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.