Legislation introduced to Parliament on final sitting day of 2016 will enable faster access to certain new medicines for Australian patients and help to cut unnecessary red tape for industry too.

The Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 was introduced by Health Minister, Hon Sussan Ley MP is the first legislative step toward the full implementation of the Medicines and Medical Devices Review.

Medicines Australia Chief Executive Milton Catelin said the Bill supports the implementation of new regulation-making powers that will create two new pathways that will help speed up approval of medicines.

“For a number of years, Medicines Australia and member companies have worked with the Australian Government to identify improvements in our registration approval processes, and related matters. The Bill addresses these concerns head-on.  The changes to approval, registration and listing times mean that Australian patients will get faster access to safe medicines. Our world-leading regulatory system will only be enhanced as a result of this Bill,” he said.

“The measures have widespread cross-political support and we expect it to pass without delay in 2017 as this is in the best interests of the Australian people. We will continue to work with the Therapeutic Goods Administration to ensure we all get the detailed regulations right”.

Medicines Australia thanks Health Minister Sussan Ley and the TGA for their open and extensive consultation process to date, and the ongoing work on changes to the regulation of therapeutic goods.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Medicines Australia welcomes the Turnbull Government’s announcement of $7.4 million in funding for medical technology and pharmaceuticals industry-led projects.

MTPConnect, established under the Australian Government’s Industry Growth Centres Initiative is co-investing in projects that will help increase commercialisation of new research.

Medicines Australia is a partner in two projects that have been awarded a share of the funding:

• the Bridge programme, led by the Bridge Consortium, will transfer practical skills on pharmaceutical commercialisation through training, including direct exposure to industry practitioners.
• a tele-trials strategy, led by Clinical Oncology Society of Australia, will increase patient access to cancer clinical trials closer to home, whilst ensuring the proper conduct of these trials.

Medicines Australia Chief Executive Milton Catelin said “I congratulate both the Bridge Consortium and the Clinical Oncology Society of Australia on being awarded funding”.

“While Australia performs well on research excellence, evidence suggests we could do better when it comes to commercialising research outcomes.  The Bridge programme provides, through training and networking, the knowledge transfer that happens naturally in other countries,” he said.

“Investing in the tele-trials strategy is critically important because it will help patients gain access to innovative treatments not otherwise available in remote regions, and improve the lives of many Australians residing in regional areas because they will be able to stay close to home.”

“We welcome the Government’s commitment to create a highly productive commercialisation environment through investing in these very worthy and exciting projects announced today.”

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Medicines Australia welcomes the release of the report commissioned by the Australian Government into the R&D Tax Incentive Programme.

The report, authored by three of Australia’s most experienced business and scientific minds has outlined some interesting and worthwhile ideas to encourage more investment in Australian research and development which deserve further exploration by the Government and affected industries.

Mr Bill Ferris AC, Chair, Innovation Australia; Dr Alan Finkel AO, Chief Scientist; and Mr John Fraser, Secretary to the Treasury, were appointed by the Prime Minister in 2015 to review the current scheme as part of the National Science and Innovation Agenda (NISA).  Under the NISA, the Medical Technologies and Pharmaceutical sector is identified as one of the key innovative industries of the future.

The members of Medicines Australia discover, research and develop the latest medicines and vaccines and are some of the largest investors in R&D around the world.

Locally, our members invest around $1 billion a year in Australian R&D and are at the forefront of collaboration and commercialisation with Australian research centres, Universities and Biotechs.

With global demand for new medicines expected to double over the next decade, Australia stands at the cusp of exciting opportunities in medical research and development.  Making the most of this opportunity will help drive economic growth, deliver more high-skilled STEM jobs and provide Australians with improved access to medicines and health innovation.

Medicines Australia supports efforts to make sure the R&D tax programme delivers on the NISA objectives by supporting industries with growth potential. We believe R&D incentives are critical to attracting additional investment in Australia’s life sciences sector.

The review panel’s final report contains several significant recommendations that will require closer examination and we look forward to the opportunity to consult with the Industry, Science & Innovation Minister, Greg Hunt, and his Department as the Government looks to finalise its policy.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Statement from Chairman Wes Cook

On behalf of Medicines Australia and our members, I would like to acknowledge the work of Ms Jane Halton as Secretary of the Department of Finance and congratulate her on an exceptional career in public service.

Ms Halton has spent many decades in public service  including her tenure as the Secretary of the Department of Health for more than 12 years before moving to the same position in the Department of Finance two years ago.

Medicines Australia and the innovative medicines industry enjoyed a strong and constructive relationship with Ms Halton and have appreciated her tireless efforts and leadership to ensure a sustainable Medicare and Pharmaceutical Benefits Scheme (PBS) for Australian patients.

Implementing difficult but worthwhile reforms were a hallmark of Ms Halton’s time as Health Secretary. This included working with the medicines industry on significant changes to the structure of the Pharmaceutical Benefits Scheme which ensured patients maintained access to medicines while delivering greater sustainability of funding, and the development of the first Memorandum of Understanding between Medicines Australia and the Commonwealth Government in 2010.

Of most significance was the development of a two-tiered pricing formulary known as F1 (for on patent therapies) and F2 (for off-patent therapies) and the introduction of enduring mechanisms which delivered savings that could be reinvested in the latest innovative treatments.

I wish Ms Halton all the best for her future endeavours and have no doubt that her depth of experience in health will continue to be a wonderful asset in the ongoing policy debate.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Medicines Australia welcomes the commitment of the Australian Government to improve the way medicines are assessed for use in Australia.

The changes should provide patients with more rapid and early access to lifesaving, innovative medicines.

The reforms are a direct response to the Medicines and Medical Devices Review which was tasked with improving and finding alternative ways to rapidly assess the safety and effectiveness of new medicines so that they can be utilised by the Australian healthcare system sooner.

Medicines Australia represents the innovative pharmaceutical industry which researches, develops and manufactures the latest generation in medicines and vaccines.

Medicines Australia is pleased that many of our recommendations have been taken into account in the Australian Government’s response to the Review. The reforms, which will be implemented over the next three years, will ensure that the Therapeutic Goods Administration (TGA) retains and grows its international reputation for ensuring medicines in Australia meet high standards of quality, safety and efficacy.

The reforms include:

• Increased flexibility in pre-market assessment processes including expedited and provisional approval;
• A faster process for priority evaluation;
• Provisions to enable earlier data sets to be considered for provisional evaluation;
• Increasing use of assessments from comparable overseas regulators (such as the US and EU); and
• Changes to the regulation of complementary medicines

These new reforms should reduce red-tape and help to lower the costs of bringing a medicine to Australia.

Implementing these changes will reduce or remove the time lag that can occur between Australia receiving new medicines and vaccines compared to other regions like the United States, Europe and the United Kingdom.

Medicines Australia looks forward to working collaboratively with the Government to ensure these reforms are successful.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Medicines Australia, the peak body representing the Innovative Medicines Industry has today announced the appointment of Mr Milton Catelin as the new Chief Executive Officer of the organisation.

Mr Catelin will commence the role from the week of 3 October 2016, after returning to Australia from the United Kingdom and will be based in Canberra.

Mr Catelin has vast experience in policy development and leadership roles both in Australia and overseas. He has two decades of experience within the Australian public service which has led to international leadership roles within policy institutions and industry associations.

“I am honoured to be appointed as the CEO of Medicines Australia which represents such an important part of the Australian health sector,” said Mr Catelin.

“Medicines Australia plays such a crucial role in advocacy and policy development to ensure that the Australian community has fast, affordable access to the latest innovative medicines and vaccines.”

“It will be a privilege to lead this important work on behalf of the members who are at the forefront of medical science innovation both in Australia and around the world.”

“I am looking forward to engaging with policy makers and the community about the wonderful work our members do to not only improve health outcomes for patients but also build the Australian economy through significant investment and jobs creation, particularly within Australia’s Universities, research centres and biotechnology businesses,” said Mr Catelin.

Medicines Australia Chairman Mr Wes Cook, congratulated Mr Catelin on his appointment as CEO.

“Milton Catelin is a fantastic appointment for Medicines Australia and on behalf of the members I congratulate him for taking on this important role for the innovative medicines industry,” said Mr Cook.

“I am confident Milton’s leadership of Medicines Australia will add further strength to our industry and benefit the patients we serve.”

“I’d also like to thank our interim CEO Lee Hill who has been in the role since February this year. Lee has done a tremendous job working with the Board, the secretariat and our members to restructure and revitalise Medicines Australia. This has been incredibly important work that means our new CEO will take over the reins of a strong organisation that is even better placed to represent the interests of the community and our members in this wonderful sector.”

“To ensure a smooth transition, Mr Hill will stay on at Medicines Australia beyond October and will help to finalise the governance and organisational restructure work he has led with the Board,” said Mr Cook.

For a more detailed biography and a photo of Milton Catelin please click here.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

On the occasion of World Hepatitis Day, Medicines Australia calls for greater awareness about hepatitis and the ongoing need for disease prevention, testing and treatment.

The day is particularly significant in Australia as it marks the year innovative therapies were introduced to the Pharmaceutical Benefits Scheme (PBS), achieving major advances in treatment for Hepatitis C, transforming this disease into a treatable and in some cases curable condition.

Investing in these therapies will provide significant savings to our health system and hospitals from curing this life threatening disease.

Research by Professor Frank Lichtenberg from Columbia University demonstrates that medicines on the PBS saved 140,000 years of life, as well as $7 billion in savings to the Australian hospital system in 2011 alone.

Access to hepatitis treatments help to reduce serious liver diseases and prevent premature deaths. A liver transplant can cost around $150,000, with transplant patients needing to miss multiple working days due hospitalisations. Time off for care-givers is often required, making the broader impact on productivity significant.

Hepatitis continues to be a major public health issue in Australia. According to the Department of Health around 230 000 people living in Australia have a chronic hepatitis C infection, including 58 000 with moderate to severe liver disease. Hepatitis Australia suggests that around 225,000 people are living with chronic hepatitis B.

Medicines Australia acknowledges the partnership between the innovative medicines industry and the Australian Government in providing new treatment options for patients.

We welcome the Australian Government’s investment in these treatment options for patients. New medicines recently listed on the Pharmaceutical Benefits Scheme for Hepatitis C are expected to increase the cure rate to 90%.

Medicines Australia also acknowledges the role of vaccines in preventing disease. The hepatitis B vaccine offers very effective protection against infection with the disease. It is part of the routine childhood immunisation programme in Australia. While many people clear the hepatitis B virus, in others it can lead to a high risk of death from liver cirrhosis or cancer.

For every $1 spent on routine childhood vaccinations an estimated $5 in direct medical costs are saved, with another $11 saved in indirect costs (for example loss of productivity through time off work).

World Hepatitis Day is an opportunity to raise awareness in our community about the prevalence of hepatitis and new ways we can prevent and treat this disease in our community.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Medicines Australia would like to congratulate the Hon. Bill Shorten as leader of the Opposition for the appointment of his Shadow Ministry following the Federal Election.

The decision to re-appoint the Hon. Catherine King MP as the Shadow Minister for Health is a welcome decision and Medicines Australia congratulates Ms King for continuing in this important role.

Medicines Australia also congratulates Tony Zappia MP on his appointment as the Shadow Assistant Health Minister. He takes over the role from the promoted Stephen Jones MP who we thank for his hard work in the portfolio and keen interest in the sector.

Labor has a strong history of engagement with the innovative pharmaceutical sector on health issues and we look forward to continuing the policy journey with Ms King and Mr Zappia over the coming Parliamentary term.

The sector will also work constructively with Labor to ensure that the Government’s reform agenda focusses on inefficiencies so that precious health dollars are prioritised towards outcomes for patients which are proven to be both clinically and cost effective.

Medicines Australia also congratulates Senator the Hon. Kim Carr on his re-appointment as the Shadow Minister for Innovation, Industry, Science & Research. Senator Carr has been a longtime passionate advocate for science and industry, in particular for research such as clinical trials, advanced manufacturing and the broad biotech and biopharmaceutical industries in Australia. The appointment of Nick Champion MP and Tim Hammond MP as the Assistant Ministers for Manufacturing & Science and Innovation respectively bring additional focus to an important sector for Australia’s future.

Policy development which encourages trade and investment is important for the biopharmaceutical sector to thrive so Medicines Australia welcomes the appointment of the Hon. Jason Clare MP to this portfolio along with Jim Chalmers MP as Shadow Minister for Finance and our members are keen to work with them over the Parliamentary term.

Medicines Australia looks forward to continuing, strong engagement with the Labor Party, which focusses on the best health outcomes for patients and a strong medical science sector for Australia.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Medicines Australia would like to acknowledge the appointment of the Turnbull Government Ministry following the Federal Election.

With the recent confirmation that Prime Minister Turnbull will lead a majority government and today’s appointment of the Ministry, Medicines Australia looks forward to the resumption of Parliamentary business and policy development which is in the interests of the Australian people.

Medicines Australia welcomes the reappointment of the Hon. Sussan Ley MP as Minister for Health, Ageing and Sport. The reappointment of the Hon. Ken Wyatt MP as Assistant Health Minister and the elevation of Dr David Gillespie MP to the role of Assistant Minister for Rural Health are also welcomed by the innovative medicines industry.

We look forward to working together to implement the Government’s election policies to improve the clinical trials framework as well as faster approval processes for innovative medicines.

As the Prime Minister has acknowledged, the Government needs to do more in health within a challenging budget environment. It’s therefore of critical importance that reform focuses on inefficiencies and that precious health dollars are prioritised towards outcomes for patients which are proven to be not only clinically effective but cost effective too.

Medicines Australia also congratulates the Hon. Greg Hunt MP on his appointment as the Minister for Industry, Innovation & Science and Craig Laundy MP as his Assistant Minister. The National Innovation & Science Agenda (NISA) provides an important opportunity to build the biopharmaceutical sector in Australia by encouraging more collaboration and commercialisation between researchers and industry which will grow the economy and create jobs.

The reappointment of Ministers in other senior portfolios, including Treasury and Finance, Employment, Trade & Investment is a welcome decision which provides continuity and confidence for the innovative medicines sector which is an important industry for investment and employment in Australia.

Medicines Australia looks forward to continuing our engagement with the Turnbull Government on the development of policy which puts the interests of patients and the community first.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au

Medicines Australia would like to acknowledge the great contribution made by Dr Anna Lavelle to Australia’s biotechnology industry as she steps down from being the CEO of AusBiotech.

Throughout her eleven years at the helm, Dr Lavelle has been a tremendous advocate for her members and the broader life science sector.

Medicines Australia has had a strong relationship with Dr Lavelle throughout her tenure and worked closely on many issues which affect the biopharmaceutical industry.

Her decision to step away will be a big loss not just to her members but the broader sector as a whole.

A strong biotechnology sector in Australia means a stronger pharmaceutical sector too.

Together, the members of AusBiotech and Medicines Australia play a critical role in the discovery and development of the latest generation in biopharmaceuticals and vaccines which help to improve the lives of millions of Australians.

Medicines Australia wishes Dr Lavelle all the best for her next career phase and we look forward to working with her in any future capacity.

We also look forward to working closely and constructively with the new CEO Glenn Cross. Mr Cross has also had a long career at AusBiotech working alongside Dr Lavelle and is a worthy replacement who will continue to represent the biotechnology industry in the best interests of AusBiotech members.

Contact:

James Boyce
Phone: 0423 239 265
Email: James.Boyce@medicinesaustralia.com.au