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Therapeutic
Goods Amendment (2013 Measures No. 1) Bill 2013
Introduced into the House of
Representatives on 20 March 2013
Portfolio: Health and Ageing
Summary of committee view
1.318
The committee
considers that the bill generally promotes enjoyment of the right to health.
However, the committee seeks further information about the removal of a right
to merits review of decisions relating to product information registration
requests.
Overview
1.319
This bill seeks
to amend the Therapeutic Goods Act 1989 (the Act) to:
- confer on the
Minister the power to make legislative instruments to exclude from the
definition of a 'therapeutic good' certain identified goods or identified goods
where the goods are used, advertised or presented for supply in a particular
way;
- include an
offence and a civil penalty provision for providing false or misleading
information in connection with a request to vary an existing entry in the
Register for a therapeutic good;
- provide that the
Secretary may cancel the registration or listing of therapeutic goods where the
presentation of the goods is not acceptable;
- to provide that
the Secretary may cancel the registration or listing of therapeutic goods where
a sponsor does not respond to a request to provide specified information or
documents about those goods; and
- clarify the
arrangements relating to the approval of product information (PI) for medicines
accepted for registration in the Register.
Compatibility with human
rights
1.320
The bill is
accompanied by a detailed statement of compatibility which refers to issues
that may arise under the right to a fair hearing and minimum criminal
guarantees under article 14(1) and 14(2) of the International Covenant on Civil
and Political Rights (ICCPR).
Right
to health
1.321
The bill seeks
to improve the effectiveness of the therapeutic goods legislative regime to
ensure that product or items which fall within the description of therapeutic
goods and which may have an adverse impact on the health of individuals and the
community are appropriately regulated. The bill accordingly may be viewed as
contributing to promoting the enjoyment of the right to the highest attainable
standard of physical and mental health, as guaranteed by article 12 of the
International Covenant on Economic, Social and Cultural Rights (ICESCR).
Right
of access to court – right to a fair hearing in the determination of rights and
obligations in a suit at law
1.322
The statement of
compatibility identifies that the removal of merits review engages the right of
access to court under article 14(1) of the ICCPR. The bill seeks to remove the
right to merits review by both the Minister and, subsequently, the
Administrative Appeals Tribunal (AAT) of a decision to approve or vary product
information (PI) for medicines accepted for registration in the Register.
Judicial review, only, remains available in relation to these decisions.
1.323
The statement of
compatibility explains this as follows:
The removal
of merits review rights in these instances is considered to be necessary
because a decision to approve, or to approve a variation to, PI is an integral
part of the decision by the Secretary to register the medicine to which the PI
relates or to approve a variation to that medicine's entry in the Register.[1]
1.324
The statement
then notes that the approval of PI for a medicine is a separate decision to the
Secretary's decision approving its registration or varying its entry in the
Register, but that the PI is always reviewed at the same time as the
application for registration or for a variation is considered.[2]
The essence of the argument seems to be that in effect the issue of approval or
otherwise of PI or a variation will be a part of these other decisions (to
register or vary registration), that these decisions are subject to internal
and AAT merits review, and therefore the separate decision does not need
separate provision for merits review.[3]
1.325
The statement of
compatibility rightly proceeds on the assumption that where the right to a fair
hearing under article 14(1) of the ICCPR applies, a person must have access to
an independent and impartial tribunal that has full competence to consider all
disputed issues of law and fact that are critical to the determination of the
person’s rights.
1.326
Judicial review
of a decision, which is in general limited to the review of the legality of a
decision and not of the substantive merits, may not be sufficient to satisfy
article 14(1) if there are issues of fact being disputed. However, the
availability of merits review before the AAT would be considered to provide
such review consistent with article 14(1).
1.327
While noting the
explanation in the statement of compatibility, it is not clear to the committee
why the existing possibility of review on the merits of product information
decisions needs to be dispensed with. If, as the statement of compatibility
maintains, such a decision will always be dealt with as part of a reviewable
decision relating to registration, then retaining merits review has no impact. However,
if it should turn out that there are circumstances in which a decision relating
to PI is made separately from a decision to register or vary registration, a
failure to provide for merits review (with only judicial review available) may
limit article 14(1) of the ICCPR.
1.328
The
committee intends to write to the Parliamentary Secretary for Health and Ageing
to seek clarification as to why it is necessary to remove the merits review of
certain decisions relating to product information and whether, as a result of
these amendments, there would be any circumstances in which merits review of a
product information decision would not be available at all.
Strict
liability offence
1.329
The statement of
compatibility notes that the introduction of a new strict liability offence
into the Therapeutic Goods Act 1989 engages the right to be presumed
innocent as contained in article 14(2) of the ICCPR. The new offence[4]
makes it a strict liability offence for a person to make a statement that is
false or misleading in any particular or in connection with a request for a
variation of an existing entry in the Register of therapeutic goods, where 'the
use of the goods, if the goods were used, would be likely to result in harm or
injury to any person'.[5]
1.330
There is
presently no offence or civil penalty provision in the Act applying to such
actions. As the statement of compatibility notes (and the explanatory
memorandum explains in more detail),[6]
the bill introduces a graduated series of sanctions.
1.331
The first is a
criminal offence in proposed new section 9G(1) making it an offence to provide
false or misleading statements in a case relating to therapeutic goods if the
use of the goods has resulted in, will result in, or would result in harm or
injury to any person. This offence is punishable by up to 5 years’ imprisonment
or 4,000 penalty units, or both.
1.332
The second
sanction is that the proposed new strict liability offence (explained above)
carries a maximum penalty of 2,000 penalty units. The third sanction is a
proposed new criminal offence[7]
(not strict liability) which is committed simply if a person makes a false or
misleading statement in relation to a request to vary the registration of any
therapeutic goods (that is, no actual or likely harm to any person needs to be
shown). This is punishable by imprisonment for 12 months or by a fine of 1,000
penalty units, or both.
1.333
Finally,
proposed new section 9H provides that a person is subject to a civil penalty if
the person makes a false or misleading statement; the maximum penalty is 5,000
penalty units for an individual or 50,000 penalty units for a corporation.
1.334
The committee
has regularly asked that statements of compatibility provide a specific
justification for each strict liability offence and reverse onus provision in
bills. This is provided here, partly in the statement of compatibility but in
greater detail in the explanatory memorandum.[8]
The committee notes that the explanatory memorandum and the statement of
compatibility provide a justification for the use of a strict liability
provision and a penalty higher than that recommended in the A Guide to
Framing Commonwealth Offences, Civil Penalties and Enforcement Powers:
However,
these penalty levels are considered to be appropriate and necessary to reflect
the seriousness of the conduct to which they relate and the potentially serious
consequences for public health of such conduct. The penalty levels are also
consistent with the maximum penalties for the existing offences in the Act
mentioned above relating to the provision of false or misleading information in
connection with an application for marketing approval.[9]
Civil
penalty provision
1.335
The committee
has previously noted even where a penalty is described as 'civil' under national
or domestic law it may nonetheless be classified as ‘criminal’ for the purposes
of human rights law. Given that these civil penalty provisions appear in a
regulatory and protective context, it is arguable that the penalties are not
'criminal' in nature. Although the penalties are large, it may be argued that
they are not excessive in terms of a business and in view of the health
interests of the public that are being protected.
1.336
The
committee considers that the civil penalty provisions in this bill do not give
rise to issues of incompatibility with human rights.
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