by reputable companies should help ensure quality drugs are produced by furnishing the technical expertise that overcomes capacity constraints. Local production enterprises in Africa will allow international companies to diversify their supply sources, the author argues, guarding against potentially disastrous shocks such as a natural disaster that would destroy an Artemisia crop and send the price of artemisinin-based malaria drugs skyrocketing. Local production partnerships could encourage trade, especially because the bulk active ingredients needed to produce them still come most efficiently from abroad. Partnerships between foreign pharmaceutical firms and African companies may also help train a pool of skilled workers, improving a country’s long-term development prospects.
In February 2011, experts gathered at the World Intellectual Property Organisation (WIPO) to rewrite the negotiating document on intellectual property rights and traditional knowledge. The new document caused disagreements over common language in most articles, in particular, Article 1 on the subject matter of protection of traditional knowledge, which includes the definition of traditional knowledge (TK), the criteria for eligibility and on secret TK. To accommodate different opinions, several options were listed in the draft document. In Article 1, one of the options mentions the fact that, among eligibility criteria, protection should extend to TK not widely known outside that community, which could imply that some TK already in the public domain would not be considered as eligible. A representative of the Indigenous Peoples Council on Biocolonialism argued that the language in Article 1 might be misconstrued as intellectual property language and it was important that Article 1 really reflect the integrity of TK in its cultural context as a dynamic form of knowledge transmitted from generation to generation to serve the interest of the community. Article 2 only contains two brackets signifying lack of agreement, one of which is around the word ‘nations’ as beneficiaries of protection. Some countries would like the protection to include indigenous peoples, local communities and nations. The representative of the Indigenous Peoples Council on Biocolonialism said beneficiaries should be TK holders themselves, and not nations. A developed country source agreed, noting that indigenous peoples and local communities are holders of TK and should be beneficiaries and managers of their rights, but that nations could not be beneficiaries of the instrument being elaborated as this would confuse intellectual property rights with public heritage protection.
The proposed intervention by The Global Fund to drastically reduce prices of Artemisinin Combined Therapies (ACTs) through its Affordable Medicines for Malaria programme (AMFm) will see ACTs from six foreign companies sell ACTs at a reduced, monitored price regime of between US$0.40 and 0.47. However, controversy has arisen over two competing development goals - making high quality medicines available to those in need at affordable prices vs strengthening local industrial capacity. The paper argues from the Nigeria situation, that manufacturers in Nigeria have practically no access to bank credit and provide their own infrastructural requirements, compared to foreign counterparts who may have access to cheap credit, enjoy tax reliefs and export incentives. This makes it difficult for Nigerian manufacturers to compete with their foreign counterparts. It is not clear whether there are actual foreign assistance efforts aimed at building the capacity of malaria endemic countries in Africa to produce their own pharmaceutical products. The author suggests that if such a longer term project were started in parallel with efforts like AMFm, there may be more acceptance for temporary set backs in the local market, given that the international community is trying to strengthen countries’ abilities to fight malaria into the future. The author calls for an aid programme that can address the infrastructural problems facing Nigerian manufacturers and provide a legal framework that protects intellectual property and gives the local companies a fair chance to compete.
In this study, the authors argue that an optimal drug registration approach for Africa should reliably evaluate safety, efficacy, and quality of drugs for African use. It should include African expertise, contribute to building African regulatory capacity, and, ultimately, expedite African access by reducing duplicative and sequential reviews by different regulators. However they present an overview of the current situation that shows the present system of drug approval to be far from achieving these goals, with inefficiencies in the use of regulatory resources and in the uptake of capacity-building opportunities for African regulators. As a result regulatory processes and decisions may not meet current needs. The authors recommend that countries institute formal twinned regulatory reviews, fund Centres of Regulatory Excellence in each of Africa’s main regions and conduct a strategic review of WHO drug pre-qualification disease and product priorities.
South-South trade is growing fast, but barriers among developing countries are still up to seven times higher than those imposed by the developed world, according to this article. The Organisation for Economic Cooperation and Development (OECD) has announced that exports from developing countries have grown to 37% of global trade, of which about 50% related to South-South trade. Historically, developing countries focused on preferential access to developed markets, but an OECD spokesperson said that the global economy had dramatically changed over the last two decades with wealth shifting from the developed world to developing countries, necessitating a change in thinking and attitude when it came to trade. The OECD anticipates that the growth trend would continue, predicting an increased contribution by developing countries. However, OECD pointed out that accelerated growth had resulted in greater inequalities in society, which could lead to political unrest, like the recent civil demonstrations in North Africa. The OECD called for good policy and governance in developing countries to build the correct developmental infrastructure, improve education and health, and increase human capital, while continuously diversifying their economies with a strong focus on productivity and innovation. One way to achieve this is through peer-to-peer learning, where policymakers can come together and share their successes and failures with each other, OECD argues.
According to this article, a drugs producer in Uganda has become the first in a least-developed country (LDC) to achieve a world-class seal of quality for its manufacturing standards. The Quality Chemicals plant, in the Ugandan capital Kampala, is the first to get this far along the World Health Organisation (WHO) pre-qualification process, a stringent quality check imposed on manufacturers of drugs. The next step is to gain approval, or pre-qualification, for each malaria and HIV/AIDS drug the firm produces, before international agencies, such as UNICEF, are allowed to buy from the company. It is an important milestone because of scepticism over domestic, or local manufacturing, in such countries, the author notes. There are around 37 manufacturers in sub-Saharan Africa. Pharmaceutical companies from Democratic Republic of the Congo to Ethiopia are being helped to reach international standards too. German development agency GTZ is even sending individual inspectors from the German regulator to Africa to do personal plant assessments. Although no substitute for a full WHO pre-qualification, the process helps identify improvements necessary to reach international standards.
The technical symposium on ‘Access to Medicines, Patent Information and Freedom to Operate’, held on 18 February 2011 in Switzerland, was hosted by the World Health Organisation (WHO) and co-organised by the World Intellectual Property Organisation (WIPO), and the World Trade Organisation (WTO). According to Margaret Chan, WHO’s Director-General, countries could save about 60% of their pharmaceutical expenditures by shifting from originator medicines to generic medicines, but a lack of essential procurement and regulatory capacities are preventing this shift in many developing countries. This is especially so in relation to non-communicable diseases, which is a growing problem in low and middle income countries. She called for more transparent and accessible data on patents to help with decisions on the ‘freedom to operate’, such as a user-friendly database that contains public information on the administrative status of health-related patents. Pascal Lamy, WTO Director-General, said the main aim of the symposium was not to enter policy discussions or legal debates but rather to evaluate the area where the three agencies could collaborate to provide an information base for policy debates. He argued for a move from raw data to accessible, trusted, neutral and relevant information that directs policymaking processes, practical innovation and procurement strategies. However, some participants at the symposium called for greater involvement of the generic industry to provide affordably priced medicines, and questioned the legitimacy of WIPO involvement in public health.