Media Releases – Page 3 – Medicines Australia

Medicines Australia Code of Conduct Edition 20 adopted at AGM

Medicines Australia Code of Conduct Edition 20 adopted at AGM

30 October 2024: The next edition of the Medicines Australia Code of Conduct has been formally adopted by members and will come into effect on 30 March 2025.

The updated Code follows an extensive review throughout 2024 with members and broader public consultation involving non-member companies, industry associations, healthcare professionals, the patient community, the TGA and global regulatory bodies.

Edition 20 maintains the principles-based approach of Edition 19 with updates to address areas of ambiguity and changing practices in advertising and engagement with health professionals.

Key amendments made in this edition based on feedback and international standards include:

-A section to clarify how companies can make ethical and responsible product-specific media statements to consumer media when the information is relevant to the Australian public. This includes the announcement of a new product or indication and new public funding, such as a PBS listing and provides assurance and clarity to companies, as well as greater clarity for the Code Committees when adjudicating any related complaint. (Section 10.1).

-A shift in Minimum Product Information no longer being a requirement in promotional material, recognising that Product Information is easily accessible electronically. Mandatory inclusions are still required to ensure information relevant to prescribing is clearly communicated (Section 2.1)

-The extension of transparency reporting to include grants and donations to healthcare organisations, providing consistency with international transparency reporting (Section 14.2).

-An additional section on ‘balance’ (Section1.1) which emphasises the need for balanced information in promotional materials. A more concise definition guides companies to achieve this.

-The inter-company dialogue process is more clearly and specifically described in a new document ‘Intercompany Dialogue Standards’, supporting more meaningful interaction between companies and discouraging Code complaints as a competitive tool (Section 15.5). Failure to follow these Standards may cause a breach of the Code, with a fine up to $100,000 to be adjudicated by the Code Committee.

-The inclusion of a non-member company representative on the Membership of the Code and Appeals Committees if there is a complaint involving a non-member, encouraging better engagement by non-members with our complaints process.

In addition to these amendments, non-member companies will be required to pay a bond of $20,000 when lodging a complaint, which will better equalise the costs to member and non-member companies and offset the cost of the complaints process (Section 15.1). Where a complaint is upheld, and the subject company is found to be in breach of the Code, the bond will be refunded to the complainant.

Medicines Australia CEO Liz de Somer said the strong engagement by members and other stakeholders in the Code review demonstrates the industry’s commitment to ethical conduct.

“The Medicines Australia Code of Conduct is regarded globally as the gold standard of industry self-regulation and Edition 20 of the Code exemplifies this,” Medicines Australia CEO Liz de Somer said.

“We thank the Code Review Working Group for their hard work over the last 12 months and everyone who contributed to the Review process.”

Medicines Australia will be hosting a series of educational webinars to help companies with their understanding of the new version of the Code between November 2024 and March 2025. This will be followed in January by a new Bridging Course, and an updated Program 1- Code of Conduct, offered by our educational partner the University of Tasmania, in line with our Continuing Education Program.

A copy of the Code of Conduct – Edition 20 can be found here. Code guidance, contained in the Code Resource Toolkit, will be updated in the first quarter of 2025.

About the Code of Conduct

The Code of Conduct sets the standards for the ethical marketing and promotion of prescription pharmaceutical products in Australia.

Launched in 1960, the Medicines Australia Code of Conduct complements the legislative requirements of Therapeutic Goods Act, 1989 and the Therapeutic Goods Regulations, 1990.

The Code is periodically reviewed to ensure it remains relevant to members, the wider industry and external stakeholders, whilst continuing to align with international self-regulation and domestic policies, legislation, standards and community expectations.

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Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.

Medicines Australia announces new Board Directors

Medicines Australia announces new Board Directors

30 October 2024: Medicines Australia welcomes five new Directors to its Board and the re-appointment of another Director for a second term.

Tori Brown (Lilly), Kathryn Evans (BioMarin), David Pearce (Takeda), Owen Smith (BMS) and Nirelle Tolstoshev (Astellas) have been voted in by members to fill vacant positions following the resignations of Dirk Otto (Boehringer Ingelheim), Liz’e Marett (Astellas), Prashant Nikam (MSD) and Urs Voegeli (J&J). Patrick Desbiens (GSK) chose to not recontest his position at the conclusion of his three-year term.

Adam Roach (Beigene) was successful in his bid to continue on the Board for a second term.

Medicines Australia Chair, Dr Anna Lavelle AM, welcomed the new Directors and said their depth of experience will be invaluable over the next three years.

“On behalf of the membership and the Board, I congratulate the successful Directors and welcome their expertise and leadership at this critical time for our industry and for patients in Australia,” Dr Lavelle said.

“The combination of experienced Board Directors and some new Directors will ensure some stability and will provide fresh insights.

“The last year has been one of progress, unwavering unity of purpose and it’s through our collective commitment to advancing healthcare and access to world-class medicines, biotherapeutics and vaccines for all Australians, that we have a Health Technology Assessment (HTA) Review.

“There is now real momentum for modernising Australia’s HTA system and the impetus for change has never been stronger.

“I thank my fellow Board Directors who have served this year for their dedication and industry leadership, and wish every success to those Directors who have served and moved on during the year.”

CEO of Medicines Australia, Liz de Somer, also welcomed the new Directors.

“I am looking forward to working with the Board as we implement HTA reforms, complete actions in the Strategic Agreement, and ensure Australia’s competitiveness as a preferred destination for clinical trials remains,” Ms de Somer said.

“These are our collective priorities and require a laser-like focus from the Board, all members and Medicines Australia.”

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Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.

Medicines Australia statement in response to PBAC submission deferrals

Medicines Australia statement in response to PBAC submission deferrals

25 October 2024: Medicines Australia met with senior representatives from the Department of Health and Aged Care yesterday to discuss concerns held by Members following the Government’s decision to defer consideration of a significant number of PBAC Submissions from the March 2025 meeting.

Industry’s concerns include:

-Lack of consultation on the process for prioritisation
-Lack of ability for sponsors to object to the prioritisation or make a case to preference submissions
-Scepticism about the PBAC’s claim that it can only assess 32 submissions.
-Implications and flow-on consequences for co-dependent submissions; particularly those that have already been scheduled for MSAC consideration.
-The negative signal this sends to sponsors about Australia as a first launch country.
-The capacity of evaluation units and how the broader HTA evaluator community is utilised.
-Alternative options to avoid delaying submissions by a full cycle.

Medicines Australia CEO Liz de Somer said the meeting was productive.

“We understand the PBAC determined to accept 32 submissions that are a mix of category1&2 and resubmissions that require a full economic evaluation and propose to defer 24 (major) category 1&2 and 21 (minor) category 3&4 submissions.”

“It is essential industry and Government work collaboratively on this matter, given the significant impact it will have on patient access to critical medicines as well as significant business planning consequences.

“Most importantly, we need to ensure that every possible option is explored to enable the submissions to be evaluated prior to July and not create ongoing delays to access for patients throughout 2025,” said Ms de Somer.

It was agreed the Department will:

-Jointly explore with Medicines Australia all possible solutions to speed up evaluations and PBAC consideration of submissions at the March and July 2025 PBAC meetings.
-Explore an ongoing evaluation process and the use of an intracycle meeting to reduce the number of submissions that need to go to the July meeting.
-Provide Medicines Australia with the criteria used by the PBAC to make its triaging decisions and the deliberative process undertaken.
-Consistent with past practice, listing will continue to occur during the caretake period, subject to an agreement between the Government Opposition ahead of an election being called.

Medicines Australia and the Department agreed to continue to work to ensure this situation is not repeated and actions that will be taken are:

-A review of evaluators currently on the Department’s panel to ensure there is capacity to deal with peak submission periods.
-A review the criteria for the appointment of evaluators so that evaluators that do work with industry are not automatically disqualified from being appointed to the Government panel if other conflict of interest strategies can be developed and effectively implemented.
-A review of the PBAC and sub-committees’ capacity and schedule of meetings to deal with evaluations and assessment of submissions going forward and to enable intracycle meetings to substantively evaluate and assess submissions.
-Genuine consultation with Medicines Australia prior to members being notified should this situation occur again.

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Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.

Vaccines are one of the best public health investments the Government can make

Vaccines are one of the best public health investments the Government can make

A new report launched today by GSK Australia, Prevention: A Productivity Superpower, is a timely and important reminder of the role of vaccines in preventing diseases in Australia and their contribution to the nation’s productivity and economy. This cost-effectiveness analysis of addressing gaps in adult vaccinations and thereby preventing diseases like shingles, influenza, respiratory syncytial virus, pertussis and diphtheria shows a $1.1 billion benefit to the Australian economy.

Medicines Australia CEO Liz de Somer said today “This new report by GSK Australia, Prevention: A Productivity Superpower, demonstrates that for every dollar the Government invests in vaccinating adults in Australia, there is a $3.50 economic return. Vaccines are truly one of the best public health investments governments can make.

“Vaccines improve life expectancy and quality of life. The effective use of vaccines reduces demand on Australia’s health system including general practice, hospitals, other government services, while at the same time they boost productivity and economic participation. Australia does so well at vaccinating our children, we now need to extend this commitment to adults,” Ms de Somer said.

This report is an incredibly important demonstration of the potential impact of an adult vaccination program in Australia. It is also timely as it is being released as the Government considers the recommendations of the HTA Review released on 10 September 2024 by the Hon. Mark Butler MP, Minister for Health and Aged Care.

The HTA Review, Accelerating Access to the Best Medicines for Australians Now and into the Future, recommends reforms to reduce the time Australians wait for access to new vaccines.

“The central tenet of the HTA Review is to improve timely access to affordable medicines and vaccines to meet the needs of all Australians. The Review found that the additional steps involved with the National Immunisation Program (NIP) assessment of vaccines means it takes longer for Australians to access new vaccines than for Pharmaceutical Benefits Scheme medicines. This is clearly not in Australia’s health and economic interest,” said Ms de Somer.

“Medicines Australia supports the HTA Review recommendations to restructure the NIP listing process, and for proportionate reviews of vaccines based on complexity and the risks and benefits of the vaccine. We also support the recommendation to reduce the discount rate to 3.5% for health technologies with high upfront costs and long-term benefits to better capture the value of vaccines and argue it should be lowered further.

“Medicines Australia welcomes the Government’s commitment to pushing on with reforms through an independent Implementation Group and are looking forward to the establishment of this Group as soon as possible.

“We cannot lose reform momentum, patients are waiting,” said Ms de Somer.

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Media enquiries to Gail Morgan, Head of Strategic Engagement and Communications – gail.morgan@medicinesaustralia.com.au or 0412 926 348.

Position statement on associations between tobacco companies and pharmaceutical entities engaged in healthcare

Position statement on associations between tobacco companies and pharmaceutical entities engaged in healthcare

25 September 2024: Medicines Australia notes the extensive work undertaken by the Commonwealth Government, Minister for Health and Aged Care, Mark Butler MP, and others in the control and regulation of unregulated, non-approved vaping products.

In respect of the public discourse on this health issue Medicines Australia has the following position:

1. Medicines Australia recognises the negative role that tobacco/vaping play in respiratory health, and that it is fully demonstrated by the available evidence.
2. Medicines Australia opposes tobacco companies assuming control of companies that provide technologies to treat respiratory and other health conditions.
3. Medicines Australia opposes associations between healthcare companies and organisations that act in a way to undermine the health of populations and individuals.
4. Medicines Australia is committed to compliance with the Australian Competition and Consumer Act (2010). It also acknowledges the freedom and independence of research-based pharmaceutical companies to make their own commercial decisions, in the best interests of their organisations and customers, and act in a manner which complies with competition laws.
5. Medicines Australia will continue promote health as the primary consideration in all our activities and those of our members, and the introduction of appropriate health policies to ensure Australians have access to the best medicines and the best health outcomes as soon as they are available.

HTA Review delivers promise of faster patient access to the best medicines

HTA Review delivers promise of faster patient access to the best medicines

10 September 2024: The Review of Australia’s health technology assessment policies and methods opens the door to improved access to new medicines and vaccines for Australians through the Pharmaceutical Benefits Scheme (PBS).

The Review, released today by the Albanese Government, outlines 50 recommendations for reforms needed to improve systems and pathways to accelerate patient access.

The Minister for Health and Aged Care, Mark Butler, also confirmed an independent implementation group will be appointed to drive forward the reforms.

Medicines Australia CEO Liz de Somer was industry’s representative on the HTA Review Reference Committee and said the recommendations will make a significant difference to Australians once implemented as a complete package.

“The recommendations reflect what has been the most comprehensive review of Australia’s HTA in more than 30 years. The input from stakeholders has been tremendous and provided a clear picture of where improvement is needed,” Ms de Somer said.

The Review found there is urgent need for system reform, with patients experiencing profound negative consequences caused by delays in access to new treatments.

“Without these changes Australians will continue to miss out on the best medicines available now and the revolutionary treatments that are on the horizon. System-wide reform will deliver a Stronger PBS for all Australians,” Ms de Somer said.

There is strong recognition throughout the report that system-wide reform is needed to address inequities in patient access, improve timely access to medicines, encourage companies to bring innovative medicines to Australia, and improve engagement with patients to value what matters to them.

The recommendations also recognise investment is needed to boost HTA capability to create sustainability and equip the system to evaluate emerging technologies into the future.

Industry will continue to work with the Government to develop effective key performance indicators and comparator selection, and to finding a solution to discount rate.

“Medicines Australia welcomes the Government’s commitment to pushing on with reforms through an implementation group,” Ms de Somer said.

“Industry stands ready to constructively participate in the implementation group alongside patients, patient advocacy groups, clinicians and the Government. We need an implementation plan and timelines, and we need to begin the co-design work that is needed to deliver these reforms.”

“We cannot lose reform momentum, patients are waiting.”

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Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.

Reporting of medicines shortages in Australia

Reporting of medicines shortages in Australia

19 June 2024: Medicines Australia has noted an increase in media reports of medicines shortages in the community over the last 12 months.

A medicine is listed on the Therapeutic Goods Administration’s (TGA) shortages reports database when supply is not likely to meet the normal or projected consumer demand within Australia at any point in the next six months. Mandatory reporting of supply information came into effect in January 2019.

“Medicines Australia encourages caution in the interpretation and reporting of supply information that may inadvertently prompt panic buying or stockpiling and further intensify supply pressures,” Medicines Australia CEO Liz de Somer said.

“The TGA database includes actual and potential shortages, as well as shortages of a particular brand where alternatives may continue to be available.”

“This information can be misunderstood and sometimes projected shortages don’t eventuate, which is why it’s important this information is considered carefully.”

“Manufacturers make every effort to ensure supplies are maintained. Where potential shortages are identified, there is collaboration with the TGA, healthcare professionals and prescribers to manage supplies for essential need.”

Shortages may be anticipated for a number of reasons including unexpected increases in demand, natural disasters, ingredient shortages, or disruptions to manufacturing and distribution channels. The global pharmaceutical supply chain is complex and any of these factors can create pressure.

“Transparency is a very important principle for the industry, prescribers and others in the supply chain. However, it is equally important this information does not cause unnecessary concerns about medicines availability for patients,” Ms de Somer said.

If consumers are concerned about the availability of a particular medicine, the best thing to do is talk to your prescribing doctor.

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Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.

Medicines Australia Board Director Prof John Skerritt recognised in King’s Honours list

Medicines Australia Board Director Prof John Skerritt recognised in King’s Honours list

11 June 2024: Medicines Australia congratulates independent Board Director, Prof John Skerritt, on his appointment as a Member of the Order of Australia (AM) in the General Division in the 2024 King’s Birthday Honours list.

Prof Skerritt was recognised for ‘significant service to public health administration and governance, and to scientific research’ which includes joint roles as head of the TGA and Deputy Secretary from 2012 to 2023.

In addition, Prof Skerritt was a member of the Australia-NZ Clinical Trial Registry Advisory Board from 2012-2021. He is a Professor of Medicine at Melbourne University, and an Adjunct Professor at Sydney University, and joined the Board of Medicines Australia as an independent Director in 2023.

Medicines Australia Chair, Dr Anna Lavelle, commended Prof Skerritt on his achievements and said all Australians have benefited from his contribution to the therapeutic regulatory environment, clinical trials system and broader health system.

“Professor Skerritt has made a significant contribution to Australia’s healthcare system over the last 15 years, through his leadership and deep understanding of regulation and government processes. This has come at a pivotal time when innovation in medical technologies has advanced at a faster pace than ever before, requiring a cautious but willing approach to embrace change.”

“Medicines Australia is very fortunate to be able to draw on John’s expertise as an independent Board Director and we warmly congratulate him on this tremendous recognition of his service.”

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Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.

Medicines Australia’s response to the 2024-25 Federal Budget

14 May 2024: The healthcare measures announced in the 2024-25 Budget show a move towards preventive care and wellbeing to ease pressure on Australia’s health system.

“The investment committed in the 2024-25 Budget to Medicare, screening programs, research, mental health, clinical trials, new PBS listings and programs to keep ageing Australians out of hospital will greatly benefit many people,” Medicines Australia CEO Liz de Somer said.

“As Australia faces the pressure of an ageing population, reduced productivity and growing Medicare costs, we must change our thinking about medicines and view the PBS as an investment in wellbeing, rather than a cost.”

“Access to medicines has a direct link to the economy and to productivity, as evidenced in the recent Productivity Commission report that found advances in cancer treatments have been one of the major drivers of productivity growth.”

“Bold PBS reform to accelerate patient access to the best medicine available will deliver step change in preventive care. The faster that patients can access new medicines through the PBS, the faster they will recover. This means fewer visits to the doctor, fewer hospitalisations and immediate, tangible impacts on the whole community.”

Clinical trials

The previously announced commitment of $62 million to support clinical trials and a further $18.8 million to progress the National One Stop Shop is welcomed by industry and is a significant step towards improving access to medicines for all Australians.

“Australia plays a vital role in the research and development of new medicines through clinical trials. The investment by Government into creating a single system for accessing clinical trials and harmonised processes will benefit patients and ensure Australia remains globally competitive as a research and development destination,” Ms de Somer said.

“As the Government focuses on a future made in Australia, it’s important that we do not inadvertently create an unfavourable environment for the launch of new medicines and medical technologies that Australians have contributed to developing.”

Health Technology Assessment reforms

The absence of any announcements about the Health Technology Assessment review is not cause for concern, given the report only went to the Minister last week.

“Delays that occurred throughout the review period meant that we did not expect any announcements about HTA reform,” Ms de Somer said.

“We know reforms will take time to implement and require forward budget planning. The Medicines Australia roadmap of reforms outlines a 3-year plan that balances the opportunities for fast wins for patients and the more complex reforms that will require legislative change.”

“Funding should not prevent or delay stakeholders coming together to commence codesigning reforms, and Medicines Australia calls on the Minister to release the HTA report and commit to the next steps towards reform implementation.”

“Patients had to wait more than two years from the House of Representatives inquiry for the New Frontiers report to be released. The HTA review has now taken over a year. Patients cannot keep waiting. We need to get on with reforming the system to accelerate access.”

“We know that a stronger PBS will deliver savings in other areas of the health system and increase productivity. Australia needs a system that delivers equitable access to the latest medical technologies within 60 days of TGA registration.”

Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.

Stronger PBS campaign radio advertising commences this weekend

3 May 2024: The second phase of Medicines Australia’s ‘Stronger PBS’ campaign will commence this weekend with radio and digital media advertisements.

The ‘Stronger PBS’ campaign aims to educate Australians about the Pharmaceutical Benefits Scheme (PBS) through the real-life stories of people whose lives have been changed because they were able to access the medicine they need, and stories of people who are still waiting for medicines they need to be available through the PBS.

Medicines Australia CEO Liz de Somer said the next phase will build on the campaign’s success on social media to reach people through traditional media platforms including radio and print.

“The Stronger PBS campaign is designed to initiate aconversation with the public about the PBS including access issues that people often are not aware of until they are personally affected.

“We know through research that Australians love the PBS but most don’t know a lot about how it works or how long it takes for medicines to be made available through the PBS.

“People are shocked to learn it takes 466 days on average from when a medicine is approved for use in Australia by the Therapeutic Goods Administration (TGA) to it being available through the PBS.”

Over the next month, radio ads will air in Canberra, Adelaide, Melbourne, Hobart and Sydney with a message that links the emotive impact of traffic delays with the stark reality of the impact of waiting for a life-changing medicine.

“We all get frustrated sitting in traffic, but for patients waiting to access a new medicine, delays can mean the difference between life and death,” Ms de Somer said.

“When you hear the worst possible news from a doctor that you or your loved one has a life-threatening condition, the last thing you expect to then hear is that there is a medicine that can treat this but it’s not yet available on the PBS and might not be in the time you have left.”

“Australians believe our health system is world class, but the reality is that when it comes to access the latest innovative medicines, we are a long way behind.”

Through the campaign, we are building a community of engaged and informed Australians who are passionate about the PBS and want to see change.

Since launching in late September, the campaign has reached more than 2 million people. The campaign will continue throughout 2024 with different phases of activity planned to build an engaged community.

Media enquiries to Kate McKeown, Senior Manager Communications and Media – kate.mckeown@medicinesaustralia.com.au or 0408 775 288.