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