Last week saw the listing of ERLYAND^® (apalutamide) for the treatment men with non-metastatic (castration-resistant) prostate cancer.

As part of the implementation of recommendations from the Review of Medicines and Medical Devices Regulation (MMDR) the TGA has introduced a priority review pathway designed to speed up the review and approval of certain medicines. This joins many other countries in meeting regulatory best practice to ensure that Australian patients can get access to the medicines they need, when they need them.

The evaluation of ERLYAND^® included a unique joint initiative between Australian and Canadian Health regulators which saw the evaluation process completed in less than half the time it normally takes for a new medicine to be approved in Australia.

The collaborative pathway provides a predictable and transparent mechanism to formalise the expedited process for sponsors of new medicines and is indicative of the Government’s genuine commitment to accelerating approval of new, innovative therapies for Australian patients.

The TGA and Department of Health have shown a long-standing commitment to ongoing policy reforms.

Medicines Australia congratulates both Departments on their quest to modernise their process through flexibility and updated processes, thus providing rapid access to new medicines for Australians.

The success of this first priority review marks another significant milestone of the MMDR, which identified ways to improve access to therapeutic goods for patients and remove unnecessary red-tape for industry whilst maintaining the safety of therapeutic goods in Australia.

A number of these reforms required legislation and the TGA, the Department of Health and both sides of Parliament have worked collaboratively and constructively to ensure that the legislature was drafted and passed efficiently.

Medicines Australia looks forward to seeing further examples of how the priority review pathway programme can mean Australians have faster access to breakthrough medicines.

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More information – Natalie Wimmer – 0450728660 | nwimmer@medaus.com.au

Medicines Australia welcomes the introduction of the Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018 into the Parliament today.

This legislation is the culmination of working together with the sector to review the issue of medicines shortages in Australia. The Medicines Partnership of Australia and a broader group of stakeholders, led by the Therapeutic Goods Administration have developed a comprehensive protocol, which is being implemented through this legislation.

This legislation will go a long way to ensuring there is timely and relevant information available on the supply of medicines, which will assist patients and their doctors (and other health care providers) to manage their treatment plans to receive uninterrupted care.

Minister Hunt’s approach for sponsors to report information about those shortages that are of particular impact on patients, so that prompt action can be taken to address the needs of affected patients, is sensible and factors in the diverse needs of the supply chain. The legislation takes a balanced approach by focusing on the overall situation for a medicine’s availability in Australia.

Medicines Australia is proud of our sector for working together to develop a mandatory reporting scheme for medicine shortages and to better address the public health implications associated with medicine shortages in Australia.

Medicines Australia, and the innovative medicines industry looks forward to the implementation of the legislation, and also working with the Government and the broader sector to reviewing the causes of shortages with an aim to minimise or avoid supply interruptions in the future.

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More information – Natalie Wimmer – nwimmer@medaus.com.au – 0450728660

Medicines Australia, the peak body representing the innovative medicines industry has today announced the appointment of Ms Elizabeth de Somer as the new Chief Executive Officer; and the first female to take on the role.

Ms de Somer is a dedicated advocate and policy expert for the pharmaceutical sector and is well known as a trusted expert in medicines policy having been Medicines Australia’s Director of Policy and and Research for the last five years and Interim CEO since April.

Ms de Somer has worked tirelessly on issues critical to the sector including the negotiation of the five-year Strategic Agreement made with the Government in 2017. Ms de Somer recognises that managing medicines policy requires a deep understanding of the commercial imperatives of companies and how policies interact with commercial decisions.

In accepting the role, Ms de Somer said “I am delighted and honoured to accept the role of CEO for Medicines Australia and to be able to play such a crucial role in ensuring that the Australian community has fast, affordable access to the latest innovative medicines and vaccines.”

“I am committed to broadening the understanding of the immense value this industry brings to the economy and to the community, and ensuring that the system is ready to handle the newest technologies.”

“Medicines Australia members are at the forefront of medical science innovation both in Australia and around the world and it is important that Australian patients continue to get access to these world class treatments.”

Mr Wes Cook, Chair of Medicines Australia congratulated Elizabeth de Somer on her appointment saying: “I have had the great pleasure of working closely with Ms de Somer over the past three years and I have the utmost confidence that she is well equipped to take on the role of CEO”

“Not only does she have the skills required but importantly she has the passion, enthusiasm and energy needed for such a challenging role in a complex environment.”

“We are fortunate to have such a depth of talent and experience in our organisation, and the Board is delighted to welcome Elizabeth to her new role as Chief Executive of Medicines Australia”

“The Board is confident that under Elizabeth’s guidance, Medicines Australia is well positioned to continue building community understanding of the value of new medicines while focusing on ensuring Australians have access to these latest innovative medicines that they need when they need them.”

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More information

Natalie Wimmer – Communications Manager

P: 0450728660
E: nwimmer@medaus.com.au

Medicines Australia congratulates the recipients of the Clinical Trial of the Year Awards for their outstanding achievements in Australian research at the annual Clinical Trials 2018 National Tribute and Awards Ceremony.

Medicines Australia Interim CEO, Ms Elizabeth de Somer said:” Australia has a first-class clinical trials network – that is something to celebrate, and we welcome the   commitment from the Government for this to continue with Clinical trials being exempted from nominal caps as part of changes announced in the 2018 Federal Budget to the Research and Development Tax Incentive (RDTI),”

“This event – which MA and industry are proud supporters of, showcases researchers and partnerships addressing a critical need or evidence gap in the Australian healthcare system.

“I’d like to congratulate the winners of today’s awards, and I’d like to thank those who conduct this important research for their contribution and collaboration throughout the wider MTP sector.” said Ms de Somer.

Also speaking at the awards ceremony, Minister Greg Hunt MP, Minister for Health reaffirmed the Government’s commitment to the research sector with the announcement of the reappointment of Professor Anne Kelso as head of the NHMRC for the next 5 years. Medicines Australia congratulates Professor Kelso on her reappointment and looks forward to working further with her and the NHMRC on strengthening Australia as a destination of choice for clinical trials.

Minister Hunt also announced the “Helping our Health” clinical trials campaign which aims to promote clinical trials to all Australians as a way to increase awareness and recruitment in Australian clinical trials.

The winner of the 2018 Trial of the Year Award is the Australian Placental Transfusion (APT) Trial which is the largest ever randomised controlled trial of delayed placental cord-clamping for premature infants.

Also recognised at the awards ceremony was:

• ACTA STInG Excellence in Trial Statistics Award is the N3RO Trial (pronounced “NERO”), a clinical trial of omega-3 fish oil in reducing a chronic lung disease in premature babies.
• The finalist for the Trial of the Year Award is the TRANSFUSE Trial, an international, multicentre, randomized, double-blind trial which investigated the age of red blood cells for transfusion and outcomes in critically ill adults.
• The finalist for both the Trial of the Year Award and ACTA STInG Excellence in Trial Statistics Award is the PRECISE Trial, a comparative study of two drugs used to treat an aggressive brain cancer, Glioblastoma Multiforme.

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CONTACT:

Natalie Wimmer

0450 728 660
nwimmer@medaus.com.au

MA welcomes the announcement of $1.4 billion for the listing of innovative medicines on the PBS, as announced in today’s 2018/19 Federal Budget. This will help ensure all Australians have access to new and innovative medicines they need when they need them.

We are encouraged by the $1 billion future listing provision and the Government’s commitment to list all new medicines recommended by the PBAC.  We look forward to further discussion on this, and on the revised payment administration systems for high cost medicines.

We know that with new highly targeted medicines coming in through the pipeline, continued investment in the PBS is needed.

The Government has acknowledged the budget is in good shape, now it’s time to see some investment in high value areas such as the PBS and the innovative medicines industry.

A strong PBS not only helps patients, it also supports thousands of medical researchers and jobs and the research-based medicines and health sectors, and encourages investment in medical research in Australia.

Medicines Australia is pleased with the Government’s commitment to research and development within the innovative pharmaceutical sector with the exemption of clinical trials under changes to the R&D Tax Incentive and no intensity threshold.

The Government has also responded to industry’s Pre-Budget submission by budgeting to boost the profile of Australia’s innovative medicines industry internationally through the National Health and Medical Industry Growth Plan.

Medicines Australia notes the new PBS listings announced in the Budget that will provide further important health benefits for patients. This includes Refractory multiple myeloma, relapsing remitting MS, PreP, relapsed of refractory Hodgkin’s lymphoma; $42.5 million over five years 2017-18 for Maternal Pertussis, High dose 65 years plus flu, 12 Month meningococcal ACWY.

There are still unanswered questions arising from the Budget, which we will be working through over the coming days.

Medicines Australia remains committed to working constructively with the Government to deliver a solution that will enable the Government to invest in the PBS so that new innovative medicines can continue to be listed for Australians.

CONTACT:

Natalie Wimmer –Communications Manager – 0450 728 660 – nwimmer@medaus.com

Medicines Australia (MA) congratulates MTPConnect on the appointment of Dr Dan Grant as Chief Executive Officer.  Dr Grant has extensive background and experience in the pharmaceutical sector and academia – most recently as Pro Vice Chancellor at La Trobe University and as head of External Research and Development Innovation Group at Pfizer.

Interim CEO of MA, Ms Elizabeth de Somer said, “Medicines Australia and MTPConnect share the same goals of increasing industry collaboration, investment and innovation.”

“Dr Grant’s extensive experience in pharmaceutical innovation make him the ideal person to further the agenda of the important MTP sector,”

“Medicines Australia and our members look forward to working with Dr Grant to continue our already close collaboration with MTPConnect,” said Ms de Somer.

MA also recognises the outstanding contribution of Sue MacLeman who, as announced in February, will assume the position of Chair.

“Under Sue’s direction, MTPConnect and Medicines Australia signed an MOU to ensure continued collaboration,”

“In addition to that, MA and consortia of our members are partnering with MTPConnect on three projects: The Bridge Program – which along with QUT, helps participants understand and navigate the complex regulatory, financial, scientific and intellectual property issues involved in translating promising research into new medicines for market; The tele-trials program – working with the Clinical Oncology Society of Australia to broaden the reach of clinical trials into remote and regional areas; and the Value of Medicines project, which will review and quantify the value of medicines and the medicines industry to the community,” said Ms de Somer.

“Ms MacLeman has been a tireless advocate for the MTP sector and wish her well in her future role as Chair of MTPConnect,” said Ms de Somer.

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Medicines Australia (MA) congratulates the AMA on the appointment of Dr Michael Schaper as its next Secretary General.  Dr Schaper has extensive background and experience in business, government, and academia – most recently as Deputy Chairman of the Australian Competition and Consumer Commission (ACCC).

Interim CEO of MA, Mrs Elizabeth de Somer said, “Medicines Australia and the AMA have a long and constructive history of collaboration. I look forward to working with Dr Schaper to continue and strengthen this.”

“Dr Schaper’s knowledge of the machinations of Government, and of the business environment mean he is well placed to represent the needs of AMA members and lead the organisation through the next important stage in the political cycle,” Mrs de Somer said.

MA also recognises the outstanding contribution of Anne Trimmer who has led the AMA for the past 5 years.

“Ms Trimmer has been responsible for some remarkable achievements and has provided strong, stable leadership of the AMA.

Mrs de Somer also said, “Under Anne’s direction, the AMA has worked with Medicines Australia and the wider industry to set the agenda on many important issues such as reforms to the Medicare Rebate, the education of medical practitioners and private health care reform.”

“I wish Anne success in her future endeavours,” said Mrs de Somer.

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CONTACT:

Natalie Wimmer
0450 728 660
nwimmer@medaus.com.au

Medicines Australia (MA) congratulates Lorraine Chiroiu on her appointment to CEO of AusBiotech.  After eight years with AusBiotech in various roles, most recently as Deputy CEO, Ms Chiroiu is extremely well qualified to lead the organisation in its continuing representation of the life sciences industry.

Interim CEO of MA, Ms Elizabeth de Somer said, “I look forward to working with Lorraine to continue, and strengthen, the collaboration between our organisations.  Lorraine will be an excellent voice for the biotechnology industry while her experience means the sector is in good hands.”

MA thanks Mr Glenn Cross, CEO of AusBiotech since 2016, for working constructively and openly with MA on a range of issues impacting both the life sciences and innovative medicines sectors.

Ms de Somer also said, “Under Glenn’s direction, both our organisations have constructively worked in parallel on common issues such as Intellectual Property rights, promoting Australia as a destination for clinical trials, and data protection for biologic medicines.  I wish Glenn success with his future.”

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CONTACT: Kim Bessell

Ph. 0423 781 291

Email: kbessell@medaus.com.au

Medicines Australia welcomes the announcement from the Minister for Health, the Hon Greg Hunt MP’s that there will be additional funding for the PBS.

Speaking at the Australian Pharmacy Professional Conference (APP2018) this morning, Minister Hunt flagged changes that would ultimately allow for more new medicines to be listed on the PBS earlier and would improve access to the latest in innovative medicines for all Australians.

Minister Hunt has flagged that there will be ‘a very significant provision’ available to fund vital new medicines, following Tuesday’s Budget, and has reinforced the Coalition’s commitment to list all new medicines recommended by the PBAC.

Medicines Australia, who represent the innovative medicines manufacturers in Australia, has consistently communicated to the Minister the need to improve PBS funding; to list new medicines through timely and efficient processes; and to ensure that Australian patients can have access to the new medicines they need, when they need them. We welcome his statements that indicate the Government’s ongoing commitment to the industry.

We note the Government’s intention to change the payment arrangements through the supply chain to resolve pharmacy cash-flow concerns. We will continue to work constructively to ensure that Australian medicines manufacturers are well prepared for the changes that will have an impact on them.

Medicines Australia looks forward to the release of more details in the next week’s Federal Budget.

MA also welcomes the Government’s commitment to ensuring value for money and transparency in all expenditure of the PBS.

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CONTACT:

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

The Board of Medicines Australia, the peak body representing the innovative medicines industry has today announced the appointment of Elizabeth de Somer, as the Interim CEO of Medicines Australia (MA).

Ms de Somer will commence in the role effective Tuesday, 3 April, following the resignation of Milton Catelin, who is returning to the UK.

Medicines Australia Chair Mr Wes Cook, congratulated Ms de Somer on her appointment as Interim CEO.

“Ms de Somer takes on this role with the full support of the MA Board and senior management team,” said Mr Cook.

“I am confident she will provide continuity, stability and strong leadership for both MA and our stakeholders until a permanent appointment is made,” he said.

“Ms de Somer is the current Director Policy & Research within the secretariat and has had a long and successful career within Medicines Australia, having worked within the organisation since 2007. Ms de Somer is highly respected both inside and outside the medicines industry due to ongoing contributions.”

“Medicines Australia is incredibly well positioned to contribute to the development of good health policy in Australia.”

“I’d also like to thank Milton Catelin, who has been in the role since October 2016. Milton has done a tremendous job working with the Board, the secretariat and our members to continue building on strong and meaningful partnerships with our stakeholders,” said Mr Cook.

The MA Board Nominations Sub-Committee has appointed Brooker Consulting to run the recruitment process for a permanent CEO.

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More information: Natalie Wimmer – Communications Manager, Medicines Australia
Ph: 0450 728 660
E: nwimmer@medaus.com.au