WHO Expert Committee on Specifications for Pharmaceutical Preparations

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new standards and guidelines were adopted and recommended for use: the current list of available International Chemical Reference Substances and International Infrared Reference Spectra; guidelines on the active pharmaceutical ingredient master file procedure; the procedure for assessing the acceptability of male latex condoms and that of intrauterine devices for purchase by United Nations and other agencies; and a review of International Nonproprietary Names for biological and biotechnological substances.     

WHO Expert Committee on Specifications for Pharmaceutical Preparations

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.     

The 2013 FAO report on dietary protein quality evaluation in human nutrition: Recommendations and implications

In January 2013, the Food and Agriculture Organization (FAO) of the United Nations released a new report on dietary protein quality, the result from an Expert Consultation that followed the International Symposium on Dietary Protein for Human Health, held in New Zealand during March 2011. The report, ‘Dietary protein quality evaluation in human nutrition’, is part of the call from the United Nations to promote sustainable diets and health, and was motivated mainly by advances in methods available to measure the quality of nutritional proteins with more accuracy. The main recommendation from the report concerns a new, advanced method of assessing nutritional protein quality. The FAO report recommends that the new method, known as Digestible Indispensable Amino Acid Score (DIAAS), replaces Protein Digestibility Corrected Amino Acid Score as the preferred method to describe protein quality and that it is adopted in Codex food labelling and claims guidelines. In addition, the report recommends that future research determines protein and amino acid needs that may be above the minimum requirements in certain circumstances. This article provides a summary of the report's findings, discusses its recommendations and implications, and outlines the next steps before the new protein quality method DIAAS can be fully adopted.     

A blueprint for professionalizing humanitarian assistance

International humanitarian response to crises employs 210,000 people and accounts for nearly $15 billion in spending globally each year. Most action is carried out by not-for-profit organizations working with United Nations (UN) agencies, military organizations, and commercial entities. UN agencies employ many technical experts, often retaining them for five or more years. As yet there is no international professional apparatus to promote the quality and integrity of this workforce. This paper reports on research exploring the case for professionalizing humanitarian action through an international professional association, the development of core competencies, and the creation of a universal certification system for aid workers.     

A human rights approach to the WHO Model List of Essential Medicines

Since the first WHO Model List of Essential Medicines was adopted in 1977, it has become a popular tool among health professionals and Member States. WHO's joint effort with the United Nations Committee on Economic, Social and Cultural Rights has resulted in the inclusion of access to essential medicines in the core content of the right to health. The Committee states that the right to health contains a series of elements, such as availability, accessibility, acceptability and quality of health goods, services and programmes, which are in line with the WHO statement that essential medicines are intended to be available within the context of health systems in adequate amounts at all times, in the appropriate dosage forms, with assured quality and information, and at a price that the individual and the community can afford. The author considers another perspective by looking at the obligations to respect, protect and fulfil the right to health undertaken by the states adhering to the International Covenant of Economic, Social and Cultural Rights (ICESCR) and explores the relationship between access to medicines, the protection of intellectual property, and human rights.     

Nutrition education in the context of the United Nations Standing Committee on Nutrition activities and publications, 1985-2006

The United Nations System Standing Committee on Nutrition (SCN) is a forum where United Nations (UN) agencies, bilateral partners, and nongovernmental agencies meet to harmonize and coordinate nutrition policy and programs. This report reviews the positions taken regarding nutrition education throughout SCN publications, annual sessions, and thematic working groups. The first Nutrition Policy Paper, published in 1985, was a State-of-the-Art Review that investigated 6 aspects of a nutrition education system. Later SCN publications and meetings have further addressed how to conduct effective nutrition education to maximize impact. For nutrition education to be worthwhile, it must reach significant audiences and lead to behavioral change, conditions which in turn require feasibility studies and investments in terms of personnel and resources. The SCN plays an important role to these ends through: 1) the advocacy opportunity offered by the SCN Annual Session; 2) the expertise of the working groups; and 3) the dissemination channels offered by the SCN publications and Web site.     

Overview: surveillance for selected public health indicators affecting older adults--United States.

The United Nations has proclaimed October 1, 1998, through December 31, 1999, as the International Year of Older Persons (IYOP). Federal agencies are working together to sponsor IYOP activities in the United States. To commemorate the goals of IYOP, CDC has published these surveillance summaries to describe important health issues and to highlight the role of public health surveillance for older adults aged > or =65 years in the United States. Although older adults are the focus of these surveillance summaries, persons aged 55-64 years have also been included, when data were available, as a comparison group.     

Summary of a workshop on regulatory acceptance of (Q)SARs for human health and environmental endpoints

The "Workshop on Regulatory Use of (Q)SARs for Human Health and Environmental Endpoints," organized by the European Chemical Industry Council and the International Council of Chemical Associations, gathered more than 60 human health and environmental experts from industry, academia, and regulatory agencies from around the world. They agreed, especially industry and regulatory authorities, that the workshop initiated great potential for the further development and use of predictive models, that is, quantitative structure-activity relationships [(Q)SARs], for chemicals management in a much broader scope than is currently the case. To increase confidence in (Q)SAR predictions and minimization of their misuse, the workshop aimed to develop proposals for guidance and acceptability criteria. The workshop also described the broad outline of a system that would apply that guidance and acceptability criteria to a (Q)SAR when used for chemical management purposes, including priority setting, risk assessment, and classification and labeling.     

A framework for evaluating the impact of the United Nations fellowship programmes

The United Nations (UN) System's agencies have been criticized for not adequately assessing the impact of their training and fellowship programmes. Critics point out that beyond documentation of the number of fellows that underwent training, and their immediate reaction to the experience, it is necessary to ascertain that fellows are using what they have learned, and most importantly that their institution and country are benefiting from the significant investments made in the fellowship programmes.     

Report of a planning conference concerning an international network of food data systems (INFOODS)

A small international planning conference on the topic of "An International Network of Food Data Systems" was held on January 30 to February 5, 1983, at the Rockefeller Conference and Study Center, in Bellagio, Italy. It was sponsored through the Food, Nutrition and Poverty Subprogramme of the United Nations University and supported by various US government agencies, private foundations, and the food industry. Participants included representatives from FAO, WHO, IUNS, and IUFoST. The purpose was to explore the needs for, and current limitations of, food composition data bases, especially in the international context, and to propose what was needed. The conference focused on the design and scope of an organization to be called INFOODS (International Network of Food Data Systems) which would promote international participation and cooperation in the acquisition and interchange of quality data on the nutrient composition of foods, beverages, and their ingredients in forms appropriate to meet the needs of government agencies; nutrition scientists; health and agriculture professionals; policy makers and planners; food producers, processors, and retailers; consumers. The conference identified the more important aspects of INFOODS to include: 1) a network of regional data centers; 2) an organizational/administrative framework for various expert task forces; 3) the generator and repository of special international data bases; 4) the stimulator of national data base programs; 5) a general and specific resource for persons and organizations interested in food composition data on a worldwide basis.(ABSTRACT TRUNCATED AT 250 WORDS)     

Food, nutrition, physical activity and the prevention of cancer: a global perspective – the WCRF/AICR second report

Summary   The 1997 World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) report, Food, Nutrition and the Prevention of Cancer: a global perspective, has become the most authoritative statement on the topic. Since then, new evidence has emerged, and more sophisticated methods of reviewing and assessing the literature have been developed. As a result, WCRF/AICR has invited a new expert panel of scientists, with observers from the United Nations and other international agencies, to work on the production of a second report, due to be published in 2006. In addition, a special methodology task force, commissioned by WCRF, has established a methodology to systematically review the evidence. No such methodology has, up to now, been used for assessing mainly observational data on causation of disease. A portfolio approach to the evidence is used, in which all types of study, with their advantages and disadvantages, contribute to the inference of causation. Seven academic centres from the UK, the USA and continental Europe are using this new methodology to comprehensively review evidence in systematic literature reviews. In a separate process, an expert panel will make conclusions from the systematic literature reviews. Together with other relevant evidence, the panel will use these conclusions as the basis for formulating recommendations. Set against this backdrop, the new report will act as the most authoritative global report ever to be published on the subject of food, nutrition, physical activity and the prevention of cancer. It will form the basis for coherent strategies for cancer prevention and control and will set the scientific agenda for years to come.     

Back to basics: HIV/AIDS belongs with sexual and reproductive health

The Programme of Action of the International Conference on Population and Development (ICPD) held in Cairo in 1994 offers a comprehensive framework for achieving sexual and reproductive health and rights, including the prevention and treatment of HIV/AIDS, and for advancing other development goals. The United Nations Millennium Development Goals now incorporate a target of universal access to sexual and reproductive health within the goal of improving maternal health, but combating HIV remains a separate project with malaria and tuberculosis. We present a brief history of key decisions made by WHO, other United Nations’ agencies, the United Nations Millennium Project and major donors that have led to the separation of HIV/AIDS from its logical programmatic base in sexual and reproductive health and rights. This fragmentation does a disservice to the achievement of both sets of goals and objectives. In urging a return to the original ICPD construct as a framework for action, we call for renewed leadership commitment, investment in health systems to deliver comprehensive sexual and reproductive health services, including HIV/AIDS prevention and treatment, comprehensive youth programmes, streamlined country strategies and donor support. All investments in research, policies and programmes should build systematically on the natural synergies inherent in the ICPD model to maximize their effectiveness and efficiency and to strengthen the capacity of health systems to deliver universally accessible sexual and reproductive health information and services.     

Closed to reason: time for accountability for the International Narcotic Control Board

For more than two decades, the International Narcotic Control Board (INCB) has tried to stop harm reduction and its HIV prevention programs. This posture is based on a fundamental misunderstanding of their responsibilities and of drug addiction itself – i.e. as a public health and clinical care matter made criminal by decree. A recent focal point for the Board's action has been rejecting the use of supervised injection facilities to reduce morbidity and mortality of drug injectors. They single out individual countries and attempt to bully them into rejecting such programs under the banner of the United Nations (falsely) and in the name of international treaties. Their unrelenting and unjustified badgering of signatories to the international treaties that established the INCB is not only unjustified; it is an affront to one of the core purposes of the Board itself: to ensure adequate medical supplies and safe use of controlled substances. The INCB's ill-conceived obsession with intravenousaddiction as a crime flies in the face of the medical view and policies of the World Health Organization and the universally endorsed principles of the General Assembly of the United Nations.     

International year of the family 1994: Family and gender equity in education

“Building the smallest democracy at the heart of society,” is the motto of the International Year of the Family being celebrated during 1994. The year 1994 has been designated by the United Nations to highlight issues concerning families locally, nationally, and globally during the year and to suggest recommendations for changes in policies and programs.

Since 1975, when the world celebrated International Women's Year, and again, in 1979 during International Year of the Child, evidence has been accruing regarding gender disparities in all countries. It is discouraging, yet perhaps not surprising, that in 1994 the world still awaits gender equity, even though a considerable amount of progress has been made since 1975.     

The Unite for Diabetes campaign: Overcoming constraints to find a global policy solution

Despite the fact that diabetes and other non-communicable diseases represent a significant proportion of the global burden of disease, proportionate global action has not occurred. A 2003 article reported on global constraints to the implementation of effective policies to curb non-communicable disease epidemics. These constraints include a lack of global advocacy, insufficient attention from funding agencies and governments, partnerships and interactions, capacity and resources, and global norms and standards, as well as orientation of health services to acute care. Building on these ideas, this paper will review the progress that has been made with regards to each constraint, focusing on the International Diabetes Federation's Unite for Diabetes campaign and United Nations resolution on diabetes to show how this event – driven by globalization – has helped remove some of these barriers. Additional progress in diabetes and NCD prevention and control is also highlighted. The paper concludes by outlining what still needs to happen for globalization to be an effective solution for diabetes and non-communicable disease prevention and control.     

Effect of two factors, source of sheep cells and concentration of amboceptor, on the estimated titre of rheumatoid factor

This report concerns estimates of rheumatoid factor in human sera made by the sheep cell agglutination test. In an international collaborative assay of rheumatoid arthritis serum, estimates of potency of tested sera in relation to the International Reference Preparation were on average higher when made on the continent of Europe than when made in the United Kingdom and USA. In the present study, potencies were estimated in the National Institute for Medical Research using several sources of sheep cells in the United Kingdom and several from the continent of Europe. No large differences were found when other factors in the test were held constant.     

History of Nutrition: The Long Road Leading to the Dietary Reference Intakes for the United States and Canada

The Dietary Reference Intakes (DRIs) are reference values to guide the planning and assessing of nutrient intakes in the United States and Canada. The DRI framework was conceptualized in 1994, and the first reports were issued from 1997–2004, based on work by expert panels and subcommittees under the guidance of the Food and Nutrition Board of the Institute of Medicine. Numerous conventions, challenges, and controversies were encountered during the process of defining and setting the DRIs, including the definition of the framework, the use of chronic disease endpoints, lack of data on requirements for children and youth, and methods for addressing nonessential bioactive substances with potential health benefits. DRIs may be used to plan and assess the nutrient intakes of both individuals and population groups, but the new paradigm particularly improved methods used for groups. It is now possible to estimate both the prevalence of inadequate intake and the prevalence of potentially excessive intake within a group. The DRIs have served as a potent influence on national nutrition policies, including those related to dietary guidance, food labeling, nutrition monitoring, food assistance programs, and military nutrition standards. Because of this important impact on nutrition policy, the DRIs must be based on the best possible and most up-to-date science. Unfortunately, no updates to specific DRIs are currently planned. Despite the long and challenging road that led to the current DRIs, it must not finish in a dead end. Monetary resources and political will are crucial to maintaining and continuously updating the DRIs.     

Radiation safety standards and their application: international policies and current issues

This paper briefly describes the current policies of the United Nations Scientific Committee on the Effects of Atomic Radiation and the International Commission on Radiological Protection and how these policies are converted into international radiation safety standards by the International Atomic Energy Agency, which is the only global organization-within the United Nations family of international agencies-with a statutory mandate not only to establish such standards but also to provide for their application. It also summarizes the current status of the established corpus of such international standards, and of it foreseeable evolution, as well as of legally binding undertakings by countries around the world that are linked to these standards. Moreover, this paper also reviews some major current global issues related to the application of international standards, including the following: strengthening of national infrastructures for radiation safety, including technical cooperation programs for assisting developing countries; occupational radiation safety challenges, including the protection of pregnant workers and their unborn children, dealing with working environments with high natural radiation levels, and occupational attributability of health effects (probability of occupational causation); restricting discharges of radioactive substances into the environment: reviewing current international policies vis-a-vis the growing concern on the radiation protection of the "environment;" radiological protection of patients undergoing radiodiagnostic and radiotherapeutic procedures: the current International Action Plan; safety and security of radiation sources: post-11 September developments; preparedness and response to radiation emergencies: enhancing the international network; safe transport of radioactive materials: new apprehensions; safety of radioactive waste management: concerns and connections with radiation protection; and radioactive residues remaining after the termination of activities: radiation protection response to the forthcoming wave of decommissioning of installations with radioactive materials. The ultimate aim of this paper is to encourage information exchange, cooperation, and collaboration within the radiation protection professional community. In particular, the paper tries to facilitate consolidation of the growing international regime on radiation safety, including the expansion of legally binding undertakings by countries, the strengthening of the current corpus of international radiation safety standards, and the development of international provisions for ensuring the proper worldwide application of these standards, such as a system of international appraisals by peer review.     

The bootstrap procedure in individual bioequivalence

A bootstrap-type hypothesis test procedure for assessing individual (or population) bioequivalence between two drug formulations is suggested in a draft guidance from the United States Food and Drug Administration (FDA). The purpose of this article is to study the unknown properties of this test procedure and propose some improved test procedures. We find that: the FDA's bootstrap computation is not correct; the power of the FDA's test can be very low; the use of the REML method suggested in the draft guidance does not have any advantage over the use of simpler methods such as the moment method; and the method of sample size determination in the draft guidance is inappropriate. We study the size and power of different bootstrap test procedures and suggest a method for sample size determination. It is our hope that this article will draw some attention to further research in this area, and eventually a satisfactory statistical method can be implemented for assessing individual (or population) bioequivalence.     

Refining estimates of public health spending as measured in national health expenditures accounts: the United States experience.

Providing for the delivery of public health services and understanding the funding mechanisms for these services are topics of great currency in the United States. In 2002, the Department of Homeland Security was created and the responsibility for providing public health services was realigned among federal agencies. State and local public health agencies are under increased financial pressures even as they shoulder more responsibilities as the vital first link in the provision of public health services. Recent events, such as hurricanes Katrina and Rita, served to highlight the need to accurately access the public health delivery system at all levels of government. The National Health Expenditure Accounts (NHEA), prepared by the National Health Statistics Group, measure expenditures on healthcare goods and services in the United States. Government public health activity constitutes an important service category in the NHEA. In the most recent set of estimates, Government Public Health Activity expenditures totaled $56.1 billion in 2004, or 3.0 percent of total US health spending. Accurately measuring expenditures for public health services in the United States presents many challenges. Among these challenges is the difficult task of defining what types of government activity constitute public health services. There is no clear-cut, universally accepted definition of government public health care services, and the definitions in the proposed International Classification for Health Accounts are difficult to apply to an individual country's unique delivery systems. Other challenges include the definitional issues associated with the boundaries of healthcare as well as the requirement that census and survey data collected from government(s) be compliant with the Classification of Functions of Government (COFOG), an internationally recognized classification system developed by the United Nations.