This report provides policy recommendations to help deliver safer and cheaper medical products to people suffering from neglected diseases in developing countries, where they are needed the most.

Although more drugs and vaccines are reaching late-stage clinical development, says the report, they are held back by a lack of funding to support clinical trials, as well as clinical research and regulatory capacity in settings where neglected diseases are endemic. This undermines safety and the validity of clinical data.

The report recommends a two-pronged approach to improving the quality and regulation of clinical trials in the developing world: establishing regional regulatory pathways for the oversight of clinical trials, and building quality and cost-efficiency into trial design and implementation. It also recommends practical steps that can be taken by donors, drug and vaccine developers, and regulatory authorities to begin implementing the changes.

This report, from medical aid organisation Médecins Sans Frontières, explores the impact of and lessons learned from the use of antiretroviral treatment (ART) for HIV/AIDS since 2000, when it began providing this to people in need of urgent treatment. It presents results of a survey conducted in 16 countries with different prevalence levels of the disease, which together account for 52.5 per cent of the global HIV/AIDS burden, and outlines the progress, strengths and weaknesses of the international response to the disease.

The report provides an overview of key treatment strategies to improve care and reduce its cost for patients and health systems; discusses the impact of decreased donor funding; and suggests policies that can help lower drug costs, for example, or foster innovations for more effective and affordable treatment. Most HIV-prevalent countries still lack the capacity to treat more than 50 per cent of their population in need of ART, or to provide ART in more than 50 per cent of existing facilities — underlining the need for more domestic and external resources.

This report examines the impact of HIV/AIDS on people's livelihoods in rural areas of Africa, China, Central Asia, India and Russia.

The authors consider labour economising technologies, and set out the potential policy options. They conclude that providing anti-retroviral drugs would have an immediate, and a long-term effect on food security and is the only way of ensuring continued access to labour in the rural sector.

This study assesses whether traditional medicine can contribute to more affordable global healthcare. It uses flowcharts to map out factors such as healthcare infrastructure and social mores that lead much of the developing world to use traditional medicine, and explains the different medicinal systems in use around the world. The author concludes that traditional medicine is a public health asset, provided it can be sufficiently standardised and verified.

This review article outlines the basic principles of traditional Chinese and Indian medicine, and the differences in how these are being integrated into national health systems. The authors discuss progress in drug discovery including traditional medicinal plants and the role of supporting industries — from breeders to manufacturers — in commercialising traditional medicine.

This report, endorsed by the African Ministerial Conference on Science and Technology, analyses the obstacles to providing better access to, and ensuring local production of, medicines in low- and middle-income African countries.

It presents a map of innovation and access activities across the continent and offers a planning tool — the Pharmaceutical Innovation Framework and Grid — to help countries do self-assessments, develop strategies, build capacity and partnerships and improve access to essential medicines.

This series of articles considers the questions and conflicts surrounding the use of patent pools for antiretroviral (ARV) treatments for HIV/AIDS.

It provides background to the debate, considers individual proposals including the UNITAID patent pool, and offers regional perspectives on the suitability of patent pools to Africa, China and India.

This series of commentaries and papers, published by The Lancet, examines the challenges to achieving a balance between trade and health.

It includes analyses of the WHO and World Trade Organisation (WTO), arguing that they facilitate trade before the health of poor people. Other authors explore issues such as global trade governance, intellectual property rights on life-saving drugs, and how trade practices adversely affect diet and exploit workers.

Richard Smith, from the London School of Hygiene and Tropical Medicine, and colleagues outline an agenda for action to strengthen the evidence on trade and health links, build capacity within health on trade issues and assert health goals in trade policy. They make specific recommendations for the WHO and WTO, donors, governments, nongovernment organisations and academics.

This paper proposes a model to provide better access to fairly priced antiretroviral (ARV) drugs for HIV-infected people in poor countries, while also safeguarding the interests of ARV manufacturers.

The authors explain what governments and brand and generic companies are doing to increase the availability of ARVs in developing countries, taking examples from Brazil, Canada, China, India, the United States and Thailand. They also discuss the implications of creating more South–South partnerships to produce and market ARVs; and the impact that the UNTAID–Clinton Foundation coalition has had on lowering ARV prices in developing countries.

The authors recommend an incentive-based strategy that includes international donors bulk-purchasing generic ARVs, individual governments providing financial relief packages for generic companies, and the WHO brokering negotiations between brand and generic companies.

Cardiovascular disease accounts for 30% of deaths worldwide and 10% of all years of healthy life lost to disease, and the figures are nearly as high in developing countries — 27 per cent and 9 per cent respectively. This compares with 10% of lives lost worldwide from HIV/AIDS, TB and malaria put together (12% in developing countries). So why have donors not invested as heavily into tackling non-communicable chronic diseases as they have with infectious ones? The authors of this article suggest several reasons: infectious diseases are in some ways easier to solve by a vaccine or drugs so it might seem sensible to use precious funding this way; Western donors may want to see epidemics contained quickly to avoid global spread; pictures of small African children dying of AIDS are more heartrending than a middle-aged man with hypertension, even if that man is supporting a large family; there is a myth that chronic diseases are more costly to prevent than infectious ones. This last issue is one that should be tackled strongly to spread awareness that low-cost methods can have an enormous effect on chronic diseases.

Vaccination for infectious diseases is a vital method of prophylaxis, and has transformed modern medicine. By contrast, research into vaccines against chronic diseases has been less successful, in part because of the increased complexity involved.

In this opinion piece, the authors outline the prospects for the development of chronic disease vaccines. These might not need to rely on the traditional method of inducing the body to produce antibodies, but rather on introducing monoclonal antibodies against specific proteins — this has so far worked well against Crohn's disease and rheumatoid arthritis.

The authors outline key hurdles in developing a successful therapeutic vaccine. Safety and efficacy are two obvious ones, but there is a third that is unique to vaccines for chronic diseases. Because these vaccines would block bodily chemicals — such as cytokines or hormones — it would not be acceptable for a vaccine to induce a life-long block (unlike a malaria vaccine, for example, where a lifelong block would be ideal).

These might be particularly useful in developing countries, say the authors. Because prophylaxis with vaccines is already a familiar concept, there should be no problem with patients' compliance, and judicious partnerships between public and private organisations could mean the vaccines are produced cheaply.

This background paper describes the basic principles behind two strategies that could be used to bring down the price of drug therapies: parallel importing (bringing drugs from another country) and compulsory licensing (restricting the monopoly rights of existing patent holders to permit generic drug production).

Other means of lowering drug prices are also briefly discussed. The paper aims to provide people with sufficient information to participate fully in the debate surrounding international trade laws and access to essential drugs (especially HIV-related medications).

The report is also available in French and Spanish.

This background briefing sets out in plain language the development aspects of intellectual property rules, from the UK government’s perspective. It describes the controversies surrounding intellectual property, lists the potential costs and benefits, outlines research into the 'appropriate level' of intellectual property rules, and discusses issues surrounding TRIPS (in particular access to medicines and biodiversity). The paper emphasises the need to maintain the flexibilities in the TRIPS Agreement, which the government believes allow all countries — including developing countries — to implement domestic intellectual property regimes that take account of their local circumstances.

The so-called 10/90 gap in health research — which refers to the fact that only about 10 per cent of funding is targeted to diseases which account for 90 per cent of the global disease burden — is a well recognised phenomenon which is being targeted by a number of initiatives. This article, by members of the Drugs for Neglected Diseases Working Group at Médicines Sans Frontières, analysed the outcomes of pharmaceutical research and development over the past 25 years and reviewed current public and private initiatives aimed at addressing the lack of research into controlling important infectious diseases in developing countries.

The authors found that of nearly 1400 new drugs marketed between 1975 and 1999, only 16 were for tropical diseases and tuberculosis (all of which had been developed with public-sector involvement). There is a 13-fold greater chance of a drug being brought to market for central nervous system disorders or cancer than for a neglected disease.

The authors conclude that there is no indication that drug development for "non profitable" infectious diseases will significantly improve in the near future and that new strategies are required to stimulate such development. They argue that a sustainable solution will require the establishment of an international pharmaceutical policy for all neglected diseases. Private sector research obligations should be explored further, and public sector not-for-profit research capacity promoted, particularly for the most neglected diseases.

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This paper was prepared by the director of the US-based Consumer Project on Technology for the United Nations Development Programme. It examines the use of a patent without permission of the patent owner.

The article focuses on models for compulsory licensing and government use of patents as a tool to increase access to medicines in developing countries. The author outlines a recommended model for government authorisations of uses of patents without the permission of the patent owner, drawing on examples from both developed and developing countries.

A detailed discussion paper that presents a human rights approach to intellectual property rights. The paper was submitted to the UN Committee on Economic, Social and Cultural Rights for its discussion on "The right of everyone to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author", which took place in Geneva in November 2000.

The paper starts with the premise that the manner in which creative works, cultural heritage, and scientific knowledge are turned into property has significant human rights implications. Various international human rights instruments have enumerated the right of an author, creator, and inventor to some form of recognition and benefit from their intellectual products — including the International Covenant on Economic, Social and Cultural Rights Article 15 (1) (c).

Recent trends underscore the need for a human rights approach to intellectual property; as various economic actors rush to stake claims over creative works and forms of knowledge — for example, through the provisions of the international agreement on Trade-Related Aspects of Intellectual Property Rights — human rights are being trampled. The author warns that unless human rights advocates provide an effective intellectual and organisational counterweight to economic interests, the intellectual property landscape will be reshaped in the years ahead without adequate consideration of the impact on human rights.