Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance
(2002; 187 pages) View the PDF document
Table of Contents
View the documentACRONYMS
View the documentPREFACE
View the documentACKNOWLEDGEMENTS
View the documentEXECUTIVE SUMMARY
Open this folder and view contents1. DRUG REGULATION: OBJECTIVES AND ISSUES
Open this folder and view contents2. MULTICOUNTRY STUDY ON EFFECTIVE DRUG REGULATION
Close this folder3. PROFILE OF THE COUNTRIES
View the document3.1 GENERAL BACKGROUND
View the document3.2 POLITICAL ENVIRONMENT
View the document3.3 PHARMACEUTICAL SECTOR ENVIRONMENT
Open this folder and view contents4. REGULATORY FRAMEWORK
Open this folder and view contents5. REGULATORY CAPACITY
Open this folder and view contents6. LICENSING OF MANUFACTURING, DISTRIBUTION AND RETAIL SALE
Open this folder and view contents7. INSPECTION AND SURVEILLANCE
Open this folder and view contents8. PRODUCT ASSESSMENT AND REGISTRATION
Open this folder and view contents9. CONTROL OF DRUG PROMOTION AND ADVERTISING
Open this folder and view contents10. DRUG QUALITY CONTROL LABORATORY
Open this folder and view contents11. ASSESSING REGULATORY PERFORMANCE
Open this folder and view contents12. CONCLUSIONS AND RECOMMENDATIONS FOR EFFECTIVE DRUG REGULATION
Open this folder and view contentsANNEX 1: GUIDE FOR DATA COLLECTION TO ASSESS DRUG REGULATORY PERFORMANCE
 

3.1 GENERAL BACKGROUND

Information on the general background of the 10 countries is presented in Table 3.1. As shown in the table, the geographical size ranges from 7.7 million square kilometres for Australia, to 9 251 square kilometres for Cyprus. In terms of population, Venezuela, with a population of 22.8 million, is the largest in the group, and Cyprus the smallest, with only 0.66 million people. The percentage of urban dwellers ranges from 85% and 86% for Australia and Venezuela, respectively, to only 11% for Uganda. Life expectancy also varies significantly- it is highest in Australia (81 years for females, 75 years for males), and lowest in Uganda (50 years for females, 45.7 years for males).

Malaysia and Australia have a federal system of government. The other countries have a unitary or centralized system of government.

 

Area of country in square km

Total pop. in million (year)

Urban pop. As % of total (year)

Life expectancy male (years)

Life expectancy female (years)

Malaysia

329,760

21.7 (1997)

54.10% (1994)

69.5 (1997)

74.3 (1997)

Australia

7,700,000

18.71 (1998)

85%

75.2 (1996)

81 (1996)

Netherlands

41,526

15.65 (1998)

Not available

75.14(1998)

81.03 (1998)

Estonia

45,227

1.45 (1998)

73% (1993)

64.68 (1997)

75.97 (1997)

Cyprus

9,251

0.66 (1997)

68.9% (1996)

75.30 (1996)

79.80 (1996)

Uganda

241,039

20.44 (1997)

11.3% (1991)

45.7 (1995)

50.5 (1995)

Zimbabwe

390,757

11.5 (1998-99)

30% (1996)

58 (1996)

62 (1996)

Tunisia

154,530

9.25 (1997)

61% (1994)

69.9 (1997)

73.9 (1997)

Cuba

110,922

11.12 (1998)

75.1% (1997)

72.9 (1997)

76.6 (1997)

Venezuela

916,445

22.77 (1997)

86.1% (1997)

69.9 (1997)

75.4 (1997)

Values for gross national product (GNP) per capita are shown in Figure 3.1. The GNP is highest in the Netherlands, Australia and Cyprus (US$22 000, US$16 544 and US$13 790, respectively). Estonia and Malaysia rank in the middle with per capita values slightly above US$3 500. Venezuela, Uganda and Zimbabwe have the lowest GNP values of the group, ranging from US$220 for Uganda to US$3 020 for Venezuela.


Figure 3.1 Values of per capita GNP*

* Venezuela (1995), Cyprus and Cuba (1996), the rest (1997), the Netherlands (1998)

Figure 3.2 shows infant mortality rates in the 10 countries. Countries with a low GNP per capita tend to have a high rate of infant mortality, and vice versa, with the exception of Cuba. Life expectancy figures (Table 3.1) show a pattern similar to those for infant mortality, although the ranking among the countries in the middle group, such as Venezuela and Malaysia, may change. The patterns reflected in these three figures-infant mortality rate, life expectancy and GNP per capita-provide a crude measure of how wealth affects health.


Figure 3.2 Infant mortality rates (IMR) per 1 000 live births*

* Zimbabwe (1994), Uganda (1995), Cyprus, the Netherlands, Venezuela (1996), Australia, Estonia, Malaysia, Tunisia (1997), Cuba (1998)

It is difficult to determine the implications for drug regulation of these background factors. Nevertheless, it is evident that population size and GNP per capita will influence drug regulatory functions. For example, arranging the inspection of distribution channels in a country where drug outlets are widely distributed across a vast area, may be much more complicated than in a smaller country where drug outlets are concentrated in the main urban areas. Similarly, the wealth of a country is likely to affect the revenue of the government, which in turn will determine the overall budget of the DRA (in those countries where financing for drug regulation is derived solely from the government budget). Similarly, decentralization of regulatory powers or responsibility in a country without effective coordination and communication mechanisms may influence drug regulatory performance.

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Last updated: May 3, 2013