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Therapeutic Goods Amendment (Pharmaceutical
Transparency) Bill 2013
Introduced into the
Senate on 28 February 2013
By: Senator Di Natale
Summary of
committee view
1.1
The
committee seeks clarification on the potential impact of the bill on the right
to freedom of expression (including the right to seek and receive information
of a commercial nature) and freedom of association
Overview
1.2
This
bill seeks to amend the Therapeutic Goods Act 1989 to create new civil
penalty provisions to prohibit pharmaceutical companies from offering certain
inducements or payments to medical practitioners. It also requires
pharmaceutical companies to report each year about any payments or inducements
made to medical practitioners (failure to do so will also be subject to a civil
penalty). The civil penalties provide for a maximum penalty of 600 or 1,200
penalty units, or $102,000 or $204,000, that could apply to corporations.
Compatibility
with human rights
1.3
The
bill is accompanied by a self-contained statement of compatibility. The
statement makes no reference to any specific human rights and maintains:
This Bill
does not negatively impact on any human rights. Although it places some small
constraints on how pharmaceutical companies may compensate doctors, most
interactions continue to be allowed under new transparency rules and there are
no restrictions on the actions of individuals. These restrictions do not
conflict with any of the rights enumerated in the applicable treaties.
1.4
The
bill is aimed at addressing the possibility that pharmaceutical companies may
exert undue influence on doctors in their choice of prescription medicines. The
explanatory memorandum explains that the bill will replace a voluntary industry
code with ‘legislation that sets more stringent restrictions on the
interactions between pharmaceutical companies and physicians that minimises the
opportunity to provide inducements and thereby unduly influence prescribing
behaviours.’[1]
1.5
The
bill forbids payment for doctors to travel or attend education seminars and
scientific conferences domestically and overseas paid for by pharmaceutical
companies, bans the sponsorship of educational meetings intended for Australian
doctors outside Australia, limits gifts and overly lavish hospitality, and
requires full reporting of any fees paid to prescribers outside the company.
Right
to health
1.6
There
are a number of human rights that are potentially engaged by the bill. The
purpose of the bill can be seen as broadly promoting the right of persons to
the highest attainable standard of physical and mental health guaranteed by
article 12 of the International Covenant on Economic, Social and Cultural
Rights (ICESCR) by ensuring that medicines are prescribed solely on the basis
of their efficacy and the choice of appropriate medicines is not influenced by
extraneous matters or incentives offered by pharmaceutical companies to
doctors.
Freedom
of expression and freedom of association
1.7
The
guarantee of freedom of expression, including the freedom to seek and receive
information (as well as to impart it), guaranteed by article 19 of the
International Covenant on Civil and Political Rights (ICCPR), applies to
commercial information as well as to other forms of information. While
corporations as such do not enjoy rights directly under the ICCPR, the freedom
of doctors to receive information may be restricted by the bill. Freedom of
association guaranteed by article 22 of the ICCPR, which also extends to
commercial association for commercial purposes, may also be engaged.
1.8
Restrictions
on the right to receive information are permissible under article 19 of
the ICCPR, but only if they are:
provided by
law and are necessary:
(a) For respect of
the rights or reputations of others;
(b) For the protection
of national security or of public order (ordre public), or of public health or
morals.
1.9
Restrictions
on the enjoyment of freedom of association are also permissible if similarly
restricted.
1.10
In
order to justify restriction on either of these rights, it must be shown that
not only does the measure pursue a legitimate goal but that it is a measure
rationally related to the achievement of the goal and is a reasonable and
proportionate measure overall.
1.11
The committee intends to write to Senator Di Natale to seek clarification
on the potential impact of the bill on the right to freedom of expression
(including the right to seek and receive information of a commercial nature)
and freedom of association.
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