Interchangeability of biosimilars: A study of expert views and visions regarding the science and substitution

Healthcare systems have reached a critical point regarding the question of whether biosimilar substitution should become common practice. To move the discussion forward, the study objective was to investigate the views of experts from medicines agencies and the pharmaceutical industry on the science underpinning interchangeability of biosimilars. We conducted an empirical qualitative study using semi-structured interviews informed by a cross-disciplinary approach encompassing regulatory science, law, and pharmaceutical policy. In total 25 individuals with experience within biologics participated during September 2018–August 2019. Eight participants were EU national medicines authority regulators, and 17 had pharmaceutical industry background: five from two originator-only companies, four from two companies with both biosimilar and originator products, and eight from seven biosimilar-only companies. Two analysts independently conducted inductive content analysis, resulting in data-driven themes capturing the meaning of the data. The participants reported that interchangeability was more than a scientific question of likeness between biosimilar and reference products: it also pertained to regulatory practices and trust. Participants were overall confident in the science behind exchanging biosimilar products for the reference products via switching, i.e., with physician involvement. However, their opinions differed regarding the scientific risk associated with biosimilar substitution, i.e., without physician involvement. Almost all participants saw no need for additional scientific data to support substitution. Moreover, the participants did not believe that switching studies, as required in the US, were appropriate for obtaining scientific certainty due to their small size. It is unclear why biosimilar switching is viewed as scientifically safer than substitution; therefore, we expect greater policy debate on biosimilar substitution in the near future. We urge European and UK policymakers and regulators to clarify their visions for biosimilar substitution; the positions of these two frontrunners are likely to influence other jurisdictions on the future of biosimilar use.

Locus of control and culture of poverty. An appraisal of Lawrence M. Mead’s ideas in ‘Culture and Poverty’

Lawrence M. Mead presented an interesting argument as to why poverty exists in the United States. He problematizes the culture of the poor of which ethnic minorities over-represent. By referring to the geographic regions from which these ethnic minorities came from, he globalised the question of poverty in the US. This invites a global policy debate rather than a US-centric policy debate. Indeed, Mead so freely made references to Africa and the African culture severally throughout his commentary. It is against this backdrop that I show that Mead was right to a large extent on the question of inner-driven individualised orientation. However, he overestimates its influence and misreads what culture is. He presented the culture of poverty as the antecedent of poverty. It was concluded that manipulating both internal drive (internal locus of control) and the structure of society is a more effective way to tackle poverty.

Making interpretive policy analysis critical and societally relevant: emotions, ethnography and language

This article summarises the main achievements of interpretive approaches to policy analysis and signposts ways to develop them to strengthen inclusivity and diversity. By visualising tangible strategies used in the approach, it demonstrates how we can better understand how policies are made and understood. At the same time, the article places a strong focus on emotions and ethnography as a way to strengthen the societal relevance of the approach. Focusing on emotions in policy research goes beyond a simple interest in emotions, using them as a specific critical lens to view the researched phenomenon while considering how policy ideas are framed as relevant or irrelevant through expressive language. Analogously, the article describes ethnography as an epistemological lens for analysing policy wherein researchers embrace human bias and the normativity of their research. To illustrate how these two lenses work in practice, the article concludes by discussing the research design of an analysis of the role of fathers in the policy debate around birth care in Czechia.

Japan and Foreign Territory Strike: Debate, Deterrence, and Defense Strength

The increased frequency of debate in Japan over foreign territory strike points to it being officially affirmed as a Japanese Self-Defense Force (SDF) mission in the near future. This article explores the foreign territory strike debate through the lens of the four key questions that have structured the post-war debate on all new overseas SDF operations: is it constitutional?; is it (militarily) plausible?; is it (strategically) wise?; and, is it (politically) acceptable? After discussing the contours of the Japanese post-war legal and policy debate on the use of force in foreign territory, the article describes contemporary doubts over the tactical effectiveness and strategic opportunity cost of configuring the SDF to conduct overseas strike operations—especially for missile defense purposes. Foreign territory strike would divert scarce fiscal resources and political attention from adaptations that enhance the US-Japan alliance’s posture resilience and enable it to sustainably generate force even after an initial attack, thereby augmenting regional deterrence. The article concludes by noting that political barriers could also still prevent the mission from being substantively and credibly implemented. Acrimonious domestic debate on foreign territory strike could also hamstring government attempts to attract public buy-in for future defense transformation in areas of greater priority and that add more to deterrence than the acquisition of modest strike capabilities.

The Rhetoric of Sexual Difference in French Reproductive Politics

What kind of rhetoric frames French reproductive policy debate? Who does such policies exclude? Through an examination of the “American import” of gender studies, along with an analysis of France’s Catholic heritage and secular politics, I argue that an unwavering belief in sexual difference as the foundation of French society defines the productive reproductive citizen. Sylviane Agacinski is perhaps the most vocal public philosopher who has framed the terms of reproductive policy debate in France, building an oppositional platform to reproductive technology around anthropological assertions of sexual difference. This paper engages with Agacinski to examine rhetorical claims of sexual difference and how such claims delayed passage of France’s revised bioethics legislation that extends access of assisted reproductive technology (ART) to “all women.” Though the “PMA pour toutes” [ART for all women] legislation was eventually passed, such rhetoric motivated the explicit exclusion of all trans person from its extension, thus hardly permitting ART to all women.

Grand Strategy and the (Re)Shaping of Greece–China Relations

This paper assesses China–Greece relations since 2006, examining them as part of China’s Grand Strategy, and Greece’s perception of them. The first aim of the paper is to provide an overview of China–Greece relations in connection with its long- and short-term goals. In essence, it focuses on understanding whether a Chinese Grand Strategy towards Greece exists. Second, it aims to examine the perception of Greeks over China’s foreign policy towards Greece. The intended contribution of the paper is to illustrate the response of national discourses over China’s increased presence in both the global sphere and specific countries. By offering the Greek perspective, we ultimately seek to provide a more balanced foundation for the ongoing scholarly and policy debate.

Convergence in Green Growth as the Key to Fighting Climate Change, 1990–2019

The consequences of climate change are an important point of contention in the current policy debate on the sustainability of economic development and growth. Climate change contributes to many socio-economic disadvantages and risks. The primary objective of global policy 2050 is to fully understand the negative externalities of environmental change. Goal and methodology: the main goal of the study is to examine convergence to the steady green growth state for a sample of 130 countries from 1990 to 2019. Setting up an efficient and consistent policy to fight climate change demands empirical knowledge on green growth. Using log (t) test methodology, we investigate convergence in green growth indicators for selected samples based on available country data. Findings: our assumptions are: (1) economies are not motivated and eager to foster energy transition; instead, they accept it as a random policy goal and (2) economies want to foster energy transition, but they are limited by a significant trade-off factor pulling their efforts down. Convergence testing shows the existence of two significant convergence clubs, one with countries moving to energy transition and the second still promoting national output based on fossil fuels. The findings indicate future divergence between the two clubs and significant convergence within identified convergence clubs. Conclusions: the energy transition is moving forward at two-tier speed with green leaders and green follower clubs. Policymakers and practitioners must closely monitor the dynamics of green growth to assess the risk and uncertainties of climate change.

The potentials of heresthetic and rhetoric in an open framing situation: theory and evidence from a survey experiment

To win a policy debate, political actors may apply two analytically distinct counterframing strategies, rhetoric and heresthetic. Rhetoric is when counterarguments are formulated in the original dimension of the debate, while heresthetic is using arguments in a different dimension compared to the original frame. Although both rhetoric and heresthetic are ubiquitous phenomena in the process of public opinion formation, there are no general rules to specify their efficacy. Drawing on a survey experiment carried out in Hungary in 2020 (N = 2000), this paper uncovers the factors determining the effect of the two strategies. Introducing a conceptual distinction between open and trade-off framing situations, the paper demonstrates that the structure of the situation matters. While heresthetic has a robust effect in trade-off framing situations, rhetoric may have a strong impact in open framing situations. Moreover, the effectiveness of counterframing depends on the party affiliation of respondents and the strength of their related attitudes.

Framing the policy debate over tobacco control legislation and tobacco taxation in South Africa

BackgroundIn 2018, South Africa opened public consultations on its newly proposed tobacco control bill, resulting in substantial public debate in which a range of arguments, either in favour of or against the Bill, was advanced. These were accompanied by the recurring discussions about the annual adjustments in tobacco taxation. This study uses the concept of framing to examine the public debate in South African print media on the potential effects of the legislation, as well as tobacco tax regulations, between their proponents and detractors.MethodsA systematic search of news articles using multiple data sources identified 132 media articles published between January 2018 and September 2019 that met the inclusion criteria.ResultsSeven overarching frames were identified as characterising the media debate, with the three dominant frames being Economic, Harm reduction and vaping, and Health. The leading Economic frame consisted primarily of arguments unsupportive of tobacco control legislation. Economic arguments were promoted by tobacco industry spokespeople, trade unions, organisations of retailers, media celebrities and think tanks—several of which have been identified as front groups or third-party lobbyists for the tobacco industry.ConclusionThe dominance of economic arguments opposing tobacco control legislation risks undermining tobacco control progress. Local and global tobacco control advocates should seek to build relationships with media, as well as collate and disseminate effective counterarguments to those advanced by the industry.