Foundation models – models trained on broad data that can be adapted to a wide range of downstream tasks – can pose significant risks, ranging from intimate image abuse, cyberattacks, to bioterrorism. To reduce these risks, policymakers are starting to impose obligations on the developers of these models. However, downstream developers – actors who fine-tune or otherwise modify foundational models – can create or amplify risks by improving a model’s capabilities or compromising its safety features. This can make rules on upstream developers ineffective. One way to address this issue could be to impose direct obligations on downstream developers. However, since downstream developers are numerous, diverse, and rapidly growing in number, such direct regulation may be both practically challenging and stifling to innovation. A different approach would be to require upstream developers to mitigate downstream modification risks (e.g., by restricting what modifications can be made). Another approach would be to use alternative policy tools (e.g., clarifying how existing tort law applies to downstream developers or issuing voluntary guidance to help mitigate downstream modification risks). We expect that regulation on upstream developers to mitigate downstream modification risks will be necessary. Although further work is needed, regulation of downstream developers may also be warranted where they retain the ability to increase risk to an unacceptable level.

Breastfeeding is the recommended way to feed infants. However, a safe and nutritious substitute for human milk is needed for infants when breastfeeding is not possible. As infants are a vulnerable population group, infant formula products are regulated by prescriptive provisions for composition and labelling. Any changes to the composition of these products must be established as safe prior to being permitted. As our knowledge of human milk expands, infant formula ingredients are developed to better replicate it. Food Standards Australia New Zealand (FSANZ) has assessed the addition of ingredients for the addition to infant formula products including human identical milk oligosaccharides (HiMOs) isolated using precision fermentation methodology. These ingredients are considered to be nutritive substances as their addition to food is intended to achieve specific nutritional purposes. In accordance with the Ministerial Policy Guidelines, FSANZ must assess both the safety and the health effect of nutritive substances for their use in infant formula. FSANZ risk assessments are undertaken by a multidisciplinary team covering toxicological and nutritional considerations using the best available scientific evidence. FSANZ assessments of the health effects concluded that the use of HiMOs in infant formula products would have a beneficial outcome for infants and align with the equivalent role of these substances in human milk(1,2). The weight of evidence supports health effects through an increase in the abundance of Bifidobacterium spp. in the infant gut microbiota, anti-pathogenic effects, inflammatory suppression and facilitation of appropriate immune responses and antigenic memory. FSANZ safety and technical assessments concluded that there are no public health and safety concerns associated with adding HiMOs to infant formula products(1, 2). The permitted levels are comparable to levels in human milk and are chemically and structurally identical to the naturally occurring forms. Food Standards Australia New Zealand, Canberra, 2606, Australia Based on the available evidence and intended purpose, a number of HiMOs have been permitted for use in infant formula products including 2′- fucosyllactose, lacto-N-neotetraose, difucosyllactose, lacto-N-tetraose, 3'-sialyllactose sodium salt, 6'-sialyllactose sodium salt. Evidence continues to emerge on the beneficial effects of HiMOs on infant health.

The Intergovernmental Negotiating Committee (INC) on plastic pollution are United Nations member states who will convene for the second part of the fifth session of the Intergovernmental Negotiating Committee in Geneva (INC5.2) 5-14 August, 2025 to negotiate a global plastics treaty. The Scientists’ Coalition for an Effective Plastics Treaty (‘The Scientists’ Coalition’) is an international network of independent scientific and technical experts who have been contributing robust science to treaty negotiators since INC1 in 2022. The Scientists’ Coalition established a series of working groups following INC5.1 in Busan, Korea 25 November – 1 December 2024. Each working group has produced science-based responses to the selected articles of ‘the Chair’s text’ (the latest version of the draft global plastics treaty text). This Letter to the Editor summarises those responses.

This article explores the interaction between the Conseil de la Concurrence (Competition Council) and the Autorité de Régulation de la Poste et des Communications Électroniques (Telecommunications and Postal Regulatory Authority) (ARPCE) in the Algerian legal system. Algerian policy-makers have given special consideration to the issue of overlapping jurisdiction between these two authorities. The article discusses the Algerian strategy to resolve regulatory overlaps in the electronic communications market and also highlights the intervention of the ARPCE as a competition authority for the electronic communications market. Furthermore, the article analyses the Optimum Telecom Algeria case as a turning point in restoring the Competition Council’s role and highlights the need for systematizing the intervention of the two authorities. Finally, the article provides a forward-looking perspective through proposing a memorandum of understanding to promote cooperation between the Competition Council and the ARPCE.

In April 2023, the Office of Management and Budget (OMB) published a draft of revisions to Circular A-4, the first changes proposed since its publication in 2003. Following a public comment period, OMB published the final revised Circular A-4 in November 2023. In this article, we provide a section-by-section comparison describing the similarities and differences between the April draft and the November revision of Circular A-4. Among other observations, we note that the revised Circular A-4 changes the default social rate of time preference from 1.7 to 2.0%, retains recommendations for using distributional weighting in benefit–cost analysis, and retains recommendations to use a global point of view when determining the spatial scope of the analysis.

Ex ante, my primary concerns were about implementation across the wide expanse of federal applications, supporting the supplemental use of distributional weighting, trying to find a supportable middle ground on discounting using the expected value of bounds and a more consistent scope of analysis. Ex post, I felt heard if not followed, perhaps not uncommon for reviewers.

This paper considers whether assisted suicide and euthanasia (AS/E) is an area for medical regulation or whether there is a better alternative regulatory mechanism to govern it. Drawing from empirical evidence across a range of jurisdictions where it is legalized, the paper argues that there are at least four good reasons to consider demedicalizing AS/E: (1) pragmatic ethical issues of infrastructural weakness in AS/E service provision in already overstretched healthcare systems globally; (2) challenges of medicalization; (3) regulatory complexities concerning medical law (including pharmaceutical law) and criminal law; (4) the risk that AS/E becomes more easily susceptible to healthcare economics. The paper suggests several recommendations concerning a possible “demedicalized model.”

This article is based on feedback I submitted in response to the Office of Management and Budget’s (OMB’s) April 2023 request for comments on its draft revisions to Circular A-4, “Regulatory Analysis.” Much has changed since I submitted my comments in June 2023. OMB issued a final circular in November 2023 and subsequently rescinded it in February 2025. This article includes my comments as submitted, along with an introductory “prologue” and an “epilogue” that reflects on the decision to abandon the 2023 revisions and return to the 2003 Circular. My comment addressed key elements of regulatory analysis, suggested areas where OMB could provide more guidance, and identified several aspects of the 2023 Circular that appeared to be internally inconsistent or contradictory. It concluded that some of the 2023 revisions were worthwhile, while others would have obfuscated for policymakers important information on the welfare effects of regulatory actions.

This article presents my 2023 peer review panel comments on the 2023 Office of Management and Budget (OMB) Circular A-4 and offers recommendations for future revisions of this circular. The Prologue section introduces my official peer review comments and indicates how the structure of my comments was tailored to the guidelines established by the OMB. The main section consists of my 2023 peer review comments as they were submitted to OMB. I recommended changes in the draft Circular A-4 to increase the discount rate from the 1.7% rate that OMB proposed, to report domestic benefits whenever global benefits are reported, to adopt a behavioral transfer test for the use of behavioral economics findings, to update the procedures for estimating the value of a statistical life, and to abandon the proposed distributional weights. The most problematic component of the new Circular A-4 is the OMB distributional weights, which will shift the role of benefit–cost analyses away from the current role of providing an efficiency-oriented test. The Epilogue to my comments summarizes how the final version of Circular A-4 differs from the draft version and how future administrations might revise Circular A-4 after President Trump rescinded it.

Benefit–cost analysis is a protocol for assessing alternative public policies, primarily in terms of efficiency. An important complementary element can be estimating distributional impacts to show net benefits for groups of interest. The fundamental advantage is enabling decision-makers to see and weigh the importance of changes in efficiency and changes in distribution. Rigorous estimates of any distributional effects should incorporate credible baselines, private behavior, and markets. Estimation for groups with limited evidence and data is hard. Primary estimates of net benefits should be based on conventional market values. Any estimates based on distributional weights should be supplementary estimates. Combining them into a single number, risks masking the impacts of efficiency and distribution. The values of regulatory effects to U.S. citizens and residents depend on where the risks of damage take place. Willingness to pay values by U.S. citizens and residents to adopt a global value of benefits to increase the probability of international agreements can be positive but will reflect uncertain negotiation and compliance. The primary analysis should focus on benefits and costs to U.S. citizens and residents within domestic borders. The recommended rate of 1.7% does not reflect the rates relevant for all members of society. Given the emphasis on distribution effects, rates should include those facing rates of 3% or more. Sensitivity analysis should include several rates. The onus should be on making the case for a specific behavioral bias and nudge that will successfully address the perceived problem. Recent meta-analyses of nudge interventions indicate difficulty in implementing effective nudges.

The evidence-based psychological therapy for obsessive compulsive disorder (OCD) is cognitive behavioural therapy (CBT) delivered by mental health professionals who are trained and regulated by a professional standards authority. In recent years, people with OCD have reported consulting unqualified and unregulated coaches. We aimed to explore the experience of people who sought unregulated coaching for OCD. Using semi-structured interviews, we explored the lived experiences of 13 people with OCD who have undertaken sessions with an unqualified individual (referred to as a ‘coach’). Thematic analysis was conducted. There were four coaches rated negatively and one rated positively. Four over-arching themes were identified in the coaches who were rated negatively: (1) Appealing content, (2) Vulnerability, (3) Cult-like experience, and (4) Complex peer relationships. There were some positive experiences of coaching described, such as positive peer support from others receiving coaching in group chats. Many of the experiences documented by people who received OCD coaching were negative. It was highlighted that unqualified coaches may increase vulnerability of people seeking OCD treatment, due to unprofessional conduct. We suggest that this unprofessional conduct may be investigated by a regulator. We suggest that people seeking OCD treatment seek help from qualified professionals and that clinicians are aware of the potential negative effects such coaches can have on people.

Key learning aims

1. (1) To understand the potential risks, vulnerabilities and potential positive aspects associated with unregulated coaching for individuals seeking OCD treatment.

2. (2) To discuss our findings to promote informed decision-making by encouraging individuals with OCD to seek treatment from regulated and qualified mental health professionals.

3. (3) Increase clinician awareness of the potential harms associated with unqualified coaching and equip them to guide patients towards evidence-based treatment options.