The Latin American Pharmaceutical Market Guide 1999

The Latin American Pharmaceutical Market Guide 1999

The Latin American pharmaceutical market offers great opportunities. In terms of value, Brazil ranks as the seventh largest pharmaceutical market in the world, with Argentina tenth and Mexico eleventh.
To help you to exploit these markets, Scrip Reports has published The Latin American Pharmaceutical Market Guide 1999. This report presents you with an authoritative overview of seven key markets, provides market data up to and including 1998, and predictions beyond 2000. Complete with a regional overview, this guide covers the following countries in detail:
* Argentina
* Brazil
* Chile
* Colombia
* Mexico
* Peru
* Venezuela

PUBLISHED: JUNE 1999
REF: BS1012E
PAGES: 250+
PRICE: £695/$1,195/¥167,000

CONTENTS
CONTENTS
LIST OF TABLES
LIST OF FIGURES
EXECUTIVE SUMMARY
ES.1 Political and economic situation
ES.2 Healthcare provision
ES.3 Regulatory environment
ES.4 The pharmaceutical industry environment
ABBREVIATIONS AND GLOSSARY

CHAPTER 1 REGIONAL OVERVIEW
1.1 Key findings
1.1.1 Political and economic environment
1.1.1.1 Argentina
1.1.1.2 Brazil
1.1.1.3 Chile
1.1.1.4 Colombia
1.1.1.5 Mexico
1.1.1.6 Peru
1.1.1.7 Venezuela
1.1.2 General health indicators
1.1.2.1 Argentina
1.1.2.2 Brazil
1.1.2.3 Chile
1.1.2.4 Colombia
1.1.2.5 Mexico
1.1.2.6 Peru
1.1.2.7 Venezuela
1.1.3 Healthcare service
1.1.3.1 Argentina
1.1.3.2 Brazil
1.1.3.3 Chile
1.1.3.4 Colombia
1.1.3.5 Mexico
1.1.3.6 Peru
1.1.3.7 Venezuela
1.1.4 Healthcare reforms
1.1.4.1 Argentina
1.1.4.2 Brazil
1.1.4.3 Chile
1.1.4.4 Colombia
1.1.4.5 Mexico
1.1.4.6 Peru
1.1.4.7 Venezuela
1.1.5 Regulations
1.1.5.1 Argentina
1.1.5.2 Brazil
1.1.5.3 Chile
1.1.5.4 Colombia
1.1.5.5 Mexico
1.1.5.6 Peru
1.1.5.7 Venezuela
1.1.6 Pharmaceutical markets
1.1.6.1 Argentina
1.1.6.2 Brazil
1.1.6.3 Chile
1.1.6.4 Colombia
1.1.6.5 Mexico
1.1.6.6 Peru
1.1.6.7 Venezuela
1.2 Healthcare summary
1.2.1 Cost-containment
1.3 Managed care
1.4 Regulatory environment overview
1.4.1 Regional/multinational trade agreements
1.4.2 Patents
1.4.3 Registration
1.5 Market overview
1.5.1 Pharmaceutical market summary
1.5.2 Market size
1.5.3 Market structure
1.5.4 Market trends
1.5.5 Pharmaceutical pricing
1.5.6 Generics
1.5.7 Merger and acquisition activity

CHAPTER 2 ARGENTINA
2.1 Executive summary
2.2 Political and economic environment
2.2.1 Government
2.2.2 Elections
2.2.3 Economic policy
2.2.4 Gross domestic product
2.2.5 Inflation and unemployment
2.2.6 Population and per capita income
2.2.7 Fiscal policy
2.2.8 Conclusions
2.3 Healthcare provision
2.3.1 Healthcare administration
2.3.2 Healthcare financing
2.3.3 Healthcare reform
2.3.4 Population and epidemiology
2.3.5 Cost-containment and reimbursement
2.3.5.1 Global budgets
2.3.6 Prescribing and dispensing
2.3.7 Private versus public sector
2.3.7.1 Hospital sector
2.3.8 Conclusions
2.4 Regulatory environment
2.4.1 Patent laws
2.4.2 Registration
2.4.3 Clinical trials
2.4.4 Good manufacturing practice/good clinical practice
2.4.5 Packaging and labelling
2.4.6 Advertising regulations
2.4.7 Harmonisation/Mercosur
2.4.8 Conclusions
2.5 Pharmaceutical industry environment
2.5.1 Industry and market structure
2.5.1.1 Industry
2.5.1.2 Market
2.5.2 Pricing
2.5.3 The over-the-counter and retail sectors
2.5.4 Generics versus copy or 'similar' products
2.5.5 Distribution
2.5.6 Merger and acquisition activity
2.5.7 Conclusions
REFERENCES
DIRECTORY

CHAPTER 3 BRAZIL
3.1 Executive summary
3.2 The political and economic environment in Brazil
3.2.1 Government
3.2.2 The economic environment in Brazil
3.2.3 Conclusions
3.3 Healthcare provision
3.3.1 Administration
3.3.1.1 Public healthcare
3.3.1.2 Private healthcare
3.3.2 Healthcare reform
3.3.3 Healthcare expenditure
3.3.4 Healthcare indicators
3.3.5 Cost-containment and reimbursement
3.3.6 Prescribing and dispensing
3.3.7 Private versus public sector healthcare provision
3.3.7.1 The hospital sector
3.3.8 Conclusions
3.4 The regulatory environment
3.4.1 Administration
3.4.2 The patent law
3.4.3 Registration
3.4.3.1 Fast-track registration
3.4.3.2 Product classification
3.4.4 New generic legislation
3.4.5 Good manufacturing practice and good clinical practice
3.4.6 Packaging and labelling
3.4.7 Counterfeiting
3.4.8 Harmonisation and Mercosur
3.4.9 Conclusions
3.5 The pharmaceutical industry environment
3.5.1 The pharmaceutical market
3.5.2 Industry structure
3.5.3 Pricing
3.5.3.1 Price structure
3.5.4 Over-the-counter and retail sectors
3.5.4.1 The over-the-counter market
3.5.4.1 The retail sector
3.5.5 Generics versus copy or 'similar' products
3.5.6 Wholesale/distribution
3.5.7 Merger and acquisition activity
3.5.8 Conclusions
REFERENCES

CHAPTER 4 CHILE
4.1 Executive summary
4.2 The political/economic environment in Chile
4.2.1 Central government
4.2.2 Local government
4.2.3 Elections
4.2.4 Foreign policy
4.2.5 The economic environment in Chile
4.2.6 Gross domestic product
4.2.7 Inflation and unemployment
4.2.8 Population
4.2.9 Fiscal policy
4.2.10 Conclusions
4.3 Healthcare provision
4.3.1 Administration
4.3.1.1 The Sistema Nacional de Servicios de Salud
4.3.1.2 Fonasa
4.3.1.3 The Mutuales de Seguridad
4.3.1.4 Private insurance companies
4.3.1.5 Private healthcare
4.3.2 Private versus public sector healthcare provision
4.3.3 Healthcare reform
4.3.4 Healthcare spend
4.3.5 Healthcare indicators
4.3.6 Cost-containment and reimbursement
4.3.6.1 Cost-containment
4.3.6.2 Reimbursement
4.3.7 Prescribing and dispensing
4.3.8 Primary and secondary care
4.3.8.1 Primary care
4.3.8.2 The hospital sector
4.3.8.3 Conclusions
4.4 The regulatory environment
4.4.1 Patents
4.4.2 Registration
4.4.3 Good manufacturing practice and good clinical practice
4.4.4 Clinical trials
4.4.5 Packaging and labelling
4.4.6 Harmonisation
4.4.7 Conclusions
4.5 The pharmaceutical industry environment
4.5.1 The pharmaceutical market
4.5.2 Market structure
4.5.3 Pharmaceutical supply sources
4.5.4 Market trends
4.5.5 Pricing
4.5.6 Over-the-counter products
4.5.7 Generics
4.5.8 Wholesale/distribution
4.5.9 Merger and acquisition activity
4.5.10 Licensing
4.5.11 Conclusions
REFERENCES

CHAPTER 5 COLOMBIA
5.1 Executive summary
5.2 Political and economic background
5.2.1 Central government
5.2.2 Local government
5.2.3 Elections
5.2.4 Foreign policy
5.2.5 The economic environment in Colombia
5.2.6 Gross domestic product
5.2.7 Inflation and unemployment
5.2.8 Population
5.2.9 Fiscal policy
5.2.10 Conclusions
5.3 Healthcare provision
5.3.1 Healthcare administration
5.3.1.1 The National Council on Social Security for Health
5.3.1.2 The National Solidarity and Guarantee Fund
5.3.1.3 Health promotion enterprises
5.3.1.4 Health institutions
5.3.2 Healthcare reform
5.3.3 Healthcare funding and expenditure
5.3.4 Private versus public sector healthcare provision
5.3.5 Healthcare indications
5.3.6 Cost-containment and reimbursement
5.3.7 Prescribing and dispensing
5.3.8 Primary and secondary care
5.3.8.1 Primary care
5.3.8.2 The hospital sector
5.3.9 Conclusions
5.4 The pharmaceutical regulatory environment
5.4.1 Patents
5.4.2 Registration
5.4.3 Good manufacturing practice
5.4.4 Advertising and promotion
5.4.5 Harmonisation
5.4.6 Conclusions
5.5 The pharmaceutical industry environment
5.5.1 The pharmaceutical market
5.5.2 Market structure
5.5.3 Market trends
5.5.4 Pricing
5.5.5 Over-the-counter products
5.5.6 Generics
5.5.7 The distribution chain
5.5.8 Merger and acquisition activity
5.5.9 Licensing
5.5.10 Conclusions
REFERENCES

CHAPTER 6 MEXICO
6.1 Executive summary
6.2 The political and economic environment in Mexico
6.2.1 Government
6.2.2 The economic environment in Mexico
6.2.3 Conclusions
6.3 Healthcare provision
6.3.1 Healthcare indicators
6.3.2 Healthcare administration
6.3.2.1 Private healthcare
6.3.2.2 Healthcare expenditure
6.3.2.3 Healthcare reform
6.3.3 Cost-containment and reimbursement
6.3.4 Prescribing and dispensing
6.3.5 The hospital sector
6.3.6 Private versus public sector healthcare provision
6.3.7 Conclusions
6.4 The regulatory environment
6.4.1 The patent law
6.4.2 Registration
6.4.3 Good manufacturing practice and good clinical practice
6.4.4 Packaging and labelling
6.4.5 New generic legislation
6.4.6 Harmonisation and NAFTA
6.4.7 Conclusions
6.5 The pharmaceutical industry environment
6.5.1 The pharmaceutical market
6.5.2 Industry structure
6.5.3 Pricing
6.5.3.1 Pricing structure
6.5.4 Over-the-counter and retail sectors
6.5.4.1 The over-the-counter market
6.5.4.2 The retail sector
6.5.5 Generics versus copy or 'similar' products
6.5.6 Wholesale/distribution
6.5.7 Merger and acquisition activity
6.5.8 Conclusions
REFERENCES

CHAPTER 7 PERU
7.1 Executive summary
7.2 Political and economic background
7.2.1 The political environment in Peru
7.2.2 Central government
7.2.3 Local government
7.2.4 Elections
7.2.5 Foreign policy
7.2.6 The economic environment in Peru
7.2.7 Gross domestic product
7.2.8 Inflation and unemployment
7.2.9 Population
7.2.10 Fiscal policy
7.2.11 Conclusions
7.3 Healthcare provision
7.3.1 Healthcare administration
7.3.2 Healthcare reform
7.3.3 Healthcare funding and expenditure
7.3.4 Private versus public sector healthcare provision
7.3.5 Healthcare indicators
7.3.6 Prescribing and dispensing
7.3.7 Cost-containment and reimbursement
7.3.8 Primary and secondary healthcare
7.3.9 Prevention and healthcare education
7.3.10 Hospital sector
7.3.11 Conclusions
7.4 The regulatory environment
7.4.1 Patents
7.4.2 Registration
7.4.3 Good manufacturing practice
7.4.4 Clinical trials
7.4.5 Advertising and labelling
7.4.6 Harmonisation
7.4.7 Conclusions
7.5 The pharmaceutical industry environment
7.5.1 The pharmaceutical market
7.5.2 Market structure
7.5.3 Market trends
7.5.4 Pricing
7.5.4.1 Essential Drugs Programmes
7.5.5 Over-the-counter products
7.5.6 Generics
7.5.7 Wholesale/distribution
7.5.8 Merger and acquisition activity
7.5.9 Conclusions
REFERENCES

CHAPTER 8 VENEZUELA
8.1 Executive summary
8.2 Political/economic environment
8.2.1 Government
8.2.2 Elections
8.2.3 Government policy
8.2.4 Gross domestic product
8.2.5 Inflation/unemployment
8.2.6 Population/per capita income
8.2.7 Economic policy
8.2.8 Conclusions
8.3 Healthcare provision
8.3.1 Healthcare administration
8.3.2 Healthcare indicators
8.3.2.1 Population
8.3.2.2 Mortality
8.3.2.3 Communicable diseases
8.3.3 Financing and cost-containment
8.3.4 Prescribing and dispensing
8.3.5 Resources/provision
8.3.6 Conclusions
8.4 Regulatory environment
8.4.1 Patent laws
8.4.2 Registration
8.4.3 Harmonisation
8.4.4 Conclusions
8.5 Pharmaceutical industry environment
8.5.1 Structure (industry and market)
8.5.2 Pricing and reimbursement
8.5.3 Over-the-counter sector
8.5.4 Generics
8.5.5 Distribution
8.5.6 Promotion of pharmaceuticals
8.5.7 Conclusions
REFERENCES

LIST OF TABLES
Table 1.1 Prescribing restrictions/formularies in Latin America
Table 1.2 Mandatory generic prescribing in Latin America
Table 1.3 The managed care environment in Latin America
Table 1.4 Patent protection provision in Latin American countries
Table 1.5 Registration processes across the Latin American region
Table 1.6 Pharmaceutical sales by country
Table 1.7 Pricing controls in Latin America
Table 2.1 Sources of healthcare financing, 1995
Table 2.2 Growth in health costs in Argentina, 1993-1997 (index: 1988=100)
Table 2.3 Main causes of death, 1993-1996
Table 2.4 Numbers of reported cases of infectious diseases, 1993 versus 1997
Table 2.5 Number of hospital beds by type of facility, 1995
Table 2.6 Hospital bed availability as percentage of total, 1980 versus 1995
Table 3.1 The Brazilian population, proportions by age, 1970, 1991 and 1996
Table 3.2 Healthcare indicators in Brazil, 1992
Table 3.3 Major provisions of the Brazilian and Argentinian patent laws
Table 3.4 Price increases by therapeutic category, May 1997 compared with May 1996
Table 4.1 Key economic indicators, 1997
Table 4.2 Key healthcare indicators for Chile
Table 4.3 The leading causes of death in Chile, 1995
Table 4.4 Key primary care statistics, 1995
Table 4.5 Hospital beds by hospital type in Chile, 1995
Table 4.6 Examples of product licensing agreements in Chile
Table 5.1 Key economic indicators, 1997
Table 5.2 Key healthcare indicators for Colombia
Table 5.3 Public healthcare facilities in Colombia, 1996
Table 5.4 Human resources in the health sector by occupational category, 1996
Table 5.5 Product licensing agreements in Colombia by Tecnoquimicas
Table 6.1 The Mexican population - proportions (%) by age, 1990 and 1997
Table 6.2 Healthcare sector indicators in Mexico
Table 7.1 Key economic indicators, 1997
Table 7.2 Key healthcare indicators for Peru
Table 7.3 Highest and lowest levels of under-reporting of deaths by region in Peru
Table 7.4 Healthcare facilities in Peru, 1995
Table 7.5 Physician rates per 10,000 population: highest and lowest figures by region
Table 8.1 GDP changes in Venezuela
Table 8.2 Venezuela: price, unemployment and exchange rate statistics

LIST OF FIGURE
Figure 2.1 Leading multinational companies in Argentina, ranked by sales, 1997
Figure 2.2 Retail pharmaceutical sales trends in Argentina, 1995-1998
Figure 2.3 Argentina: total market forecast to 2002 ($ million)
Figure 3.1 Economic indicators in Brazil, 1997-2000
Figure 3.2 Brazil: demographic profile
Figure 4.1 Chile: healthcare spend by insurance plan, 1995
Figure 4.2 Stages in the Chilean registration process
Figure 4.3 Market share by value and volume, 1996: top 10 companies' share of the Chilean market
Figure 4.4 The Chilean distribution chain
Figure 5.1 Membership of Colombian health institutions in the subsidised system
Figure 5.2 Private healthcare spend by healthcare category, 1996
Figure 6.1 Economic indicators in Mexico, 1997-2000
Figure 6.2 Top 10 pharmaceutical corporations in Mexico by retail sales, 1997
Figure 7.1 Healthcare funding by source, Peru
Figure 7.2 Percentage healthcare spend by sector in Peru, 1995

EXECUTIVE SUMMARY

ES.1 Political and economic situation
In 1998 Brazil was hit by global economic difficulties and the devaluation of the local currency, the real, in January 1999 has dented business confidence.
Key to the political and economic reforms in Latin America has been a process of deregulation and liberalisation including privatisation, which has released considerable funds for the implementation of social reform initiatives.
As the standard of living in Latin America has improved, so have general healthcare indicators. Improved health, however, has not reduced the burden on the healthcare system and as the population ages, healthcare costs can only increase.

ES.2 Healthcare provision
Health services within Latin America have undergone a period of radical reform throughout the 1990s. Management of health services is being decentralised across all markets in the region with responsibility for the administration of public services being passed down to local governments in an effort to improve efficiency and reduce costs. For example, substantial healthcare reform programmes have been implemented in Colombia and, if successful, promise to offer the population one of the most advanced health systems in Latin America. Universal coverage and free healthcare to those without alternatives are radical developments in a health service where, in the past, access to facilities has been a function of wealth.
Preventative healthcare programmes, educational initiatives and broader social reforms are among the solutions which are being put forward to ensure that even the very poor experience significant improvements in their quality of life. Unfortunately, access to healthcare facilities will remain something of a geographical lottery in all markets.
However, it is inevitable that the various health services will come under more pressure in the coming years, given that policies are being put into place which increase access to the healthcare system. The growth and development of the private sector will be a key part of the reforms, making those that can afford to seek healthcare elsewhere to do so, freeing up resources for the poorer sectors of society, thereby alleviating some of the pressure from the local authorities.

ES.3 Regulatory environment
Latin American harmonisation has more or less come to a halt because of a lack of funds and a lack of interest by the governments and industry. The ongoing Free Trade Area of the Americas (FTAA) discussions may provide renewed impetus but the wide variation in pricing, registration and drug classification will make it a long drawn-out process. The Summit of the Americas, held in December 1994 in Miami, involved the Heads of State of the 34 democracies in the region.
In many markets, patent legislation offers multinationals real protection. However, patented products will take time to infiltrate the market as prices will be high and demand low. More patented products will mean that, in the medium-to-long term, the population will have increasing access to new and innovative drugs, albeit at a price. Local industries will have to seek to develop new markets if they wish to survive.
New draft generic legislation is also being discussed and approved across the region. This is expected to bring changes to the registration, manufacturing, distribution, dispensing and promotion of generics, all of which will be designed to facilitate the development of a true generics market.
Prescribing activity has come under the scrutiny of the authorities and in countries like Argentina, Brazil, Chile and Colombia, the introduction of formularies is aimed at helping to contain costs. In Mexico, legislation introducing generic prescribing and bioequivalent generics onto the pharmaceutical market will put pressure on pharmaceutical prices and help to contain public spending.

ES.4 The pharmaceutical industry environment
As healthcare providers are subjected to reform, so too are their suppliers. In many of these markets, the local industry has developed on the basis of poor regulation. In the past, this has sustained the growth of local industry to the detriment of the multinationals. Copy products, in the absence of patent protection, have formed the basis of the pharmaceutical market in the region.
The Latin American pharmaceutical industry is on the brink of a major change. The multinational industry, which already has a strong presence in countries such as Mexico, is changing the competitive dynamics. The traditional markets for local producers are under threat, but most of the major companies claim to be well prepared for the change.
To survive the gradual elimination of copy products, local companies have already begun to look for alliances and co-marketing agreements with multinationals. In Brazil, Laboratorios Bag� and Merck KGaA, for example, are establishing a new joint sales and marketing organisation for prescription medicines which will come into operation in mid-1999. Local companies are also seeking out new export markets, diversifying into R&D and looking to establish bioequivalence for existing copy products.
The over-the-counter (OTC) market is expanding rapidly throughout Latin America. The main limitations on growth are competition from prescription products and a lack of a regulatory framework for OTCs.