PhD title: Encouraging the regulatory evaluation of off-patent repositioned medicines in Australia
Katrina is currently Director, Practice Support and Quality Section, Primary Care Division at the Department of Health, Disability and Ageing. Her responsibilities include management of the Practice Incentives Program which aims to support general practices to deliver quality care, enhance capacity and improve access and outcomes for patients. Prior to commencing her doctoral studies, Katrina’s roles included helping patients with rare, life-threatening conditions to access effective treatments; improving the sustainability of future PBS drug supply via pricing reviews; increasing patient access to new and expanded pharmacy programs and protecting public health through the scheduling of medicines and poisons. Prior to joining the department in 2010, Katrina worked on clinical trials for pharmaceutical companies both nationally and internationally.
Katrina’s thesis proposed a novel policy framework specifically designed to incentivise evidence generation, application submission and revenue generation to encourage the evaluation of off-patent repositioned medicines by the Therapeutic Goods Administration (TGA). It has the potential to improve affordable patient access to safe and effective off-patent repositioned medicines in Australia and improve the quality use of medicines and alignment with broader National Medicines Policy (NMP) objectives.
Background: Australia's NMP aims to ensure medicines meet agreed standards of quality, safety and efficacy. This is achieved when a prescription medicine is evaluated by the TGA to ensure benefits outweigh risks prior to approval. The use of a prescription medicine beyond approved limits is known as off-label use. Medicines prescribed off-label for different health conditions, usually due to a lack of effective approved treatments, are known as repositioned medicines.
Howe K, Bourke S, Sansom L (2021) 'The extent to which off-patent registered prescription medicines are used for off-label indications in Australia: A scoping review', PLoS ONE, 16(12): e0261022. https://doi.org/10.1371/journal.pone.0261022
Emily Pugin is a Kombumerri woman from the Gold Coast, Queensland. She joined the Department of Foreign Affairs & Trade (DFAT) in 2013 and has worked across Australia’s foreign policy, international development, multilateral and trade portfolios. Most recently, Emily was posted as a diplomat to Australia’s Permanent Mission to the United Nations in Vienna, Austria, where she had a range of multilateral and bilateral responsibilities to advance Australia’s interests. Emily lead Australia’s engagement at the UN Office on Drugs and Crime where she negotiated international drugs policy and represented Australia at the Organisation for Security and Co-operation in Europe, which covers a range of global security issues. Emily has also managed Australia’s bilateral relationships with Bosnia and Herzegovina, Kosovo and Slovakia. Emily is undertaking a Master of Public Policy at ANU’s Crawford School and will return to DFAT upon completion to further her contribution to the development and implementation of Australia’s foreign policy.
The Sir Roland Wilson Foundation is a partnership between The Australian National University, Charles Darwin University and the Australian Public Service.
