Final Budget Outcomes Reveal Industry Efforts To Take Pressure off PBS

Final Budget Outcomes Reveal Industry Efforts To Take Pressure off PBS

The Final Budget Outcome papers released today reveal the enormous efforts of the members of Medicines Australia to keep expenditure low on the Pharmaceutical Benefits Scheme (PBS) while providing Australians with incredible access to breakthrough medicines.

Our members invent, research, develop and manufacture the latest therapies that help to make Australia healthier and more productive and also take the pressure off our hospitals.

The Final Budget Outcome for 2016-17 shows that the Federal Government spent $13.379 billion on the PBS.

However, the final outcome is a gross figure that does not subtract the significant rebates provided by our members through pricing and supply agreements with government.

It’s understood that when these rebates are taken into account the real cost of the PBS continues to remain relatively flat year on year.

The rebates are in addition to the recent Strategic Agreement signed between Medicines Australia and the Federal Government that will deliver agreed price reductions for on-patent medicines totaling $1.8 billion over five years.

Medicines Australia Chief Executive Milton Catelin says, “these rebates offer Australians extraordinary value for money on breakthrough treatments for life-threatening conditions such as cancer and infectious disease.”

“Without these rebates, which are confidential between companies and government, many of the latest medicines may be significantly delayed in coming to Australia or may never be accessed via the PBS at all.”

“Rebates have become increasingly commonplace due to the incredibly tough pricing arrangements that have evolved due to the current budgetary position in Australia.”

“They allow companies to offer confidential agreements which deliver incredible discounts or volume agreements that would otherwise not be possible.”

“Our members continue to make significant sacrifices day in and day out to ensure that Australia has an affordable PBS that still provides incredible access to innovative medicines.”

“It’s not only rebates, there is also the recently signed Strategic Agreement that reduces prices for on-patent medicines that have taken billions of dollars and years of investment to deliver to patients.”

“In fact, our members have helped to deliver ongoing and growing cost savings measures that have reduced pressure on the PBS by more than $20 billion and counting since 2007.”

“It’s a contribution that regrettably goes largely unrecognised but the innovative medicines industry continues to deliver for Australia.”

“Our members are proud of their role in the development of breakthrough medicines and vaccines and are committed to their continued access for all Australians,” said Mr Catelin.

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Contact: James Boyce – 0423 239 265

Appointments of Departmental Secretaries

Appointments of Departmental Secretaries

Medicines Australia welcomes the appointments of Glenys Beauchamp PSM as the Secretary of the Department of Health and Dr Heather Smith PSM as the Secretary of the Department of Industry, Innovation & Science.

“I want to congratulate them both on their appointments by the Prime Minister,” said Medicines Australia Chief Executive Milton Catelin.

“Glenys and Heather are two exceptionally capable and experienced members of the public service and Medicines Australia and its members look forward to a close and constructive relationship with them both.”

“Having served as the Secretary of the Department of Industry, Innovation & Science, Ms Beauchamp has already seen the enormous value of our industry and the investment that it brings to Australia.”

“This is an important time for the Department of Health and our members as we look to steer through legislation that will support the Strategic Agreement recently signed between Medicines Australia and the Commonwealth.”

“We also look forward to working together with Ms Beauchamp and her Department on process reforms to both the Therapeutic Goods Administration (TGA) and the Pharmaceutical Benefits Advisory Committee (PBAC) that will make a difference for Australians who rely on access to innovative medicines on the Pharmaceutical Benefits Scheme (PBS).”

“Dr Smith will be an excellent replacement as the Secretary of the Department of Industry and I look forward to working with her on policies that will continue to encourage investment by our members in manufacturing and vital medical research, such as clinical trials.”

“Our members undertake around 900 clinical trials a year in Australia and manufacture medicines that make up around half the exports of medicine products which are now Australia’s largest manufactured export and we want to see that grow even more.”

“Once again I congratulate both on their appointments,” said Mr Catelin.

-Ends-

Contact: James Boyce – 0423 239 265

Ongoing transparency leadership by MA Members

Ongoing transparency leadership by MA Members

Pharmaceutical companies and medical professionals share an important partnership. We collaborate on clinical research, share knowledge and support education to ensure that medicines are constantly improving and are used safely and appropriately by doctors and their patients.

The Medicines Australia Code of Conduct is the national standard for industry self-regulation and is leading the way on transparency.

Medicines Australia and its member companies are proud of their role in developing the Code, which ensures the medicines industry leads the health sector in transparency. Our high standards of ethical conduct and transparency will help drive further improvements to Australia’s health care system.

This Code has been authorised by the ACCC and is supported by the Australian Medical Association.

The latest transparency reports, published today, provide clear information about payments to a healthcare professional so they can access the latest educational opportunities, attend conferences or symposia, or for their services as an expert.

By supporting ongoing education, companies can assist healthcare professionals to acquire the appropriate understanding and knowledge of new innovative therapies, which is appropriate and accountable.

The Code of Conduct is the Australian benchmark for accountability and transparency reporting in the therapeutic goods sector. This is the same standard that pharmaceutical companies are held to in Europe, and significantly more detailed than industry self-regulation in the USA.

Further information about the transparency requirements of the Medicines Australia Code of Conduct and hyperlinks to each member company’s reports are available here.

MA encourages consumers to talk to their doctors if they would like to know more about their relationships with different companies and the benefits to patient health.

CONTACT: Natalie Wimmer – Communications Manager – 0450 728 660

Statement on Government’s response to Productivity Commission’s (PC) Inquiry in Intellectual Property.

Statement on Government’s response to Productivity Commission’s (PC) Inquiry in Intellectual Property.

MA notes the Government has today released their response to the Productivity Commission’s (PC) Inquiry in Intellectual Property.

We know that strong IP leads to greater innovation in the pharmaceutical sector.

We’re pleased the Government does not intend to implement the detrimental recommendations made by the PC as any changes that weaken IP in Australia could have a negative impact on the ability for all Australians to access to the latest innovative medicines. It would also diminish Australia’s competitiveness for investment in vital medical research such as clinical trials.

Therefore, It’s somewhat disappointing to read the Government supports the PC’s view on so-called pay-for-delay. It seems extraordinary to introduce additional regulatory burdens to monitor something when the Government itself acknowledges that there is no evidence to support the Productivity Commission’s view.

We look forward to examining the report in more detail and consulting with members and the Government to ensure that Australia’s IP system continues to encourage innovation, investment in research and development and access to the latest breakthroughs in medicines for all Australians.

More information: Natalie Wimmer – 0450728660

Pharmaceutical industry acknowledges service of Martin Bowles PSM.

Pharmaceutical industry acknowledges service of Martin Bowles PSM.

Medicines Australia would like to acknowledge the enormous contribution made by Martin Bowles PSM as a public servant for almost 40 years and as Secretary of the Department of Health since 2014.

The health portfolio is an incredibly demanding and diverse portfolio and its effective management is critical to all Australians. Mr Bowles has served as its Secretary with distinction.

Medicines Australia has had a constructive and effective relationship with Mr Bowles and worked closely with him and his team on many issues over the past two and a half years, none more important than the successful completion of a Strategic Agreement with the Commonwealth this year.

Medicines Australia wishes Mr Bowles all the best for the future.

ENDS

CONTACT

Natalie Wimmer, Media Manager – Medicines Australia – 0450728660

PBAC announces appointment of industry expert to Committee

PBAC announces appointment of industry expert to Committee

Medicines Australia is pleased to welcome the appointment of Michelle Burke to the Pharmaceutical Benefits Advisory Committee (PBAC).

Ms Burke has enormous experience in the sector and has a long history of working with multinational bio-pharmaceutical companies and contributing to significant policy issues such as PBS reform and industry development. Ms Burke has three times been the recipient of industry recognition through the prestigious Pat Clear Award, for her contributions to broader industry policy.

The appointment of an industry nominated member to the PBAC was one of several changes made to the Committee as part of the 2015 PBS Access and Sustainability Package.

“Ms Burke is eminently qualified to bring to the PBAC the high degree of integrity and independence as well as considerable experience of the medicines regulatory and reimbursement system and its interaction with the broader, global eco-system,” said Milton Catelin, Chief Executive Medicines Australia.

“The Committee has shown a willingness to engage with the medicines industry and has a deep understanding of the issues impacting on our sector.”

“We look forward to working with the PBAC towards what should be our shared priority, namely, the timely listing of new, innovative and cost-effective medicines to the Pharmaceutical Benefits Scheme (PBS),” said Mr Catelin.

The PBAC is an independent expert body appointed by the Australian Government. Members include doctors, health professionals, health economists and consumer representatives.

Its primary role is to recommend new medicines for listing on the PBS. No new medicine can be listed unless the committee makes a positive recommendation.

Contact:

Natalie Wimmer, Media Manager – Medicines Australia
Phone: 0450 728 660
Email: nwimmer@medaus.com.au

Joint statement on skilled migration visa changes

Joint statement on skilled migration visa changes

Restoration on skilled visas welcomed across medical technology, biotechnology and pharmaceutical sector.

The restoration of key occupations for the medical technology, research and pharmaceutical sector to the skilled migration visa list has been welcomed by six representative organisations. Having participated in submissions and consultations, the combined peak body group is pleased the Government has addressed concerns that were widely shared across the medical technologies, biotechnologies and pharmaceuticals industry sector and the health and medical research sector.

The revised list of occupations is an important step for which there is significant acknowledgment and relief that the attraction of highly-skilled individuals will not be thwarted and demonstrates continued support for Australia’s competitive advantage in life sciences innovation.

The revised list has provided assurance that important recruitment of outstanding talent can continue consistent with the Australian National Innovation and Science Agenda. Australia will be able to continue to thrive as a home for some of the world’s most talented scientists and medical researchers, improve its position as a centre for high-quality R&D in medical science and receive the associated spill over benefits.

Signatory organisations include representatives of the entire life sciences research and commercialisation ‘ecosystem’, including biotechnology, pharmaceutical and medical technology companies, ranging from start-ups to mature multinationals, research institutes, universities and specialist service professionals.

We understand the need for the Government to ensure that the visa program benefits Australia and the scheme must be viewed as a tool to fill the skills gaps that exists in Australia. In this instance, the gaps are in research and industries that create highly-attractive highly skilled jobs, attract clinical research, upskills the local talent pool and grows the local economy.

About AusBiotech
AusBiotech is Australia’s biotechnology organisation, working on behalf of members for 30 years to provide representation and services to promote the development, growth and prosperity of Australian biotechnology. AusBiotech is a well-connected network of over 3,000 members in the life sciences, including therapeutics, medical technology (devices and diagnostics), food technology and agricultural, environmental and industrial sectors.

About Research Australia

Research Australia is the national peak body representing the entire health and medical research pipeline advocating for health and medical research in Australia. Independent of government, Research Australia’s activities are funded by its partners, donors and supporters from leading research organisations, academic institutions, philanthropy, community special interest groups, peak industry bodies, biotechnology, medical technology and pharmaceutical companies, small businesses and corporate Australia.

About Medicines Australia

Medicines Australia represents the discovery-driven pharmaceutical industry in Australia. Our member companies invent, manufacture and supply innovative medicines and vaccines to the Australian community, which keeps Australians out of hospitals, prevents disease and play a pivotal role in ensuring a productive and healthy community. Medicines Australia’s mission is to drive the creation and development of a predictable environment for the continued, sustainable growth of the innovative and research-based prescription medicines industry.

About BioMelbourne Network

The BioMelbourne Network is a membership-based, industry forum representing over 185 organisations and business leaders in biotechnology, medical technology and health innovation industries in the State of Victoria. Our role is to foster links between companies, research organisations, financial markets and government to create an environment for that enables conversation, collaboration and prosperity.

About Medical Technology Association of Australia (MTAA)

The Medical Technology Association of Australia represents manufacturers, exporters and suppliers of medical technology products used in the diagnosis, prevention, treatment and management of disease and disability.

About Association of Australian Medical Research Institutes (AAMRI)

AAMRI is the peak body for medical research institutes (MRIs) across Australia. Our member organisations work on a broad spectrum of human health issues such as preventive health, chronic disease, mental health, immunology and Indigenous health. Their research ranges from fundamental biomedical discovery through to clinical research and the translation of research findings from bench to bedside.

A sandwich won’t sway a doctor.

A sandwich won’t sway a doctor.

Pharmaceutical companies and medical professionals collaborate on clinical research, share knowledge and support education to ensure that medicines are constantly improving and are used safely and appropriately by health care professionals and their patients.

Our members are proud of the work that we do to ensure that the public can continue to have confidence in our local medicines industry. We consider transparency to be a key component of the bond of trust with the Australian public.

Engagement with pharmaceutical companies is an important and legitimate part of a medical practitioner’s ongoing education; foremost, because patients want to be sure that their doctors know how to use the medicines they’re being prescribed.

The developers of these medicines are the highest authority on how a medicine works, its interactions with other compounds, its efficacy and other information. It stands to reason that a medical practitioner would consider information from the maker of the medicine when making an informed decision about prescribing a medicine. It’s not however, the only source. Medical practitioners do their own research, network with their peers, consult with other clinical experts, read independent medical journals and receive information from independent bodies such as NPS MedicineWise.

It’s ludicrous to suggest that a sandwich and a soda water would sway the opinions of medical practitioners. Suggestions like the one published in the Conversation and in the BMJ article do nothing but undermine a patient’s confidence in a robust and accountable system, and call healthcare professionals into disrepute.

Moreover, when a doctor is working a 12 hour day, and uses their lunchbreak to inform themselves of the latest developments in medicines, it seems appropriate that they be provided with lunch.

It’s also important to note, the 18th Edition of the Medicines Australia Code of Conduct clearly states:

Any meals or beverages offered by companies to healthcare professionals must be secondary to the educational content. Meals and beverages must be appropriate for the educational content and duration of the meeting and should not be excessive.

The maximum cost of a meal (including beverages) provided by a company to a healthcare professional within Australia must not exceed $120 (excluding GST and gratuities).

This maximum would only be appropriate in exceptional circumstances, such as a dinner at a learned society conference with substantial educational content. In the majority of circumstances, the cost of a meal (including beverages) should be well below this figure.

For hospitality in association with overseas educational meetings this maximum and/or local guidelines should be used as a guide.

The Code of Conduct is the Australian benchmark for accountability and transparency reporting in the therapeutic goods sector. This is the same standard that pharmaceutical companies are held to in Europe, and significantly more detailed than industry self-regulation in the USA.

Medicines Australia members are proud of their Code of Conduct. They have voluntarily submitted themselves to this significant transparency despite the fact that non-Medicines Australia members do not, that includes generic medicines manufacturers and the makers of medical devices. Our positive experience with increasing transparency of our members should stand as a beacon to others to join us on the journey.

A better informed patient has more confidence in the relationships between doctor and company. They are more likely to understand the value of these relationships in the development of better medicines and devices, including a doctor’s or patient’s participation in Australian-based clinical trials.

Australian patients should be assured that their medical practitioners are keeping up to date with the latest innovation in medicines and the sharing of knowledge so that medical practitioners can determine the best outcomes for their patients.

More information – Natalie Wimmer – Communications Manager, Medicines Australia – 0450 728 660

457 Visa modifications welcomed by pharmaceutical industry

457 Visa modifications welcomed by pharmaceutical industry

Medicines Australia has welcomed the Federal Government’s modifications to Australia’s skilled migration occupation lists announced on Friday 30 June. These changes will prevent workforce and skill shortages within the critical innovative pharmaceutical sector.

Medicines Australia Chief Executive, Milton Catelin said: “As an industry that is so reliant on research and development and a workforce with very specific abilities, it’s important that we have a skilled migration policy that can support the ongoing work of this vital sector to Australia.

Our members employ more than 14,000 Australians and invest more than $1 billion a year in local research and development, including clinical trials, but without access to an appropriately targeted skilled migration system much of this work would not be able to go ahead in Australia.

“The innovative pharmaceutical sector relies on the support of our global networks and world-best research to bring the latest in biopharmaceutical research to Australian patients. This collaboration has led to many of the medical advancements that are improving lives every day.”

“Medicines Australia commends Immigration Minister Peter Dutton’s quick acknowledgement of the importance of the Australian-based sector being able to compete at a global level but it also ensures that our skilled migration policy supports the Federal Government’s National Innovation and Science Agenda,” Mr Catelin said.

“Since the government’s initial announcement in April, the sector has worked proactively with the Department of Immigration, Minister Dutton and his Ministerial Office to address what were clearly unforeseen consequences of changes to Australia’s skilled migration program.

“With the return of Biochemist, Biotechnologist, Lift Scientist, Nurse Researcher, Production Manager (Manufacturing) and Research and Development Manager to the list, there are now ongoing avenues through which these skills can be brought to Australia.”

“Between 1 -3% of our total member company employees are contracted under skilled migration conditions – yet, despite this small number – they fill roles that are critical to the ongoing operation and development of the sector.

“Minister Dutton’s decision on Friday is a welcome one for an industry that requires business and workforce certainty to bring medicines through the development pipeline. This decision will help us meet that need.”

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CONTACT: Natalie Wimmer

Ph. 0450 728 660

Email: nwimmer@medaus.com.au

Has the interim report considered long term supply chain impacts?

Has the interim report considered long term supply chain impacts?

Medicines Australia welcomes the release of the Interim Report of Pharmacy Review but has concerns about some proposals that could damage the National Medicines Policy and have negative impacts for the manufacturers of medicines, distributors, community pharmacies and patients.

Medicines Australia Chief Executive Milton Catelin said, “The innovative pharmaceutical industry believes it is important to always be looking to improve processes that relate to the supply of medicines to Australians, however, any change must be done with the full support and confidence of the companies that make the medicines, the wholesale distributors and the pharmacists who dispense them.”

“A number of ideas put forward in the interim report are of real concern to Medicines Australia as they are either ineffective, could potentially diminish medicine quality or lead to potential medicines shortages for patients,” said Mr Catelin.

These include:

  • Reducing competition in off-patent medicines by tendering for a maximum of five suppliers (four generic manufacturers and the original branded supplier) per medicine.
  • Changes to chemotherapy compounding payments and minimum standards that would allow non-TGA approved compounding facilities to offer chemotherapy compounding.
  • Removal, retention or replacement of the Community Service Obligation (CSO)

Tenders are already utilised by Australian hospitals for off-patent medicines and have proven to be problematic with acute shortages of medicines becoming more common.

“Any move towards a tender-based PBS would be a retrograde step that would limit choice for consumers, increase the risk of medicines supply shortages and could ultimately lead to higher long-term average costs for off-patent medicines on the PBS.”

“The report does not take into account recent reforms negotiated between Medicines Australia and the Government that will have a significant impact on reducing the prices paid for medicines that will see generics present even greater value to patients in the future,” said Mr Catelin.

The suggestion to remove or replace the CSO was criticised by Medicines Australia during consultation last year.

“The review suggests that manufacturers may be charged with more broadly guaranteeing supply timeframes to community pharmacies. Unfortunately, this may have the converse effect of increasing regulation, replication and inefficiency into the system,” said Mr Catelin.

“This could lead to long term supply chain issues and increased pressure on manufacturers.”

Medicines Australia does believe some of the proposals are less controversial and should be put forward for more formal consideration including:

  • Electronic prescriptions and personal medicines records
  • Consumer choice of dispenser with electronic prescribing
  • Managing Medicines Risks upon patient discharge (from hospital)
  • Transparency of public funding in pharmacy programs

“Of the many other ideas put forward in the Interim Report, some require a much more detailed explanation, analysis and consultation with the affected parties before they could be endorsed or explored by the medicines industry,” said Mr Catelin.

“I’m also pleased to note the confidence the Review has placed on the innovative pharmaceutical industry’s current commitment to Consumer Medication Information (CMI),” said Mr Catelin.

“Medicines Australia continues to work with the TGA on CMI, and encourages the use of technology to make this information further available to patients and consumers.”

“We will now spend considerable time discussing the report with our members to understand first-hand the impacts, opportunities and the consequences of these proposals.”

“Australia already has a world-class healthcare system and our pharmacists do a fantastic job delivering health care. Any reforms to how medicines are supplied to patients must maintain this standard,” said Mr Catelin.

Medicines Australia looks forward to further collaborative consultation on this report with the Government in the lead up to the final report.

Contact:

Natalie Wimmer
Phone: 0450 728 660
Email: nwimmer@medaus.com.au