National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 14) (No. PB 109 of 2014)

Administered by Department of Health, Disability and Ageing

Legislation au F2014L01795 Not in force Legislative Instrument

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EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT
INSTRUMENT 2014 (No. 14)

PB 109 of 2014

 

Purpose

The purpose of this legislative instrument, made under sections 84AF, 84AK, 85, 85A and 88 of the National Health Act 1953 (the Act), is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to ensure that pharmaceutical benefits with the drug Paracetamol, in the form ‘Tablet 665 mg (modified release)’, and with the Responsible Person ‘Apotex Pty Ltd’ are not listed on the Pharmaceutical Benefits Scheme (PBS) on 1 January 2015.

PB 71 of 2012 determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands.  It also provides for related matters (responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, determined quantity and pack quantity, section 100 only status and prescriber bag only status).

Authority

This Instrument exercises various powers in Part VII of the Act, as set out below:

Brands of pharmaceutical items listed on the PBS

The Minister may determine a brand of a pharmaceutical item (subsection 85(6)).  The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)).  Under the provisions of section 84AK the Minister may determine the pack quantity for a brand of a pharmaceutical item.

Prescribing pharmaceutical benefits

Subsection 88(1) provides that a medical practitioner is authorised to prescribe a pharmaceutical benefit.  Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).

Subsection 85(7) provides that the Minister may determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit.

Paragraph 85A(2)(a) allows the Minister to determine the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit (or of the pharmaceutical benefit where there is no pharmaceutical item) that may, in one prescription, be directed to be supplied on one occasion.  Paragraph 85A(2)(b) also allows the Minister to determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated.  The maximum quantities and repeats may be determined for all purposes or for particular purposes.

 

Variation and revocation

Subsection 33(3) of the Acts Interpretation Act 1901 is relied upon for this Instrument.

Changes to PB 71 of 2012 made by this instrument

Schedule 1 to this instrument ensures that  brands of pharmaceutical benefits with the drug Paracetamol, in the form ‘Tablet 665 mg (modified release)’, and with the Responsible Person ‘Apotex Pty Ltd’ namely: APO-Osteo Paracetamol 665 mg; Blooms the Chemist Osteo Pain Relief Paracetamol 665 mg; Chem mart Pharmacy Osteo Relief Paracetamol 665 mg; and Terry White Chemists Osteo Relief Paracetamol
665 mg, are not listed on the PBS on 1 January 2015.  These brands are included in the the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 13) (PB 101 of 2014), with the effective date of 1 January 2015.

Consultation

Pharmaceutical companies are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings. 

General

This Instrument commences on 1 January 2015.

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 (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 14)

(PB 109 of 2014)

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 (Listing of Pharmaceutical Benefits) Amendment Instrument 2014
(No. 14) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 which determines the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands.  It also provides for related matters (responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, determined quantities, pack quantities, section 100 only status and prescriber bag only status).

This legislative lnstrument ensures that brands of pharmaceutical benefits with the drug Paracetamol, in the form ‘Tablet 665 mg (modified release)’, and with the Responsible Person ‘Apotex Pty Ltd’ namely: APO-Osteo Paracetamol 665 mg; Blooms the Chemist Osteo Pain Relief Paracetamol 665 mg; Chem mart Pharmacy Osteo Relief Paracetamol 665 mg; and Terry White Chemists Osteo Relief Paracetamol
665 mg, are not listed on the PBS on 1 January 2015.

Human rights implications

This legislative instrument engages Articles 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.

 

Felicity McNeill
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health

 

Overview

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 14) was enacted to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012). The primary purpose of this legislative instrument is to ensure that certain brands of Paracetamol, specifically in the form of 'Tablet 665 mg (modified release)' and with the Responsible Person 'Apotex Pty Ltd', are not listed on the Pharmaceutical Benefits Scheme (PBS) as of 1 January 2015. This amendment was made under sections 84AF, 84AK, 85, 85A, and 88 of the National Health Act 1953. The Minister for Health is the enacting body, exercising powers to determine brands of pharmaceutical items listed on the PBS, the circumstances of prescriptions, and the maximum quantities and repeats of pharmaceutical benefits. The policy objective aligns with ensuring that the PBS provides access to medicines in a manner that is evidence-based and cost-effective, thereby advancing the human right to the highest attainable standard of physical and mental health as recognised under the International Covenant on Economic, Social and Cultural Rights (ICESCR).

Scope and Application

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 14) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 to modify the Pharmaceutical Benefits Scheme (PBS) by removing certain brands of paracetamol from the list of listed pharmaceutical benefits. Specifically, it excludes brands of pharmaceutical benefits with the drug Paracetamol in the form 'Tablet 665 mg (modified release)' and with the Responsible Person 'Apotex Pty Ltd', namely APO-Osteo Paracetamol 665 mg, Blooms the Chemist Osteo Pain Relief Paracetamol 665 mg, Chem mart Pharmacy Osteo Relief Paracetamol 665 mg, and Terry White Chemists Osteo Relief Paracetamol 665 mg, from the PBS effective 1 January 2015. This legislative instrument applies to the Minister for Health, pharmaceutical companies, and potentially patients and prescribers who rely on the PBS for access to these medications. The instrument is a Commonwealth initiative, impacting the national PBS framework, and operates under the authority of sections 84AF, 84AK, 85, 85A and 88 of the National Health Act 1953. It does not include any exclusions or exemptions beyond the specified brands and form of the drug listed, and its application is directly tied to the provisions outlined in the PBS framework, without reliance on subordinate instruments for extension or restriction.

Key Provisions

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 14) (PB 109 of 2014) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to ensure that specific brands of Paracetamol, in the form ‘Tablet 665 mg (modified release)’ and associated with Apotex Pty Ltd, are not listed on the Pharmaceutical Benefits Scheme (PBS) as of 1 January 2015 (sections 1 and 2). This legislative instrument is made under sections 84AF, 84AK, 85, 85A, and 88 of the National Health Act 1953 and operates to modify the existing schedule of PBS listings, excluding these particular brands from the scheme. This amendment directly affects the brands APO-Osteo Paracetamol 665 mg, Blooms the Chemist Osteo Pain Relief Paracetamol 665 mg, Chem mart Pharmacy Osteo Relief Paracetamol 665 mg, and Terry White Chemists Osteo Relief Paracetamol 665 mg, which were previously included in the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2014 (No. 13) (PB 101 of 2014) with an effective date of 1 January 2015 (section 3). The obligations imposed by this legislative instrument primarily concern the Minister's authority under the National Health Act 1953 to determine brands of pharmaceutical items listed on the PBS, responsible persons, and prescribing circumstances. The Minister is authorised to determine brands of pharmaceutical items and the responsible persons for these brands (subsections 85(6) and 84AF(1)). Furthermore, the Minister can determine the pack quantity for a brand of a pharmaceutical item (subsection 84AK(1)). The Minister can also determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit (subsection 85(7)), the maximum quantity or number of units of a pharmaceutical item that may be supplied on one occasion (paragraph 85A(2)(a)), and the maximum number of repeats of a pharmaceutical benefit (paragraph 85A(2)(b)). This legislative instrument ensures that the specified brands of Paracetamol are not listed on the PBS, thereby altering the availability of these brands under the scheme. There are no specific offences, penalties, or civil/criminal consequences outlined for the breach of provisions within this legislative instrument. However, any non-compliance with the determinations made under the National Health Act 1953 could potentially lead to regulatory actions by the Minister, including revocation of listings or other administrative penalties. The primary focus of this instrument is to ensure that the specified brands of Paracetamol are not listed on the PBS as of 1 January 2015, thereby excluding them from the benefits provided under the scheme.

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