National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 9) (PB 105 of 2020)

Overview

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 9) was introduced to amend the National Health (Continued Dispensing – Emergency Measures) Determination 2020 under subsection 89A(3) of the National Health Act 1953. This legislative instrument addresses the need to adjust the list of pharmaceutical benefits that can be supplied by an approved pharmacist without a prescription, known as a Continued Dispensing supply, in response to changes in the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. Enacted by the Australian Government, the primary objective of this amendment is to ensure that the list of eligible pharmaceutical benefits for Continued Dispensing aligns with the latest updates, thereby maintaining accessibility to necessary medications during emergency measures. This amendment was made in consultation with relevant peak bodies such as the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia, as well as direct consultation with Services Australia and state and territory Departments of Health. The changes reflect the need to remove certain drugs and forms from the list while adding others, ensuring that the supply of pharmaceuticals under emergency conditions remains effective and appropriate. The amendments commenced on 1 November 2020, and the legislative instrument is compatible with the human rights and freedoms recognised in international instruments, particularly advancing the right to the highest attainable standard of physical and mental health.

Scope and Application

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 9) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020, which specifies the pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the National Health Act 1953 without a prescription, and the conditions for such a supply (referred to as 'Continued Dispensing'). The amendment is made under subsection 89A(3) of the National Health Act 1953, and it involves adding and deleting certain drugs and forms of listed drugs from the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. This instrument does not override state and territory poisons laws, and states and territories have been informed of the intended Commonwealth changes and asked to consider necessary amendments to their laws to allow access to the eligible medicines. The amendments reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which also commence on the same day. The determination affects approved pharmacists supplying pharmaceutical benefits, and relevant peak bodies such as the Pharmaceutical Society of Australia and the Pharmacy Guild of Australia, as well as Services Australia and state and territory Departments of Health, were consulted prior to the commencement of the Principal Instrument. 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. Specifically, it engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) by assisting with the progressive realisation 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 the advancement of this human right by providing for subsidised access by patients to medicines. The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.

Key Provisions

The National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 9) amends the National Health (Continued Dispensing – Emergency Measures) Determination 2020, which specifies the pharmaceutical benefits that can be supplied by an approved pharmacist under Part VII of the National Health Act 1953 without a prescription, and the conditions for such a supply (a ‘Continued Dispensing’ supply). The amendments involve the addition and deletion of drugs and forms of listed drugs from the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply (section 4). The instrument adds siponimod to the list of pharmaceutical benefits and adds a form of the listed drug glycomacropeptide and essential amino acid formula with vitamins, minerals, and low in tyrosine and phenylalanine. It also deletes aurothiomalate, pneumococcal vaccine – polyvalent, sofosbuvir, and forms of flucloxacillin, glyceryl trinitrate, ketoconazole, nifedipine, periciazine, phenoxybenzamine, and quinagolide from the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply. The Act imposes obligations on approved pharmacists to ensure that the pharmaceutical benefits they supply as a Continued Dispensing supply are those listed in the National Health (Continued Dispensing – Emergency Measures) Determination 2020 and its amendments. Approved pharmacists must also adhere to the conditions for such a supply, including any requirements for record-keeping and reporting. The Act also imposes obligations on the Minister for Health to determine the pharmaceutical benefits that can be supplied as a Continued Dispensing supply, and to amend the determination as necessary to reflect changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. There are no specific offences or penalties mentioned in the legislation for breach of the requirements or conditions of Continued Dispensing supply. However, failure to comply with the requirements of the Act or the determination may result in civil or criminal liability, depending on the circumstances. For example, supplying a pharmaceutical benefit that is not listed in the determination may constitute an offence under section 101A of the Act, which carries a maximum penalty of $275,000 for a corporation and $55,000 for an individual. In summary, the National Health (Continued Dispensing – Emergency Measures) Amendment Determination 2020 (No. 9) amends the list of pharmaceutical benefits that can be supplied as a Continued Dispensing supply, and imposes obligations on approved pharmacists and the Minister for Health to ensure compliance with the requirements and conditions of such a supply. Failure to comply with the requirements of the Act or the determination may result in civil or criminal liability.