EXPLANATORY STATEMENT
National Health Act 1953
National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Amendment (Supply from Premises) Determination 2014
Authority
Subsection 92A(1)(f) of the National Health Act 1953 (the Act) provides that the Minister may determine other conditions including, but not limited to, conditions relating to premises that apply to the approval of a person as an approved pharmacist or medical practitioner.
Purpose
Subsection 92A(1) of the Act provides the approval of a pharmacist or a medical practitioner to supply pharmaceutical benefits is subject to a range of specified conditions. These conditions are set out in paragraphs 92A(1)(a) to (f), with paragraph (f) providing for “any other condition as determined by the Minister”.
The National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Amendment (Supply from Premises) Determination 2014 (‘the Determination’) amends the existing Determination, National Health (Pharmaceutical Benefits) (Conditions of approval of approved pharmacists) Determination 2007.
The Determination sets out conditions that must be met by pharmacists approved to supply pharmaceutical benefits (‘approved pharmacists’) relating to:
- professional conduct;
- competency standards for the practice of pharmacy; and
- pharmacy practice standards in supplying pharmaceutical benefits.
The Determination inserts an additional section, section 8 into the existing Determination, which specifies the circumstances in which an approved pharmacist may claim for payment by the Commonwealth for the supply of a pharmaceutical benefit at or from approved premises.
A description of each provision in the Determination is contained in the Attachment.
Consultation
The Department of Health has undertaken broad consultation with industry stakeholders including the Pharmacy Guild of Australia, the Pharmaceutical Society of Australia, the Pharmacy Board of Australia, the Consumers Health Forum, the Therapeutic Goods Administration and the Department of Human Services. Support for the amendments has been received from these stakeholders.
The Department also wrote to all approved pharmacists, and those pharmacists who had been recommended by the Australian Community Pharmacy Authority but not yet received their approval, providing them an opportunity to comment on the proposed amendments.
This Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
ATTACHMENT
NATIONAL HEALTH (PHARMACEUTICAL BENEFITS) (CONDITIONS OF APPROVAL FOR APPROVED PHARMACISTS) AMENDMENT (SUPPLY FROM PREMISES) DETERMINATION 2014
Section 1 Name of determination
This section provides for the Determination to be referred to as the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Amendment (Supply from Premises) Determination 2014. It may also be cited as PB 81 of 2014.
Section 2 Commencement
This section provides that sections 1 to 4 of the Determination commence the day after the Determination is registered.
Schedule 1 of the Determination commences on the later of the day after the Determination is registered or 1 December 2014.
Section 3 Authority
This section provides that the Determination is made under the National Health Act 1953.
Section 4 Schedules
This section provides that each instrument specified in the Schedule is amended or repealed as set out in the Schedule and any other item in the Schedule to the instrument has effect according to its terms.
Schedule 1—Amendments
Item 1 After section 4
This section inserts definitions for approved premises, medication chart prescription and reference time.
Approved premises is defined as meaning the premises in respect of which an approved pharmacist has received approval under Part VII of the National Health Act 1953 (the Act).
Medication chart prescription has the same meaning as in the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations).
Reference time means the start date upon which the Determination commences.
Item 2 Paragraph 5(c)
This section deletes the text “Code of Professional Conduct, as existing when this section commences” and replaces it with “Code of Ethics for Pharmacists 2011, as existing at the reference time”. The purpose of this substitution is to delete the obsolete reference to this document and update the reference to the current version being the Code of Ethics for Pharmacists 2011 at the time the Determination is registered.
Item 3 Paragraph 5(d)
This section deletes the text “, as existing when this section commences”, and replaces it with the new text “2010, as existing at the reference time”. The purpose of this substitution is to reflect the current version of the Pharmaceutical Society of Australia’s Professional Practice Standards which is dated 2010.
Item 4 Section 5 (note)
This section replaces the Note, updating the reference to the current Code of Ethics for Pharmacists and Professional Practice Standards. The Note directs readers to the Pharmaceutical Society of Australia website where electronic copies of the documents are available at the time the Determination is registered in 2014.
Item 5 Section 6
This section deletes the text “Competency Standards for Pharmacists in Australia 2003, as existing when this section commences” and replaces it with an updated reference to the document, “National Competency Standards Framework for Pharmacists 2010, as existing at the reference time”.
Item 6 Section 6 (note)
This section replaces the Note, updating the reference to the National Competency Standards Framework for Pharmacists. The Note directs readers to the Pharmaceutical Society of Australia website where electronic copies of the documents are available in 2014 at the time of registration.
Item 7 At the end of the determination
This section inserts a new condition, section 8, into the existing Determination.
8 Claims for payment
New subsection 8(1) states an approved pharmacist must not make a claim for payment from the Commonwealth unless a pharmaceutical benefit was supplied at or from approved premises for the pharmacist.
New subsection 8(2) states that the approved pharmacist must not make a claim for a payment from the Commonwealth for the supply of a pharmaceutical benefit where that pharmaceutical benefit has never been at premises for which the approved pharmacist holds an approval.
New subsection 8(3) states that an approved pharmacist must not claim for payment from the Commonwealth for the supply of a pharmaceutical benefit unless the pharmacist (or their agent) was present, at the approved premises for the pharmacist, at the time of dispensing the pharmaceutical benefit. This section does not allow the dispensing of pharmaceutical benefits from unapproved premises, via the use of an electronically linked network – for example where the medicine is supplied at the unapproved premises but is recorded electronically in the dispensing software at the approved premises.
New subsection 8(4) states that an approved pharmacist must not claim for payment from the Commonwealth for the supply of a pharmaceutical benefit on the basis of a prescription (other than a medication chart prescription) unless the pharmacist (or their agent) sees the prescription at the approved premises.
The note to this section points out that this subsection does not apply to supplies of pharmaceutical benefits without prescriptions (under the Act), or prescriber bag supplies (under the Regulations).
New subsection 8(5) states that an approved pharmacist must not claim for payment from the Commonwealth for the supply of a pharmaceutical benefit on the basis of a medication chart prescription unless the pharmacist (or their agent) sees a copy of the residential medication chart containing the prescription at the approved premises.
New subsection 8(6) makes it clear that subsection 8(1) is not limited in its operation by subsections 8(2) to (5).
Subsection 8(7) states that section 8 does not apply to the supply of pharmaceutical benefits where the pharmacist is entitled to a payment in accordance with subsection 99(3A) of the Act relating to the supply of pharmaceutical benefits before obtaining approval.
The note refers to subsection 100(3) of the Act which may provide for circumstances where all or part of Section 8 does not apply.
9 Application of amendments made by the National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists)(Supply from Premises) Determination 2014
New section 9 provides that the amendments made in the Determination apply on and after the commencement of Schedule 1 in relation to a pharmacist’s approval, whether it was granted before, on or after that commencement.
Further, new section 9 states that section 8 of the Determination applies in relation to a supply of a pharmaceutical benefit that occurs on or after the commencement of Schedule 1.
Finally, section 9 indicates that section 9 will be repealed on the day after the end of the period of 6 months beginning on the day the section commences.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights
(Parliamentary Scrutiny) Act 2011
National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Amendment (Supply from Premises) Determination 2014
This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The purpose of this legislative instrument, made under subsection 92A(1)(f) of the Act, is to amend the previous determination, National Health (Pharmaceutical Benefits) (Conditions of approval for approved pharmacists) Determination 2007.
To supply pharmaceutical benefits a pharmacist must be approved under section 90 of the Act and is then subject to the conditions of approval set out in section 92A. Subsection 92A(1)(f) allows the Minister to determine any other condition, including, but not limited to, conditions relating to premises.
This amending Determination updates obsolete references to professional practice standards and codes of ethics with which approved pharmacists are required to adhere. Importantly, the amending Determination also introduces a new set of conditions that restate the position already established within the Act and restrict the claiming for the supply of a pharmaceutical benefit to an approved pharmacist supplying a pharmaceutical benefit at or from premises for which the pharmacist holds an approval.
Human rights implications
This legislative instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.
The Pharmaceutical Benefits Scheme (PBS) is a benefit scheme which assists with advancement of this human right by providing for subsidised access for people to medicines. This is a positive step towards attaining the highest standard of health for all Australians. Efficient operational arrangements for the PBS support effective administration of the Scheme.
Conclusion
This Legislative Instrument is compatible with human rights because it advances the protection of human rights.
Peter Dutton
Minister for Health