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New explainer videos to educate Australians about the PBS

New explainer videos to educate Australians about the PBS

12 December 2024: Medicines Australia has developed two new explainer videos to educate Australians about the Pharmaceutical Benefits Scheme (PBS) and the regulatory and reimbursement process.

The first video explains how the PBS works, its history, and the delays that Australians experience in accessing new medicines through the PBS. 

The second video outlines how medicines are developed, and the process they go through in Australia to be registered by the TGA and then listed on the PBS.

Medicines Australia CEO Liz de Somer said there is low awareness in Australia about how the PBS works and its limitations.

“The Pharmaceutical Benefits Scheme and the systems that sit behind it, including the Health Technology Assessment, are complex and opaque. This was highlighted through the HTA review and called out in its final report as one of the drivers for reform,” Ms de Somer said.

“As we move into HTA implementation, and advocate for the full package of reforms identified by the Review, people need to understand why reforms are needed.”

“We know that Australians value the PBS but most people are not aware there is a delay of 466 days on average from the time a new medicine is approved for use by the TGA to when it is made available on the PBS. Many people also don’t realise that some medicines don’t come to Australia at all because of the complexities of our systems.”

“These short videos have been developed as a hook to begin explaining to Australians what the problem is and why change is needed. It’s important that more people understand the time and expense that goes into research and development, and the steps that companies go through to have a medicine approved for use in Australia and then made available through the PBS.”

The videos will be used as part of the Stronger PBS campaign and will be promoted on social media channels and other digital platforms over the coming months.

The videos were created by Elastic Group and are available at www.medicinesaustralia.com.au

View the videos on YouTube:

About the PBS

How medicines get from the lab to you

Australians rank access to affordable healthcare as second most important priority after cost of living: survey

Australians rank access to affordable healthcare as second most important priority after cost of living: survey

4 December 2024: Access to affordable healthcare, including fast access to new medicines through the Pharmaceutical Benefits Scheme (PBS), is the second most important priority for Australians behind cost of living, data from the latest Mood of the Nation survey by SEC Newgate shows.

The survey of 1,611 Australians found 68% believe the Government should be investing more to ensure quality affordable healthcare for all Australians and rank it as the second most important priority behind reducing cost increases for household bills and other essential expenses.

Nearly three quarters of Australians (74%) believe the Government should subside the best medicines available, even if it means more of a cost to taxpayers.

Medicines Australia CEO Liz de Somer said the results show access to medicines remains an extremely important issue for Australians and investing in a stronger PBS makes sense for the economy and the health of the nation.

“This survey shows Australians want to see more investment in the PBS. We know Australians are very concerned about their health today, as it links to their employment, financial security and quality of life,” Ms de Somer said.

“The Mood of the Nation survey shows a higher number of Australians are very concerned about access to medicines, and more people are realising our Pharmaceutical Benefits Scheme and the systems that sit behind are not keeping pace with medical advances.”

More than half of Australians (57%) rate access to the most appropriate form of medication for their circumstances as their main priority when it comes to medicines, such as a tablet, liquid, injection or other form. Around one in five (18%) rate access to the latest medicines as most important.

In addition, 11% of respondents were unable to access the medicine they need through the PBS.

“Policy makers need to start viewing the Pharmaceutical Benefits Scheme as an investment in health, wellbeing and productivity. We need to look at the productivity gains medicines offer, potential savings in other areas of the health system, and the full impact of those gains on society when determining if medicine should be made available on the PBS. This includes how we assess and value different forms of medicines.”

“Australians believe it is reasonable to expect to be able to access the most appropriate medicine available for their condition when they need it. It’s clear taxpayers want to see more investment in healthcare and medicines and want to see new medicines subsidised faster.”

Additional survey results

– 68% of Australians believe the Government should be investing more to ensure quality affordable healthcare for all Australians. This is considered the second highest national priority, behind reducing cost increases for household bills and other essential expenses (76%).

-Investing more in healthcare ranked ahead of interest rates, rental property affordability, and addressing violence in the community.

-In response to how people are impacted by the rising cost of living, 15% said they have been unable to pay for needed medical expenses.

-In the last six months, Australians were most likely to have experienced difficulty:
getting an appointment when they needed one (36%)
affording the cost of health and medical services (35%)
experiencing long waiting lists for services they needed (32%)

One in four (26%) experienced difficulty affording the cost of medicines, with renters (34%), women (29%) and those aged 18-34 (33%) more likely to have had difficulty.

About the survey
The Mood of the Nation survey by SEC Newgate included 1,611 Australians aged 18+. Quotas are set on gender, age and location to achieve an accurate representation of the nation. Data is weighted to ABS Census population statistics on age, gender, location and occupation. This survey was in the field from 10-14 September 2024.

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

It’s time to get on with Health Technology Assessment reform

It’s time to get on with Health Technology Assessment reform

3 December 2024: Medicines Australia acknowledges the Pharmaceutical Benefits Advisory Committee (PBAC), and the Medical Services Advisory Committee (MSAC), have backed Health Technology Assessment (HTA) reform in letters released today.

Now this formal step has been completed, it is time to get on with implementation and Medicines Australia calls on the Government to facilitate a meeting of the independent HTA Implementation Advisory Group before the end of the year.

“The PBAC has already had significant input into the HTA reform agenda,” Medicines Australia CEO Liz de Somer said.

“The previous PBAC Chair, Andrew Wilson, was a member of the HTA Reference Committee. The PBAC presented to the Reference Committee. Now we have a letter confirming the need for reform. It’s time to get on with implementation.”

“Comments from the PBAC Chair in the letter about the safety and efficacy of new medicines are concerning. We have a high-quality system of registration through the TGA and Australians can have confidence in the medicines and treatments they have access to for their medical needs.”

“We agree careful implementation is required to achieve beneficial reform, and believe it is possible to be bold in our thinking. System reform is needed. ‘Incremental improvements’ as suggested by the PBAC will not ensure Australians can access the best medicines available as soon as possible after they are approved for use by the TGA. A delay of 466 days from the time of TGA-approval to when a medicine is reimbursed is too long.”

“HTA Reform should also not be pitched as a trade-off. It is about creating the best system for Australian patients now and into the future.”

“Now is the time to get moving with reform implementation. We have the reform blueprint and the support of patient organisations, clinicians, government and industry for system reform. There is no time to waste,” Ms de Somer said.

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

Collaboration and HTA reform are key to improving vaccination rates in Australia: Parliamentary Friends of Medicine Future of Vaccines event

Collaboration and HTA reform are key to improving vaccination rates in Australia: Parliamentary Friends of Medicine Future of Vaccines event

21 November 2024: Recognising the full value that vaccines deliver to society and ensuring equitable access to affordable vaccines will be crucial to increasing vaccination rates as a preventive measure to fight diseases in Australia, experts have told Parliamentarians this week.

The Parliamentary Friends of Medicine ‘Future of Vaccines’ event, co-Chaired by the Hon. Dr David Gillespie MP and Dr Mike Freelander MP and hosted by Medicines Australia’s Vaccines Industry Group, examined existing and emerging infectious diseases, novel vaccines in development, and the barriers and opportunities to vaccine access and uptake in Australia.

Reflecting on his experience as a paediatrician earlier in his career, Dr Freelander said thousands of children suffered from measles and polio before affordable vaccines were available.

“We have forgotten what it’s like to have widespread infectious disease in the community,” he said.

Dr Andrew Minton, CEO of the Immunisation Coalition discussed changing perceptions and value of vaccines by Australians and declining vaccination rates, with new research showing vaccination rates among children in Australia have declined for the third consecutive year, and protection against influenza and shingles declining in adults.1

“There is misinformation about the effectiveness of vaccines, access issues in regional and remote Australia, cultural consideration, language barriers and post COVID-19 fatigue. We need factual, clear messaging repeatedly to target groups who are high at risk to address these key issues,” Dr Minton said.

Professor Terry Nolan AO FAHMS, a paediatrician and clinical epidemiologist discussed the importance of recognising the full value and benefit of vaccines, particularly as new vaccines become available.

“The so-called post-COVID vaccine hesitancy in Australia is less a result of diminished trust in the vaccines themselves, and more a growing indifference and resistance to their perceived potential benefits both by consumers and healthcare professionals,” Prof Nolan said.

“During the next five years, it is possible that we will see a number of new vaccines that will address conditions we may not have even imagined a few years ago. The HTA Review has highlighted near-term achievable improvement in our processes, with nearly halving of the time required for a funding decision.”

Medicines Australia CEO Liz de Somer said collaboration and getting on with HTA Reform are key to improving vaccination rates in Australia.

“Immunisation is key to primary health. We know that preventing illness and reducing transmission of communicable diseases reduces costs in other areas of the health system.”

“It is important Government, industry and other stakeholders work together to address declining vaccination rates given the significant benefit that vaccines provide society, from improved health and wellbeing to productivity and the overall economy.”

“Prior to COVID, vaccination rates were increasing, so we know the decline in trust is relatively new and can be rebuilt.”
“Delays in making new vaccines available on the NIP are also costing the nation. The HTA Review has made clear recommendations to improve the time it takes for vaccines to be assessed and made available on the National Immunisation Program.”

“The current delay from TGA registration to PBS listing of vaccines is an average time of 1,375 days or nearly four years, which is unacceptable. It’s time to get on with HTA reform.”

Footnote: 1 – Annual Immunisation Coverage Report 2023, National Centre for Immunisation research and Surveillance Australia, https://ncirs.org.au/ongoing-decline-childhood-immunisation-rates-sparks-concerns

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

Medicines Australia welcomes announcement of HTA Implementation Advisory Group and two industry representatives

Medicines Australia welcomes announcement of HTA Implementation Advisory Group and two industry representatives

20 November 2024: Medicines Australia welcomes the announcement of the independent HTA Reform Implementation Advisory Group and the appointment of CEO Liz de Somer and Board Deputy Chair Anne Harris as industry’s representatives.

“The independent Implementation Advisory Group announced today by Minister Butler is a step forward in progressing HTA reform, and will enable Australia to get on with fixing our broken system so patients can access new medicines without unnecessary delay,” Medicines Australia CEO Liz de Somer said.

“As Chair, Prof Andrew Wilson AO will bring unparalleled experience and understanding of the challenges in our current HTA system, and his collaborative, solution-focused approach will be needed as we move through the complexities.”

“I’m pleased to join Prof Wilson in providing consistency from the HTA Review reference committee, which will be crucial to guiding the intent of the review’s recommendations is carried through reform implementation.”

“The appointment of a second industry representative, Medicines Australia Deputy Chair Anne Harris, is greatly welcomed and recognises the significant time investment required to deliver this important package of reforms.”

“Anne is highly regarded across the industry, and will bring unique insight and extensive experience to the discussions.”

“We also welcome the inclusion of the enhanced consumer engagement framework in the remit of the Implementation Advisory Group, and strong consumer representation in the group.”

“With an election looming, it is important that we now get to work in developing an implementation plan and timelines, and commence the co-design work that is needed to deliver these reforms.”

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

Horizon scanning is an important part of the solution to fixing Australia’s HTA

Horizon scanning is an important part of the solution to fixing Australia’s HTA

15 November 2024: A robust horizon scanning process, as recommended by the HTA Review, will help to prepare Australia’s regulatory and reimbursement systems for advances in therapies and medical breakthroughs.

Medicines Australia CEO Liz de Somer said creating an effective horizon scanning process would underpin a flexible and responsive HTA system, provide greater visibility to the Pharmaceutical Benefits Advisory Committee (PBAC) of new treatments coming to the market, and ultimately reduce delays to patient access. 

“Inadequate horizon scanning over the last decade has contributed to the situation Australia is in today, where science and innovation has significantly outpaced our system for reimbursement of the latest innovations and weakened the PBS, to the detriment of patients,” Ms de Somer said.

“We know from the HTA Review there are some 1,300 new cell and gene therapies in development right now that will be available in the next few years – only 7 are currently registered in Australia.”

“From the presentations at our Horizon Scanning Forum held earlier in the year, we know that only 19 novel antimicrobials have been registered for use in the EU and/ or the US since 2011 and of those, only three are registered in Australia.”

“We know there are new vaccines in development, new technologies to prevent infectious diseases, and new AI diagnostics for neurological diseases.”  

“Digital technology is accelerating the pace of research and development, and we are now in an era of unprecedented innovations within the pharmaceutical and biotechnology sectors.”

“The PBAC is already struggling with increased numbers of submissions and complexity of medicines being assessed. This is only going to increase. This is a symptom of a broken system that needs urgent reform, and the visibility that horizon scanning provides must be part of the solution.”

The HTA Review identified the need for Australia to establish and resource a horizon scanning function that improves stakeholder engagement in considering the implications of new and emerging health technologies and support healthcare forward planning and priority setting by healthcare payers.

“We need to get on with HTA reform so new therapies entering the market today can be assessed in a timely manner and made available to Australians through the PBS quickly.”  

View the 2024 Horizon Scanning Forum report

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

Additional PBAC meeting announced so patients can access lifechanging medicines

Additional PBAC meeting announced so patients can access lifechanging medicines

6 November 2024: The announcement today by the Minister for Health and Aged Care, the Hon. Mark Butler MP, that the Pharmaceutical Benefits Advisory Committee will now hold an additional meeting in 2025 to address the immediate backlog of PBAC submissions is welcomed by industry. There should not be a delay in patients accessing life changing innovative medicines.

Medicines Australia has been in discussions with the Government over the last 10 days to prevent the cascade of consequences that would follow the PBAC’s deferral of 45 submissions that were due to be considered in March.

Medicines Australia CEO Liz de Somer said the situation should never have occurred and is pleased common sense has prevailed.

“Minister Butler has made the right call today. An additional meeting is required so patients can access the latest innovative medicines as soon as possible.”

“It is disappointing patients and industry were put in this situation without effective consultation. Australians already wait on average 466 days from the time a medicine is approved for use by the TGA to when it is made available on the PBS, which is significantly longer that comparable countries. Patients should not have to wait even longer because of a meeting schedule.”

“Proper consultation could have circumvented the need to involve the Minister and alarm patients who are waiting for access to lifesaving and life-changing medicines.”

Medicines Australia calls on the Government alongside the PBAC, to now act on reforming the system, so this situation is not repeated. There must be:

– Reform of the processes to speed up the back-end administrative processes following positive recommendations from the additional meeting to ensure later consideration is fully mitigated and patients and industry are not disadvantaged by PBAC delays.

– A review of the current list of medicine evaluators engaged by the PBAC and an expansion of the panel of evaluators so there is appropriate surge capacity to deal with consideration of new medicines as they are submitted.

– More meetings built into the annual PBAC meeting schedule noting the increasing complexity of medicines being assessed and the time take to fully assess their inclusion on the PBS.

– Health Technology Assessment reform to deal with the innovative and exciting pipelines of new medicines coming to Australia for Australian patients, avoid unnecessary resubmissions and streamline decision making.

“It is patients – taxpayers – who are impacted the most when PBS decisions are delayed. The HTA Review has demonstrated Australians do not receive timely access to new medicines. This does not need to be exacerbated by PBAC deferring consideration of new medicines in 2025. We thank the Minister for stepping in as we know he understands what delays to access can mean for Australians,” said Ms de Somer.

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

Sector leader departs as Medicines Australia Chair

Sector leader departs as Medicines Australia Chair

31 October 2024: Dr Anna Lavelle AM FTSE has announced her departure as Chair of Medicines Australia, having been Chair since 2018 and an independent Director since 2017. She has been the driver of Medicines Australia’s governance improvements and strategic positioning with the Federal Government throughout that tenure.

“Medicines Australia placed great faith in me as independent Chair and I have worked hard to deliver on their expectations,” Dr Lavelle said.

“Balancing the needs of a competitive industry with the policy goals of government brings many challenges. Medicines Australia has worked hard to place itself in a very strong position to negotiate with all parts of government and key stakeholders, including patient advocates. I am very proud to have contributed to our reputational, strategic and operational achievements.”

Dr Lavelle was well placed to fulfil the role of Medicines Australia Chair as her background spans scientific research, academia, health service provision, policy change and executive management. Her last executive role was as CEO of AusBiotech for 11 years, rounded off a curriculum vitae that cemented her reputation as a strong and visionary advocate.

For her career contributions Dr Lavelle has been recognised by Nature Scientific America, World Vision as the only Australian to be in the top 100 global biotechnology visionaries (2015), was made a Fellow of the Academy of Science Technology and Engineering in 2014 and received the Industry Leader award from Johnson and Johnson and AusBiotech in 2018 and the Women in Leadership award in 2019 from BioMelbourne Network. Dr Lavelle was inducted into the Victorian Honour Roll of Women as a trailblazer in 2022. In 2023 Dr Lavelle was appointed to the Order of Australia receiving an AM in the King’s Birthday Honours.

Dr Lavelle said: “It has been both challenging and rewarding to lead Medicines Australia during a period of change and in a complex environment, including during the COVID pandemic when the community learned so much about the value of pharmaceuticals to their health and life. The pharmaceutical sector responded vigorously to that challenge by supplying vaccines that saved lives.”

“It has been an honour to work with Directors, the Medicines Australia Executive in particular the CEO, Liz de Somer and member companies. We hold a united goal to improve the speed and choice of medicines for patients as well as better recognise the value of innovation created by companies.”

Medicines Australia CEO Liz de Somer said Dr Lavelle has made an outstanding contribution to the industry.  

“Dr Lavelle has been a fearless leader throughout her career, combining extensive understanding of Australia’s medicines and biotechnology policies plus a deep understanding of medical research,” Ms de Somer said.

“Her unwavering commitment to improving patient outcomes and quality of life is resolute. Medicines Australia was extremely fortunate to have Dr Lavelle as Chair and on behalf of the pharmaceutical industry we congratulate her for her impactful contribution to the sector.”

“On a personal note, Anna has been an incredible support and mentor to me on taking the role of CEO, and I look forward to continuing my friendship with her,” Ms de Somer said.

Dr Lavelle advised the Board of Medicines Australia that she would complete her tenure in Q1 2025 and looks forward to providing assistance for the induction of the incoming Chair in the new year.

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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 Code of Conduct Edition 20 adopted at AGM

Medicines Australia Code of Conduct Edition 20 adopted at AGM

30 October 2024: The next edition of the Medicines Australia Code of Conduct has been formally adopted by members and will come into effect on 30 March 2025.

The updated Code follows an extensive review throughout 2024 with members and broader public consultation involving non-member companies, industry associations, healthcare professionals, the patient community, the TGA and global regulatory bodies.

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.

Key amendments made in this edition based on feedback and international standards include:

-A section to clarify how companies can make ethical and responsible product-specific media statements to consumer media when the information is relevant to the Australian public. This includes the announcement of a new product or indication and new public funding, such as a PBS listing and provides assurance and clarity to companies, as well as greater clarity for the Code Committees when adjudicating any related complaint. (Section 10.1).

-A shift in Minimum Product Information no longer being a requirement in promotional material, recognising that Product Information is easily accessible electronically. Mandatory inclusions are still required to ensure information relevant to prescribing is clearly communicated (Section 2.1)

-The extension of transparency reporting to include grants and donations to healthcare organisations, providing consistency with international transparency reporting (Section 14.2).

-An additional section on ‘balance’ (Section1.1) which emphasises the need for balanced information in promotional materials. A more concise definition guides companies to achieve this.

-The inter-company dialogue process is more clearly and specifically described in a new document ‘Intercompany Dialogue Standards’, supporting more meaningful interaction between companies and discouraging Code complaints as a competitive tool (Section 15.5). Failure to follow these Standards may cause a breach of the Code, with a fine up to $100,000 to be adjudicated by the Code Committee.

-The inclusion of a non-member company representative on the Membership of the Code and Appeals Committees if there is a complaint involving a non-member, encouraging better engagement by non-members with our complaints process.

In addition to these amendments, non-member companies will be required to pay a bond of $20,000 when lodging a complaint, which will better equalise the costs to member and non-member companies and offset the cost of the complaints process (Section 15.1). Where a complaint is upheld, and the subject company is found to be in breach of the Code, the bond will be refunded to the complainant.

Medicines Australia CEO Liz de Somer said the strong engagement by members and other stakeholders in the Code review demonstrates the industry’s commitment to ethical conduct.

“The Medicines Australia Code of Conduct is regarded globally as the gold standard of industry self-regulation and Edition 20 of the Code exemplifies this,” Medicines Australia CEO Liz de Somer said. 

“We thank the Code Review Working Group for their hard work over the last 12 months and everyone who contributed to the Review process.”

Medicines Australia will be hosting a series of educational webinars to help companies with their understanding of the new version of the Code between November 2024 and March 2025. This will be followed in January by a new Bridging Course, and an updated Program 1- Code of Conduct, offered by our educational partner the University of Tasmania, in line with our Continuing Education Program.

A copy of the Code of Conduct – Edition 20 can be found here. Code guidance, contained in the Code Resource Toolkit, will be updated in the first quarter of 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.

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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 announces new Board Directors

Medicines Australia announces new Board Directors

30 October 2024: Medicines Australia welcomes five new Directors to its Board and the re-appointment of another Director for a second term.

Tori Brown (Lilly), Kathryn Evans (BioMarin), David Pearce (Takeda), Owen Smith (BMS) and Nirelle Tolstoshev (Astellas) have been voted in by members to fill vacant positions following the resignations of Dirk Otto (Boehringer Ingelheim), Liz’e Marett (Astellas), Prashant Nikam (MSD) and Urs Voegeli (J&J). Patrick Desbiens (GSK) chose to not recontest his position at the conclusion of his three-year term.

Adam Roach (Beigene) was successful in his bid to continue on the Board for a second term.

Medicines Australia Chair, Dr Anna Lavelle AM, welcomed the new Directors and said their depth of experience will be invaluable over the next three years.

“On behalf of the membership and the Board, I congratulate the successful Directors and welcome their expertise and leadership at this critical time for our industry and for patients in Australia,” Dr Lavelle said.

“The combination of experienced Board Directors and some new Directors will ensure some stability and will provide fresh insights.

“The last year has been one of progress, unwavering unity of purpose and it’s through our collective commitment to advancing healthcare and access to world-class medicines, biotherapeutics and vaccines for all Australians, that we have a Health Technology Assessment (HTA) Review.

“There is now real momentum for modernising Australia’s HTA system and the impetus for change has never been stronger.

“I thank my fellow Board Directors who have served this year for their dedication and industry leadership, and wish every success to those Directors who have served and moved on during the year.”

CEO of Medicines Australia, Liz de Somer, also welcomed the new Directors.

“I am looking forward to working with the Board as we implement HTA reforms, complete actions in the Strategic Agreement, and ensure Australia’s competitiveness as a preferred destination for clinical trials remains,” Ms de Somer said.

“These are our collective priorities and require a laser-like focus from the Board, all members and Medicines Australia.”

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