12.

2 Conclusions related to regulatory processes

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 reevaluated 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.
12.3 Recommendations for effective drug regulation
• A clear sense of the mission of the regulatory authority is important in
motivating DRA staff to pursue regulatory processes in order to achieve drug
regulation. Governments should state clearly the mission and objectives of
drug regulation, so that the attainment of the intended objectives can be easily
assessed.
• Drug laws should be sufficiently comprehensive, covering all activities involving drug
products and information, and updated regularly.
• One central agency should be accountable for the overall effectiveness of drug regulation.
• Personnel engaged in drug regulation should be individuals of integrity and appropriately
trained and qualified. Human resources development programmes should be made available to
help staff to improve their knowledge and skills and to enable them to cope with developments
in pharmaceutical science and technology. They should also have access to the latest scientific
and technological information to facilitate their work.
• Appropriate standards and guidelines should be developed and used as tools for the
application of all regulatory processes. They should be freely available to all stakeholders,
including the public, in order to increase the transparency of the DRA's operations. The same
standard of regulation should be applied to all drugs, whether they are imported and/or
manufactured by the public or the private sector, and destined for domestic consumption or for
export.
• Sustainable financing is essential to promote effective drug regulation. Drug regulatory
authority financing should strike a balance between fees covering the full cost of services and
government support. Fees should provide increased revenue to the authority so that it can
perform effectively, and serve
to discourage clients from “flooding” the system with applications that do not meet official
requirements.
• Every regulatory function contributes to ensuring the safety quality and efficacy of drugs.
The action taken by the authority should cover all drug regulatory functions in a balanced
fashion. Support for drug regulation should not be compromised by other non-regulatory tasks
with which the DRA may also be charged.
• The regulatory process should be systematically monitored in order to identify problems and
determine whether actual activities match the intended actions. Moreover, the DRA should
become a learning organization which routinely conducts self-assessment and continuous
quality improvement. There should be administrative and legislative supervision in order to
guarantee accountability. Peer review by drug regulatory authorities in other countries can
serve as a means of external auditing, whereby the performance of one agency can be compared
with that of its peers.
• Any inefficiency in the regulatory process delays decision-making and may lead to shortages
of critically needed drugs, thus endangering human lives. Drug regulatory authorities should
employ various strategies to increase efficiency of resource use, e.g. prioritization and
streamlining of the work process; job enlargement and job enrichment for regulatory staff;
pooling of international information resources; and sharing and pooling of international QC
resources.
• Drug regulatory authorities should communicate regularly with their clients. They should
also acknowledge the right of citizens to be provided with accurate and appropriate information
on drugs marketed in their country. Educating citizens about the efficacy, safety, quality and
rational use of drugs will ultimately enhance the achievement of regulatory objectives.