Medicines and the New Economic Environment: II. THE REFORM OF HEALTH CARE SYSTEMS: II.3. Regulation, Policies and Essential Drugs: 2. DRUGS: 2.5. Ongoing processes: 2.5.4. The European Community

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

Table des matières

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

2.5.4. The European Community

The European Community has long been concerned with the issue of creating a policy for the control of drugs, that adequately reflects the reality of the economic and political integration process. Accordingly, it has been concerned with creating a common political ground for the control of drugs; it has issued a series of directives to harmonize the procedures of drugs approval, and others which seek to standardize some very specific principles for drug use. But perhaps the most significant progress has been the setting up of common «supranational» institutions for the control of drugs, in particular the European Agency for the Evaluation of Drugs and the Committee of Pharmaceutical Products.

The establishment of these common and stable organizational institutions, allows to have analysis and decision-making bodies with resolutive capacity and direct communication channels with the highest decision-making levels of political power in the Community.

• Mutual acceptance of National Regulatory Authorities: The Community has made significant progress in the coordination of Approval procedures. In brief, we could say that the applicant goes to the country's authorities to apply for regulatory approval; the applicant presents the required documentation and notifies the other countries where he also wishes to obtain approval. The authorities of the first country study the application, make a decision and notify their decision to the interested party and to the other countries; in turn, these would evaluate the application based on the study conducted by the first country, and make a pronouncement in a brief and previously established period of time. If the applicant does not agree with the decision made by the first country, he may appeal to other instances, such as the Committee and the Agency, which will study the case and decide on the agreement procedure to be followed.

This avoids the duplication of efforts resulting from the various national (non communitary) schemes for pre-marketing evaluation of products, and also enables the concentration of technical resources.

• Approval of similar drugs: Progress has also been made to simplify the approval of similar products, which facilitates a better supply to the market and avoids complex evaluations for products already known and evaluated.