Around The Globe

Down Under, Changes at the Top
Perspective on the Fast-Tracking of Drug Approvals

Richard Day
Professor of Clinical Pharmacology
University of New South Wales
St. Vincent’s Hospital


ustralia has got into the habit of discarding Prime Ministers with excessive enthusiasm over the past eleven years, with Mr. Scott Morrison being the seventh to lead the country during this period. The Health Minister responsible for the TGA, Greg Hunt, returns to this position which suggests that medicines policy might remain fairly “static,” but significant changes in the pharmaceutical industry have occurred.

Released this past May, the National Medical Technology, Biotechnology and Pharmaceutical growth plan (MTP), part of the National Health and Medical Industry plan, profiles the sector and its outlook to 2030. Highlighted was the economic growth potential, with this industry now accounting for seven percent of the economy, 14 percent of the workforce, and 20 percent of the Commonwealth’s financial outlays. Forecasts include a fourfold increase in the drug, device, and therapeutic industries; 200 more MTP companies; 28,000 new highly skilled MTP jobs, half of which will be associated with research; and the country becoming a global market leader in clinical trial provision.

This upbeat assessment nicely aligns with Medicines Australia (MA), the Association of prescription pharmaceuticals companies, and its welcome appointment of one-time geneticist Anna Lavelle as the first independent Chairman of its Board in August 2018. Lavelle had been the first independent Board member when she joined it 18 months ago. The first woman to hold this position, Anna Lavelle is extremely well-known and connected in pharmaceutical circles having served as an outstandingly effective Chief Executive of AusBiotech. Lavelle was named “among the 100 most influential people in global life sciences, as determined through nominations and selections from an international panel of experts and peers” in the 2015 Scientific American Worldview: A Global Biotechnology Perspective. She was the only Australian to make that list. While at AusBiotech, Lavalle promoted the highly successful and landmark reform supporting innovation, viz., the Research and Development (R&D) Tax Incentive. Upon her appointment, Lavelle said, “[…] MA [has] a unique opportunity to demonstrate the value of the pharmaceutical sector to the broader economy and to the delivery of health outcomes. It is an exciting time in healthcare as hard won and highly effective breakthrough treatments are challenging how we view healthcare delivery.” She teams up with the new MA CEO, Liz de Somer, appointed in June 2018 with an outstanding track record in public health policy and advocacy in the pharmaceutical sector. Together, this is a formidable team working for better outcomes for all stakeholders across the health sector but with their particular focus on pharmaceuticals.

With respect to drug approvals in Australia, Paul Kubler, clinical pharmacologist and rheumatologist from Brisbane, Queensland, has written a useful update on the state of fast tracking approvals of new drugs in Australia and globally, published this month in Australian Prescriber, a highly regarded “independent peer-reviewed journal providing critical commentary on drugs and therapeutics for health professionals.” The TGA announced its Provisional Registration Process in March this year and it builds upon the experience of FDA, Health Canada and EMA. Kubler highlights the critical balance between faster access and the downside of less confidence in the safety of a provisionally registered new medicine, and calls for “improving the scientific rigor of post-marketing information to track effectiveness and safety outcomes,” a matter identified as a global concern. This is a conceptual model to assist policy makers dealing with the challenging ethical and policy issues raised by these ‘’accelerated access programmes.”

Meanwhile, Australia is in the grip of a very serious drought affecting the Eastern and Southern parts of the country, not auguring well for the bushfire season as summer approaches.