Drug regulation is a public policy that restricts private-sector activities in order to attain social goals set by the State. Drug regulation is the totality of all measures - legal, administrative and technical - which governments take to ensure the safety, efficacy and quality of drugs, as well as the relevance and accuracy of product information. Public health and safety concerns have obliged governments to intervene in the activities of the pharmaceutical sector.

Although drug regulation is basically a government function, regulatory activities can also be carried out by private organizations, provided that they have been granted authorization by the agency whose own authority is granted by law. Equally, the government may choose to apply the same regulatory requirements to government-owned facilities as to those in the private sector. For instance, the same good manufacturing practice (GMP) standards can be applied to both government and private manufacturers. Self-regulation also occurs, in which members of the group targeted for regulation organize some means of mutual control among themselves.

Guaranteeing the safety, efficacy and quality of drugs available to the public is the main goal of drug regulation, and encompasses a variety of functions. Key functions include licensing of premises, persons and practices; inspection of manufacturing facilities and distribution channels; product assessment and registration (marketing authorization); adverse drug reaction (ADR) monitoring; QC; control of drug promotion and advertising. Each of these functions targets a different aspect of pharmaceutical activities, but all of them must be undertaken simultaneously to ensure effective consumer protection.

Given that drug regulation requires the government to use public resources to impose restrictions on private business, a number of issues related to regulatory actions arise: for example, whether regulation of certain activities is justified; what restrictions should be applied and to what degree; the level of resources used to finance government interventions and their source; how effective regulatory functions are; who is responsible for the impact - both positive and negative - of regulatory actions. These issues have been debated at both philosophical and practical levels (12). This report draws on existing evidence to examine them at a practical level.

Authority and capacity

Regulatory authority is generally founded on laws, which represent policy choices. This authority is assigned to designated organizations, normally part of the bureaucratic apparatus, whose mission is to carry out drug regulation. A host of factors relating to authority and the capacity for exercising such authority affect the operation of drug regulatory activities. These include:

• the scope of regulatory authority, including functions and sanctions

• the structure of regulatory organizations - single or multiple agencies, line of command and control, coordination, communications

• human resources - number, qualifications, remuneration and human resources development

• financing - sources, adequacy and sustainability

• standards, procedures and guidelines used as guidance in performing the authorized functions.

Implementation

As Peters emphasizes: “all laws are meaningless unless they are enforced” (13). Implementation determines the success or failure of regulation. Aspects of the implementation process covered in this report include:

• the type and extent of the actual activities carried out to implement legal provisions, including sanctions for non-compliance

• planning, monitoring and evaluation

• strategies to overcome structural and resource constraints.

Outcomes

The value of all drug regulatory activities depends on whether they produce the intended outcomes. Outcomes can be measured in terms of:

• quality of pharmaceutical products marketed

• proportion of licensed pharmaceutical facilities

• proportion of pharmaceutical facilities meeting certain required standards, e.g. GMP

• number of illegal products

• number of illegal facilities.

Efficiency, transparency and accountability

In addition to effectiveness, policy-makers must also address regulatory efficiency, transparency and accountability when evaluating regulatory policies. Questions are often raised, especially by the pharmaceutical industry and consumers, regarding:

• cost-effectiveness of drug regulation

• the costs for pharmaceutical businesses and consumers of regulatory delay

• political influence over regulatory decisions

• commercial influence over regulatory decisions

• “regulatory capture” - whether and to what extent agencies are “captured” by the very interests they are supposed to regulate (14)

• the degree to which regulatory procedures and decision criteria are made public (“transparency”)

• communication between the regulatory authority, its clients and the consumers

• accountability for the results of regulatory actions.