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HEALTH PRACTITIONER REGULATION NATIONAL LAW (NSW) - SCHEDULE 5F

SCHEDULE 5F – Pharmacies [NSW[#93]

Note : This Schedule is an additional New South Wales provision.

Part 1 - Preliminary [NSW[#93]

1 Definitions [NSW[#93]

In this Schedule--

"approved premises" means premises approved under clause 12.

"associated professional services room" , in relation to a pharmacy business, means a professional services room specified as being associated with the pharmacy business in an approval in force under clause 3.

"Council" means the Pharmacy Council of New South Wales.

"exempted body corporate" means a body corporate that carries on, or has a financial interest in, a pharmacy business under clause 7.

"financial interest" has the meaning given by clause 2.

"firm" means a partnership or other unincorporated association of persons.

"holding company" has the same meaning as it has in the Corporations Act 2001 of the Commonwealth.

"listed corporation" has the same meaning as it has in the Corporations Act 2001 of the Commonwealth.

"pharmacists' body corporate" means a body corporate all the shareholders and directors of which are pharmacists.

"pharmacists' partnership" means a partnership consisting only of pharmacists.

"pharmacy" means premises in or on which a person carries on a pharmacy business and includes--

(a) the portion (if any) of the premises in or on which the person sells or offers for sale goods of any kind; and
(b) a professional services room;
but does not include premises located in a public hospital controlled by a public health organisation (within the meaning of the Health Services Act 1997 ).

"pharmacy business" means the business of a pharmacist or pharmaceutical chemist in which the dispensing and compounding of prescriptions for any substance specified in the Poisons List proclaimed under section 8 of the Poisons and Therapeutic Goods Act 1966 occurs.

"Price Information Code of Practice" means the Price Information Code of Practice published by the Therapeutic Goods Administration of the Commonwealth, as in force on 25 February 2008.

"professional services room" means premises in or on which a person carries on a pharmacy business that involves only--
(a) the preparation and packaging of drugs, or the packaging of drugs, by or under the personal supervision of a pharmacist, for supply to individual patients or to a health care facility for supply to patients or residents of that facility; and
(b) the storage of those drugs.

"public hospital" has the meaning given by the Health Services Act 1997 .

"Register of Pharmacies" means the Register of Pharmacies kept by the Council under clause 14.

"security interest" , in respect of a pharmacy business, means a mortgage, bill of sale or charge over, or other arrangement of a kind prescribed by the NSW regulations in respect of, a pharmacy business, that secures the payment of a debt or performance of some other obligation under a contract or other legally enforceable arrangement.

2 Meaning of "financial interest" [NSW[#93]

(1) A
"financial interest" means a direct or indirect monetary or financial interest and includes--
(a) a proprietary interest, including a proprietary interest as a sole proprietor, partner, director, member or shareholder, or trustee or beneficiary; and
(b) an interest, whether proprietary or otherwise, in a pharmacy business that a person has because the person is a member or shareholder of--
(i) an exempted body corporate; or
(ii) a holding company, whether a listed corporation or not, of an exempted body corporate that is not a listed corporation; and
(c) an interest, whether proprietary or otherwise, in a pharmacy business that a person has because the person is a trustee or beneficiary of a trust, the trust property of which includes shares in--
(i) an exempted body corporate; or
(ii) a holding company, whether a listed corporation or not, of an exempted body corporate that is not a listed corporation; and
(d) an interest, whether proprietary or otherwise, in a pharmacy business that a person has because the person is a trustee or beneficiary of a trust, being a trust the trustees of which, in their capacity as the trustees of that trust, carry on or have a financial interest in the business.
(2) However, a
"financial interest" does not include--
(a) an interest in a pharmacy business that a person has because the person is--
(i) a member of a friendly or other society that has a financial interest in a pharmacy business permitted by clause 6; or
(ii) a member of a listed corporation that is an exempted body corporate; or
(b) an interest in a pharmacy business that a person has because the person is a member of an exempted body corporate (other than a listed corporation referred to in subclause (1)(b)(ii)), but only if the person was a member of the body corporate before the commencement of Schedule 7.12 to the Pharmacy Practice Act 2006 ; or
(c) an interest a person has in the profits of a pharmacy business because the person is an employee employed in that business, other than an interest constituted by legal or beneficial ownership of shares or other securities of a body corporate (issued as part of an employee share scheme or otherwise); or
(d) an interest that is prescribed by the NSW regulations as not constituting a financial interest for the purposes of this Schedule.

Part 2 - Control of pharmacies [NSW[#93]

3 Pharmacies to be approved and holders of financial interests registered [NSW[#93]

(1) A person must not carry on a pharmacy business unless--
(a) the premises on which the pharmacy business is carried on are the subject of a current approval of the Council; and
(b) all holders of a financial interest in the pharmacy business are registered in the Register of Pharmacies.
: Maximum penalty--50 penalty units.
(2) Despite subclause (1)(b), a person who has lodged an application under clause 12(1)(b) may carry on the pharmacy business to which the application relates until the Council decides the application if--
(a) the premises at which the business is carried on are the subject of a current approval of the Council; and
(b) a holder of a financial interest in the business who is not the subject of the application is registered in the Register of Pharmacies.
(3) To avoid doubt, any failure to register a financial interest that is a security interest with respect to a pharmacy business does not--
(a) affect the validity, priority or enforceability of the security interest or of the agreement or other arrangement providing for the security interest; or
(b) otherwise limit the effect of the security interest or the agreement or other arrangement providing for the security interest.

4 Notification of financial interests in pharmacy businesses [NSW[#93]

(1) A person who intends to acquire a financial interest in a pharmacy business (other than an interest referred to in clause 5(4)) must, at least 14 days before acquiring the interest, give written notice to the Council of the following matters--
(a) the nature of the interest and the date on which it is intended to be acquired;
(b) the basis on which the person is entitled to hold the interest under this Schedule (for example, as a pharmacist, a pharmacists' body corporate or a friendly or other society);
(c) a copy of any bill of sale in relation to the acquisition;
(d) a copy of any sale agreement for the business;
(e) a copy of any partnership agreement for the business;
(f) a copy of any lease for the pharmacy;
(g) a copy of any agreement under which any other person has a financial interest in the business;
(h) a copy of any agreement, between persons who have financial interests in the business, that makes provision for any rights the persons possess because of having the financial interests;
(i) a copy of any agreement for the provision of management services to the business or to any pharmacists' body corporate that owns an interest in the business;
(j) a copy of any agreement (except a contract of employment) between any person who has a financial interest in the business and any entity in respect of the provision of accounting, information technology, human resources or other support services to the business;
(k) if a pharmacists' body corporate or a pharmacist is acting as a trustee (whether of a fixed trust, unit trust, discretionary trust or other kind of trust), a copy of any relevant trust deed;
(l) a copy of any security interest in respect of the business.
: Maximum penalty--50 penalty units.
(2) A person who acquires a financial interest in a pharmacy business as referred to in clause 5(4) must, within 28 days after acquiring the interest, give written notice to the Council of that fact, the nature of the interest concerned and the date on which it was acquired.
: Maximum penalty--50 penalty units.
(3) A person who ceases to have a financial interest in a pharmacy business must, within 14 days after doing so, give written notice to the Council of that fact and the nature of the interest concerned.
: Maximum penalty--50 penalty units.
(4) The NSW regulations may prescribe additional matters to be included in a notice under this clause.

5 Restrictions on who may have financial interest in pharmacy business [NSW[#93]

(1) A person must not own or otherwise have a financial interest in a pharmacy business (including as a partner or member of a firm) unless as one of the following--
(a) a pharmacist;
(b) a partner in a pharmacists' partnership;
(c) a pharmacists' body corporate or a member of a pharmacists' body corporate.
: Maximum penalty--100 penalty units.
(2) Subclause (1) does not prevent a person from having a financial interest in a pharmacy business--
(a) if the person--
(i) comes into possession of the business or any assets of the business as a result of a default on an obligation secured by a security interest; and
(ii) does not have the financial interest for more than 6 months (or the longer period specified by the Council by written notice given to the person) from the date the person comes into possession of the pharmacy business or assets; or
(b) if the person has the interest for a period of not more than 6 months (or the longer period specified by the Council by written notice given to the person) and the person has the interest because the person--
(i) is the executor, administrator or trustee of the estate of a deceased person who carried on the pharmacy business on the day of his or her death; or
(ii) is appointed or authorised under the laws relating to bankruptcy to administer the property of the person who carried on a pharmacy business and who has become bankrupt; or
(c) if the person--
(i) is a pharmacist whose registration is cancelled or suspended; and
(ii) owned or otherwise had a financial interest in a pharmacy business immediately before the cancellation or suspension took effect; and
(iii) does not have the financial interest for a period of more than 6 months immediately following the day on which the cancellation or suspension took effect; or
(d) in circumstances prescribed by the NSW regulations.
(3) Despite subclause (2)(b) and (c), a person may have a financial interest in a pharmacy business under those paragraphs only if the business is in the charge of a pharmacist who personally supervises the carrying on of that business.
(4) A person who has a financial interest in a pharmacy business under subclause (2)(c) must not, during the period during which the person holds the interest, enter or be in premises in which that business is carried on unless the person--
(a) has the Council's consent; and
(b) complies with any conditions imposed by the Council in giving its consent.
(5) The Council may, at any time--
(a) vary or revoke a consent; or
(b) vary or revoke a condition imposed on a consent.
(6) A person who holds provisional, limited or non-practising registration in the pharmacy profession is taken not to be a pharmacist for the purposes of subclause (1) during the period of that registration.
Note : Clauses 6 and 7 provide for the exemption from subclause (1) of friendly and other societies and certain bodies corporate, respectively, in the circumstances set out in those clauses.

6 Exemption for friendly societies [NSW[#93]

(1) Clause 5 does not prevent a friendly society from owning or otherwise having a financial interest in a pharmacy business in accordance with a written approval given by the Minister.
(2) An approval must not be given unless--
(a) the Minister is satisfied the net profits arising from the operation of the pharmacy business will be applied solely to the provision of benefits (other than benefits in the form of dividends or shares) to members of the friendly society; and
(b) the Minister is satisfied the operation of the pharmacy business is justified in the interests of members of the friendly society or of members of the public, or both; and
(c) the friendly society has nominated a pharmacist to be responsible for--
(i) ensuring there is displayed at or near the main entrance of each premises in which the business is carried on the owner's name; and
(ii) ensuring drug price information displayed in premises in which the business is carried on does not contravene the Price Information Code of Practice.
(3) The Minister may--
(a) give an approval unconditionally or subject to conditions; or
(b) at any time, vary or revoke an approval.
(4) The Minister must revoke an approval given to a friendly society if the Minister is satisfied.
(a) the net profits arising from the operation of the pharmacy business will no longer be applied solely to the provision of benefits to members of the friendly society in accordance with subclause (2)(a); or
(b) there is no longer a pharmacist nominated as being responsible for the matters specified in subclause (2)(c).
(5) Clause 5 does not prevent a friendly or other society that was, immediately before the repeal of section 27A(1) of the Pharmacy Act 1964 , lawfully carrying on a pharmacy business under that provision, from owning or otherwise having a financial interest in a pharmacy business.
(6) An approval granted to a friendly or other society under section 27A(2) of the Pharmacy Act 1964 and in force immediately before the repeal of that Act is taken to be an approval granted to the friendly society or other society (as if it were a friendly society), and in force, under subclause (1).
(7) Subclause (4) does not apply in relation to a society referred to in subclause (6) that, immediately before the repeal of section 27A of the Pharmacy Act 1964 , no longer satisfied the criteria referred to in section 27A(3)(a) of that Act.
(8) A friendly or other society to which subclause (1), (5) or (6) applies must not own or otherwise have a financial interest in more than 6 pharmacy businesses.
: Maximum penalty--100 penalty units.
(9) A pharmacy business and an associated professional services room are counted as one pharmacy business for the purposes of subclause (8).

7 Exemption for certain bodies corporate [NSW[#93]

(1) Clause 5 does not prevent an existing body corporate from continuing to carry on a pharmacy business or continuing to have a financial interest in a pharmacy business in accordance with--
(a) clause 21 of the Pharmacy (General) Regulation 1998 as in force immediately before its repeal; and
(b) subclause (2).
(2) The existing body corporate must nominate a pharmacist to be responsible for--
(a) ensuring there is displayed at or near the main entrance of each premises in which the business is carried on the owner's name; and
(b) ensuring drug price information displayed in premises in which the business is carried on does not contravene the Price Information Code of Practice.
(3) In this clause--

"existing body corporate" means a body corporate that, immediately before the repeal of the Pharmacy (General) Regulation 1998 , lawfully carried on a pharmacy business or had a financial interest in a pharmacy business under clause 21 of that Regulation.
Note : The definition of
"financial interest" in clause 2 operates to prohibit a person (other than a pharmacist, a partner in a pharmacists' partnership or a pharmacists' body corporate or a member of a pharmacists' body corporate) from having a financial interest (including as a shareholder) in a body corporate to which this clause applies (other than a listed corporation). That prohibition, however, does not apply where the person was a member of the body corporate before the commencement of Schedule 7.12 to the Pharmacy Practice Act 2006 .

7A Exemption for State Vaccine Centres [NSW[#93]

(1) The Secretary of the Ministry of Health may, by notice published in the Gazette, exempt a State Vaccine Centre from some or all of the provisions of this Schedule for the period specified in the notice.
(2) An exemption granted under this clause is subject to any conditions specified in the notice published in the Gazette.
(3) The Secretary must not grant an exemption under this clause unless the Secretary is satisfied that it is in the public interest to do so.
(4) In this clause--

"State Vaccine Centre" means premises designated by the Secretary of the Ministry of Health for the storage and distribution of vaccines or medicines, or both.

8 Indicating a corporation or firm to be a pharmacy business [NSW[#93]

(1) A corporation must not indicate it is a pharmacy business unless it is--
(a) a pharmacists' body corporate that carries on a pharmacy business; or
(b) a friendly or other society that has a financial interest in a pharmacy business permitted by clause 6 and that carries on that business; or
(c) an exempted body corporate that carries on a pharmacy business.
: Maximum penalty--50 penalty units.
(2) A person must not indicate a corporation is a pharmacy business if the person knows, or ought reasonably to know, an indication by the corporation itself would be a contravention of subclause (1).
: Maximum penalty--50 penalty units.
(3) A partner or member of a firm must not indicate the firm is a pharmacy business unless the firm is a pharmacists' partnership that carries on a pharmacy business.
: Maximum penalty--50 penalty units.
(4) This clause does not apply to a person who has a financial interest in a pharmacy business as referred to in clause 5(5), but only in relation to indications made in the course of, and in relation to, carrying on that business.

9 Restriction on number of pharmacy businesses in which pharmacists may have a financial interest [NSW[#93]

(1) A pharmacist must not (whether as an individual or as a partner in a pharmacists' partnership or a member of a body corporate) own or otherwise have a financial interest in more than 5 pharmacy businesses in this jurisdiction.
: Maximum penalty--100 penalty units.
(2) A pharmacy business and an associated professional services room are counted as one pharmacy business for the purposes of subclause (1).

10 Certain provisions in certain instruments to be void [NSW[#93]

(1) Any of the following provisions in a lease or a licence, or an arrangement that creates a security interest, in respect of a pharmacy business is void--
(a) a provision that requires the lessee or the licensee, or the grantor of the security interest (as the case may be), to purchase or otherwise obtain goods or services in connection with the business from the lessor or the licensor, or the grantee of the security interest;
(b) a provision that gives to the lessor, the licensor or the grantee power to control the way in which the business is to be carried on (including power to decide whether or not the pharmacy may participate in any public health programs);
(c) a provision that gives to the lessor, the licensor or the grantee access to the books of account kept for the business, other than for the purposes of determining whether or not the lessee, the licensee or grantor is complying with the terms and conditions of the lease, licence or arrangement;
(d) a provision that provides that the lessor, the licensor or the grantee is to receive consideration that varies according to the profits or takings of the business.
(2) Subclause (1)(b) does not affect a provision relating to the opening or closing hours of a pharmacy business that is located in a retail shopping centre.

11 Pharmacist to be in charge of every pharmacy business [NSW[#93]

(1) A pharmacy business carried on in approved premises must be in the charge of a pharmacist who must personally supervise the carrying on of the business.
(2) If a pharmacy business is carried on in approved premises in contravention of subclause (1), the following persons are guilty of an offence--
(a) the owner of the pharmacy business;
(b) the pharmacist in charge of the approved premises, if the pharmacist is required under the terms of the pharmacist's employment to be in charge of the approved premises at the time of the contravention.
: Maximum penalty--100 penalty units.
(3) It is a defence in proceedings against an owner for a contravention of subclause (1) if the owner proves to the satisfaction of the court that the owner used all due diligence to prevent the contravention.
(4) To avoid doubt, during a period in which a pharmacy business carried on in an associated professional services room, and the pharmacy business with which the premises are associated, operate simultaneously, subclause (1) requires each business to be in the charge of a separate pharmacist who must personally supervise the carrying on of each business.
(5) A person who holds provisional, limited or non-practising registration in the pharmacy profession is taken not to be a pharmacist for the purposes of this clause during the period of that registration.

Part 3 - Approval of premises and registration of financial interests [NSW[#93]

12 Application for approval of premises or registration of financial interest [NSW[#93]

(1) An application for either of the following may be made to the Executive Officer of the Council--
(a) an approval of premises as suitable for carrying on a pharmacy business by a pharmacist;
(b) registration of the holder of a financial interest in a pharmacy business.
(2) An application for an approval of premises must be made--
(a) in the form approved by the Council; and
(b) by the owner, or one of the owners, of the pharmacy business.
(3) An application for registration of the holder of a financial interest must be made--
(a) in the form approved by the Council; and
(b) by the following person--
(i) the owner, or one of the owners, of the pharmacy business;
(ii) if required to be made during any period in which a person referred to in clause 5(4)(a) or (b) assumes the administration of the pharmacy business, that person;
(iii) if required to be made during a period in which a person assumes the administration of the pharmacy business under a security interest granted in respect of the pharmacy business, that person.
(4) A person who is the owner of a pharmacy business to be carried on in a professional services room may apply for approval of the premises only if--
(a) the person is the owner of a pharmacy business that is carried on in approved premises other than a professional services room; and
(b) in the application, the person nominates the pharmacy business (or, if the owner of more than one such pharmacy business, nominates one of the businesses) as the business with which the professional services room is associated.
(5) The application must be accompanied by the fee prescribed by the NSW regulations.
(6) The Council may require the application to be verified by a statutory declaration.
(7) The Council may decide to--
(a) refuse the application; or
(b) approve the premises or register the holder of the financial interest.
(8) The Council must not approve premises--
(a) that fail to comply with a standard prescribed for the premises by the NSW regulations; or
(b) that are within or partly within, or adjacent or connected to, a supermarket and that the public can directly access from within the premises of the supermarket.
(9) The NSW regulations may prescribe standards for the purposes of subclause (8)(a) only for or with respect to the safe and competent delivery of pharmacy services.
(10) The Council may revoke an approval of premises if--
(a) the premises do not comply with a standard prescribed for the premises by the NSW regulations; or
(b) the premises become premises of a type described in subclause (8)(b); or
(c) the Council becomes aware the premises are no longer being used for the purposes of carrying on a pharmacy business.
(11) In this clause--

"supermarket" means any retail store, or market, selling food and other domestic goods, whether or not by self-service operation and regardless of size, but does not include a retail store or market--
(a) commonly known as a department store; or
(b) in which food or produce is sold only in a cafe, coffee shop, restaurant or other prepared food or beverage counter.

13 Appeals against refusal to approve pharmacy or to register holder of financial interest [NSW[#93]

(1) A person aggrieved by any of the following decisions of the Council may apply to the Civil and Administrative Tribunal for an administrative review under the Administrative Decisions Review Act 1997 of the decision--
(a) a decision relating to an application for the approval of premises;
(b) a decision relating to an application for the approval of the registration of the holder of a financial interest;
(c) a decision to revoke an approval of premises.
(2) For the purposes of a review, an application for an approval or for registration that has not been dealt with by the Council is taken to have been refused on--
(a) the day that is one month after the application was lodged; or
(b) if a later day was decided by the Council and notified to the applicant before the day referred to in paragraph (a), that day.

14 Council to keep register [NSW[#93]

(1) The Council must keep a register (a
"Register of Pharmacies" ) containing particulars of--
(a) approved premises; and
(b) registered holders of financial interests.
(2) The Register of Pharmacies must be kept in the form decided by the Council.
(3) The Register of Pharmacies must be available for inspection--
(a) at the office of the Council at all reasonable times; and
(b) in the other ways (for example, by Internet access) and at the times decided by the Council.
(4) The Council may charge a fee for an inspection of the Register of Pharmacies, not exceeding the amount prescribed by the NSW regulations.
(5) The Council may make the alterations and additions to the Register of Pharmacies that are necessary to ensure the information recorded in the Register is accurate.

Part 4 - Declarations and information [NSW[#93]

15 Annual declaration to be submitted [NSW[#93]

(1) A person who holds a financial interest in a pharmacy business must, on or before the declaration date in each year, give to the Council, in the form approved by the Council, a declaration for the declaration period specifying the following information--
(a) the nature of the interest;
(b) the basis on which the person is entitled to hold the interest under this Law (for example, as a pharmacist, a member of a pharmacists' body corporate, a friendly or other society under clause 6 or a body corporate under clause 7);
(c) the number of pharmacy businesses in which the person has a financial interest;
(d) in relation to each pharmacy business the person owns, a description of the policies or systems in place to ensure safe and competent delivery of pharmacy services;
(e) any other information prescribed by the NSW regulations.
: Maximum penalty--20 penalty units.
(1A) The declaration must be accompanied by the fee prescribed by the NSW regulations.
(2) The Council may require the declaration to be verified by statutory declaration.
(3) In this clause--

"declaration date" means a date notified to pharmacy owners by the Council in writing at least one month in advance.

"declaration period" means the period of 12 months ending 2 months before the declaration date.

16 Direction to supply information about financial interests [NSW[#93]

(1) The Council may, by written notice given to a person, require the person to give the Council, within the time specified in the notice, specified information or a specified document relating to a financial interest the person has in a pharmacy business.
(2) The person must not--
(a) fail or refuse to comply with the notice to the extent the person is capable of complying with it; or
(b) in purported compliance with the notice, knowingly give information or produce a document that is false or misleading.
: Maximum penalty--50 penalty units.



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