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

Medicines Australia, which represents the prescription medicines industry in Australia, welcomes discussion on transparency of the evaluation process for new medicines.

Medicines Australia wrote to the Therapeutic Goods Administration (TGA) earlier this year suggesting the establishment of an industry/TGA project team to look at the evaluation process, including the issue of transparency. While the terms of reference for that project team are yet to be established, it is anticipated that consumers will have representation on that team. The project team is expected to consider the level of information that could potentially be made publicly available, the depth and detail of that information and the timing of the release of that information

Caution should however be taken in making direct comparisons with the types and level of information available to consumers in the USA. The evaluation systems that give rise to the release of the minutes of expert committee reports in the USA vary from those in Australia on some key issues. For example, the evaluation of a new product in the USA includes a public hearing which both the public and the applicant are invited to attend. In Australia, the Australian Drug Evaluation Committee (ADEC) considers applications in closed sessions. Natural justice suggests that companies should have the opportunity to respond to the issues raised by the ADEC before the minutes are disclosed.

With respect to the release of pharmacological and clinical data, it should be noted that Article 39.3 of the World Trade Organization Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), to which Australia is a signatory, states that:

Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

That said, Medicines Australia is currently considering the establishment of a Clinical Trials Register, similar to those established in the USA, whereby healthcare professionals, and members of the general public, can be made aware of the existence of clinical trials in certain disease states. While the availability of the results of those trials, both positive and negative, is also a consideration, Medicines Australia concurs with Professor Eadie's statement that this could undermine the publication, by the principle investigator, of these results in scientific journals and the like. This is a matter that needs to be discussed with the scientific community.

On the broader issue of transparency of the Pharmaceutical Benefits Advisory Committee (PBAC), Medicines Australia concurs with comments of Dr John Hewson, who is also President of the Arthritis Foundation of Australia, who recently said in the Australian Financial Review, 'Our Pharmaceutical Benefits Advisory Committee process needs to be much more transparent as to why a drug is or is not recommended for listing'.

The decisions of the PBAC affect the quality of life of millions of Australians. Therefore it is clearly in the best interest of doctors, patients and the general public to ensure absolute transparency for the operations of the PBAC. This should include all aspects of its operations and include peer review.

And consistent with other government administrative actions, the decisions of the PBAC should be subject to appeal and review by the Administrative Appeals Tribunal.

Alan H. Evans

Chief Executive, Medicines Australia, Canberra

M.J. Eadie

Emeritus Professor, Department of Medicine, University of Queensland, and

Former chairman, Australian Drug Evaluation Committee