EXPLANATORY STATEMENT
INSTRUMENT NUMBER PB 62 OF 2012
NATIONAL HEALTH ACT 1953
AMENDMENT DETERMINATION UNDER SECTIONS 93 AND 93AA
Summary
This legislative instrument in giving effect to recommendations of the Pharmaceutical Benefits Advisory Committee (PBAC) amends the determination under sections 93 and 93AA (PB 103 of 2010) which came into effect on 1 November 2010. The amendments provide for changes to the pharmaceutical benefits obtained by medical practitioners and authorised nurse practitioners to be supplied as emergency treatment and are supplied free of charge to patients. The amendments are set out in the items of Schedule 1 to this instrument.
Purpose and operation
Part VII of the National Health Act 1953 (the Act) is the legislative basis of the Pharmaceutical Benefits Scheme (PBS) by which the Commonwealth provides reliable, timely, and affordable access to a wide range of medicines for all Australians.
Subsection 85(1) of the Act provides that benefits are to be provided by the Commonwealth in accordance with Part VII in respect of pharmaceutical benefits.
Drugs and medicinal preparations to which Part VII applies are (with the exception of some medicinal preparations with additives) declared by the Minister by legislative instrument to be so under subsection 85(2) of the Act. These are listed drugs as defined in subsection 84(1) of the Act.
Sections 93 and 93AA of the Act provide for certain pharmaceutical benefits to be obtained by medical practitioners and authorised nurse practitioners and be supplied by medical practitioners and authorised nurse practitioners to patients for treatment. These pharmaceutical benefits are supplied as emergency treatment supplies (so-called ‘emergency bag’) and are supplied free of charge to patients.
Subsections 93(1) and 93AA(1) of the Act provide that medical practitioners, except as prescribed, and authorised nurse practitioners, except as prescribed by the regulations, are authorised to supply such pharmaceutical benefits as the Minister determines to persons who are entitled under Part VII of the Act to receive those pharmaceutical benefits.
Subsection 93(2) of the Act provides that the Minister may determine the maximum quantity or number of units of a pharmaceutical benefit which may be obtained by a medical practitioner during a specified period and that the medical practitioner shall obtain the pharmaceutical benefit as prescribed.
Subsection 93AA(2) of the Act provides that, the Minister may determine the maximum quantity or number of units of a pharmaceutical benefit which may be obtained by an authorised nurse practitioner during a specified period.
These determinations under sections 93 and 93AA of the Act set out the conditions under which medical practitioners and authorised nurse practitioners are authorised to supply pharmaceutical benefits.
The Schedule to the determination lists the names of the pharmaceutical benefits to which sections 93 and 93AA applies, together with the form (strength type, size etc.) and maximum quantity of those pharmaceutical benefits.
Changes to PB 103 of 2010 made by this instrument
This instrument amends PB 103 of 2010 by the deletion of dihydroergotamine, which has ceased to be a listed drug, from the Schedule.
Consultations
This determination gives effect to recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body, established by section 100A of the Act, to make 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 the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.
Under subsection 101(4) of the Act, a drug or medicinal preparation may not be declared to be a drug or medicinal preparation to which Part VII of the Act applies unless the PBAC has recommended that it be so declared. When recommending the listing of a medicine on the PBS, the 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.
Consultation regarding implementation of arrangements for nurse practitioners as PBS prescribers occurred via advisory groups established to advise on specific issues and technical aspects. The advisory groups included practitioners from medical and allied health professions, with experience in midwifery, nursing, general practice, obstetrics, and representatives from registration bodies, state and territory health services, regional and remote health services, Indigenous populations, and consumers. Advice was provided on Medicare eligibility, collaborative arrangements with other health professionals, authorisation as PBS prescribers, and medicines for PBS prescribing.
The PBAC provided advice on pharmaceutical benefits suitable for listing for nurse practitioners. Medicare Australia, the Department of Veterans’ Affairs, the Medical Software Industry Association, and the Pharmacy Guild of Australia were also consulted.
The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation.
General
The instrument commences on 1 September 2012.
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
Amendment determination under sections 93 and 93AA
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
Determinations under sections 93 and 93AA of the National Health Act 1953 (PB 103 of 2010) provide for certain pharmaceutical benefits to be obtained by medical practitioners and authorised nurse practitioners and to be supplied by medical practitioners and authorised nurse practitioners to patients for treatment. These pharmaceutical benefits are supplied as emergency treatment supplies and are supplied free of charge to patients. The Schedule to the instrument lists the names of the pharmaceutical benefits to which sections 93 and 93AA apply, together with the form (strength type, size etc.) and maximum quantity of those pharmaceutical benefits.
This instrument removes one listed drug from the Schedule to the Determination. This drug has ceased to be a listed drug on the advice of the Pharmaceutical Benefits Advisory Committee (PBAC)
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 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.
Felicity McNeill
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing