12.1.1 Formal and informal sectors

As stated in Chapter 11, drugs distributed through the informal sector receive little attention compared with those distributed through the formal sector. Counterfeit products, products of dubious quality and faulty information - especially exaggerated claims of efficacy - are often widespread in the informal sector. Monitoring of pharmaceutical activities should cover both sectors.

12.1.2 Balance of priorities

Each drug regulatory function helps to ensure the efficacy, safety and quality of pharmaceutical products and their rational use. Drug regulation should therefore be carried out in such a way that each function receives sufficient attention and resources. Yet experiences in the countries studied indicate that the different drug regulatory functions receive varying degrees of emphasis. The disparities are found in three key areas.

Pre-marketing versus post-marketing product assessment: Drug legislation in all the countries assigns two types of power to drug regulatory authorities: the authority to assess pharmaceutical products and determine whether they should be registered, and the authority to monitor and change the information and registration status of a drug after it has been marketed. However, much more time is assigned to pre-marketing assessment than to post-marketing review. Only a small number of ADR reports, which are the main mechanism for post-marketing surveillance, are received in most countries. Few countries use them systematically in regulatory decision-making. Registered products are rarely re-evaluated routinely. Yet even if pre-marketing assessment has been thoroughly conducted, it may not be sufficient to guarantee the efficacy and, especially, the safety of drugs. Emphasis should also be placed on post-marketing surveillance.

Product registration versus regulation of distribution: The study showed that product registration is considered a major responsibility by all the drug regulatory authorities. In contrast, regulation of drug distribution and information does not seem to enjoy the same level of attention. This is particularly so in countries where licensing and inspection of distribution channels are assigned or delegated to another agency or another level of government. Yet the regulatory objective of ensuring public health and safety in the use of pharmaceuticals can be achieved only when every pharmaceutical activity operates properly, from the source to the user. All regulatory functions should therefore be given due attention.

GMP versus distribution-channel inspection: In many countries, GMP inspection receives more attention and resources than inspection of distribution channels. It is true that GMP ensures the quality of a product from the start. But it is not in the interests of the consumer if a product that has been produced according to GMP is later stored and distributed under adverse conditions. Inspection of distribution channels should therefore be given equal emphasis, particularly in countries where the drug distribution system has several intermediate levels and the climate is unfavourable.

12.2.3 Implementation

Besides structural constraints, e.g. human and financial resources, the way in which DRA employees perceive their jobs and how they perform are key factors in drug regulation performance. A clear sense of mission on the part of employees is important if regulatory processes are to be pursued consistently.

Regulatory processes should be systematically monitored in order to identify problems and determine whether the actual activities match the intended actions.

12.2.4 Assessment of DRA performance

Several approaches can be employed to assess a DRA’s performance.

Self-assessment: Self-assessment can help an organization to learn about its own strengths and weaknesses. Transforming a DRA into a learning organization which routinely conducts self-assessment and continuous quality improvement can be a powerful approach to enhancing drug regulatory performance.

Review by supervisory body: Drug regulatory legislation normally specifies the official chain of command and the supervisory body to which the DRA must report. Administrative and legislative supervision is an important means of accountability if properly applied. However, supervision should not be used as a means of political influence over legitimate regulatory decisions.

Peer review: This involves setting up mechanisms for mutual review of drug regulation systems. It serves as a means of external auditing, whereby the performance of one agency can be compared with that of others. Systems for international peer comparison of QC laboratories are one example. Proficiency tests are performed by the participating laboratories in such a way that each laboratory learns how well it is performing in comparison with the others.

The above approaches are not mutually exclusive: they may complement one another in appraising performance, as well as helping to identify areas for improvement.

The key to all the review approaches is that performance should be systematically and regularly assessed. Systematic evaluation allows an objective and comprehensive appraisal of performance and identification of strengths, weaknesses and measures for improvement. Regular evaluation enables a DRA to learn continually about the quality of its performance, and to develop awareness of any positive or negative changes in that performance. It also helps the authority to understand whether improvement strategies are working and, if so, to what extent.

12.2.5 Communication with clients and consumers

The task of the DRA is to serve the public. Its operations must therefore be transparent to both clients (e.g. drug manufacturers) and consumers. Communication with clients should be a routine activity throughout the regulatory process. Information regarding its functions and the results of decisions should also be communicated regularly to the public.

12.2.6 Consumer empowerment

Drug regulation is a societal function intended to protect the public. Traditionally it has been considered as a process involving two actors, the DRA and the regulated firms. But policies that foster such arrangements run the risk of encouraging corruption. In order to promote effective drug regulation, arrangements that foster the participation of independent third parties should therefore be considered.

Since consumers are the end-users of drugs, all drug regulatory efforts should lead, ultimately, to protection of the consumer. Consumer groups or public interest groups can contribute to these efforts by participating both in the development of regulatory policies and in regulatory activities. They can act as independent attorney generals and protect the public from undue pressure from industry or politicians. Because of the highly technical nature of drug products and information, however, support from the DRA and other organizations is needed to empower consumers so that they can make an appropriate contribution.

Educating consumers about the efficacy, safety, quality and rational use of drugs can also enhance the achievement of regulatory objectives.