Building on our strength in clinical trials

Building on our strength in clinical trials

Gardasil is now saving a quarter of a million lives a year worldwide; 250 annually in Australia.

It was an Australian-led success, the result of years of inspired research, crucially supported by partnerships with industry and government.

It is just the spirit Australia needs now if our people are to win timely access to a vaccine and the anti-viral medicines that will put paid to COVID-19.

Without such flexible and strategic thinking, the danger is that Australians will wait longer for the medicines that will enable us to put this lethal scourge behind us.

And it is not just with Gardasil that Australia as a welterweight nation has won heavyweight results.

From the very beginning of the COVID-19 crisis, Medicines Australia and the innovative pharmaceutical companies it represents have worked hand in glove with the government to overcome the significant challenges of stressed global supply chains and international competition for essential medicines to ensure that Australia is part of the global effort to ensure we get the medicines we need.

Now, as we look hopefully to the recovery, the more tightly Australia is bound into the global research effort to find treatments, the more likely it is we will have timely access to the fruits of those efforts.

One way that Australia can make a unique contribution is as an attractive destination for clinical trials.

A good first step would be for National Cabinet to expedite Health Minister Greg Hunt’s public support for Medicines Australia’s long-standing proposal for a “one stop shop” to harmonise nationwide approval of clinical trials.

It is now more than two months since the Minister acknowledged that with clinical trials in countries more heavily impacted by COVID-19 being on “deep pause” there was opportunity for Australia to fill the gap.

The proposal has apparently gone to National Cabinet, but since then, we have heard nothing.

This is perplexing, given the Minister’s enthusiasm and the Prime Minister’s initiative in establishing National Cabinet as a way of helping break the logjam that has bedevilled federal-state health relations for decades.

Here is an easy opportunity for National Cabinet to prove it is more than a new version of COAG – the place where “good ideas went to die”.

We applaud Industry Minister Karen Andrews comment that once a vaccine is developed the Government wants to be able to “manufacture it right here in Australia”.

But we cannot do it all on our own, any more than Gardasil could have gone into production without international support and expertise.

The fact is that Australian pharmaceutical manufacturing capability has declined as government support has been withdrawn over the years.

As a result, for example, of the long running (now dumped) government incentive scheme known as Factor F, AstraZeneca has a manufacturing plant in Sydney producing respiratory medicine units exported to 19 countries.

Thanks, too, to the government’s $80 million investment to the Peter MacCallum Cancer Centre, Novartis Global will manufacture Kymriah in Australia, an immunocellular therapy individually tailored for each cancer patient. There is scope for Australia to position itself as a regional manufacturing hub for export of these living therapies to Asia.

However, development of a vaccine production facility is no small matter, a world away from converting a winery to make hand sanitiser.

It typically takes a decade of development, $2 billion in investment and the availability of an array of highly skilled technicians – professionals who are in very short supply in Australia.

Harmonisation of the arrangements surrounding clinical trials nationwide is vital if we are to increase investment in this critical area and ensure a health-led recovery from the COVID-19 pandemic.

This reform would mean a healthier Australia along with investment in Australian jobs and economic growth.

So would a decision by the parliament to reject proposed changes to the Research and Development Tax Incentive which would inhibit already low levels of R&D in Australia.

Most importantly, by sending the wrong signals about Australia’s commitment to medico-pharmaceutical research to the international community the proposals may undermine opportunities for Australians to gain early access to COVID-19 vaccines and treatments.

We have a population even healthier than most, due to our relative success in suppressing COVID-19 as well as long experience, expertise and success in the area.

There are broader benefits to the community from development of vaccines; they not only save the lives of people to whom they are administered, but also those with whom they mix, meaning a healthier, bigger community, lower long term health care costs and a more productive economy.

But if Australians are to gain timely and equitable access to a COVID-19 vaccine, should one emerge, the prospects would be enhanced if the nation’s leaders showed they were fair dinkum in making a broad contribution to the global effort.

Support for Australian efforts to develop a vaccine is one clear signal, development of the one stop shop for approval of clinical trials would be another.

If we are to punch above our weight once more, it would be a blow in the right direction.

This OpEd appeared on the InnovationAus website on 22 September 2020.

Prevention is better than cure.

Prevention is better than cure.

If the current COVID-19 emergency has proved anything, it is that Australia can be relied on to improvise its way through a crisis.

What it has also demonstrated, however, is that decades of policy penny-pinching means the cost to public health and the public purse is and will be higher than might otherwise have been the case.

From the very beginnings of the COVID-19 emergency, Medicines Australia and the innovative pharmaceutical companies it represents have worked hand in glove with the government to overcome the challenges of stressed global supply chains and international competition for essential medicines to ensure that Australians are getting the pharmaceuticals and therapeutics they need.

Inevitably, though, there are lessons for the future.

The Prime Minister, understandably, talks of the need for greater economic sovereignty, resilience and security once this lethal virus has been contained if not stamped out.

His Industry Minister Karen Andrews is publicly applauding the work of Australian researchers, singling out the CSIRO and the University of Queensland, as part of the global effort to find and develop a COVID-19 vaccine.

She also declares that once a vaccine emerges the government wants to be able to “manufacture it right here in Australia”.

A noble ambition, especially given it is a reality that those nations most deeply involved in the process of development and production of any vaccine will inevitably have easier access to the fruits of that research and investment.

Demand for a vaccine, and indeed for anti-virals, will initially outstrip supply and that means those nations which have more skin in the game will be at the head of the queue.

In the early days of this emergency, the Prime Minister had the foresight to establish the National COVID-19 Coordination Commission to work out how to re-build and revamp the economy post-Coronavirus.

Australia’s record in this area in recent years has been mixed at best.

As a direct result, for example, of the long running government incentive scheme known as Factor F, but dumped in 1998, AstraZeneca has a manufacturing plant in Sydney producing respiratory medicine units exported to 19 countries.

Thanks to the government’s 80 million dollar investment to the Peter MacCallum Cancer Centre, Novartis Global will manufacture Kymriah in Australia, an immunocellular therapy individually tailored for each cancer patient.

But these examples are too few and far between.

Most recent figures show that business spending on Research and Development has declined by more than 12 percent over the past decade and that is just one of the indices.

We can and must do better, especially in a post-COVID-19 world likely to be even more uncertain where Australia will be more vulnerable to circumstances beyond its control.

With the right policies and a long term strategic focus, Australia has the potential to upgrade manufacturing and strengthen supply chains to meet some future pandemic needs and respond to a global environment where reliance on medical supplies from other nations is likely to be even riskier than it is in the midst of this emergency.

A good start would be for policy makers to re-examine previously effective policies, notably Factor F, but also the Pharmaceutical Industry Investment Program (PIIP) and the Pharmaceutical Partnership Program (P3) as well as prioritising STEM courses to boost home grown specialist workforces as well as optimising research and development excellence by better integrating academic and industry research.

It is a challenge.

Fortunately, Australia already has a template.

For close to a decade, the Department of Defence Science and Technology has been reviewing the state of Australia’s medical countermeasures (MCM), precisely to ascertain just how well prepared we are with the vaccines, therapeutic and diagnostic technologies to protect against just such a pandemic as we are now struggling to defeat.

In its latest review completed three years ago, the Department concluded that its recommendations of half a decade earlier had yet to be taken up and observed that product development capability “lacks critical mass and is not readily accessible or functionally connected to enable end-to-end MCM product development.”

The audit reiterated its 2012 recommendation for the establishment of “a national MCM initiative directed by government”.

Among its ten highly pertinent recommendations; stimulating “the creation of advanced manufacturing platforms of therapeutics and diagnostics through specialised funding mechanisms.”

Medicines Australia has offered its support to the Commission and the government to examine the opportunities and feasibility of expanding domestic biopharmaceutical manufacturing capabilities and other options.

This is no small ambition.

Australia’s record in this area in recent years has been mixed at best.

As a direct result, for example, of the long running government incentive scheme known as Factor F, but dumped in 1998, AstraZeneca has a manufacturing plant in Sydney producing respiratory medicine units exported to 19 countries.

Thanks to the government’s 80 million dollar investment to the Peter MacCallum Cancer Centre, Novartis Global will manufacture Kymriah in Australia, an immunocellular therapy individually tailored for each cancer patient.

But these examples are too few and far between.

Most recent figures show that business spending on Research and Development has declined by more than 12 percent over the past decade and that is just one of the indices.

We can and must do better, especially in a post-COVID-19 world likely to be even more uncertain where Australia will be more vulnerable to circumstances beyond its control.

With the right policies and a long term strategic focus, Australia has the potential to upgrade manufacturing and strengthen supply chains to meet some future pandemic needs and respond to a global environment where reliance on medical supplies from other nations is likely to be even riskier than it is in the midst of this emergency.

A good start would be for policy makers to re-examine previously effective policies, notably Factor F, but also the Pharmaceutical Industry Investment Program (PIIP) and the Pharmaceutical Partnership Program (P3) as well as prioritising STEM courses to boost home grown specialist workforces as well as optimising research and development excellence by better integrating academic and industry research.

It is a challenge.

Fortunately, Australia already has a template.

For close to a decade, the Department of Defence Science and Technology has been reviewing the state of Australia’s medical countermeasures (MCM), precisely to ascertain just how well prepared we are with the vaccines, therapeutic and diagnostic technologies to protect against just such a pandemic as we are now struggling to defeat.

In its latest review completed three years ago, the Department concluded that its recommendations of half a decade earlier had yet to be taken up and observed that product development capability “lacks critical mass and is not readily accessible or functionally connected to enable end-to-end MCM product development.”

The audit reiterated its 2012 recommendation for the establishment of “a national MCM initiative directed by government”.

Among its ten highly pertinent recommendations; stimulating “the creation of advanced manufacturing platforms of therapeutics and diagnostics through specialised funding mechanisms.”

Here is the prescription to boost Australia’s ability to make a genuine contribution towards finding a cure for this pandemic and preventing the need for such drastic economic measures to combat the next.

It is just the wake-up call needed for anyone concerned with Australia’s future sovereignty, security and resilience.

Elizabeth de Somer is Chief Executive Officer of Medicines Australia

Statement from Elizabeth de Somer, CEO of Medicines Australia on transparency reporting through the Medicines Australia Code of Conduct

Statement from Elizabeth de Somer, CEO of Medicines Australia on transparency reporting through the Medicines Australia Code of Conduct

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 other information that would be important to the health outcomes of a patient. 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.

When these interactions take place, we provide clear information about payments or other support provided to healthcare professionals through our ACCC authorised Code of Conduct.

Medicines Australia members are proud of their Code of Conduct. It is robust and has been in operation for almost 60 years. 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.

A change in edition 18 of the code altered the way meals and beverages offered to healthcare practitioners was reported. This was done as a reflection of the minor nature of these contributions, and the extra administrative burden this placed on both pharmaceutical companies and healthcare professionals. This may account for the decline in reporting so judiciously highlighted in the latest Sydney University churn of our transparency data – although it’s worth noting, that the research referenced is over a year old, and does not outline their methodology.

Instead, 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.

It’s ludicrous to suggest that a modest lunch would sway the opinions of medical practitioners – whether it’s captured under our code or not. Suggestions like the one published in today in the BMJ do nothing but undermine a patient’s confidence in a robust and accountable system, seek to break the trust that is fundamental to all those involved in delivering medicines to patients, and insult the judgement of healthcare professionals.

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

Medicines Australia is currently undertaking an important review of our Code of Conduct. This new revised Code is more principles-based, reflects an evolution in the way our businesses and the people we interact with, and is being developed with the knowledge and support of our important stakeholders such as those within the medical fields.

New findings confirm Australians place high value on the PBS, but acknowledge its shortfalls

New findings confirm Australians place high value on the PBS, but acknowledge its shortfalls

Medicines Australia has released a nationwide survey of 2,000 Australian adults, conducted by Nielsen in November 2018, which confirms a very positive sentiment towards medicines and the PBS over and above other Government services. However, it also uncovers a need for greater education and awareness on how the PBS is funded by Government. Plus, how its ongoing future and timely access to new medicines can be sustained.

  • The majority of Australians place medicines (69%), medical research (65%) alongside hospitals and medical services (75%), public health services (70%), as priority areas for future funding1. This is over and above other services, including welfare for the aged (64%), education (63%), and disability welfare (61%).
  • While most Australians (87%) believe government needs to allocate funding for the PBS, only one in five (22%) believe the PBS provides access to the most/widest range of medicines/high cost medicines.
  • Overwhelmingly, Australians (82%) agree breakthrough treatments should be added to the PBS faster to improve access for Australians who need them.
  • Similarly, the majority of Australians (85%) believe the PBS enables better outcomes for those who need it most1. In future, they would like to see more subsidised medicines and treatment/therapies for those suffering from serious health issues.

The PBS was originally designed in 1948 to provide reliable, timely and affordable access to a wide range of medicines for all Australians.

More than 50 years on and the PBS remains a critical service within Australian healthcare delivery. But now it requires a renewed focus to ensure it evolves and offers the potential to support access to the newer innovations and breakthroughs now arriving – including personalised medicines and cell therapies like CAR-T.

Recent analyses show overall the long-term trend of PBS investment is in decline in real terms.[1] Data from the Department of Health shows actual spend on the PBS is just over half of its claimed $10.6 billion, equating to, on average, 4.5 new or expanded listings per month, not 30+.

While an estimated $331 million[2] commitment for new medicines under the PBS has been outlined in the most recent budget announcements, other areas of healthcare continue to receive significant investment. Pre-election commitments include a doubling in hospital investment from $13.3 billion in 2012–13 to $29.1 billion in 2024–25, while Medicare will attract an additional $6 billion in funding.

Australia, like many countries around the world is facing an aging population, an increased prevalence of chronic diseases and the need for timely access to care within a fiscally constrained environment.

These findings show Australians want future access to breakthrough medicines. What is critical is to balance this innovation and affordability with the expectations of Australians. This will challenge some of our long-standing healthcare policies. We only have to look at the evolution in precision medicine and the impact targeted therapies can have on health outcomes and costs.

Rather than isolate the PBS we need to look at the interconnected, holistic relationship between medicines and their wider benefits – how they help Australians live longer and healthier lives, stay in the workplace, keep out of hospital and positively contribute to the community and the economy.

Spending on prescription medicines remains a small percentage of total health care expenditure around the world[3], accounting for about 14% of total healthcare spend in the US and just 10% in Australia. Furthermore, growth in other health care services will be five times the total medicine spending growth through the next decade.2

Ensuring we retain a viable and effective PBS into the future is a critical priority,” concluded Liz de Somer. “Australians value the PBS and believe it needs to support access, so it’s important we address how we continue to meet these needs and ensure  a balance of investment across all elements of healthcare delivery to achieve this.

[1]2019-20 Medicines Australia Federal Budget Submission. Our choice for a healthier future

[2] Department of Health. Budget 2019-20

[3] Prescription Medicines: Costs in Context. 2019. PhRMA.

What do transformational shifts mean in terms of ultimate outcomes and ‘value’ of medicines?

What do transformational shifts mean in terms of ultimate outcomes and ‘value’ of medicines?

Emerging ‘one-time’ curative therapies create important new options for patients living with difficult and incurable health conditions. While cost remains central to the discussion, it’s important to reset how we view these transformational approaches and consider what these shifts mean in terms of ultimate outcomes and ‘value’.

The Federal Government’s recent approval and funding of Australia’s first cell immunotherapy (Kymriah) should be viewed as a historical step forward in the provision of transformational treatments to Australian patients:

  • Importantly, it marked the arrival of and access to one of the most advanced forms of personalized medicines now being made available.
  • We are now in completely new territory when it comes to the formal assessment and review of these therapies. There is no question that these highly complex technologies are set to change how we review and fund medicines and health technologies moving forward.
  • That future starts now with a review of the National Medicines Policy.

An estimated 289 novel cell and gene therapies are in development worldwide – nearly half for cancer.[1] The US leads the way with access – approving the first therapy in late 2017. Five therapies have now been approved in a period of less than 2 years. Four are cancer therapies.

Early trial outcomes with these therapies highlight the potential return on these innovative approaches – significant improvement in survival rates and a reduction in the need for long-term chronic treatments and care.2 Patients could be spared pain and suffering from enduring multiple non-curative therapies; and the healthcare system could potentially benefit from reductions in the cumulative cost of hospital care and ongoing treatments.

As we head towards the Federal Election, addressing cancer has been a top priority for the major political parties – through access to clinical trials, medical scans, specialist consultations and medicines approved by the PBAC. We are working to harness this interest and direct it to the review of outdated policies and the creation of systems and processes that can accommodate the future of treatment for Australian patients. For Australians it will take us closer to world-class, sustainable access to new cancer therapies as they arrive.

Our view is that time is of the essence. It is critical we work collaboratively and quickly together to set up a clear framework for the future that can assess and review the next generation of therapies in an effective and efficient way.  Our National Medicines Policy is a good place to start.

A review of the National Medicines Policy (NMP) will need to involve a multi stakeholder approach including consumers, clinicians, industry and other supply chain participants. Healthcare consumers are fundamental to the NMP and community expectations should be a part of the review and outcomes.

Activating change is not a quick fix – a long-term view is essential. Transformative treatment involves navigating a complex array of public and private providers across multiple parts of the healthcare sector.

And the future is not just in the treatment of cancer – the innovative medicines industry is also investigating cell therapy in organ transplantation to eliminate the need for lifelong immunosuppressants. Our sector will also bring this therapy into earlier and earlier stages of disease and in the process reduce the cost of treatment and the burden of disease on patients and their families and the wider healthcare system. Some of these genomic discoveries may also even take place in Australia.[2]

The promise of successful, one-time treatment has the potential to positively affect millions of lives[3]  and we are pleased to see momentum is now underway in transformative treatment for Australians.

[1] Medicines in development for Cell Therapy and Gene Therapy. https://www.phrma.org/medicines-in-development-for-cell-and-gene-therapy

2. Hampson, G. Gene therapy: evidence, value and affordability in the US health care system

Vale Donna Staunton

Vale Donna Staunton

Medicines Australia is saddened to hear about the passing of Donna Staunton.

Donna was a tireless advocate for improving access to medicines for all Australians, and leaves a tremendous legacy.

Donna’s contributions to improving the efficiency  of the supply chain, through the NPSA and the Medicines Partnership of Australia was exceptional and her commitment, passion and willingness to collaborate were of immense value to our industry.

Staff at Medicines Australia who have worked alongside Donna in many walks of life, held her in very high regard and have looked to her for guidance and advice.

Donna was also a strong role model for women in business, and a mentor to many within the wider healthcare sector.

Donna was highly respected by all who worked with her and she will be missed for her significant contribution.

Our thoughts are with her family at this difficult time.

It’s the law, not the Code – MA’s Director of Ethics and Compliance – Deborah Monk

It’s the law, not the Code – MA’s Director of Ethics and Compliance – Deborah Monk

The Director of Ethics and Compliance at Medicines Australia Ms Deborah Monk is troubled that there may be a lack of understanding by some, about the requirements of the Therapeutic Goods Act 1989 (The Act) and the guidance provided in the MA Code of Conduct.

The Medicines Australia Code is a self-regulatory Code, which necessarily must be consistent with all Australian legislative requirements.

However, we can all agree with Carlo Montagner in his recent opinion piece, that we want patients to have access to new treatments that will help them lead longer and healthier lives, and if necessary, this includes medicines that are not yet approved in Australia.

Pharmaceutical companies provide numerous opportunities for patients to gain early access to innovative medicines. That’s something that our industry does extremely well. Not only do they provide access through clinical trials during the development of a medicine, but also through compassionate access or other early access programmes, aimed at providing patients with the treatments they need until the regulatory process concludes and the medicine is registered and more importantly available through the Pharmaceutical Benefits Scheme (PBS). Companies also provide clinicians with early access to medicines through Product Familiarisation Programmes (PFPs), which inform clinicians about how to use new medicines appropriately and manage their patients care when receiving a breakthrough medicine.

Nevertheless, the laws are clear. There is a specific section in the Therapeutic Goods Act that prohibits a person from publishing or broadcasting an advertisement about any therapeutic good that is not included on the Australian Register of Therapeutic Goods (ARTG).

The Act also makes it an offence for any person to make a claim, by any means, that they or another person can arrange the supply of therapeutic goods that are not registered or listed goods.  These legal requirements should always be carefully considered before communicating with doctors about being able to prescribe an unapproved medicine.

Medicines Australia and our members do not support promotion or advertising of compassionate access that falls outside the laws in Australia.  The MA Code of Conduct is intended to apply the Therapeutic Goods legislation to the activities of member companies when they interact with doctors.

If the TGA forms a view that companies can proactively inform doctors about the availability of an unapproved medicine through compassionate access programmes, Medicines Australia – and the innovative medicines industry – would be fully in support of it.

Medicines Australia and the TGA are working with doctors to consider a range of options to enable appropriate information on compassionate access programmes to be more accessible to clinicians who can then inform their patients.

As a result of these discussions, we are examining possibilities such as optionally listing compassionate access programmes on a third-party web site that is only available to doctors. This may represent a workable solution in line with the Therapeutic Goods Act, while still ensuring that the trusted role of the doctor as the primary source of information about a medicine is protected.

So, the question about information, advertising, promotion and the role of medical practitioners in this, is a timely discussion to have, particularly through engaging with the administrator of the legislation, the TGA to understand their perspective.

We would welcome constructive dialogue on this, and the Code of Conduct from members and non-members alike.

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

ABC’s recklessness could yet again put patient health at risk.

ABC’s recklessness could yet again put patient health at risk.

Opinion Piece attributable to Milton Catelin, Chief Executive, Medicines Australia.

You may be aware that the ABC has recently published and broadcast a series of reports relating to the prescription of Novel Oral Anticoagulants (NOACs) which claim doctors are being unduly influenced by innovative pharmaceutical companies to prescribe their products to patients potentially putting their health at risk.

The stories insinuate that doctors may be prescribing a NOAC product, even if it is not the right drug for their patient, simply because a pharmaceutical company provided food at a meeting or support to attend an independent medical conference. To back this assertion it used publicly available Medicines Australia reports on educational events provided transparently by our members. It also used questionable research from the United States which claims a doctor can be influenced to prescribe a particular product by as little as a sandwich from a pharmaceutical representative.

The articles rely heavily on insinuation and seek to misinform the reader about the safety of NOACs, even going so far as to tenuously link them to death.

Our strong fear is that the ABC’s reports may encourage patients to consider stopping taking their medicines when there is a high risk of potentially catastrophic outcomes for this group of patients, including stroke.

Let me be clear. Medicines Australia, and the entire pharmaceutical industry strongly urge Australian’s to seek the opinion of their prescribing doctor before discontinuing any medication as a result of information from a news outlet.

This isn’t about money, or a news article we disagree with. This is about lives, and the fact is, stopping medication suddenly, without medical oversight could have devastating consequences.

Whether deliberately or not, the ABC has conveniently forgotten to report that these life-changing medicines are approved by the regulator, available on the Pharmaceutical Benefits Scheme and comply with each and every mechanism to ensure they provide an acceptable balance between their effectiveness and safety, that they are reliable and prescribed in an appropriate and ethical manner by a doctor.

Further, these products, as with every medicine listed on the Pharmaceutical Benefits Scheme, have been subjected to years of research and development, peer review, regulatory review, numerous clinical trials and government regulations.

For example, the National Health and Medical Research Council, Pharmaceutical Benefits Advisory Committee (PBAC), Therapeutic Goods Administration (TGA), and NPS Medicine Wise all have clear guidelines relating to the approval of pharmaceutical use in Australia.

In addition to these measures, the TGA requires pharmaceutical companies to provide product education to medical practitioners. The idea that a medical practitioner would forgo their years of training and ethical obligations to patients at the behest of a pharmaceutical representative or because of support to attend a medical conference is preposterous.

Casting aspersions about the integrity of medical practitioners does nothing but undermine patient confidence at a time when there is already so much conflicting information surrounding medicines and appropriate treatments which is so readily available through “Dr Google” and Facebook.

The ABC must surely consider the possibility that people will, despite their ineffective warning at the end of the printed-only articles, stop taking these important medicines.

The ABC has some experience with this. In 2013, the ABC published a similarly salacious story on Statins. In that story, they alleged that there actually wasn’t all that much of a link between high cholesterol and heart disease, and that people were taking medications to prevent cardiac events needlessly.

The widely criticised program — removed from the ABC’s website a year ago after it was found to have breached the broadcaster’s impartiality standards — had an immediate impact, with 14,000 fewer people dispensed statin medications after the series went to air in October 2013, the University of Sydney’s Faculty of Pharmacy study found. In the months following the debunked broadcast, an estimated 60,897 fewer people filled their statins prescriptions, found the study, published in The Medical Journal of Australia.

This time around, we would have hoped that the ABC had learnt their lesson. Instead, there’s the very real potential that they have caused more harm than good.

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.

Our member companies are committed to transparency in their interactions with medical professionals and regularly publicly report on them. The Medicines Australia Code of Conduct is the national standard for industry self-regulation and is leading the way on transparency. This Code has the approval of the ACCC.

Regarding the novel Anti-coagulants featured in the story, and the claims that our members were influencing medical practitioners, Medicines Australia has twice provided a statement to the ABC, in December and January, refuting their unsubstantiated claims. We also provided them with links to the relevant prescribing and education guidelines by the TGA.

Given ABC’s previous experience, Medicines Australia had high hopes the ABC would be a little more balanced in their reporting and consider the effects of urging people not to take their life-saving medications.

More information – Natalie Wimmer – Communications Manager, Medicines Australia – 0450728660