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Promoting access to medical technologies and innovation. Intersections between public health, intellectual property and trade.
Geneva, Switzerland, World Health Organization [WHO], 2012.  p.Medical technologies -- medicines, vaccines and medical devices -- are essential for public health. Access to essential medicines and the lack of research to address neglected diseases have been a major concern for many years. More recently, the focus of health policy debate has broadened to consider how to promote innovation and how to ensure equitable access to all vital medical technologies. Today’s health policy-makers need a clear understanding both of the innovation processes that lead to new technologies and of the ways in which these technologies are disseminated in health systems. This study captures a broad range of experience and data in dealing with the interplay between intellectual property, trade rules and the dynamics of access to, and innovation in, medical technologies. The study is intended to inform ongoing technical cooperation activities undertaken by the three organizations (World Trade Organization, World Intellectual Property Organization and World Health Organization) and to support policy discussions. Based on many years of field experience in technical cooperation, the study has been prepared to serve the needs of policymakers who seek a comprehensive presentation of the full range of issues, as well as lawmakers, government officials, delegates to international organizations, non-governmental organizations and researchers.
Bulletin of the World Health Organization. 1954; 11:513-520.Residual-insecticide spraying methods may lead to the eradication of malaria from a country or from an area of it, and therefore to the possibility that the spraying campaign may eventually be discontinued. This is the final target to be aimed at in planning national malaria-control campaigns. As it is now known that some anopheline vector species may develop resistance to insecticides, a plea is made that control programmes should be planned to cover such large areas and with such criteria of efficiency as to eradicate malaria and to enable the campaign to be discontinued before resistance may have developed. (author's)
Bulletin of the World Health Organization. 2006 May; 84(5):338.The context for this theme collection is the publication of the report of the Commission on Intellectual Property Rights, Innovation and Public Health. The report of the Commission -- instigated by WHO's World Health Assembly in 2003 -- was an attempt to gather all the stakeholders involved to analyse the relationship between intellectual property rights, innovation and public health, with a particular focus on the question of funding and incentive mechanisms for the creation of new medicines, vaccines and diagnostic tests, to tackle diseases disproportionately affecting developing countries. In reality, generating a common analysis in the face of the divergent perspectives of stakeholders, and indeed of the Commission, presented a challenge. As in many fields -- not least in public health -- the evidence base is insufficient and contested. Even when the evidence is reasonably clear, its significance, or the appropriate conclusions to be drawn from it, may be interpreted very differently according to the viewpoint of the observer. (excerpt)
Annals of Tropical Medicine and Parasitology. 2002; 96 Suppl 2:S3-S13.Human lymphatic filariasis (LF), the sequelae of which are commonly known as elephantiasis, results from infection with nematode filarial parasites, which are transmitted by certain species of vector mosquito. Transmission of these parasites to humans continues in more than 80 countries, with a combined population of well over 1000 million people at risk. In some situations, usually where economic progress has raised the standard of living, the disease has disappeared (Australia, South Korea, U.S.A). In other settings, specific public-health interventions, such as mass drug administrations (MDA) based on diethylcarbamazine (DEC) tablets (Suriname, Trinidad and Tobago) or the mass distribution of salt fortified with DEC (China), have led to the interruption of transmission. In most areas where LF remains endemic, the disease is an important health burden. Indeed, it probably causes the loss of more disability-adjusted life-years (DALY) than any other communicable parasitic disease except malaria. Lymphatic filariasis is a painful and profoundly disfiguring disease that has a major social and economic impact. Of the estimated 120 million people who are currently infected with the causative parasites, 40 million have the clinical manifestations of the disease. (excerpt)
Lancet. 2003 Dec 6; 362(9399):1932-1934.Schistosomiasis, a chronic and debilitating disease, is draining the economic and social development in much of the tropics, especially in sub-Saharan Africa, where 85% of its global burden is concentrated. An estimated 200 million people are infected and more than 600 million live in endemic areas. Sustained heavy infection leads to morbidity, contributes to anaemia, and often results in retarded growth and reduced physical and cognitive function in children. Recent estimates suggest that the yearly death rate of schistosomiasis in sub-Saharan Africa exceeds 200 000, which is largely attributable to renal failure or haematemesis. WHO has proposed a dual strategy to control schistosomiasis. The strategy rests on morbidity control in high-burden regions and consolidation of control measures where the endemicity has been greatly reduced.2,3 Safe, effective, single-dose antischistosomal drugs—eg, praziquantel—have been available for 25 years. The large reduction in cost to less than US$0·30 per treatment3 has been the leverage for chemotherapy-based morbidity control. However, a serious limitation of chemotherapy alone is its indefinite dependence (dependence for an unlimited period of time) on praziquantel, potentially reducing the useful life-span of this drug. Preventive measures, focused on clean water, adequate sanitation, and health education, are essential features of any long-term strategy for reduction and elimination of schistosomiasis.7,8 The absence of such measures in many past programmes stems from a severe lack of resources plus inadequate capacity and political commitment to emphasise clean water and sanitation as a basic human need. We are now witnessing a sea of change in the political landscape that should facilitate provision of clean water and sanitation. High priority has been given to this task in the United Nations Millennium Development Goals, embodied in the Millennium Declaration set forth in September, 2000. Further, it was one of the top priorities at the World Summit on Sustainable Development, held in September, 2002, in Johannesburg, South Africa, and during the 3rd World Water Forum, convened in Japan in March, 2003. The specific provision is to halve the number of people without access to clean water supply and sanitation by 2015.9,10 Linking schistosomiasis control to these initiatives has the potential to ensure long-term control and, in many instances, elimination of the disease. (author's)
Lancet Infectious Diseases. 2003 Feb; 3(2):65.A 30-year campaign has successfully ended the blight of river blindness in west Africa. This monumental achievement is the result of the Onchocerciasis Control Programme (OCP), established in 1974 under the joint auspices of the United Nations Development Programme, World Bank, WHO, and the UN Food and Agriculture Organization. (author's)
World Trade Organisation reaches agreement on generic medicines. New deal will make it easier for poorer countries to import cut-price generic drugs made under compulsory licensing.
Lancet. 2003 Sep 6; 362(9386):807.After a bitter struggle over patent protection, the World Trade Organisation (WTO) reached agreement in Geneva on Aug 30 to allow developing countries stricken with HIV/AIDS, tuberculosis, and malaria to import cheap generic drugs. (excerpt)
Challenges for communicable disease surveillance and control in southern Iraq, April-June 2003. Letter from Basrah.
JAMA. 2003 Aug 6; 290(5):654-658.The recent war in Iraq presents significant challenges for the surveillance and control of communicable diseases. In early April 2003, the World Health Organization (WHO) sent a team of public health experts to Kuwait and a base was established in the southern Iraqi governorate of Basrah on May 3. We present the lessons learned from the communicable disease surveillance and control program implemented in the Basrah governorate in Iraq (population of 1.9 million) in April and May 2003, and we report communicable disease surveillance data through June 2003. Following the war, communicable disease control programs were disrupted, access to safe water was reduced, and public health facilities were looted. Rapid health assessments were carried out in health centers and hospitals to identify priorities for action. A Health Sector Coordination Group was organized with local and international health partners, and an early warning surveillance system for communicable disease was set up. In the first week of May 2003, physicians in hospitals in Basrah suspected cholera cases and WHO formed a cholera control committee. As of June 29, 2003, Iraqi hospital laboratories have con firmed 94 cases of cholera from 7 of the 8 districts of the Basrah governorate. To prevent the transmission of major communicable diseases, restoring basic public health and water/sanitation services is currently a top priority in Iraq. Lack of security continues to be a barrier for effective public health surveillance and response in Iraq. (author's)
Lancet. 2003 Jul 12; 362(9378):169.Artesunate is the key antimalarial drug in the treatment of multidrugresistant Plasmodium falciparum malaria in mainland southeast Asia. In China, Burma (Myanmar), Laos, Cambodia, and Vietnam it is widely available through the private sector. Widespread criminal production and distribution of counterfeit artesunate tablets in this region has resulted in the deaths of many people who would otherwise have survived their malaria infection. The spurious artesunate tablets contain no active drug. They are labelled to resemble a product, manufactured by Guilin Pharmaceutical Company, Guilin, People’s Republic of China, that is the most commonly available brand of artesunate. (excerpt)
Unintended consequences: drug policies fuel the HIV epidemic in Russia and Ukraine. A policy report prepared for the UN Commission on Narcotic Drugs and national governments.
New York, New York, Open Society Institute, International Harm Reduction Development program, 2003. 16 p.Taking action now to reduce HIV transmission rates and treat those already infected is critical. With the goal of avoiding adverse effects on social welfare and public health, the Russian and Ukrainian governments should reconsider how they interpret international treaties. Policy changes should be made in the following areas: Harm reduction. The governments should play an active role in establishing and supporting a large, strategically located network of harm reduction programs that provide services for IDUs, including needle exchange, HIV transmission education, condom distribution, and access to viable treatment programs such as methadone substitution. Similar services should be available in all prisons. Education. Simple, direct, and dear information about HIV transmission should be made available to all citizens-especially those most at risk. Similarly, society at large should be educated about the realities of drug use and addiction as part of an effort to reduce stigma. Discrimination and law enforcement abuse. Public health and law enforcement authorities should take the lead in eliminating discrimination, official and de facto, toward people with HIV and marginalized risk groups such as drug users. Authorities must no longer condone or ignore harassing and abusive behavior, including physical attacks, arrest quotas, arbitrary searches, detainment without charges, and other violations of due process. HIV-positive people, including IDUs, should be included in all policy discussions related to them in the public health and legal spheres. Legislation. Laws that violate the human rights of people with HIV and at-risk groups should be repealed or restructured to better reflect public health concerns. Moving forward with the above strategies may make it appear that the governments are backing away from the goals and guidelines of the UN drug conventions. They may be criti- cized severely by those who are unable or unwilling to understand that meeting the goals of the conventions, some of which were promulgated more than 40 years ago, is far too great a price to bear for countries in the midst of drug use and HIV epidemics. Governments ultimately have no choice, though, if they hope to maintain any semblance of moral legitimacy among their own people. (excerpt)
Cambridge, Massachusetts, Harvard Center for Population and Development Studies, 2002 Apr. ix, 205 p. (Harvard Series on Population and International Health)This book presents the results of the workshop. The essays in this volume offer some fresh perspectives on partnerships, probe some troubling questions, and provide empirical evidence of both benefits and challenges of public-private partnerships. The participants in the meeting also achieved some progress in creating a shared vocabulary, or at least shared understanding, on points of contention, suggesting that dialogue among partisans in public health can help move debates about critical issues forward. (excerpt)
WHO must continue its work on access to medicines in developing countries. Il faut que l'OMS poursuive son travail en vue de l'accès aux médicaments dans les pays en développement.
Lancet. 2003 Jan 4; 361(9351):3.The driving force behind all of WHO’s actions should be public health, with no compromises accepted that would ultimately prevent those needs from being effectively and swiftly met. In the face of rising infectious diseases such as AIDS, TB, and malaria, and the increasing marginalisation of health problems that do not affect the developed world, the importance of an international, independent organisation that is brave, aggressive, and vocal in its defence of global public health has never been more important. (excerpt)
ECONOMIST. 1999 Aug 14; 352(8132):11-2.The rising health problems in developing countries present a challenge to both aid agencies and developing-country governments. One major aspect of poor health among poor nations is their lack of access to medicines. The World Bank, WHO, and other agencies have formed alliances with pharmaceutical companies in order to promote research on affordable drugs for neglected tropical ailments. This is not enough: the main solution lies in the contribution that local governments can make toward the promotion of good health through strategies that improve nutrition and through improvements they can make in public health utilities such as drinking water and sewage systems. It is local governments responsibility to promote health education through encouraging changes in habits, providing primary care, and making medicines more accessible to their poor citizens.
Geneva, Switzerland, WHO, Action Programme for the Elimination of Leprosy, 1997. , 27 p. (WHO/LEP/97.4)The World Health Organization's (WHO's) Action Program for the Elimination of Leprosy made considerable progress in 1997, largely as a result of the continued reliability of multidrug therapy (MDT). At the beginning of 1997, there were about 1,150,000 leprosy cases worldwide, 888,340 of which were registered for treatment. MDT has fully cured more than 8.4 million people of leprosy since its introduction in 1981 and the number of countries with prevalence rates above 1/10,000 population has declined from 122 in 1985 to 55 at the beginning of 1997. The target of eliminating leprosy as a public health problem by the year 2000 by reducing the prevalence to below 1/10,000 should be reached. However, the drive to distribute MDT must continue since there may be provinces, districts, or even a limited number of high-endemicity countries where prevalence exceeds this rate. The Seventh WHO Expert Meeting (1997) shortened the drug regimen for multibacillary leprosy from 24 to 12 months. In patients with paucibacillary leprosy with only one skin lesion, a single dose of three antileprosy drugs in combination was deemed sufficient to produce a cure. These chemotherapy simplifications are expected to ease the burden of both patients and health services. This 1997 status report updates the situation in terms of leprosy trends in the 28 endemic countries, progress with MDT coverage, chemotherapy, and monitoring and evaluation. An appendix presents statistics on registered cases, prevalence, case detection rates, MDT coverage, and cumulative number of cases cured in endemic countries.
Geneva, Switzerland, WHO, Action Programme for the Elimination of Leprosy, . vi, 106 p. (WHO/LEP/97.7)Elimination of leprosy by the year 2000--a goal set at the 1991 World Health Assembly--is a realistic possibility as a result of 10 years of successful experience with multidrug therapy. Almost all major endemic countries have implemented action programs to eliminate the disease. Key to leprosy elimination is making the World Health Organization (WHO)-recommended antileprosy drugs accessible to all patients, including those living in remote areas. This guide was prepared by WHO's Action Program for the Elimination of Leprosy to enable health workers in endemic countries (especially field workers) to contribute to this goal. It can be used for self-learning or for training courses. The pocket-sized guide includes information on the leprosy elimination strategy, diagnosis, classification of leprosy, organizing diagnostic services, treatment, management of complications, patient care and referral activities, and organizing multidrug therapy services.
NEW ENGLAND JOURNAL OF MEDICINE. 1998 Jun 4; 338(23):1641-9.Data derived from cross-sectional surveys and surveillance reports were used to identify the prevalence of resistance to the four first-line drugs for the treatment of tuberculosis in the 35 countries participating in the World Health Organization-International Union Against Tuberculosis and Lung Disease Global Project on Anti-Tuberculosis Drug Resistance Surveillance (1994-97). The median number of patients studied in each country was 555. Resistance to antituberculosis drugs was found in all 35 countries and regions, confirming the global nature of the problem. Among patients with no prior treatment, a median of 9.9% (range, 2-41%) of Mycobacterium strains were resistant to at least one drug. Resistance to isoniazid (7.3%) and streptomycin (6.5%) was more common than resistance to rifampin (1.8%) or ethambutol (1.0%). The prevalence of primary multidrug resistance was 1.4%. Among patients with histories of treatment for 1 month or less, the prevalence of resistance to at least one drug was 36.0% (range, 5.3-100%) and that of multidrug resistance was 13% (range, 0-54%). The overall prevalences were 12.6% (range, 2.3-42.4%) for single-drug resistance and 2.2% (range, 0-22.1%) for multidrug resistance. The highest prevalences of multidrug resistance were recorded in Russia, Asia, the Dominican Republic, and Argentina. It is recommended that surveys be repeated in these 35 countries around the year 2000 to determine trends in multidrug resistance over time and in relation to programmatic interventions.
Editor's introduction [to the proceedings of the Second International Conference on Health Law and Ethics, London, July 16-21, 1989].
LAW, MEDICINE AND HEALTH CARE. 1990 Spring-Summer; 18(1-2):11-4.The editor introduces selected proceedings from the 2nd International Conference on Health Law and Ethics. Over 600 participants from more than 60 international cooperating organizations and the World Health Organization (WHO) were in attendance. Papers considered to be among the finest from the conference are included in the proceedings, and represent a widely-diverging range of cultures and approaches. While this introduction points repeatedly to the United States' health system for contrast and comparison with other systems, the conference paid special attention to global dimensions, wealth and poverty, and innovative ways of approaching health law and ethics in other nations and regions. The publication introduced by the editor considers 6 main topics, the 1st being AIDS medicine, law, and public health in industrialized and 3rd world countries. In light of the ethical challenges in international research, resource distribution, prevention, and blood supply protection, and drug and vaccine availability, steps by WHO's Global Program on AIDS and the Council for International Organizations of Medical Sciences to develop international ethical guidelines for research and development of therapeutic agents are discussed. Comparative treatments of euthanasia, medical malpractice, resource allocation and service inequity, abortion and family planning, and the state's role in medical coercion are explored.
Washington, D.C., National Academy Press, 1988. x, 239 p.The Committee for the Oversight of AIDS Activities presents an update to and review of the progress made since the publication 1 1/2 years ago of Confronting Aids. Chapter 1 discusses the special nature of AIDS (Acquired Immunodeficiency Syndrome) as an incurable fatal infection, striking mainly young adults (particularly homosexuals and intravenous drug users), and clustering in geographic areas, e.g., New York and San Francisco. Chapter 2 states conclusively that HIV (Human Immunodeficiency Virus) causes AIDS and that HIV infection leads inevitably to AIDS, that sexual contact and contaminated needles are the main vehicles of transmission, and that the future composition of AIDS patients (62,000 in the US) will be among poor, urban minorities. Chapter 3 discusses the utility of mathematical models in predicting the future course of the epidemic. Chapter 4 discusses the negative impact of discrimination, the importance of education (especially of intravenous drug users), and the need for improved diagnostic tests. It maintains that screening should generally be confidential and voluntary, and mandatory only in the case of blood, tissue, and organ donors. It also suggests that sterile needles be made available to drug addicts. Chapter 5 stresses the special care needs of drug users, children, and the neurologically impaired; discusses the needs and responsibilities of health care providers; and suggests ways of distributing the financial burden of AIDS among private and government facilities. Chapter 6 discusses the nomenclature and reproductive strategy of the virus and the needs for basic research, facilities and funding to develop new drugs and possibly vaccines. Chapter 7 discusses the global nature of the epidemic, the responsibilities of the World Health Organization (WHO) Global Program on AIDS, the need for the US to pay for its share of the WHO program, and the special responsibility that the US should assume in view of its resources in scientific personnel and facilities. Chapter 8 recommends the establishment of a national commission on AIDS with advisory responsibility for all aspects of AIDS. There are 4 appendices: Appendix A summarizes the 1986 publication Confronting Aids; Appendix B reprints the Centers for Disease Control (CDC) classification scheme for HIV infections; Appendix C is a list of the 60 correspondents who prepared papers for the AIDS Activities Oversight Committee; and Appendix D gives biographical sketches of the Committee members.
[Record of the second meeting of the WHO Collaborating Centers on AIDS] Deuxieme reunion des centres collaborateurs de l'OMS pour le SIDA: memorandum d'une reunion de l'OMS.
BULLETIN OF THE WORLD HEALTH ORGANIZATION. 1986; 64(2):221-31.Participants at the 2nd meeting of World Health Organization (WHO) collaborating centers on AIDS (acquired immune deficiency syndrome) held in Geneva in December 1985 reported on progress since the 1st meeting in September 1985 and made a number of recommendations for future action in the areas of information, education, and prevention; reference reactants and tests of anti-HTLV-III antibodies; epidemiologic evaluation; and research on vaccines and antiviral agents. It was recommended that ministries of health, education, and social services provide the public with timely and accurate information on AIDS, that physicians, nurses, and similar personnel inform the ill and the public about AIDS and its prevention, and that school age children and young people be informed about AIDS and how to avoid infection. Systems of registration of AIDS cases should be implemented in order to provide the WHO and member states with data on the international level. Standardization and availability of serologic tests is also required. Instructions for avoiding infection should be provided for health personnel and others caring for AIDS patients, for individuals providing personal services to the public, and to ensure adequate methods of disinfection. Instructions for preventing AIDS should discuss sexual and parenteral transmission as well as perinatal transmission. Specific recommendations for education and family placement for children with AIDS have already been published. Instructions should be provided for prisons and similar estabilshments. Requiring international travellers to provide certificates attesting to their AIDS-free status is not justified as a preventive measure. The significant existing demand for reference reactants including human serums with anit-HTLV-III antibodies and controls is being addressed by several institutes in different countries, but it would be premature to furnish reference reactants other than serums. The WHO collaborating centers should furnish materials for purposes of training in diagnostic techniques. Existing tests for diagnosis and confirmation should be imporved and new tests should be developed, with particular attention to simple methods appropriate for use in developing countries. It will be necessary to establish international biological standards for the HTLV-III virus, but the required specifications are not yet known. Technical cooperation and epidemiological evaluation must be planned separately, based on the different prevalence of infections and technical expertise of different countries. A clinical definition of AIDS is needed for countries lacking resources needed to apply the Centers for Disease Control/WHO definition. Surveillance methods and laboratories can be installed with WHO assistance, to help evaluate the extent of AIDS infection in different countries. Later technical cooperation in the areas of continued surveillance and laboratory capacities will depend on results of the initial evaluation in each country. Research is currently underway in several countries of possible vaccines and drugs. Careful preclinical studies should be done to evaluate the toxicity of an agent before clinical studies are conducted. Convenient animal models should be sought for future research. 3 annexes to this report specify methods of disinfection; general principles of preventing transmission of the AIDS virus through parenteral exposure or following donation of organs, sperm, or other tissue; and a proposed definition of clinical cases of AIDS.
World Health Organization Technical Report Series. 1982; (674):1-75.The World Health Organization (WHO) Scientific Group on Treponemal Infections met in Geneva during October 1980 with the objective of reviewing all aspects of the treponematoses and of providing updated standards and guidelines for their diagnosis, treatment, and control. WHO has always attached great importance to the sexually transmitted diseases and to the nonvenereal endemic treponematoses, because of the heavy burden they impose on both the individual and the society. This report of the WHO Scientific Group on Treponemal Infections covers the following: epidemiological aspects (syphilis and nonvenereal treponematoses); clinical aspects; laboratory aspects (diagnosis, microcsopic tests used to identify treponemes, serological tests for the detection of antibodies in individuals with treponemal infections, and diagnosis of neurosyphilis by cerebrosponal fluid (CSF) examination); management aspects; control aspects; and research aspects. The diagnosis of a primary or secondary treponemal infection should be established by identification of the causative organisms using darkfield microscopy. A reliable nontreponemal serological test has confirmatory value in such circumstances. A combination of nontreponemal and treponemal serological tests is essential for the diagnosis of all other stages of syphilis. In clinical outposts where nonmedical health workers deliver health care, simple clinical algorithm may help to ensure that genital ulcers and other clinical manifestations of treponemal infections are treated immediately with adequate doses of suitable penicillin preparations. After nearly 40 years, penicillin remains the drug of choice in the treatment of all forms of syphilis. The following were among the recommendations made by the Scientific Group on Treponemal Infection: the following categories should be used in reporting cases of syphilis, i.e., primary and secondary infections, early latent infections, late latent infections, symptomatic late infections, congenital infections in patients under 2 years of age, and congenital infections in patients 2 years of age and older; improved teaching should have the highest priority, particular attention being directed to congenital syphilis; darkfield microscopy should be the preferred diagnostic test for infectious treponemal disease; physicians should be cautioned never to use less than the recommended dosages of penicillin; practical guidelines should be established on the efficient epidemiological analysis of the extent of syphilis, the logistics of syphilis control programs, and the indications for, and application of, various control strategies; and the highest priority should be given to the prevention of congenital syphilis.
[Geneva, Switzerland], WHO, 1982. 17 p. (HRG/CRU.1/Rev.1/Mtg.1)In 1979, a WHO team collaborated with national personnel in The Gambia in developing a comprehensive primary health care (PHC) plan of action for the period 1980/81 - 1985/86. In his address to the legislature in August, 1980, the president declared that the plan involved the active participation of local communities and emphasized programs for health promotion and disease prevention. This monograph reports on a meeting of the Gambian Ministries of Economic Planning and Industrial Development and of Health, Labor and Social Welfare in June 1982. Improvements in rural health are a basic need. In order to provide PHC, it was fully realized that a strong supportive infrastructure was essential. The village sensitization program was considered as vital for success. Not 1 village has rejected PHC or its responsibilities. The training program for community health nurses, village health workers and traditional birth attendants was proceeding according to plan for the various levels. Recognizaing that an efficient drug supply was essential, concomitant action had been taken to reorganize the central store. Another essential element without which success could not be achieved related to provision of transport and facilities for their maintenance, so that communications could be assured with rural areas. The need for a radio network to link 6 staions and 26 sub-stations was stresses. The list of participants and the agenda are attached as are the requirements for external support for the planned provision of PHC which were considered by the participants of the meeting.