5.6.1 Political influence

A distinction should be made between the different levels of political influence operating at different levels of policy. At the macro level, the body politic is regarded as representative of the public or the electorate. Hence, politics is a means by which society decides which regulatory direction is ethically acceptable, socially preferable, economically beneficial and scientifically reliable. From the perspective of representative democracy, therefore, it is desirable for politics to determine the overall legal frameworks within which drugs are regulated. But at the micro level, where decisions are made which apply those legal frameworks to specific cases, it is not desirable for politics to exert influence on individual cases.

Drug regulatory issues which provoke political interest primarily involve ethical, religious or social concerns. In Australia, two classes of drugs, abortifacients and contraceptives, generate significant political interest. But political representatives can influence drug regulation only via questions in Parliament concerning specific drugs. The power to register drugs lies with the department, not the minister, with the exception of abortifacients, which require the approval of a minister and a secretary (i.e. a head of department). In the late 1980s and early 1990s, considerable political pressure was applied to the system by HIV/AIDS lobby groups, but this has now effectively disappeared.

In Malaysia, interference from the outside, political or otherwise, regarding decisions of the regulatory authority is rare. A recent exception was the debate over the registration of sildenafil (Viagra^®), for the treatment of erectile dysfunction.

In the Netherlands, political interests are more concerned with the reimbursement system than with traditional drug regulatory functions, such as registration and inspection.

At the micro level, all the country reports maintained that political pressure has little influence, if any, on drug regulatory decisions.

The structural arrangements of the drug regulatory authorities were cited as the key factor in preventing politics from influencing drug regulation. The level of independence assigned to the DRA, a clear decision-making framework and transparency of procedures together enable the drug regulatory authorities to base their decisions on scientific factors and maintain their technical integrity.

5.6.2 Transparency and accountability

Regulation imposes restrictions upon the behaviour of certain target groups in a society, for the public good. Although the public good is a value that all societies cherish, it is not the only value which they pursue. Public policies must seek to balance collective and individual interests. Regulatory policies of all kinds are, therefore, almost always accompanied by concerns about the transparency and accountability of government actions.

In response to such concerns, mechanisms are often instituted to ensure government accountability. There is a range of “instruments of accountability” that governments can use. Peters (13) groups these “instruments” into three categories: organizational, political and judicial methods of control.

The mechanisms provided for transparency and accountability of the drug regulatory authorities in the 10 countries are listed in Table 5.7. These mechanisms are summarized below according to the group for whose benefit accountability is sought.

Industry

Information dissemination: General information regarding DRA guidelines and other matters is disseminated regularly through a newsletter (Australia) and websites (Australia, Estonia, Malaysia, Tunisia), to which the industry has full access. Specific information regarding the acceptance or rejection for registration and licensing of a particular product is given either directly to the pharmaceutical companies as feedback information, including reasons for the decisions, or published in official gazettes (Australia, Uganda, Venezuela and Zimbabwe), or on websites (Australia, Estonia).

Regular contacts and seminars: Maintenance of regular contacts between the DRA and the industry is indicated as a means of accountability in Australia, Estonia, Malaysia and Uganda.

Appeals system: An official appeals system allowing the pharmaceutical industry to voice disagreement with decisions made by the DRA exists in all 10 countries.

Membership of committees: Australia is the only country in the group with a system for including pharmaceutical industry representatives on committees which have the power to consider applications.

Consumers/general public

Only two of the 10 countries have devised specific measures for the benefit of consumers. The Australian drug regulatory system also provides for the inclusion of consumer group representatives on various drug regulatory committees. The appeals system in the Netherlands is not limited to industry, but is also open to consumers.

Table 5.7 Mechanisms used by drug regulatory authorities to ensure transparency and accountability

For the general public, the mechanisms, where they exist at all, are limited to provision of information. As described above, regulatory information is made available regularly via government gazette, reports, website or radio. In addition, clear SOPs are cited as a means of achieving transparency.

Almost all these mechanisms for accountability are limited to organizational instruments, namely publicity (through websites, reports, gazettes, radio); citizen participation (inclusion of interest groups on the committees); and internal discipline (transparent SOPs). Four countries apply a judicial control approach: an appeals system operates in Cyprus, Malaysia, the Netherlands and Zimbabwe.

Of the 10 countries, the Australian TGA has developed a relatively more explicit and comprehensive range of accountability mechanisms. Registration decisions are not made public, but recommendations of the expert committees are. In addition, a list of approved products is published in the Commonwealth Government Gazette, issued monthly. Negative decisions are not published, although they are often the subject of public debate, in the media or in Parliament. Details of numbers of applications, type, processing times, refusals, etc. are published in the Administration’s quarterly reports. These are made available on request to industry, Parliament and interested parties. The reports contain full details of all the Administration’s activities, which are audited by the Therapeutic Goods Consultative Committee. Reports are also submitted to Parliament.