Objective 1. Policy

The national drug policy process brings all interested parties together to focus political commitment, financing and human resources on pharmaceutical sector improvements. A national drug policy therefore provides a framework for action relating to pharmaceuticals within an overall national health policy. Its goals should be consistent with broader health system objectives, and its implementation should support those objectives. WHO will help countries to actively implement national drug policies and monitor their impact. The policy objective has two main components: implementation and monitoring of national drug policies, and integration of essential drugs policies and programmes with health systems development.

Objective 2. Access

Access to essential drugs is a key priority for WHO. Four enabling factors need to be firmly in place to increase and ensure sustainable access:

• rational selection based on a national essential drugs list and treatment guidelines

• affordable prices for governments, health care providers and consumers

• sustainable financing through equitable funding mechanisms such as government revenues or social health insurance

• reliable supply systems incorporating a mix of public and private supply services.

From the patient’s or consumer’s point of view, access to essential drugs means that such drugs can be obtained within reasonable travelling distance (i.e. geographically accessible),they are readily available in health facilities (i.e. physically available),and affordable (i.e. financially available).

Objective 3. Quality and safety

Global standards for drug quality are becoming increasingly rigorous. Yet the quality of drugs on the market in many countries remains a major public health concern. Similarly, major efforts to improve drug regulation at national and international levels have been instigated, but enforcement of regulatory standards remains a challenge for every country. WHO’s work under the quality and safety objective has four components: norms, standards and guidance for pharmaceuticals; drug regulation and quality assurance systems; information support for pharmaceutical regulation; and guidance for control and use of psychotropics and narcotics.

Objective 4. Rational Use

The essential drugs concept is now applied worldwide. A growing number of countries, both developed and developing, have used it to help them improve drug use by prescribers, dispensers and the general public, and to contain drug expenditure.

The challenge now is how best to ensure therapeutically sound and cost-effective use of drugs, at all levels of the health system, in both the public and private sectors, by both health professionals and consumers. WHO is working to support three components: rational drug use strategy and monitoring; rational drug use by health professionals; and rational drug use by consumers.

Objectives

Components

Expected outcomes

Policy:
Ensure commitment of all stakeholders to national drug policies, to coordinated implementation, and to monitoring policy impact

1. Implementation and monitoring of national drug policies
Help countries to formulate and implement their national drug policy, and to monitor key components of national drug policy implementation

1.1 National drug policies developed and updated
1.2 National drug policies implemented
1.3 Global national drug policy progress monitored and impact evaluated
1.4 Poverty perspective introduced into national drug policies
1.5 Gender perspective introduced into national drug policies

2. Health system development supported by essential drugs policies and programmes
Work with countries to integrate their work in essential drugs and medicines policy into their national health system, in support of health system development

2.1 Essential drugs concept integrated into national health programmes
2.2 Development of sustainable management capacity in pharmaceuticals
2.3 Traditional medicine integrated into national health care systems

Access:
Ensure equitable availability and affordability of essential drugs, with an emphasis on diseases of poverty

3. Access strategy and monitoring for essential drugs
Help countries to ensure and monitor access to essential drugs, focusing on diseases of poverty, such as malaria, HIV/AIDS, tuberculosis and childhood illnesses

3.1 Increased access to essential drugs for priority health problems
3.2 Increased access to newly developed and abandoned essential drugs
3.3 Standard indicators to measure equitable access to essential drugs
3.4 Access to drugs promoted within international trade agreements

4. Financing mechanisms and affordability of essential drugs
Ensure the implementation of national strategies to finance the supply and increase the affordability of essential drugs, in both the public and the private sectors

4.1 Planning and advocacy for public sector drug financing
4.2 New drug-financing strategies
4.3 Increased affordability of essential drugs in public and private sectors
4.4 Expanded coverage and improved drug benefits within health insurance
4.5 Increased drug price information and guidance on drug price policies

5. National and local public sector drug supply systems and supply capacity
Support countries to run efficient public sector drug supply systems, ensuring the availability of essential drugs at all levels of the distribution chain

5.1 Enhanced drug supply management capacity
5.2 Improved drug supply management as part of health sector reform
5.3 Adherence to good pharmaceutical procurement practices
5.4 Cost-effective and reliable local drug production promoted
5.5 Adherence to good drug donation practices among donors and recipients

Quality and Safety:
Ensure the quality, safety and efficacy of all medicines by strengthening and putting into practice regulatory and quality assurance standards

6. Norms, standards and guidance for pharmaceuticals
Strengthen global norms, standards and guidelines for the quality, safety and efficacy of drugs, including traditional medicine, and provide guidance for global harmonization efforts

6.1 Norms, standards and guidelines developed or updated
6.2 Quality control specifications, basic tests, screening tests and international chemical reference materials for pharmaceuticals developed
6.3 Drug nomenclature and classification efforts continued
6.4 Promotion of WHO norms, standards, guidelines, nomenclature and WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
6.5 Coordination of regional and international harmonization of norms

7. Drug regulation and quality assurance systems
Support countries to establish and maintain effective drug regulation and quality assurance systems

7.1 Drug regulation effectively implemented and monitored
7.2 Drug manufacturing, distribution and inspection practices improved
7.3 Substandard and counterfeit drugs combated
7.4 Regulatory Situation of Herbal Medicines: Worldwide Review updated

8. Information support for pharmaceutical regulation
Improve the access of national regulatory and pharmaceutical control authorities to reliable information management systems, and to mechanisms for exchange of independent information on drug quality, safety and efficacy

8.1 Increased exchange of information on quality, safety and efficacy of medicines
8.2 Reliable information management systems created
8.3 Access to international adverse drug reaction monitoring system extended

9. Guidance for control and use of psychotropics and narcotics
Provide advice and guidance on psychotropic and narcotic substances in accordance with WHO’s mandate under international treaties

9.1 Psychoactive substances assessed for international control
9.2 Rational use of controlled medicines promoted

Rational use:
Ensure therapeutically sound and cost-effective use of drugs by health professionals and consumers

10. Rational drug use strategy and monitoring
Support countries in implementing and monitoring a national strategy to promote rational use of drugs by health professionals and consumers

10.1 Advocacy of rational drug use
10.2 Identification and promotion of successful rational drug use strategies
10.3 Responsible drug promotion encouraged
10.4 Information support on use of traditional medicine
10.5 Antimicrobial resistance contained

11. Rational drug use by health professionals
Develop national standard treatment guidelines, essential drugs lists, educational programmes and other effective mechanisms to promote rational drug use by all health professionals

11.1 Development of national standard treatment guidelines and essential drugs lists supported
11.2 Support for problem-based and skill-based in-service training programmes
11.3 Drugs and therapeutics committees established and operating effectively
11.4 International technical guidelines and standards on traditional medicine expanded

12. Rational drug use by consumers
Establish effective systems to provide independent and unbiased drug information - including on traditional medicine - to the general public and to improve drug use by consumers

12.1 Effective systems of drug information
12.2 Public education in rational drug use and consumer empowerment

Components and Numbered Country Progress Indicators

Indicator type

1999 status

2003 target

No./No. reporting

%

Component 1: Implementation and monitoring of national drug policies

1. Countries with an official national drug policy document - new or updated within the last 10 years

S

66/151

44%

55%

2. Countries with a national drug policy implementation plan - new or updated within the last 5 years

S

39/107

36%

43%

Component 2: Health system development supported by essential drugs policies and programmes

3. Countries with a national drug policy included in the national health plan

S

n.a.*

n.a.

n.a.

4. Countries with a national policy on traditional medicine

S

31/46

n.a.

n.a.

Component 3: Access strategy and monitoring for essential drugs

5. Countries where less than 50% of the population has access to essential drugs

O

30/187

16%

14%

6. % of key drugs available in health facilities (measured in countries with comprehensive programmes)

O

n.a.*

n.a.

80%

Component 4: Financing mechanisms and affordability of essential drugs

7. Countries with public drug expenditure per capita of less than U$2.00

P

39/94

41%

35%

8. Countries with generic substitution allowed in private pharmacies

P

83/134

61%

75%

9. Countries with public health insurance covering drug costs

S + P

71/111

64%

70%

Component 5: National and local public sector drug supply systems and supply capacity

10. Countries with public sector procurement based on a national list of essential drugs

P

70/132

53%

60%

11. Countries with at least 75% of public sector procurement carried out by competitive tender

P

79/88

90%

95%

12. Countries implementing the 1999 interagency guidelines on drug donations

P

n.a.*

n.a.

80%

Component 6: Norms, standards and guidance for pharmaceuticals

13. Countries participating in the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce

P

142/191

74%

80%

Component 7: Drug regulation and quality assurance systems

14. Countries operating basic drug regulatory system (key legislation and drug regulatory authority functions)

S + P

92/135

68%

75%

15. Countries with basic quality assurance procedures (good manufacturing practices and sampling to test drugs)

S + P

87/139

62%

75%

16. Countries with laws and regulations covering herbal medicines

S

48/60

n.a.

n.a.

Component 8: Information support for pharmaceutical regulation

17. Countries with computerized drug registration

S

n.a.*

n.a.

n.a.

18. Countries with adverse drug monitoring/registration system

S

56/191

29%.

35%

Component 9: Guidance for control and use of psychotropics and narcotics

19. Number of substances reviewed and recommended for classification for international control

n.a.

2/3**

66%

83%

Component 10: Rational drug use strategy and monitoring

20. Countries with basic system (including legislation) for regulating pharmaceutical promotion

S + P

58/142

41%

50%

21. Countries with national drug information centre able to provide independent drug information to prescribers and/or dispensers

S + P

57/136

42 %

50%

Component 11: Rational drug use by health professionals

22. Countries with treatment guidelines updated within the last 5 years

S

55/86

64%

70%

23. Countries with national list of essential drugs updated within the last 5 years

S

127/175

73%

75%

24. Countries that include the concept of essential drugs in basic curricula for medicine and/or pharmacy

P

88/100

88%

90%

Component 12: Rational drug use by consumers

25. Countries with public education on rational drug use

P

n.a.*

n.a.

n.a.

26. Countries with drug information centre/service accessible to consumers

S + P

n.a.*

n.a.

n.a.

S

country progress indicator that provides information on structure

P

country progress indicator that provides information on process

O

country progress indicator that provides information on outcome

S + P

composite country progress indicator that provides information on both structure and process

*

data will be collected in 2000 and the 2003 target set

**

i.e. UNDCP accepted two out of three of WHO’s recommendations concerning substances for international control