Keynote speaker on reimbursement for new medicines

Delegates at the largest annual biotech industry gathering in the Asia-Pacific will hear about delays to new medical treatments because of the slow processing of government funding approvals. In many countries, governments pay at least part of the cost of medicines and treatments. However, there is growing concern that delays in funding decisions could mean fewer new medicines are developed in the future.

“Government funding of new medicines is key for our industry and no one disputes the fact that governments must ensure the benefits of new drugs outweigh costs before they approve public funding,” says Dr Alan Robertson, CEO of Australia’s Pharmaxis. “The problem is that in many countries this funding approval is filled with lengthy delays, uncertainty and a lack of objective measures to determine the public benefit.”

Dr Robertson will deliver the annual “Millis Oration” on the topic, at the upcoming AusBiotech conference. His company, Pharmaxis, recently obtained reimbursement for the first new cystic fibrosis treatment in over 15 years, Bronchitol, discovered and developed in Australia

“Government delays in approving funding have become a serious impediment to the introduction of new pharmaceuticals and this serves nobody well – not the patient with the disease, not the pharmaceutical company and not the government that has to pay for the treatments,” says Mr Robertson.  “These delays and the uncertainty add a lot of cost. They also mean the pharmaceutical company has a shorter time in which to recoup its investment in research and development.  Paradoxically, the extended debate about the cost effectiveness of a product actually drives up the end cost of the product.”

He goes on to say his relatively small company was left in limbo after it took more than 18 months for the Australian government to decide whether to reimburse Bronchitol. Meanwhile, the country’s internationally respected Therapeutic Goods Administration took only one year to review and approve the product as safe, effective and ready for marketing. Dr Robertson says funding decisions should be relatively easy once a product is approved for sale.

“This problem is not limited to Australia. Companies are experiencing these delays around the world. Governments are tightening belts while a new generation of medicines makes it more difficult to measure public benefit of products using out-dated approaches,” says Dr Robertson. “We need to revamp the approval process, reduce unnecessary bureaucracy and perhaps even find a way to start the process earlier. Medicine makers need some certainty and assurance they will recoup the huge investment that goes into research and development. Otherwise, we’ll see fewer investors willing to take the risks needed to create new products, leaving many patients with unmet needs. “

Dr Robertson delivers the “Millis Oration” on Thursday 1^st November at the AusBiotech conference in Melbourne. The Millis Oration was 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.