Medicines and the New Economic Environment: II. THE REFORM OF HEALTH CARE SYSTEMS: II.2. Reform of Health Care Services in Developing Countries, Role of the State and Essential Drugs: REFERENCES

Medicines and the New Economic Environment
(1998; 252 pages) [Spanish]

Table of Contents

THE AUTHORS
PREFACE
INTRODUCTION
I. THE GLOBAL ECONOMIC ENVIRONMENT
	I.1. Opening Speech: Welfare State, Economic Policy and Health Services
		1. EVOLUTION AND PROBLEMS OF WELFARE PROGRAMS
		2. THE FUTURE OF THE WELFARE STATE: THE NEED FOR REFORM
		3. HEALTH CARE SERVICES: PROBLEMS AND REFORM LINES
		4. COMPETITION AND EFFICIENCY IN HEALTH CARE SYSTEMS
		5. COST OF HEALTH CARE TECHNOLOGY
		REFERENCES
	I.2. The Uruguay Round and Drugs
		1. INTRODUCTION
		2. PATENTS
			2.1. General principles
			2.2. Non-patentability: biotechnology-based drugs
			2.3. Non-discrimination clause
			2.4. Rights conferred: imports
			2.5. Rights conferred: protection of products through protection of the process
			2.6. Exceptions to exclusive rights
			2.7. Granting of compulsory licences
				2.7.1. Grounds for granting compulsory licences
				2.7.2. Conditions for granting compulsory licences
			2.8. Terms of protection
			2.9. Reversal of the burden of the proof
		3. UNDISCLOSED INFORMATION
		4. TRANSITIONAL PERIODS
			4.1. General grace period
			4.2. New patentable areas
			4.3. Protection of existing subject matter
			4.4. Prior compulsory licences and applications
			4.5. Pharmaceutical and agricultural chemical products
		5. ENFORCEMENT AND SETTLEMENT OF DISPUTES
		6. IMPLICATIONS FOR THE DEVELOPMENT, PRODUCTION AND MARKETING OF DRUGS
		7. CONCLUSIONS
		REFERENCES
	I.3. The Normalisation of the International Market for Pharmaceuticals: Future Impacts in Emerging Markets
		1. THE GLOBAL CONTEXT
		2. THE ESTABLISHMENT OF THE NORMS
			2.1. The drive towards normalisation
			2.2. The empirical framework
				2.2.1. The current structure of national markets
				2.2.2. Patents
				2.2.3. Prices
				2.2.4. The good manufacturing practices (GMP) and the quality of pharmaceuticals
				2.2.5. Generics
			2.3. The significance of the empirical information
		3. FUTURE TRENDS IN A NORMALISED WORLD
			3.1. Location of and control over production
				3.1.1. A synthesis of the structure of production
				3.1.2. What model is the international market heading for?
				3.1.3. Options for local producers in emerging countries
			3.2. International trade
		4. THE STEPS TO FOLLOW
		REFERENCES
II. THE REFORM OF HEALTH CARE SYSTEMS
	II. 1. Cost Containment and Health care Reforms: the Impact on Pharmaceuticals
		1. INTRODUCTION
		2. COST CONTAINMENT MEASURES
			2.1. Cost-sharing
			2.2. Expenditure ceilings
			2.3. Limiting doctors and hospital beds
			2.4. Alternatives to in-patient care
			2.5. Influencing the resource use authorised by doctors
			2.6. Pharmaceutical prices
			2.7. A profit control system for Europe?
			2.8. The effectiveness of cost containment measures: potential for further action
		3. LONG TERM SOLUTIONS
			3.1. Systematic approaches to establishing priorities
			3.2. Why are health care costs so explosive?
			3.3. Technology assessment and pharmacoeconomics
			3.4. Methodological problems in economic evaluation
				3.4.1. Cost benefit analysis
				3.4.2. Cost-utility analysis
				3.4.3. International cooperation
			3.5. Making health services more efficient
				3.5.1. Evaluation of the reforms
			3.6. Necessary health care and outcomes measurement
		4. CONCLUSIONS
		REFERENCES
	II.2. Reform of Health Care Services in Developing Countries, Role of the State and Essential Drugs
		1. INTRODUCTION
		2. POLITICAL, ECONOMIC AND SOCIAL BACKGROUND, AND ROLE OF THE STATE
			2.1. The economic background
			2.2. Poverty
			2.3. The role of the state
		3. HEALTH CARE REFORMS IN LATIN AMERICA
			3.1. Financing of the health care sector
			3.2. Health care expenditure
			3.3. Coverage
			3.4. Adjustment policies in the sector
			3.5. Three practical experiences
				3.5.1. The Chilean reform
				3.5.2. Costa Rica
				3.5.3. The Colombian reform
				3.5.4. 1993: A change in direction?
		4. ESSENTIAL DRUGS
			4.1. Production
			4.2. Regulations and registration
			4.3. Prescription
			4.4. Marketing
			4.5. Drugs and the public sector
			4.6. Training
			4.7. Conclusions
		REFERENCES
	II.3. Regulation, Policies and Essential Drugs
		1. TWO MAJOR TRENDS
			1.1. The role of the state
				1.1.1. The state and the civil society: regulation and participation. State control vs. Privatization?
			1.2. Internationalization
				1.2.1. From the «Nation State» to the «nationalities»
				1.2.2. Regional blocks: community areas
		2. DRUGS
			2.1. The process of innovation
				2.1.1. The end of the innovation boom
				2.1.2. Privatization of research
				2.1.3. Greater cost in research
			2.2. The selection process
				2.2.1. Prevailing health criteria
				2.2.2. Regulatory approval: selecting the useful and safe
				2.2.3. Essential drugs: the best
				2.2.4. And what about quality?
			2.3. The expansion of markets
				2.3.1. Economic and social rationale of internationalization
				2.3.2. Processes of regional and sub-regional integration
				2.3.3. Repercussions on the health care sector
				2.3.4. The challenge to surveillance and control. «Liberalization»?
			2.4. The creation of common areas: harmonization
				2.4.1. Harmonization of marketing authorization procedures
				2.4.2. Harmonization of pharmacological standards
				2.4.3. Harmonization of good manufacturing practices (GMPs)
				2.4.4. Intellectual property
			2.5. Ongoing processes
				2.5.1. World Health Organization
				2.5.2. The International Conference for Drug Regulatory Authorities
				2.5.3. The International Conference on the Harmonization of Technical Requirements for the approval of medicinal products for humans (ICH)
				2.5.4. The European Community
				2.5.5. The Andean group
				2.5.6. Mercosur
				2.5.7. Central America
		3. CONCLUSIONS
III. A CHANGING PHARMACEUTICAL INDUSTRY
	III.1. The New Structure of the Pharmaceutical Industry
		1. INTRODUCTION
		2. PHARMACEUTICAL RESEARCH AND DEVELOPMENT⁵
		3. THE REGULATION OF NEW DRUGS MARKETING
		4. RISING COSTS, DECLINING NEW PRODUCT INTRODUCTIONS
		5. DRUG TESTING AND INTERNATIONAL COMPETITIVENESS
		6. DRUG PRICES, PRICE CONTROLS, AND COMPETITION
		7. INDUSTRY RESTRUCTURING
		8. CONCLUSION
		REFERENCES
	III.2. Innovation and Regulation in the Pharmaceutical Market
		1. INTRODUCTION
		2. AN ERA OF EXPENSIVE DRUGS
			2.1. Expensive innovative drugs
			2.2. Innovation and the dynamic of drug markets
			2.3. The cost of innovation
		3. WHY ARE DRUGS EXPENSIVE?
			3.1. The R&D problem
			3.2. The nature of the market
		4. HOW TO REGULATE EXPENSIVE DRUGS?
			4.1. The ineffectiveness of direct price control
			4.2. Reinforced competition?
			4.3. Prescription control and pharmaco-economic assessment
		REFERENCES
	III.3. Change and Growth in Generic Markets in Developed and Developing Countries
		1. INTRODUCTION
		2. THE RESEARCH-BASED INDUSTRY FACES THE GENERICS
		3. SOME FIGURES FOR WESTERN COUNTRIES
		4. SOME FIGURES FOR NEW AND DEVELOPING COUNTRIES
		5. TRENDS IN GENERIC PRODUCTION
		6. THE PROTECTION OF RESEARCH (SCHERER, 1993)
		7. GENERICS BY THE YEAR 2000
		REFERENCES
IV. SYNTHESIS AND FORECASTS
	Medicines and the New Economic Environment: Summary and Forecasts (*)
		1. THE ROLE OF THE STATE AND THE REFORM OF HEALTH CARE SYSTEMS
			1.1. Problems regarding the welfare state in Western Europe and changes in Health Care Systems
			1.2. The development of health systems in Latin America and the ways of reform
			1.3. Conclusions on perspectives for change in health systems
			1.4. Cooperation from banks of development as new participants in the field of health
		2. CHANGES IN THE INTERNATIONAL SCENE
			2.1. Globalization
			2.2. Regional integration
		3. CHANGES IN THE STRUCTURE OF THE PHARMACEUTICAL INDUSTRY
		4. CALENDAR FOR FUTURE RESEARCH AND COOPERATION
BIBLIOTECA CIVITAS ECONOMÍA Y EMPRESA
BACK COVER

REFERENCES

ALTIMIR, O. (1994): «Income Distribution and Poverty Through Crisis and Adjustment", CEPAL Review, Santiago de Chile, No. 52.

THE ASPEN INSTITUTE (1994): Convergence and Community: The Americas in 1993. A Report of Inter-American Dialogue, The Aspen Institute, Washington DC.

BRAND, H. (1994): «The World Bank; The Monetary Fund and Poverty», Inter. J. Health Services, Vol. 24, No. 3.

BUSTELO, E. (1992): El ajuste a la crisis, PAHO Publication, Technical Reports Series, Health Policy Program, No. 14, Washington DC.

CEPAL (1990): Transformación productiva con equidad. La tarea prioritaria del desarrollo de América Latina y el Caribe en los años noventa, U.N. Publication, Santiago de Chile, Sales No. S.90.II.G.6.

CEPAL (1992): Equidad y transformación productiva: un enfoque integrado, U.N. Publication, Santiago de Chile, Sales No. S.92.II.G.5.

CEPAL (1993): Balance Preliminar de la Economía de América Latina y el Caribe, 1993, U.N. Publication, Santiago de Chile, LC/G.1794, pp. 1-4.

CEPAL/OFICINA REGIONAL DE LA UNESCO PARA AMERICA LATINA Y EL CARIBE (1992): Educación y conocimiento: eje de la transformación productiva con equidad, U.N. Publication, Santiago de Chile, Sales No. S.92.II.G.6.

COLLINS, CH. and GREEN, A. (1994): «Decentralization and Primary Health Care: Some Negative Implications in Developing Countries», Inter. J. Hlth. Serv., Vol. 24, No. 3.

CONGRESO DE COLOMBIA (1993): La reforma del sector de la Seguridad Social y la salud. Exposición de motivos, leyes y decretos», Santa Fé de Bogotá, August, memo.

EMMERIJ, L. (1993): «A Critical Review of the World Bank's Approach to Social Lending and Poverty Alleviation», prepared for the Group of 24, not published, Paris, June.

ENGLER, T. (1993): «Modernization of the State and leadership in Health», in State, Development and Health: Technical Discussions 1993, PAHO Publication, Technical Report Series, No. 36, Washington DC.

FEFER, E. (1994): «Drug Quality of Medicines in Developing Countries», Communication to the 30th Annual Meeting, Drug Information Association, Washington, June.

GALBRAITH, J. K. (1992): La cultura de la satisfacción, Ariel, Madrid.

GOVINDARAJ, R.; MURRAY, CH. J. L. and CHELLERAJ, G. (1994): Health Expenditure in Latin America, Harvard Center for Population and Development and the World Bank, Panamerican. Health Organization, Document Reproduction Series, No. 47, Washington DC, September.

GURINDER, S.; BINGER, A. and LAWRENCE, B. (eds.) (1995): Towards a Sustainable World: International Perspectives on Environment, Health and Development, Springer Pub., in print.

HELLING-BORDA, M. (1994): «El programa de acción sobre medicamentos esenciales», en Reunión de Coordinación de Proyectos de Medicamentos Esenciales, Informe de Reunión, PAHO Publication, Guatemala, November.

HOROWITZ, A.; FRENCH, J.; TEJADA DE RIVERO, D.; ORDÓÑEZ, A. and MIRANDA, G. (1987): El financiamiento de los servicios de salud en los países en desarrollo. Una agenda para la reforma. Mesa redonda, PAHO Bulletin, Vol. 36, No. 6, Washington DC.

LAURELL, A. S. and WENCES, M. I. (1994): «Do Poverty Programs alleviate Poverty? The Case of the Mexican National Solidarity Program», Inter. J. Health Service, Vol. 24, No. 3.

LEÓN, F. (1993): «The State, Development and Health», in State, Development and Health: Technical Discussions 1993, PAHO Publication, Technical Reports Series, No. 36, Washington DC.

LÓPEZ-ACUÑA, D. (1991): «Reforma del Estado y desarrollo social en América Latina», El Nacional, October 8, 15 and 22, Mexico DF.

MESA LAGO, C. (1994): Atención a la salud para los pobres en América Latina y el Caribe, PAHO and Inter-American Foundation, Washington DC.

NCIH HEATHLINK (1995): WHO Executive Meeting, February-March, Washington DC.

PAN AMERICAN HEALTH ORGANIZATION (1994a): «Informe Conjunto de la CEPAL y la OPS sobre Salud, Equidad y Transformación Productiva en América Latina y el Caribe», XXIV Conferencia Sanitaria Panamericana, XLVI Reunión del Comité Regional, CSP24/20, Washington DC.

PAN AMERICAN HEALTH ORGANIZATION (1994b): «Reforma del sector salud: Situación actual en los países», Technical Reports Series, unpublished, Washington DC, November.

PAN AMERICAN HEALTH ORGANIZATION (1994c): Las condiciones de salud en las Américas, Vol. I, Washington DC.

PAN AMERICAN HEALTH ORGANIZATION (1994d): Gasto nacional y Financiamiento del sector Salud en América Latina y el Caribe: Desafíos para la década de los noventa, PAHO Publication, Technical Reports Series, No. 30, Washington DC.

PAN AMERICAN HEALTH ORGANIZATION (1994e): Report of the Director. Quadriennial 1990-1993. Annual 1993, Washington DC.

PAN AMERICAN HEALTH ORGANIZATION (1994f): Informe del Comité Ejecutivo del Consejo Directivo, June-July, CE113/20, Washington DC.

RODRÍGUEZ-GARCÍA, R. (1995): «Health, Economics and Development: Working Together for Change», en GURINDER, BINGER Y LAWRENCE, 1995.

RODRÍGUEZ-GARCÍA, R.; COLDMAN, A. (eds.) (1994): The Health Development Link, The George Washington University and Pan American Health Organization, Washington DC, pp. 1-57.

ROEMER, M. I. (1991-1993): National Health Systems of the World, Oxford University Press, Vol. I, Ch. 11-12; Vol. II, Ch. 18.

SOCIETY FOR INTERNATIONAL DEVELOPMENT (1994): Annual Report 1993, Roma.

SUÁREZ, W. (1991): Estrategias alternativas de combate a la pobreza, PAHO Publication, Technical Reports Series, Health Policy Program, No. 3, Washington DC.

SUMMIT OF THE AMERICAS (1994): «Declaration of Principles» and «Plan of Action», final revised draft, December.

UNITED NATIONS DEVELOPMENT PROGRAM (1993): Human Development Report 1993, Oxford University Press.

VIERA, C. (1995): «La OPS y la reforma del Sector Salud», Presentación al Seminario sobre la Reforma del Sector Salud en Centroamérica, San José, February 23-24.

WORLD BANK (1987): Financing Health Services in Developing Countries. An Agenda for Reform. A World Bank Study, Washington DC.

WORLD BANK (1990): World Development Report, 1990: Poverty, Washington DC.

WORLD BANK (1993): Investing in Health, Oxford University Press, New York.

WORLD HEALTH ORGANIZATION (1993): Evaluation of Recent Changes in the Financing of Health Services: Report of a WHO Study Group, WHO Technical Report Series, No. 829, Geneva.

WORLD HEALTH ORGANIZATION (1993a): Boletín de Medicamentos Esenciales de la Organización Mundial de la Salud, No. 16, Ginebra.

WORLD HEALTH ORGANIZATION (1993b): Aplicación de la Estrategia Mundial de la Salud para todos en el año 2000 (Segunda Evaluación). Octavo Informe sobre la Situación Sanitaria Mundial, Ginebra.