Access <strong>to</strong> <strong>health</strong>integrating individual clinical expertise with <strong>the</strong> best availableexternal clinical evidence from systematic research whendeciding about <strong>the</strong> care of individual patients 4 . This approachhas been recognized, also, as a valuable <strong>to</strong>ol for choosing <strong>the</strong>best strategies for closing <strong>the</strong> gap between research <strong>and</strong>practice 5 <strong>and</strong> for improving <strong>health</strong> care provision, through <strong>the</strong>delivery of high-quality care that integrates knowledgecoming from evidence-based medicine <strong>and</strong> <strong>the</strong> emergingdiscipline of evidence-based management 6 .A number of barriers exist, however, for getting scientificevidence in<strong>to</strong> practice. They include many fac<strong>to</strong>rs beyond <strong>the</strong>control of <strong>the</strong> practitioner <strong>and</strong> patient, <strong>and</strong> <strong>the</strong> process oflinking <strong>the</strong> outcomes of scientific research with <strong>health</strong> policy<strong>and</strong> clinical care requires addressing all of <strong>the</strong>m in a thoroughmanner. A key step in translating <strong>the</strong> findings of relevantresearch in<strong>to</strong> actual benefit <strong>to</strong> patients is ensuring access ofdecision-makers <strong>to</strong> good quality evidence.Unexpectedly, <strong>the</strong> global system of <strong>protection</strong> of intellectualproperty rights has ended up being a barrier not only foraccess <strong>to</strong> drugs, but also a barrier for accessing informationon <strong>the</strong> efficacy <strong>and</strong> safety of drugs. The TRIPS Agreement no<strong>to</strong>nly gives patent <strong>protection</strong> <strong>to</strong> innovative drugs, but it hasalso been unders<strong>to</strong>od as protecting from divulgation <strong>the</strong>information on efficacy <strong>and</strong> safety that is submitted <strong>to</strong>regula<strong>to</strong>ry authorities, having <strong>the</strong> status of undisclosed 7 . TheTRIPS agreement states, thus, in its article 39.3:“Members, when requiring, as a condition of approving <strong>the</strong>marketing of pharmaceutical or of agricultural chemicalproducts which utilize new chemical entities, <strong>the</strong> submissionof undisclosed test or o<strong>the</strong>r data, <strong>the</strong> origination of whichinvolves a considerable effort, shall protect such data againstunfair commercial use. In addition, Members shall protectsuch data against disclosure, except where necessary <strong>to</strong>protect <strong>the</strong> public, or unless steps are taken <strong>to</strong> ensure that<strong>the</strong> data are protected against unfair commercial use”.The underlying logic of data exclusivity suggests that it isan expression of trade-secrets more than patents, asexpression of intellectual property rights 8 . The role ofregula<strong>to</strong>ry authorities in ensuring that <strong>the</strong> information onefficacy <strong>and</strong> safety of drugs is adequately analyzed has beenseriously challenged in <strong>the</strong> last years 9 . Some authors havelabelled <strong>the</strong> work of <strong>the</strong> Food <strong>and</strong> Drug Administration inUSA, as subst<strong>and</strong>ard 10 , <strong>and</strong> recent disclosure of adverseevents information on drugs such as rofecoxib (vioxx) throwsa cloak of doubt over <strong>the</strong> capacity of regula<strong>to</strong>ry authorities fordealing with safety <strong>and</strong> efficacy information in a secretmanner, <strong>and</strong> public disclosure of all information concerningdrugs has been dem<strong>and</strong>ed. A recent advance on this directionhas been <strong>the</strong> general agreement on <strong>the</strong> need of registeringclinical trials, endorsed <strong>and</strong> supported by <strong>the</strong> World HealthOrganization, <strong>the</strong> International Committee of Medical JournalEdi<strong>to</strong>rs, <strong>and</strong> even Pharmaceutical Manufacturers 11 . There aremany reasons for endorsing this initiative 12 : a publiclyaccessible register would help funding agencies in decidingwhere <strong>to</strong> allocate <strong>the</strong> money; a register of ongoing researchwould help patients interested in participating in clinical trialsidentifying suitable options, <strong>and</strong> a register leading <strong>to</strong> <strong>the</strong>results of research would help both patients <strong>and</strong> <strong>health</strong>professionals accessing comprehensive information on <strong>the</strong>safety <strong>and</strong> efficacy of medical interventions. The success ofinitiatives like The Cochrane Collaboration, aiming atproducing periodically updated reviews of all relevantr<strong>and</strong>omized controlled trials of <strong>the</strong> effects of <strong>health</strong> care 13 , relycritically on public access <strong>to</strong> all results of research.Any barrier <strong>to</strong> public access <strong>to</strong> <strong>the</strong> findings of research on<strong>the</strong> effects of <strong>health</strong> care may result, thus, in threats <strong>to</strong> <strong>the</strong>quality of care provided by <strong>health</strong> services <strong>and</strong> professionals,<strong>to</strong> <strong>the</strong> effective exercise of au<strong>to</strong>nomy of patients in choosing<strong>the</strong> most appropriate treatment for <strong>the</strong>ir condition <strong>and</strong>, in amore general way, in a threat <strong>to</strong> <strong>the</strong> fulfilment of <strong>the</strong> widelyacknowledged right <strong>to</strong> <strong>the</strong> highest attainable level of <strong>health</strong>.Barriers arising out of trade agreements <strong>and</strong> any reward <strong>to</strong>non-disclosure of <strong>the</strong> results of research <strong>protection</strong> ofintellectual property rights should be identified <strong>and</strong>adequately addressed. The effects of <strong>the</strong> implementation of<strong>the</strong> Doha Declaration should go beyond ensuring access <strong>to</strong>drugs. They should aim, also, at ensuring access <strong>to</strong>information on <strong>the</strong> efficacy <strong>and</strong> safety of drugs. Thoseconflicts arising out of article 39.3 of <strong>the</strong> TRIPS Agreement,preventing public access <strong>to</strong> research results, threatening <strong>the</strong>transparency of regula<strong>to</strong>ry authorities’ processes, <strong>and</strong>fostering <strong>the</strong> non-disclosure of data by pharmaceuticalcompanies, should be denounced <strong>and</strong> solved in <strong>the</strong> spirit of<strong>the</strong> general principles recognized by <strong>the</strong> Doha Declaration infavour of public <strong>health</strong> <strong>protection</strong>. The emphasis on <strong>the</strong>creation of mechanisms <strong>to</strong> implement this Declaration hasbeen placed, up until now, in ensuring access. Themovement <strong>to</strong>wards free access <strong>to</strong> <strong>the</strong> results of biomedicalresearch, including <strong>the</strong> creation of trials registries <strong>and</strong> freeing<strong>the</strong> access <strong>to</strong> peer-reviewed journals in low-income countries,should consider <strong>the</strong> existing conflict with extra-patentintellectual property rights granted <strong>to</strong> non-disclosedinformation on <strong>the</strong> efficacy <strong>and</strong> safety of drugs, <strong>and</strong> <strong>the</strong>current confidence crisis on how this information is appraisedby <strong>the</strong> regula<strong>to</strong>ry authorities. ❏Rodrigo A Salinas is a physician <strong>and</strong> neurologist who graduatedat <strong>the</strong> University of Chile. He holds a Master of Science in EvidenceBased Health-Care (University of Oxford) <strong>and</strong> a Master of Sciencein Health Economics (University of York). He works as a consultantat <strong>the</strong> Ministry of Health of Chile <strong>and</strong> lectures at <strong>the</strong> Faculty ofMedicine of <strong>the</strong> University of Chile. He was head of <strong>the</strong> MedicinesRegula<strong>to</strong>ry Agency of Chile (ISP) between 2002 <strong>and</strong> 2004, <strong>and</strong>former Deputy Undersecretary of Health. Since 2007 he has beenacting as a member of <strong>the</strong> Advisory Committee on Health Researchof <strong>the</strong> Pan American Health Organization.048 ✜ Global Forum Update on Research for Health Volume 4
Access <strong>to</strong> <strong>health</strong>References1.Rosenthal E. How drug patenting fails <strong>the</strong> world’s poor. InternationalHerald Tribune, 21 May 2006.2.Roffe P, Cris<strong>to</strong>ph S, von Braun J. From Paris <strong>to</strong> Doha: <strong>the</strong> WTO DohaDeclaration on <strong>the</strong> TRIPS Agreement <strong>and</strong> Public Health. In: Roffe P, TanseyG, Vivas-Egui D (edi<strong>to</strong>rs). Negotiating Health, 2006, p.9-26. London:Earthscan.3.Evidence-Based Medicine Working Group. Evidence-based medicine: a newapproach <strong>to</strong> teaching <strong>the</strong> practice of medicine. Journal of <strong>the</strong> AmericanMedical Association, 1992, 268 (17):2420-5.4.Sackett DL et al. Evidence based medicine: what it is <strong>and</strong> what it isn’t.British Medical Journal, 1996, 312 (7023):71-2.5.Haynes B, Haines A. Getting research findings in<strong>to</strong> practice: Barriers <strong>and</strong>bridges <strong>to</strong> evidence based clinical practice. British Medical Journal, 1998,317(7153):273-6.6.Shortell SM, Rundall TG, Hsu J. Improving Patient Care by LinkingEvidence-Based Medicine <strong>and</strong> Evidence-Based Management. Journal of<strong>the</strong> American Medical Association, 2007, 298(6):673-6.7.Correa CM. Protecting test data for pharmaceutical <strong>and</strong> agrochemicalproducts under free trade agreements. In: Roffe P, Tansey G, Vivas-Egui D(edi<strong>to</strong>rs). Negotiating Health, 2006. p.81-96, London: Earthscan.8.Pugatch MP. Intellectual property, data exclusivity, innovation <strong>and</strong> marketaccess. In: Roffe P, Tansey G, Vivas-Egui D (edi<strong>to</strong>rs). Negotiating Health,2006, p.97-132, London: Earthscan.9.Avorn J. Sending Pharma Better Signals. Science, 2005, 309:669.10.Avorn J. FDA St<strong>and</strong>ards – Good Enough for Government Work? NewEngl<strong>and</strong> Journal of Medicine, 2005, 353:969-72.11.Steinbrook R. Public Registration of Clinical Trials. New Engl<strong>and</strong> Journal ofMedicine, 2004, 351(4):315-7.12.Chalmers I. Current Controlled Trials: an opportunity <strong>to</strong> help improve <strong>the</strong>quality of clinical research. Current Controlled Trials in CardiovascularMedicine, 2000, 1(1):3-8.13.Chalmers I, Haynes B. Systematic Reviews: Reporting, updating, <strong>and</strong>correcting systematic reviews of <strong>the</strong> effects of <strong>health</strong> care. British MedicalJournal, 1994, 309:862-5.Global Forum Update on Research for Health Volume 4 ✜ 049
![[re-tender] RFQ for supply of Diesel Generator - Brac](https://img.yumpu.com/44421374/1/186x260/re-tender-rfq-for-supply-of-diesel-generator-brac.jpg?quality=85)
Change language