Therapeutic Goods Amendment (2022 Measures No 1) Bill 2022 - Commentary on Ministerial Responses [2023] AUSStaCSBSD 45 (8 March 2023)

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Purpose	This bill seeks to amend the Therapeutic Goods Act 1989 to: • enhance patient safety and improve the safe use of medical devices; • support innovation and investment in biologicals Australia through the introduction of a new marketing approval pathway for biologicals that are for export only; • support activities to relieve medicine shortages; • strengthen post-market monitoring and compliance; • reduce regulatory burden; • safeguard patient safety in relation to therapeutic goods advertising; and • make a number of more minor amendments.
Portfolio	Health and Aged Care
Introduced	House of Representatives on 1 December 2022
Bill status	Before the Senate

Reversal of the evidential burden of proof^[82]

2.220 Item 2 of Schedule 5 seeks to insert proposed section 45AC into the Therapeutic Goods Act 1989 (the Act) to create an offence for failing to comply with a notice from the Secretary requiring the production of information or documents. Proposed subsection 45AC(3) provides an exception for the offence if the person has a reasonable excuse, and a note to the subsection states that the defendant bears an evidential burden in relation to the matter.

2.221 In Scrutiny Digest 1 of 2023 the committee requested the minister's advice as to why it is proposed to use a defence of reasonable excuse (which reverses the evidential burden of proof) for proposed subsection 45AC(3).^[83]

2.222 The minister advised that a defence of reasonable excuse is appropriate and in line with the Guide to Framing Commonwealth Offences, stating that there are many reasons that a person may not be able to provide the information or documents that will be outside the knowledge of the Therapeutic Goods Administration (TGA). The minister provided some examples of reasons that a person may not comply with a notice, including personal circumstances like illness or natural disasters, or if documents were stored at a location affect by fire or flood.

2.223 The minister further noted that: the defence is appropriate as it would be significantly more difficult and costly for the prosecution to prove a negative (that there was no reasonable excuse for a defendant); the general mistake of fact defence available under the Criminal Code would not apply to the circumstances; and given the wide range of circumstances where a person might reasonably be unable to comply with a notice, it was not possible to frame a more narrow defence or make an exception in the offence provision itself.

2.225 The committee notes the minister's advice that a defence of reasonable excuse is appropriate in this context as it would not be possible for the TGA to know the kinds of circumstances that may arise that may prevent someone from complying with a notice.

2.226 Nevertheless, the committee remains concerned that a defence of reasonable excuse is difficult to rely on because it is unclear to a defendant what needs to be established. While it is helpful the minister has provided some examples of circumstances that may constitute a reasonable excuse, the committee remains of the view that it is preferable to develop more specific defences rather than a general defence. It is not clear to the committee that all of these examples relate to matters that are peculiarly within the knowledge of the defendant, for example the existence of natural disasters appears to be a matter that the prosecution could readily ascertain. At a minimum, the committee considers it would be appropriate for examples of what may constitute a reasonable excuse to be included in the explanatory memorandum.

2.227 The committee requests that an addendum to the explanatory memorandum containing the key information provided by the minister be tabled in the Parliament as soon as practicable, noting the importance of these explanatory materials as a point of access to understanding the law and, if needed, as extrinsic material to assist with interpretation (see section 15AB of the Acts Interpretation Act 1901). The committee draws its scrutiny concerns to the attention of senators and leaves to the Senate as a whole the appropriateness of reversing the evidential burden of proof and relying upon the defence of reasonable excuse rather than more specific defences.

Strict liability^[85]

2.228 Item 2 of Schedule 5 proposes to introduce subsections 45AC(2) and 45AD(2) which contain strict liability offences for failure to comply with a notice, and giving false or misleading information or documents, respectively. Both of these provisions are subject to a penalty of 100 penalty units.

2.229 In Scrutiny Digest 1 of 2023 the committee drew its scrutiny concerns to the attention of senators and left to the Senate as a whole the appropriateness of imposing a strict liability offence, noting that the penalties imposed under that offence are above what is recommended in the Guide to Framing Commonwealth Offences.

2.230 The minister advised that the higher penalty imposed is justified in the context of the regulatory scheme for therapeutic goods and given the potentially significant consequences for public health and safety. The minister noted that the individuals to whom such notices could be issued may include medical practitioners or pharmacists running enterprises manufacturing or selling therapeutic goods. The minister considered that these individuals are likely well-resourced and, as such, it is important that the penalties are set at a level that allows a court to impose a penalty that will be more than merely the cost of doing business in order to ensure compliance.

2.232 The committee notes the minister's advice that a higher penalty is appropriate in this context given the significant public consequences of non-compliance and the likely category of individuals to whom this may apply.

2.233 The committee requests that an addendum to the explanatory memorandum containing the key information provided by the minister be tabled in the Parliament as soon as practicable, noting the importance of these explanatory materials as a point of access to understanding the law and, if needed, as extrinsic material to assist with interpretation (see section 15AB of the Acts Interpretation Act 1901).

2.234 In light of the information provided, the committee makes no further comment on this matter.

Procedural fairness^[87]

2.235 Item 1 of Schedule 10 to the bill seeks to insert subsection 61(13) into the Act. This provision would provide that the Secretary is not required to observe any requirements of the natural justice hearing rule in relation to releasing information under section 61 of the Act. Section 61 of the Act provides that the Secretary may release certain kinds of information to the public and to various health, regulatory and law enforcement authorities, including for example: notifications concerning therapeutic goods that have been prohibited or severely restricted in Australia; the licensing status of manufacturers of therapeutic goods; contents of reports, conditions on assessment certificates; reported problems and complaints concerning therapeutic goods; investigations of complaints; decisions on registration or listing; and cases or possible cases of product tampering or counterfeit therapeutic goods.

2.237 The minister advised that a broad exclusion from procedural fairness is necessary given the importance of ensuring that all information about the safety, quality and efficacy or performance of therapeutic goods is communicated in a timely way, and the potentially significant consequences of delay on public health which could result from allowing the usual procedural fairness rules to apply. The minister noted that this justification is not limited to information that is clearly urgent, but is also relevant to the release of information that once shared with other departments or organisations may contribute to the identification of urgent safety concerns. The minister further advised that providing a requirement to consult third parties would impact information-sharing arrangements with international partners that assist in identifying safety issues with therapeutic goods.

2.238 In addition to these reasons, the minister advised of numerous practical reasons as to why, in their opinion, procedural fairness could not be provided, including that: the TGA release significant volumes of information to keep stakeholders up to date; the TGA receives verbal queries from stakeholders, for example about the stock of a medicine; the range of various kinds of information that may be released could create uncertainty as to the application of the rule in different possible contexts; it is difficult to consider the scope of procedural fairness obligations that would apply in practice; and challenges to the legality of already disclosed information may have a cooling effect on future potential releases of information, further risking public health and safety.

2.239 In relation to whether the amendment could be narrowed to exclude procedural fairness to circumstances where disclosure is required for urgent public safety reasons, the minister advised that a clear formulation for a narrower approach that would not pose safety concerns and that would be workable in practice could not be identified. In particular, the minister noted that: it would be administratively unworkable given the large range of information that may be released under section 61; it would be ambiguous and difficult to apply in practice, leading to delays that may pose a risk to public health; narrowing the exclusion would imply an intention that the natural justice hearing rule should apply in all other circumstances as the explicit exclusion would only apply in limited circumstances, and this would undermine the purpose of the proposed amendment; and a narrower approach to exclude the natural justice hearing rule would not be comprehensive due to the difficulty in identifying all possible circumstances in which disclosure may be needed for urgent public safety reasons.

2.241 The committee notes the minister's advice that providing for procedural fairness or narrowing its exclusion would be practically difficult in the context of the therapeutic goods regulatory scheme and may risk negative outcomes for public health and safety.

2.242 Nevertheless, the committee continues to have concerns in relation to the breadth of the exclusion. It is not clear to the committee why, in instances where information is released, whether subsequent notice is given to an affected party and whether they are given an opportunity to be heard. It is also not clear to the committee what consideration has been given to the impact the exclusion of procedural fairness may have on individuals and what processes the TGA have adopted to minimise this impact.

2.243 The committee draws its scrutiny concerns to the attention of senators and leaves to the Senate as a whole the appropriateness of excluding procedural fairness in relation to a decision to release information under section 61 of the Therapeutic Goods Act 1989.

Incorporation of external material as existing from time to time^[90]

2.244 Items 12, 15, 16, 20 and 30 of Schedule 12 to the bill seek to introduce proposed subsections 3C(3), 26BF(6), 28(2AA), 36(5) and 61(8C) to provide that instruments made under these sections may incorporate any matter contained in an instrument or other writing as in force or existing from time to time.

2.245 In Scrutiny Digest 1 of 2023 the committee requested the minister's advice as to whether material incorporated from time to time will be made freely and readily available to all persons interested in the law.^[91]

2.246 The minister advised that, wherever possible, material proposed to be incorporated in an instrument is freely and readily available to persons interested in the terms of the law, and that the instrument or its explanatory statement is able to explain this. However, the minister noted that this is not always possible, for example where various international benchmarks for quality and safety requirements relating to therapeutic goods are incorporated, but that it is anticipated that individuals who are required to comply with the incorporated material would have arrangements in place to ensure access in order to conduct or carry out their business.

2.247 In addition, the minister noted that the TGA also endeavours to ensure that where incorporated material is not freely available, members of the public may arrange to view the material at the TGA office in Fairbairn, ACT.

2.249 The committee notes the minister's advice that material proposed to be incorporated in an instrument will be freely and readily available wherever possible, and if not, endeavours will be made to ensure it is freely available for viewing at the TGA office.

2.250 While the committee notes that many individuals who are required to comply with the incorporated material likely have access to these materials in order to conduct their business, the committee considers that the law should be accessible to all people interested in the terms of the law.

2.251 The committee considers that where it is proposed to incorporate external material into the law, the explanatory memorandum for the bill should, at a minimum, contain an undertaking that the material will be freely and readily available in all circumstances. If it is not possible to do this, the committee expects that the explanatory memorandum state this clearly and explain why it is not possible and why it is nevertheless justifiable to allow external incorporation of non-legislative materials.

2.252 The committee requests that an addendum to the explanatory memorandum containing the key information provided by the minister be tabled in the Parliament as soon as practicable, noting the importance of these explanatory materials as a point of access to understanding the law and, if needed, as extrinsic material to assist with interpretation (see section 15AB of the Acts Interpretation Act 1901).

[82] Schedule 5, item 2, proposed section 45AC. The committee draws senators’ attention to this provision pursuant to Senate standing order 24(1)(a)(i).

[84] The minister responded to the committee's comments in a letter dated 21 February 2023. A copy of the letter is available on the committee's website: see correspondence relating to Scrutiny Digest 2 of 2023 available at: www.aph.gov.au/senate_scrutiny_digest .

[85] Schedule 5, item 2, proposed subsection 45AD(2). The committee draws senators’ attention to this provision pursuant to Senate standing order 24(1)(a)(i).

[86] The minister responded to the committee's comments in a letter dated 21 February 2023. A copy of the letter is available on the committee's website: see correspondence relating to Scrutiny Digest 2 of 2023 available at: www.aph.gov.au/senate_scrutiny_digest .

[87] Schedule 10, item 1, proposed subsection 61(13). The committee draws senators’ attention to this provision pursuant to Senate standing order 24(1)(a)(iii).

[89] The minister responded to the committee's comments in a letter dated 21 February 2023. A copy of the letter is available on the committee's website: see correspondence relating to Scrutiny Digest 2 of 2023 available at: www.aph.gov.au/senate_scrutiny_digest .

[90] Schedule 12, items 12, 15, 16, 20 and 30, proposed subsections 3C(3), 26BF(6), 28(2AA), 36(5) and 61(8C). The committee draws senators’ attention to these provisions pursuant to Senate standing order 24(1)(a)(v).

[92] The minister responded to the committee's comments in a letter dated 21 February 2023. A copy of the letter is available on the committee's website: see correspondence relating to Scrutiny Digest 2 of 2023 available at: www.aph.gov.au/senate_scrutiny_digest .

Australian Senate Standing Committee for the Scrutiny of Bills - Scrutiny Digests