Media release – Medicines Australia

Reporting of medicines shortages in Australia

Reporting of medicines shortages in Australia

19 June 2024: Medicines Australia has noted an increase in media reports of medicines shortages in the community over the last 12 months.

A medicine is listed on the Therapeutic Goods Administration’s (TGA) shortages reports database when supply is not likely to meet the normal or projected consumer demand within Australia at any point in the next six months. Mandatory reporting of supply information came into effect in January 2019.

“Medicines Australia encourages caution in the interpretation and reporting of supply information that may inadvertently prompt panic buying or stockpiling and further intensify supply pressures,” Medicines Australia CEO Liz de Somer said.

“The TGA database includes actual and potential shortages, as well as shortages of a particular brand where alternatives may continue to be available.”

“This information can be misunderstood and sometimes projected shortages don’t eventuate, which is why it’s important this information is considered carefully.”

“Manufacturers make every effort to ensure supplies are maintained. Where potential shortages are identified, there is collaboration with the TGA, healthcare professionals and prescribers to manage supplies for essential need.”

Shortages may be anticipated for a number of reasons including unexpected increases in demand, natural disasters, ingredient shortages, or disruptions to manufacturing and distribution channels. The global pharmaceutical supply chain is complex and any of these factors can create pressure.

“Transparency is a very important principle for the industry, prescribers and others in the supply chain. However, it is equally important this information does not cause unnecessary concerns about medicines availability for patients,” Ms de Somer said.

If consumers are concerned about the availability of a particular medicine, the best thing to do is talk to your prescribing doctor.

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

Medicines Australia Board Director Prof John Skerritt recognised in King’s Honours list

Medicines Australia Board Director Prof John Skerritt recognised in King’s Honours list

11 June 2024: Medicines Australia congratulates independent Board Director, Prof John Skerritt, on his appointment as a Member of the Order of Australia (AM) in the General Division in the 2024 King’s Birthday Honours list.

Prof Skerritt was recognised for ‘significant service to public health administration and governance, and to scientific research’ which includes joint roles as head of the TGA and Deputy Secretary from 2012 to 2023.

In addition, Prof Skerritt was a member of the Australia-NZ Clinical Trial Registry Advisory Board from 2012-2021. He is a Professor of Medicine at Melbourne University, and an Adjunct Professor at Sydney University, and joined the Board of Medicines Australia as an independent Director in 2023.

Medicines Australia Chair, Dr Anna Lavelle, commended Prof Skerritt on his achievements and said all Australians have benefited from his contribution to the therapeutic regulatory environment, clinical trials system and broader health system.

“Professor Skerritt has made a significant contribution to Australia’s healthcare system over the last 15 years, through his leadership and deep understanding of regulation and government processes. This has come at a pivotal time when innovation in medical technologies has advanced at a faster pace than ever before, requiring a cautious but willing approach to embrace change.”

“Medicines Australia is very fortunate to be able to draw on John’s expertise as an independent Board Director and we warmly congratulate him on this tremendous recognition of his service.”

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

Medicines Australia’s response to the 2024-25 Federal Budget

14 May 2024: The healthcare measures announced in the 2024-25 Budget show a move towards preventive care and wellbeing to ease pressure on Australia’s health system.

“The investment committed in the 2024-25 Budget to Medicare, screening programs, research, mental health, clinical trials, new PBS listings and programs to keep ageing Australians out of hospital will greatly benefit many people,” Medicines Australia CEO Liz de Somer said.

“As Australia faces the pressure of an ageing population, reduced productivity and growing Medicare costs, we must change our thinking about medicines and view the PBS as an investment in wellbeing, rather than a cost.”

“Access to medicines has a direct link to the economy and to productivity, as evidenced in the recent Productivity Commission report that found advances in cancer treatments have been one of the major drivers of productivity growth.”

“Bold PBS reform to accelerate patient access to the best medicine available will deliver step change in preventive care. The faster that patients can access new medicines through the PBS, the faster they will recover. This means fewer visits to the doctor, fewer hospitalisations and immediate, tangible impacts on the whole community.”

Clinical trials

The previously announced commitment of $62 million to support clinical trials and a further $18.8 million to progress the National One Stop Shop is welcomed by industry and is a significant step towards improving access to medicines for all Australians.

“Australia plays a vital role in the research and development of new medicines through clinical trials. The investment by Government into creating a single system for accessing clinical trials and harmonised processes will benefit patients and ensure Australia remains globally competitive as a research and development destination,” Ms de Somer said.

“As the Government focuses on a future made in Australia, it’s important that we do not inadvertently create an unfavourable environment for the launch of new medicines and medical technologies that Australians have contributed to developing.”

Health Technology Assessment reforms

The absence of any announcements about the Health Technology Assessment review is not cause for concern, given the report only went to the Minister last week.

“Delays that occurred throughout the review period meant that we did not expect any announcements about HTA reform,” Ms de Somer said.

“We know reforms will take time to implement and require forward budget planning. The Medicines Australia roadmap of reforms outlines a 3-year plan that balances the opportunities for fast wins for patients and the more complex reforms that will require legislative change.”

“Funding should not prevent or delay stakeholders coming together to commence codesigning reforms, and Medicines Australia calls on the Minister to release the HTA report and commit to the next steps towards reform implementation.”

“Patients had to wait more than two years from the House of Representatives inquiry for the New Frontiers report to be released. The HTA review has now taken over a year. Patients cannot keep waiting. We need to get on with reforming the system to accelerate access.”

“We know that a stronger PBS will deliver savings in other areas of the health system and increase productivity. Australia needs a system that delivers equitable access to the latest medical technologies within 60 days of TGA registration.”

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

Stronger PBS campaign radio advertising commences this weekend

3 May 2024: The second phase of Medicines Australia’s ‘Stronger PBS’ campaign will commence this weekend with radio and digital media advertisements.

The ‘Stronger PBS’ campaign aims to educate Australians about the Pharmaceutical Benefits Scheme (PBS) through the real-life stories of people whose lives have been changed because they were able to access the medicine they need, and stories of people who are still waiting for medicines they need to be available through the PBS.

Medicines Australia CEO Liz de Somer said the next phase will build on the campaign’s success on social media to reach people through traditional media platforms including radio and print.

“The Stronger PBS campaign is designed to initiate aconversation with the public about the PBS including access issues that people often are not aware of until they are personally affected.

“We know through research that Australians love the PBS but most don’t know a lot about how it works or how long it takes for medicines to be made available through the PBS.

“People are shocked to learn it takes 466 days on average from when a medicine is approved for use in Australia by the Therapeutic Goods Administration (TGA) to it being available through the PBS.”

Over the next month, radio ads will air in Canberra, Adelaide, Melbourne, Hobart and Sydney with a message that links the emotive impact of traffic delays with the stark reality of the impact of waiting for a life-changing medicine.

“We all get frustrated sitting in traffic, but for patients waiting to access a new medicine, delays can mean the difference between life and death,” Ms de Somer said.

“When you hear the worst possible news from a doctor that you or your loved one has a life-threatening condition, the last thing you expect to then hear is that there is a medicine that can treat this but it’s not yet available on the PBS and might not be in the time you have left.”

“Australians believe our health system is world class, but the reality is that when it comes to access the latest innovative medicines, we are a long way behind.”

Through the campaign, we are building a community of engaged and informed Australians who are passionate about the PBS and want to see change.

Since launching in late September, the campaign has reached more than 2 million people. The campaign will continue throughout 2024 with different phases of activity planned to build an engaged community.

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

Medicines Australia welcomes funding for clinical trials and One Stop Shop

2 May 2024: The announcement by the Albanese Government of $80.8 million in funding for clinical trials and a centralised approach to clinical trials known as One Stop Shop is a significant step towards improving access to medicines for all Australians.

“Australia is recognised globally as a preferred location for companies to conduct clinical trials thanks to our excellent healthcare facilities, researchers, a diverse population, and strong legal frameworks with robust IP protections,” Ms de Somer said.

“Currently there are different processes and systems for clinical trials in each state and territory and within area health services. This creates inefficiencies and makes it difficult for patients and doctors to know what options are available, which is why a national approach is needed.”

“Medicines Australia has been calling for a One Stop Shop that centralises clinical trial information and streamlined regulations since 2009, to give Australians early access to potential lifesaving and life changing treatments.”

“The commitment of $62 million to support clinical trials and a further $18.8 million by the Albanese Government to progress the National One Stop Shop is welcomed by industry and is a significant step towards improving access to medicines for all Australians.”

“Harmonising these processes will ensure patients get access to the latest medical therapies and Australia remains globally competitive as an R&D destination, benefiting both Australian patients and the economy.”

“Clinical trials are a vital step in developing innovative new medicines. They provide early access for some patients and a broader benefit to the whole economy. The next step is to ensure our reimbursement system keeps pace with the rapid advances in innovation to provide all patients with these new medicines as quickly as possible and harness the broader economic returns.”

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

Productivity Commission research provides irrefutable evidence that faster access to new medicines is needed

24 April 2024: New research released today by the Productivity Commission provides irrefutable evidence to Government that faster access to new medicines will have a measurable and overall positive impact on social and economic outcomes for Australia.

The research paper, ‘Advances in measuring healthcare productivity’, found multi-factor productivity grew by about 3% per year between 2011-12 and 2017-18 for cancers, cardiovascular diseases, blood and metabolic disorders, endocrine disorders and kidney and urinary diseases, which together account for around one-third of healthcare expenditure.
It also found more timely approval processes for pharmaceuticals and other medical technologies is needed for medicines to reach people at the right time and to maximise productivity benefits.

Medicines Australia CEO Liz de Somer said the findings further demonstrate the need for bold reform of Australia’s existing health technology assessment system.

“The Productivity Commission research recognises that advances in cancer treatments have been one of the major drivers of productivity growth, and this is consistent with productivity studies from overseas,” Ms de Somer said.
“This is irrefutable evidence that delays in getting new medicines onto the PBS are harming Australians.

“The full value of the benefits that new medicines and vaccines contribute to our society need to be given sufficient consideration and weighting in the decision-making process when a medicine is being assessed for a PBS listing.
“Productivity is linked to quality of life and a person’s ability to function and participate as a member of society. When someone cannot access the medicine they need, when they need it, in an appropriate delivery method that suits their needs, their productivity is impacted, with ripple effects through their community.”

“Medicines Australia and its members have been calling for a provisional fund to give patients with limited options faster access to new medicines. Furthermore, the current discount rate should be reduced to 1.5% in line with other OECD countries so that Australians are not disadvantaged when it comes to accessing medicines with longer-term benefits, such as cell and gene therapies and vaccines.”

The research paper noted that productivity growth was particularly strong for the treatment of cancers, which highlights the importance of quickly integrating new treatments as they emerge.

“The Minister for Health and Aged Care has said he wants bold PBS reform – this is compelling evidence that our current system is not fit for purpose and needs change,” Ms de Somer said.

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

Medicines Australia Code of Conduct review – consultation open

Medicines Australia Code of Conduct review – consultation open

3 April 2024: Medicines Australia invites all pharmaceutical companies operating in Australia and other stakeholders with an interest in the Medicines Australia Code of Conduct to participate in our 2024 Code Review.

The Medicines Australia Code of Conduct is regarded globally as the gold standard of industry self-regulation.

The first Code of Conduct was launched in 1960, and since then it has undergone regular revisions to reflect best practice and respond to changing practices in advertising and engagement with health professionals.

The Code of Conduct is reviewed approximately every five years in line with standard best practice. The last review was undertaken in 2019 resulting in a significant update, the principles-based Code Edition 19, that came into effect in March 2020.

The current review seeks input from members and non-member pharmaceutical companies as well as industry associations, peak healthcare professional organisations, patient groups, healthcare professionals, the Therapeutic Goods Administration and Australian Competition and Consumer Commission (ACCC) and other key stakeholders.

A Consultation Paper outlining seven key topics and the process objectives, timeframe, and methodology, is available for all interested stakeholders to consider and has been developed to guide the review. Feedback outside the topics identified is also welcome.

Review feedback can be submitted via our online form or via email. The consultation period will close on Thursday 2 May 2024.

Any recommendations that result from the Review will be considered by Medicines Australia members at the Annual General Meeting in October 2024.

The Consultation Paper and online form can be found on our website – www.medicinesaustralia.com.au/codereview2024

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

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

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

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

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.”