Effective Drug Regulation - A Multicountry Study and Annex 1: Guide for Data Collection to Assess Drug Regulatory Performance: 11. ASSESSING REGULATORY PERFORMANCE: 11.5 MONITORING AND EVALUATING THE ACCOUNTABILITY AND TRANSPARENCY OF DRUG regulation

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

Índice de contenido

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

11.5 MONITORING AND EVALUATING THE ACCOUNTABILITY AND TRANSPARENCY OF DRUG regulation

11.5.1 Measures of regulatory accountability and transparency

In general, drug regulatory authorities have powers of independent decision-making, based on technical considerations. Supervision of these authorities is supposed to be less stringent than that of other bureaucratic organizations. Nonetheless, accountability and transparency are key values for all public agencies: even more so in the case of drug regulatory authorities, because of the direct importance of drugs for public health.

Accountability and transparency have several aspects: reporting to and control by supervisory bodies; clarity and openness of procedures; criteria for decision-making and decisions made; and existence of systems for complaint and appeal. Accountability and transparency can be evaluated by examining, in particular: reporting requirements, external reviews of the authority’s performance; frequency of publications and content of website (and other means of communication between the DRA, the public and the regulated parties); bodies to which complaints are directed; and appeals procedures. However, the individual details of these elements of regulation make quantitative comparison difficult.

11.5.2 Performance of the 10 countries

Reporting and oversight: Although the drug regulatory authorities in all the countries publish reports, these focus more on the structure and process than on the outcomes of regulation. Self-assessment by the authorities of the effectiveness and the efficiency of their work is generally not the norm. Oversight by external bodies exists only in Australia, where the activities of the TGA are reviewed by the Therapeutic Goods Consultative Committee. In the other countries, no such mechanism exists.

Communication of procedures and decisions: All the countries have an official channel (mostly in the form of an official gazette) through which the drug regulatory authorities communicate with clients and the public concerning regulatory decisions and processes. Some drug regulatory authorities also communicate regulatory information via their website. Nevertheless, access to regulatory information is still perceived as a problem by consumer groups and the pharmaceutical industry alike.

Complaints and appeals: Complaint and appeals systems exist in all the countries. These systems can be classified according to the appeals procedure. In Uganda and Venezuela, appeals can be made only to the body that made the original decision. In Cuba and Tunisia, appeals can be made to the supervisory body, i.e. the Ministry of Health. In a third category, a combination of channels is available for appeal. An appeal may have to be sent first to the DRA or the Minister of Health, and thereafter submitted or forwarded to other channels, e.g. the courts, if the result is not satisfactory. This is the system in Australia, Estonia, the Netherlands and Zimbabwe (see Table 8.3).

Although mechanisms for ensuring accountability and transparency exist in each of the countries, not all of them can be considered adequate and independent.