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Volumn 2, Issue , 2006, Pages

Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: Enhancing an endangered global public good

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; NON PRESCRIPTION DRUG;

EID: 33746444923     PISSN: 17448603     EISSN: None     Source Type: Journal    
DOI: 10.1186/1744-8603-2-5     Document Type: Article
Times cited : (10)

References (78)
  • 1
    • 26244462586 scopus 로고    scopus 로고
    • 'Global Intellectual Property Protection for Innovative Pharmaceuticals: Challenges for Bioethics and Health Law'
    • In Edited by: Bennett B, Tomossy GF. Springer. Dordrecht
    • Faunce TA: 'Global Intellectual Property Protection for Innovative Pharmaceuticals: Challenges for Bioethics and Health Law'. In Glabolisation and Health Edited by: Bennett B, Tomossy GF. Springer. Dordrecht; 2005.
    • (2005) Glabolisation and Health
    • Faunce, T.A.1
  • 2
    • 14644396096 scopus 로고    scopus 로고
    • 'Nanomedicine: Current Status and Future Prospects'
    • Moghimi SM, Hunter AC, Murray JC: 'Nanomedicine: Current Status and Future Prospects'. FASEB Journal 2005, 19:311-330.
    • (2005) FASEB Journal , vol.19 , pp. 311-330
    • Moghimi, S.M.1    Hunter, A.C.2    Murray, J.C.3
  • 4
    • 2942612270 scopus 로고    scopus 로고
    • Health Care Cost, Quality and Outcomes
    • International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville NJ
    • Berger, et al.: Health Care Cost, Quality and Outcomes. International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville NJ; 2003.
    • (2003)
    • Berger, M.L.1
  • 5
    • 2942612270 scopus 로고    scopus 로고
    • Health Care Cost, Quality and Outcomes
    • International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville NJ. European Economic Community, Medical Device Directive Council Directive 93/42/EEC; 14 June 1993
    • Berger, et al.: Health Care Cost, Quality and Outcomes. International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville NJ. European Economic Community, Medical Device Directive Council Directive 93/42/EEC; 2003. 14 June 1993
    • (2003)
    • Berger, M.L.1
  • 6
    • 2942612270 scopus 로고    scopus 로고
    • Health Care Cost, Quality and Outcomes
    • International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville NJ
    • Berger, et al.: Health Care Cost, Quality and Outcomes. International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville NJ; 2003.
    • (2003)
    • Berger, M.L.1
  • 7
    • 28144440769 scopus 로고    scopus 로고
    • Drug prices and value for money. The Australian Pharmaceutical Benefits Scheme'
    • Henry DA, Hill SR, Harris A: Drug prices and value for money. The Australian Pharmaceutical Benefits Scheme'. Journal of the American Medical Association 2005, 294(2):2630-2632.
    • (2005) Journal of the American Medical Association , vol.294 , Issue.2 , pp. 2630-2632
    • Henry, D.A.1    Hill, S.R.2    Harris, A.3
  • 8
    • 33746427767 scopus 로고    scopus 로고
    • Medical devices Competitiveness and Impact on Public Health Expenditure
    • Directorate Entreprise of the European Commission University of Florence
    • Pammolli F, et al.: Medical devices Competitiveness and Impact on Public Health Expenditure. Directorate Entreprise of the European Commission University of Florence 2005.
    • (2005)
    • Pammolli, F.1
  • 9
    • 30444449389 scopus 로고    scopus 로고
    • 'Reform of drug regulation-Beyond an Independent Drug-Safety Board'
    • Ray WA, Stein CM: 'Reform of drug regulation-Beyond an Independent Drug-Safety Board'. New England Journal of Medicine 2006, 354(2):194-201.
    • (2006) New England Journal of Medicine , vol.354 , Issue.2 , pp. 194-201
    • Ray, W.A.1    Stein, C.M.2
  • 10
    • 33746431176 scopus 로고    scopus 로고
    • Working Towards Harmonization in Medical Device Regulation
    • Global Harmonization Task Force: (last accessed 2 March 2006)
    • Global Harmonization Task Force: Working Towards Harmonization in Medical Device Regulation. 2006 [http://www.ghtf.org/]. (last accessed 2 March 2006)
    • (2006)
  • 11
    • 8944255927 scopus 로고
    • 'Cost-Effective Prescribing of Pharmaceuticals: The Search for the Holy Grail'
    • In Edited by: Drummond MF, Maynard A. London: Churchill Livingstone
    • Bloor K, Maynard A: 'Cost-Effective Prescribing of Pharmaceuticals: The Search for the Holy Grail,'. In Purchasing and Providing Cost-Effective Health Care Edited by: Drummond MF, Maynard A. London: Churchill Livingstone; 1993.
    • (1993) Purchasing and Providing Cost-Effective Health Care
    • Bloor, K.1    Maynard, A.2
  • 12
    • 0035351404 scopus 로고    scopus 로고
    • A Cost-Effectiveness Approach to Drug Subsidy and Pricing in Australia
    • Birkett DJ, Mitchell AS, McManus P: A Cost-Effectiveness Approach to Drug Subsidy and Pricing in Australia. Health Affairs 2001, 20(3):104-114.
    • (2001) Health Affairs , vol.20 , Issue.3 , pp. 104-114
    • Birkett, D.J.1    Mitchell, A.S.2    McManus, P.3
  • 14
    • 33746431177 scopus 로고    scopus 로고
    • Australian Government Department of Health and Ageing: National Medicines Policy (last accessed 4 Sept)
    • Australian Government Department of Health and Ageing: National Medicines Policy. [http://www.health.gov.au/internet/wcms/ publishing.nsf/Content/nmp-objectives-policy.htm]. (last accessed 4 Sept 2005)
    • (2005)
  • 15
    • 33746409896 scopus 로고    scopus 로고
    • Interviews by the author with PBAC members in
    • Interviews by the author with PBAC members in. 2005.
    • (2005)
  • 16
    • 33746447031 scopus 로고    scopus 로고
    • New Zealand Pharmaceutical Management Agency last accessed 12 Dec 2005
    • New Zealand Pharmaceutical Management Agency 2005 [http://www.pharmac.govt.nz/who are pharmac.asp]. last accessed 12 Dec 2005
    • (2005)
  • 17
    • 0027596489 scopus 로고
    • 'Guidelines for economic analysis of pharmaceutical products: A draft document for Ontario and Canada'
    • Detsky A: 'Guidelines for economic analysis of pharmaceutical products: a draft document for Ontario and Canada.'. Pharmacoeconomics 1993, 3(5):354-61.
    • (1993) Pharmacoeconomics , vol.3 , Issue.5 , pp. 354-361
    • Detsky, A.1
  • 18
    • 2442608668 scopus 로고    scopus 로고
    • Outcomes-Based Drug Coverage in British Columbia'
    • Morgan S, Bassett K, Mintzes B: Outcomes-Based Drug Coverage in British Columbia'. Health Affairs 2004, 23(3):269-276.
    • (2004) Health Affairs , vol.23 , Issue.3 , pp. 269-276
    • Morgan, S.1    Bassett, K.2    Mintzes, B.3
  • 19
    • 33746466063 scopus 로고    scopus 로고
    • Canadian Coordinating Office for Health Technology Assessment Interviews by the author with CEDAC officials in 2005 last accessed 12 Dec
    • Canadian Coordinating Office for Health Technology Assessment Interviews by the author with CEDAC officials in 2005 [https:/.www.ccohta.ca/CDR/ cdr_committeese.cfm]. last accessed 12 Dec 2005.
    • (2005)
  • 20
    • 33746409400 scopus 로고    scopus 로고
    • Canadian Patented Medicines Prices Review Board last accessed 12 Dec 2005
    • Canadian Patented Medicines Prices Review Board 2005 [http://www.pmprb-cepmb.gc.ca/english/view.asp?x=272#2]. last accessed 12 Dec 2005
    • (2005)
  • 21
    • 33746407016 scopus 로고    scopus 로고
    • Interviews by the author with PMPRB senior officials in Ottawa
    • Interviews by the author with PMPRB senior officials in Ottawa. 2005.
    • (2005)
  • 22
    • 33746441321 scopus 로고    scopus 로고
    • European Medicines Agency website (last accessed 8 March 2006)
    • European Medicines Agency website 2005 [http://www.emea.eu.int/ sitemap.htm]. (last accessed 8 March 2006)
    • (2005)
  • 23
    • 11144340484 scopus 로고    scopus 로고
    • Survey of pharmacoeconomic assessment activity in eleven countries
    • Directorate for Employment labor and Social Affairs, OECD Health Working Papers No4, Organisation for Economic Co-Operation and Development
    • Dickson J, Hurst J, Jacobzone S: Survey of pharmacoeconomic assessment activity in eleven countries. Directorate for Employment labor and Social Affairs, OECD Health Working Papers No4, Organisation for Economic Co-Operation and Development 2003.
    • (2003)
    • Dickson, J.1    Hurst, J.2    Jacobzone, S.3
  • 24
    • 6944244438 scopus 로고    scopus 로고
    • 'Inclusion of cost effectiveness in licensing requirements of new drugs: The fourth hurdle'
    • Taylor RS, Drummond MF, Salkeld G, Sullivan SD: 'Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle'. British Medical Journal 2004, 329:972-975.
    • (2004) British Medical Journal , vol.329 , pp. 972-975
    • Taylor, R.S.1    Drummond, M.F.2    Salkeld, G.3    Sullivan, S.D.4
  • 25
    • 33746407015 scopus 로고    scopus 로고
    • 'The situation of health technology assessment in Hungary'
    • Poster presentation, International Society for Pharmacoeconomics and Outcomes Research 2nd Asia-Pacific Conference Shanghai. 6 March 2006
    • Kincses G: 'The situation of health technology assessment in Hungary.' Poster presentation, International Society for Pharmacoeconomics and Outcomes Research 2nd Asia-Pacific Conference Shanghai. 2004. 6 March 2006
    • (2004)
    • Kincses, G.1
  • 27
    • 22944441580 scopus 로고    scopus 로고
    • 'Cost-Effectiveness Analysis. From Science to Application'
    • Berger ML: 'Cost-Effectiveness Analysis. From Science to Application'. Medical Care 2005, 43(7):49-53.
    • (2005) Medical Care , vol.43 , Issue.7 , pp. 49-53
    • Berger, M.L.1
  • 28
    • 0026849672 scopus 로고
    • 'Institutional formularies: The relevance of pharmacoeconomic analysis to formulary decisions
    • Lipsy RJ: 'Institutional formularies: the relevance of pharmacoeconomic analysis to formulary decisions. Pharmacoeconomics 1992, 1(4):265-81.
    • (1992) Pharmacoeconomics , vol.1 , Issue.4 , pp. 265-281
    • Lipsy, R.J.1
  • 29
    • 33746390767 scopus 로고    scopus 로고
    • The PPRS sets each such company a set level of return on capital, which represents the amount that can be earned through sales to the National Health Service. Return on capital is calculated from 21% of a fixed asset figure in a submitted annual financial return, also taking into account the company's expenditure on research and development marketing and provision of information. United Kingdom Pharmaceutical Price Regulation Scheme last accessed 12 Dec
    • The PPRS sets each such company a set level of return on capital, which represents the amount that can be earned through sales to the National Health Service. Return on capital is calculated from 21% of a fixed asset figure in a submitted annual financial return, also taking into account the company's expenditure on research and development marketing and provision of information. United Kingdom Pharmaceutical Price Regulation Scheme [http://www.dh.gov.uk/PolicyAndGuidance/MedicinesPhar macyAndIndustry/PharmaceuticalPriceRegulationScheme/ThePPRSS cheme/fs/ en]. last accessed 12 Dec 2005
    • (2005)
  • 30
    • 33746450602 scopus 로고    scopus 로고
    • National Institute for Health and Clinical Excellence last accessed 12 Dec
    • National Institute for Health and Clinical Excellence [http://www.nice.org.uk/page.aspx?o=home].last accessed 12 Dec 2005
    • (2005)
  • 31
    • 28144440769 scopus 로고    scopus 로고
    • 'Drug Prices and Value for Money. The Australian Pharmaceutical Benefits Scheme'
    • Henry DA, Hill SR, Harris A: 'Drug Prices and Value for Money. The Australian Pharmaceutical Benefits Scheme'. Journal of the American Medical Association 2005, 294(20):2630-2632.
    • (2005) Journal of the American Medical Association , vol.294 , Issue.20 , pp. 2630-2632
    • Henry, D.A.1    Hill, S.R.2    Harris, A.3
  • 32
    • 33746431916 scopus 로고    scopus 로고
    • US Food and Drug Administratioj. Risk Management (last accessed 8 Feb)
    • US Food and Drug Administratioj. Risk Management [http://www.fda.gov/oc/ mcclellan/riskmngt.html]. (last accessed 8 Feb 2006)
    • (2006)
  • 33
    • 22944453059 scopus 로고    scopus 로고
    • 'What will it take to make cost-effectiveness analysis acceptable in the United States?'
    • Luce BR: 'What will it take to make cost-effectiveness analysis acceptable in the United States?'. Medical Care 2005, 43(7):44-48.
    • (2005) Medical Care , vol.43 , Issue.7 , pp. 44-48
    • Luce, B.R.1
  • 35
    • 22944436125 scopus 로고    scopus 로고
    • 'Common methodological flaws in economic evaluations'
    • Drummond M, Sculpher M: 'Common methodological flaws in economic evaluations'. Medical Care 2005, 43(7):11-5-14.
    • (2005) Medical Care , vol.43 , Issue.7
    • Drummond, M.1    Sculpher, M.2
  • 36
    • 0027351336 scopus 로고
    • A critical analysis of studies of state drug reimbursement policies: Research in need of discipline
    • Soumerai SB: A critical analysis of studies of state drug reimbursement policies: research in need of discipline. Millbank Quarterly 1993, 71(2):217-252.
    • (1993) Millbank Quarterly , vol.71 , Issue.2 , pp. 217-252
    • Soumerai, S.B.1
  • 37
    • 2442617656 scopus 로고    scopus 로고
    • 'Evidence-based and value-based formulary guidelines'
    • Neumann PJ: 'Evidence-based and value-based formulary guidelines'. Health Affairs 2004, 23:124-34.
    • (2004) Health Affairs , vol.23 , pp. 124-134
    • Neumann, P.J.1
  • 39
    • 22944441580 scopus 로고    scopus 로고
    • Cost-effectiveness analysis. From science to application
    • Berger ML: Cost-effectiveness analysis. From science to application. Medical Care 2005, 43(7):1149-53.
    • (2005) Medical Care , vol.43 , Issue.7 , pp. 1149-1153
    • Berger, M.L.1
  • 40
    • 22944440033 scopus 로고    scopus 로고
    • 'The evolving use of cost-effectiveness analysis in formulary management within the department of veterans affairs'
    • Aspinall SL, Good CB, Glassman PA, Valentino MA: 'The evolving use of cost-effectiveness analysis in formulary management within the department of veterans affairs'. Medical Care 2005, 43(7):20-26.
    • (2005) Medical Care , vol.43 , Issue.7 , pp. 20-26
    • Aspinall, S.L.1    Good, C.B.2    Glassman, P.A.3    Valentino, M.A.4
  • 46
    • 33746464736 scopus 로고    scopus 로고
    • WHO: The World Medicines Situation Geneva. World Health Organisation
    • WHO: The World Medicines Situation Geneva. World Health Organisation; 2004.
    • (2004)
  • 49
    • 0038324475 scopus 로고    scopus 로고
    • 'tHoen E: 25 Years of the WHO essential medicines lists: Progress and challenges
    • Laing R, Waning B, Gray A, Ford N, 'tHoen E: 25 Years of the WHO essential medicines lists: progress and challenges. Lancet 2003:1723-1729.
    • (2003) Lancet , pp. 1723-1729
    • Laing, R.1    Waning, B.2    Gray, A.3    Ford, N.4
  • 52
    • 33746437786 scopus 로고    scopus 로고
    • Global Harmonisation Taskforce (last accessed 20 feb)
    • Global Harmonisation Taskforce [http://www.ghtf.org/information/ information.htm]. (last accessed 20 feb 2006)
    • (2006)
  • 54
    • 0028505460 scopus 로고
    • The right to health in international human rights law
    • Leary VA: The right to health in international human rights law. Health and Human Rights 1994, 1(1):24-32.
    • (1994) Health and Human Rights , vol.1 , Issue.1 , pp. 24-32
    • Leary, V.A.1
  • 56
    • 33645229263 scopus 로고    scopus 로고
    • UNESCO: last accessed 12 Dec
    • UNESCO: Universal Declaration on Bioethics and Human Rights [http://portal.unesco.org/shs/en/ey.php-URLID=1883&URLDO= DOTOPIC&URLSECTION=201.html]. last accessed 12 Dec 2005
    • (2005) Universal Declaration on Bioethics and Human Rights
  • 57
    • 0003888259 scopus 로고
    • Effectiveness and Efficiency Random Reflections on Health Services London Nuffield Provincial Hospitals Trust
    • Cochrane AL: Effectiveness and Efficiency Random Reflections on Health Services London Nuffield Provincial Hospitals Trust 1972.
    • (1972)
    • Cochrane, A.L.1
  • 59
    • 0034716729 scopus 로고    scopus 로고
    • Problems with the interpretation of pharmacoeconomic analysis: A review of submissions to the Australian Pharmaceutical Benefits Scheme
    • Hill SR, Mitchell AS, Henry DA: Problems with the interpretation of pharmacoeconomic analysis: a review of submissions to the Australian Pharmaceutical Benefits Scheme. JAMA 2000, 283:2116-2121.
    • (2000) JAMA , vol.283 , pp. 2116-2121
    • Hill, S.R.1    Mitchell, A.S.2    Henry, D.A.3
  • 60
    • 33746444573 scopus 로고    scopus 로고
    • Brita Pekarsky Working Paper presented to CGKD
    • Brita Pekarsky Working Paper presented to CGKD 2006.
    • (2006)
  • 62
    • 33947360422 scopus 로고    scopus 로고
    • 'Who's Afraid of personal responsibility? Health savings accounts and the future of American health care'
    • Kaplan RL: 'Who's Afraid of personal responsibility? Health savings accounts and the future of American health care'. McGeorge Law Review 2005, 36:535-568.
    • (2005) McGeorge Law Review , vol.36 , pp. 535-568
    • Kaplan, R.L.1
  • 64
    • 24944577536 scopus 로고    scopus 로고
    • "Privatisation and its Discontents - The Evolving Chinese Health Care System"
    • Blumenthal D, Hsiao W: "Privatisation and its Discontents-The Evolving Chinese Health Care System". New England Journal of Medicine 2005, 353(11):1165-1172.
    • (2005) New England Journal of Medicine , vol.353 , Issue.11 , pp. 1165-1172
    • Blumenthal, D.1    Hsiao, W.2
  • 65
    • 0034881499 scopus 로고    scopus 로고
    • "Medical Savings Accounts in Singapore: A Critical Inquiry"
    • Barr MD: "Medical Savings Accounts in Singapore: A Critical Inquiry". J Health Polit Policy Law 2001, 26:709-712.
    • (2001) J Health Polit Policy Law , vol.26 , pp. 709-712
    • Barr, M.D.1
  • 66
    • 33746458230 scopus 로고    scopus 로고
    • PBS Reform for a Healthy Australia
    • Will Delaat: Address by Chairman, Medicines Australia. National Press Club, 3 August 2005 viewed 14 February
    • Will Delaat: PBS Reform for a Healthy Australia. Address by Chairman, Medicines Australia. National Press Club, 3 August 2005 [http://www.medicinesaustralia.com.au/]. viewed 14 February, 2006
    • (2006)
  • 67
    • 28644444561 scopus 로고    scopus 로고
    • Human Development Report 2005
    • United Nations: New York
    • United Nations: Human Development Report 2005. United Nations Development Programme New York 2005. at 135
    • (2005) United Nations Development Programme , pp. 135
  • 68
    • 33746384312 scopus 로고    scopus 로고
    • Foundation for Taxpayer and Consumer Rights last accessed 4 January
    • Foundation for Taxpayer and Consumer Rights [http://www.consumerwatchdog.org/pr/?postld=5512]. last accessed 4 January 2006
    • (2006)
  • 69
    • 0141871976 scopus 로고    scopus 로고
    • US politicians want federal funding to discover cost effectiveness of new drugs
    • Moynihan R: US politicians want federal funding to discover cost effectiveness of new drugs. British Medical Journal 2003, 327:642-645.
    • (2003) British Medical Journal , vol.327 , pp. 642-645
    • Moynihan, R.1
  • 70
    • 33746459594 scopus 로고    scopus 로고
    • Evidence to Committee on Finance Subcommittees on Health Care and International Trade
    • United States Senate, Washington
    • Shiner J: Evidence to Committee on Finance Subcommittees on Health Care and International Trade. United States Senate, Washington 2004.
    • (2004)
    • Shiner, J.1
  • 72
    • 33746403109 scopus 로고    scopus 로고
    • The so-called "TRIPS Agreement" is Annex 1C of the 1994 Marrakesh Agreement Establishing the World Trade Organisation. All relevant texts are published by the WTO (on line and in hard-copy with Cambridge University Press 1994) as The Legal Texts: The Results of the Uruguay Round of Multilateral Trade Negotiations
    • The so-called "TRIPS Agreement" is Annex 1C of the 1994 Marrakesh Agreement Establishing the World Trade Organisation. All relevant texts are published by the WTO (on line and in hard-copy with Cambridge University Press 1994) as The Legal Texts: The Results of the Uruguay Round of Multilateral Trade Negotiations.
  • 73
    • 33746471453 scopus 로고    scopus 로고
    • Communication from the United States, Scope and Modalities of Non-Violation Complaints Under the TRIPS Agreement (IP/C/W/194)
    • Communication from the United States, Scope and Modalities of Non-Violation Complaints Under the TRIPS Agreement (IP/C/W/194).
  • 74
    • 33746465627 scopus 로고    scopus 로고
    • Professor personal communication
    • Professor P Drahos, personal communication 2005.
    • (2005)
    • Drahos, P.1
  • 75
    • 33746405900 scopus 로고    scopus 로고
    • Deputy Secretary, Australian Department of Health and Ageing. AUSFTA Conference. Health Impacts [last accessed 4 January]
    • Davies P. Deputy Secretary, Australian Department of Health and Ageing. AUSFTA Conference. Health Impacts [http://www.apec.org.au/docs/ fta04Davies.pdf.]. [last accessed 4 January 2006]
    • (2006)
    • Davies, P.1
  • 76
    • 33746402180 scopus 로고    scopus 로고
    • Head Health Division. Delegates to the OECD Group on Health[letter] Pharmaceutical Pricing Policy. Organisation for Economic Cooperation and Development. 20 September
    • Scherer P: Head Health Division. Delegates to the OECD Group on Health[letter] Pharmaceutical Pricing Policy. Organisation for Economic Cooperation and Development. 20 September 2005
    • (2005)
    • Scherer, P.1
  • 77
    • 0003866632 scopus 로고
    • Canadian Coordinating Office for Health Technology Assessment: 1st edition. Ottawa: CCOHTA
    • Canadian Coordinating Office for Health Technology Assessment: Guidelines for economic evaluations of pharmaceuticals: Canada. 1st edition. Ottawa: CCOHTA; 1994.
    • (1994) Guidelines for Economic Evaluations of Pharmaceuticals: Canada
  • 78
    • 25144474846 scopus 로고    scopus 로고
    • The Influence of the Pharmaceutical Industry
    • United Kingdom House of Commons Health Committee: London; The Stationery Office Limited (last accessed 20 April 05)
    • United Kingdom House of Commons Health Committee: The Influence of the Pharmaceutical Industry. London; The Stationery Office Limited 2005 [http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/ 4202.htm]. (last accessed 20 April 05).
    • (2005)


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