mRNA manufacturing facility will deliver long term health benefits for Australians

14 December 2021: Medicines Australia welcomes the announcement that Australia will manufacture mRNA vaccines in a deal struck with Moderna today.

The manufacturing facility is expected to open in Victoria in 2024 pending regulatory and planning approvals. Once operational, the facility will have the capacity to produce 100 million mRNA COVID-19 vaccines each year and contribute to future pandemic preparedness.

“This is a major milestone for all Australians as we continue to fight COVID-19. It is also an enormous health opportunity for our country and will mean Australia can develop new, innovative vaccines and potentially new therapeutics that can meet the future needs of Australian patients,” said Liz de Somer, CEO of Medicines Australia.

Liz de Somer spoke about Australia’s extraordinary R&D capabilities and the flow-on effects the manufacturing facility will have in creating job opportunities, increasing R&D capabilities and timely access to medicines, therapeutics and vaccines for Australians.

“Domestic manufacturing can translate innovative research into real, long-term health and economic outcomes for Australians. The mRNA manufacturing facility will add to our high-quality medical research infrastructure and grow our skilled workforce of scientists and healthcare professionals,” she said.

Ahead of the announcement, Medicines Australia called for a national approach for mRNA manufacturing at the Senate inquiry into Australia’s manufacturing industry.

Medicines Australia is pleased to see the Federal Government working together with the States and Territories on such an important initiative which will benefit all Australians. The innovative biopharmaceutical industry looks forward to building on this in the coming years to increase Australia’s advanced manufacturing capabilities and boost the competitiveness of our life sciences ecosystem.

“In order to continue to grow our sovereign biopharmaceutical capacity and capability and to compete globally, we must improve the coordination, consistency and collaboration across Australia to drive greater social, health and economic benefits to ensure no Australian patient is left behind,” concluded Ms de Somer.

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For media enquiries and interview opportunities, please contact:
Chrystianna Moran – 0424 995 118 / chrystianna.moran@medicinesaustralia.com.au

Award winners recognised

13 December 2021: Winners from across the Australian healthcare system have been announced for the Medicines Australia Continuing Education Program (CEP) Awards.

The CEP Awards recognises individuals who were the standout, star students of the 2020 CEP course, which saw a record number of students complete the online course through the University of Tasmania.

“My warm congratulations to the Award recipients who have shown an exceptional understanding of the importance of upholding the highest standards of ethical conduct, integrity and best practice. Their newfound knowledge will be an asset to their respective organisations and ultimately, to the patient community,” said Sophie Hibburd, Head of Ethics and Compliance at Medicines Australia

“The CEP courses were updated to reflect the new Code of Conduct, which can into effect in March last year. The 19^th edition of the Code was completely updated to be more agile and flexible and so to, did the revised CEP courses, which saw a record number of completions in 2020,” she added.

Nicole Chen, recipient of the Code of Conduct Award, said “the award means a lot as I was new to the pharmaceutical industry. I very much enjoyed going through the online program which combined a mix of theory, case studies and quizzes to test my knowledge. This helped me gain the knowledge and skills needed as a marketing professional to confidently undertake my responsibilities at work.”

Medicines Australia congratulates the following award winners;

Nicole Chen – Code of Conduct Award (2020)

Nicole, employed by Eli Lilly Australia, achieved the highest mark for Program 1 (The Medicines Australia Code of Conduct).

Francis Shand, of AbbVie, and Aleksandar Jakovljevic, of Allergan Australia – won the University of Tasmania Excellence Award (Semesters 1 and 2 respectively)

The following 10 students won a CEP Achievement Award, achieving the 10 highest aggregate marks for the majority of the core programs:

Jessica Wu, currently of GSK Australia, formerly of Hahn Healthcare
Nicola Barwald, Boehringer Ingelheim
Erryn Tomkins, formerly of Mundipharma
Aleksandar Jakovljevic, Allergan Australia
Joshua Ward, AstraZeneca
Colin Eves, GSK Australia
Dylan Wan, Bayer Pharmaceuticals
Kiran Munde, Hahn Healthcare
Matt Crum, Pfizer Australia, and
Louise Welsh, GSK Australia

While an in-person CEP Awards Ceremony was cancelled due to extended lockdowns, this doesn’t diminish the award recipients’ achievements. Awards for the 2021 CEP Program will be announced in early 2022.

The Medicines Australia CEP Program educates medical representatives to a recognised high industry ethical standard. The Program is offered online through the University of Tasmania, with 2022 Semester One enrolments opening on 10 January.

More on the CEP program is on the Medicines Australia website.

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For media enquiries and interview opportunities, please contact:
Chrystianna Moran – 0424 995 118 / chrystianna.moran@medicinesaustralia.com.au

ACCC helps to protect Australians against medicine shortages caused by COVID-19

10 December 2021: Medicine shortages from the COVID-19 pandemic will continue to be actively managed by Medicines Australia and the Generic Biosimilar Medicines Association (GBMA) thanks to an authorisation confirmed by the ACCC.

The authorisation extension will allow the Federal Government to work with Medicines Australia and the GBMA to continue to implement a coordinated strategy in relation to the supply of essential medicines and related devices in response to the COVID-19 pandemic.

Elizabeth de Somer, CEO of Medicines Australia, said that the emergence of the Omicron variant demonstrates that disruption and shortage issues are far from over.

“All Australian businesses have felt the pressure on their supply chains, including challenges with freight delays. As the COVID-19 pandemic continues it remains critical that we can continue to work together for Australian patients to have access to the medicines they need.”

“This ACCC authorisation allows us to continue to manage and minimise risks that could disrupt medicine supply to hospitals and patients,” said Ms de Somer.

Marnie Peterson, CEO of the GBMA, added that the ACCC authorisation will help deliver uninterrupted and timely access to the medicines Australians need.

“The COVID-19 pandemic has thrown disruption into everyone’s lives,” Ms Peterson said. “Behind the scenes, the Australian medicines industry has been working hard to protect Australians against global medicine supply chain shocks.”

Medicines Australia and the GBMA both recently put into place respective Strategic Agreements with the Australian Government that will focus on timely access to innovative medicines, treatments and vaccines, and further strengthen protection for patients from medicine shortages.

Medicines Australia and the GBMA thank the ACCC for their consideration and final authorisation. The authorisation has been granted for a period of 12 months, expiring on 30 September 2022.

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Media enquiries:

Medicines Australia: Chrystianna Moran – 0424 995 118 / chrystianna.moran@medicinesaustralia.com.au

GBMA: Jannette Cotterell – 0419 204 059 / jcotterell@executivecounsel.com.au

About Medicines Australia

Medicines Australia leads the research-based medicines industry of Australia. Its members discover, develop and manufacture prescription pharmaceutical products, biotherapeutic products and vaccines that bring health, social and economic benefits to Australia. its members invest in Australian medical research and take local discoveries and developments to the world.

About the GBMA

The Generic and Biosimilar Medicines Association (GBMA) is the peak representative body of generic and biosimilar medicine suppliers in Australia.

Its members ensure that all Australians are offered high quality generic and biosimilar medicines, whilst providing affordable community health outcomes that benefit all Australians.

<< Read previous: Medicines industry continues to protect Australians from medicine shortages

Improvements to clinical trials will strengthen Australia’s economy and benefit patients

8 December 2021: Clinical trials in Australia need improvements if we are to increase our global competitiveness says Medicines Australia in a new paper released today.

Clinical trials provide benefits to patients, the healthcare system and the economy. The COVID-19 pandemic has shown how quickly innovative medicines, therapeutics and vaccines can evolve. Encouraging the global biopharmaceutical industry to invest in Australian clinical trials creates highly skilled jobs, a more competitive economy and places Australian patients at the front of the queue for innovative treatments.

Medicines Australia delivered evidence today at the Inquiry into the Australian Manufacturing Industry. Medicines Australia CEO, Elizabeth de Somer, and Chair, Dr Anna Lavelle, highlighted current barriers and the opportunities R&D and clinical trials can provide in reinvigorating economic growth.

“Where Australia has a competitive advantage, we need to leverage that advantage to grow the industry, the sector and create job opportunities,” Elizabeth de Somer, CEO of Medicines Australia, told the Inquiry.

In 2019, $1.4 billion were invested in clinical trials and at least 8000 Australian jobs were supported by the clinical trials sector.

“Australia punches above our weight in scientific endeavours, in our research institutions and in our healthcare provisions. However, particularly for clinical trials, each state and territory have different regulatory and ethics approval systems. In Australia, that creates a delay and a barrier to setting up and recruiting patients to those clinical trials.”

In a rapidly evolving international environment, Australia must do more if we are to remain globally competitive for clinical trials. This could be done by harmonising the different requirements across states and territories, which currently lead to unnecessary duplication and complexity.

“Clinical trial reform has been discussed since 2006 without major improvements. Current government consultations such as the ‘One Stop Shop’ and ‘Clinical Trials Front Door’, must create change and boost Australia’s international competitiveness once and for all,” said Ms de Somer.

Medicines Australia, as the lead member of the Research & Development Taskforce, has outlined four key principles to achieve a clinical research environment that is efficient, cost-effective and runs to world’s best practice now and in the long term.

Medicines Australia will continue to engage with the consultation processes and actively advocate for reform.

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For media enquiries and interview opportunities, please contact:
Chrystianna Moran – 0424 995 118 / chrystianna.moran@medicinesaustralia.com.au

About Medicines Australia

Medicines Australia leads the research-based medicines industry of Australia. Our members discover, develop and manufacture prescription pharmaceutical products, biotherapeutic products and vaccines that bring health, social and economic benefits to Australia. Our members invest in Australian medical research and take local discoveries and developments to the world.

Our mission is to drive policy outcomes in partnership with government, health sector organisations and the community which will ensure Australians have universal, affordable and fast access to treatments that keep pace with advancements in medicine.

About the R&D Taskforce

Since 2006, the RDTF has been a unique forum for developing, evaluating and providing expert advice to Government on issues affecting clinical research in Australia. Convened by Medicines Australia, AusBiotech and the Medical Technology Association of Australia, the RDTF brings together senior executives from the peak bodies and companies representing the industry sectors, including the research-based and the biotechnology sector. In addition, these sectors are among the Australian health system’s most crucial components: they research, develop, manufacture and supply products that Australians use to lead healthier and more productive lives.

The RDTF is committed to working with all stakeholders to ensure that our clinical research industry remains a strong contributor to this country’s economy and to the health and wellbeing of all Australians.

Medicines Australia thanks Minister Hunt

Medicines Australia thanks Minister Greg Hunt

Minister Hunt stands in front of a sign that reads "#Medicines Matter" — Minister Hunt at PharmAus21 ‘Room for the Patient View’ in June 2021.

2 December 2021: Medicines Australia wishes to thank the Hon Greg Hunt MP for his service to Australian patients and the health industry, following his announcement to retire from Parliament at the next election.

Minister Hunt has been the Minister for Health and Aged Care since 2017 and has been an energetic and active Health Minister, not least in his leadership of the response to the COVID-19 pandemic.

“I have had the honour of working closely with Minister Hunt over the past four years, to achieve measures that assist Australian patients today and into the future,” said Dr Anna Lavelle, Chair of Medicines Australia.

“Despite the turmoil and uncertainty of the COVID-19 pandemic, Minister Hunt has led with conviction and integrity. He has been an integral part of the biopharmaceutical industry’s response to the pandemic and most importantly, has shown great empathy and compassion for Australian patients.”

“On behalf of Medicines Australia and the Board, we thank Minister Hunt for his collaboration and extraordinary commitment, which has delivered health benefits for all Australians.”

Medicines Australia has delivered several landmark outcomes during Minister Hunt’s tenure including the recently finalised five-year Strategic Agreement which sets an ambitious plan for innovative medicines into the future.

“Minister Hunt leaves a lasting legacy, showing a deep commitment to Australian patients as the beneficiaries of our national health care compact. Whether announcing the listing of a new, innovative medicine, or working with industry and other stakeholders, the Minister’s passion and energy has been unmistakable. I am sincerely grateful for his leadership and partnership over the past few years and wish him all the best,” said Elizabeth de Somer, CEO of Medicines Australia.

Medicines Australia looks forward to continuing to work with the Minister until the end of his term and continue our strong partnership with the Department of Health to make a real difference to the health of Australians by ensuring they have access to world-class medicines when they need them.

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Media contact: Chrystianna Moran
+61424 995 118 / chrystianna.moran@medicinesaustralia.com.au

Strengthening patient access to new medicines through new landmark Bill

2 December 2021: Australians will see improved access to new and innovative medicines, vaccines and treatments as a landmark Bill passes in Parliament today.

The recently legislated laws will ensure funding for new medicines in the PBS, as well as several new initiatives that elevate Australian patients and their real-life experiences. Patients becoming more engaged in key decision-making processes is a progressive step forward that will benefit our whole health system. Involving more patients to share their real-world evidence will place a higher value on medicines and treatments that give patients better quality of life and improved health outcomes.

The new legislation formalises elements of the five-year Strategic Agreement, which was signed by the Minister for Health and Aged Care, the Hon Greg Hunt MP, and Medicines Australia in September this year.

“Medicines Australia was pleased to see this legislation pass on the last sitting day of the year,” said Elizabeth de Somer, CEO of Medicines Australia. “At the centre of our Strategic Agreement are Australian patients, who will benefit from having fast access to new and innovative medicines and technologies, such as gene and cell therapies.”

“This legislation has received a high level of bipartisan support and is an important piece in the stable footing of the PBS. It signals sustainability and predictability for the biopharmaceutical industry here in Australia and places a priority on new and innovative medicines through guaranteed funding.”

“We will continue to work closely with the Government and the Department of Health as the Bill is implemented to ensure patients continue to receive the medicines they need when they need them.”

The Medicines Australia Strategic Agreement includes many pioneering initiatives such as the independent HTA review, enhanced consumer engagement in the PBAC and a first-ever horizon scanning forum so Australia is best placed to take advantage of the latest and greatest biopharmaceutical advances that are on the cusp of discovery.

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Media contact: Chrystianna Moran
+61424 995 118 / chrystianna.moran@medicinesaustralia.com.au

Medicines Australia welcomes tabling of parliamentary report about approval processes for new drugs and novel medical technologies

25 November 2021: Medicines Australia welcomes the House of Representatives Health, Aged Care and Sport Committee Inquiry report into Approval Processes for New Drugs and Novel Medical Technologies in Australia, tabled in Parliament today.

Given the extraordinary advancements in scientific research and development, and the pace of change in technology, the Inquiry is timely and critical, and has prompted a considerable number of submissions from across Australia.

“The report, tabled in Parliament today, is the result of more than 12 months of demanding effort, and thorough consultation by the Committee to review over 200 submissions and hold over 50 public hearings,” said Elizabeth de Somer, CEO of Medicines Australia.

“The amount of energy and thoughtfulness that was put into each of these submissions was exemplary and the Committee has given considerable attention to the stakeholder contributions.”

Medicines Australia’s analysis of the submissions in June this year highlighted the call for greater involvement of the patient voice and prioritising fast access to new and innovative medicines, vaccines and treatments to ensure that no Australian patient is left behind.

“Medicines Australia is hopeful that the upcoming independent review of Health Technology Assessment (HTA) policies and methods will help address some of the issues raised during this Inquiry,” said Ms de Somer.

“I want to thank all the Committee members, but especially the Chair and Deputy Chair, Trent Zimmerman MP and Dr Mike Freelander MP for their ongoing, bipartisan support and close consultation with all stakeholders, including patients, that has resulted in today’s report.”

Medicines Australia looks forward to reviewing the report’s 31 recommendations and hearing the Government’s response.

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Media contact: Chrystianna Moran
+61424 995 118 / chrystianna.moran@medicinesaustralia.com.au

New members of the Medicines Australia Advisory Council

Advisory Council set their sights on the horizon

27 October 2021: Medicines Australia has appointed two new members to its future-focused Advisory Council. Former Secretary of the Department of Health, Glenys Beauchamp PSM and CEO of Rare Cancers Australia, Richard Vines were announced at Medicines Australia’s AGM today.

“It is with great pleasure to introduce these two brilliant minds to the Advisory Council,” said Dr Anna Lavelle, Chair of Medicines Australia Board and Chair of the Advisory Council.

“Glenys Beauchamp brings deep experience from her time serving as a senior public servant. Her leadership of the Department of Health and outstanding foresight in coordinating a whole of government response to the 2009 Victorian bushfires was recognised with the Public Service Medal. Glenys’ thorough understanding of the intersection between industry policy and health policy, having formerly led the Department of Industry, will be of enormous value to the Advisory Council and the Board,” said Dr Anna Lavelle.

“It is a great honour to join the Medicines Australia Advisory Council,” said Glenys Beauchamp PSM. “As we start to recover from the pandemic, we must identify strategic issues that will pose risks, opportunities and trends that may impact our Australian health system,” she said.

“Richard Vines is a powerhouse in patient advocacy. Rare Cancers Australia, under Richard and Kate’s leadership, has gone from strength-to-strength ensuring that patients’ values, wishes and concerns are heard loud and clear. The patient voice is an essential element as the Council look to smart and effective solutions that make a real difference to the health of all Australians,” said Dr Anna Lavelle.

“I am grateful to be contributing to the important work of the Advisory Council,” said Richard Vines. “The patient voice is a key driver to ensuring Australians from all walks of life have fast access to medicines when they need them. Looking at the long-term operational issues will be a focus area that can create real change,” he added.

Glenys and Richard will join the other members of the Advisory Council:

Dr Anna Lavelle, BSc (Hons) PhD GAICD FTSE – Chair, Independent director
Belinda Wood – Senior Director Government Affairs ANZ – Gilead Sciences
David Norton
Glenys Beauchamp PSM
Greg Allen, FCHSM, CHE – Finance Manager, Epworth Freemasons Hospital
Jane Hill, FAICD – CEO, Ovarian Cancer Australia
Kelly Constable – Co-Founder and CEO of AULUS Partners
Dr Leigh Farrell, FAICD – Executive Advisor to Certara C-Suite
Richard Vines – Founder and Chair of Rare Cancers Australia

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Media contact: Chrystianna Moran
+61424 995 118 / chrystianna.moran@medicinesaustralia.com.au

About Glenys Beauchamp PSM

Glenys Beauchamp is now working in the private sector after more than 35 years in the public service, including the Australian Public Service and ACT Public Service. She was Secretary in the Australian Public Service for nearly 10 years, leading three departments with a variety of functions. She established and led the Department of Regional Australia, Local Government, Arts and Sport following the 2010 Federal election and later headed up the Department of Industry, Innovation and Science and the Department of Health.

Soon after leaving the public service from March 2020, she chaired a Health Industry Co-ordination Group with key health and industry stakeholders to help secure PPE for Australia at the start of the COVID-19 pandemic.

About Richard Vines

In 2012 Richard and his wife Kate established Rare Cancers Australia, a patient advocacy group whose mission is to improve the lives and outcomes for rare cancer patients. Richard is now a highly sort after spokesperson for cancer patient advocacy issues and is a member of a number of committees. In September this year, Richard was named Co-Chair of the Cancer Drugs Alliance Committee, a stakeholder coalition tasked to promote timely access to drugs for cancer patients.

About the Medicines Australia Advisory Council

The Advisory Council was established in 2017 to support the Medicines Australia Board’s role in shaping strategy and maintaining appropriate continuity of direction. The future-focused Advisory Council will provide the Board with advice on trends and issues impacting Industry in the medium to long term. The Advisory Council will hold their next meeting in November this year.

Pharmaceutical industry backs workplace vaccinations

5 October 2021: Medicines Australia strongly recommends full COVID-19 vaccinations for the health and safety and protection of all employees, including those who work in the biopharmaceutical industry.

The release of the biopharmaceutical industry position follows a growing number of high-profile employers, including member companies, who introduced mandatory vaccination policies last month.

Medicines Australia are powerful advocates for the COVID-19 vaccine and stand by those who require employee vaccinations to protect the health and safety of employees, manufacturers, frontline health workers, patients, and the community they work with during these unprecedented times.

Medicines Australia is the industry peak-body for the biopharmaceutical industry in Australia, who employ almost 15,000 people around the country¹.

Elizabeth de Somer, CEO of Medicines Australia, said supporting the global and national vaccine rollout must remain a strong priority.

“The more people who get vaccinated, the less likely it is people will become critically sick from COVID-19. COVID-19 vaccines are safe and effective, according to well-understood standards of scientific and clinical evidence. We must do all that we can to protect one another, including in the workplace,” she said.

“This is a proud moment in our industry’s history. I am grateful to the highly skilled Australian workforce who are making a real difference to the health of all Australians.”

In a position developed for members, Medicines Australia outlined five key principles that underpin support of workplace COVID-19 vaccinations:

1. Vaccinations are a critical pillar of public health policy as they guard against the spread of communicable diseases and reduce the burden of illness on individuals, families, the community, and the broader healthcare system.
2. High vaccination rates must be encouraged to support herd immunity and prevent the COVID-19 virus from easily spreading from person-to-person.
3. Education is a critical component in building confidence in vaccinations.
4. The TGA rigorously assess any COVID-19 vaccine for safety, quality, and effectiveness before it can be supplied in Australia. Post Market quality safety and efficacy is assured through robust pharmacovigilance and traceability mechanisms.
5. Health is fundamental to ensure the economic prosperity of Australia and the world.

Everyone in Australia aged 12 years and over is now eligible for a free COVID-19 vaccination. To find out more about eligibility and local state and territory information, visit the Department of Health website.

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Media contact: Chrystianna Moran
+61424 995 118 / chrystianna.moran@medicinesaustralia.com.au

^{1 Arna Richardson, 2019, IBIS World. Pharmaceutical Product Manufacturing in Australia}

Medicines industry continues to protect Australians from medicine shortages

ACCC extends approval for ongoing collaboration

30 September 2021: Following 18 months of working closely to protect Australian patients against medicine shortages, the Australian medicine industry has been given the green light by the competition regulator to continue its successful collaboration.

Peak industry bodies, Medicines Australia (MA) and the Generic and Biosimilar Medicines Association (GBMA) have been granted a further conditional interim authorisation from the Australian Competition and Consumer Commission (ACCC) to continue to work together, with the Government, to secure the supply of essential medicines during the COVID-19 pandemic.

The MA-GBMA Working Group, established early last year, allows their respective member companies to coordinate with the Government so that potential or emerging medicine shortages are quickly and effectively identified and managed.

Today’s decision comes after nearly two extraordinary years where Australian medicine researchers and the local and global biopharmaceutical sector have worked tirelessly to research, develop, manufacture, and deliver safe and effective COVID-19 vaccines and treatments.

Elizabeth de Somer, CEO of Medicines Australia, said that against this backdrop, the Australian medicine industry has worked around the clock to ensure Australian patients could continue to access their medicines.

“The highly skilled, talented people, who work for the industry, have worked tirelessly so we can protect ourselves against this virus and still receive other critical medicines, but we are not out of the woods yet,” she said.

“As the spread of the Delta variant continues to put pressure on our healthcare system, it is critical that we work together to secure the supply of vital prescription medicines, including those needed for patients in ICU,” she said.

Marnie Peterson, CEO of GBMA, said the risk of medicines shortages is one of the most important challenges facing both the Government and the healthcare industry during this global health and economic crisis.

“At the forefront of all of our collective decision-making, is the safety and protection of all Australians,” she said. “It is on their behalf, that we collaborate closely with all governments to develop policies and implement protocols to secure supply and manage medicine demand by community pharmacies, prescribers and hospitals.”

The ACCC conditional interim authorisation for Medicines Australia and GBMA will continue until the ACCC makes its final determination (currently scheduled for February 2022), or the ACCC decides to revoke the interim authorisation. Medicines Australia has requested that the ACCC grant it authorisation for a period of 12 months in its final determination. The ACCC order and update can be found here.

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For media enquiries and interview opportunities, please contact:

Medicines Australia: Chrystianna Moran – 0424 995 118 / chrystianna.moran@medicinesaustralia.com.au

GBMA: Jannette Cotterell – 0419 204 059 / jcotterell@executivecounsel.com.au