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CLAUSE NOTES
Pharmacy Control Amendment Bill 2016
Clause 1 Short Title
Provides that the Act will be cited as Pharmacy Control Amendment
Act 2016
Clause 2 Commencement
Provides for the Act to commence on a day to be proclaimed.
Clause 3 Principal Act
Provides that, in the Bill, the Pharmacy Control Act 2001 is referred
to as the Principal Act.
Clause 4 Long Title amended
This clause amends the long title of the Principal Act to clarify that
the Act regulates pharmacy businesses and the registration of
pharmacy business premises.
Clause 5 Section 3 amended (Interpretation)
This clause amends section 3 of the Act to modify the way in
which certain terms and phrases used in the Act are to be
understood.
The clause:
Simplifies the meaning of “eligible person” to mean a person
who holds an eligibility certificate and applies the definition to
the whole Act. Previously the definition was in section 71A of
the Act and applied to the interpretation of Part 6A only. As it
is also relevant to other Parts of the Act it has been moved to
s3 Interpretation.
Simplifies the language to explain the meaning of “eligibility
certificate” by deleting unnecessary words.
A new meaning is inserted for “exempt person” to assist
legislative interpretation. This term means a person who may
hold an interest in a pharmacy business, but due to the
ownership structure of that particular pharmacy business or
due to the ownership structure they operate under, they are
not required to hold an eligibility certificate.
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The definition of “lapsing date” has been moved from Part 6A
of the Act to section 3 Interpretation. The new meaning
“lapsing date” has also been slightly amended. This term
provides that provisions will lapse on 30 June unless another
date is prescribed. The amendment also allows the Authority
to specify a date on which certain provisions will lapse. This
will allow the Authority to issue eligibility certificates in respect
of a particular person, pharmacy business or pharmacy business
premises for a specified period in certain circumstances; for
example for a temporary pharmacy.
Inserts a new meaning for “owner”. This meaning replaces the
term used in the Act of “responsible occupier”. The change to
the term “owner” places the responsibility for holding an
eligibility certificate and being named in the certificate of
registration for the business on the owner of that pharmacy
business. This allows other parts of the Bill to place the
responsibility to communicate with the Authority on the
owners of pharmacy businesses.
The meaning of “pharmacy business” is moved from this
section to a new Section 3A.
The meaning of “proprietary interest” is repealed. The reasons
for the deletion is there was concern regarding the apparent
difference between the meaning of “interest” and “proprietary
interest” as only the latter phrase is defined and the terms were
being used interchangeably. The meaning of interest in a
pharmacy business held is now explained in the new Section 3B
and has a consistent meaning throughout the Act.
New meanings are inserted for “relevant pharmacy business”
and “relevant pharmacy business premises”. This change
differentiates the premises with the business conducted from it.
If a premise is used to conduct a pharmacy business, it will be a
pharmacy business premises for the purpose of the Act.
The term “responsible occupier” is repealed and replaced with
a definition for the term “owner”.
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Clause 6 Sections 3A and 3B inserted
3A. Meaning of “pharmacy business”
This clause inserts or amends the meaning of “pharmacy business”
used in the section to clarify.
The term “dispensing” is inserted into section 3A. It provides
that “dispensing” means preparing the narcotic or restricted
substances for sale or supply to the public.
A new term “preparing” is used in the explanation of the term
“dispensing”. For the purpose of dispensing, “preparing”
includes packaging, labelling or recording the substances.
The clause clarifies that the terms “medicinal poison”, “narcotic
substance”, “potent substance” and “restricted substance”, have
the same meaning as in the Poisons Act 1971.
A new meaning is inserted for “pharmacy business” which has
been moved from Section 3. The clause now explains a
pharmacy business as a business which involves any, or any
combination of the following activities:
- the compounding or dispensing, by a pharmacist, of narcotic
substances and restricted substances on the prescription or
lawful request of a medical practitioner or other health
professional.
- the sale or supply, by a pharmacist, of potent substances
- the sale or supply, by a pharmacist or by an employee of
that pharmacist under his or her supervision, of medicinal
poisons that are in the possession, custody, or control of
that or another pharmacist.
Businesses that hold a licence to sell poisons under section 27
of the Poisons Act 1971 are not pharmacy businesses within the
meaning of that term in this Act.
3B. Meaning of “interest in a pharmacy business”
A new meaning is inserted for the term “interest in a pharmacy
business”. This was necessary to make clear the ownership
structures in which a pharmacy business can be held and to clarify
the meaning of “interest” to make it easier to regulate the holding
of an interest in a pharmacy business as pharmacy business
structures are frequently becoming more complex. The clause
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ensures that holding an interest in a pharmacy business means any
legal or beneficial interest in the business, including an interest as a
sole proprietor or a partner or a director, member or shareholder
of a company or a trustee, beneficiary or unit holder in a trust.
A relevant safety net provision is added in this clause to ensure
parties not covered under this section or in commercial structures
can included by regulation as being able to hold an interest in
pharmacy business.
Clause 7 Section 11 amended (Guidelines)
This clause amends the Act’s provisions for Guidelines issued by
the Authority by removing the previous provisions and inserting
new ones.
The new section provides greater scope for the Authority to issue
Guidelines necessary and appropriate to provide practical guidance
and direction to pharmacists on the registration and renewal of the
registration of a pharmacy business premises, as well as other
matters under the Act. It will result in pharmacy businesses being
provided additional practical support to meet their regulatory
requirements. The Authority can choose whether or not to
publish their Guidelines.
Clause 7 inserts Section 11(3) which makes it clear that if
guidelines are inconsistent with the provisions of any Act, the
provisions of the Act will prevail.
Clause 8 Section 58 amended (Interpretation)
This clause amends the meaning of “relevant party” by removing
the term “responsible occupier” and replacing it with the phrase
“the owner of the relevant pharmacy business”. The definition of
“responsible occupier” in section 3 is confusing and creates
interpretation difficulties. The renaming of the term in the Act to
“the owner of the relevant pharmacy business” makes the role of
the position clear and clarifies that responsibility rests with the
owner. The term “responsible occupier” has consequently been
removed from the Act in clause 5 of this Bill.
Clause 9 Section 59A amended (Powers of Authority following inspection)
This clause repeals the previous section 59A(2) in favour of a new
section 59A(2).
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The clause clarifies the powers of the Authority following an
inspection of the pharmacy business premises to carry out
specified works or actions it considers appropriate.
It also gives the Authority the power to direct the relevant party to
close and not trade from the pharmacy business premises until the
required works or actions have been carried out.
Clause 10 Section 61A amended (Application of Part)
This clause omits the definition of ‘lapsing date’ as this is dealt with
at Section 3.
This clause also omits the definition of ‘related party’ and replaces
it with the term ‘close relative’ to better reflect the structure of
modern families.
A ‘close relative’ for the purposes of this Act is a pharmacist’s:
Spouse
Child or grandchild
Parent or step-parent
Sibling, including a step-sibling, or
A child of the pharmacist’s spouse, other than their own.
Clause 11 Section 61B amended (Applying to hold an interest in pharmacy
business)
The references to how an interest in a pharmacy business can be
held are amended to make clear the ownership structures a
pharmacy business can be held. For example, to not allow
specialised trust structures may create legal and commercial
challenges for many pharmacy businesses. The clause also makes
changes to make it consistent with associated minor amending
provisions regarding “lapsing date” and “exempt person”.
In summary, superfluous and ambiguous language is simplified
without changing the intent of the original section.
Clause 12 Section 61C amended (Eligibility)
This clause simplifies language and clarifies that a person is to hold
an interest in a pharmacy business if they meet the criteria set out
in this section.
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This clause amends Section 61C to:
Ensure gender-neutral language
Reflect that natural persons, partnerships and body
corporate commercial structures can be ‘eligible persons’
under this section
Clarify that the criteria of the section applies to all eligible
persons
Updates terms changed within previous clauses of this Bill.
In the case of a body corporate, clarify that an eligible
person to hold an interest in a pharmacy business includes
a trustee of another trust, each beneficiary or unit holder of
which is a pharmacist or a close relative of a pharmacist.
Clause 13 Section 61D amended (Exemptions)
This clause clarifies, by making a minor grammatical amendment,
the requirement to apply for an eligibility certificate by omitting
“applying” and replacing it with “the requirement to apply”.
The term “or unit holder in” is added to subsection (b) to include
unit holders as well as beneficiaries of a trust as exempt under this
section.
Clause 14 Section 61E amended (Annual renewal of eligibility certificate)
This clause simplifies the language by removing an ambiguous
phrase.
Clause 15 Section 61F inserted
This clause inserts a new section after section 61E in Part 5A to
clarify who must hold an eligibility certificate.
61F. Persons are not required to hold more than one eligibility
certificate
The Act’s terminology is currently ambiguous regarding the scope
of an Eligibility Certificate. This clause requires all owners of
pharmacy businesses to hold an eligibility certificate. Owners will
not be required to hold separate eligibility certificates for each
pharmacy business they own unless their interest in those
pharmacy business is held in different legal capacities (eg, a
partnership or trust). An eligibility certificate will be required for
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each interest held in a different legal capacity.
Clause 16 Section 62 amended (Offence for certain persons to hold interest
in pharmacy business &c.)
This clause simplifies section 62 by removing unnecessary phrases
without changing the intent of the original section.
Clause 17 Section 65 amended (Limitation on number of pharmacies in
which person may have interest)
This clause repeals and replaces outdated terminology.
The clause is amended to make it clear that the pharmacy
ownership limitation provisions also apply to beneficiaries and
shareholders of trusts.
This clause also inserts a new paragraph to clarify that pharmacy
business premises, exempt by the Authority from registration for a
period not longer than 3 months under S.71J are not included in
the four pharmacy business limit provided for under s.65. Eg. A
temporary individual pharmacy business premises set up to
conduct routine vaccinations.
Clause 18 Section 70A amended (Failure to notify Authority)
Clause 18 amends the meaning of the term ‘relevant event’. It
generally clarifies and applies gender neutral language to the
existing section 70A which sets out certain events that pharmacists
have an obligation to notify the Tasmanian Pharmacy Authority of
which are indicative of unethical behaviour.
It also provides that a body corporate must also notify the
Authority when:
there is a change of membership; or
there is a change to the particulars of the body corporate.
It also defines the meaning of a “scheduled substance” to refer to
the national standard set by the Australian regulatory body.
Clause 19 Section 71A repealed
This clause repeals section 71A.
This section is no longer required as the definitions in this Part
have been amended and moved to section 3 of the Act to aid
interpretation for the entire Act, not just Part 6A.
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Clause 20 Part 6A, Division 1: Heading inserted
This clause amends Part 6A by inserting the heading ‘Division 1 –
Preliminary’ before section 71B to aid interpretation.
Clause 21 Part 6A, Division 2: Heading inserted
This clause amends Part 6A by inserting the heading ‘Division 2 –
Registration’ after section 71B to aid the reader in the purpose of
this Part.
Clause 22 Section 71E amended (Consideration of applications for
registration of pharmacy business premises)
This clause repeals subsection 71E(2)(b) which requires the
premises sought to be registered to be used solely for the
purposes of a pharmacy. The subsection is superfluous and
unnecessary.
Clause 23 Section 71F amended (Approval or refusal of applications)
The intent of the original clause remains. The clause replaces the
previous section 71F(3)(c). When refusing an application to
register a business premises the Authority is to give notice to the
applicant of their right to appeal the refusal.
Clause 24 Section 71G amended (Nature of registration of pharmacy
business premises)
This clause clarifies that the lapsing date of pharmacy business
registration is related to the date upon which the notice takes
effect.
Clause 25 Section 71H amended (Registration of pharmacy business
premises may be cancelled or suspended)
This clause repeals outdated terms in favour of new terms brought
in by this Bill.
This clause makes clear:
any failure to comply with action required by the Authority
following an inspection of the premises under section
59A(1)(b), is grounds for cancellation or suspension of
registration
responsibility rests with pharmacy business owners
the owner has a right to appeal any cancellation or
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suspension of their registration
cancellation takes effect when the Authority gives notice to
the owner, or where a business is jointly owned, ideally all
owners, but where this is not possible after making a
reasonable attempt to do so, and it is unable to do so, it
will be sufficient if at least one owner receives the notice.
Cancellation may also take effect on a specified date in the
notice.
This clause also repeals paragraph (7), which required certificates
of registration of pharmacy businesses to be returned to the
Authority upon cancellation. The clause is redundant as certificates
are sent electronically to the Authority.
Clause 26 Section 71I amended (Registration of pharmacy business premises
may be relinquished)
This clause clarifies how registration of pharmacy business premises
may be relinquished by the owners by repealing the existing
subsection (1) and inserting new subsections (1) and (1A).
The new subsections allow for owners to relinquish registration at
any time. To be effective, the owner must give notice to the
Authority that they are relinquishing their registration. Where
there is more than one owner, all owners must give notice to the
Authority, either separately or jointly. This ensures that valuable
business interests of pharmacy business owners who own a
business jointly or in a partnership are protected.
The clause removes the ambiguity of subsection (2) of the
Principal Act to remove ambiguity.
Subsection (3) is repealed and replaced with a new subsection (3)
to stipulate that pharmacy businesses are not entitled to a refund
when cancelling pharmacy business premise registration.
Clause 27 Section 71J amended (Premises exempt from registration
requirements)
This clause inserts subsection (3A) which empowers the Authority
to request such further information as it considers necessary when
assessing an application for exemption from registration.
Clause 28 Section 71K substituted (Annual renewal of registration)
This clause repeals Section 71K and replaces it with a new section
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71K. The new Section 71K removes and replaces redundant
terms. This clause focuses on the renewal of the registration of
the pharmacy business premises.
The requirements for renewal are:
Registration must be renewed on or before it is time to
renew.
The application to renew must be on the approved form
and lodged with the Authority. If a fee applies then that
fee should be included with the application form as well as
any other information the Authority may require.
This clause gives the power to the Authority to require
information, waive fees or consider the application in the event
that is has been lodged after the previous registration expired.
The Authority is given powers to renew or refuse the registration.
Grounds for refusal to renew are set. They include:
Where application is not on the approved form, lodged
with the Authority or includes the relevant fee, or
Where information required by the Authority has not been
provided.
Where the Authority reasonably believes the pharmacy
business premises no longer meet the eligibility criteria.
Where the Authority believes material facts in regards to
the pharmacy business premises have changed since the
original application.
Or the application is made more than 30 days after the
expiry of the previous registration.
This clause requires the Authority to notify the pharmacy business
owner if they refuse to renew the business registration. The
Authority must advise why the application was refused and that
the applicant may appeal the decision.
This clause ensures that businesses that have applied for renewal
of their registration within the required time period will remain
registered until the Authority makes an assessment on their
renewal application.
Clause 29 Part 6A, Division 3 inserted
This clause inserts a new Division into the Principal Act to clearly
address alterations to pharmacy business premises:
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Division 3 – Alterations
This clause inserts the following sections into the new division of
the Principal Act:
Clause 30 71KA. Interpretation of Division
This clause inserts a new meaning for ‘alteration’ to include
temporary or permanent alteration to any part of the pharmacy
business premises which will affect or interfere with dispensing or
storage of drugs or medicines, access or security arrangement to
the pharmacy business premises or any other professional activities
of the pharmacist.
71KB. Alterations to pharmacy business premises require approval
This clause is included to prohibit the owner of pharmacy
businesses to allow any alterations to the premises without prior
approval from the Authority.
A fine is prescribed for undertaking alterations without the
Authority’s permission.
Where the business has more than one owner, it is sufficient for
one owner to request permission from the Authority on behalf of
the business.
71KC. Applications for approval of alterations to pharmacy
business premises
This clause sets out the requirements for seeking approval from
the Authority for alterations to pharmacy business premises. It
allows for the Authority to request further information it considers
necessary and provides discretion to waive all or part of the
application fee.
71KD. Consideration of application for approval of alteration to
pharmacy business premises
This clause provides for the Authority to grant or refuse an
application to alter a pharmacy business premises. It provides
parameters for approval to ensure alterations will be suitable for
the purposes of a pharmacy and the pharmacy will not be located
within a supermarket or provide access to the premises directly
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from or to a supermarket.
This clause guides the Authority on matters to consider when
granting approval for alterations. These matters include
consideration of whether alterations will affect the requirements
for that pharmacy’s business premises registration under s 71E(3).
71KE. Approval or refusal of applications
This clause requires the Authority to give the applicant notice as
soon as practicable of the approval of the application and
associated details of that approval.
Where the application is refused, the Authority must provide
notice to the applicant as soon as practical of that refusal, the date,
reasons and the applicant’s right to appeal the refusal.
Clause 31 Part 6A, Division 4: Heading inserted
Part 6A of the Principal Act is amended by inserting a new heading
before section 71L:
Division 4 – Registration notices
Clause 32 Sections 71KF and 71KG inserted
This clause inserts new sections into the new Division 4.
71KF. Notice of events disruptive to registered pharmacy business
premises
This clause inserts meanings for the following new terms:
‘appropriate notice’ is a notice that advises and sets out full
particulars of an event.
‘disruptive event’ is an unforeseen event that directly affects the
business and its ability to carry on its business activities. Examples
are specified in the definition.
‘extended period’ is to be longer than three days.
This clause requires that the owner, or one of the owners, where
there is more than one, of a pharmacy business provide the
Authority with notice of a disruptive event within 7 days of that
event. A fine is prescribed for failure to notify the Authority of
such an event.
The Authority may request further information about the event
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from the owner who gave notice. A fine is prescribed for failure
to provide any further information requested.
71KG. Notice of important events relevant to registration of
pharmacy business premises
This clause inserts meanings for the following new terms:
‘appropriate notice’ – means a notice advising and setting out full
particulars of any event.
‘major change’ – means any changes to leasehold arrangements.
Examples are in the definition.
This clause requires the owner, or one of the owners where the
business is owned jointly, of the pharmacy business to notify the
Authority within 14 days of any change when the business is
abandoned, wound up due to retirement or incapacity, when the
interests in the business change, either legally or otherwise, any
major change is made to leasehold arrangements or when a
prescribed event occurs.
A fine not exceeding 2 penalty units is prescribed for owners for
failure to provide appropriate notice to the Authority.
The Authority may request further information regarding the event
from the owner who gave notice. This clause prescribes a fine not
exceeding 2 penalty units for failure to provide further information
as requested.
Clause 33 Part 6A, Division 5: Heading inserted
Part 6A of the Principal Act is amended by inserting a new heading
before section 71L to logically divide up related information:
Division 5 – Register
Clause 34 Section 71L amended (Register)
This clause repeals paragraph (2)(a) and inserts a new paragraph
(2)(a) which requires the Authority to record the name of the
owner, or owners of the pharmacy business premises.
Clause 35 Section 73 amended (Information requirements)
The term ‘corporate provider’ is repealed as it is redundant.
This clause inserts a new term ‘information’ to mean documents,
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access to documents and copies of documents.
This clause inserts a new subsection (1A) to require the owner of
a pharmacy business to give to the Authority any relevant
information it may require.
This clause repeals the current subsection (2) and inserts a new
subsection (2) to clarify that where a business is owned as a body
corporate, partnership or trust, the owners may be required to
provide relevant information on the ownership structure.
Redundant terms are repealed and replaced with updated terms to
provide clarity.
This clause makes clear that where a business is owned by more
than one person, the obligations of this section apply to all owners
however, it will be sufficient for one owner to give appropriate
notice to discharge the correspondence obligation on other
owners in respect to that notice.
Clause 36 Section 74 amended (Service of documents)
This clause repeals references which allow documents to be
provided by facsimile.
Clause 37 Repeal of Act
This clause provides for the Pharmacy Control Amendment Act 2016
to be repealed 365 days from the day it commences.
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