Media Releases – Page 15 – Medicines Australia

Medicines Australia’s Statement on the arrival of the Pfizer Vaccine

16 February 2021: Medicines Australia welcomes the arrival of the first doses of The Pfizer/BioNTech vaccine to Australia.

This marks a significant milestone in our nation’s vaccination program response to the pandemic and deliver much-needed vaccines to Australians.

We support the government in the prioritised roll-out to ensure those on the frontline and the most vulnerable receive priority access to the vaccine this includes quarantine and border workers, healthcare workers, aged care and disability care residents and staff.

The Pfizer/BioNTech vaccine is the first vaccine to receive provisional approval for use in Australia by the TGA. The Pfizer vaccines will be batch-assessed for quality, safety, and efficacy to ensure all Australians have confidence in the vaccines they receive.

Read more in the Prime Minister’s media release.

For further information, please contact Jasmine.Kaur@medicinesaustralia.com.au

Medicines Australia Statement on TGA’s provisional approval of AstraZeneca’s COVID-19 vaccine

16 February 2021: Medicines Australia welcomes the TGA’s decision granting provisional approval of the AstraZeneca/Oxford University COVID-19 vaccine, marking the second COVID-19 vaccine to receive regulatory approval in Australia.

This landmark decision is a testament to the swift action, hard work, and unprecedented collaboration between the industry, Government, and scientific community to address the pandemic.

Initial supply of the vaccine will be imported into Australia from overseas, however ongoing supply will be manufactured locally by CSL making it available for use in Australia throughout the year.

Prior to supply of vaccines manufactured onshore, AstraZeneca will submit further information and data to the TGA to confirm that onshore manufacturing will meet strict quality standards.

Medicines Australia will continue to work closely with all partners across the healthcare ecosystem locally and globally to advance progress in our fight against Covid-19 and ensure Australians have access to necessary vaccines.

Read the TGA Statement for more.

For further information, please contact Jasmine.Kaur@medicinesaustralia.com.au

Medicines Australia’s position on potential European Union restrictions and vaccines supply

30 January 2021: Medicines Australia is concerned by the reports of proposals from Europe that could impact the global supply chains of COVID-19 vaccines.

Maintaining global supply chains is a top priority for the medicines industry and is key to delivering vaccines to protect citizens against COVID-19. The making of a vaccine requires many dozens of ingredients and manufacturing components which come from multiple sources around the world.

Covid-19 vaccines are needed by everyone to get us back to a ‘new normal’ (locally in Australia and globally). We recognise this is a complex and vast undertaking, so it is critical for us to work together to manage the vaccine roll-out in Australia and around the world.

To achieve this, it is imperative that no restrictions are applied that would disrupt the manufacturing and delivery of vaccines.

We have reached out to the Federal Government regarding Australia’s supply being on track and commencement of the vaccination program from late February, including acknowledgement of Australia’s onshore manufacturing capability.

We will continue to work with the Government to support Australia’s supply chains of medicines and vaccines.

For global statements see EFPIA statement here and IFPMA statement here.

For further information, please contact Jasmine.Kaur@medicinesaustralia.com.au

Medicines Australia appoints two new Board Directors: Anne Harris, Pfizer and Shannon Sullivan, Amgen

24 November 2020: Medicines Australia is extremely pleased to announce the appointment of Anne Harris, Managing Director, Pfizer Australia and New Zealand and Shannon Sullivan, Vice President & Managing Director, Amgen Australia and New Zealand to the Medicines Australia Board.

These two new Board appointments follow a formal election process for positions previously held by Bruce Goodwin, Janssen and Melissa McGregor now in an international role with Pfizer. Bruce Goodwin will be continuing as a Selected Director on the Medicines Australia Board following today’s annual general meeting.

Welcoming Ms Harris and Ms Sullivan to the Board, Medicines Australia Chair, Dr Anna Lavelle acknowledged the significant breadth of experience and knowledge these senior leaders bring to Medicines Australia.

“This is a pivotal time for industry and requires significant strength and determination to set a clear path through the recovery of the pandemic and firmly into the future,” states Dr Lavelle. “We have outstanding knowledge and capabilities within our leadership team and now introducing the considerable leadership expertise and strategic insights from Anne and Shannon will strengthen us even further.”

“It is a great pleasure to be welcoming such exemplary and capable leaders to the Medicines Australia Board,” adds Medicines Australia CEO, Ms Elizabeth de Somer. “2021 will likely be another year of significant shifts and disruptions in our community and economy. Having such expertise on our team will place us in the firmest possible position to ensure we maximise the transformation of the innovative medicines underway – ensuring Australians who need them receive them in a timely manner.”

Anne Harris was appointed Managing Director Pfizer Australia and New Zealand in March 2020 and brings over 25 years of industry experience across strategic and operational commercial roles in Europe, Canada, and Emerging Markets.

Her most recent experience leading Pfizer’s Vaccines Business Unit for Developed Asia introduces important policy and thought leadership in vaccines access for Australians – which will be a critical focus for COVID-19 in 2021 and beyond.

Ms Harris also brings extensive experience leading major regional roles in smoking cessation and multi-channel marketing across the Asia Pacific region. Her breadth of international experience will provide clear insight into a wide range of models for access to medicines and vaccines.

“I am humbled to be elected to the Medicines Australia Board and to be granted the important responsibility of contributing to the future direction of our industry. I would like to acknowledge all the candidates in the Board election for their dedication to continually improve patient access to breakthrough medicines and vaccines,” Ms Harris said.

“It is an honour to be joining the Board at this critical time, with our industry leading the recovery of the COVID-19 pandemic which is so important for the health of the population and the economy. I am committed to the enduring strength of our medicines industry, and to help the Board deliver on its broader goals of reforming health policy to improve medicines and vaccine access for all Australians,” she said.

Shannon Sullivan was appointed Vice President & Managing Director, Amgen Australia and New Zealand in July 2020. Ms Sullivan is an accomplished healthcare executive with over 20 years of leadership experience in sales, marketing, market access, healthcare compliance, and commercial operations.

For the past decade she has held high level executive roles in the US gaining unique experience in translating strategy into actionable execution as well as delivering on outcomes and results. She is uniquely skilled at developing matrixed teams that transform outcomes based on evolving external environments and business needs.

“I am thrilled to be appointed to the Medicines Australia Board and would like to thank my peers for their support and belief in my commitment to contribute to the important work of our industry. I look forward to representing Amgen and our industry and to working hard to deliver change that will improve the lives of Australian patients,” said Ms Sullivan.

“Reinforcing our contribution in critical priority areas including the Continuity of Care Collaboration is something that must remain a priority. I will actively support and ensure we have a broad and constructive contribution to the patient community together with a broader group of stakeholders,” she adds.

Chair, Dr Anna Lavelle formally thanked both Bruce Goodwin and Melissa McGregor for their significant contributions to the Medicines Australia Board and the industry.

“Both Bruce and Melissa have been very active contributors to Medicines Australia and our vision for industry. Their commitment and determination have been outstanding. We are of course thrilled to have Bruce returning in his new capacity. We also thank Melissa for her incredible involvement and wish her great success in her new international role.”

For further information please contact Jamie Snashall on 0407 438 746 or Anne-Marie Sparrow on 0417 421 560.

Findings from New ‘Access to Medicines’ Report – Registration times for new medicines accelerating in Australia but broader reimbursed access behind international standards

Canberra, Monday 16 November 2020: A new report launched by Medicines Australia, assessing the timelines for registration and reimbursement of new medicines for Australian patients, against other OECD countries, shows faster registration by the Therapeutic Goods Administration (TGA) is being achieved, but broader access and reimbursement is behind international standards.

The Medicines Matter Report: Australia’s Access to Medicines 2014- 2019 analyses new and robust data into how Australia’s regulatory processes are faring (both registration and reimbursement) for the introduction of new molecular entities (NMEs), with first indications anywhere in the world, against other comparable OECD countries.

The report findings show significant improvements have been made with TGA registration timelines. Accelerated pathways and international collaborations are reducing timelines, on average, by 182 days. However, while 60 percent of new medicines are reimbursed in Australia within 12 months, this lags behind more than 60 percent of new medicines reimbursed within 6 months, on average, across the OECD countries assessed – highlighting an opportunity for greater attention and progress.

“Never before have innovative medicines been so integral to our nation’s health and also our economy,” states Elizabeth de Somer, CEO Medicines Australia. “It is imperative, particularly in these challenging times, we strive to keep up with the pace of transformation and therapeutic advancement for Australian patients, our community and our future.

The Medicines Matter Report involves a detailed and unique methodology, built by IQVIA, that standardises timelines for medicines registration (market authorisation) and also reimbursement across a variety of healthcare systems within comparable OECD countries including Australia.

“Pharmaceutical companies have broad and deep pipelines of innovative and advanced therapies – including gene and cell-based medicines. We recognise the breadth and complexity of these new and emerging medicines are not without many challenges,” continues Ms De Somer. “It is, however, essential we work collaboratively to ensure we have a contemporary and fit for purpose approach for the future so that patients benefit from these advancements as soon as possible.

“We believe Australia’s ability to retain a position as a ‘first wave’ country for registration and reimbursement of medicines is at risk. This not only impacts timely delivery of medicines to patients, but also how Australia is viewed and prioritised by established and emerging companies for the introduction of future innovative solutions to this country. Acting now is essential.”

TGA registration times have seen significant improvements: The introduction of the priority review and provisional registration pathways have significantly reduced evaluation and approval times: –

Six medicines were designated for the Priority Review Pathway (2018 and 2019) and on average were processed 182 days quicker than medicines on the standard review pathway.
International work sharing programs including Project Orbis and the Australia-Canada-Singapore- Switzerland Consortium (ACCSS) expedited the TGA process for seven medicines.

Further improvement is required with reimbursement timelines: In contrast, reimbursement timelines require attention, to ensure Australia tracks closer to its international counterparts: –

Close to 60 percent of new medicines achieve reimbursement in Australia within 12 months from submission to the PBAC (2014 – 2019).
In comparison, the majority of OECD countries achieve reimbursement, on average, with more than 60 percent of medicines within 6 months.
In three top OECD countries, reimbursement is achieved for 60 percent of medicines within 3 months – setting an aspirational timeline for other nations to review and work towards.

Differences across therapy areas: The findings show differences in registration and reimbursement timelines across the therapeutic areas: –

Oncology and cardiovascular medicines had some of the longest average timelines to listing (125-1144 days for oncology, 222 – 1007 for cardiovascular medicines).
This is in contrast to asthma and arthritis which had some of the fastest timelines (asthma 142 -348 days, arthritis 152 -337 days).

“It’s time now to work in partnership and introduce progressive improvements to the regulatory and reimbursement processes working on a range of requirements – that recognise the full value of innovative medicines, builds active contribution and involvement by consumers and establishes transparency and measurement of progress made,” concludes Ms De Somer.

For further information please contact Jamie Snashall on 0407 438 746 or Anne-Marie Sparrow on 0417 421 560.

New report charts future course for increased generation and adoption of Real-World Evidence (RWE)

11 November 2020: A new report, released today by Medicines Australia, draws attention to important opportunities for researchers, industry and the Australian healthcare system to fully realise the benefits of applying ‘Real World Evidence’ (RWE) to health technology assessment and healthcare decision-making.
The proposed course of action would bring Australia in line with comparable international jurisdictions allowing it to keep pace with the rapid advances in personalised medical treatment, with improved patient outcomes the ultimate goal.

According to the Report, ‘The evolving role of real-world evidence in Australia’, prepared by the Medicines Australia Oncology Industry Taskforce RWE Working Group, real world evidence has the potential to reduce uncertainty and enable more informed, evidence-based decision-making across the healthcare ecosystem. The recommendations of the report are integral to Medicines Australia’s formal submission to the current House of Representatives Standing Committee on Health, Aged Care and Sport ‘Enquiry into Approval Processes for New Drugs and Novel Medical Technologies’.

The Report, developed by a cross-industry collaboration between several of Australia’s leading developers of innovative oncology medicines, draws attention to several critical challenges associated with the planning, delivery and acceptance of RWE. It also considers steps to progress a more standardised systematic approach than currently in place.
‘Rather than being an inferior and less credible form of evidence, real world evidence, from a range of sources, has the potential to substantially increase to our understanding of the effectiveness, safety and, value of new medicines in ways that are simply not possible through other more traditional methods alone,’ stated Prof John Zalcberg, a medical oncologist from Victoria.
‘Whilst RWE cannot replace the scientific rigour associated with traditional approaches, such as the randomised controlled trial, it can prove vital as a source of valuable information when overcoming some of the practical, ethical and economic challenges the emergence of precision (or personalised) medicine have raised for us when attempting to bring new innovative and effective medicines to patients-.’ Prof Zalcberg added. ‘This can lead to lengthy delays as attempts are made by sponsors to bridge these gaps.’

The Report identifies two critical challenges to address, as a first step, in developing a long-term strategy for consistent adoption of RWE:

Methodological – the absence of agreed frameworks, methods and standards has impeded advances in the delivery of fit-for-purpose RWE
Procedural – opportunities may exist for pre-PBAC submission processes that assist in planning for non-RCT data collection and RWE generation that could support early access in areas of high unmet medical need and help align value and price

Against these challenges, the Report authors propose clear and immediate steps for improvement:

Generating an aligned view on the issues through formation of a task force comprising industry, government, healthcare professional, patient, academic and other relevant stakeholder representatives to discuss different views on the topic and to set a framework for the expansion and standardisation of existing guidelines for RWE
As one potential output from these discussions, task dedicated sub-groups to create a system to facilitate collection of accurate, structured data on a consistent basis, including applying lessons from similar programs e.g. the Early Access to Medicines Scheme in the UK.

‘Transformational change is always confronting,’ states Dr Amanda Ruth from Rare Cancers Australia, ‘but the status quo really has to be challenged if we are to overcome future delays in access to new innovative medicines that represent opportunities for patients in areas of high unmet need. These are complex matters, but they do require a level of public debate and engagement because the issues are too important to ignore.’

The report is being launched at the Clinical Oncology Society of Australia Annual Scientific Meeting 2020 on Wednesday 11 November 2020 at specific evening conference. The evening symposium – The Evolving Role of RWE – Potential Implications for Access to New Oncology Treatments features Prof John Zalcberg as the chairperson. He is the Head of Cancer Research and NHMRC (MRFF) Practitioner Fellow within the School of Public Health and Preventive Medicine at Monash University and Tony Charlton Chair of Oncology at Alfred Health.

A copy of the Report can be accessed at: https://www.medicinesaustralia.com.au/publications/reports-and-occasional-papers/

For further information, please contact Anne-Marie Sparrow at Cube on 0417 421 560.

About the ‘Evolving Role of Real-World Data in Australia’ Report 2020

For the purposes of preparing the Report, authors worked within a broad definition of RWD/E in line with the US Food and Drug Administration (FDA), i.e. “healthcare information derived from multiple sources outside of typical clinical research settings, including electronic medical records (EMRs), claims and billing data, product and disease registries, and data gathered by personal devices and health applications.”

The RWE Working Group commission research firm IQVIA to combine a quantitative analysis of information from public summary documents with a qualitative assessment of RWE guidelines and literature, to provide a holistic assessment of how approaches and attitudes to RWE differ in Australia from other major HTA markets of the UK, France, Germany and Canada. The analysis showed the UK and France more often referenced RWE in HTA submissions (55% and 47% respectively), whereas Germany, Canada and Australia show much more limited use: 10%, 6% and 5% respectively.

Federal Government makes bold commitment to the health of Australians.

6 October 2020: Medicines Australia commends the Federal Government for their commitment to improving the health of Australians as we recover from the pandemic, while balancing the need to invest in industry growth and job creation.

Medicines Australia CEO, Ms Elizabeth de Somer said: “The linkages between our health and productivity have never been clearer with the Government’s announcement of the new medicines funding guarantee, worth at least $2.8 billion over 4 years, starting immediately and at the same time, removing the requirement for cost offsets for new medicine listings on the PBS.

“This is going to allow for medicines to be listed faster, without the need to find additional savings from other critical health areas,” said Ms de Somer.

Additionally, a framework for a new Strategic Agreement has been developed which represents the shared intent to deliver greater long-term certainty for both industry and Government following the expiry of the existing Agreement in June 2022.

“Alongside the substantial investment committed to health in the Budget, predictable savings to the Government, commencing in 2023, are required to continue the effective management of the challenging Budget backdrop,” added Ms de Somer.

In addition to this, the Federal Government is building on the willingness of Australia’s patients and medical fraternity to embrace digital health during the pandemic by fast-tracking electronic prescribing ($5 million) and home delivery of medicines. This will ensure the most vulnerable in our communities can continue to access innovative medicines.

Medicines Australia also welcomes the investment of $12 million to modernise the Therapeutic Goods Administration business systems to streamline processes for the medicines industry and reduce red tape for new medicines.

“While the Government has announced an additional $2 billion and other revisions to the Research and Development Tax Incentive, we look forward to seeing the detail of how the reforms will achieve the stated objective to increase research and development investment,” said Ms de Somer.

Other measures announced in the Federal Budget include:

$2.3 billion investment in COVID-19 treatments and vaccines
An investment of $1.5 billion in the Modern Manufacturing Strategy – of which medicines manufacturing has been identified as a key industry
Development of a unique identification framework for PBS medicines will be devised to offer a tracking system for medicines.
$1 billion for new research funding for our universities.
$50 million to the establishment of the Victorian Melanoma and Clinical Trials Centre at the Alfred Hospital, helping researchers to better understand melanoma.

Medicines Australia notes the new PBS listings announced in the Budget will provide further important health benefits for patients.

Lynparza® (olaparib) will be made available for the treatment of newly diagnosed advanced high grade epithelial ovarian, fallopian tube or primary peritoneal cancers.
Tecentriq® (atezolizumab) and Avastin® (bevacizumab) will also be listed for Hepatocellular carcinoma (HCC), the most common type of primary liver cancer.
Eylea® (aflibercept) was listed for the treatment of subfoveal choroidal neovascularisation due to pathologic myopia.
Calquence® (acalabrutinib) was listed for the treatment of chronic lymphoma leukaemia or small lymphocyctic lymphoma.
Rozlytrek® (entrectinib) was listed for the treatment of non-small cell lung cancer.
Ozempic® (semaglutide) was listed for the treatment of insufficiently controlled type 2 diabetes.

“This historic Budget will bring substantial changes to the healthcare system and Medicines Australia looks forward to working with the Government on implementing these essential reforms and contributing to Australia’s health led-economic recovery,” concluded Ms de Somer.

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More information – Natalie Wimmer – nwimmer@medaus.com.au – 0450 728 600.

Landmark funding and long-term certainty for innovative medicines for Australian patients, the community and the economy

6 October 2020: Medicines Australia welcomes the Federal Government’s landmark step to introduce a guaranteed PBS new medicines funding commitment within the 2020 Budget – heralding a new chapter of greater certainty for Australian patients in accessing new, innovative medicines.

The new medicines funding guarantee, worth at least $2.8 billion over 4 years, starts immediately and removes the requirement for cost offsets for new medicine listings on the PBS.

This commitment not only brings a hopeful future for Australian patients, their families and carers, it also represents a critical measure for Australia’s economic recovery – by enabling the adoption of new and transformative advancements for Australia’s overall health needs.

At the same time, a 7-year future path for the innovative medicines industry is now underway with a framework agreed with the Government for a new 5-year Strategic Agreement, commencing from 2022. The fundamental priorities within this framework underpin the establishment of an Agreement that builds a positive long-term future for innovation in health.

“It is fantastic to see the government investing in innovation and new medicines with $2.8 billion of dedicated new funding. This recognises that a healthy community is required to maintain a healthy economy,” states Dr Anna Lavelle, Chair Medicines Australia. “The Government’s commitment to invest in innovative medicines within their unprecedented overall Budgetary health measures to address COVID-19, while also stimulating the economy, must be congratulated. Maintaining an innovation focus that supports Australia’s health is a fundamental strategy to our recovery.”

“We have worked tirelessly with Government through COVID-19 and will continue to do everything we can to get the nation back on track,” adds Elizabeth de Somer, CEO Medicines Australia. “Against this unprecedented global event, we have a unique opportunity to build a clear seven year path with a new and collaborative based Strategic Agreement that will allow our innovative capabilities to be maximised bringing significant therapeutic advances – including cell and gene therapies – to patients alongside the critical vaccines and treatments urgently needed for COVID-19.

“Our priority will be to lock-in the next Strategic Agreement for the May 2021 Budget– with a focus on supporting the PBS architecture, improving important HTA process measures and securing certainty and predictability for the innovative sector,” continues Ms de Somer.

In additional measures announced within the Federal Budget, an important move to streamlined monthly rebate payments will be introduced into the medicine supply chain by 2021 instead of the previously proposed Supply Chain reform. There will also be a commitment to unique identifiers for medicines within the supply chain to improve access and patient safety.

“The supply chain has been under the spotlight with COVID-19 and these new measures will introduce important advancements to current processes,” states Ms de Somer. “In addition, the Government’s commitment to maintain the transformation in health delivery seen with COVID-19, including home delivery of medicines, telehealth and digital reforms to the TGA are all extremely important measures.”

“The agreed framework signals an important shift and new partnering with Government where the fundamental importance of new medicines to the community has been firmly acknowledged,” adds Dr Anna Lavelle. “We believe a very important chapter in innovative medicine and health has begun that builds upon the substantial collaboration over the past 3 months and leads a very strong trajectory of new therapeutic pipelines, research and ultimately jobs. We take this responsibility extremely seriously and will commit fully to the tasks ahead.”

Additional facts on the innovative medicines industry

The innovative medicines industry contributes about $8.9 billion to the Australian economy and accounts for about 22,000 jobs¹
Clinical trials contribute $1.1 billion each year to our economy²
Clinical trials generate 16,500 Australian jobs³
Everyone million invested in clinical trials creates 15 jobs and adds $1.37 million to GDP⁴

For further information please contact Natalie Wimmer on 0450 728 660 or Anne-Marie Sparrow on 0417 421 560.

References:

The economic contribution of the innovative pharmaceutical industry to Australia Economic footprint of the innovative pharmaceutical industry. February 2018
MTPConnect (2020). Retrieved 17 August 2020 https://www.mtpconnect.org.au/Story?Action=View&Story_id=59
(2020). Retrieved 17 August 2020 https://gradaustralia.com.au/career-planning/an-introduction-to-the-pharmaceutical-industry-for-graduates
AusBiotech Ltd. (2020). Retrieved 17 August 2020 https://www.ausbiotech.org/programs/clinical-trials

Key investment in the medicines sector will bring jobs and breakthrough medicines to Australian patients – with the right investment settings.

1 October 2020: Medicines Australia welcomes today’s announcement by the Prime Minister the Hon Scott Morrison in his National Press Club address that medical manufacturing has been identified as a Key Manufacturing Priority under the Modern Manufacturing Strategy.

As an industry, the innovative medicines sector employs over 23,000 highly skilled workers and currently invests more than $9 billion into the local economy.

Medicines Australia CEO, Ms Elizabeth de Somer said: “This initiative by the Federal Government will provide opportunities for strengthening the ecosystem of research and development partnerships that are vital to domestic commercialisation, advanced manufacturing and stronger supply chains. If rolled out efficiently and effectively, this initiative opens the door for making us an even stronger industry to deliver not only jobs, but even more breakthrough medicines to Australian patients.

“As the Prime Minister outlined, this isn’t going to enable all medicines to be manufactured here in Australia, but it will enable us to identify and target niche areas like personalised therapeutics manufacturing which has immense growth potential in Australia and extending to the Asia-Pacific region,” said Ms de Somer.

“We also have a real opportunity in Australia to bridge the gap between research and translation of new medicines and we would welcome the opportunity to advise the Government on developing the medicines manufacturing industry in Australia.”

“We have some incredible research facilities in Australia, who are certainly punching above their weight in terms of discovery, but we need to ensure these innovations can be brought to market here too and not sent offshore first, and that means strengthening our entire R&D pipeline, from research, through to clinical trials and manufacturing,” said Ms de Somer.

“However,” said Ms de Somer, “this is contingent on getting other key investment support settings right like the Research and Development Tax Incentive (RDTI). Proposed reforms, currently the subject of a Senate committee inquiry, have the potential to significantly damage the sector, and ultimately impact its capacity to deliver new, innovative treatments to Australian patients. We look forward to hearing further announcements regarding this critical area in the upcoming Federal Budget.”

During his speech, the Prime Minister also outlined plans to improve our supply chain through investment in the Supply Chain Resilience Initiative.

“While the innovative medicines supply chain is robust, as demonstrated by the challenge of COVID-19, it is imperative that we identify areas where Australia needs improved domestic manufacturing capability for emergencies, to ensure we are prepared for the future, whether that be for a pandemic, an environmental crisis like the bushfires or for something yet unforeseen,” said Ms de Somer.

“The innovative medicines industry looks forward to working with the Government to identify critical products, and map capabilities and vulnerabilities for normal times and periods of surge, continuing the close partnership on supply chains we have developed throughout COVID-19,” concluded Ms de Somer.

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More information – Natalie Wimmer – nwimmer@medaus.com.au – 0450 728 660

Australian patients to benefit from ongoing collaboration between peak medicine bodies

ACCC extends conditional authorisation to Medicines Australia and the Generic and Biosimilar Medicines Association

29 September 2020: Australian patients, in particular those who urgently need medicines in their fight against COVID-19, are at the centre of a decision today by Australian Competition and Consumer Commission (ACCC) to allow the Medicines Australia (MA) and the Generic and Biosimilar Medicines Association (GBMA) to continue their collaboration.

The leadership of the two organisations today welcomed the decision by the ACCC to extend its conditional authorisation. This will enable the pharmaceutical sector to continue to work together on developing and implementing strategies that support the supply of essential medicines to all Australians.

Both the CEO of Medicines Australia, Ms Elizabeth de Somer, and the CEO of the GBMA, Ms Marnie Peterson, welcomed the ACCC’s ruling and thanked the ACCC Commissioner, Mr Rod Sims, for his support.

“Maintaining the supply of essential medicines to Australians who rely on them, is the industry’s utmost priority, especially as we face one of the biggest global health challenges of our time,” Ms de Somer said. “An integrated and informed medicines supply chain is central to this.”

“This determination will enable all medicines manufacturers to continue to coordinate their manufacturing and supply activities to deliver medicines to patients,” Ms de Somer said.

Ms de Somer said the two peak bodies will continue to exchange information to quickly mitigate any supply chain disruption and constraints. Medicines Australia and GBMA will keep working hand-in-glove with all Australian governments, to enable them to effectively respond to the global health crisis.

“This unique collaboration becomes even more critical as industry and government evolve plans to distribute an eventual COVID-19 vaccination to every Australian,” said Ms de Somer.

Marnie Peterson, CEO of the GBMA said this final conditional authorisation was a clear demonstration of the highly-engaged and productive role the sector has played in responding to the pandemic.

“Ensuring critical medicines supply for Australian patients has been essential as we respond to this health crisis and the partnership comes at a time when patients need ongoing assurance that vital medicines will be supplied, when and where they are needed.”

“Disruptions to global supply chains remain a challenge, but we have all worked around the clock to ensure that medicines continue to reach patients,” Ms Peterson said.

“We are relieved that the pressure on our medicines supply is abating, however we remain vigilant as we are still navigating ongoing freight restrictions and any potential future outbreaks of the virus,” said Ms Peterson.

The ACCC granted conditional authorisation until 30 September 2021.

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MA and the GBMA advises Australians who are concerned about the availability of their medicines to check the TGA website and to discuss their concerns with their doctor or pharmacist or the company directly, through their customer service lines.

Media inquiries:

Medicines Australia: Natalie Wimmer +61 450 728 660 nwimmer@medaus.com.au

GBMA: Jannette Cotterell +61 419 204 059 jcotterell@executivecounsel.com.au

About:

Medicines Australia (MA) members represent pharmaceutical companies who create originator products and are actively involved in original research and development, clinical trials together with manufacturing.

Generic and Biosimilar Medicines Association (GBMA) members represent pharmaceutical companies who manufacture, supply and market generic and biosimilar medicines, which account for the largest volume percentage of medicines on the PBS.

Additional Resources:

Medicines Australia – https://medicinesaustralia.com.au/

Generic and Biosimilar Medicines Association – https://www.gbma.com.au/

World Health Organisation – https://www.who.int/

Department of Health – https://www.health.gov.au/