In sum, the prevalence of counterfeit drugs can be measured in a systematic random sampling approach, both in country and across countries. As such, this measure could form the basis for a cross-country indicator on how well given countries are regulating (and also monitoring) the drug market.

# **_Governance determinants_**

The strategy for collecting information on governance determinants in ways that are comparable across countries is much less clear. Most governance determinants are context-specific despite efforts to identify objective and comparable indicators of ownership, decentralization, formal procedures and stakeholder participation. (See Box 3.)

# **Box 3: Assessing Governance Determinants with Expert Informants**

WHO has developed an assessment tool for governance of pharmaceuticals (WHO 2006). It provides a research protocol and survey instrument with 66 questions that address a wide range of formal procedural and performance measures in the regulation, procurement, distribution and dispensing of medications. The protocol provides guidance to researchers regarding the number and types of key informants who should be interviewed. The assessment is currently underway in more than 10 countries.

In 2000, the Pan American Health Organization (PAHO) convened a committee of public health experts who identified 11 Essential Public Health Functions (EPHF) and subsequently developed a survey instrument designed to assess a country‟s ability to carry out those functions. The EPHF survey is administered to individuals who are considered knowledgeable about the health sector (PAHO 2008). The intent of the survey is to answer questions about the capacity of the public health system to fulfill its essential functions in a yes-or-no format, asking for example whether the public health surveillance system is capable of analyzing a public health threat. With this series of binary questions, the EPHF assesses the public health system‟s strengths and weaknesses relative to this expert view of what a public health system should do.

Both of these initiatives, by relying on expert responses to a series of detailed questions parallel the approaches found in a number of measurement approaches being used in broader governance studies, such as the World Bank‟s CPIA and Freedom House.

One strategy would be to follow the approach of Kaufmann and Kraay, identify a limited number of governance dimensions, classify data gathering efforts by as many organizations as possible, aggregate and then normalize the measures. The advantage of such an approach is that it can reduce errors and bias by combining multiple sources of information on the structural features of health sector governance. The key disadvantage is that the quality of poor data gathering efforts – in terms of both validity and reliability – might overshadow better efforts and generate more confusion than information.

Another strategy would be to cull the existing range of indicators and select those that fulfill some basic criteria: that they are available, accurate, independent, comparable across countries and over time, and relevant. The primary difficulties here are likely to be ______________________________________________________________________________________

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