Therapeutic Goods Amendment (2017 Measures No 1) Bill 2017 - Commentary on Ministerial Responses [2017] AUSStaCSBSD 396 (15 November 2017)

• Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017
• Review rights76

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Therapeutic Goods Amendment (2017 Measures
No. 1) Bill 2017

Purpose	This bill seeks to amend the Therapeutic Goods Act 1989 to: • implement a number of recommendations of the Expert Panel Review of Medicines and Medical Devices Regulation; • clarify issues raised in relation to the processing of applications by the Department of Health, through the Therapeutic Goods Administration, by the Federal Court’s decision in Nicovations Australia Pty Ltd v Secretary of the Department of Health [2016] FCA 394 (Nicovations); and • make a number of miscellaneous amendments to the Act
Portfolio	Health
Introduced	House of Representatives on 14 September 2017
Bill status	Before House of Representatives
Scrutiny principles	Standing Order 24(1)(a)(i) and (iii)

2.169 The committee dealt with this bill in Scrutiny Digest No. 12 of 2017. The Minister responded to the committee's comments in a letter dated 1 November 2017. Set out below are extracts from the committee's initial scrutiny of the bill and the Minister's response followed by the committee's comments on the response. A copy of the letter is available on the committee's website.^[75]

Review rights^[76]

Initial scrutiny – extract

2.170 The bill seeks to create a new class of therapeutic goods, to be known as 'provisionally registered goods', which can be registered on the Australian Register of Therapeutic Goods (Register). This would allow sponsors to apply for a time-limited provisional registration of certain prescription medicines on the basis of promising early clinical data on safety and efficacy.^[77] To successfully make such a registration, a sponsor of a medicine would require approval by the Secretary of the Department of Health or their delegate of both a determination application and, subsequently, a provisional approval registration application.

2.171 Items 14 to 17 of Schedule 1 seek to amend section 60 of the Therapeutic Goods Act 1989 (the Act), which specifies review mechanisms with respect to decisions made by the Secretary or his or her delegate. These amendments would limit the ability to request a review of decisions about provisional determinations and provisional registration to 'the person in relation to whom the medicine is registered' or is the person who made the application for registration. In contrast, section 60 of the Act currently allows 'persons whose interests are affected by an initial decision' to request a review. In addition, item 19 of Schedule 2 seeks to amend section 60 of the Act to specify that only the applicant is able to request such a review of the Secretary's decision to refuse to make a recommendation to the Minister that a determination be varied.

2.172 The explanatory memorandum states that this restriction on review rights is necessary in the specific case of decisions concerning provisional registration of a medicine because an 'interested party' could be either another competitor sponsor or 'a consumer with, having regard to the very nature of medicine that may use this pathway, necessarily limited information'.^[78] The explanatory memorandum further states that 'providing an opportunity for one sponsor to appeal a decision made in relation to the medicine of another sponsor is antithetical to the purpose of the "Provisional Approval" Pathway of encouraging promising new medicines for a limited time to be brought to the market sooner.'^[79]

2.173 In relation to review of decisions to refuse an application for a recommendation to vary the permitted indications determinations,^[80] the explanatory memorandum states that this restriction is necessary as the range of 'interested parties' could potentially extend to a large number of people (other than the applicant), and 'this could create significant uncertainty in the predictability in the application process'.^[81]

2.174 The committee accepts that preventing commercial competitors from seeking review may be justified in this context. However, the committee is concerned that the exclusion of other interested parties, such as consumers, from requesting a review has not been adequately justified in the explanatory memorandum. The explanatory memorandum suggests that the exclusion of consumers is justified on the grounds that they will have 'necessarily limited information'.^[82] However, the committee notes that consumers may have a legitimate interest in whether particular medicines are provisionally registered and it is not clear that any disadvantage they may have in terms of access to relevant information is a sufficient basis on which to exclude them from requesting a review.

2.175 The committee therefore requests the Minister's detailed justification as to the appropriateness of restricting merits review in relation to decisions about provisional determinations and registrations, or determinations regarding permitted indications, so that consumers who may be affected by a decision (but who are not the applicant) would not have a right to seek review.

Minister's response

2.176 The Minister advised:

The Bill establishes a system for the provisional registration of medicines. This system will allow medicines to be made available to patients with life-threatening or seriously debilitating conditions, and unmet clinical needs, significantly earlier than might otherwise be the case. The medicines will be evaluated by the Therapeutic Goods Administration (TGA) on the basis of promising early clinical data, and if the Secretary is satisfied that the safety and efficacy of the medicine have been established, the medicine will be provisionally registered for a period of two years (renewable two times) while further clinical studies are ongoing. The person in relation to whom the medicine is registered may then apply for full registration of the medicine.
The Committee has noted in its Scrutiny Digest that preventing commercial competitors from seeking review may be justified in this context, but has sought a response in relation to the inability of consumers or consumer groups to seek review of a decision not to register a medicine or grant a provisional determination.
There are a number of reasons why rights to merits review have been limited to applicants in these cases, which are as follows:

• Expediting processes to address significant unmet clinical needs;

• Technically complex decisions;

• Other measures to promote administrative accountability;

• Alternative means to obtain medicines;

• Lack of use of appeal pathways by consumers.

Expediting processes to address significant unmet clinical needs
The principal reason for limiting appeal rights to applicants is to expedite processes for these applications. Introducing a system of provisional registration is intended to enable promising new medicines to proceed to market more quickly. It is estimated that as a result of these measures, some new medicines may be able to be provisionally registered up to two years earlier than under the current framework providing clear benefits to very sick patients. Limiting appeal rights to applicants is intended to give greater certainty and finality to applicants, expedite decision-making, and ensure that resources are directed to considering new applications. A negative decision does not preclude future applications for provisional determination by the sponsor, nor further applications by the sponsor as further clinical data becomes available.
Technically complex decisions
As the Explanatory Memorandum for the Bill notes, in seeking a review, consumers would not have access to the same information as the TGA, given the nature of the evidence available. The Secretary's decision to provisionally register a medicine requires that he or she be satisfied, on the basis of preliminary clinical data, that the safety and efficacy of the medicine have been satisfactorily established. This decision will be based on highly technical data, and will require a high degree of expertise, given that the safety and effectiveness of the medicine will only be able to be judged in relation to a limited number of patients and perhaps on surrogate endpoints. TGA has access, through its Committees, to medical experts who can provide advice to the Secretary to assist in making these decisions and may consult with other regulators.
Consumers may not be able to access all relevant information through the Freedom of Information process as some information may be commercial-in-confidence. Public information available to consumers or consumer groups about the merits of the medicine will be limited, as information about the product will be confined to the preliminary data obtained by the applicant. Consumers may not be able to access a comparable degree of medical expertise to successfully challenge such a decision. Further, as applicants will be best placed to advocate in respect of their products, the targeting of review and appeal rights to applicants is likely to benefit consumers where the exercise of such rights by applicants is successful.
Other measures to promote administrative accountability
TGA consulted consumer, patient and industry stakeholders concerning the provisional approval process during 2016-2017. Following this consultation, it was decided that in the interests of expediting provisional approval applications, appeals would be limited to the applicant in relation to certain decisions. This decision does not preclude consumers or consumer groups supporting a sponsor who is making an appeal.
This approach to appeal rights will be balanced by increased transparency of decision-making in relation to provisional registration, including publication of provisional approval determinations; rapid publication of TGA decisions relating to provisional registration; and full details of decisions relating to provisionally registered medicines in the Australian Public Assessment Reports (AusPARs) for prescription medicines. The criteria for the Secretary's decisions to grant or refuse to grant a provisional determination are intended to be set out in amendments to the Therapeutic Goods Regulations 1990, which will also be subject to Parliamentary scrutiny.
Information will be published on such matters as the automatic lapsing of provisional registration; the extension, suspension or cancellation of provisional registration; and the transition from provisional to full registration. It is intended that health professionals and consumers will have transparency of TGA decision-making processes to inform their treatment decisions and maintain confidence in the TGA's regulatory standards. Meetings with sponsors prior to submission of applications are intended to clearly set out the requirements of the application process, and to minimise the chance that an application will be refused by the Secretary.
Alternative means to obtain medicines
If the Secretary decides that a medicine is not suitable for provisional registration, but individual patients still wish to access the medicine, there are a number of other methods by which patients may obtain that medicine. The Special Access Schemes (Categories A and B) and the Authorised Prescriber Scheme provide ways for patients to access medicines which are not on the Australian Register of Therapeutic Goods, provided their medical practitioner believes that they are suitable for the patient. A product at this stage of its development may also be the subject of continuing clinical trials within Australia.
Lack of use of appeal pathways by consumers
Finally, under existing processes for registration, there have not been any AAT appeals by consumers or consumer groups against decisions not to register medicines in at least the last 10 years, so the lack of appeal rights would not appear to adversely impact on consumers. Drafting an exemption to enable consumers only to appeal these decisions could have broader implications for the interpretation of other review provisions in the Act and Regulations. Such an exemption would need to be considered in the context of review and appeal rights generally through the Act and Regulations, and would require further consultation with consumers and other relevant groups.
To assist in addressing the concerns of the Committee, the explanatory memorandum will be amended to clarify the intention behind restricting appeal rights in relation to these decisions concerning provisional registration to applicants only.
Permitted indications
The Bill represents the second stage of the legislative response to the Expert Panel Review of Medicines and Medical Devices Regulation (the Review). The Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017 (which was assented to on 19 June 2017), implemented Review Recommendation 4 7, to provide rights of review and appeal for applicants for new ingredients to be added to the list of permitted ingredients. Subsection 60(2B) of the Act limits appeal rights to the applicant. This was consistent with the recommendations of the Review (at page 40), in which the Expert Panel noted that existing appeal mechanisms under section 60 were not appropriate for new ingredients, as:
"the range of 'interested parties' could potentially extend to a large number of people, and create significant uncertainty in the predictability of the application process. This could be overcome if the review and appeal rights are restricted to the person who made the application only. This approach would allow for appropriate review of such decisions whilst ensuring that the [TGAJ was not exposed to review requests from a potentially large class of people, tying up [TGAJ resources in responding to appeals. "
In the current Bill, a similar approach has been taken to the question of appeal rights for new permitted indications. Under Schedule 2, Item 15, new section 26BJ of the Bill, a person may apply to the Secretary for a recommendation that the Minister vary a determination under section 26BF. The Secretary must consider such applications, and then either make a recommendation that the Minister vary the instrument, or refuse to do so. Review and appeal rights are available to the applicant in respect of any refusal by the Secretary to make the requested variation.
Consistently with the approach taken in relation to applicants for permitted ingredients, and for the same reasons, review rights for new permitted indications are limited to the applicant (Schedule 2, Item 19, new subsection 60(2C)).
Third parties who might wish to object to a permitted indication will be able to do so once a product with that indication appears in the marketplace by lodging a complaint with the TGA. Although this is after the event it will provide a means for consumers to voice their concerns and potentially have a review undertaken.
To assist in addressing the concerns of the Committee, the explanatory memorandum will be amended to clarify the intention behind restricting appeal rights in relation to this decision to applicants only.

Committee comment

2.177 The committee thanks the Minister for this detailed response. The committee notes the Minister's advice that the proposed limitation on merits review is based principally on the need to bring promising new medicines to market more quickly and is intended to give greater certainty and finality to applicants, expedite decision-making, and ensure that resources are directed to considering new applications.

2.178 The committee also notes the Minister's advice on the following matters relevant to the limiting of review rights:

• provisional registration decisions will be based on highly complex technical considerations and on data that will not be fully accessible to the public, which means applicants will be best placed to advocate for the registration of their products;

• consumers and consumer groups will not be precluded from supporting a sponsor who is making an appeal;

• the criteria under which the Secretary will make decisions will be set out in the Therapeutic Goods Regulations 1990 and the transparency of decision-making will be increased through publication of provisional approval determinations, TGA decisions relating to provisional approval and full details of provisionally registered medicines;

• the Special Access Schemes and the Authorised Prescriber Scheme provide alternative means by which individual patients can seek access to medicines which are not on the Australian Register of Therapeutic Goods; and

• there have been no Administrative Appeals Tribunal appeals made by consumers or consumer groups for more than 10 years under existing registration processes.

2.179 With respect to applications to vary a permitted indications determination, the committee notes the Minister's advice that the limitation of review rights has been proposed in order to minimise uncertainty in the application process. The committee also notes the Minister's advice that this limitation of review rights would mirror alterations made to review rights with respect to permitted ingredients made by the Therapeutic Goods Amendment (2016 Measures No. 1) Act 2017, and that third parties will be able to object to a permitted indication by lodging a complaint with the TGA once a product appears in the marketplace.

2.180 The committee welcomes the Minister's undertaking to amend the explanatory memorandum so as to clarify the intention behind restricting appeal rights to applicants only, noting the importance of this document 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).

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

2.1

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[75] See correspondence relating to Scrutiny Digest No. 12 of 2017 available at: www.aph.gov.au/senate_scrutiny_digest

[76] Schedule 1, items 14–17 and Schedule 2, item 19. The committee draws Senators’ attention to these provisions pursuant to principle 1(a)(iii) of the committee’s terms of reference.

[77] Explanatory memorandum, p. 2.

[78] Explanatory memorandum, p. 24.

[79] Explanatory memorandum, pp 24–25.

[80] See item 19 of Schedule 2.

[81] Explanatory memorandum, p. 35.

[82] Explanatory memorandum, p. 24.