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CONTENTS
Passage History
Purpose
Background
Main Provisions
Concluding Comments
Endnotes
Contact Officer and Copyright Details
Therapeutic Goods
Legislation Amendment Bill 1999
Date Introduced: 17 February 1999
House: Senate
Portfolio: Health and Aged Care
Commencement: Generally on a day to be fixed
by proclamation. If that does not occur within 6 months of Royal
Assent, the Act (except Schedule 2) commences 6 months and 1 day
after Royal Assent. Schedule 2 is taken to have commenced on 1
January 1999.
Purpose
The Bill
encompasses the first component of a package of reforms designed to
provide a new framework for the regulation and management of
complementary medicines. A number of other changes affecting
complementary medicines will be made on an administrative
basis.
In addition, the Bill alters other aspects of
the regime regulating therapeutic goods. A system for
pre-publication clearance of certain advertisements is moved and
adapted from existing regulations. Statutory definitions are
adjusted to relabel 'drugs' as medicines and to clarify the
distinction between 'therapeutic goods' and 'foods'. As part of
developing a uniform national approach to poisons, an existing
non-statutory committee will be given a statutory foundation with
certain responsibilities for medicines and poisons, such as
classification and publishing standards.
Background
In recent years the Commonwealth has increased
its role in the regulation of substances known variously as drugs,
medicines, poisons and therapeutic goods. Since 1991, the
Therapeutic Goods Act 1989 has been the principal
legislation regulating substances used by humans in a therapeutic
setting. Poisons have historically been a matter for States and
Territories, albeit with increasing levels of intergovernmental
co-ordination (which this Bill takes one step further).
Prior to being available for marketing in
Australia, each therapeutic good must be entered onto the
Australian Register of Therapeutic Goods (ARTG) which is maintained
by the Therapeutic Goods Administration (TGA), a division within
the Commonwealth Health and Aged Care Department. Goods can be
entered onto the ARTG as either listable or registered goods.
Schedule 3 of the Therapeutic Goods Regulations includes the types
of substances required to be registered on the ARTG while Schedule
4 of the Regulations contains goods required to be listable
goods.
Listable goods require less examination and
evaluation prior to their entry onto the ARTG. Examples of listable
goods include vitamins, sunscreens and most herbal products.
Measures in the Bill propose to ease requirements on these
lower-risk goods, enabling their faster pre-market clearance for
listing on the ARTG. Registered goods, by contrast, include goods
which require evaluation for quality, safety and efficacy, such as
prescription drugs. Evaluation of registered goods is conducted by
the TGA through its Drug Safety and Evaluation Branch, or the
Scheduling and Over the Counter Drug Evaluation Section, or the
Complementary Medicines Section.
Under a separate administrative arrangement, the
National Drugs and Poisons Schedule Committee classifies drugs and
poisons into schedules which are published as the Standard for
the Uniform Scheduling of Drugs and Poisons. Toxicity is the
main criterion for determining onto which schedule a substance is
entered, and the schedule selected has implications for issues such
as distribution, labelling, packaging, advertising and storage.
The Poisons Standard and the therapeutic goods
regime substantially overlap but they fulfil different regulatory
purposes and are not symmetrical - for example poisons outside the
TGA's jurisdiction (such as pesticides and acids) are found in the
schedules.
Measures in the Therapeutic Goods Legislation
Amendment Bill 1999 (the Bill) reflect a period of consultation
undertaken by the Government, in particular since December 1998.
Several measures are proposed, including the replacement of the
term 'drug' with 'medicine' in the Act and Regulations; increasing
the emphasis on faster pre-market clearance for low-risk products;
and the establishment of two non-statutory committees, the
Complementary Medicines Evaluation Committee (CMEC) and the
National Drugs and Poisons Schedule Committee (NDPSC) as statutory
bodies. The CMEC currently provides advice on complementary
medicines to the TGA on an administrative basis. The NDPSC is
currently a committee of the Australian Health Ministers' Advisory
Council.
To balance the measures providing faster market
access for listable goods, the Bill proposes to reinforce through
legislation two existing requirements designed to protect the
public: that sponsors of listable goods must hold evidence to
substantiate therapeutic claims made in the marketplace and that
certain advertisements for medicines placed in mainstream print
media must be cleared by the Secretary prior to publication. Both
these issues have been contentious in the past within some isolated
but vocal elements of the complementary medicines industry(1) and
it is possible that reinforcing these existing requirements in
legislation may prompt a reaction from these elements of the
industry.
Main Provisions
The substantive provisions of the Bill are found
in two schedules. Schedule 1 to the Act contains amendments to the
Therapeutic Goods Act 1989 (the Principal Act). Schedule 2
contains amendments to the Therapeutic Goods Amendment Act
1997 (the 1997 Amending Act).
Schedule 1 - Amendment of the
Therapeutic Goods Act 1989
Item 3 in Schedule 1 repeals
the definition of 'foods' in the Principal Act. This amendment is
linked to item 8 which amends the definition of
'therapeutic goods' to exclude goods traditionally used as foods in
Australia or New Zealand or referred to in the Food Standards Code
under the Australia New Zealand Food Authority Act 1991
(ANZFAA). The Explanatory Memorandum asserts that these amendments
addressed to the 'food-therapeutic good interface' will clarify
terminology and provide greater certainty. The above amendments
steer the Principal Act away from attempting to define 'foods',
leaving borderline exclusions from the therapeutic goods regime to
be determined by reference either to the Food Standards Code or to
the commonly understood meaning of the term 'food'. Substances
which fall within the definition of these exclusions may still be
declared 'therapeutic goods' under section 7 of the Principal
Act.
The Therapeutic Goods Regulations contain a
definition of 'drugs'. Item 4 inserts a virtually
identical form of words into the Principal Act itself, but
attributes it to the term 'medicine' instead. The Explanatory
Memorandum states that the latter term is 'more inclusive, positive
and publicly acceptable' and that the definition of 'drugs' in the
Regulations will be repealed before this Bill is proclaimed. Some
industry players have sought in the past to distance their products
from the term 'drug' and this recently led to a legislative
impasse, when a regulation outlawing use of the term 'drug-free' in
advertising was disallowed by the Senate on 31 March 1998 and a
committee established by the then Parliamentary Secretary was
unable subsequently to achieve unanimous agreement on the issue. It
may be that this amendment is designed to address those industry
concerns. Item 6is consequential on item 4.
Item 5 inserts a definition of
'poison' into the Principal Act for the first time. It is tied to
the legislative recognition given to the National Drugs and Poisons
Schedule Committee in item 13.
Item 9 rewrites the objects of
the Principal Act. It extends the objects to include establishing a
framework for a uniform national approach to the control of
poisons. The Explanatory Memorandum says that all States and
Territories have agreed to the extension.
Item 10 is designed to
accelerate the marketing of therapeutic goods which are regarded as
low-risk, by simplifying the procedure by which they are cleared
for import, export, manufacture and supply. Essentially, the
Principal Act prohibits dealing with goods which have, or are
claimed to have, a therapeutic application unless they are
registered or listed under the Act. As discussed above in the
Background to this Digest, such goods are divided into high or low
risk categories. Low risk goods require only 'listing', a less
stringent approval procedure than 'registration' but one which
necessitates ad hoc amendment of the Therapeutic Goods Regulations.
Item 10 will permit goods to be 'listed' by notification in the
Gazette rather than amendment of the Regulations, allowing
them to get onto the market more swiftly.
Item 11 amends section 28 of
the Principal Act which deals with the imposition of conditions on
registered and listed goods. Item 11 requires that the sponsor of a
good seeking its listing must hold at the time of application, and
thereafter, evidence to support any claim made about the product
which is included on the Register. The evidence must also comply
with any relevant regulations. The information or evidence must be
supplied on request to the Health Department - the Explanatory
Memorandum points out that such requests will only be made if an
issue of controversy arises rather than as a matter of routine.
Both the Explanatory Memorandum and Second Reading Speech indicate
that this item confirms in legislation a condition which has been
applied to date, presumably on an administrative basis.
Item 12 inserts a new Part in
the Principal Act to deal with advertising. Proposed
section 42A applies pre-publication 'clearance' of
advertisements to certain situations - essentially commercial
advertising which targets the general public, for most therapeutic
goods (excluding 'devices' and goods which appear in certain
schedules of the Poisons Standard). It does so by cross-reference
to the Therapeutic Goods Regulations, which generally speaking
exclude advertisements directed at practitioners, hospitals,
wholesalers and export markets. They also exclude communications
between practitioner and patient in the course of treatment, as
well as advertisements of goods not for human use.
Proposed section 42C creates
various offences of strict liability in relation to unauthorised
advertisements in newspapers or magazines. It obliges a product's
promoter to obtain approval for advertisements which go beyond the
provision of minimal information such as brand name, price and
points of sale. Approvals are obtained from the Health Department.
The Therapeutic Goods Regulations will continue to set out the
grounds for obtaining approval and procedures for review etc. The
offence provisions in the Bill are the same as currently spelt out
in the Regulations, but the penalties have increased generally by a
factor of 10, from $1100 to $11 000.
A publisher must not knowingly or recklessly
publish an advertisement which has not been approved:
proposed section 42D. In other words they face a
less stringent obligation than the promoter of a product, who faces
offence provisions of strict liability.
The first half of item 13
inserts a new Part 5B in the Principal Act, establishing the
National Drugs and Poisons Schedule Committee (NDPSC) (which
already exists in a non-statutory form) as a statutory body and
describing its functions and activities, and its responsibilities
for the Poisons Standard. The Standard is currently recognised in
the Therapeutic Goods Regulations but item 13 brings it into the
Principal Act itself and fixes the NDPSC with legislative
responsibility for its publication and amendment.
The retention of the word 'Drugs' in the
Committee's title appears anomalous, given that the Bill (as
discussed above) generally replaces references to 'drugs' in the
Principal Act with the term 'medicines' for public policy reasons,
and that Part 5B itself assigns to the Committee responsibilities
for 'substances' which are defined as poisons or medicines (not
drugs).
Proposed section 52B
establishes the NDPSC but, apart from specifying that each State
and Territory government together with the Commonwealth is entitled
to one representative, it leaves it to regulations to specify how
the Committee is constituted, holds meetings and makes
decisions.
Proposed section 52C delineates
the functions of the NDPSC, which include responsibilities for
classification and scheduling of substances and providing expert
advice. Other functions may be conferred by regulation.
Proposed section 52D assigns
responsibility for upkeep of the Poisons Standard to the NDPSC and
for notifying changes in the Gazette.
Proposed section 52E sets out
factors which the NDPSC must and may take into account when
considering changes to the Poisons Standard.
The second half of item 13
inserts a new Part 5C in the Principal Act dealing with
'complementary medicines'. Proposed section 52F
defines 'complementary medicines' and some related terms, adapting
definitions which currently appear in various parts of the
Therapeutic Goods Regulations. Essentially a complementary medicine
is a therapeutic good which contains an ingredient listed in
Schedule 14 of those Regulations, where the ingredient has a
well-established use in health care or a use prescribed by
regulation.
Proposed section 52G
establishes as a statutory entity the Complementary Medicines
Evaluation Committee but leaves the Committee's constitution,
functions and ways of operating to be defined by regulation. The
Second Reading Speech states that the Committee was established on
an administrative footing in December 1997. The speech suggests
that the Committee is intended to provide expert advice on the
evaluation of complementary medicines to the Therapeutic Goods
Administration and to sponsors, as well as discuss relevant policy
issues.
A Media Release from the Parliamentary Secretary
for Health and Aged Care dated 11 January 1999 foreshadowed that
the Committee will be asked to review the level of evidence
required to support claims of safety and beneficial health effects.
This exercise was mentioned in the context of industry assertions
that current advertising restrictions go too far.
Item 14 inserts a new offence
provision in the Principal Act. Proposed section
54AA makes it an offence to contravene a condition
attaching to a licence or permission to import or export
therapeutic goods. The standard penalty is 50 penalty units, but it
rises to 240 penalty units(2) where the condition is concerned with
public safety or relates to possession, custody, transport, use or
disposal of the goods. The insertion of these penalties completes
the transfer of offence provisions relating to import and export
from customs regulations to the Principal Act, begun in April
1998.(3)
Schedule 2 - Amendment of the
Therapeutic Goods Amendment Act 1997
Item 1 effects technical
re-numbering of an earlier amendment to the Principal Act.
Concluding Comments
Conflicting Terminology
The Bill proposes to replace the reference to
the term 'drugs' with 'medicines' in the interpretation section of
Part 1 of the Regulations as well as other references to 'drugs' in
the Act and Regulations. It is unclear why the opportunity was not
taken to rename the National Drugs and Poisons Schedule Committee
upon its reconstitution as a statutory entity, using the term
'medicines' rather than 'drugs' given that the Explanatory
Memorandum claims that the former is a 'more inclusive, positive
and publicly acceptable term'.
Establishing Statutory
Committees
The Bill gives a statutory basis to two existing
administrative committees, but leaves significant details about
each Committee to regulation. This may have the effect of reducing
(though not eliminating) public and Parliamentary scrutiny of the
constitution and other features of these committees, in an area of
growing public importance.
Professor Cheryl Saunders contributed a paper on
the little-analysed role of statutory advisory bodies to a past
Senate Public Lecture Program. She noted in relation to statutory
advisory bodies that, while they are often (as in this Bill) part
of the executive branch, 'the fact of creation by statute gives
such bodies a special standing' and 'the Parliament from which they
derive their authority' has a stake in their operation.(4) She
suggested some standard principles, including that the 'constituent
statute should prescribe criteria or selection mechanisms for
appointment to the advisory body'.(5) She explained that 'the
existence of criteria will require appointments to be justified and
enable them to be evaluated by reference to the purpose for which
the body was created'.(6)
Acts which establish statutory bodies frequently
include provisions dealing with issues such as criteria for
appointment, termination, disclosure of interests, quorums, voting
and record keeping.
The Complementary Medicines Evaluation Committee
(CMEC) has been described by the responsible Parliamentary
Secretary as 'the key advisory body' in relation to complementary
medicines.(7) The Government has acknowledged increased public
reliance on complementary medicines, and that diverse interests are
at stake, notably public health and safety, and business growth in
the complementary medicines sector. Industry regulation can be
expected to generate arguments over competing notions of the public
interest. For example, the Government has noted industry
dissatisfaction with the system of pre-publication clearance for
advertisements and will ask the CMEC to evaluate the level and
quality of evidence required to substantiate claims.(8) In this
context, it may be thought desirable that the Principal Act itself
spell out in more detail the membership criteria and appointment
procedures, the functions of the Committee and its method of
operation.
The National Drugs and Poisons Schedule
Committee is currently a subcommittee of the Australian Health
Ministers' Advisory Council. The Bill establishes the Committee as
a statutory entity and spells out considerably more detail
regarding functions, government representation and decision-making
criteria than is the case with the CMEC. However important details
regarding the overall membership and constitution are again left to
regulation. The scheduling of substances by the Committee has a
number of public health and commercial implications, but has taken
on added significance following the Government's decision (in
response to the Vos Committee) to propose levying a GST only on
items in certain schedules.
Endnotes
-
- The Hon. Trish Worth MP, Parliamentary Secretary to the
Minister for Health and Family Services, Health Consumers Urged
to Ignore Misleading Campaign, Media Release, 3 March 1998.
- The value of a penalty unit is set at $110 by the Crimes
Act 1914 (Cwth), unless a contrary intention appears in
another Commonwealth Act.
- Therapeutic Goods Legislation Amendment Act 1998.
- Professor Cheryl Saunders, 'The Role and Independence of
Statutory Office-Holders: The Particular Case of Advisory Bodies',
Papers on Parliament No. 7, March 1990, 63-81 at 66-67.
- Ibid., p. 68.
- Ibid.
- Senator the Hon. Grant Tambling, Parliamentary Secretary to the
Minister for Health and Aged Care, Agreement Reached on Future
Directions for Complementary Medicines, Media Release, 16
December 1998.
- Senator the Hon. Grant Tambling, Parliamentary Secretary to the
Minister for Health and Aged Care, New Partnership with
Complementary Healthcare Industry, Media Release, 11 January
1999.
Sean Brennan & Paul Mackey
3 March 1999
Bills Digest Service
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