Softmed Manufacturing Pty Ltd v Secretary, Department of Health and Aged Care

Federal Court of Australia|2024-05-13|Before: Commission J, Hespe J

The application is dismissed.
The Applicant is to pay the Respondent's costs, to be taxed if not agreed. Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

introduction 1 By further amended originating application for judicial review, the Applicant (Softmed) applies to this Court for judicial review under s 5 of the Administrative Decisions (Judicial Review) Act 1977 (Cth) (ADJR Act) or alternatively under s 39B of the Judiciary Act 1903 (Cth) of a decision of a delegate of the Respondent (Secretary) made on or about 29 July 2022 to release certain information pursuant to s 61(3) of the Therapeutic Goods Act 1989 (Cth) (TG Act). 2 Softmed is a manufacturer in Australia of personal protective equipment including face masks. For the purposes of the present proceedings, the relevant product is called an A-Med mask. It is a single use surgical respirator mask. 3 The A-Med mask is a medical device for the purposes of the TG Act and was registered on that part of the Australian Register of Therapeutic Goods (ARTG) maintained pursuant to Chapter 4 of the TG Act. Softmed, as the manufacturer of the goods, was the sponsor in relation to those goods (as defined in s 3 of the TG Act). 4 A delegate of the Secretary of the Department of Health and Aged Care made a decision on or about 29 July 2022 to release certain information about Softmed's A-Med mask to various Commonwealth, State and Territory health authorities, pursuant to s 61(3) of the TG Act. There was no dispute that the delegate was authorised. 5 The information released on 29 July 2022 included that the A-Med masks had failed a fluid resistance test that had been arranged by the delegate (failed test information). Those test results were received by the Department on 10 June 2022. Softmed was notified of the test results on 26 July 2022. 6 Pursuant to regulations made under the TG Act, Softmed sought a retesting of the masks. The A-Med masks passed that subsequent retesting. 7 Softmed seeks judicial review of the delegate's decision to release the failed test information, principally under the ADJR Act. There is no dispute that the decision was a decision to which the ADJR Act applied. Softmed relies upon three grounds of review: (1) That a breach of the rules of natural justice occurred in connection with the making of the decision (s 5(1)(a) of the ADJR Act); (2) That the making of the decision was an improper exercise of the power conferred by the TG Act because the delegate failed to take into account relevant considerations in the exercise of the power (s 5(1)(e) and (2)(b) of the ADJR Act); (3) That the making of the decision was an improper exercise of the power conferred by the TG Act because the exercise of the power was so unreasonable that no reasonable person could have so exercised the power (s 5(1)(e) and (2)(g) of the ADJR Act). 8 Softmed sought declaratory relief pursuant to s 16 of the ADJR Act in the form of an order declaring that the decision was invalid and in making the decision: the Secretary breached the rules of natural justice, failed to take into account mandatory considerations and/or the decision was so unreasonable that no reasonable person could have so exercised the power. Softmed also sought an order directing the Secretary to provide a copy of the declaration to the various Commonwealth, State and Territory health authorities. Softmed abandoned its claim for a writ of certiorari quashing the decision.

Statutory COntext 9 The Secretary is required to cause to be maintained a register, known as the ARTG, for the purpose of compiling information in relation to, and providing for evaluation of, therapeutic goods for use in humans: s 9A(1). Medical devices are included in the part of the register under Chapter 4 of the TG Act. 10 The term "medical device" is defined in s 41BD of the TG Act. The definition includes any article intended by the person under whose name it is or is to be supplied to be used for human beings for the purpose of preventing disease. 11 Medical devices are required to comply with the essential principles (that are about the safety and performance characteristics of medical devices): s 41BA and s 41BH. The essential principles are set out in regulations made for the purposes of s 41CA of the TG Act. 12 The inclusion of a kind of medical device in the register is subject to conditions provided for in s 41FN. One of the conditions is that the person in relation to whom the kind of medical device is included in the register will: …deliver a reasonable number of samples of the kind of device if the Secretary so requests: (a) within the period specified in the request; and (b) in accordance with any other requirements specified in the request. 13 Part 5 of the Therapeutic Goods Regulations 1990 (Cth) provided for the examination, testing and analysis of therapeutic goods. Relevantly, reg 27(2)(a) requires the "responsible analyst" to arrange for: (a) an analysis of [a sample of goods] by performing the tests determined under paragraph 25(3)(b) in relation to the sample to establish: (i) the quantity and quality of the goods comprising the sample; and (ii) any other matter relevant to determining whether: …(B) for medical devices - the goods from which the sample was taken comply with the applicable provisions of the essential principles… 14 "Responsible analyst" is defined in reg 23(1) in the following terms: responsible analyst, in relation to the analysis of a sample of therapeutic goods, means an analyst or official analyst who is nominated as a responsible analyst for the sample under paragraph 25(3)(c). 15 Regulation 25 relevantly provides: (1) The Secretary may, in writing, appoint a person who has appropriate qualifications and experience to be an analyst or an official analyst for the purposes of these Regulations. (3) In addition to the other powers and functions of an official analyst, an official analyst may: … (c) nominate an analyst or official analyst to be the responsible an analyst for a sample…delivered under…subsection 41FN(2) of the Act. (4) The tests determined under paragraph (3)(b), by an official analyst…must be tests covered by regulation 28… 16 The tests for determining whether a kind of medical device complies with the applicable provisions of the essential principles are set out in reg 28(2). These include: (d) any other suitable test that the Secretary requires to be carried out in respect of the kind of device for the purpose of demonstrating compliance with the applicable provisions of the essential principles. 17 Regulation 29 relevantly requires the responsible analyst to issue a certificate setting out the results of the examination and analysis and to send a copy of the certificate to the sponsor of the goods (here, Softmed). Regulations 29(4)(b) and (4A) provide: (4) If the certificate referred to in subregulation (1) states: … (b) for medical devices - that the goods do not comply with the applicable provisions of the essential principles or a requirement that is applicable to the goods under regulation 27; a copy of the certificate sent under subregulation (2) must be accompanied by a notice that complies with subregulation (4A). (4A) For subregulation (4), the notice must: (a) state that the person to whom the copy is sent may ask for the results of the analysis referred to in the copy to be reviewed in accordance with regulation 30; and (b) specify the time within which a request for a review of the results may be made; and (c) state that the person may ask for an extension of that time if it is not reasonable to expect the person to comply with regulation 30 within the specified time. 18 Regulation 30 provides for a right of review of the results of the analysis. It relevantly provides: (1) A person: (a) to whom a copy of a certificate, setting out the results of the examination and analysis of goods, is sent under subregulation 29(2); and (b) who sends to the Secretary evidence in writing establishing that the goods do conform with the specified standard or comply with an applicable requirement, or, for medical devices, do comply with the applicable provisions of the essential principles or an applicable requirement; may ask for the results of the analysis to be reviewed. (2) A request for review of the results of the analysis is to be made not later than 21 days after the person receives the copy of the certificate. … (6) Unless the results of the analysis of a sample of goods to which this subregulation applies, or other information available to the Secretary in relation to those goods, shows lack of homogeneity in the sample, the Secretary must direct: (a) if part of the sample remains unimpaired - an official analyst to send so much of the sample as remains unimpaired; or (b) if no part of the sample remains unimpaired - that a further sample be taken by an authorised officer from the same batch as the original sample and that that further sample be sent; to a person agreed (who may be an analyst or official analyst) upon by the person who requested the review and the official analyst referred to in subregulation (5), or, in the absence of agreement, to a person nominated (who may be an analyst or official analyst) by the Secretary. (7) If a sample is sent to a person as mentioned in subregulation (6), the person is to: (a) analyse the sample of the goods in accordance with the tests determined by an official analyst under paragraph 25(3)(b) on the basis of which the certificate referred to in paragraph (1)(a) of this regulation was issued; (b) send to the Secretary a certificate, signed by the person, setting out the results of the analysis; and (c) send a copy of that certificate, signed by the person to the person who requested the review. (8) A certificate under regulation 29 setting out the results of the analysis of a sample of goods ceases to have effect when the Secretary receives the certificate in relation to those goods under subregulation (7). 19 The decision the subject of review was made pursuant to s 61(3) of the TG Act. Section 61 relevantly provides: 61 Release of information (1) In this section: therapeutic goods information means information in relation to therapeutic goods that is held by the Department and relates to the performance of the Department's functions (including functions relating to the EC Mutual Recognition Agreement, the EFTA Mutual Recognition Agreement or the Australia-UK Mutual Recognition Agreement). (2) The Secretary may: (a) release to the World Health Organisation therapeutic goods information relating to:…; or (b) release, in confidence, therapeutic goods information to the World Health Organisation, being information concerning proceedings of committees established under the regulations. (3) The Secretary may release to an authority of the Commonwealth, a State or a Territory that has functions relating to therapeutic goods, therapeutic goods information relating to: (a) reported problems and complaints concerning therapeutic goods, the Department's investigation of those problems and complaints and any action that the Department has taken or proposes to take in relation to those problems and complaints; or (b) reports of inspections conducted under this Act or the regulations; or (c) decisions to revoke or suspend, or not to issue, licences for the manufacturing of therapeutic goods; or (d) conditions of licences; or (e) reports of the testing of samples of therapeutic goods; or (f) the issue of, imposition of conditions on, or revocation of, conformity assessment certificates; for use in the performance of those functions. (3A) The Secretary may release information obtained in response to a notice under section 31A, 31AA, 31B, 31BA, 32JE, 32JF, 32JG, 32JH, 41AB, 41JCA, 41JD, 41JE or 41JF to: (a) an authority of the Commonwealth, a State or a Territory that has functions relating to therapeutic goods; and (b) the body in a State or Territory responsible for the registration of medical practitioners in that State or Territory; and (c) the body in a State or Territory responsible for the registration of pharmacists in that State or Territory. (4) The Secretary may release to a national regulatory authority of another country, being an authority that has national responsibility relating to therapeutic goods, therapeutic goods information relating to:… for use in the performance of those functions or for furthering international co-operation in the regulation of therapeutic goods. (4A) The Secretary may release to: (a) an authority of the Commonwealth, a State or a Territory that has functions relating to therapeutic goods, health or law enforcement; or (b) a national regulatory authority of another country that has national responsibility relating to therapeutic goods, health or law enforcement; or (ba) an international organisation that has a function relating to therapeutic goods, health or law enforcement; therapeutic goods information relating to one or more of the following:… … (5) The Secretary may release to a national regulatory authority of another country, or an international organisation, being another country or an organisation with which the Commonwealth has cooperative arrangements relating to the assessment or regulation of therapeutic goods, the following information the release of which is consistent with those arrangements:… (5AA) The Secretary may release to a person, body or authority that is specified, or is of a kind specified, under subsection (5AB) therapeutic goods information of a kind specified under that subsection for a purpose specified under that subsection. … (5A) The Secretary may release to the public therapeutic goods information relating to any decision or action taken under this Act or the regulations. … (6) The Secretary may release to a person, on application by that person, therapeutic goods information of a kind identified in the regulations… … (7) The Secretary may release therapeutic goods information: (a) the release of which is necessary to ensure the safe use of particular therapeutic goods; or (b) relating to the reasons for the withdrawal of therapeutic goods from supply in Australia. … (12) The subsections of this section permitting the release of information have effect independently of each other. (Emphasis added.)

CHRONOLOGY OF EVEntS 20 During 2021 Softmed manufactured A-Med mask batches L2021601 to L2021605. Softmed's A-med mask was registered on the ARTG under ID number 347410. 21 Samples from these batches were tested at Softmed's inhouse testing facility on or about 18 October 2021 for resistance against penetration by synthetic blood. Each sample so tested passed. 22 In November 2021, Softmed sent 100 samples of its A-Med masks from batches L2021601 to L2021605 to an independent laboratory, Intertek, for amongst other things, fluid resistance testing. Testing was conducted between 1 to 24 December 2021 and the samples tested were found to be compliant with resistance to penetration by synthetic blood and bacterial filtration efficiency tests. These results were provided to the TGA on 21 January 2022. 23 On or about 16 February 2022, the TGA sent by email to Softmed a notice which relevantly provided: Notice requiring information/documents and samples to be provided under subsection 41FN(2) of the Therapeutic Goods Act 1989 ARTG Number: 347410 I refer to the medical device with the above Australian Register of Therapeutic Goods (ARTG) number. I am the delegate of the Secretary of the Department of Health for the purposes of subsection 41FN(2) of the Therapeutic Goods Act 1989 (the Act). Under subsection 41FN(2) of the Act, you are required to provide a reasonable number of facemasks for laboratory investigation. The samples are required for a post-market review of facemask medical devices. Reasons for requesting samples The TGA has committed to undertaking an urgent post market review of all facemasks that are included on the ARTG. The TGA has identified concerns and received a number of complaints in relation to facemasks. This is related to the increase of importation and use of facemasks within Australia since the global pandemic. The review intends to assess the safety and performance of the devices for the purposes for which they are to be used, with respect to the legislative requirements specified within the Act and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). The review will determine whether the devices you supply are a medical device and whether they meet the requirements of the Essential Principles. Further information related to the grounds of review and legislative requirements are provided in Attachment A. … Samples requested I require the following samples to be provided: Please refer to the below table regarding how many samples must be provided. Please ensure the samples are clearly labelled with the following information: • Model number/reference • ARTG number • Batch code • Sample registration form in accompanying email • one form must be completed per model • must be submitted electronically using the "Submit Form" button Note: • The samples must be provided to the TGA as they would be supplied upon sale to an Australian user and be representative of the batch they are labelled under. • The samples must be stored and transported to the TGA in accordance with the manufacturer's required environmental and storage conditions. Temperature controlled and monitored shipping is recommended for sensitive products where adverse shipping conditions may compromise the quality or performance of samples. • The TGA will not return any samples. Samples required Samples are required for the following models • SM-RA201 A-Med Respirator … For single use respirators: • If you have not yet supplied or sold any masks or respirators, please provide 350 samples (from a single batch intended to be supplied). • If you have supplied or sold masks or respirators, please provide 350 samples per batch of sample supplied (up to 3 batches). • If you no longer have sufficient samples in previous batches supplied, provide 350 samples from a current batch. 24 By 2 March 2022, Softmed provided samples from three batches of respirators included in ARTG 347410, which included the A-Med mask. The samples supplied were from batches L2021602, L2021603 and L2021605 with 360 samples being provided from each batch (tested batches). The batches had an expiry date of October 2023. 25 By letters dated 25 and 26 May 2022, the party commissioned by the TGA to conduct performance testing, namely the National Measurement Institute (NMI), provided the TGA with a "Measurement Report" on the Softmed A-Med surgical respirators for each of the tested batches. The main body of the tested masks and the seam passed the compliance assessment. The lower main body of the tested masks did not pass the compliance assessment. The report was received by the TGA on 10 June 2022. 26 By email sent on 26 July 2022, the TGA informed Softmed that the A-Med masks from the tested batches had not passed fluid resistance testing performed by NMI. Softmed was also informed that: Entitlement of Review Should you decide to request a review of the results of the analysis (and supporting evidence) it is to be made no later than 21 days after you receive the certificate, COB 18 August 2022 5pm. If you cannot meet the 21-day time frame, you should write as soon as possible to request an extension of time. In accordance with reg 30(4) of the Regulations, the written evidence accompanying your request for review must include a certificate from an analyst who has appropriate qualifications and experience setting out: • a statement that the analyst has analysed a part of the same sample, or a similar sample from the same batch of the goods; and • the results of that analysis; and • details of the tests used in the analysis Release of information Please note that these results may be released under s 61 of the Therapeutic Goods Act 1989 (the Act) on the TGA Website (including at URL and URL ). This publication will generally not take place until either your right to request review under reg 30(1) of the Regulations (Request for Review) has expired or, if you have made a valid Request for Review, until the process set out in reg 30 of the Regulations has concluded. If this publication takes place after the process set out in reg 30 of the Regulations has concluded, the publication will generally include information reflecting the outcome of that process. These results may also be released in other circumstances outlined in s 61 of the Act. Results are commonly released to State or Territory authorities and / or to national regulatory authorities of another country under this provision. This release may take place before your right to make a Request for Review has expired, or before the process set out in reg 30 of the Regulations has concluded. Where this occurs, the information released will include a statement to the effect that the test results are (or may be) subject to review. 27 Softmed was requested to immediately quarantine stock from the tested batch(es) that had not been distributed. 28 By email sent on 29 July 2022, Softmed was informed of a decision by a delegate within the TGA made under s 61 of the TG Act to release the failed test information to Commonwealth, State and Territory authorities with functions related to therapeutic goods, and was provided with a copy of the information released. The information released included a statement to the effect that the test results may be subject to review, along with a statement relating to treating the information as confidential and not disclosing the information to any other party without first consulting with the TGA. 29 The information released was in the following form: The information set out below / attached includes non-public information and is being released to you on the basis it will be treated in confidence and not disclosed to any other party without first consulting with the TGA, except in cases where your laws require disclosure. • Testing arranged by the TGA has produced test reports stating that all tested batches of Softmed A-Med Surgical Respirator P2 Level 3 (SM-RA201) failed level 3 fluid resistance at the main body lower level panel. • Softmed Manufacturing has been requested to quarantine affected stock pending the outcome of further investigations. • Softmed Manufacturing is entitled to request a review of the results of TGA's analysis if they provide evidence (i.e. a statement that a third party has analysed a part of the same sample, or a similar sample from the same batch and the results of that analysis) establishing that the goods do comply with the applicable provisions of the essential principles or an applicable requirement. • For two of the affected batches (L2021603 and L2021605), Softmed Manufacturing has previously provided TGA with reports from other laboratories indicating these respirators pass fluid resistance testing. However, these reports indicate that the number of specimens tested was not sufficient to meet the requirements of the standard (F1862 or ISO 22609) to test all areas of difference (main body (upper, middle, lower) and seams) separately. • TGA will be working with Softmed Manufacturing on an appropriate post-market actions for the affected products. • Testing arranged by the TGA has produced a report stating that the Healthcare Particulate Respirator P2/N95 - Flat Fold (SM-SR202) model passed fluid resistance testing. Testing carried out by the TGA has indicating that this model also passed visual inspection and PFE testing. • The test results referred to above are set out in the following table: Product ARTG Batch No. TGA Findings A-Med Surgical Respirator P2 Level 3 (SMRA201) 347410 L2021602 Visual Inspection: Pass (Trifold / Willow Leaf) L2021603 PFE: Pass L2021605 Fluid Resistance: • Pass at Level 3 (Main Body Centre Panel & Seam) • Fail at Level 3 (Main Body Lower Panel) Healthcare Particulate Respirator P2/N95 - Flat Fold (SM-SR202) 347410 L2021831 Visual Inspection: Pass PFE: Pass Fluid Resistance: Pass (Main Body, Seam & Line)

30 Softmed was informed in the 29 July email that the communication of the information was considered by the delegate to be: crucial to enable the State and Territory health departments to assess the potential risk to the health and safety of their frontline healthcare workers, and take appropriate action. 31 Later on 29 July 2022, Softmed (by its legal representative) sent an email to the TGA informing the TGA that: (1) none of the tested batches had been supplied by Softmed to the market; (2) Softmed considered the test results to be inherently defective due to the overstretching of the mask in the testing method employed by NMI; and (3) the TGA's decision to release the information has caused and would continue to cause Softmed "immense reputational and commercial damage". Softmed demanded an immediate retraction of the information. 32 By email sent on 1 August 2022, the TGA acknowledged receipt of the letter dated 29 July 2022 and that they "will notify Commonwealth, State & Territory authorities that Softmed has advised that the affected batches are not in circulation, and that Softmed disputes the results but has not yet exercised its review rights". 33 On 2 August 2022, Softmed provided to VicLab, an independent third party, samples of A-Med masks from batch numbers L2021603, L2021605, L2022066, L2022067, L2022089 and L2022090, for testing for resistance to penetration by synthetic blood, as required by AS4381:2015 using Test method ISO 22609. Softmed was unable to draw a sufficient sample from batch L2021602 for further testing. Softmed had samples from L2022066, L2022067, L2022089 and L2022090 tested as they had been recently supplied to the National Medical Stockpile. 34 On 3 August 2022, Intertek issued a revised report of the testing it had conducted in December 2021 confirming that all parts of the body of the devices had been tested. 35 On 3 August 2022, the TGA informed the Commonwealth, State and Territory health authorities that Softmed had advised that the tested batches had not been in circulation and that Softmed was disputing the test results but had not yet exercised review rights. 36 By reports of testing completed between 3 and 5 August, VicLab confirmed that the lower panel of the tested A-Med masks passed the fluid resistance testing. 37 On 15 August 2022, Softmed (by its legal representative) made a request for review of the TGA's testing results of the lower panel of the A-Med masks. 38 On 16 September 2022, a delegate of the Secretary accepted the review request. Review testing was conducted by Nelson Laboratories, another independent third party. The TGA provided samples that remained from the tested batches that had been provided to the TGA on 2 March 2022. 39 By letter attached to an email sent to Softmed's legal representative by the TGA on 16 December 2022, Softmed was informed that: Results of r 30 testing 2. Nelson has analysed the samples and on 15 December 2022 provided signed certificates to the TGA setting out the results of its analysis (Nelson Conclusive Certificates). A copy of the Nelson Conclusive Certificates is at Attachment A. 3. I note that the Nelson Conclusive Certificates state that all samples passed fluid resistance testing on the main body (lower panel)… 4. As the Secretary has received the Nelson Conclusive Certificates, the Certificates of Responsible Analyst cease to have effect in relation to the test results for Resistance Against Penetration by Synthetic Blood (ISO 22609:2004) stated in them (r 30(8) of the Regulations). The Nelson Conclusive Certificates will, in the absence of evidence to the contrary, be conclusive proof of the matters stated in them (r 30(10) of the Regulations). Request to quarantine 5. The requests made by Mr Baillie, in his capacity as responsible analyst, in the Certificates of Responsible Analyst for you to quarantine stock of the above-mentioned batches are rescinded. … Post Market Review 7. The outcome of this review has been provided to the Medical Devices Surveillance Branch, who will be in contact regarding any required action. Proposed publication of test results in Nelson Conclusive Certificates on TGA website 8. As a delegate of the Secretary under s 61 of the Therapeutic Goods Act 1989 (Act), I am proposing to release to the public the test results subject of the Nelson Conclusive Certificates pursuant to Therapeutic Goods information (Laboratory Testing) Specification 2017 and s 61(5C) of the Act. 9. Specifically, I am proposing (consistent with usual TGA practice) to publish the attached information (Attachment B) on the TGA website at https://www.tga.gov.au/testingfacemasks-and-respirators. Proposed publication of test results in Nelson Conclusive Certificates to Commonwealth, State and Territory health authorities 10. As a delegate of the Secretary under s 61 of the Act, I am also proposing pursuant to s 61(3) of the Act to release to Commonwealth, State and Territory health authorities the test results subject of the Nelson Conclusive Certificates. 11. Specifically, I am proposing to publish the annexed information (Annexure 1) to the same email addresses contained in the 3 August 2022 Email… 40 Following consideration of the correspondence from Softmed, on 21 December 2022, a delegate of the Secretary decided to release the following information to the Commonwealth, State and Territory health authorities: The information set out below / attached includes non-public information and is being released to you on the basis it will be treated in confidence and not disclosed to any other party without first consulting with the TGA, except in cases where your laws require disclosure. Below is an update on regulatory testing of three batches (L2021602, L2021603 and L2021605) (Batches) of the Softmed A-Med Surgical Respirator P2 Level 3 (SM-RA201) (A-Med Respirator) manufactured by Softmed Manufacturing Pty Ltd (Softmed Manufacturing): • As stated previously, testing arranged by the TGA (TGA Results) found that samples of the Batches of the A-Med Respirator: • passed visual inspection, PFE and fluid resistance testing at level 3 for the main body (centre panel) and seam; • failed level 3 fluid resistance at the main body (lower panel). • Pursuant to r 30 of the Therapeutic Goods Regulations 1990, Softmed Manufacturing requested a review of the TGA Results and provided evidence that a third party with appropriate qualifications and experience had analysed similar samples from the Batches and that those samples had passed level 3 fluid resistance testing. That evidence was sufficient for the TGA to accept the request for review of the TGA results. • That review was subsequently conducted by Nelson Laboratories (Nelson), a third-party tester agreed to by the TGA and Softmed Manufacturing. Nelson conducted fluid resistance of the main body (lower panel) at level 3 of 32 samples from each of the Batches pursuant to ISO 22609 / ASTM F1862. Nelson's results passed all specimens tested from the samples of all three Batches (Nelson Results). • The Nelson Results were obtained from testing specimens drawn from the same samples of all three Batches as originally used for the TGA Results. • Consequently: • the TGA Results in relation to fluid resistance testing of the lower panel have no effect; • the Nelson Results are conclusive proof that the Batches comply with fluid resistance of the main body (lower panel) at level 3 pursuant to ISO 22609 / ASTM F1862; and • the sum of the Nelson Results (lower panel fluid resistance) and the remaining TGA Results is that the Batches of the A-Med Respirator are compliant with each of the tested aspects of applicable Australian regulatory requirements. • In light of the above, TGA's request to Softmed Manufacturing to quarantine stock of the Batches has been rescinded (noting that Softmed has advised that the Batches are not (and have not been) in circulation). • The test results referred to above are set out in the following table: Product ARTG Batch No. TGA Results, as superseded by Nelson Results A-Med Surgical Respirator P2 Level 3 (SM-RA201) (Trifold / Willow Leaf) 347410 L2021602 Visual Inspection: Pass L2021603 PFE: Pass L2021605 Fluid Resistance - Pass at Level 3 at the main body, seam and lower panel

As per the disclaimer above, this is non-public information to be treated in confidence and not disclosed to other parties unless in consultation with the TGA or where your laws required disclosure. If you have you disclosed information concerning the TGA Results to any other party in consultation with the TGA, we request that you provide this information about the Nelson Results to the same recipients. If you have disclosed information concerning the TGA Results to any other party because disclosure was required by law, you may wish to consider whether this information is required to be disclosed to the same party by law. 41 After 29 July 2022, over the remaining part of 2022, Softmed sales to public sector customers reduced by 97% compared to total sales in 2022 prior to 29 July 2022. Sales reduced further in 2023.

Softmed's contentions 42 Softmed contends that a breach of the rules of natural justice occurred in connection with the making of the decision made on or about 29 July 2022 to release the information to the Commonwealth, State and Territory health authorities. Softmed contends that it was denied the opportunity to be heard in relation to the decision before it was made. More specifically, Softmed contends that it was denied the opportunity to explain that the tested batches had not been supplied to the market and that the testing had not been conducted in accordance with international standards. 43 Softmed contends that a requirement to afford the opportunity to be heard prior to the release of the information ought to be implied as a matter of statutory interpretation because the release of the information - the failure of the lower panel of the A-Med mask of the fluid resistance requirements - was apt to adversely affect Softmed's interests as the manufacturer of the masks: Minister for Immigration and Border Protection v SZSSJ [2016] HCA 29; (2016) 259 CLR 180 at [75]. 44 Softmed contends that reputation and financial interests are recognised interests for this purpose. Personal reputation is an established interest which should not be damaged by an executive decision unless the person whose reputation is likely to be affected has had a full and fair opportunity to show why that decision ought not be made: Annetts v McCann [1990] HCA 57; (1990) 170 CLR 596 at 598 (Mason CJ, Deane and McHugh JJ), 608-9 (Brennan J); Ainsworth v Criminal Justice Commission [1992] HCA 10; (1992) 175 CLR 564 at 578 (Mason CJ, Dawson, Toohey and Gaudron JJ); Johns v Australian Securities Commission [1993] HCA 56; (1993) 178 CLR 408 at 470-1 (McHugh J). The failed test information was said to reflect unfavourably on Softmed. 45 Softmed contends that there was no matter of urgency in the circumstances that negated the implied obligation to accord natural justice. There was no need for urgency in the present case that would modify or exclude a duty to accord procedural fairness. Softmed relied upon the following statement by Finn J in South Australia v Slipper [2004] FCAFC 164; (2004) 136 FCR 259 at [115]: When one has regard to the actual circumstances of the present matter, it cannot properly be said that a situation of such exceptional urgency existed as would justify the reduction of the requirements of procedural fairness to 'nothingness'. 46 Softmed relied upon the chronology of events to support the submission that there was no urgency in the present case: (1) Although in receipt of the report on 10 June 2022, the test results were not certified by the responsible analyst under reg 29(1) until 22 July 2022. (2) A notice under reg 29(4) to quarantine the stock from the tested batches that had not been distributed was issued to Softmed on 25 July 2022. (3) The email releasing the information to the Commonwealth, State and Territory departments was sent on 29 July 2022. It was not expressed as an urgent communication.

Consideration 47 Whether the observance of the principles of natural justice is a condition of the valid exercise of a statutory power is a matter of statutory interpretation: Saeed v Minister for Immigration and Citizenship [2010] HCA 23; (2010) 241 CLR 252 at [13] (French CJ, Gummow, Hayne, Crennan and Kiefel JJ); Disorganized Developments Pty Ltd v South Australia [2023] HCA 22 at [32] (Kiefel CJ, Gageler, Gleeson and Jagot JJ). There is an assumption that the legislature, being aware of the common law principles, would have intended that they apply to the exercise of a power of the kind referred to in Annetts: Saeed at [12]. It follows that a statute conferring a power the exercise of which is apt to affect an interest of an individual is presumed to confer that power on condition that the power is exercised in a manner that affords procedural fairness to that individual. The presumption operates unless clearly displaced by the particular statutory scheme: SZSSJ at [75] (French CJ, Kiefel, Bell, Gageler, Keane, Nettle and Gordon JJ). 48 To determine whether the legislature's intention is to condition the exercise of a statutory power upon observance of the principles of natural justice, one must have regard to the text of a statute creating the power, the subject-matter of the statute, the interests which exercise of the power is apt to affect and the administrative framework created by the statute within which the power is to be exercised: Kioa v West [1985] HCA 81; (1985) 159 CLR 550 at 616 (Brennan J). 49 Although the rules of natural justice may be excluded because the power in question is of its nature one to be exercised in circumstances of urgency or emergency: Marine Hull & Liability Insurance Co Ltd v Hurford (1985) 10 FCR 234 at 241 (Wilcox J); "urgency cannot generally be allowed to exclude the right to natural justice": Minister for Aboriginal and Torres Strait Islander Affairs v Western Australia [1996] FCA 395; (1996) 67 FCR 40 at 59 (Black CJ, Burchett and Kiefel JJ). 50 Although the question of whether a statutory power is conditioned on the observance of the principles of natural justice demands a universal answer, what is necessary to satisfy that condition can depend on the particular circumstances of the particular case: Kioa at 611 (Brennan J). It has been said that (Kioa at 615): the intention to be implied when the statute is silent is that observance of the principles of natural justice conditions the exercise of the power although in some circumstances the content of those principles may be diminished (even to nothingness) to avoid frustrating the purpose for which the power was conferred. 51 Urgency may be a circumstance that affects the content of the obligation to afford natural justice: J Wattie Canneries Ltd v Hayes (1987) 74 ALR 202 at 214 (Keely, Wilcox and Gummow JJ); Western Australia v Native Title Registrar [1999] FCA 1591; (1999) 95 FCR 93 at 103 (Carr J). 52 There are thus two questions which must be addressed: (1) Was the obligation to afford procedural fairness a condition of the exercise of the power to release information under s 61(3)? (2) If so, what did procedural fairness require in the particular factual circumstances? 53 The Secretary contended that as a matter of statutory interpretation, the exercise of the power under s 61(3) to release information was not impliedly conditioned on the observance of procedural fairness because: (a) the s 61(3) power was not a statutory power the exercise of which is capable of having an adverse effect on legally recognised rights or interests. (b) the statutory scheme displaced the presumption that the exercise of the power was so conditioned. 54 It is difficult to discern how a release of information might adversely affect any financial interest or propriety interest of Softmed that was unrelated to, and did not flow from, any adverse impact on Softmed's reputation. 55 Although the Secretary accepted that reputation is a legally recognised interest that may engage the presumption, it is an interest which must give way to the public interest in the free exchange of information between persons who are under a public duty and the information is relevant to the performance of that public duty. The Secretary relied upon the decision in L v State of South Australia; H-P v State of South Australia [2017] SASCFC 133; (2017) 129 SASR 180. 56 The plaintiffs in L sought judicial review of three actions: (a) the findings of the Care Concern Investigations Unit (CCIU) of the South Australian Department for Education and Child Development made with respect to children in their foster care; (b) the endorsement of those findings by the Chief Executive of the Department for Education and Child Development (Chief Executive); and (c) the decision to remove children from their care and place them with other carers. 57 It was held that neither the making of the CCIU reports nor their endorsements were amenable to judicial review. The Court further held that even if there was an obligation to accord procedural fairness in the investigation and the report, then the plaintiffs did not have an interest of the kind which would be protected. It was said at [176]: The agreed facts in this matter show that the CCIU reports were not sent or made available to any officer of the Department or member of another government agency who did not have a reason to access it for the purposes of his or her public duties. The law does not confer procedural protections on the dissemination of reports affecting reputations which are preparatory, and do not in themselves affect rights interests or privileges, to persons who may properly have regard to that information for the purposes of discharging their public duties. There is an analogy here with the limits on the tort of defamation which does not impose liability for communications between persons with a legitimate common interest in receiving communications on that subject matter. True it is that the occasion may be abused and that the failure to give an opportunity to be heard may result in unnecessary reputational damage. Private law remedies will be available in these cases. However, for the purposes of public law, the individual's interest in his or her reputation must give way to the higher public interest in the free exchange of information between persons who have a duty to evaluate that information. 58 The agreed facts in L included the following: (1) The CCIU is a business unit of the Department for Education and Child Development which provided child protection services and for which the Minister for Education and Children Development (the Minister) was responsible. The CCIU was staffed by public servants who are subject to the direction of the Department for Education and Child Development's Chief Executive. (2) The CCIU report was forwarded to the Chief Executive who determined whether or not to endorse its outcome. The endorsed report and outcome were sent to other business units of the Department for Education and Child Development known as Families SA, Adverse Events, Regional Offices and the Incident Management Directorate (IMD). The report was stored electronically and could be accessed by those business units and also by the Care Registration Unit (CRU) which is another business unit of the Department for Education and Child Development. It could also be accessed by the Screening Unit which is a business unit of the Department for Communities and Social Inclusion. (3) The Teachers' Registration Board (TRB) was an independent statutory authority established under the Teachers Registration and Standards Act 2004 (SA) which regulated the South Australian teaching profession and was staffed by public sector employees. The TRB could request CCIU reports from the Department for Education and Child Development. The Chief Executive had authorised release of CCIU reports to the TRB if they were relevant to its functions. (4) In the particular case of L, the CCIU forwarded a copy of the report under cover of a letter from the Manager of the CCIU to: • the Deputy Chief Executive; • AC Care; • IMD; and • the responsible Regional Office. (5) The report was also forwarded to Adverse Events and the TRB and was accessible by the CRU. 59 Softmed sought to distinguish L and instead sought to rely upon the decision of the Full Court of the Victorian Supreme Court (as it was then called) in State of Victoria v Master Builders' Association of Victoria [1995] 2 VR 121 (MBA). Having decided that the power exercised in that case was amenable to judicial review, the Court concluded in MBA that, in the circumstances disclosed by the evidence in that case, the appellant owed a duty of procedural fairness to those contractors whose names had been or were to be placed on a black list prepared and promulgated by the Building Industry Task Force. Justice Tadgell concluded (at 140): The dissemination of the black list among government departments and agencies and the like having a dominant influence in the building industry, and the letters accompanying them, were and are likely to damage the commercial reputations of those whose names are on the list. As a matter of law Ainsworth's case authorises the conclusion that commercial reputation is an interest attracting the protection of the rules of natural justice against its being unwarrantably harmed by executive decision: at 576-8, 591. The compilation and publication of the black list were, as I have concluded, the results of a decision made in exercise of the power in performance of a public duty to which I have referred. Implementation of the decision being inherently capable of endangering an interest of contractors that they were entitled to protect against an excessive exercise of the power, the rules of procedural fairness applied to the exercise. 60 The letters referred to were letters sent by the Building Industry Task Force to state government departments and statutory agencies and to municipal councils. Enclosed with the letter was a "list of tenderers not clear to tender, nor be awarded contracts". 61 Softmed submitted that the decision in L was distinguishable from the circumstances of the present case because L "only involved intra-departmental communication". That submission is not accepted. As demonstrated above, the information in L was disseminated and available for access to different statutory authorities and departments within the South Australian government. 62 The Court in L at [165] considered that "the dissemination of the list to local government authorities is an important feature of the circumstances in the MBA case because there was no identity of interest between the State government departments involved in the compilation of the list, and the local government authorities to which the list was sent". Having regard to the factual context of L, the reference to "identity of interest" is not to be strictly construed. The authority and departments to which the information in L was disseminated performed complementary albeit not identical public functions. 63 The release of information pursuant to s 61(3) is analogous to the circumstances in L. It is a power to release limited categories of information to government authorities with complementary functions relating to therapeutic goods for the specific purpose of enabling those government authorities to discharge those functions. The nature of the information which can be disclosed is not a black list or a direction to not acquire or procure products from named suppliers. It is information of a limited nature provided for a limited purpose. 64 The authorities to whom information can be released are State/Territory authorities and an authority of the Commonwealth itself. One of the examples relied upon by Softmed to demonstrate the adverse effect of the release of the information related to correspondence Softmed received from the Commonwealth Department of Health itself - being a letter from a representative of the National Medical Stockpile authority. There is an inherent public interest in the free exchange of information within a government department which is not consistent with a duty to accord procedural fairness before exchanging information. In the public health context of s 61(3), and the release of information relating to therapeutic goods to other government bodies performing functions relating to those goods for the purpose of performing those functions, there is no logical basis for distinguishing the release of information within the Commonwealth Department of Health and between the Commonwealth and State/Territory authorities performing related and complementary functions. 65 In this respect, s 61(12) is important. Each of the subsections of s 61 have effect independently of each other. A release of information under s 61(3) is not to be equated with a release of information to the public where no limit is placed on the purposes for which the information is to be used by the public. A conclusion that a release of information under s 61(3) is not subject to an obligation to afford a right to be heard prior to the release of that information says nothing about whether a release of information under other subsections of that section are subject to such a duty. 66 For these reasons, the obligation to afford procedural fairness is not a condition of the exercise of the power to release information under s 61(3). 67 Furthermore, even if the obligation to afford procedural fairness is a condition of the exercise of the power to release information under s 61(3), the content of that duty was reduced in the factual context of the present case. The statutory power to release information to government authorities was being exercised in relation to the release of results of testing undertaken with the objective of testing the efficacy of medical devices in the context of a global pandemic which required close co-ordinating between Commonwealth and State/Territory governments. The information released was qualified in its terms. It included an acknowledgement of Softmed's right to request a review of the analysis and that, in respect of two of the batches, Softmed had previously provided reports from other laboratories indicating these respirators passed fluid resistance testing. It also expressly recognised that other product models produced by Softmed had passed fluid resistance testing. The information released included a statement relating to treating the information as confidential and not disclosing the information to any other party without first consulting with the TGA. 68 The form of the information released did not include a direction to State/Territory authorities to not acquire products from Softmed. It was information provided for the purpose of assisting in the discharge of functions to be performed by government authorities subject to public duties and was provided to persons who might reasonably be expected to be experienced or qualified users of such information. The use of such information could reasonably be expected to be measured and considered. Any adverse effect on the reputational interest of Softmed as a result of the information released is to be balanced against the broader interests of the public in the context of the exchange of information between government authorities in a global pandemic. 69 In these circumstances, the content of any duty of procedural fairness did not require the release of information under s 61(3) be delayed for the duration of the period during which Softmed might seek and obtain a review. Nor did it require Softmed have a right to settle the terms of the disclosure to be made. 70 Softmed contends that the duty to accord it procedural fairness at least required the TGA to confirm with it that the tested batches had been distributed to the market before releasing the failed test information. That contention is not accepted in circumstances where the volume of samples provided by Softmed to the TGA was consistent with the TGA request for samples that was applicable where "you have supplied or sold masks or respirators". Furthermore, the power to release test results under s 61(3) is not statutorily limited to circumstances where the devices tested are from batches in fact supplied or sold. 71 Softmed had been put on notice on 26 July 2022 that a release of the failed test information to government authorities might be made before its right to request a review had expired, or before the review process had concluded. It was open to Softmed to immediately respond with a notification to the TGA that the tested batches had not been distributed as Softmed in fact did when advised of the actual release of the information on 29 July 2022. Following the release of the information, Softmed contacted its customers who were government health departments or agencies to which it had supplied products informing them that the three batches of the A-Med mask referred to by the TGA in the information had not been supplied to any customers and that Softmed disputed the manner in which the testing relied upon by the TGA had been performed. On 3 August 2022 the TGA informed the Commonwealth, State and Territory health authorities that Softmed had advised that the tested batches had not been in circulation and that Softmed was disputing the test results but had not yet exercised review rights. The relevant procurement authorities for New South Wales, Western Australia and Queensland indicated to Softmed that they were awaiting further advice from the TGA in relation to Softmed's A-med masks. The TGA provided updated advice in December following the retesting. 72 There was accordingly no breach of an obligation to accord Softmed procedural fairness.

GrOUND 2: RELEVANT CONSIDErATIONS 73 Softmed contends that the making of the decision to release the failed test information was an improper exercise of the power conferred by s 61(3) of the TG Act because the delegate failed to take into account relevant considerations in the exercise of the power (s 5(1)(e) and (2)(b) of the ADJR Act). The considerations said to be relevant but not considered were the following preconditions to the exercise of the power: (1) Whether the authorities to which the information was released in fact performed functions relating to therapeutic goods; (2) Whether and how the information released was capable of being used in the performance of those functions. 74 Softmed contended that the record of the delegate's decision failed to disclose any "active intellectual process" engaged in by the decision-maker as to either of these matters. 75 There is some merit in the Secretary's criticism of the manner in which this ground of review is framed in that it appears to confuse a condition to the exercise of the power with a consideration that must be taken into account in deciding whether to exercise the power. The power to release information under s 61(3) is limited in scope. It is limited in terms of the types of information that might be released, the persons to whom the information can be released and the purposes for which the information so released might be used. Strictly speaking those are matters that go to the scope of the power and not considerations which are required to be taken into account in considering whether to exercise the power. They are conditions to the existence of the power rather than considerations to be taken into account in determining whether to exercise the power. 76 Softmed did not demonstrate that the persons to whom the information was released did not perform functions relating to therapeutic goods. Softmed relied upon State/Territory drugs and poison legislation as demonstrating that the State/Territory health departments had responsibilities for medicines but not medical devices. However, the fact that the State or Territory authorities may not have statutory responsibility for the regulation of therapeutic goods is not the question. It is whether the authorities perform "functions relating to" therapeutic goods. Section 61(3) does not require that the relevant State or Territory authority perform a statutory as opposed to purely executive function in relation to therapeutic goods. For example, the functions relating to therapeutic goods can extend to the provision of those goods to those providing services in the public health system. There is also a logical disconnect between Softmed's contention that the State/Territory authorities to which the information was released did not perform relevant functions and the contention that the release of the information resulted in harm to its reputation amongst authorities responsible for procuring those products for use in the public health system. 77 Section 61(3) requires that the information be released for use by a Commonwealth, State/Territory government authority in performance of their functions relating to therapeutic goods. The term "for use" looks to the purpose for which the information released may be used. 78 The Record of Decision discloses that the information was released following a request made by at least some authorities for "requested information regarding the Products to assist those authorities in performing their functions". The information released was of a kind specified in s 61(3)(a) to (e). The terms of s 61(3) indicate that the information of the kind specified in s 61(3)(a) to (e) is capable of being used in performance by authorities of functions relating to therapeutic goods. Section 61(3)(e) does not limit the information that may be released to reports of testing of samples from batches of therapeutic goods that have been distributed or supplied. In those circumstances it was not for the delegate to form a view about how the information ought to be used by the authorities in the performance of their functions relating to therapeutic goods. There is nothing to suggest that the request for information, or the provision of it, was not made for the bona fide purpose of being used by the authorities in the performance of the authorities' functions relating to therapeutic goods. 79 The making of the decision to release information was not beyond power as it has not been shown that the requirements of s 61(3) were not satisfied. Nor was the making of the decision to release information an improper exercise of power by reason of the failure by the delegate to take into account a mandatory relevant consideration.

ground 3: UNreasonableness 80 It was not disputed that it was an implied condition of the power to release information under s 61(3) that it be exercised in a manner that is not legally unreasonable as described in s 5(2)(g) of the ADJR Act, namely an exercise of a power that is so unreasonable that no reasonable person could have so exercised the power. 81 Softmed contended that the exercise of power to release information was so unreasonable because it was exercised: (a) without any information regarding distribution of the tested batches; (b) prior to expiration of the 21-day period for Softmed to request review under reg 30 of the Regulations (and in circumstances where the delegate was already in possession of evidence that the A-Med mask passed fluid resistance testing); and (c) having also acted in the capacities of official analyst and responsible analyst in connection with the decision. 82 That contention is not accepted. Softmed provided samples from three batches consistent with the number of samples requested by the TGA "if you have supplied or sold masks or respirators". It cannot be accurately said that in those circumstances the information was released "without any information regarding distribution of the Impugned Batches". The delegate releasing the information had a reasonable basis for assuming that the samples were from batches that had been supplied by Softmed. Furthermore, the terms of s 61(3) do not suggest that it is only test results from samples of batches that have in fact been distributed that might be disclosed to Commonwealth, State or Territory authorities performing relevant functions. 83 The exercise by the delegate of the power to release the failed test information was not so unreasonable that no reasonable person could have so exercised the power by reason of the fact that the information was released prior to the expiration of the 21-day period for review given the terms in which the information was released. The terms of the release contained an express acknowledgement of Softmed's right to request a review of the analysis and that, in respect of two of the batches, Softmed had previously provided reports from other laboratories indicating these respirators passed fluid resistance testing. The release was made to a confined, informed group of recipients subject to public duties. 84 The third basis on which Softmed contended the decision to release the failed test information was so unreasonable that no reasonable person could have so exercised the power was related to the fact that the delegate was also the individual who acted as the "official analyst". As official analyst, the individual made the determination under reg 25(3)(b) of the tests to be performed. The testing here included the testing of the lower panel. He also nominated himself as the responsible analyst to arrange for the performance of the tests. Softmed contended that in making the decision to release the test results in relation to the lower panel, the delegate did not know (in his capacity as official and/or responsible analyst) if the lower panel was intended to be fluid resistant. 85 This contention is, in substance, directed to the testing performed. This was the subject of the reg 30 review. In seeking that review Softmed did not seek to exclude a testing of the lower panel and indeed procured testing of the lower panel in its own testing. Softmed has not demonstrated that the decision to release the failed test information was unreasonable based on this contention.

RElief 86 By its further amended application, the relief sought by Softmed was primarily declaratory relief. 87 Even if satisfied that any of the grounds of relief had been made out, this is not a case in which relief in the form sought ought to be granted. 88 Declaratory relief must be directed to the determination of a legal controversy and not to answering an abstract or hypothetical question. For declaratory relief to be granted in exercise of judicial power, the declaration must be seen at the time of its making to produce foreseeable consequences for the parties: Union NSW v New South Wales [2023] HCA 4 at [16] (Kiefel CJ, Gageler, Gordon, Gleeson and Jagot JJ). 89 The High Court in Ainsworth granted declaratory relief in circumstances where the Criminal Justice Commission had failed to observe the requirements of procedural fairness in preparing a report tabled in Parliament, the plurality stating (at 582): That report has already had practical consequences for the appellants' reputations. For all that is known, those consequences may extend well into the future. It is appropriate that a declaration be made in terms indicating that the appellants were denied natural justice. That may redress some of the harm done. 90 For the following reasons, the Court is not satisfied that the failed test information may have practical consequences for Softmed's reputation into the future. 91 The circumstances of this case are distinguishable from those in Ainsworth. When it was released on 29 July 2022, the information included an acknowledgement that Softmed could seek a review of the test results. The information also acknowledged that other products manufactured by Softmed had passed all tests. On 3 August 2022 the TGA informed the Commonwealth, State and Territory health authorities that Softmed had advised that the tested batches had not been in circulation and that Softmed was disputing the test results but had not yet exercised review rights. The evidence indicates that prior to 21 December, some of the authorities were not willing to acquire at least the A-Med masks pending further advice from the TGA. On 21 December 2022 the authorities were advised that all testing had been passed (cf M House Pty Ltd v Secretary, Department of Health and Aged Care [2023] FCA 768, where impugned information remained published on the TGA website). 92 Softmed provided evidence of its sales volumes collapsing over the period from July 2022. Although Softmed's sales have collapsed since July 2022, the pandemic, which generated so much demand for medical devices in the form of face masks and respirators, has since ended. The period from July 2022 was a period in which public health measures were reducing. To compare sales over a period during which the pandemic waned and public health measures changed to demonstrate that a release of information in July 2022, and retracted in December 2022, continues to cause a loss of sales is not a simple matter of showing a decrease in sales volumes. It requires, at the least, a relative understanding of market size, market share and other competitive factors such as price. The evidence was that on 4 October 2022, the National Medical Stockpile Taskforce issued a request for applications. In a subsequent debriefing, Softmed was advised that it had been unsuccessful primarily on price. The reduction in sales experienced by Softmed was attributable to at least a number of factors which could not be addressed by the making of a declaration on whether the release of information had been made without compliance with the rules of natural justice or other statutory duty. 93 Furthermore the information released specifically related to three batches of devices which have expired. The subject of the information released no longer exists in a saleable form. 94 In these circumstances it is difficult to conclude that a declaration can produce any foreseeable consequence for Softmed. The effect of the information released on 21 December 2022 was to supersede both factually and legally the information provided in July. Any declaratory relief cannot declare the results of the earlier testing invalid - that was the function of the review process. Softmed successfully pursued the review process, and thereby nullified the results of the earlier testing, and had the TGA release the revised results with a statement that those revised results render the earlier results of no validity. Following the review, the TGA also published the fact that the devices were compliant on its publicly accessible information on its website. 95 Having pursued and successfully obtained merits review of the test results, and having secured the publication of a conclusive evidence certificate nullifying the evidentiary effect of the impugned test results, the Court is not satisfied that declaratory relief in respect of the decision to release information concerning the impugned test results would have foreseeable consequences for Softmed. 96 The application is dismissed. I certify that the preceding ninety-six (96) numbered paragraphs are a true copy of the Reasons for Judgment of the Honourable Justice Hespe.

Therapeutic Goods Act 1989(Cth)ss 3, 4, 9A, 41BA, 41BD, 41BH, 41CA, 41FN, 61

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