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Certain fields of research are deeply shaped by their proximity with policy-makers and administrations. The so-called 'regulatory sciences' and their corresponding expert communities emerge from this intermediary space between science and policy. Social studies of expertise and scientific experts show, however, that modes of engagement with policy-making vary greatly from one scientist to another. Two scientists that are part of the same research group or laboratory may engage the policy realm differently. How then does the social organization of research influence scientists' participation in scientific advice and the production of regulatory sciences? The paper looks at toxicology, a field in which knowledge production is centrally motivated by risk assessment, but one that has also seen the emergence of different knowledge-making motives, including advancement of fundamental knowledge and frontier research. A toxicology laboratory may thus harbor a diversity of moral economies of scientific advice. The paper argues that scientists' engagements with policy, through scientific advice and regulatory risk assessment, create organizational tensions and force changes to the standard, team-based social organization of research work. [ABSTRACT FROM AUTHOR]

During the Covid-19 pandemic, many governments have resorted to scientific advisory bodies to aid in public health decision-making. What then has been the public's perception of those new structures of scientific advice? In this article, we draw on a survey conducted in November 2020 among a representative sample of the French adult population (n  = 1,004) designed specifically to explore public perceptions of the dedicated Covid-19 Scientific Council created in March 2020 and of scientific advice in general. After only 8 months, three-quarters of French people said they had heard of it, but only a quarter had a positive opinion about its usefulness. Despite the diversity of perceptions of what scientific advice is and should be, it appeared that scientific advice bodies are perceived as useful mainly by a public already largely supportive of the delegation of the management of public life to the government and public institutions. [ABSTRACT FROM AUTHOR]

Scientific advisory boards are frequently established to provide scientific insights and advice to policymakers. Advisory board appointing bodies often state that research excellence and scientific seniority are the main grounds on which advisory board members are selected. Many authors have pointed out that there is more to giving good scientific advice than just being an expert for a specific research field. The aim of this study is to analyse if and how research excellence correlates with the probability of being appointed as a scientific advisory board member. We collected data for scientific advisory boards from both the USA and Germany. We use logit regression models to analyse how research excellence correlates with the probability of appointment to a scientific advisory board. Our results suggest that research excellence is insignificant or even correlates negatively with the probability of being appointed to a scientific advisory board. [ABSTRACT FROM AUTHOR]

This article examines the contestation that in the summer of 1972 disrupted workshops in Western Europe featuring renowned physicists affiliated to the top-secret JASON advisory group. Set up by the US Department of Defense research division, JASON was responsible for outlining new bombing strategies in the context of the Vietnam War. Some of the physicists involved in the protest had contributed instead to the International War Crimes (Russell) Tribunal, gathering evidence in Indochina on the allegedly genocidal character of the US bombing. In reconstructing the history of the contestation, this article contends that the conflict was an opportunity for advertising diverging political stances in the rebellious atmosphere of early 1970s, as much as to convey competing views about the physicists' influence on global affairs. In particular, while JASON members boasted that their advisory roles stifled bellicose approaches, the protesters recalled the merits of independent inquiry and advocacy "from below" the elitist sphere of government advice, describing these as a better way to advance principles of global social justice. [ABSTRACT FROM AUTHOR]

Objective: Patients have unique insights and are (in-)directly affected by each decision taken throughout the life cycle of medicinal products. Patient preference studies (PPS) assess what matters most to patients, how much, and what tradeoffs patients are willing to make. IMI PREFER was a six-year European public-private partnership under the Innovative Medicines Initiative that developed recommendations on how to assess and use PPS in medical product decision-making, including in the regulatory evaluation of medicinal products. This paper aims to summarize findings and recommendations from IMI PREFER regarding i) PPS applications in regulatory evaluation, ii) when and how to consult with regulators on PPS, iii) how to reflect PPS in regulatory communication and iv) barriers and open questions for PPS in regulatory decision-making. Methods: PREFER performed six literature reviews, 143 interviews and eight focus group discussions with regulators, patient representatives, industry representatives, Health Technology Assessment bodies, payers, academics, and clinicians between October 2016 and May 2022. Results: i) With respect to PPS applications, prior to the conduct of clinical trials of medicinal products, PPS could inform regulators' understanding of patients' unmet needs and relevant endpoints during horizon scanning activities and scientific advice. During the evaluation of a marketing authorization application, PPS could inform: a) the assessment of whether a product meets an unmet need, b) whether patient-relevant clinical trial endpoints and outcomes were studied, c) the understanding of patient-relevant effect sizes and acceptable trade-offs, and d) the identification of key (un-)favorable effects and uncertainties. ii) With respect to consulting with regulators on PPS, PPS researchers should ideally have early discussions with regulators (e.g., during scientific advice) on the PPS design and research questions. iii) Regarding external PPS communication, PPS could be reflected in the assessment report and product information (e.g., the European Public Assessment Report and the Summary of Product Characteristics). iv) Barriers relevant to the use of PPS in regulatory evaluation include a lack of PPS use cases and demonstrated impact on regulatory decision-making, and need for (financial) incentives, guidance and quality criteria for implementing PPS results in regulatory decision-making. Open questions concerning regulatory PPS use include: a) should a product independent broad approach to the design of PPS be taken and/or a product-specific one, b) who should optimally be financing, designing, conducting, and coordinating PPS, c) when (within and/or outside clinical trials) to perform PPS, and d) how can PPS use best be operationalized in regulatory decisions. Conclusion: PPS have high potential to inform regulators on key unmet needs, endpoints, benefits, and risks that matter most to patients and their acceptable trade-offs. Regulatory guidelines, templates and checklists, together with incentives are needed to foster structural and transparent PPS submission and evaluation in regulatory decision-making. More PPS case studies should be conducted and submitted for regulatory assessment to enable regulatory discussion and increase regulators' experience with PPS implementation and communication in regulatory evaluations. [ABSTRACT FROM AUTHOR]

In this contribution, I present emergent analysis of a preoccupation with managing COVID-19 through border control, among non-Governmental public health actors and commentators. Through a reading of statements, tweets, and interviews from the 'Independent Sage' group – individually and collectively – I show how the language of border control, and of maintaining immunity within the national boundaries of the UK, has been a notable theme in the group's analysis. To theorize this emphasis, I draw comparison with the phenomenon of 'green nationalism', in which the urgency of climate action has been turned to overtly nationalistic ends; I sketch the outlines of what I call 'viral nationalism,' a political ecology that understands the pandemic as an event occurring differentially between nation states, and thus sees pandemic management as, inter alia, a work of involuntary detention at securitized borders. I conclude with some general remarks on the relationship between public health, immunity, and national feeling in the UK. [ABSTRACT FROM AUTHOR]

In a modern democracy, a public health system includes mechanisms for the provision of expert scientific advice to elected officials. The decisions of elected officials generally will be degraded by expert failure, that is, the provision of bad advice. The theory of expert failure suggests that competition among experts generally is the best safeguard against expert failure. Monopoly power of experts increases the chance of expert failure. The risk of expert failure also is greater when scientific advice is provided by only one or a few disciplines. A national government can simulate a competitive market for expert advice by structuring the scientific advice it receives to ensure the production of multiple perspectives from multiple disciplines. I apply these general principles to the United Kingdom's Scientific Advisory Group for Emergencies (SAGE). [ABSTRACT FROM AUTHOR]

Objective: Patients have unique insights and are (in-)directly affected by each decision taken throughout the life cycle of medicinal products. Patient preference studies (PPS) assess what matters most to patients, how much, and what trade-offs patients are willing to make. IMI PREFER was a six-year European public-private partnership under the Innovative Medicines Initiative that developed recommendations on how to assess and use PPS in medical product decision-making, including in the regulatory evaluation of medicinal products. This paper aims to summarize findings and recommendations from IMI PREFER regarding i) PPS applications in regulatory evaluation, ii) when and how to consult with regulators on PPS, iii) how to reflect PPS in regulatory communication and iv) barriers and open questions for PPS in regulatory decision-making.Methods: PREFER performed six literature reviews, 143 interviews and eight focus group discussions with regulators, patient representatives, industry representatives, Health Technology Assessment bodies, payers, academics, and clincians between October 2016 and May 2022.Results: i) With respect to PPS applications, prior to the conduct of clinical trials of medicinal products, PPS could inform regulators’ understanding of patients’ unmet needs and relevant endpoints during horizon scanning activities and scientific advice. During the evaluation of a marketing authorization application, PPS could inform: a) the assessment of whether a product meets an unmet need, b) whether patient-relevant clinical trial endpoints and outcomes were studied, c) the understanding of patient-relevant effect sizes and acceptable trade-offs, and d) the identification of key (un-)favorable effects and uncertainties. ii) With respect to consulting with regulators on PPS, PPS researchers should ideally have early discussions with regulators (e.g., during scientific advice) on the PPS design and research questions. iii) Regarding external PPS communication, PPS could be reflected in the assessment report and product information (e.g., the European Public Assessment Report and the Summary of Product Characteristics). iv) Barriers relevant to the use of PPS in regulatory evaluation include a lack of PPS use cases and demonstrated impact on regulatory decision-making, and need for (financial) incentives, guidance and quality criteria for implementing PPS results in regulatory decision-making. Open questions concerning regulatory PPS use include: a) should a product independent broad approach to the design of PPS be taken and/or a product-specific one, b) who should optimally be financing, designing, conducting, and coordinating PPS, c) when (within and/or outside clinical trials) to perform PPS, and d) how can PPS use best be operationalized in regulatory decisions.Conclusion: PPS have high potential to inform regulators on key unmet needs, endpoints, benefits, and risks that matter most to patients and their acceptable trade-offs. Regulatory guidelines, templates and checklists, together with incentives are needed to foster structural and transparent PPS submission and evaluation in regulatory decision-making. More PPS case studies should be conducted and submitted for regulatory assessment to enable regulatory discussion and increase regulators’ experience with PPS implementation and communication in regulatory evaluations.

The role of science in environmental decision-making calls for an improved understanding of how scientific advice can best inform policy. Policy-relevant science is trapped in the conundrum of being close to policy and politics while trying not to become too close, to avoid politicization. We investigate this dilemma in three scientific advisory organizations: the International Council for the Exploration of the Sea (ICES), the Intergovernmental Panel on Climate Change (IPCC), and the Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (IPBES). Comparing marine, climate, and biodiversity governance at the international level, we reveal how the science-policy interface is understood and arranged in the institutional designs of these organizations. While they are all mandated to be policy-relevant, they aim to provide a neutral space for science that is not overtly impacted by politics. Our analysis reveals key differences in science-policy interactions regarding four issues: mandate; science-policy separation; politicization of advisory science; and knowledge inclusion. After discussing how these dimensions exhibit challenges connected to the 'proximity vs. distance' dilemma, we formulate an ideal-typical continuum comprising the following arrangements: a clear-cut boundary, a boundary zone, a fuzzy boundary. Based on this three-tiered model, we argue for a non-dichotomous understanding of science-policy relationships. [ABSTRACT FROM AUTHOR]

Despite strong expertise and a sophisticated scientific advisory system, the UK's response to the Covid-19 pandemic has been, and continues to be, weak in terms of preventing death and illness, and damage to the economy. This article argues that an important reason for this failure has been that the policies of the UK government have at critical times failed to take adequate account of scientific evidence, while at the same time attempts have been made to blame scientists for resulting policy failures. This paper analyses the role of scientific advice in addressing Covid-19 in the UK and draws three lessons for how such expertise can be better deployed in the future. It argues that: (1) Government scientific advisors and advisory bodies should be more independent of political influence and interference; (2) Government scientific advisors should be empowered to challenge misrepresentation and misuse by decision-makers of the scientific evidence, and undermining of public-health policies; and (3) Government scientific advice should be more transparent and advisors should engage more proactively with the public. Acting on these lessons will be important for ongoing handling of the current crisis, for the current UK Covid-19 Public Inquiry, and for the UK's preparedness for future crises. [ABSTRACT FROM AUTHOR]

The Intergovernmental Negotiating Committee on Plastic Pollution seeks to address, among other issues, the science-policy interface of plastic pollution in the forthcoming international legally binding instrument on plastic pollution, including in the marine environment (ILBI) to be finalised in 2024 by the United Nations Environment Assembly (UNEA). Given the importance of protecting the marine environment from plastic pollution, this paper reviews ILBI and argues that the UNEA should by Resolution establish an independent scientific committee. The committee should have an overarching global, regional, and local presence with institutional openness and accessibility to elucidate the science behind plastic pollution. This paper proposes that an independent scientific approach is preferrable to a combined science-policy institution seen in Secretariats and Conference of Parties in some conventions. The latter often exhibit numerous weaknesses. Establishing an independent scientific committee will ensure the science behind plastic pollution is robust, credible, and effectively informs policy decisions. [Display omitted] • Procedural content of plastic pollution treaty is not yet known. • Revised draft of treaty delivered a mixed message. • Science-policy interface approach is challenging and has weaknesses. • Proposal for independent scientific committee on plastic pollution is better. [ABSTRACT FROM AUTHOR]

International environmental advisory bodies are tasked with the daunting challenge of collecting and synthesizing knowledge about a specific issue-area by speaking in one 'global scientific voice'. However, the 'type of knowledge' issuing from these bodies can hardly meet the expectations of 'getting the science right', as scientific issues inevitably end up being framed in different ways. Although accounts of contestation between various knowledge claims are abundant in the literature focusing on international advisory bodies, the implications of these tensions for science–policy interplay remain poorly understood. In particular, analyses of and reflections on the relationship between knowledge outputs and particular institutional arrangements are underdeveloped. This paper attempts to address this gap, postulating a link between knowledge outcomes and institutional design. By introducing the concept of 'epistemic framings', it explores the different ways in which soil and land degradation issues are framed by scientific advisory bodies at the global level. The analysis, conducted through the Qualitative Content Analysis (QCA) method, suggests that international scientific advisory bodies may frame epistemic issues in ways that are influenced by the policy setting to which they are institutionally bound. Further research on the dynamics of science–policy interaction at the global level could test the assumptions made in this paper and shed light on the structural (including institutional design) and agential factors influencing advisory bodies' epistemic framings. [ABSTRACT FROM AUTHOR]

Background: The Chief Medical Officer (CMO), one of the UK's most senior public health leadership roles, was crucial in supporting policymakers in responding to COVID-19. Yet, there exist only a handful of (largely historical) accounts of the role in England. This article is the first to empirically examine how the scope, focus and boundaries of the CMO role vary over time across the four UK nations, including during public health emergencies., Methods: We undertook semi-structured interviews with 10 current and former CMOs/Deputy CMOs in the four UK nations and analysed relevant documents., Findings: The CMO role is not clearly defined in contemporary UK legislation and is instead shaped by iterative policies, incumbent preferences, and organizational needs, leading to variation over time and between nations. Nonetheless, most participants framed the role as primarily providing 'independent' advice to government despite being senior civil servants who, in communicating with the public, sometimes speak 'on behalf' of government., Conclusions: The flexibility of UK CMO roles allows for responsive adaption but poses risks for how well these roles are understood. A potential tension between providing 'independent' policy advice and a need to publicly communicate government policies and guidelines may be exacerbated in emergency contexts., (© The Author(s) 2024. Published by Oxford University Press on behalf of Faculty of Public Health.)

Current challenges to healthcare, i.e. the emergence of new diseases, lack of therapies for known diseases and life-threatening conditions, identification of patients who do not respond to standard treatment, on the one hand, and the evolution of scientific understanding of disease processes, medicines, therapies, causes of treatment failures, and implementation in clinical practice of innovations related to molecular biology and genetic engineering, on the other hand, create conditions and opportunities for the development of innovative medicinal products. A relatively new class of medicines is based on human cells and tissues (the term used in Russian legislation is biomedical cell products, BCP). However, the inability to accurately predict the efficacy and financial rewards of such medicines for pharmaceutical companies, as well as significant labour and financial costs associated with their development and clinical use, hinder their entry into the market. The aim of the study was to analyse the foreign regulatory setting for the development and launch of human cell- and tissue-based products, as well as approaches of foreign regulatory authorities to scientific advice, which can be drawn upon by the Russian expert authority when providing advice to BCP developers. The paper summarises the results of analysis of regulations establishing the procedure for providing scientific advice by EU, USA, and Russian regulatory authorities, and analyses the advice provided for the human cell- and tissue-based products which are now authorised in the EU and USA. The analysis of advice provided by foreign regulatory authorities shows that the largest number of consultations were given for medicinal products based on genetically modified cells for the treatment of cancer and genetic diseases. The questions were mainly related to the contents of specifications for finished pharmaceutical products, safety evaluation, curtailing of preclinical studies due to the lack of relevant animal/disease models, the number of subjects and efficacy endpoints in clinical studies, assessment of the appearance of replication-competent retroviruses.

IntroductionEarly advice in the process of developing health technologies allows manufacturers to plan their production and transfer to health care systems more accurately. This review aims to describe frameworks used within HTA and their current use by HTA Agencies.Material and methodsWe carried out a systematic literature review in Pubmed, Embase, Scopus, and WoS, including all references published in Spanish and English. This was last updated in March 2022. We extracted all available information regarding the organizations involved, services offered, types of technology, collaborators involved, fees, output and impact. Websites of several HTA organizations and Google were also searched in order to update and complete the information obtained from this generic search.ResultsFive-hundred and forty one articles were identified and screened, of which 26 met the eligibility criteria and were selected. Seven of them were non-systematic reviews that described two or more HTA organizations. Ten studies were focused on the advice offered by individual organizations, and eight described the EMA and EUnetHTA parallel or joint advice. We found variations in the technology assessed, services offered, stage of development and costs for advisory services.ConclusionsEarly and scientific advice would help manufacturers focus their product development on what is needed for the management of specific diseases. Most of the examples or services found refer to drugs as well as to some medical devices and diagnostics. A common definition of the type of advice that could be offered for different health technologies by HTA bodies to ascertain health care systems and manufacturers' needs, in addition to the timeline in which that advice needs to be given, would help HTA bodies provide the right support at the right time.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020219401, PROSPERO CRD42020219401.

Immense uncertainty and the need for drastic interventions cause politicians to rely heavily on scientific advice for underpinning or legitimating their COVID-19 decision-making. This paper explores the role of scientific advice in this policy field in Germany, Italy, the Netherlands and the UK. It shows that scientific advice is based on the disciplinary, mainly medical, backgrounds of advisors but is also influenced by social and economic values, which are core to what politicians find important. During the pandemic a growing gap between scientific advice and political decisions is observed. [ABSTRACT FROM AUTHOR]

This article presents a preliminary analysis of the advice provided by the UK government's Scientific Advisory Group for Emergencies (SAGE) held between 22 January and 23 March 2020 in response to the emerging coronavirus pandemic. Drawing on the published minutes of the group's meetings, the article examines what was known and not known, the assumptions and working practices that shaped their work, and how this knowledge was reflected in the decisions made by the government. In doing so, the article critically examines what it means for policy making to be 'led by the science' when the best available science is provisional and uncertain. Using ideas of 'externality' and 'evidential significance', the article argues that the apparent desire for high levels of certainty by both scientists and political decision-makers made early action impossible as the data needed were not, and could not be, available in time. This leads to an argument for changes to the institutions that provide scientific advice based on sociologically informed expectations of science in which expert judgement plays a more significant role. [ABSTRACT FROM AUTHOR]

Drawing on the SAGE minutes and other documents, I consider the wider lessons for norms of scientific advising that can be learned from the UK’s initial response to coronavirus in the period January–March 2020, when an initial strategy that planned to avoid total suppression of transmission was abruptly replaced by an aggressive suppression strategy. I introduce a distinction between “normatively light advice”, in which no specific policy option is recommended, and “normatively heavy advice” that does make an explicit recommendation. I argue that, although scientific advisers should avoid normatively heavy advice in normal times in order to facilitate democratic accountability, this norm can be permissibly overridden in situations of grave emergency. SAGE’s major mistake in early 2020 was not that of endorsing a particular strategy, nor that of being insufficiently precautionary, but that of relying too heavily on a specific set of “reasonable worst-case” planning assumptions. I formulate some proposals that assign a more circumscribed role to “worst-case” thinking in emergency planning. In an epilogue, I consider what the implications of my proposals would have been for the UK’s response to the “second wave” of late 2020. [ABSTRACT FROM AUTHOR]

Science is increasingly expected to help in solving complex societal problems in collaboration with societal stakeholders. However, it is often unclear under what conditions this can happen, i.e., what kind of challenges occur when science interacts with society and what kind of quality expectations prevail. This is particularly pertinent for Social Sciences and Humanities (SSH), which are part of the object they study and whose knowledge is always subject to provisionality. Here we discuss how SSH researchers can contribute to societal problems, what challenges might occur when they interact with societal stakeholders, and what quality expectations arise in these arrangements. We base our argumentation on the results of an online consultation among 125 experts in Germany (representatives from SSH, learned societies, stakeholders from different societal groups, and relevant intermediaries).

Background: Cancer is a serious global health problem and a major cause of death. The European Medicines Agency (EMA) has established several regulatory initiatives to expedite the development and authorization of drugs to ensure timely access of patients. In this study, we analyzed the procedural timelines of marketing authorization applications for anticancer drugs in the EU, with a specific focus to special regulatory programs, scientific advice and company size. Methods: Anticancer drugs that received an opinion from the EMA between January 2010 and December 2019 were included in the study. Public assessment reports were used to obtain publicly available information of the drugs. Results: We identified 96 applications for new anticancer drugs. 34 applications were granted access to at least one expedited program offered by the EMA. Total procedure time was reduced from average 370 to 200–215 days when accelerated assessment was granted. Granting of a conditional marketing authorization or an orphan designation, as well as having scientific advice, only mildly affected total procedure time. Average total procedure time of small companies was much longer compared with medium-sized and large companies (483 versus 356 days), which was caused by an increased clock stop time. Conclusion: Total procedure time for anticancer is mainly affected by the granting of accelerated assessment, which reduced the total procedure time, and company size, where total procedure time is much longer for small companies. Small companies are advised to have, and especially adhere to scientific advice to reduce procedure time and increase the chance of success. [ABSTRACT FROM AUTHOR]

Scientific advice (SA) is an important tool offered by regulators to help developers generate robust evidence on a medicine's benefits and risks. Drawing on accumulated experience and looking at the SA provided by the European Medicines Agency in 2018 to advanced therapy medicinal products originally developed by public bodies, we discuss most commonly raised issues and the complexity and timings of the questions posed. Earlier and more frequent SA could help advanced therapy medicinal product developers to pre‐empt delays at the marketing authorisation stage. Carefully addressing quality and nonclinical issues before entering the pivotal phase of development will clear the path for a smooth clinical development and successful marketing authorisation. [ABSTRACT FROM AUTHOR]

Aims: The field of cell‐based therapies for human diseases is currently evolving from promising treatment options to established therapeutic concepts. The design of the nonclinical development program for cell‐based products, intended to provide a rationale for treatment and to gain insight into the safety profile, is challenging because of limitations caused by species‐specificity. The elements of the nonclinical package for cell‐based products were evaluated using advice reports from the European Medicines Agency database from 2013 to 2018 to identify the approach followed for nonclinical development of these products. Methods: The number and purpose of proposed and performed in vivo studies was recorded, as well as the type and design of in vitro and in vivo studies addressing biodistribution and tumorigenicity. Subsequently, the nonclinical development program was analysed for consistency across products. Results: In vivo studies for cell‐based therapies were primarily aimed at proof‐of‐concept (75/86), followed by addressing safety (64/86), biodistribution (49/86) and tumourigenicity (46/86). No animal studies were performed or proposed by sponsors or regulators for 6/86 products which contained cell types that have been studied in humans for a relatively long time. For one‐third of the products in vivo biodistribution and/or tumourigenicity studies were not considered necessary. in vivo tumourigenicity studies were regarded as having limited value. Conclusions: Compared to more conventional medicinal products, the nonclinical development program for cell‐based products was more tailored and focused on proof‐of‐concept. For tumourigenicity an in vitro approach may suffice. Total omission of in vivo studies appears to be possible for products with sufficient clinical experience. [ABSTRACT FROM AUTHOR]

The use of science, scientific information, and other knowledge to inform decision-making is increasingly recognised as an integral feature of environmental governance – a governance principle which is reflected in the new agreement for the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction (BBNJ Agreement). To support the integration of science and knowledge, the BBNJ Agreement establishes a Scientific and Technical Body (STB) and confers the task of finalising the formulation and function of this new advisory body to the Conference of Parties once the agreement enters into force. Therefore, it is a critical time for careful consideration of what is needed to achieve an effective STB. However, to date, there is limited research on what a fit-for-purpose STB would involve for BBNJ or what is needed to operationalise this in practice. As such, we aim to fill this knowledge gap by providing insights garnered from semi-structured interviews with key BBNJ stakeholders. Using qualitative content analysis, we identify and examine eight characteristics that stakeholders deem as important qualities for the STB to encompass, as well as challenges and opportunities for operationalising these qualities in practice. Our findings indicate that a fit-for-purpose STB extends beyond the mere production of high-quality scientific advice - it also necessitates the inclusion and due consideration of other fundamental qualities such as inclusivity and equity, transparency, flexibility, and synergy with the existing governance framework, amongst others, as well as proactive consideration of trade-offs associated with different design choices. These findings are pertinent to the forthcoming endeavour of designing and implementing an STB under the BBNJ Agreement, and more generally, provide insights on normative qualities that stakeholders perceive as important for science-policy interfaces. [ABSTRACT FROM AUTHOR]

International environmental advisory bodies are tasked with the daunting challenge of collecting and synthesizing knowledge about a specific issue-area by speaking in one ‘global scientific voice’. However, the ‘type of knowledge’ issuing from these bodies can hardly meet the expectations of ‘getting the science right’, as scientific issues inevitably end up being framed in different ways. Although accounts of contestation between various knowledge claims are abundant in the literature focusing on international advisory bodies, the implications of these tensions for science–policy interplay remain poorly understood. In particular, analyses of and reflections on the relationship between knowledge outputs and particular institutional arrangements are underdeveloped. This paper attempts to address this gap, postulating a link between knowledge outcomes and institutional design. By introducing the concept of ‘epistemic framings’, it explores the different ways in which soil and land degradation issues are framed by scientific advisory bodies at the global level. The analysis, conducted through the Qualitative Content Analysis (QCA) method, suggests that international scientific advisory bodies may frame epistemic issues in ways that are influenced by the policy setting to which they are institutionally bound. Further research on the dynamics of science–policy interaction at the global level could test the assumptions made in this paper and shed light on the structural (including institutional design) and agential factors influencing advisory bodies’ epistemic framings.

Addressing the wide range of marine pollution problems facing the global ocean requires a continual transfer of credible, relevant and timely scientific information to policy and decision makers in coastal and ocean management. The United Nations GESAMP (Joint Group of Experts on the Scientific Aspects of Marine Environmental Protection) is a long-standing scientific advisory group providing such information on a wide range of marine topics and emerging issues of concern to ten UN Sponsoring Organizations. This paper presents an overview of GESAMPs operation and examples of its current work. The group's scientific output is often cited by national governments, inter-governmental groups, and a range of non-governmental groups. Given the growing concerns about ocean health and the impacts of many stressors in an era of climate change, the development of timely and effective ocean policy and decision making would benefit from wider recognition and application of GESAMPs work. • GESAMPs working groups review key marine protection topics of concern. • Chemicals, plastics, ballast water management, and climate change mitigation are examples. • Its publications are used widely by ocean scientists, managers, and United Nations policy makers. • Using new scientific information directly for decision making is crucial to maintain ocean health. [ABSTRACT FROM AUTHOR]

Abstract Envisioning the expertise of the future in the field of food safety is challenging, as society, science and the way we work and live are changing and advancing faster than ever before. Future challenges call for multiple and multidimensional responses, some of which were addressed at EFSA's Third Scientific Conference. The participants indicated that risk assessment bodies involved in food safety such as EFSA must recognise that data, methods and expertise (i.e. people) are the three basic elements underlying risk assessments. These elements need constant consideration and adaptation to ensure preparedness for the future. Moreover, it should be recognised that knowledge and expertise are distributed throughout society and are thus not limited to scientists. Aspects considered during the breakout session included: (1) increased complexity, (2) the crowd workforce, (3) citizen science, (4) stakeholder engagement, (5) talent pools and (7) entrepreneurship. To account for future challenges, behavioural, attitudinal and cultural changes must be implemented successfully. At a societal level, people are increasingly going hand in hand with robotics and artificial intelligence in sharing expertise and producing outcome. This needs consideration on ethics and values, both for organisations and individuals. At an organisational level, risk assessment bodies will have to tap into new talent pools and new solutions for a more fluid and ad hoc‐based workforce. Future risk assessment bodies will have to actively engage with stakeholders when performing their assessments. It is expected that the impacts of citizen science and involvement of the crowd will become part of risk assessment practices. Consequently, EFSA will have to continue to invest in massive, ongoing skills development programmes. At an individual level, potential recruits will need to be assessed against a whole new set of competencies and capabilities: technical competencies in data science, computational science and artificial intelligence, alongside a large set of soft skills.