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Published by: Urch Publishing
Published: Oct. 26, 2001 - 255 Pages
Table of Contents
Executive Summary
Chapter 1: Introduction
Chapter 2: Argentina
Political, socio-economic and demographic overview
Mortality and morbidity profile
The Argentine health services
Organisation of the health sector
Expenditure and financing
Health sector reform
The pharmaceutical market in Argentina
The Argentine pharmaceutical market
Market structure
Regulation
The current context with regards to IPRP
The current patents regime
Copyrights
Good manufacturing practices
Supply- and demand-side measures for pharmaceuticals
General overview
Pricing and reimbursement of pharmaceuticals
The OTC market
Distribution channels
Generics
Argentina and the WTO
References
Chapter 3: Brazil
Political, socio-economic and demographic overview
Mortality profile
The Brazilian health services
Organisation of the health sector
Health sector expenditure and financing
Resource allocation
Health sector reforms
Implementing health care reform
Health care regulation - decentralisation
Health care regulation - private health insurance
The pharmaceutical market in Brasil
The Brazilian pharmaceutical market
Overview
Market profile
Regulation
Patents and trademarks
Supply- and demand-side measures for pharmaceuticals
Pricing of pharmaceuticals
Reimbursement of pharmaceuticals
Generic pharmaceutical policies
Taxation
Market growth
Current issues in intellectual property rights protection
Brazil and the WTO
References
Chapter 4: China
Political, socio-economic and demographic overview
Health indicators and mortality profile
The Chinese health services
Expenditure and financing
National health priorities
Health sector reform
Health market profile
Issues in pharmaceuticals in China (People’s Republic of China)
The market
Issues intellectual property rights protection
IPR legislation and administration
Patents and administrative protection
Anti-counterfeiting efforts
Data exclusivity
Trademarks and copyrights
Domain name dispute
Electronic commerce
Drug price regulation
The future
References
Primary sources
Secondary sources
Chapter 5: Egypt
Political, socio-economic and demographic overview
GDP growth
The Egyptian health services
Organisation of the health sector
The pharmaceutical market in Egypt
The Egyptian pharmaceutical market
Regulation
Government procurement
Intellectual property rights protection
Patents
Pricing and reimbursement of pharmaceuticals
The future
References
Primary sources
Secondary sources
Chapter 6: India
Political, socio-economic and demographic overview
Mortality profile
The Indian health services
Expenditure and financing
Health sector reform
The pharmaceutical market in India
Main market trends
Export promotion
Regulation
Government procurement
Export subsidies
Good manufacturing practice for traditional medicines
Intellectual property rights protection
Patents
Copyrights
Trademarks
Delays with the new patent law
Patents, trade and development: new drug patents
Protecting the industry
What the market will bear
A boom in generic drugs
Industrial policy for pharmaceuticals
Fund to promote R&D
Policy objectives
India’s comparative advantages
Pharmaceutical pricing: national pharmaceutical pricing
authority of India Price Control Order 1986 Basic approach
Coverage
Norms of pricing
NPPA India modification of Price Control Order 1986 (year 1994)
Pricing
Establishment and functions of National
Pharmaceutical Pricing Authority (NPPA) Drug pricing and objectives
Wholesale and retail margins
The future
Patent piracy
References
Primary sources
Secondary sources
Chapter 7: Mexico
Political, socio-economic and demographic overview
Mortality profile
The Mexican health services
Organisation of the health sector
Mexico private health care groups
Expenditure and financing
Health sector reform
The Mexican pharmaceutical care system
Market structure of the Mexican pharmaceutical market
Manufacturing
Other industry indicators
Capacity utilisation and employment
Pharmaceutical trade
Wholesale distribution
Retail distribution
Pharmaceutical R&D in Mexico
Pharmaceutical industry lobby organisation
Regulation
Intellectual property rights protection
Marketing authorisation
Trade and industrial policy
Trade policy
Regulation of imports
Regulation of exports
Foreign investment
Industrial policy
Supply- and demand-side policies for pharmaceuticals
Health insurance coverage of pharmaceuticals
Public insurance
Private insurance
Formularies
Price control policies
Control of physician prescribing practices
Regulation of pharmacies and pharmaceutical distribution
Policy towards generics
Competition issues in the pharmaceuticals sector
Market definition issues and barriers to entry and exit
References
Chapter 8: The Philippines
Political, socio-economic and demographic overview
Mortality profile
The Philippines health services
Organisation of the health sector
The health care reform agenda (HSRA)
Defining the problems
Health sector reforms: government hospitals
Health sector reforms: public health programmes
Health sector reforms: local health systems
Health sector reforms: regulatory agencies
Health sector reforms: financing of health services
Health insurance for indigents project
Title and description
Rationale and objectives
Expected goals/outputs
The pharmaceutical market in Philippines
The Philippine pharmaceutical market
Size and composition of the pharmaceutical market
Pre-marketing regulation
Government procurement
Export subsidies
Intellectual property rights protection
Patents
Trademarks
Copyrights
Technology licensing
Government initiatives on regulation
Post-marketing regulation: costs, pricing, procurement and reimbursement
The future
References
Secondary sources
Chapter 9: Poland
Political, socio-economic and demographic overview
Mortality profile
The Polish health services
Organisation of the health sector
Expenditure and financing
Health sector reform
The pharmaceutical market in Poland
The Polish pharmaceutical market
Market characteristics
Distribution
Regulation
Government procurement
Export subsidies
Intellectual property rights protection
Drug regulation
Overview
Pricing
Reimbursement
Promotion
Future prospects
Recent developments
Reference pricing
Wholesale margins
Health economic guidelines
References
Primary sources
Secondary sources
Chapter 10: Russian Federation
Political, socio-economic and demographic overview
Mortality profile
The Russian health services
Organisation of the health sector
Expenditure and financing
Pharmaceutical care in Russia
The Russian pharmaceutical market
Pharmaceutical regulation
Pharmaceutical legislation
Patenting
Supply- and demand-side measures for pharmaceuticals
Pharmaceutical pricing and distribution
Pharmaceutical distribution
Decree on measures for state control over pricing on medicines
Reimbursement of pharmaceuticals
Future prospects
References
Primary data
Secondary sources
Chapter 11: South Korea
Political, socio-economic and demographic overview
Mortality profile
The Korean health services
Organisation of the health sector
National health insurance programme
Expenditure and financing
Health sector reform
The pharmaceutical care in Korea
The Korean pharmaceutical market
Market situation
Distribution channels
Regulation
Patenting
Marketing authorisation
Good manufacturing practice
Trade regulation and industrial policy
Trade regulation
Industrial policy
Supply- and demand-side policies for pharmaceuticals
Health insurance coverage of pharmaceuticals
Formularies
Pricing and reimbursement regime
Competition among pharmacies
Hospitals
Prescribing and dispensing
Control of physician prescribing practices
Regulation of pharmacies and pharmaceutical distribution
Generics
Problems with the pricing and reimbursement regime
Current issues in intellectual property rights protection
References
Chapter 12: South Africa
Political, socio-economic and demographic overview
Mortality profile
The South African health services
Organisation of the health sector
The structure of the provincial departments
Health sector reform?
Proposed regulation of the medical insurance industry
Expenditure and financing
The pharmaceutical market in South Africa
The South African pharmaceutical market
Regulation
Intellectual property rights protection
South African Patents Act 57 of 1978
Medicines and related substance control amendment act 90 of 1997
Marketing authorisation
Trade policy and parallel imports
The overall environment
Access to medicines and trade disputes
Supply- and demand-side policies for pharmaceuticals
The national drug policy (1996)
South African Medicines and Meical Devices
Regulatory Authority Act, 172 of (SAMMDRA)
TRIPS and amendments to the South African intellectual property rights protection provisions
Pricing issues in the South African market context
Pricing of pharmaceuticals
Reimbursement of pharmaceuticals
Prescribing policies
Wholesaler and retailer mark-ups
Sales tax
Pharmaco-economic studies
Co-payment exemptions
The proportion of prescriptions not subject to co-payments
The sale of OTC products
Current issues in intellectual property rights protection
References
Chapter 13: Thailand
Political, socio-economic and demographic overview
Mortality profile
The Thai health services
Organisation of the health sector
Expenditure and financing
Health sector reform
Health insurance schemes
The Civil Servants Medical Benefits Scheme
Social Security Scheme
Voluntary Health Card Scheme
Low-Income Card Scheme
Private health insurance
Out of pocket payments
The pharmaceutical market in Thailand
The Thai pharmaceutical market
Basic indicators
Safety Monitoring Programme (SMP)
Drug development, production and importation
The pharmaceutical industry
Overall drug markets
Regulation
Drug legislation
The Thai patent act and drug patent
Safety Monitoring Programme (SMP)
Compulsory licensing
Parallel imports
Patents, copyrights and trademarks
Enforcement of intellectual property rights (IPR) protection
Standards, testing, labeling and certification
Government procurement
Good manufacturing practices
Supply- and demand-side measures for pharmaceuticals
National drug policy
National Essential Drug List (NEDL)
Pricing of pharmaceuticals
The Reference Price System (RPS)
The Ministry of Commerce (MoC) price control
International price comparison
Hospital formulary
Prescribing control
Self-medication and over-the-counter products
Drug procurement
Current issues in intellectual property rights protection
Restrictive formularies
Future prospects
Price regulation
Reference price system
References
Primary sources
Secondary sources
Chapter 14: Pharmaceutical Industry Contacts
Argentina
ADDIF
A.D.E.M.
Asociacion Iberoamericana de Industrias Farmaceuticas. ALIFAR
Cámara Argentina de Especialidades Medicinales - CAEME
Cámara Argentina de Productores de Especialidades Medicinales de Venta Libre
Argentine Chamber of Producers of Pharmaceutical Chemicals. CAPDROFAR
CILFA
Brazil
Associacao Brasileira da Iindustria Farmaceutica. ABIFARMA
Associação Brasileira da Indústria de Produtos para Saúde (ABIPS)
Brazilian Association of Health Products
Associaçáo da Indústria Farmacéutica de Pesquisa - INTERFARMA
Sao Paulo Association of Pharmaceutical Industries - SINDUSFARM
China
CAPC
China Nonprescription Medicines Association (CNMA)
Chinese Pharmaceutical Association - CPA
Foreign Research-based Pharmaceutical Industry Association - FRPIA
Syndicat National de la Industrie Pharmaceutique (France) - SNIP
India
Indian Drug Manufacturers’ Association - IDMA
IPA
National Pharmaceutical Pricing Authority - Government of India
Organisation of Pharmaceutical Producers of India - OPPI
PharmaIndia Website
South Korea
Korea Pharmaceutical Association - KPA
Korean Pharmaceutical Manufacturers Association - KPMA
Korea Pharmaceutical Wholesale Association - KPWA
Korea Pharmaceutical Traders Association
Mexico
Asociación de Fabricantes de Medicamentos de Libre Acceso AC (AFAMELA)
Asociación Mexicana de Industriales Farmacéuticos A. C. - AMIF
Cámara Nacional de la Industria Farmacéutica CANIFARMA
Philippines
Pharmaceutical and Healthcare Association of the Philippines, Inc. - PHAP
Poland
Stowarzyszenie Przedstawicieli Firm
Farmaceutycznych w Polsce - SPFFwP Polska Izba Przemyslu Farmaceutycznego I Sprzetu
Polish Pharmaceutical Services Ltd
Russia
Association of International Pharmaceutical Manufacturers - AIPM
Syndicat National de la Industrie Pharmaceutique (France)
South Africa
National Association of Pharmaceutical Manufacturers NAPM
Pharmaceutical Manufacturers Association of South Africa Ltd - PMASA
Self-Medication Manufacturers Association of South Africa (SMASA)
Taiwan
International Research-Based Pharmaceutical
Manufacturers Assoc - IRPMA PMMA
Thailand
Pharmaceutical Producers Association - PPA
Chapter 15: Useful Internet Links
WHO EUROPE
WHO Asia Pacific
Argentina
Brazil
China
India
South Korea
Mexico
Philippines
WHO Pacific
Poland
Russia
South Africa
Thailand
Pharmaceutical Industry Associations
South Centre
Patent offices
Japan
Other
Chapter 16: Questions Regarding National Pharmaceutical Policies
Requests to national correspondents
Further questions
List of Tables
Table 1.1: Leading countries in 1999 global pharmaceutical sales (growth measured in US$)
Table 1.2: Pharmaceutical market in middle income countries
Table 2.1: Causes of mortality rate per 100,000 population
Table 2.2: Argentina health and economic indicators
Table 2.3: Argentine pharmaceutical industry; sales in units (millions)
Table 2.4: Argentine pharmaceutical market (sales in US$m and in %)
Table 3.1: Proportional death rate by groups of causes (1997)
Table 3.2: Brazil health and economic indicators
Table 3.3: Market shares of Mercosur countries (in %)
Table 3.4: The ten largest pharmaceutical markets in the world (1997)
Table 3.5: Employment-related indicators
Table 3.6: Brazilian pharmaceutical market (US$bn)
Table 4.1: China’s mortality indicators
Table 4.2: Gross domestic product, population, and health spending (1978- 93) (constant 1993 prices)
Table 4.3: Per capita annual expenditure on medicines and medical services, 1990-98 (yuan)
Table 4.4: China health and economic indicators
Table 5.1: Egypt health and economic indicators
Table 5.2: Statistical data for the Egyptian pharmaceutical industry (US$m)
Table 5.3: Market shares in the Egyptian pharmaceutical market
Table 5.4: 1998 market share per country of origin multinational companies
Table 5.5: Distribution outlets and their market share
Table 6.1: India health and economic indicators
Table 6.2: Major Indian drug exports in 1998-99
Table 7.1: Mexican macroeconomic indicators (1993-98)
Table 7.2: National health expenditure (1992-94)
Table 7.3: Mexico health and economic indicators
Table 7.4: Market shares of the main pharmaceutical firms (April 1998- 87 March 1999)
Table 7.5: Sales of medicines according to therapeutic classes (level 1) (April 1998-March 1999)
Table 7.6: Market shares for some therapeutic classes (level 3)
Table 7.7: Mexican pharmaceutical market (1998)
Table 7.8: Mexican market value (US$m)
Table 7.9: Mexican market volume units (millions)
Table 7.10: Pharmaceutical sector trade balance (1998)
Table 8.1: The leading causes of morbidity in 1997 and mortality in 1995 (rate per 100,000 population)
Table 8.2: Sources of funds for health in the Philippines
Table 8.3: Expenditures for health in the Philippines (1991-97)
Table 8.4: Philippines health and economic indicators
Table 8.5: Breakdown of total pharmaceutical market (in US$m)
Table 8.6: Number of brands and drugs registered in the Philippines
Table 8.7: Concentration of pharmaceutical market, 1993-96 (cumulative Percentages)
Table 8.8: Pharmaceutical market value in US$bn - key markets
Table 8.9: Per capita drug expenditure in selected South East Asian countries (1995)
Table 9.1: Approximate number of hospitals in Poland
Table 9.2: Percentage of main sources of finance
Table 9.3: Poland health and economic indicators
Table 9.4: Top 16 Polish pharmaceutical companies
Table 9.5: Polish pharmaceutical market: Imports of pharmaceuticals 1991-98
Table 9.6: Polish pharmaceutical market: Basic indicators
Table 9.7: Approximate number of pharmacies and wholesalers
Table 10.1: Mortality structure: Russia and the rest of Europe
Table 10.2: Health care resources indicators in Russia
Table 10.3: Russia health and economic indicators
Table 11.1: The five leading causes of morbidity (1993) and mortality (1995) - rate per 100,000 population
Table 11.2: Revenues and expenditures of national medical insurance system (in US)
Table 11.3: Korea health and economic indicators
Table 11.4: Korean pharmaceutical exports (in US$m)
Table 11.5: Korean pharmaceutical imports (in US$m)
Table 11.6: Korean pharmaceutical industry (in US$m)
Table 11.7: Consumption of pharmaceuticals in different settings (% of total pharmaceutical expenditure)
Table 12.1: The racial composition of the South African population and growth rates (1995)
Table 12.2: Inequality - South Africa and comparable countries
Table 12.3: Incidence of noticeable conditions in South Africa (1993)
Table 12.4: Age-standardised mortality rates (1984-86) per 100,000 population per annum
Table 12.5: Percentage breakdown of expenditure by private medical insurance schemes (1990-94)
Table 12.6: Selected health indicators
Table 12.7: 1995/96 and 1996/97 health budgets and provincial allocations
Table 12.8: South Africa health and economic indicators
Table 13.1: National health expenditure (1994, in baht m)
Table 13.2: Health insurance coverage in Thailand (1998)
Table 13.3: Thailand health and economic indicators
Table 13.4: Thai pharmaceutical market (US$m)
Table 13.5: Healthcare spending per source of expenditure
List of Figures
Figure 8.1: Reform process and its end-objectives
Figure 13.1: Health and drug expenditures and Thai gross domestic product (1980-98) in nominal terms
Figure 13.2: Nominal value and percentage of local drug production and drug importation (drug for human use only), 1987-89
Figure 13.3: 1998 drug consumption/distribution in Thailand
AbstractDrug regulators and representatives of the pharmaceutical
industry from the US, Europe and Japan have been
participating for nine years in the International Conference on
Harmonisation (ICH). The purpose is to eliminate duplicative
requirements for drug development and approval in the three
regions, thus providing patients with more timely access to
new medicines. The current major focus of ICH is
development of a Common Technical Document that would
form the basis for drug approval in the three regions.
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