Medicines and the New Economic Environment: THE AUTHORS

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

Índice de contenido

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

THE AUTHORS

Julio Segura is Professor of Economics at the University Complutense, Madrid. As director of the Fundación Empresa Pública he has been instrumental for the development in Spain of a number of research fields, such as Industrial Economics, Public Economics and the Economics of the Welfare State. He has published several books and many articles in scientific journals. He was awarded the prize King Juan Carlos I in Economics, the highest award in Spain for the profession.

Carlos Correa, lawyer and economist, is the director of the Master in Science and Technology Policy and Management at the University of Buenos Aires. He has been consultant for a large number of international organizations such as UNIDO, UNCTAD, and OECD. He is considered one of the leading world experts in Industrial Property. He has extensively worked in the Economics of the Pharmaceutical Industry and is the author of a large number of publications.

The economist Peter O'Brien worked for a number of years at the United Nations Trade and Development Conference. After leaving UNCTAD he has been working extensively as consultant for many international organizations especially in developing countries. He is well known for his works in the Economics of the pharmaceutical sector and the automobile industry. He has published books and articles in many scientific and professional journals.

Elias Mossialos is doctor in Medicine and in Economics, the later degree obtained at the London School of Economics. Presently he is senior lecturer in European Health policy and executive director of the LSE Unit dedicated to research on health policy and he has contributed decisively in the establishment of the European Health Policy Research Network. He is the author of a number of books and articles.

Alberto Infante, medical doctor, is an specialist in public health and health services management. He has had important responsibilities at the Ministry of Health and Consumers Affairs in Spain, such as beeing Deputy Director for international relations. Presently he is consultant for the Pan-American Health Organization at Washington. He knows very well Latin-American health systems and is the author of many publications.

Juan Ignacio Arango, economist, presently works as consultant for the Pan-American Health Organization at Bogota. He is an expert in Latin-American health systems and particularly in the pharmaceutical sector of the region.

Frederic Scherer, presently Roy E. Larsen Professor at the Kennedy School at the University of Harvard is considered throughout the world one of the most distinguished scholars in the field of Industrial Economics. His manual Industrial Market Structure and Economical Performance, with three editions published in 1970, 1980 and 1990, is essential for the comprehension of contemporary economies. He has made very important contributions to the analysis of the Pharmaceutical Industry.

Claude Le Pen, economist, presently is the director of the Health Economics Laboratory at the University Paris-Dauphine. His doctoral dissertation was dedicated to the Pricing Policies in the Pharmaceutical Industry and Regulations by the State.

Graham Dukes, medical doctor, worked for the Medicines Commission of the United Kingdom and the European Office of the World Health Organization. Presently he works as consultant for WHO and the World Bank. He has an extensive knowledge of the pharmaceutical sector in developed and developing countries.

Pedro Lobato, economist and Professor of Economics at the University Complutense in Madrid. He was head of Economic Advisers at the Ministry of Health and Consumer Affairs in Madrid and director of the Office of Health Economics. He now teaches a course of Health Economics at the University Complutense. He is the author of books and articles mainly related with the Pharmaceutical Industry.

Joan Rovira is one of the most distinguished Spanish health economists. His capacity as organizer has contributed enormously to the development of the Spanish Association for Health Economics and to the celebration of many conferences and scientific meetings on the field. He is professor of Economics at the University of Barcelona and director of Soikos, consulting firm specialised in Health Economics and Management. Economic evaluation of health care technologies and medicines is at present one of his fields of interest.

Germán Velásquez, economist, has a long experience as manager of cooperation programs in the pharmaceutical field in developing countries, particularly African and Latin-American. Nowadays he works as technical officer at the Essential Drugs Program with WHO. He is the author of an important book on the Pharmaceutical Industry and developing countries.

Félix Lobo, doctor in economics and law. Since 1990 he is Professor of Applied Economics at the University Carlos III in Madrid, where he chairs the Seminar on Social Studies on Health and Medicines. In 1992 he published the book Medicamentos, política y economía. From 1983 to 1988 he was General Director for Pharmacy and Health Products at the Ministry of Health and Consumer Affairs in Spain.