Australian Greens Dissenting Comments
Introductory
1.1
The Australian Greens wish to provide dissenting comments to the report
by the Senate Standing Committee on Finance and Public Administration into
Senator Di Natale's Therapeutic Goods Amendment (Pharmaceutical
Transparency) Bill 2013.
1.2
The integrity of the professional relationships between pharmaceutical
companies and medical practitioners is of paramount importance in maintaining
the quality of health care in Australia. This Bill intended to safeguard the
integrity of those professional relationships through regulation and
transparency. This inquiry provided a good opportunity for the community to
discuss this important issue. The inquiry attracted a good range of submissions
and quality evidence which helped to inform this discussion.
1.3
The question at hand was whether there is a problem of undue influence
by pharmaceutical companies over the prescribing habits of medical
practitioners. While some of the submissions raised substantive issues with the
scope of the Bill, there was a general agreement amongst submitters and
witnesses that the problem of undue influence either exists, or that there is a
perception in the broader community that such undue influence exists. Industry
is aware of this perception and appears to be moving in the direction of
transparency to address it. The Australian Greens believe that the clearest and
most effective way to address these concerns is through legislation.
1.4
The Greens have considered the substantive issues that were raised
throughout the inquiry and accept the need to amend the Bill.
Applicability to other
industries
1.5
While this Bill was premised on the need to preserve the integrity of
the professional relationships between pharmaceutical companies and medical
practitioners, the inquiry has made clear the fact that the need for
transparency within the field of therapeutic goods is broader than just this
one industry. Comment submitted by the Department of Health and Ageing points
out that the Bill in its current form will exclude other relationships between
therapeutic goods companies and health professionals.[1]
The Greens accept that the broader community will benefit by the transparency
envisaged by this Bill being extended to other therapeutic goods companies such
as those that sell medical devices.
1.6
Therapeutic goods are currently covered by eight codes of conduct.
Simplifying this situation would be consistent with a decades-long trend
towards more efficient and harmonised regulation of industry. The Greens note
concerns regarding the potential for overly complex regulation to create an
uneven playing field, but feel that this Bill presents an opportunity to
overcome the existing patchwork of regulations, and deliver a consistent
regulatory environment for therapeutic goods and services in this country.
Recommendation 1
1.7
That the bill be amended to include interactions between health
professionals and vendors of other therapeutic goods besides pharmaceuticals.
Voluntary Codes
1.8
Both the Australian Government and therapeutic goods industry noted a
preference for self-regulation. The inquiry heard that while this decreases the
cost to the Australian taxpayer, there are many well-documented problems with
self-regulation, including that:[2]
-
Multiple codes of conduct, the content of which vary
significantly across industry sectors, creating an uneven playing field;
-
It is difficult to improve standards due to industry oversight
and veto;
-
Codes can represent lowest common denominator standards by
requiring majority sign off;
-
Numerous codes can increase complexity for consumers trying to
navigate the regulations when filing a complaint; and
-
Voluntary codes don't apply to non-members, greatly reducing
their reach and effectiveness.
1.9
The voluntary nature of codes of conduct is a key concern. There is no
legal obligation for industry actors to join a trade association and become
bound under a code of conduct. Industry actors who have no intention of
conducting themselves in a responsible manner simply choose not to submit
themselves to an association's code of conduct. The inquiry heard that the
Generic Medicines Industry Association of Australia (GMiA) provides an option
for non-members to voluntarily sign up to the GMiA code of conduct without
joining the association, and that to date, no company had chosen to do so. The
inquiry further heard that in 2012, Ranbaxy Australia offered pharmacists
$14,648 worth of free Trovas stock (a generic atorvastatin) and a 90% discount
for subsequent orders. This offer appeared to breach the Codes of Conduct of
both GMiA and Medicines Australia. A complaint was submitted to GMiA but
Ranbaxy declined to participate in an investigation of this complaint as it was
not a member of any self-regulated industry association.[3]
Such is the nature of voluntary self-regulation that a company facing action
under an industry association Code of Conduct could simply leave the
association to avoid the sanction.
1.10
Several submissions called for a move to a co-regulation model to
strengthen existing industry codes.[4]
This co-regulation model would require that each company should agree to abide
by an applicable industry self-regulatory code in its entirety as part of
registering a product on the Australian Register of Therapeutic Goods (ARTG).
The Australian Greens note that such a model was also a recommendation of the
Government’s own Working Group on the Promotion of Therapeutic Products. The
Australian Greens further note that the Government chose not to support that
recommendation in their response to the 2011 report, but adopted a “wait and
see” attitude.[5]
1.11
The Australian Greens note that various submissions to the inquiry were
informed by other work currently underway in this field, including the work of
the Codes of Conduct Advisory Group established in early 2013. That there are
positive developments occurring by other means does not preclude the relevance
of this Bill. This Bill will create a broad, consistent and enforceable context
in which Codes of Conduct can operate more effectively. Legislation will not supplant
industry Codes of Conduct, but will deliver a minimum level of compulsory
regulation in this field. The Australian Greens consider a co-regulatory model
requiring mandatory industry participation in a Code of Conduct system would be
preferable to the current regime, but that legislation targeted to address
existing deficiencies in regulation would deliver a better result.
Transparency Working Group
1.12
The Australian Greens note that Medicines Australia have establishment
the Transparency Working Group (TWG), that intends to report in June 2013. We
find it encouraging that the TWG contains members (such as Dr Ken Harvey of the
School of Public Health at La Trobe University) who made submissions to this
inquiry in support of greater transparency in the therapeutic goods industry.
While the TWG's recommendations will still be voluntary, they will no doubt
contribute to the ongoing discussion around adequate regulation of this sector
and will hopefully progress improvements in Codes of Conduct in line with the
intentions of this Bill.
Training for doctors
1.13
Evidence presented to this inquiry raised concerns regarding the
proposed regulations preventing Doctors from obtaining further professional
education. The Australian Greens appreciate the need for legitimate and
appropriate educational interaction between healthcare professionals and those
who supply the products they prescribe. These interactions ensure Australian
healthcare professionals are engaged and informed about medical developments.
The Australian Greens also appreciate that many doctors are subsidised to
attend sponsored events and that they attend in good faith to engage and
information share with peers, ultimately improving health outcomes.
1.14
The inquiry heard evidence that non-transparent inducements such as
funded travel and sponsored attendance at conferences can encourage conscious
or unconscious reciprocity by the recipients of largesse. This reciprocity can
manifest itself in uncritical uptake of newer, expensive and less
well-evaluated products; and underutilisation of more cost effective drugs and
devices. These relationships have also been shown to distort published medical
evidence by influencing how studies are designed and conducted, as well as
which studies are published and which are not.
1.15
Evidence suggests that such patronage by commercial entities of medical
practitioners has the capacity to skew doctors’ ongoing education towards areas
where industry chooses to invest and that sponsored education may unduly focus
on the newest and most expensive therapies. Given this tension between the need
for the ongoing education of doctors and the commercial imperative of sponsored
education, the Greens note that it would be better if ongoing education was
provided through a neutral agency like the National Prescribing Services (NPS).
A non-aligned clearing house of information would allow Australia’s medical
practitioners to remain up-to-date with developments in their field without the
lens of commercial interest distorting their view. This might include the use
of cutting-edge medicines but also, for instance, new uses for existing
therapies.
1.16
Evidence submitted to the inquiry by GlaxoSmithKline suggests that
medical practitioners can struggle to find the time and money to undertake
further education and profession development.[6]
Given this circumstance and the potential for industry sponsorship to result in
skewed medical application, it would make sense to provide practitioners with
assistance from a neutral party like the NPS rather than leaving such
facilitation to industry.
Online publication in central
place
1.17
Evidence was presented regarding the publication of transparency reports
which raised concerns regarding the Bill’s provisions for reporting on the
websites of industry entities. It was pointed out that transparency reporting
on numerous commercial websites would be difficult for consumers to access
effectively and that the information would be more easily accessed via a
single, public repository. The Australian Greens note that Medicines
Australia’s Transparency Working Group also supports such a centralised portal,
enabling the information to be audited and validated by healthcare
professionals and companies, and supported by an educational process to assist
all parties to interpret the information in context.[7]
The Australian Greens agree that such a central repository of information would
be superior to the reporting provisions originally proposed, and that the Bill
should be amended to reflect that improvement.
Recommendation 2
1.18
That the bill be amended so that reporting requirements are satisfied
with publication to a searchable central repository, rather than on the web
sites of individual companies.
Other issues with the Bill
1.19
Submissions received by the inquiry raised other concerns with the Bill
which should be taken into consideration. The University of Sydney suggested
that definitions of the parties to which the Bill applies may be problematic
and unintentionally exclude or include certain groups based on their ability to
prescribe.[8]
The Australian Greens accept this criticism and would see the definition of
‘registered medical practitioner’ improved in an amended Bill.
1.20
The University of Sydney also raised concern with the definition of
'regulated corporation' in the Bill suggesting that it may capture universities
that import regulated pharmaceuticals for medical research or to conduct
clinical trials on behalf of international pharmaceutical companies, exposing
them to the penalties and regulatory requirements intended for that industry.[9]
The Bill is not intended to apply to universities in this way, and the
Australian Greens would see such parties specifically excluded in an amended
Bill or the Explanatory Memorandum amended to make it clear that such cases
were excluded.
1.21
Pfizer also noted that the Bill failed to provide a mechanism for
doctors to check the validity of the details of reports which are required to
be provided on company websites under section 42DT of the Bill.[10]
The Australian Greens accept this criticism and note that the proposal by the
Medicines Australia Transparency Working Group for "a single, public
repository, enabling the information to be audited and validated by healthcare
professionals and companies" provides an effective remedy to the Bill’s
original lack of facility.
Conclusion
1.22
The inquiry made it clear that there are serious concerns regarding the
transparency and integrity of the therapeutic goods sector in Australia. This
Bill would address those concerns by bringing Australia up to world’s best
practice in terms of transparent disclosure and reduction of conflicts of
interest arising in the medical profession as a result of their interactions
with industry.
Recommendation 3
1.23
That the bill be passed.
Senator
Richard Di Natale
Senator for
Victoria
Navigation: Previous Page | Contents | Next Page