Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance: 11. ASSESSING REGULATORY PERFORMANCE: 11.1 ASSESSING GOVERNMENT FUNCTIONS: AN ESSENTIAL PART OF POLICY-MAKING

Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance
(2002; 187 pages)

Table of Contents

ACRONYMS
PREFACE
ACKNOWLEDGEMENTS
EXECUTIVE SUMMARY
1. DRUG REGULATION: OBJECTIVES AND ISSUES
	1.1 DRUGS AS AN INSTRUMENT OF PUBLIC HEALTH
	1.2 CONTROLLING PRIVATE BEHAVIOUR FOR PUBLIC PURPOSES
	1.3 OBJECTIVES AND ORGANIZATION OF THIS REPORT
2. MULTICOUNTRY STUDY ON EFFECTIVE DRUG REGULATION
	2.1 PROJECT RATIONALE AND DEVELOPMENT
	2.2 STUDY OBJECTIVES
	2.3 METHOD OF STUDY
	2.4 DRUG REGULATION FROM A COMPARATIVE PERSPECTIVE
3. PROFILE OF THE COUNTRIES
	3.1 GENERAL BACKGROUND
	3.2 POLITICAL ENVIRONMENT
	3.3 PHARMACEUTICAL SECTOR ENVIRONMENT
4. REGULATORY FRAMEWORK
	4.1 MISSIONS AND GOALS OF DRUG REGULATION
	4.2 DOMAINS OF CONTROL
	4.3 OTHER NON-REGULATORY PHARMACEUTICAL FUNCTIONS
	4.4 NATIONAL DRUG POLICY
	4.5 HISTORICAL DEVELOPMENT OF DRUG REGULATION
5. REGULATORY CAPACITY
	5.1 LEGAL BASIS, ORGANIZATIONAL STRUCTURE AND AUTHORITY
	5.2 HUMAN RESOURCES
	5.3 FINANCING DRUG REGULATION
	5.4 PLANNING, MONITORING AND EVALUATING IMPLEMENTATION
	5.5 PROBLEMS ENCOUNTERED AND STRENGTHS IDENTIFIED
	5.6 POLITICAL INFLUENCE AND ACCOUNTABILITY
6. LICENSING OF MANUFACTURING, DISTRIBUTION AND RETAIL SALE
	6.1 POWER AND PROCESS
	6.2 HUMAN RESOURCES
	6.3 PAYING FOR LICENSING
	6.4 PERFORMANCE
7. INSPECTION AND SURVEILLANCE
	7.1 POWER AND PROCESS: COMPARING STRUCTURES AND PROCESSES
	7.2 HUMAN RESOURCES
	7.3 PAYING FOR INSPECTION
	7.4 PLANNING, PROCESS AND PERFORMANCE
8. PRODUCT ASSESSMENT AND REGISTRATION
	8.1 POWER AND PROCESS
	8.2 HUMAN RESOURCES
	8.3 PAYING FOR REGISTRATION
	8.4 PERFORMANCE
	8.5 ADVERSE DRUG REACTION MONITORING
	8.6 CLINICAL TRIALS
9. CONTROL OF DRUG PROMOTION AND ADVERTISING
	9.1 POWER AND PROCESS: COMPARING STRUCTURES AND PROCESSES
	9.2 PERFORMANCE
10. DRUG QUALITY CONTROL LABORATORY
	10.1 POWER AND PROCESS
	10.2 HUMAN RESOURCES
	10.3 PAYING FOR QUALITY CONTROL
	10.4 PERFORMANCE
11. ASSESSING REGULATORY PERFORMANCE
	11.1 ASSESSING GOVERNMENT FUNCTIONS: AN ESSENTIAL PART OF POLICY-MAKING
	11.2 MONITORING AND EVALUATION SYSTEM
	11.3 MONITORING AND EVALUATING THE EFFECTIVENESS OF DRUG REGULATION
	11.4 MONITORING AND EVALUATING THE EFFICIENCY OF DRUG REGULATION
	11.5 MONITORING AND EVALUATING THE ACCOUNTABILITY AND TRANSPARENCY OF DRUG regulation
	11.6 AVAILABILITY OF INFORMATION FOR ASSESSMENT
12. CONCLUSIONS AND RECOMMENDATIONS FOR EFFECTIVE DRUG REGULATION
	12.1 CONCLUSIONS RELATED TO REGULATORY STRUCTURES
	12.2 CONCLUSIONS RELATED TO REGULATORY PROCESSES
	12.3 RECOMMENDATIONS FOR EFFECTIVE DRUG REGULATION
ANNEX 1: GUIDE FOR DATA COLLECTION TO ASSESS DRUG REGULATORY PERFORMANCE
	1. Background information
	2. Drug regulation: overview
	3. Regulatory functions
		3.1 Licensing: persons, premises and practices
		3.2 Inspection and surveillance
			3.2.1 GMP inspection
			3.2.2 Inspection of distribution channels
		3.3 Product assessment and registration
		3.4 Adverse drug reaction monitoring
		3.5 Clinical trials
		3.6 Control of drug promotion and advertising
		3.7 Drug quality control laboratory

11.1 ASSESSING GOVERNMENT FUNCTIONS: AN ESSENTIAL PART OF POLICY-MAKING

Drug regulation is a government function serving societal objectives and is thus subject to societal scrutiny. The objectives of drug regulation are the protection and promotion of public health. The question to ask is: are these objectives being effectively achieved?

Effectiveness is not, however, the only value society demands of the DRA. Efficiency, accountability and transparency are also required.

Efficiency means carrying out regulatory responsibilities using as few resources (human, financial and time) as possible. Efficiency is also an issue in relation to the resources which the regulated parties must invest, and the opportunity costs they incur in conforming with regulatory requirements (i.e. in expending resources in that way, which cannot then be used for another purpose).

Accountability and transparency involve conducting the business of government in such a way that it is open to the scrutiny of supervisory bodies and the public. In addition, government procedures and the criteria for decision-making must be clearly defined and available to all.

Governments are responsible for devising measures and mechanisms for assessing their own functions. Government agencies must monitor and evaluate their regulatory activities in order to ensure that they are responsive to society’s examination of government functions. Monitoring and evaluating the workings of regulation are essential to enable the responsible agencies to learn about their performance and identify problems and opportunities for improvement.

This chapter explores approaches for monitoring and evaluating the effectiveness, efficiency, accountability and transparency of drug regulatory activities, and examines how the 10 countries perform in these areas. The conceptual spheres of regulation described in Chapter 4 are used as a framework for assessing and analysing country data, where available. Some data are unavailable, but the conceptual foundations laid out for the analysis can still be used to design a system for collecting and analysing data in the future.