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Reports

Displaying 1-9 of 9 key documents

Safer, Faster, Cheaper Improving Clinical Trials and Regulatory Pathways to Fight Neglected Diseases

Source: Working Group on Clinical Trials and Regulatory Pathways | November 2011

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.

Assessment of medicines regulatory systems in Sub-Saharan African countries: An overview of findings from 26 assessment reports

Source: WHO | December 2010

This report, published by the WHO, collates data obtained over 8 years by WHO assessment teams working in 26 African countries. The teams analysed different aspects of national regulatory systems such as management, funding and quality control procedures. Poor regulatory systems in impoverished nations are often blamed for allowing the spread of counterfeit drugs in the developing world.  The report says that although mechanisms for drug regulation existed in every country, and there were guidelines for quality-control inspections, these were often not well executed because of a severe lack of resources and staff.

National policy on traditional medicine and regulation of herbal medicines — Report of a WHO global survey

Source: WHO | May 2005

This WHO report summarises the findings of a global survey on national policy and regulation of traditional medicine in 141 countries. It presents data on existing policies for traditional medicine and regulation of herbal medicines. The report highlights common hurdles to implementing these and provides a profile of each country surveyed.

Traditional medicine: modern approach for affordable global health

Source: WHO | March 2005

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.

Antibiotic resistance: an ecological perspective on an old problem

Source: The American Academy of Microbiology

This report summarises current understanding of antibiotic resistance, the scope of the problem, and the methods available for detecting and preventing it. It highlights unique challenges faced by developing countries including poor research infrastructure and counterfeit antibiotics.

The authors highlight the need to build laboratory capacity, improve diagnostic tools, establish surveillance programs and implement tighter controls on antibiotic use in these countries.

Using climate to predict infectious disease epidemics

Source: WHO | 2005

This report from the WHO assesses the potential for creating early warning systems for vector-borne disease. It reviews the current state of research for several diseases such as dengue fever, leishmaniasis, malaria and West Nile virus.

The report includes an algorithmic framework for developing early warning systems, outlining data requirements and the different components of the system. It also contains two useful tables: one on the sensitivity of different infectious diseases to climate; and one summarising the existing research, identifying in which region the disease is most common, data availability and proposed actions.

A key problem in developing early warning systems, as highlighted by this report, is that non-climatic risk factors such as population immunity and food security strongly affect the potential for a disease outbreak. Equally challenging is the poor disease surveillance in many developing countries — the authors call on these countries to strengthen these systems, to help in the fight against climate change.

The report concludes that it will be important for researchers not to design these systems in isolation — health policymakers should be included at all stages of the design.

Global climate change and extreme weather events: Understanding the contributions to infectious disease emergence

Source: Institute of Medicine | 2008

This extensive report from the Institute of Medicine of the US National Academies takes on the considerable challenge of understanding how, and to what extent, climate change will affect infectious diseases.

The report provides detailed summaries of current knowledge on diseases such as cholera and rift valley fever. Several pages are devoted to reviewing the latest climate science to contextualise the effect on infectious disease; it also includes several maps on climate anomalies to show how they are linked to disease.

One section highlights methods to assess climate change impacts on infectious diseases. These include analyses of historical records; monitoring programs, especially those that track disease in wild animals; and comparisons of satellite-derived environmental measurements with epidemiological data.

The report concludes with an analysis of the challenges facing policymakers. In many cases, it says, the best public health measures against climate change are those that strengthen health systems in general, such as better training for professionals and better disease surveillance. Policymakers will need to move away from the traditional thinking of individual policies for individual diseases, towards a joined-up approach aimed at tackling "systemic, long-term" stresses that cause a range of effects.

Research capacity for mental health in low- and middle-income countries: Results of a mapping project

Source: WHO/Global Forum for Health Research | 2007

This joint publication between the World Health Organization and the Global Forum for Health Research reveals mental health research capacity in 114 low-income and middle-income countries in Africa, Asia, and Latin America and the Caribbean. The extensive review identified over 10,000 articles, 4,633 mental health researchers and 3,829 other stakeholders. The authors argue that this is "the first systematic attempt to confirm the pressing needs of improving research capacity in mental health".

The publication provides useful details in table and charts, analysed by group of stakeholders and by region, on topics such as: researchers' profiles; priority-setting process; amount and type of research production; services and technical support available to them; courses and trainings offered; funding patterns; and dissemination of research findings. The appendix provides two extensive lists — by country — of policy and practice that resulted from research evidence, as well as research evidence that was never translated into policy and practice.

Nine recommendations indicate how the management of mental health research can be strengthened so that it meets the national needs of the countries as well as contributes to the global fund of knowledge. The authors say their report thus enables evidence-based decision-making in funding and priority setting in the area of mental health research in low-income and middle-income countries.

Preventing chronic diseases: a vital investment

Source: World Health Organization | October 2005

This extensive report was one of the first to document the scale of the problem of chronic diseases in developing countries, and crucially, to offer guidance on feasible and practical methods of tackling them.

The document starts by laying out in detail the profiles of chronic diseases in different countries, projections for the future, and how chronic diseases are linked with poverty. It also examines in depth the economic costs of such diseases and the macroeconomic consequences of not tackling them quickly enough. The authors outline interventions — whether community, workplace, or school — that have robust evidence supporting them.

The report ends with a call for a unifying framework of global health experts and stakeholders, in which the government has a key role. It also specifies what policymakers need to do to ensure that measures to tackle chronic diseases are put into action.