Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules 2017 [F2017L00868], Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules 2017 [F2017L00867] and Therapeutic Goods (Authorised Supply of Specified Medicines) Rules 2017 [F2017L00859]-Concluded matters [2017] AUSStaCSDLM 349 (13 September 2017)

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Instrument	Therapeutic Goods (Authorised Supply of Specified Biologicals) Rules 2017 [F2017L00868] Therapeutic Goods (Authorised Supply of Specified Medical Devices) Rules 2017 [F2017L00867] Therapeutic Goods (Authorised Supply of Specified Medicines) Rules 2017 [F2017L00859]
Purpose	Authorise specified classes of health practitioners to supply specified biologicals, medical devices, and medicines
Authorising legislation	Therapeutic Goods Act 1989
Department	Health
Disallowance	15 sitting days after tabling (tabled Senate 8 August 2017) Notice of motion to disallow currently must be given by 16 October 2017
Scrutiny principle	Standing Order 23(3)(a)
Previously reported in	Delegated legislation monitor 10 of 2017

Unclear meaning of the term ‘good medical practice’

The committee previously commented as follows:

These rules authorise health practitioners to supply specified biologicals, medical devices and medicines which have not been approved for inclusion on the therapeutic goods register. The supply of these items to patients is subject to conditions which are set out in paragraph 4(1)(f) of each of the rules.

Sub-paragraph 4(1)(f)(iii) requires the health practitioner to ensure that the items are supplied in accordance with 'good medical practice'. However, neither the rules nor their ESs expressly define the term 'good medical practice'.

The committee is concerned that the term 'good medical practice' is insufficiently precise, such that it may be difficult for a health practitioner or patient to know how the unapproved items may be appropriately supplied.

The committee requested the advice of the minister in relation to the above.

Minister's response

The Minister for Health advised:

The effect of the above Rules instruments is to list unapproved products that health practitioners can supply to their patients by notifying the Therapeutic Goods Administration (TGA), rather than (as was the case before these instruments were made) through pre-approval.
The term 'good medical practice' has been used in regulation 12A of the Therapeutic Goods Regulations 1990 since 1991. This provision authorises medical practitioners to supply unapproved medicines to persons who are 'Category A' patients (persons who are seriously ill), and supply under this mechanism must be in accordance with good medical practice.
The TGA document Special Access Scheme: Guidance for health practitioners and sponsors (July 2017), which includes guidance on the supply of unapproved goods under these Rules, explains that 'good medical practice' refers to a series of standards that health practitioners should adhere to when treating patients. These standards are generally patient-centred and comprise ethical and professional benchmarks expected by a health practitioner's professional peers, as well as the community. For example, registered medical practitioners operate in accordance with the principles in the Medical Board of Australia's Good Medical Practice: A Code of Conduct for Doctors in Australia, and dental practitioners would be expected to comply, in most cases, with the Dental Board of Australia's Code of Conduct for registered health practitioners.
Given the above, it is expected that health practitioners in particular, and patients, would be familiar with, and understand, the meaning of this term.
It is anticipated that the above Rules for medicines and biologicals will shortly be re-made to include additional products, and that the explanatory statements for those re-made Rules will incorporate the above explanation. A replacement explanatory statement for the medical devices Rules that incorporates the above will also be provided.
Committee's response

The committee thanks the minister for his response and has concluded its examination of the above.

The committee notes the minister's advice that the meaning of 'good medical practice' is well established within the health sector, and also that it is explained in the Therapeutic Goods Administration's guidance document on the special access scheme. In this case, the committee further notes that the supply of items under these instruments is subject to a set of safeguards: supply is limited to specified circumstances, and the requirement that the supply be in accordance with 'good medical practice' is one of a range of specified conditions.

The committee notes nonetheless that patients and practitioners who use or are affected by the instruments should not be expected, without guidance in the instrument, or, at a minimum, the ES, to rely on an external document to fully understand their content.

In this regard the committee notes the minister's advice that the rules relating to medicines and biologicals are expected to be remade shortly, and that the explanatory statements for those remade rules will incorporate an explanation of the term 'good medical practice'.

The committee also notes the minister's undertaking to provided a replacement explanatory statement for the medical devices rules that incorporates this information.