2.3.1 Framework for data collection
The framework for data collection, as depicted in Figure 2.1, lays down the focus and scope of this study. The regulation of human pharmaceuticals, as addressed in this study, has four dimensions: administrative elements, regulatory functions, technical elements and level of regulation. As well as capturing the various dimensions of drug regulation, this framework allows for comparison of drug regulation between countries.
Administrative components are input factors that allow for the functioning of drug regulation, including policy, legislation and regulations, organizational structures, human and financial resources and mechanisms for planning, monitoring and evaluation.
Regulatory functions include licensing of persons, premises and practices, inspection of pharmaceutical establishments, product assessment and registration, QC, control of drug promotion and advertising and monitoring of ADR.
Technical elements concern the existence and the type of standards, norms, guidelines, specifications and procedures.
The level of regulation indicates the level at which the various regulatory functions are undertaken. The political structures of a country determine the overall governance of drug regulation.
Figure 2.1 Study framework showing key components of drug regulation
2.3.2 Country selection
Ten countries from the six WHO regions were selected to participate in this study:
• African Region: Uganda and Zimbabwe;
• Region of the Americas: Cuba and Venezuela;
• Eastern Mediterranean Region: Cyprus and Tunisia;
• European Region: Estonia and the Netherlands;
• South-East Asia Region: Malaysia;
• Western Pacific Region: Australia.
The criteria for the selection of countries included:
• existence of a national DRA;
• type of government - federal or unitary;
• developed country/middle-income or low-income developing country/newly independent country;
• willingness of the government to participate in the study.
3.2.3 Data collection methods
Data collection was carried out using a standardized study guide developed by WHO (see Annex 1). This study guide consists of lists of questions developed from the framework in Figure 2.1. The questions are arranged in three sections: Section 1 - country background information; Section 2 - overview of drug regulation; and Section 3 - the various drug regulatory functions shown in the framework. In each of the sections on regulatory functions, there are subsections with questions on legislation/regulations, organization, human resources, financing, activities and monitoring and evaluation. Indicators to measure implementation are found at the end of each section.
The guide was tested before being applied in the 10-country study.
In each country, the study was carried out by independent national investigators recruited from universities and other institutions. Study advisers were also recruited.
Two general methods were used to collect data: archival study and interview of key informants.
Archival study: This involved a review of relevant documents and records, including: drug laws and executive orders; inspection checklists; DRA annual reports; economic, health and other indicators; and reports of other studies available (e.g. opinion surveys, drug use studies).
Key informant interviews: The investigators in each of the participating countries first identified organizations involved in drug regulation, then interviewed key informants in those organizations, using the specific questions listed in the study guide. These organizations included, but were not limited to, drug regulatory agencies, trade groups (e.g. manufacturers’ associations, importers, pharmacies), professional societies and associations and consumer groups. Each national investigator then prepared a country report and submitted it to WHO, together with the completed data collection guide. The country reports and study guides served as the basis for this synthesis report.
3.2.4 Methods of data analysis and synthesis
Drug regulation systems in the 10 selected countries were examined using the following methods.
• Data for each question in the study guide, representing a single simple construct, were tabulated by country, and then analysed to identify their similarities and differences. For quantitative data, the range of values was analysed, where meaningful.
• Quantitative data for two or more questions were computed into a ratio to permit further comparison.
• Relationships between certain constructs were identified to find possible explanations for system performance. Quantitative data for some constructs were plotted and correlations computed.
• Each relevant construct, representing an aspect of drug regulation structure, process or outcome, was analysed to show how and why a certain area of drug regulation does - or does not - work.
A number of conceptual frameworks were set up for comparative analysis and synthesis of country data. These included: spheres of regulation, historical development and structure-process-outcome of regulation.