Recusal

Neilson DCJ in Andrew Learmont v SAS Trustee Corporation [2020] NSWDC 595 states 

[1] This is an application that I "recuse" myself. The use of such terminology is deplorable. The Latin root is the verb, recuso, recusare, recusavi, recusatum. That is a technical term in Roman law. It is used by certain jurists meaning, to make an objection or to demur. It is so used by Cicero, Celsus, Quintilian and Julian. It gives a noun form, recusatio, recusationis, which means either a counter plea or a demurrer. However, the verb could also be used generally, meaning to make an objection or to protest. It is so used by Cicero, by Ovid, by Seneca, by Livy and by Caesar. It can also mean, not to accept or consent, or to decline, to reject, or to oppose. It is not used reflexively and is not used in Latin to mean to disqualify oneself. 

[2] According to the second edition of the Oxford English Dictionary published in 1989, the word, recuse, is rare and means, to refuse or to make an objection. There is a form of the word, recusal, but that means an objection to a judge as being prejudiced, but not the action of the judge in disqualifying himself. However, the primary meaning assigned to one form of the word, recuse, was that of being a “recusant” and the associated status of recusancy. A recusant was a person who refused to attend the services of the Church of England as established by Parliament. It applied to all who refused to attend the services of the Church of England but, in particular, members of the Catholic faith. The second edition of the Oxford English Dictionary does not admit the use of the verb "recuse" to mean, the action of a judge in disqualifying himself. 

[3] The 5th ed of the Shorter Oxford English Dictionary published in 2002, does give the verb, recuse, a fourth meaning, when used reflexively, of a judge withdrawing from a hearing of a case because of a possible conflict of interest or lack of impartiality. However, it is clear, from the other entries in the Shorter Oxford English Dictionary that that use is United States usage. It does not admit to the usage being either British, Australian, Canadian, New Zealander or South African. 

[4] However, the verb, recuse, in English has the same meanings as it does in Latin, to refuse a thing offered, to reject or renounce a person or his authority or to object or to refuse to do something. The use of the word "recuse" being a request of a judge to disqualify himself from the hearing of a case is not consistent with its Latin etymology, is inconsistent with English usage and, although it may be used in the United States of America, it is not part of the Queen's English and its use is to be eschewed.

Export Controls

Catching up with the 'Export Controls and Human Rights Initiative Code of Conduct' released at the Summit for Democracy in March this year. 

The US State Department comments

 The United States continues to put human rights at the center of our foreign policy. The Export Controls and Human Rights Initiative – launched at the first Summit for Democracy as part of the Presidential Initiative for Democratic Renewal – is a multilateral effort intended to counter state and non-state actors’ misuse of goods and technology that violate human rights. During the Year of Action following the first Summit, the United States led an effort to establish a voluntary, nonbinding written code of conduct outlining political commitments by Subscribing States to apply export control tools to prevent the proliferation of goods, software, and technologies that enable serious human rights abuses. Written with the input of partner countries, the Code of Conduct complements existing multilateral commitments and will contribute to regional and international security and stability. 

In addition to the United States, the governments that have endorsed the voluntary Code of Conduct are: Albania, Australia, Bulgaria, Canada, Costa Rica, Croatia, Czechia, Denmark, Ecuador, Estonia, Finland, France, Germany, Japan, Kosovo, Latvia, The Netherlands, New Zealand, North Macedonia, Norway, Republic of Korea, Slovakia, Spain, and the United Kingdom. The Code of Conduct is open for all Summit for Democracy participants to join.

Indeed, Bulgaria and Albania 

The Code of Conduct calls for Subscribing States to:

• Take human rights into account when reviewing potential exports of dual-use goods, software, or technologies that could be misused for the purposes of serious violations or abuses of human rights. 

• Consult with the private sector, academia, and civil society representatives on human rights concerns and effective implementation of export control measures. 

• Share information with each other on emerging threats and risks associated with the trade of goods, software, and technologies that pose human rights concerns. 

• Share best practices in developing and implementing export controls of dual-use goods and technologies that could be misused, reexported, or transferred in a manner that could result in serious violations or abuses of human rights. 

• Encourage their respective private sectors to conduct due diligence in line with national law and the UN Guiding Principles on Business and Human Rights or other complementing international instruments, while enabling non-subscribing states to do the same. 

• Aim to improve the capacity of States that have not subscribed to the Code of Conduct to do the same in accordance with national programs and procedures.

Surveillance

'Under Their Eye: The Surveilled Student' by Danielle Keats Citron in (2023) 76 Stanford Law Review (forthcoming) argues 

We live in a golden age of student surveillance. Some surveillance is old school: video cameras, school resource officers, and tip lines. Old-school surveillance, which is largely cabined in time and location, is now paired with new-school surveillance, which extends monitoring far beyond school hours and hallways. School-provided laptops have corporate software installed that does two things: first, it blocks “objectionable” material and informs administrators about the content that students tried to access; second, it scans students’ online activities wherever (home) and whenever (weekends). If inclined, teachers and school resource officers can watch in real-time students’ searches, browsing, emails, chats, photos, calendar invites, geolocation, and more. Companies continuously monitor students’ laptop activity in the name of safety. Student surveillance is 24 hours a day, seven days a week, 365 days a year. There is no reprieve. 

This essay does what many school districts and companies refuse to do in the open—provide a clear-eyed analysis of the costs and benefits of student surveillance. My assessment is limited to what investigative journalists, advocacy groups, and researchers have discovered about opaque corporate practices and companies reveal. What we know is too little—the lack of transparency is part of the problem. Lawmakers and the public need a full view of the stakes, so they can have a meaningful say. 

Children’s safety is a paramount value. The question remains whether student surveillance protects students from self-harm, violence, and cyber bullying, as companies claim. School administrators say that the monitoring services make them “feel” safer and better informed. But feeling isn’t fact. Continuous and indiscriminate monitoring of students’ online activities is “security theater.” From what we know, students may be less safe and less well-off. Companies claim that their algorithms detect suicidal ideation, bullying, and impending violence, and that content moderators alert school officials and law enforcement so they can prevent harm. Proof of concept is scant, but from what we do know, most often, alerts from surveillance companies create a chain reaction of discipline for minor infractions. Serious punishment, like suspension, is disproportionately meted out to Black female and male students. Monitoring systems “out” LGBTQ+ students to teachers and parents (who may be unsupportive or worse). These costs are mostly borne by students from disadvantaged backgrounds—a blow to equal opportunity. 

Dragnet-style surveillance exacts profound costs to what I describe as student intimate privacy. Student intimate privacy is essential for children’s self-development and self-expression. Unlike most other periods in their lives, students experience tremendous personal growth and development. Students’ job is learning, listening, reading, speaking, exploring, and befriending. It is figuring out who they are and want to become. Schools play a central role in all of that—their job is preparing and cultivating an engaged citizenry. Student surveillance diminishes that potential. It harms students as listeners because filtering software blocks sources of knowledge, including news stories and resources for sexual health; it harms students as speakers because it creates an atmosphere of fear and intimidation that results in self-censorship and conformity. 

Schools justify their contracts with surveillance companies by pointing to a federal law designed to prevent students from accessing obscene material, a law that by its own terms rejects continuous tracking of students’ online activities. Congress must step in to clear up the confusion. Lawmakers should provide incentives to schools to ensure that surveillance technologies work and that they minimize intrusions on student intimate privacy, free expression, and equal opportunity to the greatest extent possible. Reforms providing vigorous protection for students’ intimate privacy are crucial to students’ free expression and schools’ role in cultivating democratic citizens.

Moderation

'The effectiveness of moderating harmful online content' by Philipp J Schneider and Marian-Andrei Rizoiu in (2023) 120(34) PNAS comments 

 In 2022, the European Union introduced the Digital Services Act (DSA), a new legislation to report and moderate harmful content from online social networks. Trusted flaggers are mandated to identify harmful content, which platforms must remove within a set delay (currently 24 h). Here, we analyze the likely effectiveness of EU-mandated mechanisms for regulating highly viral online content with short half-lives. We deploy self-exciting point processes to determine the relationship between theregulated moderation delay and the likely harm reduction achieved. We find that harm reduction is achievable for the most harmful content, even for fast-paced platforms such as Twitter. Our method estimates moderation effectiveness for a given platform and provides a rule of thumb for selecting content for investigation and flagging, managing flaggers’ workload. 

Social media platforms are the new town squares (1)—dematerialized, digital, and unregulated town squares. In 2022, Elon Musk acquired Twitter with the stated goal of preserving free speech for the future. However, alongside free speech, harmful content disseminates and prospers in this unregulated space: mis- and disinformation that spreads faster than its debunking (2), social bots that infiltrate political processes (3), hate speech against women, immigrants, and minorities (4) or viral challenges that put teens’ lives at risk. In response, there have been calls for the governments to intervene and regulate. As the first move of its kind, the European Council introduced the Digital Services Act (DSA) and the Digital Markets Act (DMA) (5), EU legislation aimed at projecting the regulations of our offline world onto the digital one. It implements notice and action mechanisms (cf. Art. 16) to report harmful online content. Furthermore, the regulation introduces a process for appointing trusted flaggers, subject matter experts in detecting harmful content (cf. Art. 22). Once such content is flagged, platforms must promptly remove the content. However, online content is notorious for its “virality”—it spreads at high speeds and has short lifespans. Therefore, we ask about the effectiveness of this new legislation: how to quantify the likely harm caused by harmful content and how to determine the response time for effective mitigation? 

In this work, we leverage state-of-the-art information spread modeling to assess the effectiveness of the DSA regulation and the EU code of conduct for countering harmful online speech. Fig. 1 conceptualizes an online discussion, where each post (or) draws more people into the discussion and generates more posts, referred to as offspring. This phenomenon of content spreading is known as the self-exciting property. A harmful post() will therefore generate potentially other harmful posts (and) with a decreasing intensity, shown by the red dashed line on the Bottom panel of Fig. 1. How would the new EU legislation potentially stop the propagation of the harm? The core concept is to limit harmful posts’ reach and the offspring generation. We denote the number of harmful, direct offspring as the potential harm—denoted asn∗ and comparable in meaning to R0,the basic reproduction number of infectious diseases (6). Content moderation is achieved by removing the harmful post () at time Δ after posting and thus stemming offspring generation after this time (). In addition, we assume that any harmful direct offspring generated before Δ() are also moderated; their number defines the actual harm—labeled as n∗Δ. The harm reduction휒is the percentage of all harmful offspring avoided, both direct and indirect—i.e., offspring of the offspring generated via the recurrent branchingprocess. 

The effect of the policy heavily depends on the speed at which the discussionsunfold on social networks. We quantify this using thecontent half-life, defined as thetime required to generate half of the direct offspring. A recent (as of 2023) empirical investigation (7) determined the half-life of social media posts on different platforms:Twitter (24 min), Facebook (105 min), Instagram (20 h), LinkedIn (24 h), YouTube(8.8 d), and Pinterest (3.75 mo). A lower half-life means that most harm happens right after the content is posted, and content moderation needs to be performed quickly to be effective.

Relevance

Nice snappy articulation of 'relevance' in R v BELL (No 6) [2023] SADC 112 

 The law of relevance 

[42] Relevance is a question of law. It is most simply encapsulated in two long-cited propositions: None but facts having rational probative value are admissible; and All facts having rational probative value are admissible, unless some specific rule forbids. 

[43] A fact is relevant if it tends to directly or indirectly prove or disprove a fact in issue or to prove some relevant fact. It will be relevant where the evidence to be called relates to that other fact in a way that, according to the ordinary course of events, either by itself or in connection with other facts, proves or makes probable the past, present or future existence or non-existence of that other fact. 

[44] ‘Facts in issue’ are what the High Court has described as either ‘main facts in issue’ which are generally those that must be established to secure a conviction, establish a cause of action, or to enable some defence or answer to a case to be made out, or ‘subordinate or collateral facts in issue’ which might affect matters such as the credibility of a witness or the admissibility of particular items of evidence. Relevance will be assessed by reference to not only the elements of the offences charged, but also to the subsidiary issues that arise in relation to facts that may be probative of those ultimate issues. Importantly, these subsidiary issues may extend to matters that are necessary to contextualise and explain matters that a jury must consider and determine, including the credibility of witnesses. 

[45] Evidence will also be relevant if it provides an explanatory framework for other evidence; for example, if it may explain a statement or an event that would otherwise appear curious or unlikely; it may cut down, or reinforce, the plausibility of something a witness has said; or it may provide a context that is helpful or necessary for an understanding of the narrative. 

[46] Relevance must obviously be assessed with reference to the issues at trial, the purpose of the tender, and the state of the other evidence in the trial. 

[47] In cases involving circumstantial evidence, relevance must be resolved by reference to the whole of the evidence in the case. 

[48] The law recognises that particularly where, as here, the trial is by jury and consequently the Court is being asked to rule on questions of relevance prior to the commencement of the jury trial, and consequently before all the issues that may become relevant in the trial become apparent, it is undesirable and unnecessary to set the hurdle of relevance too high.

Comparative IP Law

'Everything You Want: The Paradox of Customized Intellectual Property Regimes' by Derek E Bambauer in  Berkeley Technology Law Journal,(Forthcoming)  comments 

Special interest groups share a dream: enacting legislation customized for, and hopefully drafted by, their industry. Customized rules created via legislative capture, though, are the worst case scenario from a public choice perspective: they enable narrow interests to capture rents without generating sufficient societal benefits. American intellectual property law offers useful case studies in legislative capture: special interests have created their own rules three times in the past forty years with the Semiconductor Chip Protection Act, Audio Home Recording Act, and Vessel Hull Design Protection Act. Paradoxically, though, these customized IP systems have consistently disappointed their drafters: all three of these systems lie in desuetude. This result challenges the conventional wisdom about regulatory capture by special interests, suggesting there is less to fear from legislative capture than most legal scholars believe, in intellectual property and beyond. The puzzle is why, when given free rein to design the rules that govern them, interest groups have done such a poor job in seizing that advantage. 

 

This Article brings together two scholarly debates. The first is within intellectual property: should IP doctrines be tailored by industry or comprise rules of general application? The second is within public choice: how risky is regulatory capture by special interests? 

 

The Article identifies two key reasons for the ineffectiveness of customized regimes. First, industry groups are fragile, fractal-like coalitions of disparate interests that often fracture between creators and copyists. Groups must choose between narrower, more politically attainable legislation and broader, more rewarding proposals that strain the coalition. Second, interest groups embed current business models and technologies into these systems, making regulation vulnerable to disruptive innovation. It explores how these findings affect proposals for customized regimes for artificial intelligence, weather data, traditional knowledge, privacy, and fashion. The Article concludes with a cautionary tale for interest groups that is otherwise welcome news: customized regimes are often less effective, and less threatening, than previously supposed.

Pharmaceuticals

'Off-Label Speech' by David A. Simon in (2023) 72 Emory Law Journal 549 comments 

This Article argues that the Food and Drug Administration (“FDA”) should regulate drug manufacturer speech about off-label uses based on the evidentiary support for the relevant use. The more evidence that an off-label use is safe and effective, the less restrictive the regulation should be. The less evidence that an off-label use is safe and effective, the more restrictive the regulation should be. Although intuitive, this is not exactly how current regulation of off-label information works. If the FDA approves a drug, the manufacturer can advertise to doctors and patients for the approved indication. Drug manufacturers cannot, however, promote or provide information about an approved drug for an unapproved use—so-called “off-label” use—unless they fall within two narrow safe harbors. Yet many off-label uses are just as safe and effective as on-label (approved) ones. Other off-label uses are supported by quality clinical trial data even though they are not approved. 

While the FDA recognizes that not all off-label uses are equally (un)supported by the same level of evidence, it has faced legal and practical challenges regulating information about them in a nuanced way. Courts have held unconstitutional the FDA’s regulations purporting to ban promotional off-label speech by drug manufacturers. And the safe harbors it has constructed are too shallow for much useful speech. To address these challenges, this Article proposes a new approach: working collaboratively with the Centers for Medicare and Medicaid Services, the FDA can use drug compendia—which identify, evaluate, and rate off-label uses—to create a graded system for regulating how drug manufacturers disseminate information about off-label uses that links informational restrictions to the level of evidence supporting the disseminated use. Not only does this system enable a flexible and evidence-based regulatory regime, it also can be easily designed to survive constitutional scrutiny. ... 

Doctors need information about drugs. And drug companies are ready to give it to them. When the information concerns a use of a drug the Food and Drug Administration (“FDA”) approved, drug companies can promote their approved drugs to physicians. Drug companies that want to provide information to physicians about an unapproved use of an approved drug, on the other hand, cannot do so except in limited circumstances. 

There are two reasons why. The first is that unapproved uses of approved drugs—so-called off-label uses—often pose greater risks, both physically and monetarily, to patients than approved, on-label uses. Because the FDA has not vetted unapproved uses, they may lack the evidentiary support enjoyed by their on-label counterparts. When drug companies promote off-label uses, they increase the probability that a physician will prescribe a drug off-label—and, hence, increase the risk that the patient suffers harm from the unapproved use. 

The second is that promoting off-label uses undermines the FDA approval process. Currently, a primary function of FDA approval is to incentivize firms to generate and disclose clinical trial data about a drug’s safety and efficacy. If companies can promote drugs off-label once a drug is approved, they have little incentive to conduct clinical trials to obtain approval for off-label uses. Rather than spend large sums of money to conduct clinical trials for an uncertain result (an FDA approval determining a drug is safe and effective), drug companies can spend much smaller amounts for a sure thing (promote the off-label use and obtain additional sales regardless of safety/efficacy). 

Yet many off-label uses are necessary and appropriate.6 For some patients, they are the only available treatment; for others, they represent the medically accepted “standard of care.” Here, dissemination of off-label information can have positive, rather than negative, effects. By providing the physician information about a previously unknown treatment option, dissemination of off-label information increases the chance that a physician will prescribe a drug off- label to a patient who needs it. Limiting promotion of off-label uses, in this case, increases the risk that a physician will not prescribe a needed off-label treatment. 

In the FDA’s view, the risk of too much off-label information outweighs the risk of too little. Despite the FDA’s position that off-label drug promotion is illegal, however, courts have not been inclined to agree. Indeed, recent judicial decisions have called into question whether any prohibition on off-label promotion is constitutional. 

Responding to these judicial losses, the FDA has carved out safe harbors for manufacturer off-label speech. Unfortunately, these safe harbors are rather wooden and impractical. Drug manufacturers must provide an excessive amount of information in a format that is not useful to physicians. And there are few gradations on the kind, nature, and content of information drug manufacturers can provide if they fall within the safe harbors. All off-label uses that qualify for a safe harbor can be distributed in only the prescribed manner—a manner a physician is unlikely to find helpful. 

Both of these challenges—the practical and the legal—are fundamentally about the quality and kind of evidence that supports an off-label use. When there is weak or no evidence supporting an off-label use, the risks posed by dissemination of off-label information are high. Restrictions on speech in such cases are likely to be constitutional because manufacturer statements about potential off-label uses are unlikely to be supported by evidence. When strong evidence supports an off-label use, by contrast, the risks posed by dissemination of off-label information are low—and the risk of not disseminating enough information is high. Here, restrictions on off-label information dissemination are unlikely to be constitutional because manufacturer statements about potential off-label uses are likely to be supported by evidence. Put differently, restrictions on unsupported statements will be more likely to satisfy the constitutional test than will restrictions on supported statements. Since both the legal and practical challenges of off-label promotion relate directly to the evidence supporting off-label uses, this Article argues that the best way to address them is to tie informational restrictions of off-label uses directly to the evidence base for the disseminated use. Uses supported by strong evidence could be disseminated more than those supported by weak or no evidence. 

To tie dissemination to evidence, this Article argues that the FDA, working with the Centers for Medicare and Medicaid Services (“CMS”), should regulate and use drug compendia: privately produced, publicly regulated publications that collect, evaluate, organize, and rate information about drugs. In this system, off-label uses with higher evidentiary ratings can be disseminated more freely than those with low ratings. The graded approach allows for regulations with a tighter fit to evidence, which, in turn, enables a greater flexibility in information dissemination activities. Because regulations will be tied directly to vetted evidence, the FDA can increase the kind and nature of information dissemination it allows. At the same time, it can limit these activities sufficiently to preserve traditional incentives for FDA approval. 

Linking information dissemination to evidence using compendia also enables the FDA to develop and use a new tool: a simplified and uniform disclosure document that can be included in manufacturer communications to physicians about off-label uses. This form—an example of which appears in the Appendix—effectively communicates to physicians complete and relevant information about evidence supporting an off-label use. 

This approach not only solves the legal and practical problems with current regulation, but it also balances the two problems faced by public and private solutions posed by other scholars. Public-oriented solutions rely on a centralized authority, usually the FDA, to either conduct its own research or independently review evidence for off-label uses. Determinations about the evidence for a use could then inform decisions about whether promotional activities can occur. Because they fear promotional false positives—allowing promotion of uses that are not safe and effective—these proposals tend to overregulate at great expense, requiring significant government funding, gatekeeping, and administration. 

Private-oriented solutions, on the other hand, typically allow off-label dissemination once a private organization determines a particular use meets certain evidentiary requirements. Unlike their public-oriented counterparts, private-oriented proposals fear promotional false-negatives: not allowing promotion of uses that are safe and effective. As a result, these solutions are cheaper but lack enforcement and underregulate the conflicts likely to arise in a private market. 

Using drug compendia to link information dissemination to the evidence supporting the disseminated use marries the best of both solutions—leveraging the efficiency benefits of private-oriented solutions with the oversight function of public-oriented ones. Because compendia are privately run, they have low administrative costs. But they are also subject to public regulation by the FDA and the CMS, which ensure that the process by which they evaluate and rate off- label uses is unbiased, reliable, and transparent. To the extent that promotional false positives and negatives exist, they will result from bad evidence, not bad regulation. In short, using compendia to regulate dissemination of off-label promotion is likely to be cheaper than most public-oriented solutions and more effective than most private-oriented ones. 

Compendia, though, have their own set of problems. Central among them are opacity, bias, and unreliability. Because these are significant problems, this Article does not propose using compendia in their current form. Instead, the FDA—working with the CMS—should regulate compendia directly and indirectly. Direct regulation specifies conditions, which, if met, would entitle a compendium to “recognized” status under current law. This includes uniform systems of (1) identifying, evaluating, and grading evidence; (2) identifying, evaluating, and acting on conflicts of interest and bias; and (3) publishing all information about (1) and (2). It could also entail additional compliance mechanisms that do not currently exist, including a requirement that compendia apply to “renew” their recognized status periodically and the audit or inspection of compendia by the CMS and/or the FDA. Because the CMS already has the statutory authority to regulate compendia this way—and because compendia are in need of reform—this aspect of the proposal is both practical and desirable. 

Direct regulation, however, is not sufficient to link promotion to evidence. To do so, the FDA must regulate compendia indirectly. Currently the CMS indirectly regulates compendia by specifying what evidentiary ratings are sufficient to guarantee reimbursement. This Article proposes that the FDA do the same for purposes of information dissemination of off-label uses: it should specify the level of permissible information dissemination by reference to the evidence grade assigned for the disseminated use. Under this system, uses assigned high evidentiary grades could be disseminated with fewer restrictions than those assigned low evidentiary grades. Because compendia will not produce uniform assessments of evidence, this also gives the FDA flexibility in how it interprets the evidence base for a given use. 

This Article proceeds as follows. Part I explains the current framework for regulating manufacturer speech about off-label uses. It highlights how the FDA’s current approach to off-label information faces serious practical and legal challenges. It then argues that the best method for overcoming both of these obstacles is to link information regulation of off-label uses to the evidence supporting the use in question by relying on drug compendia. Part II explains drug compendia and their current weaknesses. Part III then reviews five different methods for using drug compendia to link the level of off-label information dissemination to the evidence base supporting that use. It argues that while drug compendia can provide this linkage, they need to be regulated more closely to do so effectively. After describing the proper nature and scope of this additional regulation, this Article illustrates how this proposal could work in practice using three examples.