Comment on Professor M.J. Eadie’s' editorial 'The secrecy of drug regulatory information’' (Aust Prescr 2002;25:78-9)

Recent debate about the sustainability of the Pharmaceutical Benefits Scheme (PBS) has again raised the issue of transparency of the decision-making processes of the Pharmaceutical Benefits Advisory Committee (PBAC). The excellent editorial by Professor Eadie entitled '‘The secrecy of drug regulatory information’' widens the debate about the release of information about drugs into the public domain.1

There is no question that the public has a right to know the basis on which decisions are made for the approval or rejection of a drug for marketing and subsidy. In order for those decisions to be able to be debated and discussed, full disclosure of information at the time the decisions are made is needed. Professor Eadie raises a number of critical issues which may be seen by some as barriers to such action. However, they should not be seen as insurmountable, but simply as issues which need to be addressed in the development of a strategy towards the timely disclosure of relevant information.

The PBAC is committed to the release of information regarding its decisions. This includes the reasons for both positive and negative recommendations and in addition the reasons why a drug has been recommended as a restricted or authority required benefit. It has been suggested that prescribing outside of subsidy-approved indications (i.e. leakage) is a major cause of the cost increases in the PBS. While such prescribing certainly does occur, the PBAC has never been in a position, at the time that a drug is approved for subsidy, to disclose the evidence on which decisions to include such restrictions were made or to be able to place the use of the drug in an appropriate clinical and cost-effective context. The PBAC is hopeful it will be able to initiate these reforms in the near future. However, as Professor Eadie clearly points out, there are matters of ‘'commercial-in-confidence’' which must be acknowledged and attended to, and discussion with the pharmaceutical industry is essential to address their legitimate concerns on this and other issues. Notwithstanding these concerns the overriding consideration must be the right of doctors and the public to have access to information. It is the responsibility of regulatory authorities to provide it in a manner appropriate to each stakeholder group. There is no doubt that disclosure of information will make the decision makers more accountable, but that is how it should be in a transparent system.

The saying '‘Don'’t tell me why it cannot be done but how it can be done'’ is appropriate in the context of this issue. Professor Eadie’'s comments are an excellent starting point.