Pharmaceuticals

The World Health Organization 2019 Antibacterial agents in clinical development: an analysis of the antibacterial clinical development pipeline is the WHO third annual review of the clinical antibacterial pipeline to analyse how the pipeline responds to the WHO priority pathogens list.

This report covers direct-acting small molecules and biological agents that are in development worldwide. It assesses to what extent the pipeline addresses the WHO priority pathogens, Mycobacterium tuberculosis and Clostridioides difficile and to what extent the antibacterial agents are innovative. This report is part of the WHO’s efforts in global research and development (R and D) priority setting to contain antimicrobial resistance. 

Key messages:

• The clinical pipeline remains insufficient to tackle the challenge of increasing emergence and spread of antimicrobial resistance. 

• It is primarily driven by small- or medium-sized enterprises (SMEs), with large pharmaceutical companies continuing to exit the field. 

• Eight new antibacterial agents have been approved since 1 July 2017, but overall, they have limited clinical benefits. 

• One new anti-tuberculosis (anti-TB) agent, pretomanid, developed by a not-for-profit organization, has been approved for use within a set drug-combination treatment for MDR TB. 

• The current clinical pipeline contains 50 antibiotics and combinations (with a new therapeutic entity) and 10 biologicals, of which 32 antibiotics are active against the WHO priority pathogens: o Six of these agents fulfil at least one of the innovation criteria; only two of these are active against the critical MDR Gram-negative bacteria. 

• More than 40% of the pipeline targeting WHO priority pathogens consists of additional β-lactam and β-lactamase inhibitor (BLI) combinations, with a major gap in activity against metallo-β-lactamase (MBL) producers. 

• The anti-TB and C. difficile antibacterial pipeline is more innovative than the WHO priority pathogens pipeline, with more than half of the antibiotics fulfilling all of the innovation criteria. 

Market approvals 

Since 2017 eight new antibiotics ― including one for the treatment of TB ― have been approved (Table 1). Two, vaborbactam + meropenem and lefamulin, were classified as meeting at least one of the innovation criteria. The other newly approved antibiotics are derivatives of known classes, such as the two tetracycline derivatives eravacycline and omadacycline. Half of the new agents target carbapenem-resistant Enterobacteriaceae (CRE); however, only one is of a new class. New approved antibiotics to treat carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa are absent. Thus, there is a visible mismatch between the few newly approved antibiotics and the WHO priority pathogens list. Of the two new β-lactam/BLI combinations that have been approved, vaborbactam is a first-in-class BLI that contains a cyclic boronate pharmacophore and relebactam, a diazabicyclooctane (DBO) analogue. Both are active against many CRE isolates, but not against CRE where resistance is due to MBLs such as the New Delhi metallo-β-lactamase (NDM) enzyme. Pretomanid, which was approved by the US Food and Drug Administration (FDA) in August 2019 for use within a set drug-combination treatment for MDR TB, is the first new TB drug to be developed and registered by a not-for-profit organization, the Global Alliance for TB Drug Development (TB Alliance). 

Overall, the newly approved products have limited clinical benefit over existing treatments. The lack of differentiation against existing treatments, their non-inclusion in clinical guidelines and their higher prices in comparison to existing generic treatments make it difficult to predict their place in the treatment landscape. As six of the eight are from existing classes where multiple resistance mechanisms are well established, the possibility of fast emergence of resistance to these new agents is foreseen. Clinical antibacterial pipeline As of 1 September 2019, there are 50 antibiotics and combinations (with a new therapeutic entity), and 10 biologicals in the clinical pipeline (Phase 1– 3) targeting the WHO priority pathogens, TB and C. difficile (Fig. 1). Of these 50 antibiotics, 32 target the WHO priority pathogens, and 12 of those have activity against at least one of the critical Gram-negative pathogens (Table 2). There are 12 antibiotics targeting TB and six for the treatment of C. difficile infections. 

Of the 32 antibiotics that are being developed and that target the WHO priority pathogens, six fulfil at least one of the four criteria that were used to assess the extent to which agents in the pipeline can be classified as innovative (see criteria under section 2.3.2). Only two of the antibiotics that meet at least one of the innovation criteria are active against the critical Gram-negative bacteria. On 17 July 2019, Polyphor terminated development of the intravenous form of murepavadin, which was the only potential treatment option against Gram-negative bacteria that fulfilled all four of the innovation criteria, due to concerns over nephrotoxicity observed in Phase 3. Seven of the 12 antibiotics under development for TB meet at least one of the innovation criteria (Table 4). The current pipeline is dominated by β-lactam/BLI combinations (n = 13, 41% of products targeting WHO priority pathogens). Of the β-lactam/BLI combinations, the majority target extended-spectrum β-lactamase (ESBL)-producing Enterobacteriaceae, Klebsiella pneumoniae carbapenemase (KPC) and oxacillinase-48 (OXA-48)-producing Enterobacteriaceae. There are only two agents (cefiderocol and durlobactam [ETX-2514] + sulbactam) that are active against MDR A. baumannii and one (cefiderocol) that is active against MDR P. aeruginosa. 

Market dynamics and funding situation 

Public and philanthropic investment in developing antibacterial agents has increased in recent years, through mechanisms such as the Biomedical Advanced Research and Development Authority (BARDA), Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), the Replenishing and Enabling the Pipeline for Anti-Infective Resistance (REPAIR) Impact Fund, and the Global Antibiotic Research and Development Partnership (GARDP). 

Private investment, however, has further decreased, with large pharmaceutical companies and private venture capital investors abandoning the area. Recognizing the need to ensure that effective antibiotics are available to enable and secure modern medicine (e.g. for patients undergoing chemotherapy or organ transplantation), governments are testing different models to change the value and market dynamics for antibiotics. Current examples include the United States’ revised hospital reimbursement system and the United Kingdom and Sweden’s pilots on alternative antibiotic procurement and payment models. It is important that all these efforts focus on the most useful and innovative products in the clinical and preclinical pipeline. This assessment should help governments in making appropriate decisions in this regard.

The important 'Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study' by Nicholas J DeVito, Seb Bacon and Ben Goldacre in (2020) The Lancet comments

 Background 

Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers' ethical obligations to participants, and represents an important source of research waste. The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. The first trials covered by the Final Rule of this act became due to report results in January, 2018. In this cohort study, we set out to assess compliance. 

Methods 

We downloaded data for all registered trials on ClinicalTrials.gov each month from March, 2018, to September, 2019. All cross-sectional analyses in this manuscript were performed on data extracted from ClinicalTrials.gov on Sept 16, 2019; monthly trends analysis used archived data closest to the 15th day of each month from March, 2018, to September, 2019. Our study cohort included all applicable trials due to report results under FDAAA. We excluded all non-applicable trials, those not yet due to report, and those given a certificate allowing for delayed reporting. A trial was considered reported if results had been submitted and were either publicly available, or undergoing quality control review at ClinicalTrials.gov. A trial was considered compliant if these results were submitted within 1 year of the primary completion date, as required by the legislation. We described compliance with the FDAAA 2007 Final Rule, assessed trial characteristics associated with results reporting using logistic regression models, described sponsor-level reporting, examined trends in reporting, and described time-to-report using the Kaplan-Meier method. 

Findings 

4209 trials were due to report results; 1722 (40·9%; 95% CI 39·4–42·2) did so within the 1-year deadline. 2686 (63·8%; 62·4–65·3) trials had results submitted at any time. Compliance has not improved since July, 2018. Industry sponsors were significantly more likely to be compliant than non-industry, non-US Government sponsors (odds ratio [OR] 3·08 [95% CI 2·52–3·77]), and sponsors running large numbers of trials were significantly more likely to be compliant than smaller sponsors (OR 11·84 [9·36–14·99]). The median delay from primary completion date to submission date was 424 days (95% CI 412–435), 59 days higher than the legal reporting requirement of 1 year. 

Interpretation 

Compliance with the FDAAA 2007 is poor, and not improving. To our knowledge, this is the first study to fully assess compliance with the Final Rule of the FDAAA 2007. Poor compliance is likely to reflect lack of enforcement by regulators. Effective enforcement and action from sponsors is needed; until then, open public audit of compliance for each individual sponsor may help. We will maintain updated compliance data for each individual sponsor and trial at fdaaa.trialstracker.net.

Huawei

'What to Make of the Huawei Debate? 5G Network Security and Technology Dependency in Europe' by Tim Rühlig and Maja Björk (Swedish Institute of International Affairs 1/2020) comments

Europe is controversially discussing whether to ban the Chinese tech-giant Huawei from the roll-out of the new generation of mobile infrastructure, better known as 5G, not least due to conflicting pressures from the governments of the United States and the People’s Republic of China. 5G is a critical infrastructure and will penetrate European society and its economy to an unprecedented extent. Proponents of a ban argue that Huawei is closely allied with the authoritarian Chinese party-state, which could utilise Huawei equipment for espionage and sabotage. The argument is that banning Huawei is a matter of increasing network security in Europe. This paper explains that while scepticism is reasonable, and the security concerns are valid, a ban on Huawei is not an effective solution for generating network security. Other technological measures – first and foremost better encryption, and redundancies coupled with vendor diversity – would be more effective, although complete network security can never be achieved. Scepticism of China’s influence over Huawei is reasonable. However, the idea of banning Huawei stems, rather than from concerns over network security, from a geopolitical logic. In this context, a ban on Huawei would help decrease European technological dependency on China. The geopolitical fear is that China could leverage this dependency to extract political concessions from Europe in the future. We argue that Europe should indeed respond to this challenge but instead of striving for technological self-reliance, we discuss how the European Union could preserve access to strategic technology by means of diversification of the supply chain and underlying patents, coupled with “protectionism light”. We believe this could help respond to the emerging geopolitical rivalry over high-technology such as 5G while at the same time attempting to preserve free trade as far as possible. In short, our sceptical view on the idea of banning Huawei from the roll-out of 5G in Europe does not stem from a trust in China or Chinese tech companies, but rather from the perspective that it is not the most effective response to the future challenges of 5G networks and technology dependence.

Rights

'Robot Rights? Let's Talk about Human Welfare Instead' by Abeba Birhane and Jelle van Dijk (Accepted to the AIES 2020 conference in New York, February 2020. The final version of this paper will appear in Proceedings of the 2020 AAAI/ACM Conference on AI, Ethics, and Society) comments

The 'robot rights' debate, and its related question of 'robot responsibility', invokes some of the most polarized positions in AI ethics. While some advocate for granting robots rights on a par with human beings, others, in a stark opposition argue that robots are not deserving of rights but are objects that should be our slaves. Grounded in post-Cartesian philosophical foundations, we argue not just to deny robots 'rights', but to deny that robots, as artifacts emerging out of and mediating human being, are the kinds of things that could be granted rights in the first place. Once we see robots as mediators of human being, we can understand how the `robots rights' debate is focused on first world problems, at the expense of urgent ethical concerns, such as machine bias, machine elicited human labour exploitation, and erosion of privacy all impacting society's least privileged individuals. We conclude that, if human being is our starting point and human welfare is the primary concern, the negative impacts emerging from machinic systems, as well as the lack of taking responsibility by people designing, selling and deploying such machines, remains the most pressing ethical discussion in AI.

International Courts

'The Legitimacy of International Courts' by Andreas Føllesdal in Journal of Political Philosophy (forthcoming) comments

 States are free, yet everywhere live under international courts and tribunals (ICs). As they proliferate and gain power across ever more domains, ICs become targets of resistance and criticism that they are illegitimate authorities. What reasons might a state have to defer to an IC’s judgment or interpretation, even when the state regards it as mistaken, and even when it conflicts with the interests and objectives of government? Section I sketches the multiple tasks of ICs, in complex interdependence with other actors. Their core task is to adjudicate disputes through interpretation and application of international law by legal methods. This may also contribute indirectly to a range of further tasks. Section II addresses some aspects of the relation between normative legitimacy of ICs and descriptive legitimacy - actors’ beliefs therein. Section III shows how a wide range of legitimacy challenges concern ways ICs fail to carry out their tasks. This account does not seek to provide substantive arguments or seek to show that all such criticisms are correct. The aims are rather to make many such criticisms comprehensible as legitimacy concerns, to provide a rationale for popular taxonomies of legitimacy criticisms, and to indicate which premises and arguments are required for such criticisms to be sound.

Speech, Free and Hateful

'Is There a Common Law 'Right' to Freedom of Speech?' by Dan Meagher in (2019) 43(1) Melbourne University Law Review 269 comments

The recognition of political speech as a constitutional principle and the emergence of the principle of legality have driven the doctrinal evolution of freedom of speech at common law. The High Court now treats freedom of speech as something more than a residual liberty. Yet this doctrinal and taxonomic transformation is not complete. This article posits that at some point the High Court may incorporate proportionality into the methodology of common law rights protection. That development would be problematic, but the forces driving it may well be inexorable. However, the article concludes that there is an alternative. The High Court has an opportunity (if so minded) to develop a distinctive, indigenous conception of freedom of speech at common law. 

Meagher argues

 It may seem an odd, if not anachronistic, thing to ask whether there is a ‘right’ to freedom of speech at common law. Surely in our age of statutes and human rights the answer is an unqualified ‘yes’. With the continued expansion in the size and complexity of the statute book, our judges are more alive than ever to the threat this poses to fundamental rights, including free speech. The pressing nature of that threat was outlined in painstaking detail in the recent 600-page report of the Australian Law Reform Commission on Traditional Rights and Freedoms: Encroachments by Commonwealth Laws. Indeed, a chapter of nearly 50 pages was devoted to freedom of speech. Its opening summary noted that, amongst other things, the chapter ‘discusses the source and rationale of the common law right of freedom of speech’. And significantly, the interpretive approaches of our courts was said by then Chief Justice Spigelman to have established a ‘common law bill of rights’ which included freedom of speech.

These contemporary observations seem to assume, if not require, the existence of a common law ‘right’ to freedom of speech. Yet the orthodox view at common law is that freedom of speech is not a ‘right’ but a residual liberty — that in the event of government or legislative action infringing the freedom of speech of an individual, that breach is not directly actionable. Part II will outline this position and explore the nature of a common law ‘right’ to freedom of speech.

There are, however, contemporary developments in Australia and throughout the common law world which have put pressure on the common law’s residual conception of freedom of speech. These developments will be the focus of Part III. In Australia, for example, it will be argued that the recognition of political speech as a constitutional principle and the emergence of the principle of legality have driven the doctrinal evolution of freedom of speech at common law. 

The equivalence proposition is considered in Part IV. This is where judges (in both Australia and the United Kingdom) have asserted that the common law provides equivalent protection to freedom of speech as the relevant articles in international human rights treaties such as the International Covenant on Civil and Political Rights (‘ICCPR’) and the European Convention on Human Rights (‘ECHR’). That important doctrinal and methodological claim will be unpacked and critiqued. Part V will suggest that at some point the High Court may well adopt the equivalence proposition. Whilst such a development would be problematic in my view, the doctrinal and normative forces driving it may well be inexorable. 

Finally, Part VI considers whether there is an alternative at common law to recognising the equivalence proposition (and proportionality) in order to outline the protection it provides to freedom of speech. It is suggested that an opportunity exists for the High Court to develop a distinctive, indigenous conception of freedom of speech at common law.

'Digital Platforms and the Rise of Global Regulation of Hate Speech' by Paolo Cavaliere in (2019) 8(2) Cambridge International Law Journal comments

The EU Code of Conduct on hate speech requires online platforms to set standards to regulate the blocking or removal of undesirable content. The standards chosen can be analysed for four variables: the scope of protection, the form of speech, the nature of harm and the likelihood of harm. Comparing the platforms’ terms of use against existing legal standards for hate speech reveals that the scope of speech that may be removed increases significantly under the Code’s mechanism. Therefore, it is legitimate to consider the platforms as substantive regulators of speech. However, the Code is only the latest example in a global trend of platforms’ activities affecting both the substantive regulation of speech and its governance. Meanwhile, states’ authority to set standards of acceptable speech wanes. 

Cavaliere argues

The Code of Conduct on countering illegal hate speech online, introduced in June 2016, represents the latest attempt by the European Union (EU) to tackle the rise of illegal content online. The Code is a voluntary agreement subscribed to by a group of information technology companies (Facebook, Microsoft, Twitter and YouTube, later joined by Instagram, Google+ until its shutdown in April 2019, Snapchat, Dailymotion and Jeuxvideo) that agreed on sharing a collective responsibility in promoting freedom of expression online. These intermediaries have bound themselves to prohibit incitement to violence and hateful conduct in their community guidelines; to provide for flagging mechanisms to allow users to submit notices and set up clear and effective procedures to review any such notifications they receive; and to review the majority of them within 24 hours ‘against their rules and community guidelines and where necessary national laws’. After review, platforms may decide to remove or disable access to such content.The increasing centrality of platforms in setting substantive standards of acceptable speech is the focus of this work. Analysing the platforms’ terms of service as de facto normative sources, as the EU Code of Conduct frames them, allows an assessment of the ways that this emerging dynamic comports with the existing legal standards set up by relevant international and regional treaties, national statutes and prominent caselaw. In the remainder of this article, the impact of the private standards included in the platforms’ terms of service is assessed against current international frameworks of hate speech as found in relevant academic literature, legal provisions at the international and domestic levels, and caselaw. 

The analysis is based on a framework focusing on four variables of hate speech provisions: the scope of protection, the forms of speech that the provisions seek to restrict, the nature of the harm that the different provisions seek to prevent and the causal link between the speech and the harm. Although based on prominent academic literature, the four elements feature traditionally in legislative processes and judicial reasoning. After introducing, in the next two sections, the EU Code of Conduct and the analytical framework used in this study, the article will illustrate how each platform addresses the variables. For each of these elements, the current state of the academic debate, legal provisions and courts’ practices will be compared with the relevant guidance offered in the platforms’ terms of service. The analysis will eventually inform a discussion on emerging trends in privatised regulation of speech: short- term dynamics raise concerns regarding lack of transparency, lack of accountability and lack of foreseeability of whether content posted online would cross a threshold of acceptability; long-term dynamics involve online platforms acting as speech regulators at the global level, possibly causing states’ authority to set standards of acceptable speech to wane.

Last year the Victorian Parliament, following up proposed changes to the Racial and Religious Tolerance Act 2001 (Vic) noted here, launched an inquiry into the state's vilification regime, following up last month's District Court decision in Cottrell v Ross [2019] VCC 2142 noted here and the interesting Reason Party proposal noted here.

The terms of reference for that inquiry are -

An inquiry into current anti-vilification laws, their possible expansion, and/or extension of protections beyond existing classes to the Legal and Social Issues Committee for consideration and report no later than 1 September 2020. The Committee should consider: 

1) The effectiveness of the operation of the Racial and Religious Tolerance Act 2001 (the Act) in delivering upon its purposes; 

2) The success or otherwise of enforcement of the Act, and the appropriateness of sanctions in delivering upon the Act’s purposes; 

3) Interaction between the Act and other state and Commonwealth legislation; 

4) Comparisons in the operation of the Victorian Act with legislation in other jurisdictions; 

5) The role of state legislation in addressing online vilification. 

6) The effectiveness of current approaches to law enforcement in addressing online offending. 

7) Any evidence of increasing vilification and hate conduct in Victoria; 

8) Possible extension of protections or expansion of protection to classes of people not currently protected under the existing Act; 

9) Any work underway to engage with social media and technology companies to protect Victorians from vilification.

Australian Data Breach Settlement

The settlement of proceedings in Evans v Health Administration Corporation [2019] NSWSC 1781 - important Australian data breach litigation - features the following Confidential Opinion of Counsel  -

 In the present case, I had the benefit of a confidential memorandum of advice prepared by Mr Michael Rivette of Counsel (Counsel retained by the plaintiff in these proceedings) in which he expresses the opinion that the Settlement Sum and proposed distributions fall within the range of fair and reasonable outcomes, and that the settlement is in the interests of the Group Members. 

Central to Mr Rivette’s opinion in that regard is that, from information obtained through the issuing of subpoenas, it now appears that the information disseminated was confined to only that information contained in what is defined in the amended statement of claim as “the Coloured List” (that being a document allegedly prepared by or at the instigation of the second defendant in which is recorded the information the subject of the present complaint). 

In particular, Mr Rivette has advised that, although the Coloured List contained personal information as defined under the Privacy and Personal Information Protection Act (and contained what in his opinion was confidential information, being health information), that health information was descriptive of the injury suffered by each individual only, and did not contain any details of medical treatments or medical history. Mr Rivette also attaches significance to the fact that it now appears that the Coloured List was provided by the second defendant only to a single recipient (a lawyer who reported it to police once he suspected that the second defendant might not have had the necessary authority to give him the Coloured List). 

Mr Rivette has pointed in his opinion to the inherent risks in this litigation (noting his instructions that the second defendant is unlikely to have funds to pay any compensation orders), those risks including the following: that it is presently undecided in New South Wales whether an equitable cause of action for breach of confidence will sound in damages or equitable compensation for mental distress falling short of psychiatric illness (as claimed by certain of the Group Members); that the causes of action pleaded for breach of the tort of invasion of privacy depend upon the court accepting that “it should take an incremental step and recognise the existence of the new tort” (as has been the case in New Zealand and the United Kingdom); the fact that, insofar as the second defendant committed criminal offences through conduct that was outside the scope of his engagement/employment, the first defendant may contend that it cannot in these circumstances be held vicariously liable for the second defendant’s actions (especially when the disclosures occurred around twelve months after he had left the first defendant’s employment); and, in relation to the misleading and deceptive conduct claim, that the plaintiff will need to meet the first defendant’s claim that its dealings with its employees are not in trade and commerce, and therefore not covered by either s 18 or s 29 of Schedule 2 of the Australian Consumer Law. 

As to the nature of the information and its dissemination, as noted above Mr Rivette accept that the information was of a limited nature and its dissemination was limited to one person. The Coloured List contains the following types of information about the individuals there recorded: name; address; date of birth; a short general description of how the injury occurred (for example: manual handling of a patient; twist/bend-no patient; exposure to mental stress factors); and a short general description of the affected body part (for example: back-lower; forearm; psychological system). Mr Rivette is of the opinion that this constitutes personal information as defined in the Privacy and Personal Information Protection Act, health information as defined in the Health Records and Information Privacy Act and confidential information as it contains some health information relating to those individuals; but notes that any health information was generally descriptive only, and in no way detailed as to treatment or prognosis. 

By way of elaboration of the risks inherent in the litigation, Mr Rivette points to the following. 

As to the claim for breach of confidence, he is not aware of any decision in New South Wales in which the equitable cause of action for breach of confidence has sounded in damages or equitable compensation for mental distress falling short of psychiatric illness. He notes that s 38 of the Supreme Court Act 1986 (Vic) (which was relied upon to justify the award of compensation in Giller v Procopets (No 2) (2009) 24 VR 1; [2009] VSCA 72 (Giller v Procopets) per Neave JA), differs from the form of s 68 of the Supreme Court Act 1970 (NSW). It is, however, also noted that (as a matter of principles of precedent), as a decision of an intermediate appellate court, at first instance a court in this jurisdiction (and also the Court of Appeal) should not depart from that decision unless convinced it is plainly wrong (see Farah Constructions Pty Ltd v Say-Dee Pty Ltd (2007) 230 CLR 89; [2007] HCA 22 at [135]). 

As to the causes of action pleaded for breach of the tort of invasion of privacy, it is noted that such a tort has not been recognised in this jurisdiction. 

As to the claim that the first defendant has vicarious liability for the conduct of the second defendant (in addition to the direct claims made against the first defendant as to the second defendant being given direct and unfettered access to the information in question), it is noted that the first defendant will argue that it cannot be held vicariously liable for the second defendant’s actions in circumstances where: the second defendant committed criminal offences; through conduct that was outside the scope of his engagement/employment; and where the disclosures occurred around twelve months after he had left his employment with NSW Ambulance. It is noted that the first defendant will seek to rely on the decision of Director General, Department of Education and Training v MT (2006) 67 NSWLR 237; [2006] NSWCA 270; and that although it is arguable that this decision is distinguishable, it is a defence the first defendant will press and that will need to be met by the plaintiff in relation to the vicarious liability claims. 

As to the Australian Consumer Law claims, it is noted that one argument the plaintiff must meet is that the first defendant’s dealings with its employees are not in trade and commerce, and therefore not covered by either ss 18 or 29 of the Australian Consumer Law. It is noted that although the activities of the first defendant have a commercial component to them (referring to subscription payments or charges for use of ambulances) the argument will be whether the internal relationships are relationships are in trade or commerce; and this will be a defence that the plaintiff will need to meet. Mr Rivette notes that in order to determine whether the distribution amounts fall within the appropriate range of what may be considered a fair and reasonable outcome, guidance can be obtained from awards of compensation in different jurisdictions relating to privacy and data breaches. In this regard, it is his opinion that although direct claims for compensation have not been made under either the Privacy and Personal Information Protection Act or the Privacy Act 1988 (Cth), determinations under these Acts still offer guidance as to the appropriate range of compensation for non-economic loss in privacy breach cases.

In relation to compensation for breach of confidence, Mr Rivette draws attention to three cases in which it has been found that breach of confidence will sound in damages or equitable compensation for mental distress falling short of psychiatric illness (which he considers also offer some guidance, albeit as to what can be considered the higher end of compensation for the “most egregious disclosures”). 

The most comparable complaint that Mr Rivette has identified is a complaint determined by the Office of the Australian Information Commissioner (OAIC) in Jo and Comcare [2016] AICmr 64 (Jo and Comcare). It is noted that Comcare was found to have interfered with the complainant’s privacy by disclosing information about workplace injuries at his current employment to his former employer and an insurance company, in breach of Australian Privacy Principle 6. It is noted that, unlike the current proceeding, this was a disclosure made to multiple recipients, which were all large organisations. An award of $3,000 was made by way of compensation for the loss or damages suffered by the complainant by reason of this interference with his privacy. 

Mr Rivette points out that, generally, higher awards will be given by the OAIC when the dissemination is broader, or the suffering arising from the breach is greater (reference there being made to: ‘EQ’ and Great Barrier Reef Marine Authority [2015] AICmr 11; 'D’ and Wentworthville Leagues Club [2011] AICmr 9; and ‘DK’ and Telstra Corporation Limited [2014] AICmr 118). 

Relevant decisions by the New South Wales Civil and Administrative Appeals Tribunal (NCAT) on the assessment of compensation for breach of the Privacy and Personal Information Protection Act as identified by Mr Rivette are: CJU v SafeWork NSW [2018] NSWCATAD 300; ALZ V SafeWork (NSW) (No 4) [2017] NSWCATAD 1; and AOZ v Rail Corporation NSW (No 2) [2015] NSWCATAP 179. 

As to awards of compensation for breach of confidence, reference is made to Giller v Procopets; Jane Doe v Australian Broadcasting Corporation [2007] VCC 281; and Wilson v Ferguson [2015] WASC 15. It is noted that each of those cases involved the wide broadcast or dissemination of highly sensitive and personal matters relating to rape or intimate sexual material (and hence it is said that the awards must be seen to be in the highest category of compensation for non-economic loss or injury falling short of psychiatric injury). It is noted that these awards relate to far more explicit and confidential material than that disclosed by the second defendant and that in all those cases there was actual distress (or psychiatric illness) that resulted from the breach, and not a mere presumption of loss through distress. 

As to the differential amount of the minimum initial distribution to the lead plaintiff (approximately four times that of the minimum initial payment to the remaining Group Members), Mr Rivette has opined that the additional amount so allocated is justified given the time, money and energy expended in preparing witness statements, attending on experts for the purposes of those experts providing expert evidence to the court, and generally providing instructions in relation to the proceeding; and the fact that she has assumed the risks associated with being the lead plaintiff in a class action. Thus, Mr Rivette has concluded that, having regard to the awards by the OAIC and NCAT in other cases, the settlement amount and the proposed initial distributions are within the range of acceptable outcomes “even before one factors in the risks associated with the litigation”. It is his view that the awards for breach of confidence relate to the wide dissemination of highly sensitive, intimate and confidential information that was never meant to be seen or heard by any other person and are therefore not representative of what could be expected if the plaintiff’s claims in breach of confidence succeeded in the present case; and that the most comparable award of compensation is the $3,000 award by the OAIC in Jo and Comcare being for the dissemination by an employer of worker’s injury information (but noting that the disclosure in Jo and Comcare was direct and was not from an illegal act by a person employed/engaged by the defendant paying the compensation; and hence that that proceeding did not have the same inherent risks that appear in this proceeding).