Drug regulation is a process encompassing various activities aimed at ensuring the safety, efficacy and quality of drugs, as well as the appropriateness and accuracy of product information. Its ultimate goal is to promote and protect public health.
The special nature of drugs demands that they should not be treated as normal commercial commodities by governments or those involved in trade. In particular, governments should take responsibility for regulating the production, importation, exportation, storage, distribution, sale and supply of drugs. This process should cover the whole spectrum of drugs - from new innovative to long-established products - and should be applied to drugs from all sources, whether produced domestically or imported by the public or private sector.
For many years, various countries, the World Health Organization (WHO), and other international organizations have sought to improve drug regulation at national and international level. This has included the development of adequate norms, standards, guidelines and guides. However, despite these efforts, only a few countries operate a well-developed drug regulatory system. In many other countries such a system has been developed only partially and thus operates weakly. In yet others, a drug regulatory system is lacking entirely. Consequently, the market circulation of substandard drugs remains a concern in many countries.
This paper presents an overview of the development of drug regulation and the rationale for drug regulation. It also reviews the drug regulation situation in selected countries, examines key contributing factors to observed drug regulation weaknesses, and identifies the measures that must be taken to improve drug regulation.
Assess drug regulation performance
The reasons for drug regulation weaknesses vary from country to country. However, the most important influences on drug regulation outcomes are: the political and socioeconomic environment; drug policies and legislation; drug regulation organizational structure; enforcement and regulatory strategies; human and financial resources; and corruption. In order to take corrective action governments need to systematically assess their drug regulation performance, identify weaknesses therein and the reasons for them, and consider alternative policy options.
Identify and develop priority functions
A national drug regulatory system should reflect the level of development of the relevant country’s pharmaceutical sector. In industrialized countries where the pharmaceutical industry is highly developed, and there are no constraints on human or other resources, all the components of drug regulation need to be in place if the safety, efficacy and quality of drugs are to be assured. In developing countries, drug regulation should be developed in phases, beginning with the most basic (but priority) and less resource-intensive functions. For instance, in countries where there is little domestic manufacturing, good manufacturing practice (GMP) inspection cannot be considered a priority, compared to inspection of distribution channels, or registration of imported drugs.
Provide a clear mission and purpose
Governments should make clear the rationale for regulating drugs by providing a written mission statement. The specifics of this statement will depend on the resources available and the priority objectives. Such a statement will be crucial to. any assessment of whether the purpose of drug regulation has been achieved and to making known the need for drug regulation. This statement should be published and should indicate the various parties who will be involved in drug regulation, as well as its beneficiaries.
Create a supportive environment
Government support and commitment are essential to effective drug regulation. Policy statements are not sufficient for demonstrating this commitment. A mechanism should also be in place that guarantees public accountability and transparency. Additionally, drug regulation should be independent of political pressure, and adequate resources made available for its smooth operation. Governments should recognize too the positive role that professional associations, consumer groups and other public interest groups can play in drug regulation, and create mechanisms for their participation.
Formulate adequate drug legislation
Drug legislation forms the basis of drug regulation. Governments should examine their drug legislation and amend it if necessary, to make it sufficiently comprehensive. They should also provide the relevant agency with adequate power to ensure that the drug regulation objectives are met. The role, responsibilities and duties of the parties involved in drug regulation should be defined clearly. Provisions for administrative measures and legal sanctions, to be taken in the event that the drug laws and regulations are violated, should be made.
Create appropriate organizational structure
Governments should provide appropriate organizational structure for effective drug regulation. Responsibilities, duties and functions should be distributed appropriately between the various bodies responsible. Structural and functional linkages should be defined clearly and a system of accountability should operate. The structure should provide independence in decision-making, as well as financial and administrative autonomy.
Allocate adequate human and financial resources
Drug regulation requires appropriately trained and highly qualified individuals of high integrity. Governments must therefore pay salaries that are commensurate with level of responsibility. Accordingly, they should allocate specific financial resources for drug regulation. A realistic fee system to ensure financial sustainability should be imposed for services rendered, and the agencies responsible for drug regulation should have the power to collect and use them. A national plan to develop the needed human resources, including recruitment and retraining, should be established.
Minimize corruption and conflict of interest
A number of actions can be undertaken that will contribute significantly to reducing corruption in drug regulation. For example, drug regulation rules and procedures should be clear and transparent. Additionally, drug regulation enforcement should be based on written rules, and the discretionary power of regulators should be limited in order to prevent abuse. Governments should also establish a pay structure that rewards regulators for honest work, and personnel such as inspectors who have frequent contact with regulates should be rotated regularly. A mechanism for public complaints should be established, and public interest groups encouraged to participate in regulatory and enforcement activities.
Apply most appropriate strategy
As well as traditional command-and-control government regulation, governments should consider encouraging the pharmaceutical industry and trade associations to practise self-regulation, particularly if government resources and infrastructure are limited. They can also consider encouraging public interest groups to participate in certain regulatory activities. Such an approach should be based on written terms of reference or laws, and a mechanism should be instituted to ensure accountability. Governments should also seek to improve compliance with drug legislation - for instance, by designing escalating enforcement strategies, including persuasion, warnings and fines.
The way forward
At present, drug regulation is weak or non-existent in many developing countries. Consequently, the problem of substandard and counterfeit drugs, as well as the existence of large numbers of drugs that are of no therapeutic significance, continue to be of serious concern. The pressure on countries to open their markets, including that of the pharmaceutical sector, will exacerbate these problems unless governments strengthen drug regulation. This paper highlights some of issues that countries should consider when designing drug regulation policy.
“Drugs are the key to modern medicine. Surgery, radiotherapy, and diagnostic tests are all important, but the ability of health care providers to alter health outcomes depends primarily on drugs. Our age has been given many names - atomic, electronic, space, and the like - but measured by impact on people’s lives it might just as well be called the “drug age”.1