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PUBLIC HEALTH (COMMUNITY PHARMACY OWNERSHIP) AMENDMENT REGULATION 2012 (NO 1) (NO 30 OF 2012)
THE LEGISLATIVE ASSEMBLY FOR
THE
AUSTRALIAN CAPITAL
TERRITORY
PUBLIC HEALTH (COMMUNITY
PHARMACY OWNERSHIP)
AMENDMENT
REGULATION 2012 (No 1)
SL2012-30
EXPLANATORY
STATEMENT
Minister for Health
Public Health (Community Pharmacy Ownership)
Amendment Regulation 2012 (No 1)
When the Health Practitioner Regulation National Law
(ACT) 2010 was enacted by the Legislative Assembly it did not contain a
provision that would ensure that pharmacies can only be owned by registered
pharmacists or a complying pharmacy corporation. This was an important and
unintended oversight.
To correct this problematic oversight,
section 13 of the Health Practitioner Regulation National Law
(ACT) 2010 was used to make a Regulation that modified the Health
Practitioner Regulation National Law (ACT) 2010, and consequentially
the Health Act 1993 (the Health Act). The modification made was the
insertion into the Health Act of section 129A, which limits pharmacy
ownership to pharmacists or a complying pharmacy corporation by way of an
offence.
Modification of the Health Practitioner Regulation National
Law (ACT) 2010 is authorised by section 13 of the Health
Practitioner Regulation National Law (ACT) 2010. Section 13
provides that a regulation may prescribe transitional matters necessary or
convenient to be prescribed because of the enactment of the Health
Practitioner Regulation National Law (ACT) 2010. Transitional powers
are inserted into legislation where there is some complexity arising from a
reforming Bill. A clause of this nature ensures that any matters that may have
been inadvertently omitted or inadequately dealt with when developing a Bill can
be addressed.
The Health Practitioner Regulation National Law (ACT)
(Transitional Provisions) Regulation 2010 (No 2) was made pursuant to
section 13 of the Health Practitioner Regulation National Law
(ACT) 2010 to modify the Act, and consequentially amend the Health Act.
However, the Health Practitioner Regulation National Law (ACT) (Transitional
Provisions) Regulation 2010 (No 2) is a transitional provision that
has a limited life, and as such will expire on 1 July 2012.
Subsequently, section 129A as inserted into the Health Act also
expires on 1 July 2012 at midnight. The purpose of this Regulation is
essentially to permanently preserve the restriction on pharmacy ownership beyond
1 July 2012. This is being achieved by reproducing in the Public
Health Regulation 2000, as much as possible, the offence currently in
section 129A of the Health Act.
Several factors influenced
the decision to place the permanent restriction on pharmacy ownership in the
Public Health Regulation 2000. The first factor is the objectives of the
Public Health Act 1997 (the PHA), which include protection of the
public from public health risks, including those associated with facilities,
products and activities not adequately controlled by another Territory or
Commonwealth law. To this end regulations may be made under the PHA, including
in relation to matters pertaining to drug preparation and supply. As pharmacies
are integral to the preparation and supply of drugs and medicines to the
community, the Public Health legislation is an appropriate place to house
provisions restricting pharmacy ownership. This is reflected by the fact that
the Public Health Regulation 2000 already contains a Division applying to
Pharmacies; Division 5.6. Accordingly, it is appropriate for additional
provisions pertaining to pharmacies to be located within that Division of the
Public Health Regulation 2000.
Another influencing factor is that
it is intended to declare the operation of a community pharmacy to be a
licensable public health risk activity pursuant to section 18 of the PHA.
This will enable greater regulatory oversight and scrutiny of community
pharmacies. Furthermore, it will enhance the ability of the regulator to
identify and assess the suitability of all persons that own and are operating
community pharmacies. In the absence of a licensing regime, it is considered
that the ability of the Health Directorate as the regulator to identify all
persons with ownership or control of a pharmacy business is limited.
Furthermore, the powers available to the regulator where contraventions of the
requirements for pharmacies have been identified would be very
limited.
It is also expected that the declaration of community pharmacies
as a licensable public health risk activity would be supported by a code of
practice under the PHA to which licensed operators of community pharmacies would
need to comply.
The preparation and supply of drugs and medicines has
the ability to have a significant impact on the health of individuals in the
context of the wider health of the community. It is critically important to the
wider health of the community that the supply of medicines from community
pharmacies be supported by advice and guidance from suitably qualified and
registered persons (pharmacists), who are bound by ethical responsibilities, and
unencumbered by competing and inappropriate considerations and influences. Put
simply, the community expects that pharmacists at community pharmacies are
independent, and not beholden to competing business interests or influences
which may undermine, detract or counter the provision of a vital health service.
On this basis it is regarded that restrictions on pharmacy ownership are
directly relevant to the protection of public health because of the central role
pharmacies play in the preparation and supply of drugs and medicines in the
ACT.
Background information
On 26 March 2008
the Council of Australian Governments (COAG) signed the 2008
Intergovernmental Agreement for a National Registration and Accreditation
Scheme for Health Professions (the Agreement). The objective of the
agreement was to fully implement a national scheme of registration and
accreditation for health professions (the National Scheme) in Australia by
1 July 2010.
In the ACT the final stage was achieved through
the Health Practitioner Regulation National
Law (ACT) Act 2010. The consequential amendment section of
the Health Practitioner Regulation National
Law (ACT) Act 2010 contained amendments to other existing ACT
legislation affected by the reforms; such as the Health Act and Health
Professionals Regulation 2004.
Among the amendments to the Health
Act were provisions about pharmacists and pharmacy premises. The explanatory
statement for the amendments stated the purpose of the amendments that inserted
Part 9 into the Health Act was “to ensure that the status quo
regarding pharmacy premises is maintained”. The intended position was that
in order to protect the wider health of the community that pharmacists have
direct, personal control of the operation of community pharmacies.
It
was later identified that this position was not given full effect. Consequently,
the power in the Health Practitioner Regulation National Law
(ACT) 2010 was used to modify the Health Act to give effect to the
intended position.
The first clause of the Regulation declares that the name of the Regulation
is to be the Public Health (Community Pharmacy Ownership)
Amendment Regulation 2012 (No 1).
Clause 2 provides for the commencement of the Act, which is to occur on
2 July 2012.
The Health Practitioner Regulation National Law
(ACT) (Transitional Provisions) Regulation 2010 (No 2) utilised the
power in the Health Practitioner Regulation National Law (ACT) 2010
to make modifications to the Act.
Modification of the Health
Practitioner Regulation National Law (ACT) 2010 is authorised by
section 13 of the same Act, which provides that a regulation may prescribe
transitional matters necessary or convenient to be prescribed because of the
enactment of the Act. Transitional powers are inserted into legislation where
there is some complexity arising from a reforming Bill. A clause of this nature
ensures that any matters that may have been inadvertently omitted or
inadequately dealt with when developing a Bill can be addressed.
When the
Health Practitioner Regulation National Law (ACT) 2010 was enacted
by the Legislative Assembly in did not contain a provision that would ensure
that pharmacies can only be owned by registered pharmacists or a complying
pharmacy corporation. This was an important and unintended oversight.
Accordingly, section 13 of the Health Practitioner Regulation National
Law (ACT) 2010 was used to correct this oversight by modifying the
Health Act by inserting section 129A (ownership of pharmacy business).
Section 129A restored the restriction on pharmacy ownership to pharmacists
or a complying pharmacy corporation by way of an offence.
However, the
Regulation used to make the modifications is a transitional provision that was
to have a limited life, and as such will expire on 1 July 2012.
Subsequently, section 129A as inserted into the Health Act 1993
also expires on 1 July 2012. Pursuant to section 85(3) of the
Legislation Act 2001, the expiry of the modification occurs at
midnight on 1 July 2012.
The purpose of this Regulation is
essentially to preserve the restriction on pharmacy ownership beyond
1 July 2012. This is being achieved by reproducing in the Public
Health Regulation 2000, as much as possible, the offence currently in
section 129A of the Health Act.
Therefore, the
amendments in this Regulation will take effect at the beginning of
2 July 2012 in accordance with section 74(1) of the
Legislation Act 2001. This will ensure that a restriction on
pharmacy ownership to pharmacists or a complying pharmacy corporation continues
seamlessly beyond 1 July 2012.
This provision alerts the reader that this Regulation amends the Public
Health Regulation 2000.
Upon commencement this Regulation will
alter the Public Health Regulation 2000 in accordance with the provisions
that this Regulation contains. This Regulation will then be immediately
repealed. Consequentially, from the date that this Regulation commences a new
republication of the Public Health Regulation 2000 will be available. That
new republication will feature the alterations made by this Regulation.
Clause 4 inserts a new section 62 into Division 5.6 of the
Public Health Regulation 2000, relates to pharmacies.
The first
subsection of the new section 62 makes it an offence for a person to own a
pharmacy unless the person is a pharmacist or a complying pharmacy corporation.
The offence carries a maximum penalty of 10 penalty units. Unless the
offence applies to a utility, section 138(3) of the PHA determines
that 10 penalty units is the highest maximum penalty that can imposed in
the Public Health Regulation 2000.
Contained with
subsection 62(2) are explanations of terms utilised in the offence in
subsection 1. The provision directs the reader to section 128A of the
Health Act for the meaning of complying pharmacy
corporation. Similarly, the reader is directed to the section 11
of the Medicines, Poisons and Therapeutic Goods Act 2008 for the
meaning of medicine, and to the dictionary of that Act for the
meaning of community pharmacy.
For the purposes of the
offence, the supply, compounding or dispensing of a medicines is considered to
be a pharmacy service, as is the provision of advice and counselling regarding
the effective use of a medicine. As a consequence, a business that provides one
or more of these pharmacy services will be considered a pharmacy business to
which the offence relates.
According to subsection 62(2), owning a
pharmacy includes having a legal or beneficial interest in the pharmacy
business. This extends the concept of ownership of the pharmacy, and ensures
that anyone that may have the ability to influence the operation of the pharmacy
business through a legal or beneficial interest is relevant to the application
of the provision.
However, the subsection also recognises that following
the death of a pharmacist that owns a community pharmacy, the public trustee or
a legal representative of the deceased pharmacist may be called upon to deal
with the assets of the deceased pharmacist’s estate. As the pharmacy
business is likely to be one of those assets, the provision makes it clear that
the legal representative or the public trustee will not be considered to own the
pharmacy business for the purposes of the offence. This prevents the offence
from applying merely because a legal representative or the public trustee has
taken control of assets from the estate of a deceased pharmacist.
The
operation of the offence will however, prevent the legal representative or the
public trustee from transferring ownership of the pharmacy to a beneficiary or
next of kin of the pharmacist, unless that person also happens to be a
pharmacist. In such circumstances the legal representative or public trustee
would need to organise for the sale of the pharmacy business, and the proceeds
of the sale would be become part of the deceased pharmacist’s estate.
It should be noted however, that it may be possible for the executor of
a deceased pharmacist’s estate to apply to the Chief Health Officer for
permission to operate the pharmacy briefly to allow for the sale or disposal of
the pharmacy. Section 128B of the Health Act enables the Minister for
Health to approve standards about premises for community pharmacies, which the
Minister has done through the Health (Community Pharmacy Premises) Approved
Standard 2010 (No 1). Part 4 of those declared standards
has application in circumstances where a pharmacist operating a community
pharmacy dies. The provision in the Standard is reasonable and appropriate to
prevent a community pharmacy from needing to immediately cease operating due to
the death of the owner pharmacist. This prevents the loss of employment for
staff at the pharmacy, and the associated impact on the community. It also
ensures that the executor of the deceased pharmacist’s estate has
reasonable time to organise for the sale of the pharmacy, without the value of
the pharmacy and the good will of the business being lost.
The offence
within section 62 does not involve strict or absolute liability. It also
does not displace any defences or rights of a defendant, or place any
evidentiary burden on the defendant. As such, the offence in section 62
does not engage or limit any rights under the Human Rights
Act 2004.
This clause amends the Dictionary in the Public Health Regulation 2000
by adding the word “pharmacist” to Note 2 of the Dictionary.
The purpose of Note 2 is to alert the reader to the fact that the
dictionary in the Legislation Act 2001 defines a range of terms that
are used in the Public Health Regulation 2000. These terms include ACT,
chief health officer, doctor, and nurse. As this regulation will add
references to a ‘pharmacist’, which is also a term defined in the
Legislation Act 2001, it is appropriate to amend Note 2
accordingly.