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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.
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)
Lancet. 2003 May 31; 361(9372):1873.US Health and Human Services Secretary Tommy Thompson earlier outraged developing countries and activists by submitting a resolution stressing the need to “promote innovation in the field of public health by encouraging respect for strong intellectual property rights”. (excerpt)
Policy statement on preventive therapy against tuberculosis in people living with HIV. Report of a meeting held in Geneva, 18-20 February 1998. World Health Organization. Global Tuberculosis Programme and UNAIDS.
[Geneva, Switzerland], World Health Organization [WHO], Global Tuberculosis Programme, 1998. 26 p. (WHO/TB/98.255; UNAIDS/98.34)During February 18-20, 1998, the Global Tuberculosis (TB) Programme of the WHO and the Joint UN Programme on HIV/AIDS convened a meeting in Geneva to review available data on TB and to make updated recommendations to governments concerning preventive therapy (PT). This document presents the policy statement arising from the meeting regarding PT against TB in people living with HIV. It also forms a technical annex to those guidelines and sets out the process by which the guidelines were developed, as well as the technical information on which they are based. The meeting brought together 50 people comprising technical experts, potential consumers, policy-makers, and donor agencies. The meeting was spent reviewing knowledge on the interactions between TB and HIV; strategies for TB control; approaches to HIV care; experience with voluntary HIV counseling and testing; efficacy, feasibility and cost-efficacy of PT.
Lancet. 1999 Jul 10; 354(9173):158-9.The International Child Health Group of the Royal College of Pediatrics and Child Health is displeased with the UNAIDS, UNICEF, and WHO policy statement endorsing the artificial feeding of infants. The statement holds that with nutritionally adequate breast milk substitutes safely prepared and fed to the infants of mothers with HIV infection, the infants are at less risk of morbidity and mortality than if they were breast-fed. This global policy has more potential to harm than help, for women in extremely poor and unsuitable settings may wrongly decide to adopt bottlefeeding. The better strategy is to promote exclusive breast-feeding for 4-6 months. Efforts should also be made to reduce the vertical transmission of HIV by increasing the use of short-course zidovudine wherever feasible. Further efforts should be made to address the factors which contribute to HIV infection and prevent social and economic development.
HEALTH POLICY AND PLANNING. 1990 Jun; 5(2):186-9.WHO and UNICEF joined forces to support the Bamako Initiative agreed upon by African ministers of health at a 1987 meeting. Primary health care (PHC) should be advanced by identifying and introducing self-financing mechanisms at the district level (specifically, revenue from drug sales), securing a constant supply of drugs, and promoting social mobilization. UNICEF has produced several policy papers on recurrent costs and the sales of drugs. The 1988 UNICEF policy paper Problems and Priorities Regarding Current Costs reviews UNICEF practices of financing programs and proposes recommendations. For example, about 40% of program expenditure goes to recurrent costs, especially the financing of drugs and vaccines. Another 1988 UNICEF working paper is Community Financing Experiences for Local Health Services in Africa, which reviews 3 case studies on community financing. Today, however, UNICEF no longer considers drug cost recovery as essential to the Bamako Initiative. In July 1989, the WHO Regional Office for Africa published Guidelines for the Implementation of the Bamako Initiative. Charging for Drugs in Africa: UNICEF's 'Bamako Initiative' (1989) critiques UNICEF's policy in the context of the IMF and the World Bank adjustment programs. Availability of Pharmaceuticals in sub-Saharan Africa: Roles of Public, Private and Church Mission Sectors (1989) highlights the success of cost recovery in church mission health care and the efficiency of distribution through the commercial sector. Its authors consider the Bamako Initiative to be unrealistic. One of the first shots at reviewing community financing experiences is the 1982 article, Community Financing of PHC. Other works are Financing PHC Programmes (Christian Medical Commission), Financing PHC: Experiences in Pharmaceutical Cost Recovery (PRITECH), WHO's Financing Essential Drugs, and A Price to Pay: The Impact of User Charges in Ashanti-Akim District, Ghana.
BMJ. British Medical Journal. 1989 Jul 29; 298(6694):277-8.Under the Bamako initiative, UNICEF will provide free drugs to participating countries for the 1st few years; drugs will be sold to patients; and communities will control the finances. The aims are to establish a revolving drug fund to pay for future drug supplies and to use leftover money to maintain and improve primary health care services. Several problems with the initiative are foreseen. Firstly, charging users may reduce utilization by the poor. Although UNICEF agrees that provision of free service for indigents in necessary, systematic identification of these people may be difficult. Secondly, financing will be difficult to implement given the rarity of managerial skills and the poor quality of local supervision. The sustainability of the initiative is also in doubt. UNICEF initially proposed large mark ups on the basic cost of the drugs; now partial recovery of the cost is proposed, although how charges will be set is unclear. The question of whether services will be dependent when the free drugs stop remains to be answered. A further objection to the scheme is the almost inevitable deterioration of rational prescribing; paying patients will feel justified in demanding drugs and injections. UNICEF's solutions and strategies for implementation of policy remain vague and lack attention to detail. For instance, initial training courses aide community management of drug funds, but there is no commitment to continued support and local evaluation. Other sources of funding need to be considered. Host governments should commit to continued financial and supervisory input and to maintaining control over their own health services. Communication between staff and government should be established and maintained. Gradual and sensitive introduction, with careful monitoring of equity, utilization, and rational drug use, is essential to prevent failure of this important proposal.
CONTRACEPTIVE TECHNOLOGY UPDATE. 1989 Jun; 10(6):77-81.Although generic oral contraceptives (OCs) are bioequivalent to brand-name formulations, many family planning professionals do not prescribe the significantly lower-priced generics. The Planned Parenthood Federation of America, for example, has refused to approve generic OCs for use in the organization's clinics, presumably because of concerns about their equivalent efficacy and safety. However, much of this skepticism may be fueled by misleading marketing by brand-name OC manufacturers. Sales representatives have reportedly told clinicians that generic OCs can be as much as 20% different from brand-name formulations, despite evidence collected by the US Food and Drug Administration confirming that there is virtually no difference except in terms of inert ingredients. In the case of many formulations, the variability between the generic and brand-name products is no different than the variability found between different lots of the same brand-name drug. Another obstacle to wider use of generic OCs is that discounts for large volume purchases make brand-name OCs the best buy for family planning clinics. Clinicians also note that clients complain of minor side effects whenever OC brands are changed, even if the compounds are the same. As the price of medication continues to rise, the more widespread availability of generic OCs will be especially important for teenagers and other low-income clients.
CONTACT. 1989 Feb; (107):1-24.The 1st part of this report discusses essential drugs for health care programs. In addition to a model list of essential drugs it is felt a clear strategy was needed to implement rational drug policies. The World Health Organization (WHO) launched its Action Program on Essential Drugs and Vaccines in 1981. Advantages to a standard essential drugs list include: 1) selection of drugs can be made based on the best information available and on real needs; 2) correct dosages are easier to remember, increasing safety; 3) it causes less wastage than switching from 1 drug to another, increasing cost-effectiveness; 4) ordering, storage, and distribution of drugs are easier to manage; and 5) it helps to obtain reliable data on drug consumption. Various misconceptions, some related to politics and power, have slowed the acceptance of the essential drugs concept. Steps to implement a rational drug policy include: 1) assess drug needs, not market demand; 2) ban hazardous and irrational drugs; 3) produce and supply adequately essential drugs; 4) use generic names; 5) ensure quality; 6) ensure correct information; 7) ensure ethical marketing; 8) ensure reasonable price; 9) promote indigenous research and development; and 10) plug legal loopholes. Problems with pharmaceutical donations commonly include drugs that: arrive expired or near expiry; are inappropriate and do not cover treatment of diseases which are problems in the country of destination; are sent without asking the recipient about needs; are sent without prior notification or shipping documents; or are inadequately packaged, labelled, and unaccompanied by any prescriber or patient information. To prevent these complaints donations should only consist of drugs included in National Drug Lists in existing, or the WHO model list of essential drugs. They should be of known good quality, and labelled by their generic-international nonproprietary name. If a drug is sent to the same place/program regularly, the strength of the drug should not change. Packaging units of larger quantities are more suitable than small packets. Drugs should have a shelf-life of at least 1 year after estimated arrival in the country. To enable local purchase, a financial contribution will, in many cases, be more appropriate. The WHO model list of essential drugs is included in the back of the report.
London, England, London School of Hygiene and Tropical Medicine, Evaluation and Planning Centre for Health Care, 1985 Winter. 97 p. (EPC Publication No. 8)Many developing countries spend sizeable sums on the purchase of drugs yet an estimated 60-80% of their populations, particulary in rural areas, do not have constant access to even the most essential drugs. The provision of adequate amounts of effective drugs to treat the most important and common disease conditions is crucial if health services are to be effective and credible. Many problems are associated with the provision and utilization of therapeutic drugs in developing countries: inequitable access to cost-effective safe drugs; inequitable production and consumption with market concentration in the hands of a few multinationals encouraging competition based on product differntion and not price; escalating drug costs; inefficient procurement, distribution, management; and irrational prescription and consumption. To combat these problems, the essential drug concept was introduced by the WHO in 1977. In 1981, WHO established a special Action Program on Essential Drugs. This is a worldwide collaborative program that aims at urging member states to adopt national drug policies, as well as helping developing countries procure and use essential drugs. Several countries have implemented some of the suggestions of the Drug Action Program. Though some progress has been made towards achieving an increase in the use and availability of cost-effective drugs, very few countries have succeeded in decreasing the use of unsafe drugs and those of low cost-effectiveness. Effective legislation is a prerequisite to the effective use of drugs. Recommended action for governments of developing countries to involve the private sector include: creating incentive for increased domestice production; controlling promotional practices; and exerting price controls.