When US Trade Representative Robert Zoellick met representatives of the US pharmaceutical industry in April this year hopes were raised in the international community, particularly in developing countries, who viewed the meeting as a way forward in breaking the impasse in the WTO over how to provide developing countries with access to affordable generic drugs.
It is now six months after the Doha-mandated deadline passed on the 31st December 2002 for WTO members to come up with a solution to public health crises exacerbated by unaffordable patented drugs. With only three months left before the 5th WTO Ministerial Conference in Cancun, Mexico, nothing is expected to materialise before the conference.
Hopes were pinned on the US compromising on its earlier decision to limit the scope of diseases but nothing came out of that meeting, which Zoellick attended. In fact industry representatives last year had pressurised Zoellick to reject a proposal that would be open-ended in terms of allowing developing countries (without or with limited manufacturing capacity) to grant compulsory licences for the manufacture and importation of generic drugs to combat a variety of health problems. This made the US government issue a moratorium that carried the concerns of their pharmaceutical industries, basically on strict limits on the number of diseases covered by these new flexibilities.
The TRIPS (Trade-Related Aspects of Intellectual Property Rights) Council, which last met sometime in February, met again in Geneva to try and see how best to break the impasse. The TRIPS Council meeting on June 4-6, in its last formal session before the Cancun Ministerial Conference in September, did not make progress towards agreement on a solution for the Paragraph 6 problem.
Reports coming from Geneva said although the WTO members had not expected a breakthrough at this meeting, many developing country negotiators expressed their frustration at the seemingly unbreakable impasse in the negotiations. It is reported that the US had reinforced this perception by stating that a consensus was not yet possible, in response to the Kenyan negotiator's comment that there appeared to be no objection to the 16 December 2002 text.
The US objection to the December 16 text was based on the issue of scope of diseases and the reference to Paragraph 1 of the Doha Declaration which refers to “the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.” The reference to "public health problems as recognised in Paragraph 1 of the Declaration" was too broad for the US. The US then proposed that the scope of diseases in the December 16 text should be limited to "HIV/AIDS, malaria, tuberculosis or other infectious epidemics of comparable gravity and scale, including those that may arise in the future". This had been opposed by the majority of the WTO Members as an attempt to limit the scope of diseases already agreed to at Doha.
The TRIPS Council considered two submissions, one from the group of African, Caribbean and Pacific (ACP) countries, and the other, from the European Communities (EC).
The ACP countries basically reiterated their previous position that they would want to see a solution that covers all public health concerns, without limiting agreement to specific diseases. The Group also rejected attempts to confine the application of the Paragraph 6 solution to national emergencies and other circumstances of extreme urgency.
The European Communities last year made a proposal on an initial list of diseases that would be covered under Paragraph 6 of the Declaration. The EU Trade Commissioner Pascal Lamy argued that other diseases applicable under the Declaration could be checked or approved by the World Health Organisation (WHO) as the situation arises. Such proposals were nothing but measures to protect the corporate world. In addition to limiting the scope of diseases, the EC effectively wanted to add bureaucratic and political hurdles for poor countries, who would have to go through the rigours of the WHO system to prove that a health problem actually exists in the country for a disease that is not on the initial WTO list.
Again in their submission to the TRIPS Council the EC did not move away from their previous position. The EC suggested that WTO Members could agree on an initial list of diseases that would be covered by the December16 text, and any Member wishing to import medicines to meet a public health concern that was not explicitly covered in the list would be encouraged to seek WHO advice on the matter. The ACP group rejected this, saying it was designed to place limits on the scope of diseases.
With the differences that exist between and amongst the WTO members, particularly the rift between the EU and the US and between both the developed and developing countries, it is highly unlikely that a solution will be found before Cancun. It is reported that the TRIPS Council chairman, Ambassador Vanu Gopala Menon of Singapore, told the meeting that he would continue to hold consultations in small groups and bilaterally until a permanent solution is found.
At the Southern and Eastern African Trade, Information and Negotiations Institute (SEATINI) 6th Workshop held in Arusha (April 2003), participants from fifteen African countries urged African governments and delegations “to stand firm before Cancun, by insisting on a solution that is true to the spirit and letter of the Doha Declaration”. They went on to say that whatever the final outcome of the negotiations, it must cover “all diseases and public health issues”. Governments must have the right, they argued, “to determine what constitutes a public health problem”. The solution, in other words, should not be confined only to some diseases, or to emergencies, or to circumstances of extreme urgency.
Again this recommendation was apparently in reference to the 2002 year-end moratorium issued by the US, which effectively was not consistent with the spirit of Doha. The US had rejected the text that primarily carried the concerns of developing countries due to concerns over the scope of diseases covered.
Western industrial and pharmaceutical corporations, aided by bilateral donors, in the meantime, are putting pressure on certain African countries to amend their patent laws so that they protect the property rights of these corporations. This is the case, for example, with Uganda, where, alarmingly, under pressure from certain quarters, the Government is pressing for legislation in the Parliament - the Uganda Industrial Property Law (IPL) – that seeks to modify the laws of Uganda to conform to the TRIPS provisions of the WTO, when, in fact, Uganda, as an LDC, need not have such a law until 2016.
Meanwhile, the Third World Network reports that WHO Member states meeting at the World Health Assembly (May 19-28, 2003) in Geneva adopted a resolution on Intellectual Property Rights, Innovation and Public Health, directing the WHO Director-General to establish a "time-limited" body that would study and make concrete proposals on the question of appropriate funding and incentive mechanisms to promote the creation of new medicines for diseases affecting developing countries.
The resolution also asks the WHO to cooperate with Member states to develop "pharmaceutical and health policies and regulatory measures" to "mitigate the negative impacts" of international trade agreements.
Other operative parts of the resolution include references to the WTO TRIPS Agreement, in which Member states were urged to "use to the full the flexibilities contained in the TRIPS Agreement" in their national laws. The resolution also called on governments to agree on a "consensus solution" for Paragraph 6 of the Doha Declaration on TRIPS and Public Health before the Fifth WTO Ministerial Conference in September this year.
The Paragraph 6 problem refers to the inability of many developing countries to effectively use compulsory licences to obtain affordable medicines from domestic generic drug producers, since the majority of the developing countries do not have domestic manufacturing capacity in pharmaceutical products. WTO Members have not been able to agree on the solution for this contentious issue, even though the end of 2002 deadline set in the Doha Declaration has passed.
The compromise text of the resolution was adopted only after prolonged consultations and negotiations, primarily between the US, Brazil and a number of African countries. Developed countries, in particular the US, had not been in favour of a strong mandate for the WHO to address IPR issues. Developing countries, on the other hand, had been pressing for a clearer mandate to permit the WHO to properly assess the public health implications of tightened IPR protection, as a result of obligations under the TRIPS Agreement, as well as regional and bilateral trade agreements.
* Rangarirai Machemedze is the SEATINI Programmes Coordinator.
From the SEATINI BULLETIN: Southern and Eastern African Trade, Information and Negotiations Institute
Produced by SEATINI Director and Editor: Y. Tandon; Advisor on SEATINI: B. L. Das Editorial Assistance: Helene Bank, Rosalina Muroyi, Percy F. Makombe and Raj Patel.
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1. Editorial
2. Equity in Health
South Africa's health system will soon offer drugs blocking the Aids virus, the body that advises the government on HIV/Aids has said. The South African National Aids Council (Sanac) made the announcement following a meeting with the Treatment Action Campaign (TAC) - a group that has been urging the government to supply the drugs.
The Common Market for Eastern and Southern Africa, Africa's major free trade bloc, plans to lobby the United States and pharmaceutical companies for the right to produce generic antiretroviral drugs, according to the group's secretary general, Reuters reports. COMESA Secretary-General Erastus Mwencha said that patent disputes in the World Trade Organisation are "robbing the region of a key weapon against AIDS," according to Reuters.
Leaders of the world's richest countries agreed at the G8 summit to provide billions of dollars to help fight AIDS in Africa but, under present trade rules, much of that cash will go to multinational pharmaceutical companies. To the disappointment of pressure groups monitoring the summit, the leaders failed to make progress on new trade rules to allow poor countries to buy cheap, generic versions of new medicines - including the drugs which arrest AIDS.
Malawi's government has issued a warning to vendors involved in the illegal sale of HIV/AIDS drugs, the Malawi Standard newspaper reported. Despite calls for their arrest, the informal businesses have maintained that these were the benefits of a liberal economy. However, the Registrar of the Pharmacies, Medicines and Poisons Board, Patrick Tembo, said: "Liberalisation doesn't mean trading in pharmaceutical drugs. It is illegal. Only registered institutions like hospitals and pharmacies are allowed to sell pharmaceutical drugs."
U.S. President George W. Bush's surprise pick of a former top executive of a major U.S. pharmaceutical company and major Republican contributor as his global AIDS co-ordinator has drawn expressions of concern and even outrage among Africa and AIDS activists.
The unregulated supply of AIDS drugs in the developing world could accelerate the development of drug-resistant HIV strains, according to an expert at the London School of Hygiene and Tropical Medicine, United Kingdom. Better regulation of private-sector providers of drugs in poor nations is needed to ensure that patients use antiretroviral drugs correctly, thereby reducing the risk that a strain of drug-resistant HIV will develop.
The Nobel Prize winning Organisation Médecins Sans Frontières (MSF) and four eminent public research institutes from around the world have joined forces to address the lack of research and development in drugs for neglected diseases. A mere 10% of global health research is devoted to diseases that account for 90% of the global disease burden.
Questions about what percentage of Africa's HIV infections are caused by dirty needles has prompted U.S. Health and Human Services Secretary Tommy Thompson -- who is also the chairman of the Global Fund to Fight AIDS, Tuberculosis and Malaria -- to order a review of all research linking HIV/AIDS and medical injections, Associated Press has reported. The review could affect how funding from the $15 billion U.S. initiative to fight HIV/AIDS in Africa and the Caribbean is distributed, AP reported.
U.N. Special Envoy for HIV/AIDS in Africa Stephen Lewis, during a speech at the Global Health Council's annual conference in Washington, D.C., said that he was "aghast" at the way in which "AIDS was deepening hunger and hunger was deepening AIDS" in Southern Africa. According to Lewis, Africa "reaps what the world sows, and with a vengeance."
The World Health Assembly, the policy-framing body that gives guidance to the World Health Organisation (WHO) on the views of member states and sets global health policy, voted to support a resolution affirming that public health interests should remain paramount when framing policy on pharmaceuticals.
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3. Human Resources
Despite the undoubted importance of human resources to the functions of health systems, there is little consistency between countries in how human resource strategies are monitored and evaluated. This paper, published in the journal Human Resources for Health, presents an integrated approach for developing an evidence base on human resources for health (HRH) to support decision-making, drawing on a framework for health systems performance assessment. It concludes that evidence-based information is needed to better understand trends in HRH. Although a range of sources exist that can potentially be used for HRH assessment, the information that can be derived from many of these individual sources precludes refined analysis. A variety of data sources and analytical approaches, each with its own strengths and limitations, is required to reflect the complexity of HRH issues.
About 3% of the South African workforce - or about 500 000 people -could have full-blown Aids by 2010, Department of Labour guidelines on HIV/Aids have forecast, reports the Mail and Guardian newspaper. The projected rate of 2,9% in the terminal stage of the illness represents a three-fold increase since 2001, when it stood at 0,93%. Statistics South Africa estimates the current economically active population at 16,5-million, including a million in the informal sector.
4. Public-Private Mix
Equity is a frequently stated justification for government involvement in the health care market. This is often taken to mean directly providing all segments of the population with a wide range of government-operated health services at no cost: free universal care. Yet a look at the record suggests that this goal all too often remains elusive, especially in poor countries; that governments in fact serve only some of the population; and that the people served are disproportionately concentrated among the better-off. When this happens, government health services, far from promoting equity, work against it. The purpose of this chapter is to illustrate that there are many ways for governments to pursue the goal of ensuring that the poor receive adequate, affordable services through alternative approaches to resource allocation and purchasing. The first section summarizes the information known about the distribution of benefits from government health services across social groups in order to document the regressive pattern that now frequently exists and the need for significant changes in approach if the poor are to benefit. The second and third sections illustrate the kinds of changes that might be considered.
5. Resource allocation and health financing
Health system performance is a function of how effective the health system's approach to treating diseases is in improving health outcomes and reducing resource costs, according to a document from the Organisation for Economic Cooperation and Development (OECD). In an era when health systems account for increasing sums of money aiming to provide their citizens with the best healthcare possible, surprisingly little is known about how effective much of this spending is. Health policy makers have extensive information available to them on how much is spent on healthcare at an aggregate level. But their knowledge of what, in terms of health outcomes, they receive in return for this spending remains very limited, the document says.
Of the 40 million people that are infected with HIV globally, approximately 95% live in severely resource-constrained settings. From a humanitarian perspective alone, not bringing antiretroviral therapy to those in need implies accepting a number of casualties that is difficult to imagine and impossible to accept. But there is another important argument to take up the challenge: HIV/AIDS mainly affects adults in their productive prime, leaving the very young and old to cope alone. This severely hampers economic growth and development of countries concerned. There is little doubt that poverty facilitates the spread of HIV/AIDS, but conversely HIV/AIDS perpetuates poverty. Generalizing HIV/AIDS into a problem of poverty will paralyze an effective and specific response to it, and conflicts with the "art of the soluble" principle that we should adhere to.
This report authored by the Global HIV Prevention Working Group assesses the shortfall in access to HIV prevention services worldwide, detailing the specific shortfall in the regions of Sub-Saharan Africa, Asia and the Pacific, Eastern Europe and Central Asia, and North Africa and the Middle East. It discusses regional prevention priorities for each and identifies funding gaps. The document calls for the scale up of treatment and care programs, in coordination with prevention work. The authors finally call on political leaders, both nationally and in donor countries, to increase their commitment to effective prevention programmes.
Health care for all does not always mean increased health expenditure. This article looks at various strategies that may be employed to save costs and maximise resources. Health policy reforms alone have not been successful in containing health care cost. While lack of money is often a governing constraint, it does not mean that progress is not possible without the injection of money into the system. It is necessary to identify areas of wastage, inappropriate spending and strategies to contain health care cost while improving quality of health care provision. It makes sense to start by spending money on cost-effective interventions that save a lot of lives. A recent experiment in Tanzania illustrates the impact of rational spending. Researchers were sent to the rural districts of Morogoro and Rufiji. They carried out a door-to-door survey asking whether anyone had died or been laid low recently, and if so, with what symptoms. They found that the amount of money local authorities spent on each disease had no relation whatsoever to the harm it inflicted on local people.
Hospital costs are difficult to measure when there is limited or poor quality data. Current accounting methods may miss key aspects of inefficiency. Researchers from the London School of Hygiene and Tropical Medicine find that using ‘tracer’ illnesses is a more effective way to assess costs in Zimbabwe’s hospitals. Crude methods of hospital costing do not consider case mix or severity – both vital to understanding cost structures and differences between hospitals. They may miss unnecessary costs that stem from wasted staff time, over-prescription of drugs, needless diagnostic tests, inappropriate length of stay and other redundant activities. Using the tracer approach may resolve some of these problems.
6. Governance and participation in health
Is there a relationship between people’s degree of community involvement and participation and their sexual behaviour? If this is the case, it may help to identify possible areas of HIV/AIDS intervention at community level. Researchers from the London School of Economics (LSE) investigated this relationship in a mining town in South Africa. The results were mixed. Whereas some forms of community participation were associated with safer sexual behaviour and lower levels of HIV infection, others acted in the opposite way. The findings highlight the need for further research.
How can we tell if teenagers are responding to HIV/AIDS awareness campaigns? Is it acceptable to conduct randomised trials in schools to find out? University College London, together with the University of Zimbabwe and the London School of Hygiene and Tropical Medicine, looked into the sensitive topic of interviewing and testing teenagers for sexually-transmitted diseases (STDs) including HIV, in a feasibility study for a large community randomised trial. It found that communities in Zimbabwe were enthusiastic about taking part in trials in schools and recognised the importance of these.
7. Monitoring equity and research policy
Adherence to therapies is an indicator of inequities as well as access to drugs. In average, 50% of patients in developed countries do not take their prescribed medicines after one year, despite having full access to medicines. In developing countries it is even worse, due to poor access to health services, medicines, lack of education and unhealthy lifestyles, which especially affects the poorest populations. Intended for policy-makers, health managers, and clinical practitioners, this report provides a concise summary of the consequences of poor adherence for health and economics. It also discusses the options available for improving adherence, and demonstrates the potential impact on desired health outcomes and health care budgets. It is hoped that this report will lead to new thinking on policy development and action on adherence to long-term therapies.
Health policy and systems research (HPSR) is increasing in prominence in low and middle income countries, stimulated by social and political pressure towards health system equity and efficiency. Yet the institutional capacity to fund and produce quality research and to have a positive impact on health system development has been little examined and touches mainly on specific areas such as malaria research or the impact of research on health reforms. This paper seeks to develop an empirical basis for assisting decisions on what are likely to be good investments to increase capacity in health policy and systems research (HPSR) in developing countries.
8. Useful Resources
Oxford University Press has set up a program wherein scholars from developing nations are eligible for free or greatly discounted electronic access to a large number of professional journals.
'HIV & AIDS Treatment in Practice' is an email newsletter for doctors, nurses, health care workers and community treatment advocates working in limited-resource settings. The newsletter is published twice every month by NAM, the UK-based HIV information charity behind www.aidsmap.com.
The Organisation for Economic Co-operation and Development (OECD) and WHO have recently jointly published Poverty and Health in the Development Assistance Committee - DAC Guidelines and Reference Series. This DAC Reference Document dedicated to health and poverty in developing countries expands on the DAC Guidelines on Poverty Reduction and provides a set of policy recommendations to a broad range of development agency staff working on policy and operations. It provides a framework for action within the health system, and beyond it, through policies in other sectors and through global initiatives.
In developing countries, most medicines are paid out-of-pocket by individual patients rather than being subsidised through social insurance. High prices are a major barrier to the use of medicines and better health, yet too little is known about the prices that people pay for medicines in low- and middle-income countries. This manual and the accompanying workbook and database, produced by the World Health Organisation (WHO) and Health Action International (HAI), provide a new approach to measuring the prices of medicines. The survey is focused on thirty key medicines covering the spectrum of the global disease burden, particularly as it falls on low- and middle-income countries. This manual results from the widely-felt need for greater transparency on prices in the global medicines marketplace.
The Synergy APDIME Toolkit is a resource to support programme designers and managers in HIV/AIDS prevention, care and support programming in the developing world. It is a window through which you can learn about programme outcomes, training guides and research findings. Tools include worksheets, budget templates, survey instruments, data and software produced by HIV/AIDS organisations from around the world. It was developed in collaboration with the University of Washington and contains five modules covering Assessment, Planning, Design, Implementation Monitoring, and Evaluation. Each module outlines a comprehensive step-by-step method and weblinks to hundreds of resources for programming.
Throughout the world, reproductive health programmes are facing a growing crisis as a result of a lack of supplies which are essential for HIV/AIDS prevention, family planning, contraception and other vital sexual and reproductive health care services. This threatens the lives and rights of millions of men, women and children. The Supply Initiative has been set up to call attention to this crisis as well as to increase the availability and efficient use of human, institutional and financial resources for reproductive health supplies. The Supply Initiative web site is online under http://www.rhsupplies.org. Here you will find more details on reproductive health supply shortage and the activities of the Supply Initiative.
Gender-Based Violence (GBV) is one of the most widespread human rights abuses and public health problems in the world today, affecting as many as one out of every three women. It is also an extreme manifestation of gender inequity, targeting women and girls because of their subordinate social status in society. The consequences of GBV are often devastating and long-term, affecting women's and girls' physical health and mental well-being. At the same time, its ripple effects compromise the social development of other children in the household, the family as a unit, the communities where the individuals live, and society as a whole. Violence against Women: The Health Sector Responds provides a strategy for addressing this complex problem and concrete approaches for carrying it out, not only for those on the front lines attending to the women who live with violence, but also for the decision-makers who may incorporate the lessons in the development of policies and resources.
The new WHO Macroeconomics and Health website was launched in May 2003. The website will provide detailed information on WHO macro-economics and health work, the latest action in countries, news and links with related sites, and links to the CMH Report and its Working Group Reports. Published documents and reports can be downloaded from the site. To ensure that the website becomes a forum for sharing ideas, information and news, readers are encouraged to submit their views and work on macroeconomic and health issues.
9. Jobs and Announcements
The Southern African Network of AIDS Service Organisations (SANASO) is a Network of Non-governmental organisations (NGOs), Community based Organisations (CBOs), Faith based Organisations (FBOs) and groups of People living with HIV/AIDS (PWAs) involved in HIV/AIDS prevention, care and mitigation activities in 10 Southern African countries: Angola, Botswana, Lesotho, Malawi, Mozambique, Namibia, South Africa, Swaziland, Zambia and Zimbabwe. The 7th SANASO Conference which will bring together many different sectors including NGOs, CBOs, FBOs, PWAs, the Media, Legal, Civil Rights groups, the Business Community and government representatives, is calling for Abstracts around the Theme and the following Sub-Themes: HIV/AIDS Stigma and the Family; Stigma in the Health Care Setting; Stigma and Faith Based Organisations; Stigma and Communication; Stigma in the Workplace.
Applications are invited from African physicians/scientists in the employment of African health research, control, and/or training institutions. Applicants must at least be middle to senior level investigators, key members of ethics (or scientific) review committees, study monitors, members of data safety monitoring boards, sponsors of research involving human subjects, members of regulatory bodies or writers/editors of biomedical journals.
Southern Africa HIV/AIDS Information Dissemination Service (SAfAIDS), is a dynamic regional NGO based in Harare. Our mission is to use information as a change agent to support ethical and effective development responses for HIV prevention, care and long-term mitigation. Central to this is an understanding of the HIV epidemic as a crucial issue for development rather than primarily as a health problem to be dealt with in isolation. Underlying our mission is an emphasis on the three priority areas of gender, human rights and development. The organisation seeks a dynamic leader to continue our development. The successful candidate must bring dedication and commitment to the organisation and its mission.
Nationals from the WHO Eastern Mediterranean Region or WHO Africa Region are invited to apply for a 12-24 month career development fellowship on management of public health training. The fellowship is a placement at the WHO Mediterranean Centre (Tunis, Tunisia) working with the professional staff located in the centre.