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Influence and convergence to higher standards: the dual examination of pharmaceutical patents in Brazil
Get PDFBetween 2001 and 2021, pharmaceutical patent applications filed in Brazil were examined by the patent office (INPI) and the national health regulator (Anvisa). This paper investigates how health regulators can contribute to patent examination by shifting the set of criteria cited as grounds for 2589 negative decisions from both entities. Initially, the INPI focused on the traditional criteria of novelty, inventiveness and industrial applicability, while Anvisa adopted a more diverse approach and cited invention description most often. Over time, the entities converged to higher citation rates, with more criteria being considered relevant, indicating greater examination rigour. The most significant shift was the INPI's decisions becoming closer to Anvisa's than to its own previous decisions, and this paper provides concrete evidence of Anvisa influencing changes in the INPI's guidelines. Once Anvisa's main contribution became non-binding opinions, this policy's stability and enforcement were strengthened, and having both entities became almost symbiotic or mutually nutritious. Still, the lack of clarity about shared responsibilities and the intense debate that ensued have made implementing this multi-entity policy even more complex. Thus, this paper provides lessons about the dual examination system and similar policies as flexibilities within the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement
Integrating Scope 3 emissions into corporate climate change litigation: volution, challenges, and responses
No full textThis article takes the appeal decision in Milieudefensie et al. v. Royal Dutch Shell plc. as an opportunity to critically examine the evolution of responsibility for reducing Scope 3 emissions in corporate climate change litigation. To this end, the article first provides an overview of the scientific, accounting, and regulatory contexts pertaining to corporate Scope 3 emissions, followed by an assessment of a set of twelve ‘corporate framework’ cases brought before courts and quasi-judicial bodies across a variety of jurisdictions. The analysis examines the key arguments advanced by plaintiffs for Scope 3 emissions reductions as well as the counterarguments raised by defendant companies. It further explores how judicial and quasi-judicial bodies have engaged with three overarching questions: first, whether companies have a general legal obligation to reduce their Scope 3 emissions; second, whether such an obligation can be translated into a specific reduction requirement; and third, whether such an emissions reduction order would be effective in practice
How do cities absorb a large immigration shock? the role of housing
Get PDFWhile the literature has extensively studied the impact of immigration shocks on cities, we know surprisingly little about how cities absorb large immigration waves. This paper helps fill that gap by analyzing the neighborhood-level population dynamics among Spanish-born residents, non-EU15 immigrants, and EU15 immigrants in Spanish cities during the major immigration wave of 2001–2009. Drawing on the monocentric city model, and within a context of path-dependent urban development with outward city growth, we explore how different population groups sort spatially within cities. Higher-income Spanish-born residents tend to settle in more distant suburbs to access larger housing. In contrast, younger and highly educated EU15 immigrants concentrate in central neighborhoods to benefit from urban amenities. Initially, lower-income non-EU15 immigrants settled in central areas with deteriorated housing stock, but over time they increasingly moved to mid-distance neighborhoods with small dwellings built between 1950 and 1970
Does rapport always make better research interviews?
Get PDFStandard textbooks for qualitative research emphasise the need for and benefits of developing rapport with participants in interview based research. However, as Aliya Rao discusses, prioritising rapport in all instances can often have unintended consequences
The AI regulatory capability framework and self-assessment tool
Get PDFWell-designed and implemented regulation, which addresses risks while supporting innovation, can provide a basis for safe and trustworthy AI, positively shaping AI development, and facilitating societally beneficial AI adoption.2 On the other hand, poorly designed or implemented regulation can have the opposite effect, causing market confusion and stifling innovation, while failing to manage risks or build trust.3 Ensuring that AI regulation is well-designed and implemented is therefore a crucial foundation for a flourishing UK AI ecosystem and a critical challenge to be addressed. The AI Opportunities Action Plan reaffirms the UK’s decentralised regulatory approach for AI, underpinned by the notion that the UK’s expert regulators are best placed to understand AI risk, opportunities, and to manage the impacts of AI within their respective domains.4 This regulator-led approach aims to enable the development of tailored guidance, appropriate to context-specific AI risks in different regulatory domains.5 Justifying placing this responsibility on existing regulators, however, requires understanding whether they are adequately equipped – as regulatory professionals, organisations, and as a broader regulatory system – to understand the risks and opportunities associated with AI, and to develop and implement effective regulation.6 This is the reason for developing the AI Regulatory Capability Framework and Self-Assessment Tool, which aims to support UK regulators to build the capability to regulate effectively under the UK’s approach. This Framework defines AI regulatory capability broadly – drawing from the UNDP (1998) definition of the closely related term, “capacity”7 – as: “An ability of individuals, organisations, and systems to perform AI regulatory functions effectively, efficiently, and sustainably across the lifecycle, to achieve defined strategic and policy objectives for AI regulation.” The Framework provides a reference point for using the regulatory Capability Self- Assessment Tool and comprises three core informational elements. These are: (1) activities for AI regulation, (2) capabilities for AI regulation, and (3) good practice for AI regulation
Computational hermeneutics: evaluating generative AI as a cultural technology
Get PDFGenerative AI (GenAI) systems are increasingly recognized as cultural technologies, yet current evaluation frameworks often treat culture as a variable to be measured rather than fundamental to the system's operation. Drawing on hermeneutic theory from the humanities, we argue that GenAI systems function as "context machines" that must inherently address three interpretive challenges: situatedness (meaning only emerges in context), plurality (multiple valid interpretations coexist), and ambiguity (interpretations naturally conflict). We present computational hermeneutics as an emerging framework offering an interpretive account of what GenAI systems do, and how they might do it better. We offer three principles for hermeneutic evaluation—that benchmarks should be iterative, not one-off; include people, not just machines; and measure cultural context, not just model output. This perspective offers a nascent paradigm for designing and evaluating contemporary AI systems: shifting from standardized questions about accuracy to contextual ones about meaning
Unknowing the future: speculative foresight in international institutions and the unexpected ‘origins’ of expertise
Get PDFAmidst a deepening sense of uncertainty and polycrisis, how do international organizations (IOs) relate to the future? This article explores the politics of speculative foresight as a pervasive but sparsely researched and undertheorized form of future-oriented expertise in international institutions that taps into eclectic knowledge genres – such as art and literature, management philosophy, geopolitics, and esotericism. First, I examine how foresight is created and validated as a bundle of epistemic practice in contemporary IOs. As a way of knowing, I find that foresight is authorized through claims to innovation, imagination, pluralism, and methodological correctness, challenging established understandings of IO expertise as based on bureaucratic rationality and scientific objectivity. Moreover, I argue that foresight differs from more well-researched future-oriented practices, like risk technologies, forecasting, and anticipatory modeling, by imagining the future as contingent, plural, and unknowable. In a second genealogical move, I illustrate how this specific rendering of the future was made possible historically through the establishment of futures studies as an activist, utopian, and aesthetic counter-project to ‘scientific’ Cold War futurology. The article mobilizes performative thinking in social theory and STS and builds on a transversal analysis of IO documents, digital platforms and archives, futurist writings, and historical literature
Societal consequences of IPS implementation in Norway 2012–2019: study protocol for the IPSRON effectiveness study
Get PDFIntroduction: Individuals experiencing moderate to severe mental illness have low rates of workforce inclusion, with a consequence of high welfare dependency, affecting both societal costs and health. Individual Placement and Support (IPS) is an approach to supported employment where the goal is to help people obtain jobs on the open rather than sheltered labour markets. Despite multiple randomised controlled trials (RCTs) indicating that the IPS model enables employment better than treatment as usual, with widespread adoption in some jurisdictions, the broader impacts of this large-scale implementation on mental health, quality of life and social functioning remain unknown. Methods and analysis: Between 2012 and 2019, Norway introduced IPS through both local and national government projects. This study assesses the social and economic benefits of the implementation of IPS using Norwegian registry data, focusing on 18–45-year-old people receiving specialist mental healthcare, and who did not have steady employment at treatment start. Instead of assessing IPS efficacy in an RCT design, we use a naturalistic study design, evaluating IPS effectiveness by comparing aggregate population-level outcomes over time between areas where IPS was not available. In work package (WP) 1, we mapped the availability and implementation of IPS across Norway. This involved analysing information on funding, resource and capacity levels to understand how IPS had been rolled out across the country. While completed, we include a description of WP1 here, as it informs WP2 and WP3. WP2 is an effectiveness evaluation investigating the population-level outcomes of implementing IPS, focusing on health, mortality, quality of life and social functioning. Finally, in WP3, we assess the financial implications of implementing IPS from a public purse perspective, synthesising data on resource use and costs of implementation with data from WP2. Overall, we will examine the societal effects of IPS implementation on employment, welfare dependency, mental healthcare use, emergency care visits, self-harm and suicide, general mortality, crime and victimisation. Emphasis will be on long-term outcomes, and we will model the economic consequences of IPS. This study aims to inform policy making and strategies for implementing IPS at scale. Ethics and dissemination: This is an effectiveness study using registry data. The Regional Committee for Medical Research Ethics Northern Norway, REK North has approved the use of registry data without informed consent for this project (approval number 134553). The findings will be disseminated both in academic peer-reviewed journals, directly to informants in WP1, to the public through media and the project website, and at relevant conferences and seminars for specific relevant target groups. Trial registration number: Not applicabl
The lives and legacies of the British Gay Liberation Front badge, 1970-2024
No full textThe original and most commonly worn British Gay Liberation Front (GLF) badge often features in archives holding material on GLF, yet there is limited scholarship on why and with what effect this badge was worn. By combining archival research and oral histories, this article uses this badge to explore the experience and identity of GLF members both during GLF’s formal existence and in its afterlife. During GLF’s initial existence, between 1970 and 1973, the badge was a means of coming out to oneself and others. In turn, wearing the badge helped to construct and reinforce a new and distinct gay community. After the breakup of GLF, the badge continued to be worn and its imagery evoked to demonstrate allegiance to GLF and its ethos, whilst a tradition of gay badge-wearing emerged as a legacy of GLF. Overall, this badge was a major tool to signify identity and build community, not just during GLF’s initial existence, but up to the present day. Through its combination of extensive oral histories and archival research, this article provides new insights into how material culture can be used to understand social movements and their long-term impacts