Public Disclosure of Payments to Doctors
from Drug Companies
By Prof Philip Morris
I note a newspaper report in
The Australian on 18/2/12, recorded
that, ‘GlaxoSmithKline’ drug company
has stepped up it’s push for greater
disclosure of industry payments to
doctors, warning research shows the
public only supports such financial links
when they are fully declared. Pfizer and
Eli Lilly are also making attempts at
greater disclosure of doctor payments.
Back in 2009, I requested the Australian
Competition and Consumer Commission
(ACCC), to require public disclosure of
cash payments and sponsorship in-kind
support (for primarily business class
overseas travel, five star accommodation, and registration fees to
overseas conferences and meetings) in the Medicines Australia Code
of Conduct. I hoped the AMA would support this reform, but it’s
support was not forthcoming at that time. On that occasion, the ACCC
encouraged the Pharmaceutical industry and Medicines Australia “to
consider these issues with respect to disclosure and transparency of
such sponsorship”. Since then the American ‘Sunshine Act’ has made it
compulsory in the USA for drug companies to make a record available
publically of payments to individual doctors of over $10. A US Federal
Government database of these payments will be available in 2013.
I have no objection to a collaborative interaction between the medical
profession and the Pharmaceutical Industry and I acknowledge the
good work drug companies do in supporting medical education
particularly with unrestricted educational grants. It is good to see that
the ACCC currently expects the Medicines Australia Code of Conduct
to require drug companies to publish for public review their summary
expenditure on educational (and other) expenses for doctors to attend
company meetings. However, a more significant influence over the
medical profession is made possible by drug companies providing
doctor ‘opinion leaders’ sponsorship of business class travel, five star
accommodation and meals, and payment of registration fees to attend
overseas conferences and meetings. All up, this often equals the
equivalent of $20 to $30,000 per trip. Some ‘opinion leaders’ receive two
or more trips per year.
It is clear the drug companies do not provide this form of sponsorship
to all doctors. It is limited to a small number of leading members or
‘opinion leaders’ of each specialist group – doctors who are likely to
influence prescribing practices of the profession. These arrangements
raise the possibility of undue influence or conflict of interest concerns
being brought to bear on doctors receiving sponsorship in terms of
them covertly or overtly giving support to a company product due to
the effect of receiving this sponsorship or hoping for sponsorship in
the future.
I am not against this sponsorship support, but I believe the profession
and the public should know what financial in-kind support a doctor is
receiving from a drug company, especially if that doctor is involved with
influencing prescribing habits in medical practice. These payments
should be made accountable and transparent – both in a publically
searchable database and at the beginning of any doctor’s presentation
to colleagues or to the public. While legitimate privacy issues need to be
addressed, the greater good is achieved by public disclosure of these
payments that are at present hidden.
Comments from readers would be welcome.
Update 2014
Post ACCC pre-determination Medicines Australia Code of Conduct meeting submission
I attended the November 2014 ACCC pre-determination meeting recently.
I appreciate that Medicines Australia want the ACCC to authorise the Code of Conduct because if the Code receives authorisation then any practices by arising from the Code by Medicines Australia member companies that could be seen to be anti-competitive would be protected from prosecution.
The ACCC is charged to make the determination concerning provision of authorisation based on the public interest – a judgment that a practice that may be anti-competitive can be allowed if the public interest is served by the arrangement. In this case it means that any anti-competitive actions arising from the Medicines Australia Code can be allowed if the public interest is served by the arrangement.
The recent draft ruling by the ACCC recommends authorisation of the Code subject to the Code having a public interest requirement that includes transparency features where significant transfers of value to health care practitioners are made transparent by regular public disclosure of individual practitioner’s accumulation of transfers of value (converted to money amounts) over set periods of reporting time. This will allow conflicts of interest to be identified that were previously held secret.
Most participants at the pre-determination meeting agreed that the transparency arrangements should be mandatory. That is, if a health care practitioner (eg. doctor) is offered a gift (or transfer of value or other form of payment) and the practitioner accepts the gift, then this gift (in monetary amount) would be made public, not in aggregate form, but in terms of an accounting of the value to the individual practitioner.
The new model would be on the basis that any contractual arrangement between a practitioner and a pharmaceutical company would include these transparency terms. Therefore, any practitioner entering into an agreement with a company involving a transfer of value would be clear that acceptance would mean that the transfer of value would be made publicly transparent on a regular reporting schedule as identified payments to that particular practitioner.
No consent is required and therefore no consent given can be withdrawn. The Privacy Commissioner’s advice has confirmed that this is an appropriate way to avoid the transparency arrangements conflicting with privacy law.
At the pre-determination meeting Medicines Australia tried to argue that it was better if a practitioner gave consent first to have transfers of value made public. But then Medicines Australia argued that if a practitioner accepted and used the gift, but then later on withdrew consent, then the transfer of value should be kept secret from public disclosure. This of course would make a mockery of the transparency arrangements as companies and practitioners would avoid public scrutiny of potential conflicts of interest via this means.
This proposal by Medicines Australia was termed the ‘opt-out clause’ by other non-pharmaceutical company attendees at the meeting. All these meeting participants strongly disagreed that his ‘opt-out’ method should be included in the ACCC authorised Code.
The second main matter discussed at the meeting was how long it should be before the transparency arrangements should be implemented. Medicines Australia wants the transparency parts of the Code to be delayed for one year from October 2015 (ie. to October 2016). In my view (and in the view of many others at the meeting) the reasons given for this delay were not persuasive.
Once the ACCC makes a final determination in early 2015 it would not take more than six months for Medicines Australia companies and health care practitioners to be made aware of the new arrangements and to implement methods of complying with the arrangements. Therefore a start-up deadline of no longer than the end of 2015 should only be acceptable.
Finally, work will be required by Medicines Australia to set up a centralised repository or data base for making public all transfers of value to individual practitioners. This could take some time, perhaps up to two years. In the meantime I believe the best way forward is for all Medicines Australia companies to start recording transfers of value to individual practitioners and making this information available in a PDF file (or similar) on a three to six monthly basis to Medicines Australia to be published on its website in one location. This would then make the information available to patients (and their advocate organizations) and to the wider health professions to scrutinize when assessing conflicts of interest.
Prof Philip Morris
Comments welcome.