Media Releases – Medicines Australia

Radiopharmaceuticals An Important Focus for Medicines Australia

Radiopharmaceuticals An Important Focus for Medicines Australia

13 June 2025: Medicines Australia is building an increased focus on the policy environment to support the provision of safe and effective patient access to advanced radiopharmaceuticals with the creation of an expert interest group drawn from across its membership. The organisation is currently calling for expressions of interest among member companies to become part of this priority group which will formally come together in July.

The development and availability of advanced radiopharmaceuticals is an evolving and exciting area in the treatment of cancers – notably where a specific biomarker is present. The cancer types where innovative radiopharmaceuticals can offer an important and effective treatment option include prostate cancer, neuroendocrine cancers and lymphoma. There are currently very few innovative radiopharmaceuticals approved by the Therapeutics Goods Administration (TGA).

“As this area gains momentum, Medicines Australia believes the application of a clear regulatory framework, coupled with appropriate Health Technology Assessment (HTA) practices, is essential, and must apply the same rigour and assessment of high-quality clinical evidence to safeguard patients that is required for other pharmaceuticals,” said Sue MacLeman, Chair, Medicines Australia.

The requirements Medicines Australia will assert for include evaluation by the Therapeutics Goods Administration for quality, safety and efficacy and a transparent, evidence-based assessment of cost-effectiveness to support reimbursement on the Pharmaceutical Benefits Scheme (PBS).

“This Medicines Australia working group will look at the parameters required to provide access to these advances that meet strict regulatory requirements and ensures safety and quality remains our top priority for the patient community,” Ms MacLeman said.

“It is critical we explore how to get these cancer treatments to patients whilst meeting high regulatory standards. While historically unapproved medicine pathways have been applied, this is no longer necessary or appropriate. We look forward to a collaborative and productive interaction with Government to form a considered and efficient path forward,” she added.

For further information the Medicines Australia Position Paper on Radioligand therapies – is available here (PDF).

Media enquiries to: Anne-Marie Sparrow, Medicines Australia /Cube – media@medicinesaustralia.com.au or 0417 421 560

About Medicines Australia

Medicines Australia leads the research-based pharmaceutical industry of Australia. Our members discover, develop and manufacture the medicines that are the foundation of a healthy and prosperous society, including prescription pharmaceutical products, biotherapeutic products and vaccines. Our members invest in Australian medical research and take local discoveries and developments to the world.

Medicines Australia congratulates Health Minister and ministerial team

Medicines Australia congratulates Health Minister and ministerial team

12 May 2025: Medicines Australia congratulates the Hon. Mark Butler MP on his reappointment as the Minister for Health and Ageing and for adding the portfolios of Disability and the National Disability Insurance Scheme to his remit. Minister Butler MP can now fix what he acknowledges as a “clunky” Health Technology Assessment (HTA) system and strengthen the Pharmaceutical Benefits Scheme (PBS) for future generations.

CEO of Medicines Australia Elizabeth de Somer welcomed the reappointment of Minister Butler, noting his deep understanding of the complexities of the health portfolio including the PBS and the medicines industry.

In welcoming the appointment, Ms de Somer emphasised Minister Butler’s public commitment, in this term of Government, to deliver faster access to medicines, vaccines, and treatments by modernising our PBS. “Minister Butler’s constructive leadership over the past term has laid important groundwork for bold and forward-looking reforms that will set the course for world’s best health care for future generations.”

“Reform of the PBS must be the priority. Science and medicines have evolved significantly in the 30 years where no meaningful reform has occurred. The system is no longer fit for purpose and patients are waiting too long – on average 466 days when elsewhere in the world the wait may be as low as 60 days.”

“It is now more than two and a half years since the HTA review commenced and more than six months since its recommendations landed. Delays in accessing new medicines through the PBS are profoundly impacting patient lives.”

“Australians have waited long enough – the time for action is now and we look forward to working with Minister Butler to deliver all the commitments made under the existing Strategic Agreement and commence active implementation of the HTA Review.”

Medicines Australia welcomed the continuity in the Government’s senior economic team and congratulated other Ministers in the broader health and life sciences portfolios: Rebecca White, Assistant Minister for Health, Indigenous Health and Women; Tim Ayres, the Minister for Industry, Innovation and Science; Andrew Charlton, Assistant Minister for Science and Technology; and Dan Repacholi, Special Envoy for Men’s Health. Medicines Australia will seek meetings with these Ministers at the earliest opportunity to discuss the way forward to improve the health of all Australians.

“Medicines save lives and improve lives. Investment in the health of all Australians means better outcomes for our society, our economy, and our overall health and wellbeing. We look forward to working with the Government’s health, life sciences, industry and economic teams to ensure 2025 is a year of HTA implementation action so Australian patients can access life changing new medicines when they need them,” Ms de Somer said.

Media enquiries to: Anne-Marie Sparrow, Medicines Australia /Cube – media@medicinesaustralia.com.au or 0417 421 560

About Medicines Australia

Medicines Australia congratulates Labor Government on its re-election

Medicines Australia congratulates Labor Government on its re-election

04 May 2025: Medicines Australia congratulates the Hon. Anthony Albanese MP and the Australian Labor Party on their return to Government.

The return of the Labor Government presents a significant opportunity to realise bold, forward-looking reforms to strengthen the PBS by delivering on the agreed improvements to our health technology assessment (HTA) system.

Medicines Australia CEO, Elizabeth de Somer, said today that “Strengthening the PBS through implementation of the health technology assessment (HTA) reform recommendations will ensure Australians see faster access to safe and effective, innovative medicines.

“Active Australian-led reform of the PBS must be the priority. Science and medicines have evolved significantly in the last 30 years where no meaningful reform has occurred. The system is no longer fit for purpose and patients are waiting too long – on average 466 days when elsewhere in the world the wait may be as low as 60 days.”

“Patients, clinicians, the medicines industry and government are all aligned on the need for reform. The blueprint is sitting on the desk of the Hon Mark Butler MP, and now with the election out of the way, we need to get on with it.

Prior to the election, Health Minister Mark Butler restated the Government’s commitment to delivering all the commitments made under the existing Strategic Agreement, confirming that progress on the HTA Review is a high priority.

“I welcome the Government’s ongoing commitment to HTA reform. Medicines Australia will work with the Health Minister to ensure this is an early term priority of the re-elected Albanese Government,” Ms de Somer said.

Media enquiries to: Anne-Marie Sparrow, Medicines Australia /Cube – media@medicinesaustralia.com.au or 0417 421 560

About Medicines Australia

Medicines Australia appoints communications director

Medicines Australia appoints communications director

28 April 2025: Medicines Australia is pleased to announce the appointment of Rachael Coghlan as Communications Director and a new member of the Medicines Australia Executive Team.

Rachael Coghlan is an award-winning, cultural sector leader with a track record of success across the full suite of strategic, multi-channel communication initiatives in public, community and membership environments.

As an experienced executive, board director and researcher Rachael has executed carefully designed strategic renewal and engagement programs in complex environments. She led the strategic transformation of Parliament House’s public engagement, implementing an ambitious program of retail strategy (instore and online), visitor services, events, and collaborations to maximise attendance, revenue and public benefit.

She also brings experience in membership organisations as CEO of Craft ACT (Australia’s longest, continuous-running visual arts membership organisation). A new strategic plan, expanded communications, and strong governance transformed the organisation with financial security, increased relevance and value, and expanded engagement.

“We are thrilled to welcome Rachael to the Medicines Australia team and have someone of such a high calibre to bring a new emphasis to our strategic communication campaigns. As the momentum now builds on our HTA Reform priorities having the best strategic communications capabilities within our organisation is imperative,” says Liz de Somer, CEO Medicines Australia.

Rachael has built a reputation as a trusted, professional and innovative collaborator with professionals, educators, industry and government. She gained her PhD from the Australian National University, and her thesis received an Australian Museums and Galleries Association National Award for Research.

“It’s a great privilege to be joining Medicines Australia and working at such a critical time with the organisation’s members to ensure Australians have access to the latest medicines through the PBS,” adds Rachael Coghlan.

“Progressing the early success of the #strongerPBS campaign will be an extremely rewarding and immediate priority.”

Rachael continues to support the arts as Deputy Director of the Cultural Facilities Corporation overseeing the Canberra Theatre, Canberra Museum and Gallery and ACT Historic Places.

She will report to CEO Liz de Somer and commenced in the role on 28 April 2025.

Media enquiries to: Anne-Marie Sparrow, Medicines Australia /Cube – media@medicinesaustralia.com.au or 0417 421 560

About Medicines Australia

Medicines Australia appoints senior policy leader

Medicines Australia appoints senior policy leader

15 April 2025: Medicines Australia is pleased to announce the appointment of Dr Melanie Shakespear to a newly created senior leadership role, strengthening the organisation’s policy capacity and executive team.

Dr Shakespear brings a unique blend of scientific expertise and public service leadership to the organisation, with a career spanning immunology research and national health policy development.

As a new member of the Medicines Australia Executive Team, Dr Shakespear’s appointment reflects a strategic investment in the organisation’s policy capability, together with increased capacity to respond to the evolving needs of the sector and the Australian community.

Dr Shakespear began her career as a research scientist in both the UK and Australia, earning her PhD in Immunology from the University of Queensland. She later took up an inaugural Australian Science Policy Fellowship, applying her scientific expertise within the Department of Health and Aged Care in Canberra.

Her extensive experience includes leading health policy and program work across national research funding priorities, access to COVID-19 vaccines and treatments, and reform of Australia’s newborn screening programs.

“Melanie brings a unique perspective and proven leadership in public health policy, and we are thrilled to welcome her to our Executive Team at such a critical time for the sector,” said Medicines Australia CEO, Liz de Somer.

“This appointment reflects our commitment to bolstering our strategic capability with deep scientific knowledge and policy expertise,” she added.

Dr Shakespear said “I’m looking forward to bringing together my two passions in this great role: promoting the power of innovation and science and its contribution to life changing medicines – and developing evidenced based policy to deliver meaningful outcomes for patients.

“It is an exciting time to join Medicines Australia with health technology assessment reform on the horizon, a challenging geopolitical environment calling for greater sovereign capability and the opportunity to put forward new policy ideas with an incoming Government”, said Dr Shakespear.

Dr Melanie Shakespear will commence in the role on 22 April 2025.

Media enquiries to: Anne-Marie Sparrow, Medicines Australia /Cube – media@medicinesaustralia.com.au or 0417 421 560

About Medicines Australia

Australia’s PBS cemented in our healthcare system

Australia’s PBS cemented in our healthcare system

03 April 2025: Speculation about the United States (US) Administration’s views on the Pharmaceutical Benefits Scheme (PBS) has reconfirmed the sanctity of the PBS as the cornerstone of Australia’s healthcare system.

In responding to announcements from the US today on tariffs, Liz de Somer, CEO of Medicines Australia said: “Speculation about the PBS has quite rightly prompted Australians to reaffirm their commitment to our PBS. Australia’s medicines industry, all sides of politics, patients, and clinicians all support patient access to new and breakthrough medicines through the PBS and want a stronger PBS now and in the future.”

“Strengthening the PBS though implementation of the health technology assessment (HTA) reform recommendations sitting on the Health Minister’s desk will ensure Australians see faster access to safe and effective, innovative medicines.

“Active Australian-led reform of the PBS must be our priority and that of the next Government. Science and medicines have evolved significantly in the 30 years where no meaningful reform has occurred. The system is no longer fit for purpose and patients are waiting too long – on average 466 days when elsewhere in the world the wait may be as low as 60 days.”

On tariffs, the Australia’s medicines industry notes the US Government has not placed tariffs on Australia’s pharmaceuticals exports.

“Medicines Australia and our members support free, fair and open trade. We called for no tariffs and US based pharmaceutical companies called for no tariffs. Australia is a responsible trading partner and the industry here and in the United States will continue to advocate for free trade,” said Liz de Somer.

“We will continue to monitor the prospect of future sector specific tariffs and will support the Australian Government’s efforts to ensure medicines remain tariff free so that they can get on with improving the PBS for Australian patients,” she added.

Media enquiries to: Anne-Marie Sparrow, Medicines Australia /Cube – media@medicinesaustralia.com.au or 0417 421 560

About Medicines Australia

Medicines Australia Launches Code of Conduct Edition 20 and enhances user experience

27 March 2025: Medicines Australia has today launched Edition 20 of its internationally recognised Code of Conduct, reaffirming the standards for the ethical marketing and promotion of prescription pharmaceutical products in Australia. To support Edition 20 and the user experience, Medicines Australia has introduced a new interactive, web-based format of the Code. This transformation enhances user experience by seamlessly integrating Guidance, recorded webinars, and Notes from the Help Desk.

Edition 20 maintains the principles-based approach of Edition 19 with updates to address areas of ambiguity and changing practices in advertising and engagement with health professionals. The interactive Code introduces enhancements designed to support accessibility, transparency, and compliance across the pharmaceutical sector.

Key amendments in this Edition include:

– Clarity about media engagement: Strengthened guidance on ethical and responsible product-related statements to consumer media, including social media, guiding non-promotional communication.
– Updated promotional material requirements: The removal of Minimum Product Information in promotional materials acknowledges the digital shift while maintaining essential prescribing information and a balanced representation of risks and benefits.
– Expanded transparency reporting: Grants and donations to healthcare organisations are now included in transparency reporting, reinforcing industry’s commitment to openness and accountability.

CEO of Medicines Australia Liz de Somer said today, “After a year of consulting with members and other stakeholders, it is exciting to officially launch industry’s Code Edition 20 that builds on and improves Edition 19 of the Code. Our collective commitment to transparency, accessibility, and education ensures the Code continues to uphold the highest standards of industry self-regulation”.

The interactive Code of Conduct Edition 20 includes the Code Resources Toolkit and updated and new Guidance to support implementation of this Edition. The new digital format supports diverse working styles, making it easier than ever to navigate, understand, and apply the Code’s principles in real-world scenarios.

“To support Code compliance, industry now has an engaging suite of dynamic and varied resources. This contemporary digital approach will transform how the industry engages with the Code by:

– enhancing accessibility and ease of search;
– improving understanding and interaction with the Code; and
– supporting stronger knowledge and compliance across the industry.

“As an industry we are committed to ongoing and progressive refinement of self-regulation and I am pleased that together with members we have developed new tools to best support them in their implementation of the Code”, said Liz de Somer.

Code Edition 20 comes into effect on 30 March 2025.

About the Code of Conduct

The Code of Conduct sets the standards for the ethical marketing and promotion of prescription pharmaceutical products in Australia. Launched in 1960, the Medicines Australia Code of Conduct complements the legislative requirements of Therapeutic Goods Act, 1989 and the Therapeutic Goods Regulations, 1990.

The Code is periodically reviewed to ensure it remains relevant to members, the wider industry and external stakeholders, whilst continuing to align with international self-regulation and domestic policies, legislation, standards and community expectations. After an extensive review, Edition 20 was formally adopted by members at the Medicines Australia Annual General Meeting in October 2024. For more information on the adoption of Edition 20, see here.

About Medicines Australia

Medicines Australia represents the research based pharmaceutical industry in Australia. Our members discover, develop and manufacture medicines and vaccines that are the foundation of a healthy and prosperous society founded on conduct of the highest ethical standards.

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Media enquiries to: Anne-Marie Sparrow, Medicines Australia /Cube – media@medicinesaustralia.com.au  or 0417 421 560

Investments in Australia’s health squarely on election agenda

Investments in Australia’s health squarely on election agenda

25 March 2025: Medicines Australia welcomes today’s announcements by the Government that increase the investment in the health of our nation. Similarly, we acknowledge the Opposition’s matching of these announcements in recognition of the need for additional investment in health.

“Strengthening Medicare, investments in precision medicines, onshore manufacturing of IV fluids and assisting Australians to access healthcare as they juggle cost of living pressures through initiatives including a reduced co-payment for access to medicines on the PBS is very welcome,” said Liz de Somer, CEO of Medicines Australia.

“We are pleased with the Government’s commitment of $1.8 billion to the Pharmaceutical Benefits Scheme (PBS) and the listing of new medicines within this budget.

“Securing more choice for Australian women with new and amended listings for contraception, endometriosis and IVF on the PBS and the overall $793 million investment in women’s health is particularly welcomed as so many Australian women have had to wait for access to the latest medicines due to a system that is in dire need of reform,” added Liz de Somer.

The substantial commitment to Medicare of $8.5 billion to support bulk billing and to build health workforce through incentives for GPs, nurses and midwives to train and to add 50 Medicare urgent care clinics are extremely important measures.

Alongside this investment in the delivery of healthcare must be a commitment to support a stronger PBS and timely access to medicines. However, Australia’s Health Technology Assessment System that reviews medicines for cost effectiveness and inclusion on the PBS has not been comprehensively reviewed in over 30 years and as Minister Butler says, it is “clunky” and needs reform.

Patient organisations, clinicians, industry, government and the Federal Opposition all support HTA reform and the focus of the next Federal Budget must now be implementation.

“It should not take on average 466 days after a new medicine has been found to be safe and effective by the Therapeutic Goods Administration for it to reach patients. While we welcome the increased investment in health in this budget, these investments need to be complimented by reforms to the PBS.

“HTA reform must be the focus of the next Health budget, so Australians get access to the best medicines when they need them. The PBS is a critical part of Medicare. A stronger Medicare needs a #strongerPBS,” concludes Liz de Somer.

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Media enquiries to: Anne-Marie Sparrow, Medicines Australia /Cube – media@medicinesaustralia.com.au  or 0417 421 560

About Medicines Australia

Medicines Australia announces appointment of new Board Chair

Medicines Australia announces appointment of new Board Chair

The Board of Medicines Australia is pleased to announce the appointment of Ms Sue MacLeman as the new Chair of Medicines Australia.

Ms MacLeman has more than 30 years’ experience as a pharmaceutical, biotechnology and medical technology executive having held senior roles across Australia’s corporate and life sciences sector.

As an experienced corporate leader and Board Director, Ms MacLeman has served as CEO and Board member of several ASX, AIM and NASDAQ-listed companies in the healthtech sector. She is a Non-Executive Director on public, private and not-for-profit boards and is appointed to several academic, industry and government advisory boards and committees. 

“I am honoured to be appointed as Chair of Medicines Australia and I look forward to working with the Medicines Australia Board and Executive to continue championing the latest advancements in medicine, and advocating for patients to have fast, universal access to new treatments,” Ms MacLeman said.

Ms MacLeman’s broad commercial and technical experience is underpinned by a Bachelor of Pharmacy from the University of Queensland, a Master of Laws from Deakin University and a Master of Marketing from Melbourne Business School.

She is also a member of the NSW Government Innovation and Productivity Council, Fellow and a Non-Executive Director of the Australian Academy of Technology and Engineering and Fellow/Graduate of Australian Institute of Company Directors.

In welcoming Ms MacLeman, Medicines Australia CEO Liz de Somer said, “I congratulate Ms MacLeman on her appointment on behalf of the Board and our members. We are looking forward to her decades of experience, knowledge and leadership being applied to advocating for a stronger Pharmaceutical Benefits Scheme with faster patient access to medicines, and to strengthening Australia’s life sciences sector.

“With the need to get moving with Health Technology Assessment reform, the ongoing work to implement our Strategic Agreement with the Government, and our work to ensure Australia’s competitiveness as a destination for clinical trials remains, we look forward to Ms MacLeman’s stewardship at this crucial time for our industry,” she adds.

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Media enquiries to: Anne-Marie Sparrow, Medicines Australia /Cube – media@medicinesaustralia.com.au  or 0417 421 560

Patient access to medicines strengthened with PBS co-payment reduction

19 March 2025: Medicines Australia welcomes the Government’s announced reduction in the Pharmaceutical Benefits Scheme co-payment to $25 designed to reduce cost of living pressures for Australians. Access to medicines is essential for a healthy nation and should not be placed at risk due to cost-of-living pressures.

“As cost-of-living increases, Australians should not have to choose between medicines and other essentials. The Government’s announcement of a reduction in the PBS Co-pay today is an important measure to ensure patients do not interrupt their treatment and can continue their life changing and lifesaving medicines,” said Liz de Somer, CEO of Medicines Australia.

Liz de Somer added; “We look forward to working with the Government to ensure the implementation of this ad hoc change in the co-pay policy is smooth and appropriately supports patient access to the very latest medicines that deliver the best outcomes for Australians.”

Australia’s PBS is a cornerstone of the nation’s healthcare system. It is a crucial part of Medicare and is a scheme Australians rely on to stay healthy and productive.

Liz de Somer said, “Medicine access and affordability is essential, the PBS has delivered for Australians since 1945, and it is now time the Government did some more work to ensure timely access to the latest innovations is provided to Australians.

“It’s been more than 30 years since the assessment processes for PBS listing have been comprehensively reviewed and in that time science and innovation has transformed the medicines available. A comprehensive review of the assessment processes (the HTA review) was released in September 2024. This review demonstrates it takes too long for a patient to access a new medicine after it has been proven to be safe and effective by the Therapeutic
Good Administration.

“Affordability and access go hand-in-hand. Let’s get both sides of the equation right for Australians,” said Liz de Somer.

Media enquiries to: Anne-Marie Sparrow, Medicines Australia /Cube – media@medicinesaustralia.com.au or 0417 421 560