In all the countries studied, laws form the foundation from which drug regulatory powers are derived. The implementation of these laws relies on the creation of agencies specifically responsible for drug regulation. The DRA is organized differently, however, in different countries. In some countries, all drug regulatory functions are assigned to a single agency. In others, specific functions are performed by different organizations.

In the countries reviewed, the drug regulatory authorities:

• all belong to the government
• are all specialized agencies
• all have centralized authority
• all employ advisory boards/committees to provide technical support.

In most of the countries, a single national agency is responsible for drug regulation.

Table 5.1 summarizes the drug regulatory authorities in terms of: main regulatory authority; its legal status; existence of a central council structure; supervisory body; links with other regulatory agencies; unity of command; power to hire and dismiss staff; financial independence; performance of non-regulatory functions. The various regulatory functions and names of agencies responsible for carrying out those functions are listed in Table 5.2.

Table 5.1 Key aspects of the 10 drug regulatory authorities

• = Yes = No N/A = not applicable

Table 5.2 Agencies responsible for various drug regulatory functions in the 10 countries

• = Yes = No - = information or data not available

5.1.1 Structural arrangements for regulatory administration

The DRA is entrusted with ensuring the efficacy, safety and quality of medicines, and is expected to carry out its tasks by applying the best available scientific knowledge and skills without bias. Competent human resources, adequate financial resources and freedom from the influence of politics and the interests of individuals, groups and the public are therefore critical. A sound organizational structure, the power to acquire and use resources and to appoint and dismiss staff and determine the level of their remuneration are essential for ensuring independent and unbiased decision-making regarding drug regulation.

This section assesses the drug regulatory authorities of the 10 countries from the perspective of organizational structure, particularly organizational forms, human resources and financing.

The way a regulatory administration is organized has implications for the execution of drug regulatory functions. Two common organizational forms for a regulation authority are the commission/board format and the executive department format. These two forms differ mainly in their degree of independence in carrying out their functions.

The distinctive feature of a commission or board format is that it is headed by a number of commissioners or board members who form a non-partisan body, and typically hold fixed and staggered terms of office. The purpose of this arrangement is to insulate the workings of the regulatory commission or board from electoral politics. It provides a degree of stability and continuity in the commission or board, and protects the members from rapid changes in leadership when the partisanship of the executive or legislative branch changes. The commission or board is designated, in the public interest and in the long term, to regulate a particular sector of the pharmaceutical economy, or an aspect of pharmaceutical commerce. It should, therefore, function independently of politics.

Alternatively, the regulatory authority may be a department or division of the executive branch. Authorities of this type are headed by a director, who is appointed by the head of the executive branch or ministry. This structural arrangement allows the head of the executive branch/ministry greater influence or control over the decision-making and enforcement activities of a regulatory authority (22).

Analysis of the study reports shows that the MEB in the Netherlands and the drug regulatory authorities of Uganda and Zimbabwe are organized in a board format. The MEB, which is the main DRA in the Netherlands, is organized as a board whose members are appointed directly by the Crown. This appointment procedure makes it relatively free from the influence of other Government bodies. The MCAZ and the Ugandan NDA are also established as statutory authorities, with executive committees plus some specialized advisory committees. Although board members are appointed by the Minister of Health, their independence is established by statute.

In Cuba, Tunisia and Venezuela, the drug regulatory authorities are departments within the executive branch, the Ministry of Health, which possesses decision-making powers regarding drug regulation. Expert committees are consulted on technical issues, rather than as decision-making bodies. Under this structure, the superior agency (the Ministry of Health) theoretically has the authority to alter a decision if it chooses to do so.

The Cypriot and Malaysian drug regulatory authorities employ a mixed structure. Regulatory functions are administered through an executive department, with an additional structural arrangement in the form of a central committee, whose role is not limited to advising the authority, since it also has some decision-making powers regarding drug regulation. Generally, the main DRA serves as the central committee’s secretariat. Under such a central committee, a number of subcommittees are responsible for different regulatory areas. Additionally, advisory committees may provide scientific advice on specific issues. The appointment and composition of this type of committee ties it more closely to the executive branch than in the board format, and hence makes it less “free”.

Malaysia has the DCA, whose members are appointed by the Minister of Health. The National Pharmaceutical Control Bureau (NPCB), within the Pharmaceutical Services Division, is the secretariat to the DCA. Advisory boards are “semi-independent” structures whose chairperson is either the Director-General of Health or the Director of the Pharmaceutical Services Division. These advisory boards report to the Minister of Health.

In Cyprus, drug regulation is also organized under the Pharmaceutical Services Division. The Drug Council serves as the central committee, with the Drug Control of Quality and Supply Sector (DCQSS) under the Pharmaceutical Services Division as its Secretariat. Drug Council members are drawn from both the public and private sectors, and are appointed by the Ministerial Council.

The organizational format, however, is only one of the factors that determine the level of independence of an organization. An executive department can also be highly independent in terms of decision-making if it is invested by law with full authority. The TGA of Australia is an example of such an executive department.

The power to hire and dismiss the organization’s personnel and generate and use revenue are also important in determining an authority’s degree of independence. Because all laws have to be interpreted when they are applied to a particular case, those who are appointed to make decisions regarding drug regulation must possess discretionary powers. For example, when considering whether an application for registration of a pharmaceutical product should be accepted or rejected, a staff member of the DRA has to make a judgement about the validity and reliability of the efficacy and safety information submitted, and probably also about several other issues, before reaching a decision.

The appointment and dismissal, as well as the remuneration, of those whose decisions influence drug regulation are therefore key factors in the independence of the DRA and determine its freedom (or otherwise) from political influence.

The drug regulatory authorities of Australia, Cyprus, Malaysia and Tunisia are all organized as an executive department. The last three do not have the power either to hire and dismiss their own personnel or to determine their own financing, while the drug regulatory authorities of Australia, the Netherlands and Zimbabwe have full authority over the recruitment and dismissal of their staff, and are also self-financing. It should be pointed out that the Australian TGA is autonomous, even though it is organized as an executive department. Estonia comes close to being self-financing, with fees and charges making up 88% of its income. The Venezuelan and Ugandan drug regulatory authorities have the power to hire and dismiss their personnel, but lack the power to secure financial resources. Most of Uganda’s income comes from foreign aid-60% in 1997. This reliance on foreign sources of funds raises serious concerns about the sustainability of drug regulation in this country.

In the two countries with a federal system of government-Australia and Malaysia-drug regulatory powers are divided between the federal and the state levels. Implementing a public policy through multiple levels of government with autonomous authority requires a concerted effort between the agencies at both levels in order to attain the same regulatory objectives throughout the entire country. In Malaysia, coordination between the federal and state regulatory authorities has been created by establishing a Deputy Director of Health in each state, who reports directly to the Pharmaceutical Services at federal level. In Australia, the TGA has two committees: the National Coordinating Committee on Therapeutic Goods and the National Drugs and Poisons Schedule Committee, whose role is to ensure adequate and appropriate communication between federal and state levels.

Divided lines of command are also observable in the Netherlands and Venezuela. In the Netherlands, drug registration is undertaken by the MEB, while other activities are carried out by other institutions, including the Ministry of Health, Welfare and Sports (MoHWS). Under this type of structural arrangement, command and control regarding regulation must be exerted across different government agencies. Coordinating a multitude of drug regulatory functions to ensure that overall objectives are achieved is an enormous and sometimes difficult task. In extreme cases, such an arrangement can limit policy coherence and effectiveness, and lead to unclear accountability and failures of communication. The multiple functions across multiple agencies can be streamlined by establishing inter-agency SOPs or creating a central coordinating and supervisory body. In the former case, SOPs should be designed with the focus on the goals of quality, efficacy and safety, rather than the relative authority or existing routines of the agencies involved.

If regulatory control is fragmented among agencies, responsibilities overlap, the involved agencies have different perspectives and missions and act independently, and there is no strong and authoritative mechanism for coordinating regulatory activities at national level, regulatory power and effectiveness will suffer.

The country data also show that some drug regulatory authorities are assigned non-regulatory functions, in addition to drug regulation. In Malaysia, the Pharmaceutical Services are responsible not only for drug regulation, but also for procuring and distributing drugs and managing hospital pharmacies. Similarly, in Cyprus, the Pharmaceutical Services Division is responsible for public sector drug manufacturing and supply activities.

The fact that an authority performs multiple functions is not in itself a cause for concern, provided that there are no conflicts of interest and all the functions are carried out according to procedures and plans aimed at achieving all the authority’s objectives. Thus deviation from the normal, set course of action, for example following a change in priority among the various functions, owing to political considerations or shortage of resources, could lead to a shift in personnel and budget from one function to another, and compromise performance.

However, putting drug regulatory responsibilities and drug manufacturing and supply responsibilities under one management will undoubtedly contribute to conflicts of interest, as seen in some of the countries included in the study. For instance, in Cyprus, drugs manufactured or imported by the public sector are not subject to assessment and registration, unlike those imported or manufactured by the private sector, thus creating double standards in drug regulation.