EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2018 (No. 1)
PB 27 of 2018
Authority
This legislative instrument is made pursuant to subsection 84AG(1) of the National Health Act 1953 (the Act), which gives the Minister the power to determine a therapeutic group and that two or more listed drugs are in the same therapeutic group.
Purpose
This legislative instrument amends the National Health (Pharmaceutical Benefits – Therapeutic Groups) Determination 2010 (PB 1 of 2010) (the Principal Determination), which determines a number of therapeutic groups and the listed drugs that are in those therapeutic groups.
The purpose of this amending instrument, which is required by subsection 84AG(4) of the Act, is to remove from its therapeutic group, each listed drug which has at least one listed brand to which section 99ADH will apply on 1 April 2018. Section 99ADH deals with price disclosure price reductions. This amending determination is effective 1 April 2018.
This instrument amends Part 2 of Schedule 1 to the Principle Determination. Part 2 sets out the ATRA group (the Angiotensin II receptor antagonist group). This instrument removes the listed drugs ‘olmesartan and valsartan’ from this group.
Variation and revocation
Unless there is an express power to revoke or vary PB 1 of 2010 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 1 of 2010.
Consultation
The Amending Instrument affects pharmaceutical companies with medicines listed on the PBS. It is required by subsection 84AG(4) of the Act, as consequence of the 2018 April Cycle of Price Disclosure.
Pharmaceutical companies with a listed or delisted brand subject to the price disclosure requirements for the 2018 April Cycle disclosed information relevant to this determination directly to Australian Healthcare Associates Pty Ltd (AHA), known as the Price Disclosure Data Administrator (PDDA). AHA is prescribed by subsection 85(6) of the Regulations as the person to whom, in accordance with paragraph 99ADC(1)(a), a responsible person is to provide price disclosure information. The PDDA provided responsible persons with an opportunity to check that the information disclosed to the PDDA was translated correctly to PDDA data files. This was done prior to that data being used to apply the method set out in the Regulations to arrive at the weighted average disclosed price for listed brands.
Further consultation on this Amendment Determination was not considered necessary because affected pharmaceutical companies were provided with an opportunity to dispute any of the outcomes that resulted in this Determination, through an industry agreed dispute resolution process. Any disputes are resolved through this mechanism prior the reduction day.
This instrument commences on 1 April 2018.
This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Pharmaceutical Benefits – Therapeutic Groups) Amendment Determination 2012 (No. 2) (PB XX of 2012)
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
This Legislative Instrument is made pursuant to subsection 84AG(1) of the National Health Act 1953 (the Act), which relates to therapeutic groups. This instrument amends the principle instrument which determines a number of therapeutic groups and the listed drugs that are in those therapeutic groups.
Human rights implications
This legislative instrument engages Article 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 PBS is a benefit scheme which assists with 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..
Conclusion
This Legislative Instrument is compatible with human rights as it does not raise any human rights issues.
Adriana Platona
Assistant Secretary, Pharmaceutical Evaluation Branch
Pharmaceutical Benefits Division, Department of Health and Ageing