Singapore: A prominent healthcare industry leader sounded the alarm over Australia's system for approving government funding of new drugs. Dr Alan Robertson, CEO of Australian-based Pharmaxis, highlighted that delays and uncertainty around public funding for new treatments could leave patients without the medicines they need.

Australia's Therapeutic Goods Administration (TGA) is responsible for determining if products are safe and effective. Once they have been approved, another body called the Pharmaceutical Benefits Advisory Committee reviews the products for listing on the Pharmaceutical Benefits Scheme. Medicines costing more than $10 million a year must also be approved by the cabinet.

Dr Robertson said that, "Government funding in Australia and many other countries is critical to the success of a new product, however, the approval system is in need of reform. The process is filled with uncertainties, lengthy bureaucratic delays, red tape and a lack of objective measures to determine the public benefit of a new treatment. There is no absolute truth in these funding decisions, only opinion and mathematical models that rely on inherently uncertain inputs."

Dr Robertson will speak about the problem when he delivers the "Millis Oration" at the upcoming AusBiotech conference in Melbourne, during the beginning of November. The Millis Oration is named after Emeritus Professor Nancy Millis, a pioneer of Australian biotechnology, who passed away recently. Professor Millis has been described as the First Lady of Australian biotechnology for her work in fermentation and appeared on a postage stamp as one of five Australian legends.

He also pointed out that even with the strengthening of safety regulations in recent years, regulatory approvals are relatively streamlined and clear compared to the reimbursement approval process. He said that obtaining funding, ironically, has now become the most cumbersome part of bringing a new drug to market.