Medicines and the New Economic Environment: I. THE GLOBAL ECONOMIC ENVIRONMENT: I.3. The Normalisation of the International Market for Pharmaceuticals: Future Impacts in Emerging Markets: 4. THE STEPS TO FOLLOW

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

4. THE STEPS TO FOLLOW

The standardisation accomplished in recent years in the International Pharmaceutical Industry, signifies a major leap ahead for the innovative pharmaceutical firms along the road which they have spent years building and improving. The fact that the norms are consecrated precisely at that point in time when emerging countries are undergoing epoch-making changes in their approaches to development, means that there is an urgent need to examine the steps these countries can and should follow. Such steps encompass actions at national level and efforts aimed at reinforcing the interchange of information and experiences. The sketch which follows in no way lays claim to originality regarding the methods suggested - but it does underline that the context in which the measures are to be undertaken is new. Three broad headings may be signalled:

(i) Regarding Products; critical aspects are:

• organisation of national committees for register and evaluation of pharmaceuticals, and for the exchange of working methods, guides and staff among them;

• likewise with regard to good manufacturing practices;

• exchanges of experience/information regarding the application of new standards and the space which thereby remains for the design of policies (whether national or wider in scope) in this area:

- data banks on technology and production systems sources;
- the functioning of public purchasing systems.

(ii) Regarding skill formation and information; key elements are:

• diffusion of information to doctors and pharmacists on choice of drugs and prescription handling;

• detailed examination of the lessons to be learned from countries where standards have been operating for some time (for example, in the management of cost containment policies, the use of incentives to R&D);

• choice of key investments to promote skill formation and R&D.

(iii) Regarding the organisation of pressure groups. It should never be overlooked that changes of context in the International Pharmaceutical Industry are the outcome of political struggles which demand good organisation. Whether the mechanisms used are the «industry clubs» of ASEAN, the sectoral councils that frequently function in multilateral negotiations in Latin America, or through groups such as ALIFAR, it is vital to seek a joint vision, establish what that implies in terms of political/institutional context, and invest in the necessary entities and logistics to consolidate the steps. If this does not happen the pharmaceutical industry in emerging countries runs the risk in the future of being the «standardised object», instead of being the prime actor in the setting of standards.