Media Releases – Page 13 – Medicines Australia

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.

-ENDS-

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

Joint Statement of support for an Australian Patent Box

13 September 2021: Australia’s health innovators support the introduction of a Patent Box, and we welcome this initiative by the Australian Government. With the right policy settings, a Patent Box will ensure Australian discoveries in health are developed here, ensuring Australia captures the opportunity for new industries and jobs in health innovation. We look forward to working with Treasury to ensure the design of the patent box adequately incentivises Australian health innovators to develop and manufacture their ideas onshore.

This collective statement is made by Research Australia, Medicines Australia, AusBiotech, and the BioMelbourne Network. In short, we represent a broad cross-section of health innovators. Our combined membership conducts most health-related research and development (R&D) activities in Australia with the objective of discovering and delivering better health outcomes and an enhanced health system for Australian patients and the world. This membership includes universities, research institutes, consumers, and small, medium and large companies.

What is a Patent Box?

A Patent Box is a tax concession that provides a lower tax rate for income derived from certain forms of intellectual property (IP), typically patents. The policy goal of patent boxes is to promote R&D and the commercialisation of IP.

Key Points

We strongly support the introduction of a Patent Box in Australia. Many of us have advocated for the introduction of a Patent Box for several years.
We acknowledge the need for the design of the Patent Box to be consistent with the OECD’s Base Erosion and Profit Sharing (BEPS) Action 5 Minimum Standard.
The UK’s patent box provides a model for Australia which is superior in many ways to the model proposed in the Australian Treasury’s Discussion Paper.
The Government should establish an expert working group with industry representation to support the design and implementation of the Patent Box.

Leap forward for patients accessing medicines

7 September 2021: Medicines Australia has secured a 5-year Strategic Agreement with the Federal Government, centered on earlier patient involvement and influence in the availability of new medicines in Australia.

The new Agreement sets out a hardworking, five-year plan that heralds a new era by securing stronger patient involvement in critical processes and ensuring Australia keeps pace with access to rapidly transforming medical advancements developed around the world.

“This Agreement, signed and supported by Minister Greg Hunt today, will ensure what is important to patients is a priority focus in creating faster access to lifesaving medicines and treatments,” said Dr Anna Lavelle, Chair of Medicines Australia.

In a major step forward, the Agreement ensures patients will become fundamental contributors to the first independent review of Australia’s Health Technology Assessment (HTA) system in nearly 30 years. The HTA system reviews new medicines and technologies before they are made available in Australia.

“This Agreement firmly demonstrates the Government and industry’s shared goal of ensuring patient voices are heard earlier and new medicines are accessed faster. It is critical we capture patients’ experiences and realise the benefits of quickly evolving medicines and new technologies,” said Elizabeth de Somer, CEO of Medicines Australia.

A new process will incorporate patients’ views and experiences early in the Pharmaceutical Benefits Advisory Committee (PBAC)assessment of medicines to be funded on the Pharmaceutical Benefits Scheme (PBS). Earlier involvement will help to make the full value of new medicines clear, in terms of what is important to patients. The enhanced consumer engagement is expected to improve efficiencies in PBAC decisions and create faster access to lifesaving medicines and treatments.

“I want to thank and acknowledge Medicines Australia for their collaboration on these patient focused reforms and through successive Strategic Agreements which continue to provide significant benefits for Australian patients,” said Minister for Health and Aged Care, the Hon Greg Hunt MP.

Resilience in the PBS is critical for Australia’s future, for patients and for our economy. The Agreement provides more funding to be invested into the PBS in addition to at least $2.8b already expected from the New Medicines Funding Guarantee announced in October 2020. The injection of funds is necessary to allow future entry of the latest medical discoveries and innovative treatments as soon as they become available.

“The arrival of cell and gene therapies are just a few examples of how innovation is speeding ahead, providing hope for many Australians living with incurable cancers, viruses and rare diseases. We want to ensure patients can quickly receive these advancements,” said Elizabeth de Somer.

A further benefit for patients is a commitment in the Agreement to identify major advances in healthcare in future years through improved horizon scanning. This will be achieved in consultation with Government, industry and patients, and ensure Australia’s healthcare system can adequately prepare for changes ahead of time.

“I would like to thank the Minister for Health, the Hon Greg Hunt MP, for his commitment to patients, who will benefit from these improvements, and to the pharmaceutical industry. It will take continued effort and effective partnerships between industry, Government and patients to optimise these achievements for the community and our economy,” said Dr Anna Lavelle.

“The COVID-19 pandemic has demonstrated the importance of ensuring Australia has a health care system that can adequately prepare for and adapt to changes. This Strategic Agreement will support the supply of medicines, treatments and vaccines and help us better prepare for future health challenges.”

Further details and a more in-depth summary of the Strategic Agreement 2022-27 are available on our website.

-ENDS-

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

Statement on Moderna COVID-19 vaccine

6 September 2021: Medicines Australia welcomes the TGA provisional approval for the COVID-19 vaccine, Spikevax (Moderna) for Australia. The Moderna vaccine is expected to arrive in Australia this month.

The TGA announced provisional approval for the Moderna vaccine in August and on Saturday, also provided provisional approval to include Australians between the ages of 12-17 years old. The Pfizer and Moderna COVID-19 vaccines will both be made available to adolescents and be an important tool for Australia’s social and economic recovery.

“The more people in Australia that get vaccinated, the more chance there is of eradicating the national COVID-19 pandemic,” said Elizabeth de Somer, CEO of Medicines Australia.

“When you get vaccinated you are not just protecting yourself. You are also reducing the risk of passing on COVID-19 to your family, friends and community. I am grateful to have received both of my vaccine shots and to do my bit to fight against COVID-19.”

The Moderna vaccine, similar to the Pfizer COVID-19 vaccine, uses mRNA (messenger RNA) technology, which has experienced decades of research efforts. This technology acts as a messenger by providing genetic instructions to the body about how to protect against the virus. It shows the body’s cells what a virus may look like so the immune system has time to build powerful antibodies.

The COVID-19 vaccines have been developed without compromising safety or efficacy, thanks to the extraordinary collaboration between industry, Government, and scientific community.

In addition to the years of research behind vaccine technology, speed has been achieved due to a large injection of funding from pharmaceutical companies as well as running development and implementation phases side-by-side, instead of one after the other.

Medicines Australia will continue to work closely with all our partners across healthcare to ensure all Australians have access to COVID-19 vaccines.

For further information, visit the Department of Health website for accurate, evidence-based answers to questions about COVID-19 vaccines.

-ENDS-

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

COVID-19 vaccine claims scheme

29 August 2021: Medicines Australia commends the Australian Government on the COVID-19 Vaccine Claim Scheme for anyone who experiences the very rare, serious side effects from a TGA-approved COVID-19 vaccine.

The announcement of this Scheme is another critical step in Australia’s COVID-19 vaccination program and encouraging a high vaccinated population. The Scheme provides a safety net for those who receive the vaccine and for those who administer it, in the very rare case of a serious adverse side effect.

From 6 September 2021, Australians will be able to submit intentions to claim, backdated to February 2021. The Scheme will cover verified claims valued above $5,000 by a team of independent experts.

Medicines Australia provided recommendations to the Government last year, which formed part of the extensive consultation between peak medical, healthcare, business and insurance sectors.

“Australians have truly shown the values of selflessness and mateship as they have rolled up their sleeves in large numbers and received a vaccination against this deadly virus,” said Medicines Australia CEO Elizabeth de Somer.

“If someone does experience an adverse side effect from a vaccination, these are normally short-term. But in the rare case that the effects are moderate or serious, Australians now have the option to seek compensation.”

“All parties who have been involved in the research, development, manufacturing and deployment of these COVID-19 vaccines have moved mountains to deliver safe, effective and quality vaccines. As well as shielding the employees and medical professionals who administer the vaccine, it is important that appropriate protection should also be extended to the manufacturers, distributors, or other entities who are involved in the development or deployment of the COVID-19 vaccine.”

The COVID-19 Vaccine Claim Scheme will play an effective role in enhancing national and global vaccination efforts so we can begin to recover from this pandemic. We look forward to further collaborating with the Australian Government and industry to advance our shared public health goals and ensure no Australian is left behind.

For further information or media interviews with CEO Elizabeth de Somer, please contact:
Chrystianna Moran – 0424 995 118 / chrystianna.moran@medicinesaustralia.com.au.

National Medicines Policy Review will be significant for all Australians

30 July 2021: Medicines Australia is eager to be part of a significant moment in history for Australian health care. August 2021 will mark the start of the National Medicines Policy (NMP) review, as announced by the Minister for Health and Aged Care, the Hon Greg Hunt MP, at Medicines Australia’s event in Parliament House ‘Room for the Patient View’.

Announced this morning, the Review will be completed in six months and is timely to make sure our health care system is fit-for-purpose and pandemic proof. The Review’s Expert Advisory Committee is made up of a good representation of experts that have experience and expertise across the health system including medicines policy, clinical practice, consumer engagement and the pharmaceutical industry.

The Committee will be 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 NMP was first introduced in 1999 and this year will be the first time it has been reviewed since its implementation. Over the past two decades, medicines have changed and so have patient and consumer expectations.

The overall goal of the NMP is to optimise health outcomes for all Australians but to do that, there needs to be a greater focus on medicines governance – and this is what the NMP should do. A key part of the Review will focus on implementing metrics and measuring outcomes.

As announced this morning, the NMP Review Terms of Reference reveal a broad scope that will look at the definitions of medicines, the governance structure, implementation, and evaluation. Most importantly, the Review will put the patient at the centre of policy thinking.

One of the key considerations in transforming the NMP will be consumer expectations and having a stronger patient focus.

Two of the pillars of the NMP are that all Australians should have timely and affordable access to essential medicines, and that medicines should be prescribed and used appropriately.

Yet the reality is that these goals are not being met for all Australians – such as those in remote and regional communities, or Aboriginal and Torres Strait Islander people.

A key part of Medicines Australia’s recommendations will continue to be ensuring that the central role of consumers and patients is appropriately reflected in a refreshed NMP that is fit-for-purpose.

-ENDS-

For further information or media interviews, please contact:
Chrystianna Moran – 0424 995 118 / chrystianna.moran@medicinesaustralia.com.au.

>> Next: Medicines Australia calls for new National Medicines Policy (NMP) to be pushed back until after the Federal Election

Clinical trial national approach will benefit patients and our economy

20 July 2021: Medicines Australia welcomes the clinical trial ‘one-stop-shop’ consultation, recently announced by the Australian Commission on Safety and Quality in Health Care.

Clinical trials in Australia are a significant enabler for faster access for patients and make an important contribution to the economy but we require a consistent, national approach to remain competitive. This newly launched consultation presents an opportunity to achieve a national, interconnected, rapid and streamlined pathway for attracting clinical trials to our shores.

The COVID-19 pandemic drew the world’s attention to the benefits of clinical trials. These have been well documented, such as job creation, better health outcomes for patients and an increased body of scientific knowledge and medical innovation. In 2019, the biopharmaceutical industry is estimated to have invested over $1 billion in Australia for clinical trials.

Australia has been an attractive environment for clinical trials and R&D, but many large companies stumble at the first hurdle due to the inconsistent processes between the different states and territories.

Last night, Medicines Australia CEO, Elizabeth de Somer, spoke on ABC Nightlife and says that clinical trials remain a crucial path to bring innovative drugs, vaccines and therapies to patients in Australia in a safe and regulated manner.

“Clinical trials are critical for a lot of Australian patients, important for our economy and increase our R&D capabilities. We must make our country a more attractive option for international investment,” she said.

Medicines Australia has been working with the Government to harmonise these arrangements, which were also supported by the Minister for Health, the Hon Greg Hunt MP, during his CEDA address in June last year. Since then, considerable progress has been made on this commitment by The Research & Development Task Force (R&DTF), a multi-sector collaboration between Medicines Australia, AusBioTech and the Medical Technology Association of Australia (MTAA). The one-stop-shop consultation is the next step in this vital work.

Elizabeth was joined on the ABC Nightlife program by clinical trial participant Karen Van Gorp and Professor Meg Jardine, Director of Sydney University Clinical Trials Centre.

A recording of the interview is available on the ABC website.

For further information or media interviews, please contact:
Chrystianna Moran – 0424 995 118 / chrystianna.moran@medicinesaustralia.com.au.

Aboriginal and Torres Strait Islander Medicines Committee launches during NAIDOC Week

7 July 2021: A new joint committee between National Aboriginal Community Controlled Health Organisation (NACCHO) and Medicines Australia (MA) launches this week, with a key focus on improving medicines access and health outcomes for Aboriginal and Torres Strait Islander peoples.

This year’s theme for NAIDOC Week is “Heal Country”, which highlights the need to listen to Aboriginal and Torres Strait Islander peoples who have been calling for action to address the grave social and economic disadvantages experienced for generations. This includes targeting health inequalities currently being experienced by Aboriginal and Torres Strait Islander peoples and building better access to medicines and treatments.

The NACCHO and MA Aboriginal and Torres Strait Islander Medicines Committee will have a strong representation of Aboriginal and Torres Strait Islander voices including health consumers, health practitioners, ACCHO sector representatives, as well as from industry.

The group acknowledges the ongoing disparities in access to medicines and associated services for Aboriginal and Torres Strait Islander peoples compared to other Australians.

Discussions will initially focus on exploring ways of working together, such as strengthening the medicines sector’s cultural responsiveness, addressing health literacy, improving Aboriginal and Torres Strait Islander representation in the sector, addressing medicines access and affordability, and considering remote and regional access. The group will also consider how reforms in health policy, legislation and the Health Technology Assessment processes may improve meeting the needs of Aboriginal and Torres Strait Islander peoples.

According to NACCHO CEO, Pat Turner, the creation of this Committee will enhance the voices of Aboriginal and Torres Strait Islander peoples in the biopharmaceutical sector, particularly when it comes to policies and medicine access.

“Up until now, there has not been a formal coordinated way for ACCHOs to engage with industry. The creation of this Committee will help streamline this process and effectively support medicines-related measures that improve health outcomes for Aboriginal and Torres Strait Islander clients and communities.”

Medicines Australia CEO, Elizabeth de Somer, says this Committee will enable stronger collaboration that will help improve access for Aboriginal and Torres Strait Islander patients.

“This Committee is the next step in maturing the partnership between NACCHO and Medicines Australia. The enhanced collaboration will contribute to important decision-making and policy improvement – including how to strengthen access to quality, affordable healthcare; and how to ensure that being part of the Aboriginal and Torres Strait Islander community is no longer a barrier to being healthy.”

For further information or media interviews, please contact:
Chrystianna Moran – 0424 995 118 / chrystianna.moran@medicinesaustralia.com.au.

Moving patient stories highlight opportunities to strengthen our healthcare systems for all Australians

Moving patient stories highlight opportunities to strengthen our healthcare systems for all Australians

24 June 2021: It was an emotional evening among the nearly 200 in-person and online attendees at Parliament House last night who heard from patients openly sharing their personal stories. Their message was simple: the time is right for evolution.

Patients, advocacy groups, politicians, Government officials and industry representatives came together in Canberra for the event, titled ‘Room for the Patient View’.

Dr Anna Lavelle, Chair of Medicines Australia, said it was wonderful to see patients represented at the event and at the centre of discussions.

“I’m grateful for the willingness of everyone who attended to share their personal experiences with honesty and openness. We have all been touched by illness or disease and at some point, in all our lives, each of us will be a patient. The event highlighted what we can achieve through compassion and unity.”

Medicines Australia CEO, Liz de Somer, reflected on the night the importance of this work.

“Together, we can shape healthcare in Australia to ensure that it is fit for purpose and the future. We must harness this momentum and collectively ensure that all Australians have timely access to treatments and medicine no matter their age, gender, location or background,” she said.

Medicines Australia is the industry peak-body of the research-based medicines industry of Australia.

The forum included discussions about how to include patients earlier in the decision-making process, the value of medicines, better access, and medicines innovation – all of which are currently being considered by a House of Representatives Inquiry into approval processes for new drugs and novel medical technologies in Australia.

Jessica Bean, President and Secretary for Patient Voice Initiative and Cystic Fibrosis patient, joined yesterday’s panel discussion focusing on how our health care system can innovate and evolve.

She recently addressed the House of Representatives Inquiry stating, “innovation on its own, without access, is useless for patients.”

“I really hope…that we can build a system that recognises the fullness of patient lives…if there is one thing more heartbreaking than there not being a treatment for your disease, it’s knowing that there is a treatment available and not being able to access it,” she said.

Dr Mike Freelander, the Member for Macarthur and Deputy Chair of the Standing Committee on Health, Aged Care and Sport, said that a patient’s voice is paramount.

“Too often, the views and needs of the patient are overlooked. Over my many years in medicine, I came to appreciate the significance of the patient perspective – and often in my field of paediatrics, the parents’ perspective.”

“The needs of the patient ought to always come first, and it is crucial that we strengthen our healthcare system to ensure that all patients are provided with a voice.”

“The patient voice should also include the family’s voice. As a paediatrician, I understand the effects of chronic illness upon a child and its effect on the whole family.”

– ENDS –

Photos of the event are available – please email chrystianna.moran@medicinesaustralia.com.au.

For further information or an opportunity to interview Medicines Australia Chair, Dr Anna Lavelle or CEO, Liz de Somer, please contact Jasmine Kaur – 0452 303 565 / jasmine.kaur@medicinesaustralia.com.au or Chrystianna Moran – 0424 995 118 / chrystianna.moran@medicinesaustralia.com.au.

Prestigious event at Parliament House will ‘make room for the patient view’

Prestigious event at Parliament House will ‘make room for the patient view’

18 June 2021: Respected journalist and broadcaster, Tracey Spicer will MC an event in Parliament House next week titled ‘Room for the Patient View’. Next Wednesday 23 June, 4:00 – 8:00pm, politicians, patient advocacy groups and representatives from the health industry will gather in Canberra to discuss opportunities and barriers in Australia’s health system.

COVID-19 has highlighted some of the brilliant strengths of Australia’s healthcare system and sparked many conversations about accessing medicines and vaccines. Attendees will hear about how we can build on this momentum and strengthen gaps that have become evident during the pandemic.

Attendees will hear from patients, an expert panel as well as from the Minister for Health and Aged Care, the Hon Greg Hunt MP, and Shadow Minister for Health and Ageing, the Hon Mark Butler MP.

Many of those at the event have been impacted by disease, including Tracey, who has spoken about her personal connection and experience with cancer and illness in her immediate and extended family.

‘Room for the Patient View’ is a PharmAus event, hosted by Medicines Australia is the peak body for the research-based pharmaceutical industry.

The event is timely, and will address topics that are currently being considered by the House of Representatives Inquiry that impact all Australians, such as:

How we can minimise the time Australians spend waiting for new drugs and novel medical technologies in Australia.
How we can empower patients to be part of the decision-making process for their treatment.
Next steps to improve Australia’s healthcare system.

Media who wish to attend the event can contact chrystianna.moran@medicinesaustralia.com.au. Virtual and in-person attendance may be available, depending on venue capacity.

ABOUT TRACEY SPICER:

Tracey Spicer AM BBus (Comm) GAICD is a multiple Walkley Award winning author, journalist and broadcaster who has anchored national programs for ABC TV and radio, Network Ten and Sky News. Tracey also has a personal connection and experience with disease in her immediate and extended family.

For further information or an opportunity to interview Medicines Australia CEO, Liz de Somer, please contact: Chrystianna Moran – 0424 995 118 / chrystianna.moran@medicinesaustralia.com.au.