here has been a contentious debate about nicotine vaporizers (vapes) in Australia. On one hand, the use of nicotine vapes registered as therapeutic goods as an aid to quitting cigarette smoking is accepted. However, this use required a prescription from a general practitioner and dispensing from a chemist, adding to the product cost.

However, to no one’s surprise, an avalanche of unregistered vapes containing variable amounts of nicotine and a wide range of other substances has tumbled into Australia and has unfortunately been taken up most enthusiastically from convenience stores by adolescents and young adults.

Following much debate and consultation, and in specific response to significant concerns for these consumers and their potential to develop nicotine addiction and lung and other injuries, multiple laws have been or are about to be enacted to:

1. Ban importation of disposable vapes
2. Restrict access by requiring prescriptions for therapeutic vapes used for smoking cessation and nicotine-dependence management
3. Monitor compliance with relevant product standards prior to importation or release of domestically manufactured vapes.

As of 1 March 2024:

1. Importation of all vapes without an import license and permit from the Office of Drug Control will be banned.
2. Personal Importation Scheme for vapes (an exemption for travelers bringing a small quantity of vapes into Australia) will be banned.
3. Quality requirements for therapeutic vapes for smoking cessation, including restricting flavors to mint, menthol, and tobacco, will be upgraded.
4. A new medical device standard for therapeutic vaping devices that were previously excluded from the therapeutic goods framework will be introduced.

Minister for Health Mark Butler announced that the government will introduce a bill into Parliament early in 2024 that seeks to “impose a domestic ban on the manufacture, supply, advertising, and commercial possession of disposable vapes, and non-therapeutic vapes to ensure comprehensive controls across all levels of the supply chain.” How well the reforms serve the twin aims of reducing the risks of addiction amongst adolescents and assisting nicotine-addicted smokers in quitting remains to be seen. The Therapeutic Goods Administration (TGA) website offers a useful Vaping Hub to educate and inform on this challenging matter.

John Skerritt Appointed to Board of Medicines Australia

Recently retired head of TGA (and regular Global Forum contributor) Professor John Skerritt has been appointed to the board of Medicines Australia as an Independent Selected Director. John’s appointment was welcomed by Medicines Australia Board Chair Anna Lavelle, who said: “I am delighted to announce Professor John Skerritt will be joining the Medicines Australia Board to provide strategic leadership, informed by decades of government experience, at a pivotal time for the pharmaceutical industry.” Lavelle pointed out that “John’s knowledge of the Australian therapeutics regulatory environment is unmatched,” and forecast that his “deep understanding of government, and policy development and implementation, will be invaluable as Medicines Australia builds on the work undertaken to date with the Government on the reforms needed to speed up patient access to new medicines.” Skerritt commented that “The ability of innovative medicines to positively impact the lives of so many Australians drove me to choose this area as my university major some 45 years ago. Now, in the same way over, it has been rewarding for me to support patient access to innovative medicines through leadership of Australia’s regulator over the last decade. I now look forward to working with Australia’s top leaders in the sector through this new Board role.” (We also look forward to new Global Forum contributions as he settles into this new role.)

ACTA Trial of the Year

In 2023, the Australian Clinical Trials Alliance (ACTA) had another outstanding year pursuing its mission: “Promoting cost-effective healthcare in Australia through investigator-initiated clinical trials and Clinical Quality Registries that generate evidence to support decisions made by health practitioners, policymakers and consumers.” ACTA and its members, member organizations, programs, and products present significant opportunities for high-quality, cost-effective, collaborative international partnership projects to advance healthcare quality (see ACTA Annual Report).

An annual highlight is the hotly contested ACTA “Trial of the Year,” awarded to the TEAM trial (Trial of Early Activity and Mobilisation) for 2023. A multicenter, multinational, and multidisciplinary randomized controlled trial, TEAM tested whether early mobilization, which had been widely advocated and practiced based on limited evidence but incorporated in most global clinical practice guidelines, countered the muscle weakness and wasting, longer hospitalization, higher mortality post-discharge, and poorer functional recovery associated with immobilization accompanying mechanical ventilations. Led by Chief Investigator Carol Hodgson, the TEAM collaborators (perhaps counterintuitively) found no difference in the number of days patients were alive and out of the hospital with early active mobilization compared to usual care mobilization, but patients who received early activity were more likely to experience adverse events. Professor Hodgson noted: “Millions of dollars per year are now being saved in healthcare costs across Australia and New Zealand alone, and the risk of harm to critically ill patients has been reduced.”