Theme Paper for Discussion - Effective Drug Regulation: What Can Countries Do?, Geneva, 16-19 March 1999
(1999; 53 pages) [French] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentAcronyms and abbreviations
View the documentExecutive summary
Open this folder and view contents1. Drug regulation: an early concern
View the document2. Rationale for regulating drugs
View the document3. Where are we today?
Close this folder4. How can drug regulation be made effective?
View the document4.1 Assess drug regulation performance
View the document4.2 Identify and develop priority functions
View the document4.3 Provide a clear mission and purpose
View the document4.4 Create a supportive environment
View the document4.5 Formulate adequate drug legislation
View the document4.6 Create appropriate organizational structure
View the document4.7 Allocate adequate human and financial resources
View the document4.8 Minimize corruption and conflict of interest
View the document4.9 Apply most appropriate strategy
View the document5. The way forward
View the documentAnnex 1. Status of drug regulation and drug quality assurance in WHO African Region and selected countries
View the documentAnnex 2. A model framework for assessing drug regulation
View the documentAnnex 3. Possible approaches to developing drug regulation a
View the documentAnnex 4. Examples of mission statements concerning drug regulation
View the documentAnnex 5. Fees collected for drug registration
View the documentReferences
 

4.8 Minimize corruption and conflict of interest

Corruption is often seen at the intersection of the public and private sectors. Moreover, it is not specific to drug regulation.34 In other words, it cannot be attacked effectively in isolation from other problems.

In their study of Australian business regulatory agencies, Grabosky and Braithwaite35 found that corruption is more likely to occur when:

• regulators regulate a small number of client companies;
• regulators regulate a single industry rather than diverse industries;
• the same inspectors are in regular contact with the same client companies;
• a high proportion of inspectors have a background in the industry that is being regulated.

They found too that corruption was more likely in agencies that maintain close cooperative relationships with the industry. Corruption is also more likely when agencies engage in regular sanctioning of the industry; for example, if an agency frequently punishes companies and individuals it will doubtless be offered bribes to deflect such punishments.

Other factors that can act as incentives for corrupt behaviour are:

• wide discretionary powers;

• little or no accountability of public officials;

• distorted or unclear government policies that are difficult to interpret, resulting in bureaucratic delay and even in bribery if there is a possibility of interpreting the policies in a way that is more favourable to the industry;

• lack of a government system, such as a court of appeal or tribunal (where decisions taken by the regulatory authority can be questioned), that deters bribery and serves as a system of checks and balances;

• failure of the salaries offered to public employees to match those given in the private sector.

There are no simple solutions to these problems. Strategies to reduce corruption vary from country to country and depend much on political and socioeconomic conditions. For Grabosky and Braithwaite, one means of counteracting the evolution of corruption is by adopting a tripartism policy. This is a process in which relevant public interest groups become the fully-fledged third player in the “game” of regulation. Such an approach requires, of course, that a democratic system be already in place.

Other approaches to minimizing corruption in drug regulation that could be considered include:

• developing an appropriate civil service code of conduct and an appropriate culture of regulation;

• creating a rule-based bureaucracy with a pay structure that rewards regulators for honest work;

• creating a merit-based recruitment and promotion system;

• reducing regulators’ discretionary power or authority;

• enhancing accountability by creating mechanisms for monitoring and punishment;

• creating mechanisms whereby citizens and consumer groups can lodge official complaints and contribute to the exposure of corruption;

• making rules and decisions transparent;

• punishing those who take or offer bribes;

• rotating regulators or assigning them in teams to reduce the frequency of contact between the same regulators and regulates.

Corruption also arises in some developing countries when drug regulators or inspectors are permitted to run businesses in order to supplement their government salaries. This usually means that they operate their own pharmacy or work as a technical manager for a private pharmacy or company. Understandably, such a situation often leads to conflict of interest and corruption. Countries operating such a system should consider other means of increasing the salaries of their staff. One possibility is to collect fees for regulatory services rendered and to use them to supplement salaries.

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Last updated: January 19, 2012