Use of the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce - EDM Research Series No. 016
(1995; 156 pages) Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGMENTS
Afficher le documentPREFACE
Afficher le documentEXECUTIVE SUMMARY
Ouvrir ce répertoire et afficher son contenu1. INTRODUCTION
Afficher le document2. RATIONALE AND OBJECTIVE OF THE ASSESSMENT
Afficher le document3. ACTIVITIES UNDERTAKEN: Preparations and Method of Work
Fermer ce répertoire4. ANALYSIS OF RESULTS FROM IMPORTING COUNTRIES
Afficher le document4.1 Pharmaceutical Import and Consumption
Afficher le document4.2 National Drug Policy and Essential Drugs List
Afficher le document4.3 Infrastructure
Afficher le document4.4 Functioning of Bodies Responsible for Regulation, Procurement and Quality Assurance
Afficher le document4.5 Operation of the WHO Certification Scheme
Ouvrir ce répertoire et afficher son contenu5. ANALYSIS OF RESULTS FROM EXPORTING COUNTRIES
Afficher le document6. ANALYSIS OF RESULTS FROM INTERNATIONAL SUPPLY AGENCIES
Ouvrir ce répertoire et afficher son contenu7. SUMMARY ANALYSIS
Afficher le document8. CONCLUSIONS
Afficher le documentANNEX 1: Resolution adopted by the Twenty-second World Health Assembly
Afficher le documentANNEX 2 (a): Resolution Adopted by the Twenty-Eighth World Health Assembly
Afficher le documentANNEX 2 (b): Certificate of Pharmaceutical Product(S)1
Afficher le documentANNEX 3 (a): Resolution adopted by the Forty-first World Health Assembly
Afficher le documentANNEX 3 (b): Certificate of Pharmaceutical Product(s)1 (Proposed Layout)
Afficher le documentANNEX 4 (a): Proposed Guidelines on the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Afficher le documentANNEX 4 (b): Certificate of a Pharmaceutical Product
Afficher le documentANNEX 4 (c): Statement of Licensing Status of Pharmaceutical Product(s) Model Statement of Licensing Status of Pharmaceutical Product(s)
Afficher le documentANNEX 4 (d): Manufacturer’s/Official Batch Certificate of a Pharmaceutical Product
Afficher le documentANNEX 5: Protocol for the Assessment of the Use of the WHO Certification Scheme by Importing Country
Afficher le documentANNEX 6: List of Participants in the Study
Afficher le documentANNEX 7: Protocol for the Assessment of the Use of the WHO Certification Scheme by Exporting Country
Afficher le documentANNEX 8: Protocol for the Assessment of the Use of the WHO Certification Scheme in an International Supply Organization
Afficher le documentANNEX 9: Study Instrument for Assessment of the WHO Certification Scheme by Importing Country
Ouvrir ce répertoire et afficher son contenuANNEX 10: Summaries of Mission Reports on the Assessment of the Use of the WHO Certification Scheme
Afficher le documentBACK COVER
 

4.1 Pharmaceutical Import and Consumption

In all countries visited the vast majority of pharmaceutical products, usually over 90%, was imported. In Malaysia, the value of imported drugs was 70% of the total consumption with the rest from local production using imported materials. Exporting countries were usually the major industrial nations with a predominance of Australia, Canada, China, France, Germany, India, the Netherlands, South Africa, Switzerland, UK and USA. However, other countries, such as Egypt, Hong Kong, Jordan, Malaysia, Singapore and Thailand, were also noted as exporters. The estimated annual value of pharmaceutical imports for the 15 countries in 1992 ranged from US$ 5 million for Fiji to US$ 150 million for Malaysia.

In all countries, importation of drugs was through both the public and private sector with the public sector varying from 2% to 80% of the total imports for 1992. In addition, for some countries there was reported to be appreciable illicit importation of pharmaceutical products (annex 10).

The consumption of pharmaceuticals by the private sector during 1992 was, on the whole, higher than consumption by the public sector.

The public sector drug budget for the same year ranged from US$ 1 million for Myanmar to US$ 49 million for Malaysia. The contribution of national resources ranged from 10% for Fiji to 100% for Malaysia, Sri Lanka and Tunisia. External assistance varied from 0% for the three countries, Malaysia, Sri Lanka and Tunisia to 67% for Central African Republic.

Table 1 summarizes the information on pharmaceutical importation and consumption by the countries.

Table 1. Estimated pharmaceutical import and consumption in 1992 (US$ million)

Country

Total Import in 1992 US$ million

Consumption in 1992, US$ million

Public sector drug budget in 1992 US$ million



Public sector

Private sector

NGOs


Benin

18.96

2.90

24.86

NA

4.00

Cameroon

63.00*

3.60**

112.00**

7.20**

8.00**

Central African Republic

16.27

1.24

9.05

0.01

1.72

Ecuador

140.80

2.50

150.10

NA

3.40

Fiji

5.00

3.00

2.00

0.40

3.40

Jamaica

19.50

3.00

20.50

NA

4.90

Kenya

125.50

39.80

52.70

10.80

39.80

Malawi

9.00

5.70

3.30

NA

5.70

Malaysia

150.00

48.00

172.00

NA

49.00

Myanmar

20.00

5.00

15.00

0.50

1.00

Papua New Guinea

15.00

13.00

2.50

NA

12.00

Sri Lanka

30.00

20.00

70.00

NA

13.00

Tanzania

38.20

11.50

NA

NA

7.10

Tunisia

112.79

29.00

131.00

NA

27.00

Yemen

68.63

18.80

46.65

0.18

20.80

Figures extracted from the country reports by the missions.
* Figure for 1991.
** Figures for 1989.
NA Data not available.

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