EXPLANATORY STATEMENT
National Health Act 1953
National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2017 (No.2)
PB 43 of 2017
Authority
Subsection 100(2) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits.
Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).
Purpose
The purpose of this legislative instrument, made under subsections 100 (2) of the Act (this Instrument), is to amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 (PB 118 of 2010) (the Special Arrangement) to make changes to the Special Arrangement relating to the Paraplegic and Quadriplegic Program.
‘Authorised associations’ may supply pharmaceutical benefits under the Special Arrangement to ‘eligible persons’. A person is an ‘eligible person’ for the purposes of the Special Arrangement if:
(a) they are an ‘eligible person’ within the meaning of the Health Insurance Act 1973, that is, eligible to receive Medicare benefits, and
(b) have paraplegia or quadriplegia, and
(c) are a member of an ‘authorised association’.
This Instrument amends ‘the Responsible Person’ in the Special Arrangement for the listed drug Bisacodyl with the brand name Dulcolax, Boehringer Ingelheim Pty Ltd, ABN 52 000452 308 (with the ‘Responsible Person Code’ of BY) has been replaced by Sanofi-Aventis Australia Pty Ltd, ABN 31 008 558 807 (with the ‘Responsible Person Code’ of VZ) as the Responsible Person. This necessitated amendments to Schedule 1 and Schedule 2 of the Special Arrangement.
These changes reflect changes made to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the Act, which commence on the same day.
Consultation
The amendments made by this Instrument accord with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC).
An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the PBAC.
PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available as pharmaceutical benefits. PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions. Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC. When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (PBS), PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.
Pharmaceutical companies were consulted throughout the process of changes to the listings on the PBS and for this Instrument. This includes consultation through the PBAC process, and agreement to final listing details.
Commencement of the Legislative Instrument
This instrument commences on 1 June 2017.
This instrument is a legislative instrument for the purposes of the Legislative Act 2003.
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2017 (No 2)
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 subsections 100(2) of the National Health Act 1953 (the Act), is to amend the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 (PB 118 of 2010) (the Special Arrangement) to make changes to the special arrangement relating to the Paraplegic and Quadriplegic Program.
This Instrument amends ‘the Responsible Person’ in the Special Arrangement for the listed drug Bisacodyl with the brand name Dulcolax, Boehringer Ingelheim Pty Ltd, ABN 52 000452 308 (with the ‘Responsible Person Code’ of BY) has been replaced by Sanofi-Aventis Australia Pty Ltd, ABN 31 008 558 807 (with the ‘Responsible Person Code’ of VZ) as the Responsible Person. This necessitated amendments to Schedule 1 and Schedule 2 of the Special Arrangement.
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 because it advances the protection of human rights.
Julianne Quaine
Assistant Secretary
Pharmaceutical Access Branch
Pharmaceutical Benefits Division
Department of Health