Australia launches new medicines road map and substitution policy

Home/Policies & Legislation | Posted 12/03/2021 post-comment0 Post your comment

The Australian Government has launched a Medicine-Medical Product Manufacturing Road Map and new legislation to support medicine substitutions.

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The Australian Government’s Department of Industry, Science, Energy and Resources announced the launch of the Medicine-Medical Product Manufacturing Road Map on 2 March 2021. The road map aims to strengthen Australia’s manufacturing capability and is part of six priority manufacturing areas that the Australian Government has identified as requiring strategic investment.

Within the medicines’ priority area, the government has identified five areas of opportunity for growth. These include medical devices, high value-add medicines, cutting-edge treatments, digitally integrated products and platforms, and animal health.

In the area of high‑value pharmaceuticals, biologicals and complementary medicines, the government acknowledges that ‘generic pharmaceuticals and biosimilars command lower profit margins’. Therefore, ‘investing in highly efficient and automated facilities could offer Australia some opportunities to manufacture certain generics and biosimilars which are particularly complex products’.

The Generic and Biosimilar Medicines Association (GBMA), the representative body of generic and biosimilar medicine suppliers in Australia, applauded the initiative. Board member of the GBMA founding Chair of the largest Australian-owned pharmaceutical company, Arrotex, Mr Dennis Bastas, said that although ‘medicine manufacturing has long been a sector slowly disappearing from our shores’ … with advanced technology, innovation, the right policy levers, funding and industry’ … there will be ‘a vibrant and burgeoning home-grown, export-driven pharmaceutical sector develop again’. GBMA CEO, Ms Marnie Peterson, said that ‘this roadmap recognises that Australia needs to build its own sovereign medicine manufacturing capability whilst ensuring patients can still access a reliable and resilient global supply chain of medicines’. She added that the GBMA is looking ‘forward to working closely with the government in ensuring both outcomes can be achieved to the benefit of our economy and our citizens’.

Then on 5 March 2021, Australia’s drug regulator, the Therapeutic Goods Administration (TGA) announced that new legislation has been passed to allow pharmacists to substitute a different medicine when a patient's usual medicine has been declared to be in ‘serious scarcity’. The new law formalizes the Serious Shortages Substitution Notices (SSSNs) that have been in operation since May 2020 and removes the need for each SSSN to be recognised in individual state and territory legislation before pharmacists can make the substitution.

Related articles
Switching from biologicals to biosimilars in Australia

Biosimilars in Australia – a-flagging and sustainability


To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.



Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

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Source: Australian Government, GBMA, TGA

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