Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Globalization and Health
Published in: Globalization and Health 1/2006

Open Access 01-12-2006 | Debate

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

Author: Thomas Alured Faunce

Published in: Globalization and Health | Issue 1/2006

Login to get access

Abstract

• Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets.
• Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins.
• This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations.
Literature
1.
Faunce TA: 'Global Intellectual Property Protection for Innovative Pharmaceuticals: Challenges for Bioethics and Health Law'. In Globalisation and Health. Edited by: Bennett B, Tomossy GF. Springer. Dordrecht; 2005.
2.
Moghimi SM, Hunter AC, Murray JC: 'Nanomedicine: Current Status and Future Prospects'. FASEB Journal 2005, 19: 311-330. 10.1096/fj.04-2747revCrossRefPubMed
3.
Neumann PJ, Rosen AB, Weinstein MC: 'Medicare and Cost-Effectiveness Analysis'. New England Journal of Medicine 2005,353(14):1516-1522. 10.1056/NEJMsb050564CrossRefPubMed
4.
Berger , et al.: Health Care Cost, Quality and Outcomes. International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville NJ; 2003.
5.
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.
6.
Berger , et al.: Health Care Cost, Quality and Outcomes. International Society for Pharmacoeconomics and Outcomes Research, Lawrenceville NJ; 2003.
7.
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. 10.1001/jama.294.20.2630CrossRefPubMed
8.
Pammolli F, et al.: Medical devices Competitiveness and Impact on Public Health Expenditure. Directorate Entreprise of the European Commission University of Florence 2005.
9.
Ray WA, Stein CM: 'Reform of drug regulation-Beyond an Independent Drug-Safety Board'. New England Journal of Medicine 2006,354(2):194-201. 10.1056/NEJMsb053432CrossRefPubMed
10.
11.
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.
12.
Birkett DJ, Mitchell AS, McManus P: A Cost-Effectiveness Approach to Drug Subsidy and Pricing in Australia. Health Affairs 2001,20(3):104-114. 10.1377/hlthaff.20.3.104CrossRefPubMed
13.
Day RO, Birkett DJ, Miners J, Shenfield GM, Henry DA, Seale JP: 'Access to medicines and high-quality therapeutics: global responsibilities for clinical pharmacology. Medical Journal of Australia 2005,182(7):322-323.PubMed
14.
15.
Interviews by the author with PBAC members in 2005.
16.
17.
Detsky A: 'Guidelines for economic analysis of pharmaceutical products: a draft document for Ontario and Canada.'. Pharmacoeconomics 1993,3(5):354-61.CrossRefPubMed
18.
Morgan S, Bassett K, Mintzes B: Outcomes-Based Drug Coverage in British Columbia'. Health Affairs 2004,23(3):269-276. 10.1377/hlthaff.23.3.269CrossRefPubMed
19.
20.
21.
Interviews by the author with PMPRB senior officials in Ottawa 2005.
22.
23.
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.
24.
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.CrossRefPubMedPubMedCentral
25.
Kincses G: 'The situation of health technology assessment in Hungary.' Poster presentation. International Society for Pharmacoeconomics and Outcomes Research 2 nd Asia-Pacific Conference Shanghai. 2004.
26.
Giuliani G, Selke G, Garattini L: The German Experience in Reference Pricing Health Policy. 1998,44(1):73-85.
27.
Berger ML: 'Cost-Effectiveness Analysis. From Science to Application.'. Medical Care 2005,43(7):49-53.PubMed
28.
Lipsy RJ: 'Institutional formularies: the relevance of pharmacoeconomic analysis to formulary decisions. Pharmacoeconomics 1992,1(4):265-81.CrossRefPubMed
29.
30.
31.
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. 10.1001/jama.294.20.2630CrossRefPubMed
32.
33.
Luce BR: 'What will it take to make cost-effectiveness analysis acceptable in the United States?'. Medical Care 2005,43(7):44-48.PubMed
34.
Kamae I: 'Health economics in Japan: Dawning or Staggering?'. International Society for Pharmacoeconomics and Outcomes Research 2nd Asia-Pacific Conference Shanghai 6 March 2006
35.
Drummond M, Sculpher M: 'Common methodological flaws in economic evaluations'. Medical Care 2005,43(7):II-5-14.
36.
Soumerai SB: A critical analysis of studies of state drug reimbursement policies: research in need of discipline. Millbank Quarterly 1993,71(2):217-252.CrossRef
37.
Neumann PJ: 'Evidence-based and value-based formulary guidelines'. Health Affairs 2004, 23: 124-34. 10.1377/hlthaff.23.1.124CrossRefPubMed
38.
Neumann P: 'Evidence-based policy and benefit design for health care value'. International Society for Pharmacoeconomics and Outcomes Research 2nd Asia-Pacific Conference Shanghai 6 March 2006.
39.
Berger ML: Cost-effectiveness analysis. From science to application. Medical Care 2005,43(7):II49-53.
40.
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.PubMed
41.
Hu S: 'Pharmacoeconomics and outcome research in China'. International Society for Pharmacoeconomics and Outcomes Research 2nd Asia-Pacific Conference Shanghai 6 March 2006
42.
Yang B-M: 'Use of economic evaluation in insurance decision making: South Korea'. International Society for Pharmacoeconomics and Outcomes Research 2nd Asia-Pacific Conference Shanghai 6 March 2006
43.
Chuen LS: 'Recent changes in the healthcare scene in Singapore'. International Society for Pharmacoeconomics and Outcomes Research 2nd Asia-Pacific Conference Shanghai 6 March 2006
44.
Tangcharoensa V: 'Role of pharmaco-economic in Thailand'. International Society for Pharmacoeconomics and Outcomes Research 2nd Asia-Pacific Conference Shanghai 6 March 2006
45.
Hameed A, Aljunid SM: 'Pharmaco-economics and outcomes research in Pakistan''Pharmaco-economics and outcomes research in Malaysia'. International Society for Pharmacoeconomics and Outcomes Research 2nd Asia-Pacific Conference Shanghai 6 March 2006
46.
WHO: The World Medicines Situation. Geneva. World Health Organisation; 2004.
47.
Danzon PM, Towse A: Theory and implementation of differential pricing of pharmaceuticals. In International Public Goods and Transfer of Technology Under a Globalised Intellectual Property Regime. Edited by: Maskus KE, Reichman JH. Camb university Press NY; 2005:425-456.CrossRef
48.
Bapna JS: 'Pharmaco-economics and Outcomes research in India'. International Society for Pharmacoeconomics and Outcomes Research 2nd Asia-Pacific Conference Shanghai 6 March 2006
49.
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. 10.1016/S0140-6736(03)13375-2
50.
Drummond M: 'ISPOR and the medical device world' ISPOR Asia medical device and diagnostics council forum'. International Society for Pharmacoeconomics and Outcomes Research 2nd Asia-Pacific Conference Shanghai 6 March 2006
51.
Drummond M: 'ISPOR and the medical device world' ISPOR Asia medical device and diagnostics council forum'. International Society for Pharmacoeconomics and Outcomes Research 2nd Asia-Pacific Conference Shanghai 6 March 2006
52.
53.
Maskus KE, Reichman JH: "The Globalisation of private knowledge goods and the privatisation of global public goods" in KE Maskus and JH Reichman 2005 International Public Goods and Transfer of Technology Under a Globalised Intellectual Property regime Cambridge University Press, NY . 2005, 3-45.
54.
Leary VA: The right to health in international human rights law. Health and Human Rights 1994,1(1):24-32.CrossRefPubMed
55.
World Trade Organisation: Declaration on the TRIPS agreement and public health WT/MIN(01)/DEC/2. 20 November 2001
56.
57.
Cochrane AL: Effectiveness and Efficiency: Random Reflections on Health Services London Nuffield Provincial Hospitals Trust. 1972.
58.
Lopez-Casasnovas , Puig-Junoy : Review of the literature on reference pricing health policy 2000. 2000, 54: 87-123.
59.
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. 10.1001/jama.283.16.2116CrossRefPubMed
60.
Brita Pekarsky Working Paper presented to CGKD. 2006.
61.
Stocker H, Waitzkin H, Iriart C: 'The Exportation of Managed Care to Latin America,'. New England Journal of Medicine 1999, 340: 1131-1136. 10.1056/NEJM199904083401425CrossRefPubMed
62.
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.
63.
US Department of Commerce International Trade Administration: Pharmaceutical Price Controls in OECD Countries. Implications for US Consumers, Pricing, Research and Development and Innovation Washington DC. 2004.
64.
Blumenthal D, Hsiao W: "Privatisation and its Discontents-The Evolving Chinese Health Care System". New England Journal of Medicine 2005,353(11):1165-1172. 10.1056/NEJMhpr051133CrossRefPubMed
65.
Barr MD: "Medical Savings Accounts in Singapore: A Critical Inquiry". J Health Polit Policy Law 2001, 26: 709-712. 10.1215/03616878-26-4-709CrossRefPubMed
66.
67.
United Nations: Human Development Report 2005. United Nations Development Programme New York 2005. at 135
68.
69.
70.
Shiner J: Evidence to Committee on Finance Subcommittees on Health Care and International Trade. United States Senate, Washington 2004.
71.
US Department of Commerce International Trade Administration: Pharmaceutical Price Controls in OECD Countries. Implications for US Consumers, Pricing, Research and Development and Innovation Washington DC. 2004.
72.
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.
Communication from the United States, Scope and Modalities of Non-Violation Complaints Under the TRIPS Agreement, (IP/C/W/194).
74.
Professor P Drahos, personal communication. 2005.
75.
76.
Scherer P: Head Health Division. Delegates to the OECD Group on Health[letter] Pharmaceutical Pricing Policy. Organisation for Economic Co-Operation and Development 20 September 2005
77.
Canadian Coordinating Office for Health Technology Assessment: Guidelines for economic evaluations of pharmaceuticals: Canada. 1st edition. Ottawa: CCOHTA; 1994.
78.
Metadata
Title
Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good
Author
Thomas Alured Faunce
Publication date
01-12-2006
Publisher
BioMed Central
Published in
Globalization and Health / Issue 1/2006
Electronic ISSN: 1744-8603
DOI
https://doi.org/10.1186/1744-8603-2-5

Other articles of this Issue 1/2006

Globalization and Health 1/2006 Go to the issue

Debate

An economic perspective on Malawi's medical "brain drain"

Review

Globalization, migration health, and educational preparation for transnational medical encounters

Debate

HIV/AIDS mitigation strategies and the State in sub-Saharan Africa – the missing link?

Research

Overweight in the Pacific: links between foreign dependence, global food trade, and obesity in the Federated States of Micronesia

Research

The developing world in The New England Journal of Medicine

Debate

Globalization and local response to epidemiological overlap in 21st century Ecuador