EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Paxlovid) Special Arrangement Repeal Instrument 2024
Purpose
The National Health (Paxlovid) Special Arrangement Repeal Instrument 2024 (PB 23 of 2024) (Instrument) repeals the National Health (Paxlovid) Special Arrangement 2022 (PB 39 of 2022) (Paxlovid Special Arrangement).
Background
The Paxlovid Special Arrangement was made under subsection 100(1) of the Act and provided for the supply of the combination product nirmatrelvir and ritonavir (Paxlovid) on the Pharmaceutical Benefits Scheme (PBS) for the purpose of treating COVID-19. The Paxlovid Special Arrangement specified that the responsible person for Paxlovid under the Act, for the purposes of listing this drug on the PBS, was the Commonwealth. It also provides for the approved ex-manufacturer price (AEMP) of Paxlovid to be set at $1,000. The AEMP of a pharmaceutical benefit is usually set by agreement between the Minister and the responsible person. The arrangement whereby the Commonwealth was the responsible person for Paxlovid was intended to be a temporary measure to make this treatment for COVID-19 available on the PBS.
That temporary arrangement will cease on 1 March 2024.
Paxlovid will remain available under the PBS, but with the company which is the sponsor of the product on the Australian Register of Therapeutic Goods (ARTG) as its responsible person. The change to the responsible person for Paxlovid from the Commonwealth to the ARTG sponsor will not affect matters such as which patients are eligible to receive Paxlovid under the PBS, who can prescribe Paxlovid, the amount of the patient co-payment (if any) for the supply of Paxlovid®, or the patient’s contribution to their safety net. A determination of a new responsible person for the purposes of the Act will be made under the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.
Authority
Subsection 100(1) of the Act enables the Minister to make special arrangements for, or in relation to, providing that an adequate supply of pharmaceutical benefits will be available to certain persons. Subsection 100(2) of the Act provides that the Minister may vary or revoke an arrangement made under subsection 100(1) of the Act.
Commencement
The Instrument commences on 1 March 2024.
Consultation
The Department of Health and Aged Care consulted with the ARTG sponsor of Paxlovid in relation to the making of the Instrument, and the Pharmaceutical Benefits Advisory Committee (PBAC) provided advice in connection with the transition away from the Commonwealth as the responsible person for Paxlovid. The ATRG sponsor and the PBAC are supportive of the transition of the role of responsible person from the Commonwealth to the sponsor, similar to other listings on the PBS.
The Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
Details of the Instrument are set out in Attachment A.
The Instrument is compatible with the human rights and freedoms recognised or declared under section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011. A full statement of compatibility is set out in Attachment B.
ATTACHMENT A
Details of the National Health (Paxlovid) Special Arrangement Repeal Instrument 2024
Section 1 – Name
Section 1 provides that the name of the Instrument is the National Health (Paxlovid) Special Arrangement Repeal Instrument 2024 and may also be cited as PB 23 of 2024.
Section 2 – Commencement
Section 2 provides that the Instrument commences on 1 March 2024.
Section 3 – Authority
Section 3 provides that the Instrument is made under subsection 100(2) of the National Health Act 1953.
Section 4 – Repeal
Section 4 provides that the National Health (Paxlovid) Special Arrangement 2022 (PB 39 of 2022) is repealed.
ATTACHMENT B
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Paxlovid) Special Arrangement Repeal Instrument 2024
(PB 23 of 2024)
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 National Health (Paxlovid) Special Arrangement Repeal Instrument 2024 (Instrument) repeals the National Health (Paxlovid) Special Arrangement 2022 (the Paxlovid Special Arrangement). The Paxlovid Special Arrangement specified the Commonwealth as the responsible person for the combination product nirmatrelvir and ritonavir (Paxlovid) for the purposes of the Pharmaceutical Benefits Scheme (PBS). It also provides for the approved ex-manufacturer price (AEMP) of Paxlovid to be set at $1,000. The AEMP of a pharmaceutical benefit is usually set by agreement between the Minister and the responsible person.
The arrangement whereby the Commonwealth was the responsible person for Paxlovid was intended to be a temporary measure to make this treatment for COVID-19 available on the PBS. That temporary arrangement will cease on 1 March 2024.
Paxlovid will remain available under the PBS, but with the company which is the sponsor of the product on the Australian Register of Therapeutic Goods (ARTG) as its responsible person. A determination of a new responsible person for the purposes of the Act will be made under the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.
Human Rights implications
The Instrument engages Articles 2, 9 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 social security and to the enjoyment of the highest attainable standard of physical and mental health.
The change to the responsible person for Paxlovid from the Commonwealth to the ARTG sponsor will not affect matters such as which patients are eligible to receive Paxlovid under the PBS, who can prescribe Paxlovid, the amount of the patient co-payment (if any) for the supply of Paxlovid, or the patient’s contribution to their safety net.
The repeal of the Paxlovid Special Arrangement will therefore not result in any changes for patient access to PBS-subsidised Paxlovid. However, the cessation of temporary arrangements under which the Commonwealth is the responsible person for Paxlovid (together with the separate determination of its ARTG sponsor as the responsible person) will normalise arrangements for the ongoing listing of Paxlovid on the PBS.
Broadly, the PBS is a benefits scheme which assists with the advancement of these human rights by providing subsidised access to medicines for people in the community. The recommendatory role of the PBAC ensures that decisions about subsidised access to medicines on the PBS are evidence-based.
Conclusion
This Instrument is compatible with human rights. The repeal of the Paxlovid Special Arrangement is necessary to enable the effective determination of the ARTG sponsor of Paxlovid as the responsible person for the drug, which will normalise arrangements under which Paxlovid is supplied under the PBS.
Nikolai Tsyganov
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division