For several years there have been complaints about the transparency of the Australian drug regulatory system. Pharmaceutical companies complain about the transparency of decisions to approve or reject a product for marketing or subsidy, while clinicians complain that they cannot access the data used to make those decisions.
The Pharmaceutical Benefits Advisory Committee has been working with the pharmaceutical industry to address some of these criticisms. Greater transparency of the operation of the Pharmaceutical Benefits Scheme (PBS) was also a key feature of the free trade agreement between Australia and the USA.
While the pharmaceutical industry has achieved some of its goals, much of the clinical data it provides to government remains secret. The Editorial Executive Committee believes that clinical information which could be used to help patients should not be kept as 'commercial-in-confidence'.12
In view of the pharmaceutical industry's interest in greater transparency, the Editorial Executive Committee has been inviting companies to supply the information that supported the approval of their products in Australia. This information can then be used in the preparation of the New Drugs section of Australian Prescriber and enhances the evidence base for these comments.
While there has been a range of responses (Table 1), the Editorial Executive Committee is pleased that some companies are willing to provide information for independent review. Companies have also been supplying information to assist the National Prescribing Service in preparing its RADAR review of new listings on the PBS. We hope this is the beginning of a trend which will lead to increased transparency in drug regulation.