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Access to health integrating individual clinical expertise with the best available external clinical evidence from systematic research when deciding about the care of individual patients 4 . This approach has been recognized, also, as a valuable tool for choosing the best strategies for closing the gap between research and practice 5 and for improving health care provision, through the delivery of high-quality care that integrates knowledge coming from evidence-based medicine and the emerging discipline of evidence-based management 6 . A number of barriers exist, however, for getting scientific evidence into practice. They include many factors beyond the control of the practitioner and patient, and the process of linking the outcomes of scientific research with health policy and clinical care requires addressing all of them in a thorough manner. A key step in translating the findings of relevant research into actual benefit to patients is ensuring access of decision-makers to good quality evidence. Unexpectedly, the global system of protection of intellectual property rights has ended up being a barrier not only for access to drugs, but also a barrier for accessing information on the efficacy and safety of drugs. The TRIPS Agreement not only gives patent protection to innovative drugs, but it has also been understood as protecting from divulgation the information on efficacy and safety that is submitted to regulatory authorities, having the status of undisclosed 7 . The TRIPS agreement states, thus, in its article 39.3: “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use”. The underlying logic of data exclusivity suggests that it is an expression of trade-secrets more than patents, as expression of intellectual property rights 8 . The role of regulatory authorities in ensuring that the information on efficacy and safety of drugs is adequately analyzed has been seriously challenged in the last years 9 . Some authors have labelled the work of the Food and Drug Administration in USA, as substandard 10 , and recent disclosure of adverse events information on drugs such as rofecoxib (vioxx) throws a cloak of doubt over the capacity of regulatory authorities for dealing with safety and efficacy information in a secret manner, and public disclosure of all information concerning drugs has been demanded. A recent advance on this direction has been the general agreement on the need of registering clinical trials, endorsed and supported by the World Health Organization, the International Committee of Medical Journal Editors, and even Pharmaceutical Manufacturers 11 . There are many reasons for endorsing this initiative 12 : a publicly accessible register would help funding agencies in deciding where to allocate the money; a register of ongoing research would help patients interested in participating in clinical trials identifying suitable options, and a register leading to the results of research would help both patients and health professionals accessing comprehensive information on the safety and efficacy of medical interventions. The success of initiatives like The Cochrane Collaboration, aiming at producing periodically updated reviews of all relevant randomized controlled trials of the effects of health care 13 , rely critically on public access to all results of research. Any barrier to public access to the findings of research on the effects of health care may result, thus, in threats to the quality of care provided by health services and professionals, to the effective exercise of autonomy of patients in choosing the most appropriate treatment for their condition and, in a more general way, in a threat to the fulfilment of the widely acknowledged right to the highest attainable level of health. Barriers arising out of trade agreements and any reward to non-disclosure of the results of research protection of intellectual property rights should be identified and adequately addressed. The effects of the implementation of the Doha Declaration should go beyond ensuring access to drugs. They should aim, also, at ensuring access to information on the efficacy and safety of drugs. Those conflicts arising out of article 39.3 of the TRIPS Agreement, preventing public access to research results, threatening the transparency of regulatory authorities’ processes, and fostering the non-disclosure of data by pharmaceutical companies, should be denounced and solved in the spirit of the general principles recognized by the Doha Declaration in favour of public health protection. The emphasis on the creation of mechanisms to implement this Declaration has been placed, up until now, in ensuring access. The movement towards free access to the results of biomedical research, including the creation of trials registries and freeing the access to peer-reviewed journals in low-income countries, should consider the existing conflict with extra-patent intellectual property rights granted to non-disclosed information on the efficacy and safety of drugs, and the current confidence crisis on how this information is appraised by the regulatory authorities. ❏ Rodrigo A Salinas is a physician and neurologist who graduated at the University of Chile. He holds a Master of Science in Evidence Based Health-Care (University of Oxford) and a Master of Science in Health Economics (University of York). He works as a consultant at the Ministry of Health of Chile and lectures at the Faculty of Medicine of the University of Chile. He was head of the Medicines Regulatory Agency of Chile (ISP) between 2002 and 2004, and former Deputy Undersecretary of Health. Since 2007 he has been acting as a member of the Advisory Committee on Health Research of the Pan American Health Organization. 048 ✜ Global Forum Update on Research for Health Volume 4
Access to health References 1. Rosenthal E. How drug patenting fails the world’s poor. International Herald Tribune, 21 May 2006. 2. Roffe P, Cristoph S, von Braun J. From Paris to Doha: the WTO Doha Declaration on the TRIPS Agreement and Public Health. In: Roffe P, Tansey G, Vivas-Egui D (editors). Negotiating Health, 2006, p.9-26. London: Earthscan. 3. Evidence-Based Medicine Working Group. Evidence-based medicine: a new approach to teaching the practice of medicine. Journal of the American Medical Association, 1992, 268 (17):2420-5. 4. Sackett DL et al. Evidence based medicine: what it is and what it isn’t. British Medical Journal, 1996, 312 (7023):71-2. 5. Haynes B, Haines A. Getting research findings into practice: Barriers and bridges to evidence based clinical practice. British Medical Journal, 1998, 317(7153):273-6. 6. Shortell SM, Rundall TG, Hsu J. Improving Patient Care by Linking Evidence-Based Medicine and Evidence-Based Management. Journal of the American Medical Association, 2007, 298(6):673-6. 7. Correa CM. Protecting test data for pharmaceutical and agrochemical products under free trade agreements. In: Roffe P, Tansey G, Vivas-Egui D (editors). Negotiating Health, 2006. p.81-96, London: Earthscan. 8. Pugatch MP. Intellectual property, data exclusivity, innovation and market access. In: Roffe P, Tansey G, Vivas-Egui D (editors). Negotiating Health, 2006, p.97-132, London: Earthscan. 9. Avorn J. Sending Pharma Better Signals. Science, 2005, 309:669. 10. Avorn J. FDA Standards – Good Enough for Government Work? New England Journal of Medicine, 2005, 353:969-72. 11. Steinbrook R. Public Registration of Clinical Trials. New England Journal of Medicine, 2004, 351(4):315-7. 12. Chalmers I. Current Controlled Trials: an opportunity to help improve the quality of clinical research. Current Controlled Trials in Cardiovascular Medicine, 2000, 1(1):3-8. 13. Chalmers I, Haynes B. Systematic Reviews: Reporting, updating, and correcting systematic reviews of the effects of health care. British Medical Journal, 1994, 309:862-5. Global Forum Update on Research for Health Volume 4 ✜ 049
Page 1 and 2: Global Forum Update on Research for
Page 3 and 4: Editorial Advisory Board: Luis Gabr
Page 5 and 6: Contents 096 Child immunization: ac
Page 7 and 8: Introduction Research contributions
Page 9 and 10: Introduction Type I Type II Type II
Page 11 and 12: Introduction making), takes account
Page 13 and 14: Access to health Strengthening heal
Page 15 and 16: Access to health raising public awa
Page 17 and 18: Access to health Recent trends in r
Page 19 and 20: Access to health districts with a p
Page 21 and 22: Access to health Understanding heal
Page 23 and 24: Access to health This study investi
Page 25 and 26: Access to health References continu
Page 27 and 28: Access to health combining particip
Page 29 and 30: Access to health 2002 2005 Diff. SU
Page 31 and 32: Access to health References continu
Page 33 and 34: Access to health Americans think th
Page 35 and 36: Access to health threatening and se
Page 37 and 38: Access to health References 1. Worl
Page 39: Access to health Open access to res
Page 43 and 44: Access to health national and globa
Page 45 and 46: Access to health Senior Research Fe
Page 47 and 48: Access to health ✜ Rights alone a
Page 49 and 50: Access to health meaningful communi
Page 51 and 52: Access to health Inequality, margin
Page 53 and 54: Access to health questions, develop
Page 55 and 56: Access to health reasonable in abou
Page 57 and 58: Access to health References 1. Kohn
Page 59 and 60: Access to health The diverse pathwa
Page 61 and 62: Access to health 2001, WTO ruled th
Page 63 and 64: Access to health knowledge and educ
Page 65 and 66: Access to health References 1. Lee
Page 67 and 68: Innovation 076 Towards the developm
Page 69 and 70: Innovation ✜ Creating a viable va
Page 71 and 72: Innovation Natural sciences and env
Page 73 and 74: Innovation References 1. Morel C et
Page 75 and 76: Innovation The changes in internati
Page 77 and 78: Innovation promoting health in deve
Page 79 and 80: Innovation efficiently converted in
Page 81 and 82: Innovation future global health fin
Page 83 and 84: Innovation References 1. See http:/
Page 85 and 86: Innovation Health system strengthen
Page 87 and 88: Innovation Being healthy: the role
Page 89 and 90: Innovation when much progress and a
Page 91 and 92:
Innovation The role of Knowledge Tr
Page 93 and 94:
Innovation knowledge - the “know
Page 95 and 96:
Research resources 110 Research imp
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Decision-making implemented on a sm
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Research resources 30 27.5 25 20 19
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Research resources poliomyelitis an
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Research resources Nursing research
Page 105 and 106:
Research resources utilization are
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Research resources The need to deve
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Research resources ✜ Health resea
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Research resources References 1. Co
Page 113 and 114:
Research resources investigated the
Page 115 and 116:
Research resources A new landscape
Page 117 and 118:
Research resources 13 + 1*- HIV/AID
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Research resources References 1. Da
Page 121 and 122:
Research resources international le
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Research resources Partnership dyna
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Research resources that many public
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Research resources compounds from m
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Research resources References 1. So
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Decision-making Delivering evidence
Page 133 and 134:
Decision-making Equitable access: g
Page 135 and 136:
Decision-making years’ experience
Page 137 and 138:
Decision-making Policy-makers Compl
Page 139 and 140:
Decision-making interview studies),
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Decision-making References 1. Haine
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Decision-making reviews in this fie
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Decision-making Inequities in healt
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Decision-making Deaths Crude death
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Decision-making Group I Group II Gr
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Decision-making Low- and middle-inc
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Decision-making Europe and Central
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Decision-making Europe and Central
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Decision-making References 1. Banni
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Decision-making irresponsible-to be
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Decision-making Several strategies
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To achieve better health, particula
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