Category: COVID-19

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

Medicines Australia and AusBiotech say COVID-19 vaccine patent waiver will not speed up global vaccination

14 September 2021: Medicines Australia and AusBiotech, the peak bodies representing the Australian innovative pharmaceutical and biotechnology sectors, urge the Australian Government not to support a proposed patent waiver for COVID-19 vaccines and therapies, as it will not help global vaccination.

The proposed patent waiver at the World Trade Organization (WTO), also known as the TRIPS waiver (Trade-Related Aspects of Intellectual Property Rights waiver), is a form of forced technology transfer or compulsory acquisition of intellectual property that would undermine the global vaccination effort rather than strengthen it.

The comments made by Trade Minister Dan Tehan last week were part of a continuing discussion held on that day and do not appear to indicate a change in the Government’s position. Medicines Australia and AusBiotech acknowledge the Australian Government’s determination to play a constructive role in the resolution of this issue, including their recognition that the multilateral intellectual property system critically supports innovation and that patents are not the barrier to vaccine availability.

As previously reported, vaccine manufacturers worldwide are now producing 1.5 billion doses per month, which has been achieved through significant increases in production, supply chain, and voluntary technology transfer agreements across the world. By January 2022, there will be sufficient vaccines produced for every adult on every continent and attention must now be urgently shifted to distribution. All humans should have equitable and timely access to COVID-19 vaccines and the biopharmaceutical industry continues to call for governments to increase dose sharing and remove delivery bottlenecks.

Elizabeth de Somer, CEO of Medicines Australia, and Lorraine Chiroiu, CEO of AusBiotech, have both consistently stated the importance of upholding strong intellectual property protections as the key to innovative vaccines and treatments against COVID-19 and future pandemics. In a joint statement, they both said:

“Since the start of the pandemic, the global biopharmaceutical industry has worked day and night to find solutions to the SARS-CoV-2 virus. Our industry collaborates closely with governments, academia and charities around the world to manufacture and distribute safe, effective COVID-19 vaccines. This tremendous collaboration has been enabled – not undermined – by the international intellectual property system. As a result, 3.3 billion people are inoculated, saving countless lives and enabling economies to re-open.”

“Despite this momentous effort, recent figures show that unfortunately, around only 1% of the population in low-income countries have received at least one dose of a COVID-19 vaccine. While our industry is committed to sharing COVID-19 vaccines quickly and equitably, the proposed patent waiver is a wishful solution to a complex problem. Waiving patents for COVID-19 vaccines and therapies will not address the real challenges to vaccinating the world: eliminating trade barriers, addressing bottlenecks in supply chains, and a greater willingness to share more doses with developing countries.”

“Worryingly, the proposed TRIPS waiver is a forced transfer and acquisition of knowledge and technology, which will undermine the development of safe, effective and quality vaccines. Vaccine manufacturing is highly complex, requires specialist technical equipment and know-how which takes years to build.”

“For example, the Pfizer/ BioNTech mRNA vaccine contains 280 different ingredients sourced from 86 suppliers in 19 different countries. The success of this vaccine relies on highly specialised expertise, advanced customised technical capabilities and strong relationships along numerous supply chains that have been built over decades.”

“If a compulsory acquisition of patents are put into place, there will be serious, long-term impacts, which will dampen the drive for investment into medical research and innovation, placing us in a worse position to tackle new COVID-19 variants and preparation for future health crises.”

“The only way to solve this is through continuing to build robust partnerships backed by a reliable international intellectual property system. Rather than causing more bottlenecks and delays by supporting the TRIPS waiver, we hope that the Australian Government will engage in a pragmatic and constructive dialogue with industry focused on the real barriers to global vaccination.”

Medicines Australia and AusBiotech strongly support the five steps to urgently advance COVID-19 vaccine equity, as outlined by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA): stepping up dose sharing, optimising production, eliminating trade barriers, supporting country readiness and driving further innovation.

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

Medicines Australia updated position on Intellectual Property (in light of TRIPS Waiver)

Thursday 6 May 2021: Medicines Australia continues to express our sympathies to all those affected by the pandemic. The importance of accessible, lifesaving vaccines and treatments could not be more important.

The US Government’s decision to support a patent waiver on COVID-19 vaccines will not increase vaccine production nor increase the rate of vaccination in poorer countries.

The Biden Administration’s decision made yesterday undermines the hard work of the global vaccine efforts. Safe, effective vaccines require robust partnerships that need to be supported by the international intellectual property system.

We echo the statements released by International Federation of Pharmaceutical Manufactures & Associations (IFPMA), PhRMA and Biotechnology Innovation Organization (BIO). To achieve a high vaccination rate globally, we must have the right mechanisms in place to scale-up research, development, manufacturing, and supply of such products in our fight against COVID-19.

This will only be achieved by supporting innovative COVID-19 vaccines and treatments, not by weakening the ecosystem of research and development (R&D) partnerships underpinned by the current Intellectual Property (IP) protections that brought them to communities around the world.

Our innovative biopharmaceutical sector has rapidly developed safe and effective vaccines thanks to its scientific expertise, its willingness to take financial risks, and a strong framework for the protection of IP.

Some individuals, organisations, and governments have called for suspending IP protections to improve access, including compulsory licensing via section 31 of the TRIPS waiver. Yet the current IP system has increased access to COVID-19 products – for example, through voluntary licensing and manufacturing arrangements.

Members of Medicines Australia are at the forefront of this global vaccine effort. We acknowledge their unprecedented dedication and determination to address COVID-19. Some of them are also members of our international body the IFPMA which is a founding partner of the ACT Accelerator and heavily engaged in the COVAX pillar, through which vaccines will be made available in 92 low-and middle-income countries. IFPMA and its members are committed to delivering COVID-19 vaccines to national populations on an equal basis, regardless of their ability to pay.

Medicines Australia and our Members will continue to work with the Government and partner with stakeholders across the healthcare ecosystem and beyond to ensure Australians continue to have access to much needed medicines and vaccines.

For global statements see IFPMA statement on Intellectual Property here. See Medicines Australia previous statement here.

Medicines Australia position on Intellectual Property (in light of TRIPS Waiver)

Friday 30 April 2021: Medicines Australia is deeply saddened by the worsening situation and devastation in countries resulting from the pandemic. Our thoughts go out to the families of those who have lost loved ones.  

We acknowledge the need to secure timely access to affordable medical products and to scale-up research, development, manufacturing, and supply of such products in our fight against COVID-19. This will only be achieved by supporting innovative COVID-19 vaccines and treatments, not by weakening the ecosystem of research and development (R&D) partnerships underpinned by the current Intellectual Property (IP) protections that brought them to communities around the world.

Medicines Australia is concerned by the Trade Related Aspects of Intellectual Property Rights (TRIPS) waiver proposal to the TRIPS Council by India and South Africa, as the proposal incorrectly portrays IP as a barrier to rapid innovation, R&D collaboration, and ample manufacturing of COVID-19 technologies. 

We believe the right policies can drive innovation and access to COVID-19 vaccines and treatments. Developing lifesaving vaccines and treatments so quickly would have been impossible without a legal and regulatory framework that protects IP and rewards innovation and risk-taking. Bolstering this framework will help governments rebuild their healthcare systems and prepare for future crises.

Our innovative biopharmaceutical sector has rapidly developed safe and effective vaccines thanks to its scientific expertise, its willingness to take financial risks, and a strong framework for the protection of IP.

Some individuals, organisations, and governments have called for suspending IP protections to improve access, including compulsory licensing via section 31 of the TRIPS waiver. Yet the current IP system has increased access to Covid-19 products – for example, through voluntary licensing and manufacturing arrangements.

Members of Medicines Australia are at the forefront of this global vaccine effort. We acknowledge their unprecedented dedication and determination to address COVID-19. Some of them are also members of our international body the IFPMA which is a founding partner of the ACT Accelerator and heavily engaged in the COVAX pillar, through which vaccines will be made available in 92 low-and middle-income countries. IFPMA and its members are committed to delivering Covid-19 vaccines to national populations on an equal basis, regardless of their ability to pay.

John-Arne Røttingen, Chair of the WHO Solidarity Trial of Covid-19 treatments, also agrees that technology transfer is crucial, but believes that voluntary mechanisms are a better way to achieve this, he noted in the Lancet: “Covid-19 therapeutics and vaccines are complex biological products in which the main barriers are production facilities, infrastructure, and know-how, rather than the IP.”

Medicines Australia and our Members will continue to work with the Government and partner with stakeholders across the healthcare ecosystem and beyond to ensure Australians continue to have access to much needed medicines and vaccines.For global statements see IFPMA statement on Intellectual Property here.

Medicines Australia welcomes Day 1 of Australia’s vaccination rollout

22 February 2021: Today marks a landmark occasion that signifies the extraordinary work and partnership between industry, the Government, the scientific community, and all stakeholders across the healthcare ecosystem in our fight against Covid and to bring much-needed vaccines to Australians.

Under the Australian Vaccination Strategy the COVID-19 Vaccine rollout begins with the Pfizer/BioNTech vaccine, and will include the AstraZeneca/Oxford vaccine from March 2021.

The plan today starts with  60,000 Pfizer/BioNTech COVID-19 vaccine doses to be administered to priority populations.

Medicines Australia supports the Government’s approach to ensure Australians living and working in aged care and disability care, and quarantine, border and frontline health workers, will receive the COVID-19 vaccine first.

We also want to echo the Government’s position that every Australian will be given the opportunity to receive the COVID-19 vaccine, free and voluntarily.

To find out the phase in which you’ll be able to access vaccines answer a few questions via the recently launched eligibility checker at www.australia.gov.au.

For the most reliable source of pandemic and vaccine related information, please refer to the Department’s website www.health.gov.au.

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

Medicines Australia’s Statement on Anti-vax Protests

20 February 2021: Medicines Australia is aware of the anti-vaccinations protests held across the country today. We encourage Australians to be mindful of COVID-19 and vaccine misinformation that can lead to harmful and unsafe decisions.

Patient safety is our top priority at Medicines Australia, for our Members and the Government. Medicines Australia urges the community to remain secure in the rigorous and robust processes governing the approval and rollout of vaccination programs across the country, including the role of the Therapeutic Goods Administration (TGA) as regulator.

Medicines Australia also wants to reinforce the Government’s position that all COVID-19 vaccines rolled-out across our nation will be voluntary and free.

For the most reliable source of pandemic and vaccine related information, please refer to the Department’s website www.health.gov.au.

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

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