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.
Health equity in economic and trade policies
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.
The international debate around patents has been largely framed in terms of ‘protection for’ versus ‘access to’ intellectual property (IP), according to this article. If the framing of the debate shifts to a focus on research and development, this is likely to strengthen the leverage of developing countries to change the dynamics of IP negotiations in trade agreements, the authors argue. In fact, shifting the entire debate from IP rights to the research and development (R&D) gap may help tackle the fundamental problem of a monopoly-based innovation and access system. One example is nonexclusive licensing practices, such as those used by the not-for-profit Drugs for Neglected Diseases Initiative. The initiative finances R&D up front and offers the outcome of its research on a nonexclusive basis to generic producers, allowing for technology transfer and competition among multiple producers. Furthermore, universities currently hold important patents on many life-saving drugs, which prompted Universities Allied for Essential Medicines to propose that when a university licenses a promising new drug candidate to a pharmaceutical company, it should require that the company allow the drug to be made available in low income countries at the lowest possible cost. Another alternative to overcoming current patent barriers is the use of patent pools, as proposed by the World Health Organization, Médecins Sans Frontières, and UNITAID. Here, a number of patents held by different entities, such as companies, universities, or research institutes, are pooled and made available to others for production or further development. The patent holders receive royalties that are paid by those who use the patents. The pool manages the licences, the negotiations with patent holders, and the receipt and payment of royalties, in a manner that facilitates access to medicines in low income countries. The author proposes that other innovative policy proposals, such as the Heath Impact Fund (a strategy to create a publicly funded ‘pot of gold’ that would attract the private sector to create R&D innovations that effectively address priority global heath needs), be implemented. However the author argues that using patents as the financial incentive to encourage the pharmaceutical industry to develop drugs for the world's poor is of limited use, given that the market is nonexistent as neither governments nor patients can afford the end product.
According to this report by Oxfam, poor-quality, or ‘substandard’, medicines threaten patients and public health in developing countries. Prioritisation of medicines regulation by developing-country governments, with the technical and financial support of rich countries, is badly needed. However, under the guise of helping to address dangerous and ineffective medicines, rich countries are pushing for new intellectual-property rules and reliance on police – rather than health regulatory – action. This approach will not ensure that medicines consistently meet quality standards. Worse, new intellectual property rules can undermine access to affordable generic medicines and damage public health. Oxfam argues. Developing countries must improve medicines regulation – not expand intellectual-property enforcement – in order to ensure medicine quality. Oxfam recommends that developed-country governments should expand funding and support for national and regional initiatives that increase the ability of drug-regulatory authorities in developing countries to protect their populations from harmful products, and stop pursuing TRIPS-plus enforcement measures (intellectual property rules that exceed minimum obligations under global trade rules) through internal regulations, multilateral trade initiatives, bilateral trade agreements, or through technical assistance. Developing-country governments should prioritise the expansion of public health-care infrastructure and invest in drug-regulatory authorities' capacity together with the provision of free essential medicines, as well as promote generic competition in national medicines policies, including implementation of TRIPS flexibilities in national laws, and reject initiatives modeled on ACTA, and any other TRIPS-plus enforcement initiatives. Oxfam calls on the World Health Organisation (WHO) to prioritise its comprehensive programme of work, which underpins access to affordable, quality medicines for its Member States, and disband IMPACT, the controversial task force that inappropriately uses an intellectual property framework to evaluate the public-health problem of unsafe medicines. Oxfam also calls on pharmaceutical companies to adhere consistently to WHO quality standards and to recognise the damage inflicted on public health as a result of the confusion of quality with intellectual-property issues in initiatives such as IMPACT, and correct this fundamental error in their public statements and documents.
This report is an update of Global Financial Integrity’s 2008 report, which found that developing countries lost between US$859 billion and US$1.06 trillion in illicit financial outflows in 2006. On the same basis, this report finds that illicit outflows increased to between US$1.26 and US$1.44 trillion in 2008 and that, on average, developing countries lost from US$725 billion to US$810 billion per year over the nine-year period, 2000-2008. Globally, illicit flows increased by 18% per annum from US$369.3 billion at the start of the decade to US$1.26 trillion in 2008. When adjusted for inflation, the real growth of such outflows was 12.7%. Illicit flows from Africa grew by 21.9% over the nine years, representing 4.5% of total illicit flows. Trade mispricing accounts for 54.7% of cumulative illicit flows from developing countries, according to the report, which identifies bribery, theft, kickbacks and corporate tax evasion as other significant sources of illicit flows.
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 Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising, adopted on 29 October 2010 and the Convention of Biological Diversity (CBD), both have implications for the WHO intergovernmental dialogue on influenza preparedness and virus sharing. Article 8 requires countries to ‘pay due regard’ to ‘cases of present or imminent emergencies that threaten or damage human, animal or plan health’. Article 4 calls for ‘due regard’ to be paid to ongoing work or practices, provided such work or practices are supportive of and do not run counter to the objectives of the Convention of Biological Diversity (CBD) and the Protocol. The CBD and protocol are important as they have a legally binding status as they are treaties. Notably the United States is not party to the CBD.
South Africa is set to launch its own development aid agency in 2011. The South African Development Partnership Agency is expected to become operational before mid-2011 and will work with other external funding agencies to coordinate development programmes, mainly on the African continent. Although the government is hoping for contributions from the private sector, most of the funding will come from public money, according to Ayanda Ntsaluba, Director-General of the Department of International Relations and Cooperation. Since 2001, the South African government has channelled its aid contributions through the African Renaissance Fund (ARF), which is administered by the department. Much of the assistance provided by the ARF has focused on conflict resolution and peacekeeping in various countries, including Mali, Zimbabwe, Burundi and the Democratic Republic of Congo. However, transparency and accountability was problematic and Ntsaluba conceded that the tracking of ARF funds had not been optimal. Although the mandate for the new agency was still in draft form, he said South Africa would continue providing assistance to countries recovering from conflict. He assured critics that the new agency would be set up as a separate institution, with the administrative capacity to track and oversee all the programmes it funded.