New guidelines will impact innovation

Latest News

New innovation minister Greg Hunt should request a briefing on the revised PBAC guidelines according to Dr Phil Kearney, Director of Licensing and External Research for MSD Australia.

Writing in Australasian BioTechnology, Dr Kearney proposed a 100-day action plan for Mr Hunt, who was sworn in as Minister for Industry, Innovation and Science earlier this week, including an international investors forum, active support for clinical trials reform, and implementation of the recommendations of the TGA review.

"MSD and other innovative pharmaceutical companies are actively involved in translational research, clinical development and commercialisation in Australia. Together, innovative pharmaceutical companies invest more than $1 billion in Australian research and development, employ 14,000 Australians directly, and underwrite thousands more jobs in universities and research institutions.

"The industry is well placed to support the deeper integration of Australian science into global markets, as well as the significant employment and economic benefits that this will generate. There has never been a more exciting time to be involved in biotech research, commercialisation and policymaking, and the industry minister will play a critical role in facilitating the relationships and reforms that will help the sector reach its full potential," he said.

In relation to the PBAC guidelines, Dr Kearney said the minister should request a briefing because they "include new provisions that could seriously compromise the valuation of innovative therapies, significantly reducing the incentive to bring new medicines to market in Australia."

Industry has raised a number of objections to the new guidelines, particularly in relation to comparators, with the revised guidelines proposing a more explicit approach to using the lowest cost therapy as the main comparator. The current guidelines give more discretion in the choice of comparators.

"These provisions have implications that go well beyond the health portfolio, and need whole-of-government consideration," said Dr Kearney.