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Journal of Health Care Finance. 2010; 36(4):75-79.When the United Nations declared "health care for all" (at the conferences at Alma-Ata in 1978 and the Ottawa Charter in 1986),(1) the declarations were largely premature to impact the upcoming HIV/AIDS epidemic. These UN declarations still apply today, as multitudes of humanity continue to die from what amounts now to be a treatable chronic disease. Can the wealthier, industrialized countries stand by and watch the decimation of the populations of the developing world by HIV / AIDS? The global "health 9/10 gap," relates that only 10 percent of global heath resources go to developing countries - i.e., those having 90 percent of the poorest world populations. (2) The World Bank/World Health Organization has been at the forefront of providing resources for the global HIV/AIDS epidemic, (3) but for many countries of the developing world (especially Sub-Saharan Africa) it may be too little, too late. This work explores the application of an ecological model to global policy against HIV/AIDS, highlighting access to antiretroviral drugs (ARV). ARV distribution is constrained by patents and laws protecting the intellectual property rights of the international pharmaceutical corporations. In response to this situation, more questions arise. Will governments in the developing world invoke compulsory licensing (patent-breaking) in their negotiations with the international pharmaceutical corporations to provide medications against HIV/AIDS in their countries? Can international political and financial negotiations with these pharmaceutical corporations speed the growing push for a solution to this solvable crisis? The answers may lie in the "Brazilian model," that is a developing world government using all means available to provide ARV drugs for all its citizens with HIV/AIDS. The basis of this model includes negotiating with the pharmaceutical corporations over patent rights and importation of copied drugs from the Far East.
Symposium proceedings. HPV Vaccines: New Tools in the Prevention of Cervical Cancer and Other HPV Disease in Asia and the Pacific, Bangkok, Thailand, 2 November 2006.
Bangkok, Thailand, Family Health International [FHI], Asia / Pacific Regional Office, 2007. 55 p.Cervical cancer -- the most preventable and treatable of all cancers -- is the most common cancer among women in developing countries. This report presents the proceedings of a November 2006 symposium organized by FHI in Bangkok, Thailand, that brought together leading specialists in immunization, cancer prevention, and other disciplines to start building consensus on a comprehensive approach to programming for the prevention and early detection of cervical cancers in the Asia region. Presentations covered such topics as improved screening methods for cervical cancer, the latest research on human papillomavirus (HPV) vaccines, and country and social perspectives related to HPV vaccination. Participants concluded that there is a need to 1) further educate health professionals, especially so they can influence policymakers and service planners, and 2) devise communication strategies that will shape debates on HPV vaccines.
[Bangkok, Thailand], ITPC, 2007 Dec.  p.In the first section of the report, nine country teams provide first-hand reports on central issues related to AIDS service scale-up in their countries. Each demonstrates that increasing access to AIDS treatment brings not only better life and new hope, but also shines light on challenges and effective approaches to a spectrum of health, poverty, and human rights issues. In part two of this report, 14 national teams review drug access issues, and find that global and national processes for AIDS drug registration are burdened by inefficiencies, duplications, delay, and, in some instances, corruption. In many cases key ARVs, particularly newer and second-line therapies, are not yet registered in high impact countries - an administrative roadblock that puts lifesaving care out of reach for hundreds of thousands of people. The report makes a number of concrete recommendations to the key players who are responsible for making near universal access to AIDS treatment a reality by 2010. (excerpt)
Social Science and Medicine. 2007 Jan; 64(2):287-291.This article builds on a previous study which found low numbers of patent applications for HIV antiretroviral drugs in African countries. A high level of variation was noted across individual countries, and consequently, the present study has sought to account for sources of the variation through statistical analyses. First, a correlation between the number of patents and HIV infection rate was observed (r = 0.448, p < 0.001). T-tests identified significantly higher numbers of patents in national members of two intellectual property organizations (IPOs)--African Regional Intellectual Property Orginisation (ARIPO) and the Organisation Africaine de la Proprie´ te´ Intellectualle (OAPI)--than in countries who did not belong to an intellectual property organization. The relationship between IPO membership and number of patents was also statistically significant in a multivariate Poisson regression. These findings demonstrate that higher numbers of patents are found in countries where they are more easily filed. This has important policy implications given the worldwide trend toward increased recognition of pharmaceutical patents. (author's)
Bulletin of the World Health Organization. 2006 May; 84(5):405-411.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. (author's)
Access to HIV / AIDS drugs and diagnostics of acceptable quality. Procurement Quality and Sourcing project. Manufacturers and suppliers whose HIV-related medicines have been found acceptable, in principle, for procurement by UN agencies. 18th ed.
Geneva, Switzerland, WHO, 2004 Aug 9. 19 p.A "Procurement, Quality and Sourcing Project: Access to HIV/AIDS drugs and diagnostics of acceptable quality" was actively started by WHO in collaboration with other United Nations Organizations (UNAIDS, UNICEF, and UNFPA) in March 2001. The World Bank supports this initiative. The background to the project is described in the project description. The procedure for assessing the acceptability in principle of HIV/AIDS drugs comprises various components including 1) The evaluation of product data and information provided by manufacturers and suppliers, and 2) Inspection of manufacturing sites. Due to the particular properties of several substances used in some pharmaceutical finished dosage forms in the treatment of HIV/AIDS (e.g. chiral activity, isomerism, sensitivity to relative humidity etc.), and the current status where there are no Pharmacopoeia monographs and standards available for several substances and finished products, WHO appointed experts have performed a comprehensive and rigorous evaluation of the products included in the list, with a view to establishing their compliance with international standards. (excerpt)
[Brazilian policy for the distribution and production of antiretroviral drugs: a privilege or a right?] A política brasileira de distribuição e produção de medicamentos anti-retrovirais: privilégio ou um direito?
Cadernos de Saude Publica. 2002 Jan-Feb; 18(1):213-219.This article focuses on the Brazilian National AIDS Program and its policy of distributing and producing antiretroviral drugs, emphasizing links between local decisions and global HIV/AIDS policies. Emphasizing recent developments in the Brazilian and international scenario with regard to access to treatment for people with HIV/AIDS, the article highlights the participation by the pharmaceutical industry, governments, civil society, and UN agencies in establishing responses to the pandemic. The author concludes by identifying transnational activism as a key response to both the power of pharmaceutical corporations and the law of the market (including patent laws), thus fostering global solidarity for people with HIV/AIDS. (author's)
Network. 2003; 22(4):11.For female condom users, use of a new female condom for every act of sexual intercourse continues to be recommended by the World Health Organization (WHO). Likewise, the female condom (a potential alternative for the male condom) is approved only for one-time use by the U.S. Food and Drug Administration. Such positions by public health experts reflect, in part, concerns that women may be unable to clean the device adequately to make its reuse safe. However, female condom reuse has been reported in a number of settings, likely because many women cannot afford to buy multiple female condoms. Recognition that reuse is occurring -- and may be acceptable, feasible, and safe in some circumstances -- led WHO to declare in July 2002 that "the final decision on whether or not to support reuse of the female condom must ultimately be taken locally." (excerpt)
Lancet. 2002 Mar 30; 359:1134.In an effort to improve access to HIV/AIDS drugs, the WHO published on March 20, 2002 its first list of products that meet the agency’s recommended standards and are thus classified as suitable for procurement by UN agencies. The list, which includes 40 products from eight manufacturers, features 11 antiretrovirals and five products for opportunistic infections. The Indian firm as well as the Medecins Sans Frontieres welcomed the inclusion of generic manufacturers although International Federation of Pharmaceutical Manufacturers Associations, which represents international companies with patents to defend, was more critical. However, WHO said it was satisfied that the approval process conformed with its own rigid norms. It is said that products and manufacturing sites would be assessed at regular intervals and will be removed from the list if they no longer comply with the standards.
New York Times on the Web. 2002 Mar 21;  p..In a move that could help bring down the price of AIDS medicines for poor countries, the WHO released its first list of manufacturers of safe AIDS drugs. The list includes 41 different formulations of drugs, among are 11 antiretroviral drugs and five for infections that often accompany AIDS. Of the total, 26 come from major manufacturers: GlaxoSmithKline, Bristol-Myers Squibb Company, Roche Holding, and Abbott Laboratories. However, 10 were from Cipla Limited, the generic drug maker based in Bombay, India, that was the first to try breaking Western patent monopolies by offering AIDS therapy for $350 a year to charities and African governments. Cipla products accepted by WHO include the antiretrovirals nevirapine, zidovudine, and lamivudine. It is said that the list will encourage price competition in poor nations by telling health officials which of the hundreds of generic suppliers make safe drugs. Up to 100 more applications from manufacturers are awaiting approval from the WHO and UN.
SANASO NEWSLETTER. 2000 Jan-Mar; (35):11.Following an AIDS consultation in Harare, experts agreed to recommend the use of cotrimoxazole in sub-Saharan Africa. It is noted that the drug has proved to be effective in warding off some of the infections to which HIV-infected patients are prone. The Joint UN Programme on HIV/AIDS and WHO have welcomed this recommendation for the drug's use among HIV-positive patients in Africa; however, some scientists argue that the use of the drug in sub-Saharan is questionable, because the parasitic type of pneumonia, for whose prevention the drug is routinely used in the West, is not as prevalent in Africa. In addition, concerns have been expressed that most patients in Africa will not have access to, or be able to afford alternative drugs if they develop resistance to cotrimoxazole. Despite these issues, the experts in Harare agreed to recommend the drug as a medium-term solution while awaiting the results of research into other antimicrobial agents.
BMJ (CLINICAL RESEARCH ED.). 1996 Oct 26; 313(7064):1085.Jacqui Wise reports that artemether, the active ingredient of a traditional Chinese remedy for fever, has been found to be as effective as quinine in severe malaria. She states that most deaths from malaria occur in Africa and then quotes Dr. Peter Trigg, a scientist with the World Health Organization's malaria unit, as saying that the WHO appreciates the operational advantages of the new drug in the field but will not "recommend its introduction into Africa because of fears that ... resistance would spread." This decision by the WHO is unethical and unprofessional. The organization is condemning African patients with malaria to the possibility of death even while it is announcing that a new drug has shown better outcomes than occur with quinine. It is incredible that an organization that is part of the United Nations and that is charged with implementing health for all in the world by 2000 should decide to abandon patients to possible death from malaria on the basis of the lame excuse that resistant strains might develop if a new drug was introduced. Would this kind of trial be approved by an ethics committee? Rather than deprive African patients of the benefits of a new drug, the WHO should use its influence and resources to educate the governments and people in Africa about the dangers of misuse of drugs and the emergence of resistant strains of malaria. (full text)
QUINACRINE STERILIZATION NEWSLETTER. 1996 Jul; 1(1):1.The QS Newsletter is published to provide information on progress in development of the quinacrine pellet method of female sterilization. Specialists in the population field describe this method as the most important contraceptive to emerge since the introduction of the Pill. Yet it is largely unknown. There are several reasons for this unfortunate state of affairs. First, it involves a drug that has been in the public domain for decades. Because information on its use for sterilization has been published, it cannot be patented. So it is not an attractive investment for a pharmaceutical house. Secondly, neither the World Health Organization (WHO) nor the regulatory agency of any industrialized country has given the method its blessing. The estimates are that it would take about 8 years and $8 million to obtain such approval. Family Health International with support of the United States Agency for International Development (AID) has twice sought approval and twice given up the effort. While little is known of this method, even among population experts, its use continues to spread in developing countries. By now, over 100,000 women in various settings in 19 countries have accepted QS. Some of this experience is with formal government sanction and much is "off-label use." Quinacrine is an authorized drug for other purposes, including treatment of malaria, in all these countries. Physicians prescribing any off-label use of a drug are exposed to a degree of liability if there is a complication resulting from procedures, especially if there has been no recommendation by a "consensus meeting" of experts. Fortunately, complications with QS are very infrequent and increasing numbers of doctors and nongovernmental agencies are offering QS as one of their services. We believe that feminist organizations will have a particular interest in QS because it affords an additional option for women. Comments from our readers are always welcome. (full text)
Social Science and Medicine. 1996 Apr; 42(7):1011-9.Inappropriate drug use is a major problem in the control of diarrheal diseases. Addressing the problem, the World Health Organization's (WHO) Program for the Control of Diarrheal Diseases reviewed the literature on the most commonly used antidiarrheal agents, and distributed the resulting document widely in 1990. Individual and group campaigns against the registration and use of antidiarrheal drugs also brought considerable attention to the issue in the popular media. This article evaluates the actions taken against antidiarrheal drugs by national drug regulators during and after these events, January 1989 through December 1993. Information on regulatory actions was requested from countries and extracted from published and unpublished sources. 16 countries reported regulatory actions on 21 occasions during the period of study, with the majority of actions taken against antimotility drugs. Few were against adsorbents, antidiarrheal drugs containing antimicrobials, or adult formulae. Six countries took action against large and heterogenous groups of antidiarrheal drugs, with most actions occurring within two years of the distribution of the WHO review and the attention in the media. Many more antidiarrheal drugs may lose their register in the future through a passive deregistration process. The deregistration of inappropriate drugs, however, will probably take quite a while, with widespread deregistrations unlikely. Moreover, regulatory actions alone are probably not enough to achieve a more appropriate use of drugs. Greater effect can be expected from simultaneous regulatory, managerial, and educational interventions directed at providers, combined with communication to the general public.
REPRODUCTIVE HEALTH MATTERS. 1994 May; (3):104.In reply to a summary of an article by Bhupesh Mangla (Lancet, May 29, 1993), a representative of Finishing Enterprises, Inc, the original licensee of the Population Council for manufacture of the Copper T IUD, maintains that the components supplied to Hindustan Latex Ltd (HLL), the Indian company selected in a program of the Indian government and the UN Population Fund (UNFPA) to manufacture the finished IUDs, were neither defective nor substandard. The National Centre of Technical Evaluation of the Indian Institute of Technology, which had no previous experience in this area, established its own specifications prior to transfer of the technology. Finishing Enterprises was uninformed of the changes and delivered components made according to US Food and Drug Administration and international standards. Since they did not meet the Indian specifications, it was recommended that they be held. This does not mean they were unsafe. Differences in the standards were discussed in March 1992 by experts during a Population Council meeting organized by the Indian government and UNFPA. The components were certified to meet international standards and were found to be safe and suitable. The statement that the Ministry was pressured to accept the consignment without further action is, therefore, inaccurate. The Indian Ministry of Health and HLL have since resolved the issue, and manufacture of the IUDs is proceeding with the components supplied by Finishing Enterprises. This resolution was complicated by political motivation, personal bias, and pressure brought by competing Indian firms. In order to prevent this in the future, manufacturers who are experienced with international standards should be involved in evolving national standards, and care should be taken that these are communicated to the appropriate parties.
REPRODUCTIVE HEALTH MATTERS. 1993 Nov; (2):125-6.In June 1993, scientists, clinicians, family planning specialists, officials of national drug regulatory agencies, and pharmaceutical industry representatives attended a World Health Organization [WHO] expert group meeting in Geneva to examine all available data from preclinical and clinical trials on the safety and efficacy of two once-a-month injectables containing both an estrogen and a progestogen (Cyclofem and Mesigyna). WHO's Special Programme of Research, Development and Research Training in Human Reproduction developed Cyclofem and Mesigyna. The two new preparations have much lower doses of estrogen and progestogen as well as a different type of progestogen than do the older preparations. The Programme decided on these two formulations because they completely suppress ovulation and have the least effect on menstrual patterns. 5 clinical trials sites examined 9793 women for 102,058 woman-months of use. Pregnancy rates were considerably less than 1%. Predictable regular cycles occurred in 65% of the women. The discontinuation rate for bleeding problems was less than 50% of that for progestogen-only injectables. Ovulation returned within 2-3 months after discontinuation. Pregnancy, suspicion of pregnancy, and breast feeding are contraindications of the two new formulations. Meeting participants recommended that clinicians provide potential users with adequate information and family planning advice, undergo training in the new methods, and follow appropriate distribution and storage procedures. They found the two preparations to be as effective as Depo-Provera and to cause good cycle control and few side effects. Thus, they gave their approval for the two methods to be added to the range of existing contraceptive options.
BMJ. British Medical Journal. 1993 Nov 27; 307(6916):1375-6.The World Health Organization (WHO), at a meeting in Geneva in November 1993, launched a campaign that will coordinate efforts of the pharmaceutical industry, academic research institutes, and drug regulatory bodies to find a vaginal antiviral agent that will either inactivate the human immunodeficiency virus (HIV) or prevent its attachment to vaginal cells, without harming the genital tract or killing sperm. Spermicides, such as nonoxynol 9, which kill HIV in test tubes may increase HIV transmission by harming the vaginal lining. However, this may be due to the carrier substance. Clinical research, using a protocol designed by the WHO and international regulatory authorities, will begin examining existing vaginal microbicides. Other candidates include sulphated polysaccharides and reverse transcriptase inhibitors. Included are comments by Dr. Michael Merson and Prof. Don Jefferies. The meeting was organized by the United Kingdom's Medical Research Council and Department of Health.
In: Vaccines for fertility regulation: the assessment of their safety and efficacy. Proceedings of a Symposium on Assessing the Safety and Efficacy of Vaccines to Regulate Fertility, convened by the WHO Special Programme of Research, Development and Research Training in Human Reproduction, Geneva, June 1989, edited by G.L. Ada, P.D. Griffin. Cambridge, England, Cambridge University Press, 1991. 173-84. (Scientific Basis of Fertility Regulation)Biologicals specialists at WHO review quality assurance of vaccines at the national level for participants in a symposium on vaccines to regulate fertility. National control authorities (NCA) authorize a company to manufacture biological products only after it convinces the NCA that it will comply with good manufacturing practices (GMP) and WHO requirements for manufacturing establishments and control laboratories. Experts periodically inspect the facilities to assure that the company abides by GMP, WHO, and national regulations. NCA makes a decision to permit product use after successful evaluation for a set period of time (licensing). The manufacture must renew its license. Licensing involves a review of manufacturer's data on production methods and laboratory tests. The manufacturer does not need to conduct some tests for each production lot including data on characterization of banks of seeds (cells, bacteria, and viruses), details on production methods, and principal harmlessness of the product. The NCA also reviews test data from each production batch at the bulk level, at the final bulk and/or at the final product level, and at the final product level. Bulk level tests may include tests for neurovirulence and for the absence of virulent mycobacteria. Purity tests are carried out at the final bulk and/or at the final product level. Tests for potencies of live vaccines, the absence of contamination, and adjuvant content are final product level tests. Results of clinical studies on the safety and efficacy of the product also accompanies requests for licensing. After granting a license, the NCA must define release modalities (free release, partial free release, or release after the NCA has issued a release certificate). It must also operate a postmarketing surveillance system to prevent the unexpected from happening.
SCIENCE. 1992 Jun 26; 256:1754.Depo-Provera (DP) was unanimously recommended for approval as a contraceptive by a Food and Drug Administration (FDA) advisory committee. This had happened once before in the mid-1970s, but Congress raised concerns about DP's possible link to cervical cancer. DP has been in use for 20 years as a treatment for uterine cancer. DP is an injectable progesterone analog that induces infertility for 3 months in 99% of the women who use it. It is already in use in 90 countries and has annual sales of US$100 million. The 4 annual shots cost US$120 and is an economical alternative to Norplant. There are still many unanswered questions about its safety. A recent WHO study found that it increased breast cancer by 21%, which was almost statistically significant. However, in the <34 age group breast cancer was twice as common, which is statistically significant. DP was found to increase the number of breast cancer cases by 5.6/100,00; but, it reduced the number of uterine cancer cases by 19.2/100,000. A New Zealand Hospital study found that DP use reduced bone density by 7.5% in the lumber spine and 6.5% in the neck of the femur. Critics charge that Upjohn has had 20 years to compile data but has failed to do so. There is little or no data about its effect on developing fetuses, osteoporosis, or the mechanism that causes breast cancer. All these areas were recommended for follow-up study by the FDA advisory committee.
MARHIA - MEDIUM FOR THE ADVANCEMENT AND ACHIEVEMENT OF REPRODUCTIVE RIGHTS, HEALTH INFORMATION AND ADVOCACY. 1989 Jul-Sep; 2(3):1, 3-9.4 major contraceptives are being examined by health care professionals throughout the world. They are: injectables, the IUD, condoms and the pill. This article discusses the advantages and disadvantages of all four. Injectable contraceptive are most commonly either Depo-provera or Noristerat. Depo-provera is approved for use as a contraceptive in 90 countries. Noristerat is approved for use in 40 countries. Detractors of Depo-provera say that is produces breast tumors in beagle dogs, possible tetratogenecity upon failure concern that abnormal bleeding might lead to additional estrogen therapy, and that the simple nature of this type of drug might lead to abuse of informed consent. However, World Health Organization studies have shown no cancerous effects of the drug and a failure rate of 1 in 100 women. When failure occurs, tetratogenecity is very low. It must be looked at in the context of risk assessment before judgement is passed on it. In countries where pregnancy can mean a decrease in the quality of life for the mother or the family, this is an easy method of birth control. The IUD has many questions surrounding its use: infection, expulsion, tubal infertility, ectopic pregnancy and uterine laceration. While it is an effective method of birth control, not an abortifacient, it does have certain disadvantages that must be considered. Condoms have the added benefit of preventing the spread of disease as well as preventing pregnancy. However, in many countries there is a cultural bias against using a condom. Men complain about reduced sensitivity. Also, they break with a certain frequency that is unavoidable in a mass produced product (about 1 in 10,000). Their biggest weakness is most users do not use them consistently. This is where injectables, the IUD and the pill have an advantage over the condom. Use patterns also increase their failure rate in terms of contraception. The pill is the most popular and widely used form of hormonal contraception. It has been proven safe at lower doses and is very effective. It is however, incapable of preventing the spread of disease. Also, women who smoke and use the pill run a higher risk of breast cancer.
New York, New York, Population Council, 1990 Dec 10. 4 p.The US Food and Drug Administration (FDA) has approved the marketing of NORPLANT, an effective and long-acting contraceptive method that is convenient for women who want to delay having children or who desire no more children but wish to avoid sterilization. Developed by the Population Council at a cost of more than $20 million, NORPLANT has been tested on more than 55,000 volunteers and is currently being used by more than half a million women worldwide. The new contraceptive works by implanting 6 capsules made of silicone rubber containing levonorgestrel under the skin of the woman's arm, a procedure that takes 10-15 minutes. Containing no estrogen, the capsules release a low dose of progestin, which prevents pregnancy by inhibiting ovulation and by thickening the cervical mucus. NORPLANT provides protection for up to 5 years, and the effects can be quickly reversed by removing the capsules. More effective than oral contraceptives and IUDs during the first two years, NORPLANT is just as effective as sterilization. Tests show a rate of less than 1 pregnancy per year for every 100 women, and a rate of 3.9 over the 5 years. The FDA's decision makes the US the 17th country to give regulatory approval to NORPLANT, and allows the US Agency for International Development to supply the new contraceptive to developing countries engaged in family planning.