11 April 2023: Medicines Australia welcomes the official start of the Health Technology Assessment (HTA) Review consultation that should deliver bold reforms to how medicines are assessed, valued and made available in Australia.
CEO of Medicines Australia, Elizabeth de Somer, said that after 30 years it is long past time for reform to the HTA policies and methods to ensure Australians have timely access to the latest medicines and vaccines.
“We are all patients at one point in our life and our pharmaceutical benefits scheme (PBS), as part of our Medicare system should provide access to the innovative medicines, treatments and services that are needed as quickly as possible. Access should be fair and equitable, regardless of ability to pay or capacity to research what may already be available overseas,” Ms de Somer said.
“This consultation signals the start of a reform process that must introduce long-term thinking to speed up access to innovative medicines for today’s generation and the next.
“The review will run until December 2023 and a rigorous consultation process with all stakeholders – including industry, scientists, clinicians, and patients – will ensure the best ideas and reforms are put forward for government consideration.
“Today marks the first round of public consultation, which will run for eight weeks from today until 6 June.
“Substantial, enduring change cannot happen without the input and insights from everyone across the health and medicine landscape. I encourage all stakeholders to develop and put forward their ideas, present them to decision makers, and stand up for bold reform.
“As a member of the HTA Review Reference Committee, I will continue to advocate for a review that is consultative, collaborative, inclusive and transparent,” Ms de Somer said.
These are the views of Elizabeth de Somer as CEO of Medicines Australia representing the research based pharmaceutical industry and do not intend to represent views of the HTA Review Reference Committee.
Further information about how to engage in the HTA Review consultation can be found on the Department of Health’s website.
-ENDS- For further information or media interviews, please contact: Anne-Marie Sparrow on 0417 421 560/anne-marie@cube.com.au
30 March 2023: Medicines Australia welcomes a new report that calls for investment in the vital adult vaccines that will underpin the future health and prosperity of our nation.
CEO of Medicines Australia, Elizabeth de Somer, said the new report from GSK Australia, ‘Risk to Resilience: A roadmap to vaccine access for older Australians’, highlights the health initiatives Australia will need to prepare for our growing ageing population and burden of chronic disease.
“Vaccinations prevent deadly diseases and save lives,” Ms de Somer said.
“Historically, Australia has always had a high immunisation rate, yet this latest report shows we need to more to improve access to the vaccinations that protect Australians of all ages – not just children.
“We must especially protect older Australians and currently, not enough people are accessing vaccines that can stop diseases such as whooping cough and shingles, which increase in risk as we age.
“Health should not be linked to location. This report highlights the steps we must take as a nation to close the immunisation gap among marginalised groups – including First Nations people and those living in regional and remote communities.
“The National Immunisation Program has been an integral part of our impressively high childhood vaccination rate, and now that same focus must be applied to equitable vaccine access for all age groups.
“This latest report shows that it can take an average of almost four years before an innovative and safe vaccine becomes available through the National Immunisation Program. We know how important fast access to vaccines is, and work must be done to reduce that time lag.
“This year’s Health Technology Assessment (HTA) review should look at how systems can improve and speed up access to innovative vaccines, medicines, and treatments.
“By keeping individuals healthy, vaccinations can decrease the burden on primary care and hospitals and in turn, benefit both our community and economy.
“The medicines industry is ready to work with governments and to partner with patients and health sectors to reform how vaccines are valued in this country and improve access to them,” she said.
The GSK Risk to Resilience report calls for governments to partner with the medicine industry, experts, healthcare professionals and patients to reform reimbursement systems and processes to recognise the value of vaccines and disease prevention and prioritise adult vaccination in delivery of the National Immunisation Program.
HTA Reform gets underway – Terms of Reference released today
22 March 2023: Medicines Australia acknowledges the Health Technology Assessment (HTA) Review Terms of Reference – released today – and will continue to advocate for bold policy reform to speed up access to innovative medicines.
CEO of Medicines Australia – and newly appointed HTA Review Reference Committee member – Elizabeth de Somer said that the release of the Terms of Reference kickstarts the HTA Review process which must deliver equitable, timely, safe and affordable access to innovative medicines for all Australians.
“The Australian medicines access system has not seen this type of review in 30 years and rapid advances in health, medicine, and technology, require reform so Australians don’t miss out,” Ms de Somer said.
“The HTA Review is an opportunity to improve our health and medicine system, so it is fit-for-purpose and realises the Government’s National Medicines Policy vision of providing the world’s best healthcare for all Australians.
“Reforms must remove the barriers in current policies, methods and decision-making systems that are stopping patients from having rapid access to innovative medicines, vaccines and treatments,” she said.
Medicines Australia welcomes changes to the Terms of Reference that strengthen the focus on patients and notes the specific mention of additional groups of Australians who experience access equity issues, such as First Nations people.
“After advocacy from Medicines Australia, there is now a stronger focus on having ‘earliest possible access’ to medicines, as well as a ‘person-centred approach’,” Ms de Somer said.
“The Terms of Reference are broad enough to consider system-level policy reforms and will allow all stakeholders to put their issues on the table.
“But this is just the beginning. Health reform like the HTA Review must make lasting, impactful change.
“Moving forward, the HTA Review must be transparent and create appropriate space and time to listen to the views, experiences, and challenges of all stakeholders.
“The House of Representatives Health Committee’s inquiry and the New Frontier report shows there is a groundswell of support for bold reform and everyone involved in that inquiry should have the opportunity to put forward their ideas.
“The Government, medicines industry, patients and health experts must work together that ensure all Australians have better access to innovative medicines,” she said.
Medicines Australia looks forward to the prompt public release of the HTA Review workplan and any discussion papers prepared by the HTA Expert to provide greater understanding for stakeholders and how everyone can engage.
Media statement: CEO’s appointment to HTA Review Reference Committee
14 March 2023: CEO of Medicines Australia, Elizabeth de Somer, has been appointed as the medicines industry representative on the Health Technology Assessment (HTA) Review Reference Committee.
The appointment was made today by the Minister for Health and Aged Care, the Hon. Mark Butler MP, which recognises Ms de Somer’s understanding of the issues, extensive industry experience, willingness to work collaboratively with all interested stakeholders, and commitment to reforming HTA in the best interest of all Australians.
“It is an honour to represent the medicines industry and take part in ensuring the reforms needed to speed up patient access to innovative medicines,” Ms de Somer said.
This position on the HTA Review Reference Committee was previously held by John Young, who has recently been appointed to the Novartis Board and has advised is unable to continue to serve the Committee in a voluntary capacity. Ms de Somer steps immediately into this role and thanked Mr Young for his service to date.
“On behalf of the Medicines Australia Board and the medicines industry, I wish to thank John for his exemplary contribution to the HTA Review Reference Committee and wish him all the best with his new role,” Ms de Somer said.
“John is a globally experienced industry leader and Medicines Australia is extremely pleased with what he has achieved on behalf of the medicines industry and will continue through a prominent and important Board position.
“The HTA Review is a crucial step in improving access to innovative medicines for all Australians.
“Success will hinge on a strong voice for reform and a collaborative approach – I intend to bring both to this important appointment,” she said.
Budget: Life sciences industry calls for better funding for medicine and technology regulator
31 January 2023: The life sciences, health and medicine sectors have come together to call for improved funding of the Therapeutic Goods Administration (TGA) after the agency flagged increases in costs this year due to unexpected issues such as the regulation of cannabis and nicotine vaping products.
CEO of Medicines Australia, Elizabeth de Somer, said the Federal Budget is an opportunity to demonstrate the value the TGA contributes to the health of every Australian.
“The TGA plays a critical role in making sure the health products we use are safe, effective and high quality,” Ms de Somer said.
“Cost recovery (fee for service funding) is not unusual between Government and industries, and the health and medicines industry accepts the requirement to pay for TGA services. However, what is unusual is that 93% of the TGA’s revenue is collected through fees and charges and only 7% of public funding is available for almost a third of the TGA’s functions.
“The small percentage of public funding does not give the TGA enough resources to provide public health functions into the long term or be able to properly support unexpected health emergencies.
“A recent report[1] to Government recommended the TGA’s current cost recovery model be updated to create a more sustainable, modern approach that is in line with international practice and the evolving health and technology world.
“The TGA is well-respected globally for its role in delivering high quality regulation on lifesaving and life changing medical and health products.
“Government should also recognise the critical public health functions provided by the TGA by properly funding important public health measures rather than redirecting industry fees to cross-subsidise these activities.
“Establishing a public funding mechanism will enable the TGA to guarantee timely public health services for the Australian community and the ability to respond to emerging health crises into the future,” she said.
Medicines Australia, along with AusBiotech, Medical Technology Association of Australia, BioMelbourne Network, ANDHealth, Life Sciences Queensland and Life Sciences WA, has co-signed the Federal Budget submission letter.
Budget: Government must place a higher value on vaccines and medicines that deliver long term benefits
27 January 2023: Medicines Australia has used its budget submission to remind Government of its commitment to lower Australia’s high discount rate for vaccines and medicines.
A discount rate is a technical correction applied to medicines and vaccines that values immediate health effects higher than long-term health benefits, such as childhood vaccines. This means preventative and curative vaccines and treatments are disadvantaged and delayed by a rate that is higher in Australia than other comparable countries.
The Pharmaceutical Benefits Advisory Committee (PBAC) – the expert committee that assesses the value for money of medicines in Australia – acknowledged Australia’s discount rate could be reduced for medicines and vaccines. The medicines industry urges the Government to implement the reduction now.
Medicines Australia CEO, Elizabeth de Somer, said Australia’s discount rate has not been adjusted since it was set in the 1990s and needs to be reduced to meet today’s international standards.
“Medicines, vaccines and treatments help Australians live longer, healthier lives. They keep people out of hospitals, in the workforce and contributing to our economy,” Ms de Somer said.
“For example, a recent peer-reviewed study shows the COVID-19 vaccines reduced the pandemic’s economic toll in Australia by an estimated $214 billion.
“Medicines and health technologies have dramatically transformed in the last 30 years providing patients with longer term health benefits and even curing some diseases.
“Left unchanged, there is a risk that Australia’s high discount rate will contribute to a lag in patient access to cutting edge therapies and impact the long-term health of future generations.
“Under Medicines Australia’s Strategic Agreement with the Government, a reduction to the discount rate should have been implemented by July 2022. It is important for this overdue policy change to be implemented immediately.
“Medicines Australia is again reiterating its call to lower Australia’s discount rate from 5% to 1.5% for vaccines and 3% for other medicines, to recognise the value of preventative and longer-term treatments and cures.
“The Government and the medicines industry share the goal to reduce the time it takes for a patient to access the medicines they need on the PBS. A reduced discount rate is an opportunity to move closer to achieving this goal,” she said.
Just released National Medicines Policy sets high ambitions for better health outcomes for all Australians
20 December 2022: Medicines Australia congratulates the Government on the release of the much-anticipated National Medicines Policy (NMP), after a comprehensive review process with stakeholders.
CEO of Medicines Australia, Elizabeth de Somer, said the refreshed NMP affects every Australian and sets the ambitions for our healthcare system to provide fair, timely, reliable and affordable access to high-quality medicines, vaccines and treatments.
“The release of the new NMP signals the end of a comprehensive consultation process and the beginning of a collaborative partnership to deliver on those ambitions for all Australians,” Ms de Somer said.
“The NMP incorporates a bold vision statement ‘To achieve the world’s best health, social and economic outcomes for all Australians through a highly supportive medicines policy environment.’
“Importantly, the new NMP includes modernised language that emphasises the need for good public medicines policy to ensure that the patients and the people it serves are central to the ambition.
“This is the first time the NMP has been updated in over 20 years and we now have a chance to establish this document as foundational for all Australians, and to prepare Australia’s health systems for the next health crisis.
“The pandemic has shown us that collaborative efforts across the health ecosystem can deliver wide, positive health outcomes. All Australians should have timely and equitable access to high-quality, safe, and effective medicines and health services, regardless of their background, age, or any other factor.
“It is encouraging to see a focus on fairness and access, especially to support improving the longstanding health disparities experienced in the community, particularly for Aboriginal and Torres Strait Islander people.
“Medicines Australia also supports the inclusion of some explanation on governance and responsibilities, but we would hope to see further clarification on these areas to provide proper monitoring and evaluation measures.
“The addition of a regular, five-year review and update of the NMP is also a significant commitment from Government and we look forward to ongoing consultation to ensure the NMP keeps pace with rapidly evolving medicines and new technologies so that Australia does not get left behind.
“The release of the NMP will support the further reforms to health policy including the Health Technology Assessment (HTA) Review in 2023 to speed up access to innovative medicines and technologies for Australian patients.
“We look forward to supporting the implementation of the NMP to ensure Australians and the next generations have equitable, fast and affordable access to innovative medicines, vaccines and therapies that will save lives and change lives,” Ms de Somer said.
What is the National Medicines Policy (NMP)? Watch this short explainer video.
Published in 2000, Australia’s National Medicines Policy (NMP) is a framework that aims to deliver positive health outcomes for all Australians through their access to, and appropriate use of, medicines.
The NMP guides the range of activities encompassing medication management, access, and affordability of medicines in Australia through a partnership approach between all sectors.
The Review of the NMP (the Review) was commissioned by the then-Minister for Health, the Hon. Greg Hunt MP, originally in 2019 in recognition of the substantial changes to the health landscape since the policy was implemented.
The Review has been led by an Expert Advisory Committee established by the Minister. The Committee is chaired by Deputy Chief Medical Officer, Professor Michael Kidd AM. Its members include Professor Lloyd Sansom AO; Mrs Janette Donovan; Dr Sarah Dineen-Griffin and Mr David Herd.
The Committee undertook a 12-week period of public consultation that commenced on 30 August 2021 and concluded on 17 November 2021. The Committee also held a virtual stakeholder webinar forum in December 2021 to present the key themes from the consultation process.
The then-Minister for Health deferred the NMP Review in March 2022 until after the May Federal Election following calls from a wide range of stakeholders who asked for more consultation and consideration time.
The new Minister for Health and Aged Care, the Hon. Mark Butler MP, restarted the Review in August 2022, re-convened under the Review Chair, Professor Michael Kidd AM. This was followed by another consultation period and the new draft released was much more considerate of views from stakeholders.
New report indicates COVID-19 vaccines saved Australia’s economy
19 December 2022: Medicines Australia welcomes the latest peer-reviewed research paper indicating the rollout of the COVID-19 vaccinations significantly reduced the economic impact of the pandemic.
CEO of Medicines Australia, Elizabeth de Somer said the paper – titled The Value of Vaccines: A Tale of Two Parts in Vaccines – demonstrates the benefit of fast access to medical innovations and points to the need for reform to our medicines assessment system so we are prepared for the next health challenges.
“Responding to the COVID-19 pandemic was a historic collective effort between the medicines industry, scientists, governments, and many individuals right across our health sector,” Ms de Somer said.
“This peer-reviewed paper confirms that the rollout of COVID-19 vaccinations – and the large, collaborative effort behind it – not only improved health outcomes for individuals, but had a dramatic positive impact across our economy, including the tourism and education sectors, employment and government finances.
“COVID-19 vaccines are estimated to have reduced the impact of the pandemic on the economy to an estimated $214 billion, resulting in a positive incremental benefit of $181 billion.
“This study also demonstrates the value of the wider, flow-on effects of vaccines that should be considered when the Government assesses the supply of medicines for our population.
“Australia’s assessment process does not adequately include the broader social and economic impacts of vaccines, medicines and treatments.
“The paper indicates that if the COVID-19 vaccines had followed the current formal Australian Government assessment processes – known as a health technology assessment (HTA) – Australians would have been waiting a long time. More lives would have been lost and our economy would have suffered.
“There is an intrinsic link between healthy people and a healthy economy.
“Preventative health measures, such as vaccinations, are clearly an investment in the prosperity of our nation.
“Our industry is committed to working with Government to ensure Australians have rapid access to the latest medical innovations as soon as they have been approved as safe and effective.
“We cannot afford possibly deadly delays,” Ms de Somer said.
Biointelect in conjunction with the Centre of Policy Studies, Victoria University developed the peer-reviewed publication The Value of Vaccines: A Tale of Two Parts. The publication estimated the economic impact of population-wide COVID-19 vaccination rollout in Australia for the period January 2020 to June 2023 and compared international health technology assessment (HTA) approaches to assessing the value of vaccines, along with recent efforts to consider broader Health Technology Assessment (HTA) valuation frameworks to capture the true value of medical interventions.
The funding for this research, including for model development, analysis, and medical writing, was provided by Pfizer Australia. The Article Processing Charge (APC) was funded by Pfizer Australia. The Value of Vaccines: A Tale of Two Parts was published online in Vaccines on 30 November 2022 and is available at: https://doi.org/10.3390/vaccines10122057.
Landmark event advances horizon scanning for disruptive health technologies in Australia
6 December 2022: For the first time, senior representatives from patient organisations, government and the life sciences industry have come together nationally to consider how Australia should prepare for disruptive health technologies.
‘Medicines of Tomorrow: Australia’s First Horizon Scanning Forum’ was held in Canberra to promote a greater understanding of new and emerging medicines and to facilitate faster access to these innovations for Australian patients.
Elizabeth de Somer, CEO of Medicines Australia, said the inaugural event brought together more than 300 stakeholders from across Federal and State/Territory Governments, the medicines and life sciences industry, researchers, clinicians and patient group organisations.
“The COVID-19 pandemic showed us how important it is to have rapid access to innovative medicines, vaccines and treatments once they have been approved as safe and effective,” Ms de Somer said.
“We cannot predict the future, but we are getting better at forecasting future health needs. Using science, data and human ingenuity, the future looks bright for health innovation – and we must be ready for its arrival.
“Horizon scanning means looking at trends in disease areas, populations, healthcare and technology solutions to identify disruptions which could challenge our health system.
“Without identifying disruptive technologies, we would not know what to prepare for. But we cannot just look at the horizon – we must act. And act in collaboration, as we did during the pandemic.
“Only by acting in partnership with industry, health experts, governments and patients will we be able to ensure that Australian patients have rapid access to the latest, disruptive health technologies that can transform and save lives,” Ms de Somer said.
Almost 300 attendees joined in Canberra and via an online stream. Highlights included:
Four insightful case studies on disruptive approaches to deal with challenging disease areas: precision medicine for mental health; gene therapy for Duchenne muscular dystrophy; disease modifying therapies for Alzheimer’s disease and combination therapies for cancer patients.
A presentation from University of Melbourne’s PRIMCAT team demonstrated how faster access to innovative cancer treatments could have economic impacts.
Attendees also heard how patients can benefit from horizon scanning and the key lessons from other countries’ horizon scanning systems.
The Minister for Health and Aged Care, the Hon. Mark Butler MP, addressed attendees via video message.
“Our Government is very pleased to see collaborations like today,” Minister Butler said in his video address.
“Myself and my team from across the Health Portfolio are committed to improving the outcomes for all Australians and events such as today move us forward in the right direction.
“I’m looking forward to progress horizon scanning in Australia to ensure our health systems are fit for purpose to bring innovative technologies to patients quickly,” Minister Butler said.
A key panel session with experts from across industry, patients, genomics and Government agreed that Australia needs a nationally coordinated horizon scanning system to benefit patients.
In summarising the event, Elizabeth de Somer said the day was a positive stride towards tighter collaboration that will in the end, benefit all Australians.
“At some point in our lives, we are all patients.
“We do not know what the future holds but by working together, we can better prepare for the latest medical and health innovations to make sure no Australian patient is left behind,” she said.
New Translational Science Hub in Queensland to boost Australia’s biomedical capacity and capability and deliver faster access to mRNA innovations
5 December 2022: Medicines Australia welcomes the new mRNA vaccine hub – the ‘Translational Science Hub’ – to be established in Queensland in an announcement by Sanofi and the Palaszczuk Government today.
Elizabeth de Somer, CEO of Medicines Australia, said the new Hub, once functional, will bring long-term health and economic benefits to Australia.
“The new Translational Science Hub is a $280 million partnership between Sanofi, the Queensland Government, the University of Queensland, and Griffith University.
“Collaboration is key to successful biomedical innovation and a lesson the world has taken from the COVID-19 pandemic.
“Bringing together the brightest minds from science, health and medicine to create centres of excellence for innovative technologies, here in Australia, will further boost Australia’s contribution to benefit patients and the broader economy.
“Australia has extraordinary talents and potential when it comes to our research and development capabilities. Manufacturing biotherapeutics domestically critically widens our workforce and talent pipelines to the vital areas of medicine and health.
“Today’s announcement demonstrates not only the importance of investing in our domestic capabilities but the importance of investing in medicines and science.
“Congratulations to Sanofi and all the partners for taking bold strides towards a pioneering, international scientific community that focuses on mRNA technology and translational science,” Ms de Somer said.
The Translational Science Hub will be established under an agreement between Sanofi, the University of Queensland, Griffith University and the Queensland Government. For more information, read the Queensland Government announcement and the Sanofi announcement.
