Governments must employ people with specialized knowledge and skills if they wish to promote effective drug regulation. Moreover, they must employ individuals of great integrity and pay them well, particularly since drug regulation involves various stakeholders with commercial interests who will often exert pressure to secure favourable decisions.
In promoting effective drug regulation, adequate budgeting is therefore essential to providing:
• salaries that will attract personnel with the required training and experience, and that are comparable with salaries paid to their counterparts in private structures;
• the facilities and infrastructure necessary for the proper conduct of drug regulation activities.
Provision of funds must also be regular and uninterrupted to ensure smooth running of regulatory activities.
Evidently, different countries use different financing mechanisms. In Zimbabwe, for instance, the funds of the Medicines Control Authority consist of: fees collected according to the provisions of the country’s drug regulations; moneys appropriated by parliament; and moneys and assets that accrue to the Authority.31
In the case of the USA’s Food and Drug Administration, the budget is derived from user fees as well as moneys appropriated by the US Government. (For 1999, the budget approved by the US Congress was US$ 1,012,729,000, of which US$ 141,230,000 is to come from user fees, including drug user fees.)32
In Uganda, the 1993 National Drug Policy and Authority Statute authorizes the following funding sources:33
• government grants;
• grants and loans from any body, organization, or person;
• money (fees) that may accrue to the Authority in discharge of its functions;
• interest and savings made by the Authority;
• money from any other sources, as approved by the Minister of Health and Child Welfare.
Other Member States such as Barbados, Colombia and Indonesia do not collect any fees, and are totally dependent on government funding. In such cases, the total resources available to the country, and the priority that the government assigns to drug regulation, will influence the amount of funds allocated by government.
Fees collected for drug registration in developed countries are very high. Moreover, drug regulatory authorities in developed countries have the power to control and use the funds to finance their activities. In developing countries, however, not only are the fees collected very low, but they are also transferred to the government treasury, making drug regulation exceptionally difficult to finance. (For some details of the differences in the levels of fees collected by developed and developing countries, see Annex 5.)
Experience to date tells us that government resources are unlikely to be sufficient for promoting effective drug regulation. So in order to improve their drug regulation, developing countries must revise their drug legislation and introduce a fee system for the services provided by drug regulatory authorities, as is already the case in developed countries. However, establishing a fee system may encourage authorities, particularly if they are totally dependent on such income, to facilitate regulatory processes that generate income but that are not necessarily the best means of meeting regulation requirements. Equally, low fees or the absence of fees will encourage the submission of applications for registration of products of little or no therapeutic value. When establishing a fee system, the following criteria should therefore be considered:
• total dependence on fees should be avoided and a mechanism established whereby part of the budget for the regulatory authority comes from government and only the remainder from fees;
• fees should be appropriate to providing increased revenue to the authority (so that it can carry out its work effectively) and to discouraging industry from flooding the system with applications that do not meet official requirements;
• the fee system should cover all services: licensing of premises, persons and practices; registration of products; inspection; quality control; and control of clinical trials;
• there should be a legal basis for collection of fees and empowerment of the authority to use the funds collected;
• there should be provisions for fee reduction or exemption to ensure that vital or life-saving drugs, but which have only a limited market, are reliably available. Such provisions may also be required for locally produced drugs, generic products, etc., in line with the national drug policy.
In addition to ensuring sustainability of qualified and skilled human resources, governments must create mechanisms for human resources development. There should be a system and means for updating the knowledge and skills of regulatory personnel, either locally, or by sending them abroad to centres of excellence or academic institutions.