EXPLANATORY STATEMENT
NATIONAL HEALTH ACT 1953
NATIONAL HEALTH (GROWTH HORMONE PROGRAM) SPECIAL ARRANGEMENT AMENDMENT INSTRUMENT 2017 (No. 1)
PB 78 of 2017
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).
Subsection 100(3) of the Act provides that Part VII of the Act, and instruments made for the purposes of Part VII, have effect subject to a special arrangement made under subsection 100(1).
Purpose
This is the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2017 (No. 1) (the Amendment Instrument). The purpose of the Amendment Instrument is to amend the National Health (Growth Hormone Program) Special Arrangement 2015 (PB 85 of 2015) (the Special Arrangement), to make changes to the Special Arrangement relating to the Growth Hormone Program.
The purpose of the Special Arrangement is to ensure that an adequate supply of pharmaceutical benefits is available for patients who require treatment with growth hormone (somatropin). Restrictions on the provision of this treatment mean that these pharmaceutical benefits can more conveniently or efficiently be supplied under a special arrangement.
The amendments made by this Amendment Instrument reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012, which commence on the same day.
The amendments in PB 78 of 2017 include the deletion of a brand of somatropin.
A provision by provision Description of this instrument is contained in the Attachment.
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), 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.
Pharmaceutical companies were consulted throughout the process of changes to the listings on the PBS. This includes consultation through the PBAC process. Further consultation for this Instrument was considered unnecessary due to the nature of the consultation that had already taken place in the decision to list the medication.
Details of the instrument are set out in the Attachment.
This Instrument commences on 1 October 2017.
This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.
ATTACHMENT
Details of the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2017 (No. 1)
PART 1 PRELIMINARY
Section 1 Name of Instrument
This section provides the name of this instrument as the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2017 (No. 1). It can also be cited as PB 78 of 2017.
Section 2 Commencement
This section provides that this instrument commences on 1 October 2017.
Section 3 Amendment
This section provides that the Schedule amends the National Health (Growth Hormone Program) Special Arrangement 2015 (PB 85 of 2015).
Schedule - Amendments
Item 1 amends Schedule 1 of the Special Arrangement by removing a brand of somatropin that has the form ‘Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)’.
Overview
The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2017 (No. 1) was enacted to amend the National Health (Growth Hormone Program) Special Arrangement 2015, ensuring that patients requiring treatment with growth hormone (somatropin) continue to have access to an adequate supply of pharmaceutical benefits. This amendment was introduced to address specific changes in the pharmaceutical landscape, particularly those related to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The instrument was made under the authority of subsection 100(1) of the National Health Act 1953, which allows the Minister to establish special arrangements for the supply of pharmaceutical benefits. The policy objective behind this amendment was to align with recommendations made by the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises on which drugs should be available as pharmaceutical benefits. The PBAC's recommendations were based on factors such as clinical effectiveness, safety, and cost-effectiveness. This amendment reflects the ongoing consultation process involving various stakeholders, including pharmaceutical companies and members of the PBAC, ensuring that the changes are well-considered and align with broader healthcare objectives.
Scope and Application
The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2017 (No. 1) amends the National Health (Growth Hormone Program) Special Arrangement 2015 to reflect changes in the listing of pharmaceutical benefits on the Pharmaceutical Benefits Scheme (PBS). The Amendment Instrument applies to entities involved in the supply of growth hormone (somatropin) under the special arrangement for the Growth Hormone Program, ensuring that patients requiring treatment with growth hormone have access to an adequate supply of pharmaceutical benefits. This special arrangement is established under the National Health Act 1953, enabling the Minister to make arrangements for the supply of pharmaceutical benefits. The Amendment Instrument specifically deletes a brand of somatropin from the Special Arrangement, aligning it with changes to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. The instrument is a legislative instrument for the purposes of the Legislation Act 2003, and it commenced on 1 October 2017. The amendments were made in accordance with recommendations from the Pharmaceutical Benefits Advisory Committee (PBAC), an independent expert body that advises the Minister on the listing of drugs on the PBS.
Key Provisions
The National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2017 (No. 1) amends the National Health (Growth Hormone Program) Special Arrangement 2015 (sections 3 and Schedule). This instrument is designed to ensure that an adequate supply of pharmaceutical benefits is available for patients requiring treatment with growth hormone (somatropin) and to reflect amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012. Specifically, it removes a particular brand of somatropin from the arrangement (Schedule, Item 1).
The Act imposes certain obligations on parties involved in the Growth Hormone Program. The Minister, under subsection 100(1), is empowered to make special arrangements for the supply of pharmaceutical benefits, including the growth hormone program. Additionally, under subsection 100(2), the Minister has the authority to vary or revoke these special arrangements if necessary. The special arrangement, as amended by this instrument, must ensure that patients receive an adequate supply of somatropin as per the Pharmaceutical Benefits Scheme (PBS).
Failure to comply with the provisions of this Act may lead to civil or criminal consequences. While the Act does not specify maximum penalties in this context, breaches of similar legislative instruments generally result in fines up to several thousand Australian dollars, depending on the severity and nature of the breach. Non-compliance could also lead to revocation of the special arrangement, potentially affecting the supply of essential pharmaceutical benefits to patients.
In summary, the National Health (Growth Hormone Program) Special Arrangement Amendment Instrument 2017 (No. 1) is a legislative measure aimed at ensuring that patients requiring growth hormone treatment have access to necessary pharmaceutical benefits. It amends the existing special arrangement to reflect changes in the PBS listings and imposes obligations on the Minister to manage and oversee these arrangements. While the Act does not explicitly detail penalties for non-compliance, breaches could lead to significant fines and the potential revocation of the special arrangement.