Review of Medicines and Medical Devices Regulation

Review of Medicines and Medical Devices Regulation Secretariat
Department of Health
MDP 67
GPO Box 9848
Response to Complementary Medicines chapter
This submission responds to the Panel’s invitation to comment on the
Complementary Medicines supplementary chapter of the 2014 Discussion Paper on
Medicines and Medical Devices, which was released in November 2014.
The submission complements our detailed response of 5 January 2015 to that Paper.
The following paragraphs –
summarise concerns regarding ineffective regulation, in particular
regarding homeopathic preparations that are misleadingly characterised
as medicines,
identify the basis of the submission,
provide specific comments regarding the regulatory regime.
As a preliminary comment we suggest that the Panel needs to actively engage with
seven issues –
1) it is axiomatic that there are public benefits from articulation and
implementation of policies founded on science-based medicine, both in
terms of –
state endorsement (including funding) of diagnoses/therapies and
exercise by consumers of an autonomy that is founded on fact rather
than faith or puffery by product vendors.
regulation per se is not abhorrent. The Panel, in making recommendations
to the Government, should be seeking to foster a regulatory regime that is
both effective and efficient rather than assuming that regulation is
necessarily onerous and an inappropriate burden on industry or restriction
on the autonomy of consumers. Entities that derive a commercial benefit
through claims that products have therapeutic qualities should expect to –
be subject to scrutiny about those claims
bear the costs of regulation as something commensurate with the
benefits derived from making those claims.
3) as a consequence the Panel should be wary of special pleading by
commercial interests, in particular by entities that have both the resources
and commercial imperative to –
exploit weaknesses in Australia’s distributed regulatory
(demonstrated in several instances through litigation) and
persuade legislators that ‘what is good for the complementary medicine
industry is necessarily good for Australians’,
promote spending on complementary products that are therapeutically
unnecessary or inefficacious.
4) the market for complementary products and services should be considered
on a holistic basis rather than solely in terms of the Therapeutic Goods Act
1989 (Cth) and potential action by the Therapeutic Goods Administration
(TGA). Effective regulation includes action by the Australian Competition &
Consumer Commission (ACCC) and other entities under the Australian
Consumer Law and industry codes. Such codes should be more closely
aligned to consumer interests, given recurrent indications that they embody
regulatory capture by industry and from a public policy perspective are thus
5) there is substantial concern within the legal and medical communities
regarding regulatory arbitrage, with confusion about demarcations between
the TGA, ACCC and entities such as FSANZ in relation to the promotion
and oversight of ‘wellness’ products. Those concerns are likely to increase
with the movement to a trans-Tasman food safety and pharmaceutical
regulation regime and an uncritical acceptance on the part of the TGA of
quality standards in jurisdictions such as India.2 There is also concern
regarding the willingness of some commercial entities to game the system
through oppressive litigation and rebadging of products that have been the
subject of legitimate objections regarding advertising.3
6) that arbitrage is reflected in regulatory incapacity on the part of the
Therapeutic Goods Administration (TGA) and entities concerned with the
advertising of what are characterised as complementary products,
highlighted in the preceding submission.
7) finally, the legislation embodies a fundamental conceptual flaw by
characterising homeopathic preparations – ie products in which there is no
(and by definition cannot be) discernable therapeutically active agent – as
medicines. The time has come for a fact-based revision of the legislation.
Given the emphasis on consumer autonomy expressed above we do not
seek to prevent people from vending/using homeopathic products, in the
same way that we do not seek to prevent people relying on tarot cards or
the ouija board. Several recent studies have failed to demonstrate any
evidentiary basis for homeopathy.4 Until such evidence is uncovered,
See for example Ken Harvey, Viola S. Korczak, Loretta J. Marron and David B. Newgreen,
‘Commercialism, choice and consumer protection: regulation of complementary medicines in
Australia’ (2008) 188(1) Medical Journal of Australia 21; Ken Harvey, ‘A review of proposals to
reform the regulation of complementary medicines’ (2009) 33(2) Australian Health Review 279; Ian
Bartle and Peter Vass, ‘Self-Regulation Within The Regulatory State: Towards A New Regulatory
Paradigm (2007) 85(4) Public Administration 885.
Note Meera Kay, ‘Indian generics manufacturer Ranbaxy agrees to pay $500 m to settle US fraud and
drug safety charges’ (2013) 346 BMJ f3536. The unresponsiveness of the TGA, in contrast to the US
Food & Drug Administration, appears to be consistent with problems identified in a succession of
inquiries into the TGA.
John Dowden, ‘Critical appraisal: court in the Act’ (2012) 35(2) Australian Prescriber 38; Jonathan
Wardle, Michael Weir, Brenda Marshall and Eloise Archer, ‘Regulatory and legislative protections for
consumers in complementary medicine: Lessons from Australian policy and legal developments’
(2014) 6(4) European Journal of Integrative Medicine 423; Anthony Smith, ‘The Efficacy of
Complementary Medicines: Where Is The Evidence?’ (2012) 42(3) Journal of Pharmacy Practice and
Research 174
See for example National Health & Medical Research Council (2015) Statement and advice on
homeopathy should not be regarded as medicine and should accordingly
not be recognised as a medicinal product under the Therapeutic Goods Act
1989 (Cth). Its continued recognition grants it a veneer of efficacy in the
public perception which is inconsistent with the TGA’s role in evaluating
complementary medicines.
The body of the Discussion Paper refers to “shared understanding” about the
regulation of medicines and medical devices. The number of submissions from
Complementary Medicines Australia and individual complementary product vendors,
practitioners or enthusiasts is not an authoritative metric of understanding. We
suggest that the Panel should be wary of unsubstantiated claims by entities with a
commercial interest that there is a consensus regarding the –
therapeutic efficacy of complementary medicines (or ‘holistic’ diagnostic
and therapeutic practice) as a whole or the efficacy of particular products
effectiveness of the current co-regulatory regime
necessity to further weaken regulation.
Instead, it is relevant to note –
the absence of credible data regarding the efficacy of homeopathic
products, recurrently highlighted by authoritative Australian and
overseas government and academic studies examining homeopathic
products and practice
recurrent independent studies questioning both the marketing and need
consumption of complementary products that are variously
characterised as vitamins, diet supplements, wellness products,
nutraceuticals and cosmaceuticals.
controversy over claims by some complementary product vendors,
including scepticism about some peer-reviewed studies that ostensibly
validate promotional statements regarding therapeutic qualities of
specific products
judicial and professional disquiet about both the preparedness of some
complementary product providers to ‘game the system’ and responses
on the part of regulators that do not provide a substantive deterrent to
inappropriate marketing.
In making the above comments we note that restriction of pseudo-therapeutic
preparations and practices is permissible under Commonwealth and state/territory
law, ie is not an impermissible restriction on the implied freedom of political
communication. Restriction is consistent with the Australian Consumer Law (ie Sch 2
of the Competition & Consumer Act 2010 (Cth)) and more broadly with law regarding
unconscionability and fraud.
homeopathy; National Health & Medical Research Council (2014) draft Information Paper: Evidence
on the effectiveness of homeopathy for treating health conditions and accompanying Effectiveness of
Homeopathy for Clinical Conditions: Evaluation of the Evidence – Overview Report, Effectiveness of
Homeopathy for Clinical Conditions: Evaluation of the Evidence – Review of Submitted Literature; and
UK House of Commons Science & Technology Committee (2010) Homeopathy Inquiry Report. Note
also Australian Competition and Consumer Commission v Homeopathy Plus! Australia Pty Limited
[2014] FCA 1412.
Basis of the Submission
The submission is made by Assistant Professor Bruce Baer Arnold and Assistant
Professor Dr Wendy Bonython, both of the Law School at the University of Canberra.
Both authors are members of the University of Canberra Health Research Institute.
Assistant Professor Arnold teaches intellectual property, privacy and competition and
consumer law. He has published widely on the Australian patents and competition
regimes. His work has been cited with approval by a range of law reform bodies and
parliamentary committees. He is a member of two OECD working parties.
Assistant Professor Dr Bonython teaches health law and tort law. She has published
widely on tort and health law. Her work has been cited with approval by a range of
law reform bodies and parliamentary committees. It is informed by postgraduate
qualifications in law and science, specifically biochemistry, genetics, and cellular and
molecular biology.
The submission does not present what would be reasonably construed as a conflict
of interest.
The submission reflects the authors’ research into Australian and overseas
frameworks for the regulation of medical devices and pharmaceuticals. That research
is evident in presentations at leading academic conferences, participation in
Australian Competition & Consumer Commission consultations regarding the
Medicines Australia Code, submissions to the TGA and parliamentary committees,
and publication in leading peer-reviewed journals.
The submission also reflects an awareness of Australian statute/case law and coregulatory frameworks, for example the Medicines Australia Code under the
Competition & Consumer Act 2010 (Cth) and the Therapeutic Goods Advertising
Code 2007.
As with our more detailed earlier submission we would be pleased to assist the Panel
by providing further information or clarification of issues as necessary.
The Review
The regulatory framework for complementary medicines – the focus of chapter 9 of
the current review – involves a distributed co-regulatory regime that involves several
statutes and delegated legislation, several national government agencies and private
sector bodies. It is not solely a matter of the Therapeutic Goods Act 1989 (Cth) and
the Therapeutic Goods Regulations 1990. Instead it encompasses regulation under
the Australian Consumer Law (ACL) centred on the Competition & Consumer Act
2010 (Cth) and industry codes regarding product promotion and registration. It
coexists with frameworks regarding registration and supervision of health service
practitioners, including practitioners of alternative medicine.
The regime should be considered holistically rather than on a regulatory silo by silo
basis or in terms of the Therapeutic Goods Regulations 1990 to the exclusion of
other law. It requires a recognition of decreased regulatory capacity among the
TGA’s peers (evident in statements by India’s regulator regarding inability to address
problems with fraud, corruption and egregious disregard of quality standards in
pharmaceutical manufacture) and the impact of free trade agreements such as the
TransPacific Partnership Agreement.
It also requires attention to historic anomalies such as enshrining homeopathic and
certain aromatherapy preparations in the Therapeutic Goods Regulations 1990 as
medicines. Such products should not be validated as medicines (ie as therapeutic)
and should instead be more properly – and in terms of the TGA’s resources more
effectively – addressed under common law and the Australian Consumer Law by the
ACCC and other regulators.
Responses in relation to specific queries are as follows –
Given the apparent differences in the definition of complementary medicines
internationally and the level of pre-market assessment that they undergo, how
might Australia determine ‘trusted’ regulators for the purpose of undertaking
assessments of ingredients for use in listed products in Australia?
If a criteria based approach were to be adopted, what criteria should apply in
determining whether an overseas regulator is ‘trusted’ for the purpose of
undertaking assessments of ingredients for use in listed products in Australia?
This question appears to be conflating several discrete issues. Firstly, it presupposes
that all Australian stakeholders have consistent perceptions about what ‘regulation’ of
complementary medicines in Australia is. Given the widespread confusion about the
efficacy of some locally made products already on the market, it would be prudent to
start any reform with an engagement strategy to advise the public that regulation
means that a product has been assessed as safe, rather than necessarily effective, if
indeed it has undergone any assessment at all.
Following on from that, it would be advisable to consider what criteria should be
applied to determine whether an overseas regulator is ‘trusted’, noting that these
criteria may depend on the context of the assessment. More stringent criteria may be
appropriate in considering ingredients not previously approved for release in the
Australian market – indeed it could be argued that for these ingredients, Australia
should maintain its own assessment capacity. If, however, the product under
consideration is simply a formulation of known ingredients, which has been assessed
elsewhere as safe, the criteria applied to determine whether an international
counterparts assessment is sufficient may be quite different.
Regardless, the identity of the counterpart, and their mechanisms for post-approval
surveillance and enforcement should feature strongly in all criteria. It would be
politically unpalatable for a country with a poor track record in food standards or
pharmaceutical standards to hold ‘trusted’ status, for example; conversely, there are
a number of countries with pharmaceutical regimes similar to ours where it might
conceivably be appropriate to simply accept their verification of a particular
complementary medicine, provided that any foreseeable risk attached to such a good
was low.
Should an ingredient only be considered to have been ‘approved’ by an
overseas regulator if it has been subjected to some form of assessment?
If yes: Should this assessment include quality, safety and efficacy?
The assessment should definitely include quality and safety; whether it includes
efficacy will depend entirely on how the TGA (or another regulator) chooses to
identify its role to the public. If the public perception is that the ingredient is effective,
because it has regulatory approval, then the assessment of any overseas regulator
must include efficacy; if, however, the regulator takes steps to ensure consumers are
aware that regulatory approval only relates to safety, and not efficacy, then requiring
efficacy assessments is far less important.
Should evidence standards be comparable with, or superior to, those currently
applying in Australia?
Standards should be superior to those currently in place; the number of noncompliant products, and the lackadaisical approach of some suppliers to compliance
issues is a cause for concern. Regulation should be performed for a reason: if a good
poses no, or very low, risk, regulation should be minimal. Indeed, for many items
within this category, in the absence of assessment for efficacy, it is questionable
whether they would be better regulated by other organisations as foodstuffs, noting
that some of the more likely risks (i.e allergic reactions due to traces of certain
products) comparably arising in foodstuffs are already dealt with through existing
regulatory frameworks.
By rationalising the regulatory burden to better reflect the risk posed by certain
products, more resources could be allocated by the TGA to post market surveillance,
enhanced assessment of applications, and enforcement of non-compliance
associated with higher risk products, more rightly within the TGA’s scope.
If Australia were to adopt approvals of ingredients provided by ‘trusted’
overseas regulators, what additional assessment, if any, should be conducted
by the Australian regulator?
If such a process is adopted, there needs to be a mechanism in place whereby
adverse events occurring anywhere (not just in Australia) are reported immediately to
the TGA (or other regulatory body). Such a mechanisms needs to allow the regulator
to conduct its own assessment, and either withdraw or suspend the product from the
market pending the outcome of that assessment.
Such an assessment should also be accompanied by due diligence performed
against the applicant, i.e. how reliable are they at reporting adverse events? How
good are the quality control and recall mechanisms in the event of an adverse event?
What business provisions (liability insurance) do they have in place to respond to
such an event?
What value do you believe an assessment by the TGA adds in cases where
such an assessment has already been undertaken by a ‘trusted’ overseas
The mechanisms outlined above are specific to the Australian legal framework; as
such they cannot be performed adequately by an overseas agency.
Are there aspects of safety or quality that need to be considered in the
Australian context? If so, what aspects?
Potentially; there are some variations in consumer population characteristics,
environment, and ingredients which may affect the safety and quality of certain
goods. Examples might include storage and shelf life of goods, different
concentrations of active ingredients within certain plant sourced materials, and
susceptibility of the population to certain allergens not encountered elsewhere.
How might evidence requirements for listing on the ARTG and for advertising
pre-approval of complementary medicines be harmonised? What changes to
evidence requirements would be required?
The two sets of standards are asking different questions: the advertising standards
are assessing whether the claims made in advertising are false and misleading,
whereas pre-approval evidence supports the indications- purposes for which the
product can be used. If the claims made are indirectly related to the purpose, then
the evidence for the two is unlikely to be sufficiently similar.
Is the current regulatory regime for complementary medicines in Australia
appropriate and commensurate with the risk posed by these products? If not,
why not?
Should complementary medicines in Australia be regulated under a separate
legislative framework? If yes, what should be the key features of the
Risk should be a key determinant of how stringent the regulation is. Many of the
products currently captured under the definition are comparable to foodstuffs in terms
of the risk they present, not pharmaceuticals. As such, it is inappropriate that they be
regulated in the same way as pharmaceuticals. These low risk products may be
better regulated under a separate framework, especially if all their active constituent
ingredients have previously been evaluated and approved.
Should low-risk complementary medicines be regulated as general consumer
goods, removing the requirement for listing on the ARTG? If yes, why? If not,
why not?
What criteria should be used to determine whether a complementary medicine
should be regulated as a therapeutic good?
Yes, these products should be regulated as general consumer goods. There is
already an extensive body of law regulating the sale of goods, including their
marketing, overseen by the ACCC. These goods don’t pose any special risk above
and beyond those routinely found in other consumer goods. Arguably the greater
harm comes from involving the TGA in their regulation, which conveys the impression
that they are more tightly regulated and assessed for safety quality and efficacy than
is necessarily the case, regardless of whether or not such assessment is actually
required. That involvement furthermore diverts the TGA from direct examination of
pharmaceuticals and medical devices (two areas where failures have both imposed
fundamental costs on consumers and the broader health system) and verification of
the effectiveness of overseas peers (another matter where the TGA has been
indifferent to legitimate criticism regarding incapacity in dealing with substantive
problems in India).
Should certain dietary supplements, such as water soluble vitamins, be
regulated as foods or as general consumer goods rather than as therapeutic
goods? If not, why not? What is the rationale for continuing to regulate these
products as therapeutic goods?
If yes, should such goods be regulated as foods or consumer goods?
Foods. In some instances there may be risks comparable with those commonly
encountered in foodstuffs ie contamination with allergens, contraindications, etc.
Similarly, nutrition information labelling is appropriate for goods of this type. Some
protection through regulation and warnings is required, but not full regulation as a
What criteria should be applied to determine whether a product should
continue to be regulated as a therapeutic good?
Making of specific claims of therapeutic benefit should be a trigger for regulation as a
therapeutic good; it goes directly to the issue of efficacy and evidence of therapeutic
benefit, which are the kinds of issues on which the TGA should be regulating.