Risks associated with compounded medicines

Risks associated with compounded medicines

2 April 2024: Medicines Australia is aware of reports of compounded medications being sold to patients in place of medicines that are experiencing supply shortages.

It’s important that patients understand compounded products are ‘unapproved’ therapeutic goods and have not been evaluated by the TGA for safety, quality or efficacy. This includes compounded products purchased from pharmacies, from naturopaths and from online retailers.

The ingredients used in compounded medicines may be counterfeit or may have been illegally imported into Australia, and each formulation may differ in quality.

Medicines Australia holds strong reservations about the environment in which compounded medications are made, and the equipment specifications being at the discretion of the pharmacist or person preparing the formulation.

It is our position that all complex compounding should take place in TGA-licenced or facilities of equivalent manufacturing standards to reduce adverse events and lower the risk compounded medicines.

Patients should be aware that in Australia it is illegal to advertise prescription-only medicine to the public. This means that if you see advertising for a prescription medicine, it is illegal and may represent a counterfeit product or a scam.

In addition to safety concerns, compounded medications may infringe on the intellectual property rights of the innovator company under Australian law.

Further information about compounded medicines is available on the TGA website – www.tga.gov.au/news/safety-alerts

A Stronger PBS is needed for Australians to access future medicines showcased at Australia’s only horizon scanning forum

A Stronger PBS is needed for Australians to access future medicines showcased at Australia’s only horizon scanning forum.

22 March 2024: The innovative pharmaceutical industry has showcased new technologies and major global therapeutic advances set to enter the healthcare system in the coming years at the Medicines of Tomorrow: horizon scanning forum.

Hosted by Medicines Australia, Medicines of Tomorrow is Australia’s only horizon scanning forum that brings together government, patient groups and industry to showcase new technologies and major global therapeutic advances that stand to deliver a step change in treatment regimens and require planning for system readiness.  

This year’s forum brings together experts across four therapeutic areas where innovative new classes of medicines and treatments are on the horizon for Australians: cell and gene therapies, vaccine technology, novel antimicrobial therapies to combat growing antimicrobial resistance and digital technologies such as artificial intelligence that are impacting medicine discovery, research and development processes.

Medicines Australia CEO Liz de Somer said the innovations showcased at Medicines of Tomorrow demonstrate the urgent need for system reform and investment into the PBS so that Australian patients can access the best treatments possible, when they come to Australia.

“Today we have seen the incredible advances in medical innovation and technology led by our innovative pharmaceutical industry, and possibilities in treatment options that exist for patients today,” Ms de Somer said.  

“Cell and gene therapies can drastically change the long term outcomes for conditions that are currently considered life-limiting. This is the future of healthcare, but our system to make these therapies available at an affordable cost to patients, is not prepared.”

“Australians are missing out on world-class treatments that can drastically improve quality of life because past governments failed to adequately prepare for these treatments entering the market.”

“It is unacceptable that Australia’s out-dated systems are preventing people from accessing life-saving medicines and vaccines. Patients want change, doctors want change and industry wants change.”

“Australia needs to prioritise investment in our PBS and urgent system reform so patients can access innovative new therapies as they become available. The ripple effect of this will be improved health, wellbeing and economic outcomes, and reduced pressure on health systems.”

View the full agenda and speaker bios here – www.medicinesaustralia.com.au/horizonscanning

Implementation of PBS reforms key focus of Pre-Budget submission

Implementation of PBS reforms key focus of Pre-Budget submission

3o January 2024: Medicines Australia is calling on the Government to plan for the implementation of reforms from the current Health Technology Assessment Review in the 2024 Budget and to provide disaggregate PBS spending in the budget papers.

“Our ask of Treasury this year is very clear – commit to funding the reforms that will come out of the HTA Review to give Australians faster access to new medicines and improve transparency of PBS spending by providing disaggregate data in budget papers,” Medicines Australia CEO Liz de Somer said.

Medicines Australia supports the Government’s call for bold PBS reform to deliver equitable and timely access for all Australians to new medicines and vaccines, while encouraging the global industry to bring the latest and best medicines to Australia to address unmet patient need.  

Medicines Australia and its members have developed a three-year implementation Roadmap for HTA Reform, which outlines the steps needed to achieve reforms consistent with those proposed through the review.

“Our Roadmap offers a realistic timeframe to achieve meaningful change for patients as early as year 1, while the reforms that will require investment by Government can be rolled out in years 2 and 3,” Ms de Somer said.

“This aligns with Government’s promise of bold reform and offers pathways to enable Australians to access innovative medicines within 60 days of TGA registration.” 

The innovative medicines industry has partnered with governments over decades to ensure the continued listing of new medicines.

Industry has delivered billions in budget savings through successive Strategic agreements that are embedded in the system. The savings agreed to include: 2010 ($1.9 billion), 2015 ($6.5 billion), 2017 ($1.8 billion) and 2022 $1.9 billion). These savings were agreed in return for policy initiatives including the current HTA Review.

“PBS expenditure has grown by $3 billion over 10 years in nominal terms and has shrunk as a proportion of healthcare expenditure from 20% to 17%. Investing in the PBS reduces costs in other areas of the health system and contributes to economic productivity,” Ms de Somer said.

“After 30 years without a comprehensive review, it is time for fundamental reform of the PBS so it delivers the world’s best health, social and economic outcomes for all Australians.”

Professor John Skerritt appointed to Medicines Australia Board

Professor John Skerritt appointed to Medicines Australia Board

4 December 2023: Professor John Skerritt has been appointed to the Medicines Australia Board as an Independent Selected Director. 

“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,” Medicines Australia Board Chair, Dr Anna Lavelle AM, said.

“As a former Deputy Secretary of the Australian Department of Health and Aged Care and former head of the Therapeutic Goods Administration, John’s knowledge of the Australian therapeutics regulatory environment is unmatched.”

“This expertise is critical as Australia seeks to harness the step change in technology and ensure that Australian patients have access to new innovative therapies as they become available.”

“John’s 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.”

Prof Skerritt said he is looking forward to working closely with the industry at this transformational time. 

“It is a tremendous honour to be joining the Board of Medicines Australia as an Independent Selected Director,” he said.  

“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.”  

Prof Skerritt officially commences on Monday 4 December 2023.

Medicines Australia welcomes Government response to New Frontier report

Medicines Australia welcomes Government response to New Frontier report

Medicines Australia welcomes the Government’s response to the New Frontier report, and its acceptance of nearly all 31 recommendations, which stand to improve patient access to new medicines.

The report is the outcome of a 15-month Parliamentary inquiry into the process for bringing new medicines to Australian patients commenced in 2020 by the Standing Committee on Health, Aged Care and Sport, Chaired by former MP Trent Zimmerman and co-Chaired by Dr Mike Freelander MP. The inquiry received over 200 submissions and held more than 50 public hearings.

“Medicines Australia thanks the Government for its commitment to 26 of the 31 recommendations in the New Frontier report,” Medicines Australia CEO Liz de Somer said.

“It is clear that much relies on the HTA review and the crucial need for bold reform, with many references to the review throughout the Government’s response.”

“It is encouraging to see the Government’s continuing commitment to improving timely access to new and emerging medicines and health technologies for Australian patients, including those with rare diseases, and to improving meaningful patient engagement. These are consistent themes across submissions for the HTA review and priorities for Medicines Australia.”

“We are also pleased to note the Government’s commitment to the Strategic Agreement with Medicines Australia. Several of the recommendations are in progress through our agreement, such as the need for clear and measurable benchmarks to track the implementation of the recommendations, which will be refined in the coming months in consultation with industry and stakeholders.”

“It is our view that the current process improvement metrics do not provide adequate transparency around time to access, and this will be an important step in achieving a world class system.”

“We particularly welcome the Government’s commitment to Recommendation 30, which aligns with the industry’s objectives of the HTA review. Additionally, a labour market and skills strategy to boost capability and capacity by expanding the number of health economists within Australia aligns with Medicines Australia’s calls to strengthen the skills and capacity in the Department’s Office of HTA.”

“The HTA review is a once-in-a-generation opportunity to improve the system and ensure it can meet the needs of Australians into the future. This will require collaboration, legislative change and flexibility to accommodate new and disruptive technologies.”

“Medicines Australia and its members look forward to continuing to work with the Government, the Department and all stakeholders on these critical matters.”



Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.      

The importance of intellectual property in future pandemic preparedness: MJA Letter to the Editor

The importance of intellectual property in future pandemic preparedness: MJA Letter to the Editor

7 November 2023: Medicines Australia CEO, Liz de Somer, has joined the General Director of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Thomas Cueni, to refute calls for an intellectual property waiver on pharmaceuticals.

In response to an article published in the Medical Journal of Australia (2023; 219: 46-48), Mr Cueni and Ms de Somer penned a letter to the editor highlighting the critical role of the intellectual property (IP) framework in enabling companies to work together to develop vaccines during COVID.

“As we address the equity challenge, we must not lose sight of the innovation delivered in response to COVID‐19, with pharmaceutical companies producing billions of safe and effective vaccines and therapeutics at a speed very few thought possible,” they wrote.

“This was facilitated by a strong innovation ecosystem, which provides a framework to manage the risks and cost involved in pursuing new medicines and vaccines.”

“Of the 23 mRNA vaccines that went to clinical trials, only two were successful. The intellectual property (IP) framework is core to this ecosystem.”

Ms de Somer and Mr Cueni argue that rather than address the root causes of inequitable access, an IP waiver would undermine the very system that delivered billions of safe and effective vaccines and therapeutics against COVID‐19, and which will be central to our response to any future pandemics.

“Contrary to acting as a barrier to equitable roll out, IP enabled companies to partner on a voluntary basis. The latest data show that over two‐thirds of the 374 manufacturing and supply chain announcements for COVID‐19 vaccines have involved a collaboration — voluntary licensing partnerships, technology transfers and contract manufacturing agreements — between licensors and licensees, and of the 84 active voluntary licensing.”

“Instead, we must focus on the multilateral and regional policies needed, including regulatory harmonisation, supply chain and health care system strengthening, and the removal of trade barriers.”

The letter has been published this week in the latest edition of MJA. View article at https://onlinelibrary.wiley.com/doi/10.5694/mja2.52126


Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.        

Australian Cancer Plan recognises crucial role of pharmaceutical, biotherapeutics and vaccine industry.

Australian Cancer Plan recognises crucial role of pharmaceutical, biotherapeutics and vaccine industry.

3 November 2023: Medicines Australia welcomes Australia’s landmark national Cancer Plan, which recognises the crucial role of the pharmaceutical, biotherapeutics and vaccine industry in the prevention, detection, management and treatment of cancers.

Medicines Australia CEO Liz de Somer said the six strategic objectives in the Plan reflect the priorities called for by stakeholders including industry and she welcomed the focus on prevention, early detection and treatment and increased workforce capability.

“Medicines Australia congratulates the Minister for Health and Aged Care, Department of Health and Cancer Australia on producing this landmark Plan that recognises holistic change and collaboration is needed to end the devastating impact of cancer on our society.”

“Over the last 40 years, the pharmaceutical industry has invested significantly in the research and development of innovative new vaccines, diagnostics and therapies,” Ms de Somer said.

“This perseverance has led to a new era where genomic testing and personalised medicine are now available and improving the prognosis and quality of life of many patients.

“The Plan recognises this but it also recognises that access to early diagnostic technology and treatment options through the PBS remains the biggest hurdle for too many Australians.

“This must be addressed through HTA reforms if Australia is to have a world class health system.”

Medicines Australia welcomes the commitment to a new policy framework for genomics in cancer control and the establishment of an Australian Comprehensive Cancer Network (ACCN) to share expertise and reduce access inequity.

“We agree with the identified need in the Plan for system-wide, cross-sector, inter-jurisdictional and national collaboration,” Ms de Somer said.

“The pharmaceutical industry will continue to work closely with patients, governments, universities and other stakeholders to advance our health system for the benefit of patients, and ensure everyone has access to the right vaccines, diagnostics and treatments when they are needed.”

Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.

Medicines Australia announces new Board Directors

Three new Directors and one re-elected Director have been appointed to the Medicines Australia Board at today’s Annual General Meeting.

Anne Harris (Pfizer) was re-elected for a second 3-year term. Gabi Mittas (Amgen), Dirk Otto (Boehringer Ingelheim) and Urs Voegeli (Janssen-Cilag) were elected to fill positions vacated by Stuart Knight (Roche) who is retiring, Ashraf Al-Ouf (Bayer) who has accepted a promotion and is relocating to Singapore and James McDonnell (Vifor) who stepped down from the Board in June 2023.

MA Chair, Dr Anna Lavelle AM, welcomed the new Directors and congratulated Anne on her re-appointment at the Medicines Australia AGM today, recognising their depth of industry experience and commitment to continuing to drive reforms.

“I am thrilled to welcome our new and re-elected Directors – Anne Harris, Gabi Mittas, Dirk Otto and Urs Voegeli – who each bring unique global perspectives combined with a deep understanding of the policy challenges and political landscape that Australia’s pharmaceutical industry is facing,” Dr Lavelle said.

“As we continue to build on momentum for reforms, there are strong foundations in place to address other pressing policy issues that ultimately affect patient access to medicines and vaccines. The harmonious leadership of our Board and ability to unite the industry on shared goals during this period is critical to our success.”

“The strong position that Medicines Australia is in today is thanks to vision and leadership of our current Board, and I thank you for your dedication and drive, and extend my deepest gratitude to outgoing Directors, Stuart Knight, Ashraf Al-Ouf, and James McDonnell who have made a significant contribution during their service.”

Stuart Knight has been on the Medicines Australia Board since October 2019 and served as Chair of the Performance, Nominations and Remuneration committee and on the Independent Health Technology Assessment Board subcommittee (iHTAC).

Ashraf Al-Ouf has been a Director since February 2022 and was a member of the Performance, Nominations and Remuneration Committee and Finance Risk and Audit Committee.

James McDonnell joined the Board in October 2019 and served as a Chair of the Finance, Risk and Audit Committee.


Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.

Medicines Australia Chair appointed a Member of the Order of Australia

Medicines Australia Chair, Dr Anna Lavelle, has been appointed a Member of the Order of Australia (AM) for her significant service to science and innovation.

Dr Lavelle was named in the King’s Birthday Honours Roll in June and attended the investiture held in Melbourne on Thursday 14 September.

Over the course of her career, Dr Lavelle has contributed significantly to Australia’s medicines, research and biotechnology industries. She has been a pioneer for women in these industries, holding executive and board positions and driving innovation for the benefit of society for more than 25 years.

“Dr Lavelle has been fearless leader throughout her career, combining her extensive understanding of Australia’s medicines and biotechnology policies with deep experience in medical research. Her unwavering commitment to improving patient outcomes and quality of life is resolute,” Medicines Australia CEO Liz de Somer said. 

“Medicines Australia is extremely fortunate to have Dr Lavelle as our Chair and on behalf of the pharmaceutical industry, we congratulate Dr Lavelle on this prestigious and most deserved achievement.”

Intergenerational report: Faster access to new medicines must be part of the solution

Intergenerational report: Faster access to new medicines must be part of the solution

25 August 2023: The sixth Intergenerational Report released by Treasurer Dr Jim Chalmers highlights the need to modernise Australia’s healthcare system to sustainably meet Australia’s care and support needs into the future. 

In addition to the foreshadowed reforms to Medicare, aged care and NDIS, Australia needs a stronger PBS so that patients have faster access to modern medicines.  

“Reducing the burden of disease and improving quality of life for thousands of Australians will help to alleviate the forecast rise in hospital and MBS costs and productivity decline,” Medicines Australia CEO Liz de Somer said. 

“Over the coming decades, Australia faces a decline in productivity and increased pressure on the healthcare system driven by the realities of an ageing population and growing NDIS. This is not new information and now is the time for us as a nation to take a hold of this challenge together to drive higher levels of productivity,” Ms de Somer said.  

“Innovative medicines, vaccines and medical technologies will be a crucial part of the solution to keep people healthy, out of hospital and actively engaged in society for as long as possible.”    

“This will require our PBS to be fit for purpose to ensure Australians have access to new medicines as they become available, and to attract investment by the pharmaceutical industry into our market.” 

“Industry has done the heavy lifting needed to control PBS growth that was flagged in earlier IGRs as a concern. We have flat PBS growth and an ageing population.”  

“We need policy focus on our PBS and investment in strengthening faster access to new medicines today, to better position Australia for the next 40 years.”  

Medicines Australia and the pharmaceutical industry will continue to work with Government to strengthen the PBS and realise the productivity benefits of access to innovative medicines. 



Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.