Federal Register of Legislation - Australian Government

Primary content

PB 87 of 2013 Arrangements as made
This instrument amends the National Health (Paraplegic and Quadriplegic Program) Special Arrangement 2010 (No. PB 118 of 2010) to add a new listed brand of the listed drug Macrogol 3350 lax-sachets.
Administered by: Health
Registered 18 Nov 2013
Tabling HistoryDate
Tabled HR19-Nov-2013
Tabled Senate02-Dec-2013
Date of repeal 02 Dec 2013
Repealed by Division 1 of Part 5A of the Legislative Instruments Act 2003

EXPLANATORY STATEMENT

National Health Act 1953

National Health (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2013 (No.3)

PB 87 of 2013

Authority

Subsection 100(1) 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(1) and (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 adds a new listed brand of the listed drug Macrogol 3350, lax‑sachets, this necessitated an amendment to Schedule 1 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.

This instrument commences on 1 December 2013.

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 (Paraplegic and Quadriplegic Program) Special Arrangement Amendment Instrument 2013 (No.3)

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(1) and (2) of 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 adds a new listed brand of the listed drug Macrogol 3350, lax‑sachets, this necessitated an amendment to Schedule 1 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.

Mr Kim Bessell

Assistant Secretary

Pharmaceutical Access Branch

Principal Pharmacy Advisor

Pharmaceutical Benefits Division

Department of Health