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TASMANIA
__________
PHARMACISTS REGISTRATION AMENDMENT
BILL 2005
__________
CONTENTS
1. Short title
2. Commencement
3. Principal Act
4. Section 3 amended (Interpretation)
5. Section 4 amended (Act binds Crown)
6. Section 8 amended (Functions of Board)
7. Section 9 amended (Powers of Board)
8. Section 10 amended (Objectives of Board)
9. Section 28 amended (Special grounds for refusing to grant
registration)
10. Section 30 amended (Certificates of registration)
11. Section 32 amended (Register)
12. Section 37 amended (Annual registration fees)
13. Section 38 amended (Removal from register)
14. Section 43 amended (Specific matters of complaint)
15. Section 53 amended (Actions that Board may take following
formal disciplinary proceedings)
16. Section 56 amended (Suspension of registration)
17. Section 59 amended (Inspections)
18. Section 60 amended (Right of appeal)
[Bill 89]-III
19. Section 62 amended (Offence to engage in pharmacy, &c., if
unregistered)
20. Section 65 amended (Limitation on number of pharmacies in
which pharmacist may have interest)
21. Section 67 amended (Failure to notify Board of civil claims)
22. Part 6A inserted
PART 6A - Registration of pharmacy business premises
71A. Interpretation of Part
71B. Application of Part
71C. Pharmacy business premises to be registered
71D. Applications for registration of pharmacy business
premises
71E. Consideration of applications for registration of
pharmacy business premises
71F. Approval or refusal of applications
71G. Nature of registration of pharmacy business premises
71H. Registration of pharmacy business premises may be
cancelled or suspended
71I. Registration of pharmacy business premises may be
relinquished
71J. Premises exempt from registration requirements
23. Section 80 amended (Regulations)
2
PHARMACISTS REGISTRATION AMENDMENT
BILL 2005
(Brought in by the Minister for Health and Human Services,
the Honourable David Edward Llewellyn)
A BILL FOR
An Act to amend the Pharmacists Registration Act 2001
Be it enacted by His Excellency the Governor of Tasmania, by
and with the advice and consent of the Legislative Council and
House of Assembly, in Parliament assembled, as follows:
1. Short title
This Act may be cited as the Pharmacists
Registration Amendment Act 2005.
2. Commencement
This Act commences on the day on which this
Act receives the Royal Assent.
3. Principal Act
In this Act, the Pharmacists Registration Act
2001* is referred to as the Principal Act.
*No. 90 of 2001
[Bill 89] 3
s. 4 No. Pharmacists Registration Amendment 2005
4. Section 3 amended (Interpretation)
Section 3 of the Principal Act is amended as
follows:
(a) by omitting the definition of "business
address";
(b) by omitting the definition of "pharmacy"
and substituting the following
definitions:
"pharmacy business" means a
business that involves the
compounding and dispensing of
medicines and drugs on the
prescription of medical
practitioners and other health
professionals;
"pharmacy business premises"
means a shop or other premises
where a pharmacy business is
carried on;
(c) by inserting the following definition after
the definition of "Pharmacy Code":
"pharmacy premises" means a place
in or from which a person
engages in the practice of
pharmacy;
5. Section 4 amended (Act binds Crown)
Section 4 of the Principal Act is amended by
inserting ", other than Part 6A," after "Act".
4
2005 Pharmacists Registration Amendment No. s. 6
6. Section 8 amended (Functions of Board)
Section 8 of the Principal Act is amended as
follows:
(a) by omitting from paragraph (b)
"pharmacists" and substituting
"pharmacy";
(b) by inserting in paragraph (f) "respect of
the practice of" after "in".
7. Section 9 amended (Powers of Board)
Section 9 of the Principal Act is amended as
follows:
(a) by inserting in paragraph (d) "the
practice of" after "in";
(b) by inserting in paragraph (e) "the
practice of" after "pharmacists or".
8. Section 10 amended (Objectives of Board)
Section 10(b) of the Principal Act is amended by
omitting "practise as pharmacists" and
substituting "engage in the practice of
pharmacy".
9. Section 28 amended (Special grounds for refusing to
grant registration)
Section 28 of the Principal Act is amended as
follows:
5
s. 10 No. Pharmacists Registration Amendment 2005
(a) by omitting from paragraph (a) "practise
as a pharmacist" and substituting
"engage in the practice of pharmacy";
(b) by omitting from paragraph (b) "practise
as a pharmacist" and substituting
"engage in the practice of pharmacy".
10. Section 30 amended (Certificates of registration)
Section 30(3)(b) of the Principal Act is amended
by omitting "practise as a pharmacist" and
substituting "engage in the practice of
pharmacy".
11. Section 32 amended (Register)
Section 32(3) of the Principal Act is amended as
follows:
(a) by omitting from paragraph (f) "person."
and substituting "person;";
(b) by inserting the following paragraph after
paragraph (f):
(g) such other matters as this Act
may require to be recorded in the
register.
12. Section 37 amended (Annual registration fees)
Section 37(7) of the Principal Act is amended by
omitting "practised" and substituting "engaged
in the practice of".
6
2005 Pharmacists Registration Amendment No. s. 13
13. Section 38 amended (Removal from register)
Section 38(1)(b)(vii) of the Principal Act is
amended by omitting "practise as a pharmacist"
and substituting "engage in the practice of
pharmacy".
14. Section 43 amended (Specific matters of complaint)
Section 43 of the Principal Act is amended as
follows:
(a) by omitting from subsection (1)(c)
"practise as a pharmacist" and
substituting "engage in the practice of
pharmacy";
(b) by inserting in subsection (2)(a) ",
section 71C" after "section 59(4)";
(c) by omitting from subsection (2)(i)
"practising as a pharmacist" and
substituting "the practice of pharmacy";
(d) by omitting from subsection (2)(j)
"practising as a pharmacist" and
substituting "the practice of pharmacy".
15. Section 53 amended (Actions that Board may take
following formal disciplinary proceedings)
Section 53(5) of the Principal Act is amended as
follows:
(a) by omitting from paragraph (g) "business
premises" and substituting "pharmacy
premises";
7
s. 16 No. Pharmacists Registration Amendment 2005
(b) by omitting from paragraph (h) "business
premises" and substituting "pharmacy
premises".
16. Section 56 amended (Suspension of registration)
Section 56 of the Principal Act is amended as
follows:
(a) by omitting from subsection (1)(b)
"practise as a pharmacist" and
substituting "engage in the practice of
pharmacy";
(b) by omitting from subsection (1)(g) "a
provision of";
(c) by inserting in subsection (1)(j)
"pharmacy" after "inappropriate";
(d) by omitting from subsection (3)
"business premises" and substituting
"pharmacy premises";
(e) by omitting from subsection (4)
"business premises" and substituting
"pharmacy premises".
17. Section 59 amended (Inspections)
Section 59 of the Principal Act is amended as
follows:
(a) by omitting from subsection (1)(d)
"practise as a pharmacist" and
substituting "engage in the practice of
pharmacy";
8
2005 Pharmacists Registration Amendment No. s. 18
(b) by inserting in subsection (1)(e)
"pharmacy" after "inappropriate";
(c) by omitting from subsection (2)
"business" and substituting "pharmacy";
(d) by omitting from subsection (3)
"business premises" and substituting
"pharmacy premises".
18. Section 60 amended (Right of appeal)
Section 60(1) of the Principal Act is amended as
follows:
(a) by omitting from paragraph (g)
"section 53(1)." and substituting
"section 53(1); or";
(b) by inserting the following paragraphs
after paragraph (g):
(h) refuse to register premises as
pharmacy business premises
under Part 6A; or
(i) suspend or cancel the registration
of pharmacy business premises
under Part 6A; or
(j) refuse to grant an exemption
under Part 6A; or
(k) revoke an exemption under
Part 6A.
9
s. 19 No. Pharmacists Registration Amendment 2005
19. Section 62 amended (Offence to engage in
pharmacy, &c., if unregistered)
Section 62 of the Principal Act is amended as
follows:
(a) by omitting from subsection (1)(b) "or in
the business carried on in a pharmacy."
and substituting "business.";
(b) by omitting from subsection (2)(b) "or in
the business carried on in a pharmacy"
and substituting "business";
(c) by omitting from subsection (2)(e)
"practice, pharmacy or business, as the
case may be, are" and substituting
"pharmacy practice or pharmacy
business is";
(d) by omitting from subsection (3)(a) "or in
the business carried on in a pharmacy"
first occurring and substituting
"business";
(e) by omitting from subsection (3)(a)(ii)
"the pharmacy" second occurring and
substituting "pharmacy business";
(f) by omitting from subsection (3)(a)(iii)
"pharmacy in this State or in the business
carried on in a pharmacy" and
substituting "pharmacy business";
(g) by omitting from subsection (3)(b)
"pharmacy or in the business carried on
in a pharmacy" and substituting
"pharmacy business".
10
2005 Pharmacists Registration Amendment No. s. 20
20. Section 65 amended (Limitation on number of
pharmacies in which pharmacist may have interest)
Section 65 of the Principal Act is amended as
follows:
(a) by omitting "A" and substituting "(1) A";
(b) by omitting from subsection (1)
"pharmacies or in the business carried on
in more than 4 pharmacies." and
substituting "pharmacy businesses.";
(c) by inserting the following subsection:
(2) In this section -
"pharmacy business" means a
pharmacy business that is
carried on in or from the
one premises.
21. Section 67 amended (Failure to notify Board of civil
claims)
Section 67(1) of the Principal Act is amended by
omitting "his or her practice as a pharmacist"
and substituting "the practice of pharmacy".
22. Part 6A inserted
After section 71 of the Principal Act, the
following Part is inserted:
11
s. 22 No. Pharmacists Registration Amendment 2005
PART 6A - REGISTRATION OF PHARMACY
BUSINESS PREMISES
71A. Interpretation of Part
In this Part -
"eligible person" means any of the
following:
(a) the holder of full or
interim registration as a
pharmacist;
(b) an applicant for
registration as a
pharmacist;
(c) a body corporate lawfully
providing, or proposing to
lawfully provide,
pharmacy services;
(d) a body that is -
(i) lawfully permitted
to call itself a
Friendly Society;
and
(ii) lawfully
providing, or
proposing to
lawfully provide,
pharmacy
services;
"responsible occupier", of premises,
means a person who is, for the
12
2005 Pharmacists Registration Amendment No. s. 22
time being, providing pharmacy
services in or from those
premises, other than a person who
works under the control and
supervision of a registered
pharmacist at those premises.
71B. Application of Part
(1) This Part does not bind the Crown.
(2) This Part does not apply to -
(a) premises that are used for the
purposes of a pharmacy business
and are located wholly within a
hospital operated by an agency or
instrumentality of the Crown in
right of Tasmania or the
Commonwealth; or
(b) prescribed premises, prescribed
persons or prescribed pharmacy
practices or services.
71C. Pharmacy business premises to be registered
After 1 September 2006, a person must
not use any premises for the purposes of
a pharmacy business unless those
premises are -
(a) registered as pharmacy business
premises; or
13
s. 22 No. Pharmacists Registration Amendment 2005
(b) exempt, under section 71J, from
the requirement to be registered
as pharmacy business premises.
Penalty: Fine not exceeding 25 penalty
units and, in the case of a
continuing offence, a further fine
not exceeding 2.5 penalty units
for each day during which the
offence continues.
71D. Applications for registration of pharmacy
business premises
(1) A person may apply to the Board to have
premises registered as pharmacy business
premises.
(2) The application is to be -
(a) in an approved form; and
(b) lodged with the Registrar; and
(c) accompanied by the prescribed
application fee, if any; and
(d) accompanied by such information
or evidence as the Board requires.
(3) The Board may require the applicant to
provide such further information or
evidence as it considers necessary in
order to consider the application.
(4) The Board may waive all or part of the
fee.
14
2005 Pharmacists Registration Amendment No. s. 22
71E. Consideration of applications for
registration of pharmacy business premises
(1) The Board, after considering an
application to have premises registered as
pharmacy business premises, may -
(a) approve the application; or
(b) refuse the application.
(2) However, the Board must not approve
the application unless it is satisfied that -
(a) the applicant -
(i) is an eligible person; or
(ii) has, by virtue of some
other status, reasonable
grounds for making the
application; and
(b) the premises sought to be
registered are used, or are being
made ready to be used, for the
purposes of a pharmacy business;
and
(c) the premises -
(i) are not located wholly or
partly within a
supermarket; or
(ii) are not capable of being
entered from within a
supermarket; or
15
s. 22 No. Pharmacists Registration Amendment 2005
(iii) are not capable of being
used to gain entry to a
supermarket; and
(d) in terms of the objectives set out
in section 10, the premises sought
to be registered are suitable, or
are being made suitable, to be
used for the purposes of a
pharmacy business.
(3) The matters that the Board may have
regard to for the purposes of
subsection (2)(d) include, but are not
limited to -
(a) the standard or proposed standard
of presentation of the premises,
including the external appearance
and internal fittings; and
(b) the physical condition of the
premises, and the condition of
associated amenities such as
lighting, ventilation and
sanitation; and
(c) the security of the premises and,
in particular, the security of
dispensing and storage areas; and
(d) key professional requirements
such as the need for -
(i) professional supervision
of the sale and supply of
medicines and drugs; and
(ii) customer privacy and
counselling; and
16
2005 Pharmacists Registration Amendment No. s. 22
(iii) sufficient storage for
medicines and drugs; and
(e) whether there is or will be
reasonable public access to the
premises and, in particular, access
for disabled persons; and
(f) if there is or will be direct access
to or from adjoining premises, the
nature of the activities carried out
on those adjoining premises; and
(g) any issues of compliance
regarding State or council
legislative requirements on
matters such as fire safety and
occupational health and safety;
and
(h) in the case of leased premises, the
terms of the lease.
(4) For the purposes of subsection (2)(c) -
(a) a supermarket is taken to be any
large enclosed shop that primarily
sells fresh and processed foods
(including beverages) and where
the selection of goods is
organised on a self-serve basis,
even though -
(i) customer advice may
always or sometimes be
available in the shop; and
(ii) customer service and
assistance may always or
17
s. 22 No. Pharmacists Registration Amendment 2005
sometimes be available in
a part of the shop; and
(iii) other goods (including
household goods like
cleaning and kitchen
products and personal
care products like
toiletries) may also be
offered for sale in the
shop; and
(b) a large enclosed shop that sells
general merchandise (commonly
known as a department store) is
not taken to be a supermarket
even though it may -
(i) contain a restaurant or
café; or
(ii) sell specialty foods such
as biscuits, confectionery
and condiments.
(5) If the Board is unsure, in respect of an
application under this Part, whether or
not any premises are a supermarket, it
may apply to the Secretary for a ruling.
(6) If subsection (5) applies -
(a) the Secretary, after making such
inquiries as he or she considers
necessary, may, in writing, make
the ruling; and
(b) the Board is bound by that ruling.
18
2005 Pharmacists Registration Amendment No. s. 22
71F. Approval or refusal of applications
(1) If an application to have premises
registered as pharmacy business premises
is approved -
(a) the Board is to register the
premises by making an
appropriate entry in the register;
and
(b) the registration takes effect as
soon as the Board has complied
with paragraph (a).
(2) The Board must, as soon as practicable
after registering the premises, give the
applicant notice of the approval and the
date of registration together with a notice
or certificate, in an approved form, in
evidence of the registration.
(3) If an application to have premises
registered as pharmacy business premises
is refused, the Board is to give the
applicant notice of -
(a) the refusal; and
(b) the reasons for the refusal; and
(c) the applicant's right of appeal.
71G. Nature of registration of pharmacy business
premises
(1) The registration of pharmacy business
premises remains in force, subject to any
19
s. 22 No. Pharmacists Registration Amendment 2005
period of suspension, until it is cancelled
by the Board or relinquished.
(2) However, the Board, having regard to the
objectives set out in section 10, is to
periodically review the registration of
pharmacy business premises.
(3) For the avoidance of doubt, the
registration of pharmacy business
premises is not affected by a transfer in
the ownership of the premises or of the
pharmacy practice or pharmacy business
conducted in or from the premises.
71H. Registration of pharmacy business premises
may be cancelled or suspended
(1) The Board may cancel or suspend the
registration of premises as pharmacy
business premises if it is satisfied that -
(a) the premises have temporarily
ceased to be used for the purposes
of a pharmacy business; or
(b) having regard to the objects set
out in section 10, and the matters
set out in section 71E(3), the
premises are no longer suitable to
be used for the purposes of a
pharmacy business.
(2) The Board is to cancel the registration of
premises as pharmacy business premises
if it is satisfied that -
20
2005 Pharmacists Registration Amendment No. s. 22
(a) the premises have been, or are
about to be, demolished; or
(b) the premises have ceased
permanently to be, or are
incapable of ever again being,
used for the purposes of a
pharmacy business.
(3) If the Board decides to cancel or suspend
the registration of any premises as
pharmacy business premises, it is to
make an appropriate entry to that effect
in the register and give the responsible
occupier of the premises notice of -
(a) the cancellation or suspension;
and
(b) the reasons for the cancellation or
suspension; and
(c) in the case of a suspension on the
ground referred to in
subsection (1)(b), the actions that
need to be taken to have the
suspension revoked; and
(d) the responsible occupier's right of
appeal.
(4) The cancellation or suspension takes
effect when the notice is given to the
responsible occupier of the premises, or
on such later date as is specified in the
notice.
(5) The Board may, for any reason it
considers sufficient, revoke the
suspension of the registration of premises
21
s. 22 No. Pharmacists Registration Amendment 2005
as pharmacy business premises at any
time.
(6) If the Board decides to suspend the
registration of premises as pharmacy
business premises it may afford the
responsible occupier of the premises an
opportunity to be heard but it is not
required to do so.
71I. Registration of pharmacy business premises
may be relinquished
(1) The responsible occupier of premises that
are registered as pharmacy business
premises may relinquish that registration
at any time by -
(a) giving an appropriate notice to
the Board; and
(b) returning the certificate or notice
of registration to the Board.
(2) On receiving the notice the Board is to
cancel the registration of the premises by
making an appropriate entry to that effect
in the register.
(3) However, the Board is not required to
comply with subsection (2) if it is not
satisfied that -
(a) the giver of the notice is the
responsible occupier; and
22
2005 Pharmacists Registration Amendment No. s. 22
(b) each other eligible person with an
interest in the registration has
been consulted in the matter; and
(c) those other persons, if any, have
no objection, or no justifiable
objection, to the registration
being relinquished.
71J. Premises exempt from registration
requirements
(1) The Board, by instrument in writing, may
exempt any premises used for the
purposes of a pharmacy business from
the requirement to be registered as
pharmacy business premises.
(2) An exemption may be granted on the
Board's own initiative, at the written
request of the Director of Public Health
or on an application by or on behalf of a
registered pharmacist.
(3) An application under subsection (2) is to
be -
(a) in an approved form; and
(b) lodged with the Registrar; and
(c) accompanied by the prescribed
application fee, if any; and
(d) supported by such information or
evidence as the Board requires.
(4) The Board may waive all or part of the
fee.
23
s. 22 No. Pharmacists Registration Amendment 2005
(5) An exemption may be granted -
(a) for individual premises or a class
of premises; and
(b) unconditionally or on conditions.
(6) Without limiting subsection (5)(b), the
conditions of an exemption may restrict
its operation according to matters or
limitations, whether as to time,
circumstance or otherwise, specified in
the instrument of exemption.
(7) A registered pharmacist must not engage
in the practice of pharmacy contrary to a
condition of an exemption under this
section.
Penalty: Fine not exceeding 25 penalty
units.
(8) The Board may revoke an exemption if it
is satisfied on reasonable grounds that
the exemption is no longer justified or
required.
(9) In determining whether to grant or
revoke an exemption the Board is to have
regard to the prescribed criteria, if any.
(10) The Board may publicise exemptions and
their revocation in the Gazette and in
such other ways as the Board thinks fit
having regard to the nature of the
exemptions.
24
2005 Pharmacists Registration Amendment No. s. 23
23. Section 80 amended (Regulations)
Section 80 of the Principal Act is amended as
follows:
(a) by omitting from subsection (2)(c)
"pharmacies" and substituting "pharmacy
business premises";
(b) by omitting from subsection (6)
"pharmacies" and substituting "pharmacy
business premises".
Government Printer, Tasmania 25