Strong political will and commitment

In countries where political will and commitment are weak or absent, NRAs often lack adequate and sustainable human and financial resources, appropriate facilities and strong enforcement power. They are also vulnerable to external influence - for example, pharmaceutical manufacturers wielding strong political power may be able to influence decisions in their own favour. To promote strong political commitment and support, NRAs must raise government awareness on the rationale for regulating medicines, the serious consequences of not doing so, and the threats posed by unsafe, ineffective, substandard and counterfeit medicines.

Strong public support

Experience in countries such as Australia, Canada, France, the UK and the USA, shows that the participation of consumers and public interest groups in medicines regulation enhances political support for the regulatory process, promotes NRAs’ transparency and accountability, and protects them from negative external influence. It can also help to reduce conflicts of interest and corruption.

NRAs can increase public support through advocacy campaigns to encourage different sectors of the public to participate in groups through which they can voice their views on public health issues. Governments should encourage the creation of such consumer and other public interest groups, and establish mechanisms to enable them to participate in medicines regulation.

A clear mission and purpose

A clear mission statement, which includes the NRA’s goals, is necessary to guide its work. Goals usually include the protection and promotion of public health by ensuring the safety, efficacy and quality of medicines, and their appropriate use; and ensuring the appropriateness of medicines information provided to the public and health professionals.

In some countries, NRAs are also assigned nonregulatory tasks, such as managing public sector drug supply or developing the pharmaceutical sector. Such additional duties will reduce the NRA’s efficiency because it cannot focus solely on medicines regulation. The assignment of multiple missions with conflicting objectives can lead to conflicts of interest in fulfilling mandates, allocating resources or setting priorities. For example:

• Where NRAs are mandated to manufacture, import and/or distribute medicines, there is a risk of products being introduced to the market without undergoing the formal registration process. This leads to a double standard that can result in increased circulation of counterfeit and substandard medicines on national and international markets. Attempts to regulate often fail due to political interference.

• In medicines-exporting countries, where the main policy is to encourage exports and improve the national economy, the NRA’s mission is often limited to the regulation of medicines for domestic use.

Governments should ensure that: NRAs are structurally independent of the government agency responsible for managing the national medicine supply system and should control it; regulatory controls are applied equally to the entire public and private sectors; and that the same regulatory standards are applied to medicines, whether for domestic use or export.

Comprehensive medicines legislation and regulation

In many countries medicines legislation and regulation are not regularly updated or are “imported” from other countries and do not reflect national realities. Countries should update their medicines legislation and regulations regularly to address new pharmaceutical issues as they arise. To protect the public from harmful and dubious medicines, legislation should cover all products for which medicinal claims are made, as well as related manufacture and trade activities, in the public and private sectors. Legislation should provide a basic legal framework and be flexible enough to provide adequate powers to the NRA (Box 4).

In addition, because medicines regulation deals with products, processes and practices that involve rapid scientific and technological change, the executive branch of the government responsible for drug regulation must be empowered to formulate new regulations, or to propose modifications to existing ones.

Appropriate organizational structure

Many countries organize their NRAs as small units or sections under divisions or departments of ministries of health, which results in a low profile for the NRA. This organizational structure also tends to result in very limited government allocation of human, financial and other resources. In such circumstances, NRAs will have no independence in decision-making, acquiring and using resources, or in appointing and dismissing staff. Staff salaries will also be low, making it difficult to attract and retain qualified and competent staff. Overall, medicines regulation will be very weak.

Where NRAs have a high profile they are organized as a commission, board, statutory authority or department, with the legal power from government to acquire and use resources, and appoint and dismiss staff, and have independence in decision-making. In this way medicines regulation is well developed and operational.

Appropriate distribution of responsibilities

In some countries, regulatory functions come under the jurisdiction of a single agency with full authority over the command and control of all regulatory activities. In others, these functions are distributed between different authorities, either horizontally(e.g. ministry of health, ministry of agriculture) or vertically (federal, state and local governments) and to function in an effective and coherent manner need coordination at national level. If horizontal or vertical distribution of responsibilities between different agencies is necessary, governments should:

• create a central coordinating body with overall responsibility and accountability for all aspects of medicines regulation for the entire country;

• ensure that the distribution of responsibilities between agencies is based on regulations or written terms of reference;

• develop coordination and information flow systems to support medicines regulation;

• build in a monitoring and evaluation system to assess implementation of regulation, identify shortcomings and their causes, and make timely corrections.

Adequate and sustainable human resources

For many countries the main problem is the shortage of qualified and skilled personnel. Low salaries, the scarcity of trained pharmaceutical and other essential professionals, a shortage of training institutions, inflexible recruitment procedures, lack of career structures and incentives, and the “brain drain” all contribute to the difficulties. Staffing problems cannot be solved quickly or easily (Box 5).

Adequate and sustainable financing

In developed countries and a few developing ones, such as Uganda and Zimbabwe, fees and charges levied for services represent a substantial proportion of NRA funding. For example, Australia’s Therapeutic Goods Administration recovers 100% of all regulation costs in this way. In Canada, the United Kingdom and the United States the NRAs recover 70%, 100% and around 50% of their costs respectively through fees. NRAs in developed countries charge higher fees than those in developing ones (Table 1), as the fees more accurately reflect the actual cost of services provided. Moreover the authorities have the power to control and use the funds to finance their activities. In developing countries fee revenues are usually transferred to the government treasury, making regulation exceptionally difficult to finance.

Experience to date indicates that government resources alone are insufficient to ensure that medicines regulation is sustainable and effective. Governments must revise their medicines legislation and introduce fee systems that reflect the real costs of services provided. However, special considerations, such as fee reduction or exemption, should be made for essential medicines, as is the case in most developing countries. NRAs should not be entirely dependent on fees and should receive some financial support from government sources.

Table 1 Medicines registration fees in US$ - 1998/9

 

* Imported products

Strong cooperation and collaboration between stakeholders

Enforcing drug legislation effectively requires NRAs and other government enforcement agencies, such as customs, police and prosecutors, to work together, but in many countries cooperation is non-existent.

NRAs should work with customs and police in inspecting products at ports, other points of entry and distribution outlets, detecting and investigating criminals involved in the illegal trade of medicines and counterfeiting, and apprehending and prosecuting criminals. NRAs should also seek the cooperation of health professionals, pharmaceutical and consumer associations, and other interested parties.

Transparency and accountability

Many NRAs do not make regulatory policies, administrative procedures, guidelines and criteria for decisions publicly available to all stakeholders. And many NRAs are not obliged to submit reports on their activities, either to the supervisory authorities or to the general public. Often decisions are not explained to clients in writing, and clients may not have access to an appeals system.

Lack of accountability and transparency mean that communication on medicines regulation between NRAs and their clients, government and the general public is likely to be lacking or highly unsatisfactory. Clients will not understand why certain regulatory decisions have been taken; governments will be ill-informed about the extent and significance of the activities of their NRAs; and the public will be unable to question any aspect of drug regulation because of lack of understanding of individual components and how they should be undertaken. But by building relationships with its stakeholders and promoting public confidence, NRAs can foster support for medicines regulation (Box 6).

Good management

In most developing countries, NRA management capacity remains very weak, with no written guidance for staff on the principles, practices and methods to be followed. Activities are seldom based on work plans, and tools, such as guidelines and standard operating procedures, are seldom developed and distributed to stakeholders. Monitoring and evaluation of implementation are rare, and are difficult because of the lack of information on regulatory activities and outcomes, and weak data management.

To function optimally NRAs must develop workplans with clear objectives, activities, time-frames and expected outputs. They must also introduce self-assessment programmes into their management systems to enable weaknesses in programme implementation to be identified and corrected quickly.