n mid-2023, Professor Tony Lawler succeeded Professor John Skerrit as Deputy Secretary, Health Products Regulation Group (HPRG), Australian Government Department of Health and Aged Care, leaving his position of Chief Medical Officer of the State of Tasmania, Australia.
Tony’s responsibilities include the Therapeutic Goods Administration (TGA), the Office of Drug Control, the Office of the Gene Technology Regulator, and the Australian Industrial Chemicals Introduction Scheme.
Professor Lawler is a specialist emergency physician, specialist medical administrator, and public service leader. He has delivered front-line emergency care, emergency medicine leadership, hospital-based medical administration, and system-wide clinical and quality governance. He has been deeply involved and committed to professional engagement and leadership through roles with the Australasian College for Emergency Medicine (President), the Royal Australasian College of Medical Administrators (Board member), and the Australian Medical Association (Branch President and Federal Councillor). His experience in the application of regulatory and standard-based frameworks includes regulatory oversight of private health service establishments, accreditation of specialist training organizations with the Australian Medical Council, and membership of the Board of the Australian Commission on Safety and Quality in Health Care. He has been active in jurisdictional representation on broad policy initiatives, including the Council of the National Health and Medical Research Council, the Medical Workforce Reform Advisory Committee, and the Jurisdictional Advisory Committee of the Australian Health Practitioner Regulation Agency (Ahpra).
His career has been characterized by his enthusiastic leadership and support for a solid, stable, innovative policy, regulatory, and cultural environment to support high-quality healthcare that is delivered by empowered clinicians and other healthcare workers so that the health and well-being needs of Australia are met.
Professor Lawler was pleased to respond to questions about himself and his plans for TGA in the following interview.
DIA: What attracted you to taking on this significant position as head of TGA?
Tony Lawler (TL): Who wouldn’t jump at the opportunity to lead a recognized, understood, and valued national regulator? Moving into a senior role with the Commonwealth Department of Health and Aged Care is a great step, and while I recognize it isn’t everyone’s cup of tea, I have loved moving back to Canberra, where I grew up.
I am genuinely delighted to be here and working with the TGA and broader HPRG team. In my first 10 months in the role, I already have a strong sense of the enormous breadth and depth of the work being undertaken by the TGA and the professionalism of staff who are proud to provide a world-class regulatory system that helps protect the health of Australians.
DIA: What previous roles and experiences will be of most benefit in your new role?
TL: Probably all of them! Certainly, my clinical and health system experience as a practicing emergency physician in a tertiary hospital will be invaluable, as will my time as a specialist medical administrator in both hospital and state health system roles.
I’ve been fortunate to have broad experience in standards and accreditation with the Australian Medical Council, professional representation work with both medical colleges and the Australian Medical Association, safety and quality work with the Safety and Quality Commission, and also research governance and policy work on the NHMRC Council.
I also think my most recent role as Tasmanian Chief Medical Officer will help me in navigating complex stakeholder environments to enhance our regulatory role.
DIA: What are the biggest challenges facing TGA?
TL: The scientific world is rapidly evolving, and with it comes new health challenges and emerging technologies. This past year alone, we’ve seen innovations in cellular and gene therapies, advances in AI-driven diagnostics and decision support, and the continuous evolution of pharmaceuticals. As the regulatory body responsible for ensuring the safety and efficacy of these therapeutics and medical devices in Australia, the TGA understands the vital role that up-to-date scientific knowledge plays.
The challenge for regulatory agencies like ours isn’t merely to keep pace with the science. It’s to be ahead of it. That is why gatherings with our international analogs and other meetings with our regulatory colleagues, where the best minds in regulatory science come together, are invaluable. It offers us a platform to share insights, update best practices, and collectively define the future trajectory of our field.
We are also currently exploring issues about compounding practices and off-label prescribing, particularly in respect of their impact on shortages, safety, and quality. This falls into broader concerns we have in relation to the current regulatory framework for these practices.
The regulatory reforms on vaping are a significant focus for us at the moment and have the potential to drive significant public health improvement.
DIA: Have the TGA’s regulatory reforms around vaping raised interest amongst other regulatory authorities who have not introduced similar changes?
TL: In traveling and meeting with international colleagues last year, the issue of the rise in vape use came up frequently. We are seeing some similar moves in other countries, such as the banning of single-use disposable vapes, but the Australian approach of a prescription model of regulation is generating interest among other regulators.
DIA: What are your priorities for the organization?
TL: Our ongoing work on the government’s vaping reforms: An enormous amount of effort has gone into this crucial work with hugely important public health impact.
Continuing the suite of medical device reforms, which are based on an Action Plan for Medical Devices, and are an element of a three-part strategy to strengthen Australia’s regulatory system, whilst continuing to be patient-focused and have greater transparency and increase public confidence in Australia’s medical device regulatory system.
Our continuing efforts to implement digital transformation to deliver modern tools and digital platforms are also a key focus, including introducing a contemporary online business portal and case management system. This will make it faster and simpler for the therapeutics sector and our staff. The TGA’s activities and priorities will be to enhance our commitment to regular and multifaceted stakeholder engagement, to drive continuous improvement, and to better understand the impacts of our regulatory actions.
DIA: How do you feel the collaboration on registration of medicines and devices with other national regulatory agencies is proceeding?
TL: In an increasingly interconnected world, no one regulatory authority can address all the challenges of therapeutic goods regulation on their own, and it is important that regulators continue to work together to develop a way forward.
I am proud of the work TGA does with our international colleagues through collaborative mechanisms like the International Coalition of Medicines Regulatory Authorities (ICMRA), the International Medical Device Regulators Forum (IMDRF), and Access. This work helps to ensure that Australia continues to be a mature regulator from a global perspective, with a robust regulatory framework that aligns with international best practices and ensures the safety and efficacy of therapeutic goods available to the Australian public.
I also enjoy the strongly positive collaborative arrangement we have with other regulatory bodies such as the Australian health practitioner regulatory agency (Ahpra), the professional Boards, and our State and Territory colleagues.
DIA: What is the next direction for TGA to pursue with ICMRA?
TL: We had an incredibly successful ICMRA Summit in Melbourne last year. Delegates enjoyed engaging and provoking sessions on artificial intelligence and machine learning, the evolution of clinical trials, and advanced medical products.
Our ongoing engagement with our colleagues in ICMRA will continue to bear fruit and will support the key elements of the TGA’s international engagement strategy, including global regulatory policy alignment, pre-market collaboration, and post-market global monitoring.