Medicines Amendment Act 2003

1: Title
1: This Act is the Medicines Amendment Act 2003.
2: In this Act, the Medicines Act 1981 the principal Act
2: Commencement
This Act comes into force on the day that is 1 year after the date on which this Act receives the Royal assent.
3: Interpretation
1: Section 2(1) approved laboratory authorised prescriber
2: Section 2(1) disease dispensing
a: the preparation of that medicine for sale to the public (whether in response to the issue of a prescription or a request by an individual to be supplied with the medicine); and
b: the packaging, labelling, recording, and delivery of that medicine.
3: Section 2(1) dentist licensing authority medical practitioner optician pharmacist pharmacy registered health professional registered midwife dentist Health Practitioners Competence Assurance Act 2003 licensing authority
a: means the Director-General; and
b: to avoid doubt, includes any person or persons acting as the Director-General's delegate as a consequence of a delegation under section 41 of the State Sector Act 1988 medical practitioner Health Practitioners Competence Assurance Act 2003 pharmacist Health Practitioners Competence Assurance Act 2003 pharmacy registered health professional Health Practitioners Competence Assurance Act 2003 registered midwife Health Practitioners Competence Assurance Act 2003
4: Section 2(1) pharmacy pharmacy practice
a: the compounding and dispensing of prescription medicines, restricted medicines, or pharmacy-only medicines:
b: the supply of a medicine by a pharmacist to suit the needs of a particular person:
c: the sale of prescription medicines, restricted medicines, or pharmacy-only medicines.
4: New
sections 5A 5B The principal Act is amended by inserting, after section 5
5A: Meaning of holding an interest in a pharmacy
1: For the purposes of this Act, a person holds an interest in a pharmacy if the person has, or acquires, any direct or indirect estate or interest in the pharmacy (whether by way of shares in a company or by way of charge, loan, guarantee, indemnity, or otherwise) that affects the ownership, management, or control of the pharmacy practice carried on in the pharmacy.
2: For the purposes of subsection (1)
3: Despite subsections (1) and (2)
a: a person does not hold an interest in a pharmacy merely by—
i: making, in good faith and in the ordinary course of business to facilitate the carrying on of the pharmacy, any loan of money; or
ii: holding any security for repayment of that loan:
b: a person does not hold an interest in a pharmacy that is being carried on by an administrator of the estate of a deceased pharmacist, or by an administrator of the estate of a deceased operator of a pharmacy, merely by holding an interest in that estate.
4: Despite subsection (3)
5B: Meaning of operating a pharmacy
For the purposes of this Act, a person operates a pharmacy if the person—
a: establishes, or carries on business in, a pharmacy; or
b: establishes, owns, or is responsible for the management or control of a hospital in which there is a pharmacy; or
c: establishes, or is responsible for the management or control of a pharmacy carried on, on a not for profit basis. 1970 No 143 s 2(2)-(4)
5: Manufacturers, wholesalers, and packers of medicines to be licensed
1: The heading to section 17 and packers of medicines packers of medicines, and operators of pharmacies
2: Section 17(1) paragraph (c)
c: pack or label any medicine; or
d: operate any pharmacy,—
3: Section 17 subsection (2)
2: Every person who contravenes subsection (1)
6: Sale of medicines by retail
1: Section 18(1) paragraphs (a) (aa) (b)
a: any prescription medicine unless—
i: the medicine is sold, supplied, or distributed by a pharmacist in a pharmacy or hospital; or
ii: the medicine is supplied in accordance with a standing order by a person who is authorised to supply and administer any specified class or description of prescription medicine under that standing order; or
b: any restricted medicine unless the medicine is sold, supplied, or distributed by a pharmacist in a pharmacy or hospital; or
c: any pharmacy-only medicine unless the medicine is sold, supplied, or distributed by—
i: a person under the supervision of a pharmacist in a pharmacy or a hospital; or
ii: a person who sells, supplies, or distributes the medicine in any shop described in section 51(2) Part 3
2: Section 18(5) $1,000 $40,000
7: Administering prescription medicines
Section 19 subsection (4)
8: Exemptions for practitioners and others
Section 25 subsection (4)
9: Exemptions for veterinarians and opticians
1: The heading to section 27 opticians certain registered health practitioners
2: Section 27 paragraph (b)
b: any person registered with the Optometrists and Dispensing Opticians Board continued under section 114(1) of the Health Practitioners Competence Assurance Act 2003
i: sell or supply a medicine for use in cleaning, soaking, or lubricating contact lenses if the medicine is suitable for that purpose; and
ii: pack or label the medicine for the purposes of any sale or supply:
3: Section 27 paragraph (c)(ii)
ii: to any person referred to in paragraph (b) subparagraph (i) and (ii) of that paragraph
10: Exemptions for agents and employees
Section 31
4: Subsection (3)(a) section 26
11: New heading and
sections 42A to 42C The principal Act is amended by inserting, after section 42 Restrictions on operation of pharmacies
42A: Every pharmacy must be under supervision of pharmacist
No person may operate any pharmacy that is not for the time being under the immediate supervision and control of a pharmacist.
42B: Security of pharmacies
1: Every person who operates a pharmacy must ensure that every prescription medicine or restricted medicine in the pharmacy is at all times secured in a way that prevents the public gaining ready access to the medicine.
2: Every person who operates a pharmacy must ensure that all medicines held in storage for the purposes of the pharmacy are secured in a way that prevents the public gaining access to the medicines.
3: Subsections (1) and (2)
4: The requirements imposed by subsections (1) and (2) section 47
42C: Restriction on authorised prescribers holding interest in pharmacies
1: No authorised prescriber may hold an interest in a pharmacy other than a pharmacy for which the person holds a licence to operate, except with the consent of the licensing authority and in accordance with any conditions or restrictions imposed by that authority.
2: No person who has an interest in a pharmacy may permit or enable any authorised prescriber to hold or acquire that or any other interest in the pharmacy contrary to subsection (1)
3: The licensing authority may not give its consent under subsection (1) 1970 No 143 s 41
12: Powers of Minister to prohibit prescribing, etc
1: Section 48(2)(c) Council of the Pharmaceutical Society of New Zealand Pharmacy Council
2: Section 48(2)(d) on the recommendation of the Midwifery Council or
3: Section 48(2)(f) Council or Board authority under the Health Practitioners Competence Assurance Act 2003
13: Applications for licences
1: Section 50 subsection (1)
1: Every application for a licence must be made in the prescribed form to the Director-General or to any person designated for the purpose by the Director-General by notice in the Gazette
2: Section 50 subsections (4) (5)
4: An application may be made either by an individual who is a New Zealand resident on the person's own behalf or by an appropriate officer of a body corporate that is incorporated in New Zealand on behalf of that body corporate.
5: If a person authorised to receive an application under subsection (1)
14: Grant of licences
1: Section 51(1) section 52 of this Act sections 52, 55A, and 55B
2: Section 51(1)(f) or, in the case of an application for a licence to operate a pharmacy, in respect of medicines that are manufactured, stored, packed, labelled, or sold on the premises or in any other place for which the licence to operate is sought
3: Section 51(2) in respect of which a licence to operate has been, or is deemed to have been, issued
4: Section 51 subsection (6)
6A: If the licensing authority is satisfied that the holder of a licence to operate a pharmacy has failed to comply with any conditions affecting the licence, the licensing authority may, instead of or as well as exercising the powers conferred by subsection (6)
a: impose on the holder of the licence a penalty not exceeding $40,000:
b: forbid the licence holder or any person with an interest in the pharmacy from holding any interest in or operating a pharmacy for a period, not exceeding 5 years, specified by the licensing authority.
6B: A penalty imposed under subsection (6A)
5: Section 51(7) cancels a licence under this section or under section 55A
15: Effect of licences
1: Section 52(1)
e: a licence to operate a pharmacy authorises the establishment of the pharmacy and the carrying on of pharmacy practice in the pharmacy.
2: Section 52(3) (including, without limitation, any conditions that restrict or prohibit the licence holder from undertaking any specified activity or using any specified process)
16: Duration of licence
Section 53 subsection (1)
1: Subject to subsections (2) and (3) section 55G section 55A(3) or section 83
17: New
sections 55A to 55G The principal Act is amended by inserting, after section 55
55A: Additional criteria to be satisfied by pharmacy operators
1: The licensing authority must not grant an application for a licence to operate a pharmacy unless the authority is satisfied that, in addition to satisfying the criteria set out in section 51(1)
a: the applicant is a person who is qualified under any of sections 55D, 55E, or 55G
b: the applicant is a person who is able to satisfy the condition set out in section 55C
2: If the licensing authority has reasonable grounds to believe that the holder of a licence to operate a pharmacy has ceased to be a person who satisfies each of the criteria set out in subsection (1)
3: If, after giving the holder of a licence to operate a pharmacy whose licence is suspended under subsection (2) subsection (1)
4: If, after giving the holder of a licence to operate a pharmacy whose licence is suspended under subsection (2) subsection (1)
55B: Licensing authority may require further information
1: The licensing authority, may for one or more of the purposes set out in subsection (2)
2: The purposes referred to in subsection (1)
a: the determination of the nature of the interest held by any person in the pharmacy:
b: the assessment required by section 51(1)(b)
c: the assessment required by section 55A(1)
3: If the applicant fails to supply the information requested within 30 days of the date of the request, or within any further time allowed by the licensing authority, the application lapses.
55C: Mandatory condition of licence to operate pharmacy.
It is a condition of every licence to operate a pharmacy that the holder of the licence must not request or require any pharmacist who is employed or engaged in duties at a pharmacy to act in a way that is inconsistent with the applicable professional or ethical standards of pharmacy practice. Restrictions on persons allowed to operate pharmacies
55D: Restriction on companies operating pharmacies
1: No company may be granted a licence to operate a pharmacy unless any of paragraphs (a) to (e) of subsection
2: A company may be granted a licence to operate a pharmacy if—
a: at all times more than 50% of the share capital of the company is owned by a pharmacist or pharmacists, and effective control of the company is vested in that pharmacist or those pharmacists; or
b: it is exempt from the requirements set out in paragraph (a) section 105C
c: it is deemed to have been issued with a licence under section 114A(2)
d: the pharmacy is in a hospital owned or operated by the company; or
e: it is a company that, at the commencement of this section, was lawfully operating a pharmacy.
3: Subsection (2)(e)
4: For the purposes of subsection (2) Insolvency Act 1967
a: the expiry of the period of 1 year after the date of the death of the deceased pharmacist, or the date on which the pharmacist was adjudicated bankrupt, has expired; or
b: subject to any conditions that the licensing authority proposes, the expiry of any extended period or periods permitted by the licensing authority. 1970 No 143 s 42
55E: Restriction on individuals operating or holding majority interest in pharmacies
1: No person, either alone or in partnership, may be granted a licence to operate a pharmacy, or hold a majority interest, in a pharmacy unless
a: the person is a pharmacist; or
b: the person is exempt from the requirements set out in paragraph (a) section 105C
c: the person is deemed to have been issued with a licence under section 114A(2)
d: the pharmacy is in a hospital owned or operated by the person; or
e: the person, at the commencement of this section, was lawfully operating a pharmacy.
2: For the purposes of subsection (1)
3: For the purposes of subsection (1) person pharmacist
a: an administrator of the estate of a deceased pharmacist:
b: an assignee, within the meaning of the Insolvency Act 1967
c: a liquidator carrying on a pharmacy under the authority of section 260 and Schedule 6 of the Companies Act 1993
d: a receiver or manager of the property of a company carrying on, subject to the Receiverships Act 1993
4: Subsection (3)
a: the expiry of 1 year after the date of the death of the deceased pharmacist, or the date on which the pharmacist was adjudicated bankrupt, or the date of the first appointment of a liquidator, receiver, or manager, in respect of a company that has carried on a pharmacy; or
b: subject to any conditions that the licensing authority imposes, the expiry of any extended period or periods permitted by the licensing authority.
5: In this section and in section 55F 1970 No 143 s 43
55F: Prohibition on operating or holding of majority interest in more than 5 pharmacies
1: Despite sections 55D and 55E subsection (2) or subsection (3)
a: no company may operate more than 5 pharmacies:
b: no person referred to in section 55E(3)
2: Subsection (1) section 55E(3) section 55E(4)
3: Subsection (1)
4: Subsection (3) sections 55D and 55E 1970 No 143 s 45
55G: Exemption for mortgagees in possession
1: Despite sections 55D and 55E
2: In this section, mortgagee in possession has the same meaning as in section 2 of the Property Law Act 1952 1970 No 143 s 47
18: New
section 76A The principal Act is amended by inserting, after section 76
76A: Offences in relation to authorised prescribers
Every pharmacist, person licensed to operate a pharmacy, or operator or manager of a pharmacy commits an offence against this Act who gives, offers, or agrees to give to any authorised prescriber or to any other person any money or other consideration as a commission on prescriptions. 1970 No 143 s 49(1)(a)
19: Regulations relating to practitioners, veterinarians, and registered midwives
Section 105A(2)(a) Council or Board authority under the Health Practitioners Competence Assurance Act 2003
20: Regulations relating to designated prescribers
Section 105B(2) Council or Board authority under the Health Practitioners Competence Assurance Act 2003
21: New
section 105C The principal Act is amended by inserting, after section 105B
105C: Orders in Council providing for exemption from, or modifications of, restrictions on pharmacy ownership and operation
1: The Governor-General may, by Order in Council made on the recommendation of the Minister,—
a: exempt any person or class of person from any of the requirements of section 55D(2)(a) or section 55E(1)(a)
b: modify the application of the provisions of section 55D(2)(a) or section 55E(1)(a)
2: The Minister must not recommend the making of any Order in Council under subsection (1)
a: health services or access to those services will be improved by the making of that Order in Council; and
b: the making of that Order in Council is necessary to meet the needs of the community in the particular location of the pharmacy or proposed pharmacy.
3: The Minister's reasons for making the recommendation must be included in, or appended to, the Order in Council.
22: New
sections 114A 114B The principal Act is amended by inserting, after section 114
114A: Certain persons deemed to have licence to operate pharmacy
1: Every person who, immediately before the commencement of this section, was entitled under the Pharmacy Act 1970 section 51
a: any conditions relating to the establishment or carrying on of business in that pharmacy imposed by the pharmacy authority and in force immediately before the commencement of this section; and
b: the condition set out in section 55C
2: Every person who, immediately before the commencement of this section, owned or was responsible for the management of a hospital or other place in which pharmacy practice was undertaken in reliance on any authority conferred by this Act or any other enactment or regulations is deemed, on the commencement of this section, to have been issued with a licence to operate the pharmacy, subject to the condition set out in section 55C
3: The licensing authority must, as soon as is reasonably practicable after the commencement of this section, send to every person to whom a licence is deemed to have been issued under subsection (1) or subsection (2)
a: the conditions referred to in subsection (1)(a) and (b) subsection (2)
b: notice of the revocation or variation of any of those conditions under subsection (4)(a)
c: any conditions imposed by the licensing authority under subsection (4)(b)
4: Despite subsections (1) to (3) subsection (1) or subsection (2)
a: vary or revoke any condition referred to in subsection (1)(a)
b: impose any other condition that it considers appropriate.
114B: Expiry of
section 114A Section 114A