Northern Territory Numbered Acts Northern Territory Numbered ActsAfter Chapter 7 heading
insert
In this Part:
"corresponding law" means a law of the Commonwealth, a State or another Territory that:
(a) provides for the establishment of a database about monitored medicines; or
(b) is prescribed by regulation to be a corresponding law for this Part.
"data source entity "means a person or entity approved by the CHO under section 243N.
"monitored medicine" means:
(a) a Schedule 8 substance; or
(b) any other Scheduled substance prescribed by regulation.
"monitored medicines database", see section 243C(1).
"recordable prescription", see section 243B(1) and (2).
"recordable supply", see section 243B(3) and (4).
"relevant prescriber" means a dentist, doctor, endorsed midwife, nurse practitioner, podiatrist or another health practitioner prescribed by regulation.
(1) A recordable prescription is a prescription for a monitored medicine that:
(a) is issued to a person in the Territory; or
(b) is issued outside the Territory to a person who is ordinarily resident in the Territory; or
(c) is issued outside the Territory to a person who has the prescription filled in the Territory; or
(d) is issued in circumstances prescribed by regulation.
(2) Despite subsection (1), a prescription for a monitored medicine that the regulations prescribe to be exempt from a recordable prescription is not a recordable prescription.
(3) A recordable supply is a supply of a monitored medicine for administration to a person that:
(a) occurs within the Territory; or
(b) occurs outside the Territory if the supply is made to a person ordinarily resident in the Territory; or
(c) occurs outside the Territory if the supply is made on the basis of a prescription issued in the Territory; or
(d) is supplied in circumstances prescribed by regulation.
(4) Despite subsection (3), a supply of a monitored medicine that the regulations prescribe to be exempt from a recordable supply is not a recordable supply.
(1) The CHO may establish and keep a database containing information about monitored medicines (the monitored medicines database ) to be known by the name prescribed by regulation.
(2) The purposes of the monitored medicines database are as follows:
(a) to promote and protect public health and safety by ensuring that information is available to monitor the supply and sale of monitored medicines to a person;
(b) to reduce harm from monitored medicines;
(c) to facilitate evaluation and research into monitored medicines and the operation of the monitored medicines database.
(3) The monitored medicines database must be kept electronically.
(4) The monitored medicines database may contain any of the following:
(a) records received from a relevant prescriber, pharmacist, data source entity or another person or entity about recordable prescriptions or recordable supplies;
(b) information relating to the issuing of authorities under the Act;
(c) any other information prescribed by regulation.
(1) The CHO may do any of the following in relation to the monitored medicines database:
(a) collect and hold the information specified in section 243C(4) in the database;
(b) access and use the database to:
(i) correct an error or omission in the database; or
(ii) change information held in the database to keep it accurate and up-to-date; or
(iii) facilitate research into public health and the provision of health care; or
(iv) administer, develop and operate the database;
(c) disclose information held in the database:
(i) to the person or entity responsible for keeping an equivalent database to the monitored medicines database under a corresponding law in a State or another Territory, if:
(A) the State or other Territory has a regime for an equivalent database; and
(B) the information only relates to monitored medicines, as defined by the corresponding law in the State or other Territory; and
(C) the information relates to a recordable prescription or recordable supply; or
(ii) for a purpose connected with the administration of this Part, including a legal or disciplinary proceeding arising out of the operation of this Part; or
(iii) to a health profession body; or
(iv) to a law enforcement agency.
(2) The CHO may do any thing or exercise any power reasonably necessary:
(a) to implement, maintain and oversee the monitored medicines database; or
(b) to further the purposes of the database.
(3) The CHO may, by written notice, authorise a person or entity to exercise any of the CHO's powers or perform any of the CHO's functions specified in subsection (1).
(4) An authorisation given under subsection (3) may be subject to any conditions the CHO considers appropriate.
(5) In this section:
"health profession body" means a National Health Practitioner Board established under the Health Practitioner Regulation National Law.
"health service provider", see section 5 of the Health Practitioner Regulation National Law.
"law enforcement agency", see section 4 of the Information Act 2002 .
(1) Subject to subsection (2), for the purposes of maintaining the monitored medicines database:
(a) a relevant prescriber must, as soon as practicable after issuing a recordable prescription, give the prescribed information to the CHO in the manner or form the CHO considers appropriate; and
(b) a pharmacist must, as soon as practicable after making a recordable supply, give the prescribed information to the CHO in the manner or form the CHO considers appropriate; and
(c) a data source entity must, as soon as practicable after receiving information from a relevant prescriber or pharmacist about a recordable prescription or recordable supply, give the prescribed information to the CHO in the manner or form the CHO considers appropriate.
(2) In addition, the CHO may require:
(a) the relevant prescriber or pharmacist give the prescribed information specified in subsection (1)(a) or (b) to a data source entity; and
(b) the data source entity give the prescribed information to the CHO in the manner or form the CHO considers appropriate.
(3) The CHO may, by written notice, exempt a specified person from the requirement to give information under subsection (1).
(4) The CHO may, by written notice published on the Agency's website, exempt a specified class of persons from the requirement to give information under subsection (1).
(1) The CHO may, on application, authorise a person who is a relevant prescriber or pharmacist to access, use and disclose information held in the monitored medicines database for the following purposes in the performance of the person's duties as a relevant prescriber or pharmacist:
(a) accessing records and information in relation to a person for whom a monitored medicine is intended to be supplied, prescribed or administered;
(b) accessing records and information in relation to a person in relation to the medical treatment or care of that person;
(c) disclosing information in relation to a person to a health practitioner if the relevant prescriber or pharmacist believes, on reasonable grounds, the practitioner intends to supply, prescribe or administer a monitored medicine to the person;
(d) any other purpose prescribed by regulation.
(2) An application for authorisation must be made in the approved form by the person.
(3) The CHO may request further information from the person making the application.
(4) The CHO must consider the application and decide whether to give the authorisation.
(5) The CHO must give the person:
(a) written notice of the CHO's decision; and
(b) if the CHO refuses to give the authorisation – written notice of the reasons for the refusal.
(6) An authorisation given under this section may be subject to any conditions the CHO considers appropriate.
(7) The CHO may revoke an authorisation given under this section at any time by giving the person written notice of the revocation and the reasons for the revocation.
Note for section 243F
A relevant prescriber or pharmacist's access, use or disclosure of the information may be subject to guidelines made under section 243Q.
(1) The CHO may, by written notice published on the Agency's website, authorise a person or class of persons to access, use and disclose information held in the monitored medicines database for the following purposes:
(a) the access, use and disclosure would assist in achieving the purposes of:
(i) promoting safe supply, prescription and dispensing practices; and
(ii) reducing harm from monitored medicines;
(b) the access, use and disclosure is for technical or administrative purposes relating to the maintenance of the database;
(c) the access, use and disclosure is to facilitate evaluation and research into monitored medicines and the operation of the monitored medicines database.
(2) Before giving an authorisation under subsection (1), the CHO must be satisfied that the person or class of persons has appropriate arrangements for:
(a) the security of the information; and
(b) when the person or class of persons no longer requires the information – the destruction or disposal of the information.
(3) An authorisation given under subsection (1) may be subject to any conditions the CHO considers appropriate.
(4) The CHO may revoke an authorisation given under subsection (1) at any time.
Note for section 243G
A person's access, use or disclosure of the information may be subject to guidelines made under section 243Q.
(1) A person commits an offence if:
(a) the person is required, under section 243E, to give information to the CHO in the manner or form the CHO considers appropriate; and
(b) the person contravenes the requirement.
Maximum penalty: 50 penalty units.
(2) An offence against subsection (1) is an offence of strict liability.
(3) It is a defence to a prosecution for an offence against subsection (1) if the person has a reasonable excuse.
(1) A relevant prescriber commits an offence if:
(a) the relevant prescriber issues a prescription for a monitored medicine to another person; and
(b) the relevant prescriber does not check the information held in the monitored medicines database in relation to the other person before issuing the prescription; and
(c) the prescription is not issued in circumstances that are prescribed by regulation to be exempt.
Maximum penalty: 50 penalty units.
(2) An offence against subsection (1) is an offence of strict liability.
(3) It is a defence to a prosecution for an offence against subsection (1) if the relevant prescriber has a reasonable excuse.
(1) A pharmacist commits an offence if:
(a) the pharmacist supplies a monitored medicine to another person; and
(b) the pharmacist does not check the information held in the monitored medicines database in relation to the other person before supplying the monitored medicine; and
(c) the supply is not made in circumstances that are prescribed by regulation to be exempt.
Maximum penalty: 50 penalty units.
(2) An offence against subsection (1) is an offence of strict liability.
(3) It is a defence to a prosecution for an offence against subsection (1) if the pharmacist has a reasonable excuse.
(1) A person commits an offence if:
(a) the person is not authorised by or under this Act to access information held in the monitored medicines database; and
(b) the person intentionally accesses information held in the monitored medicines database.
Maximum penalty: 200 penalty units or imprisonment for 2 years.
(2) A person commits an offence if:
(a) the person is not authorised by or under this Act to use information held in the monitored medicines database; and
(b) the person intentionally uses information held in the monitored medicines database.
Maximum penalty: 200 penalty units or imprisonment for 2 years.
(3) A person commits an offence if:
(a) the person is not authorised by or under this Act to disclose information held in the monitored medicines database; and
(b) the person intentionally discloses information held in the monitored medicines database.
Maximum penalty: 200 penalty units or imprisonment for 2 years.
(4) A person commits an offence if:
(a) the person is authorised by or under this Act to access, use or disclose information held in the monitored medicines database; and
(b) the person intentionally accesses, uses or discloses information held in the database; and
(c) the access, use or disclosure results in the contravention of the authorisation or any conditions of the authorisation and the person is reckless in relation to that result.
Maximum penalty: 200 penalty units or imprisonment for 2 years.
(5) Strict liability applies to subsections (1)(a), (2)(a), (3)(a) and (4)(a).
(6) It is a defence to a prosecution for an offence against subsection (4) if the person has a reasonable excuse.
(1) A relevant prescriber, pharmacist or person authorised under section 243G(1) is not liable for anything done in good faith in carrying out any duty in relation to, or in accessing, using or disclosing information held in, the monitored medicines database in accordance with this Act or the Regulations.
(2) Without limiting subsection (1):
(a) the accessing of information held in the monitored medicines database in respect of a person or the giving of information to the database in respect of a person does not constitute unprofessional conduct or a breach of professional etiquette or ethics; and
(b) no liability for defamation is incurred by a person mentioned in subsection (1) because of the accessing of any person's information or the provision of that information.
The CHO may, by written notice published on the Agency's website, approve a person or entity to be a data source entity.
The CHO may enter into an agreement or arrangement with the Commonwealth, a State or another Territory or an entity for the sharing of the information held in the monitored medicines database and any equivalent database maintained in a State or another Territory under a corresponding law.
(1) The CHO may make guidelines in relation to the access, use and disclosure of information held in the monitored medicines database under this Part.
(2) The guidelines must be published on the Agency's website.