Is regulatory innovation fit for purpose? A case study of adaptive regulation for advanced biotherapeutics

The need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article investigates the regulation of advanced biotherapeutics in the European Union and shows that it presents several defining features of an adaptive regulation regime, notably institutionalized processes of planned adaptation that allow regulators to gather, generate, and mobilize new scientific and risk evidence about innovative products. However, our in-depth case analysis highlights that more attention needs to be paid to the consequences of the introduction of adaptive regulations, especially for critical stakeholders involved in this new regulatory ecosystem, the capacity and resource requirements placed on them to adapt, and the new tradeoffs they face. In addition, our analysis highlights a deficit in how we currently evaluate the performance and public value proposition of adaptive regulations vis-à-vis their stated goals and objectives.     

Correlations Among the HLA-DQB1 Alleles and Suicidal Behavior

Suicide is a worldwide health problem with multiple causes, including genetic factors. The major histocompatibility complex (MHC) is represented by an assembly of gene encoding the human leukocyte antigen (HLA). The purpose of our study was to determine associations between the HLA profiles and predisposition for suicidal behavior. We harvested blood samples from persons with history of suicidal attempts (case group) and persons never exhibiting such behavior (control group). The DNA was extracted and amplified via polymerase chain reaction (PCR) to determine the HLA-DQB1 profiles. Statistical data processing was performed with the Epi Info program. We found that the presence of the HLA-DQB1*02 allele increases the risk of suicidal behavior, while HLA-DQB1*05 alleviates such risk. The genotype that presented the most increased risk for suicidal behavior was found to be HLA-DQB1*02/HLA-DQB1*03. Our study has demonstrated the presence of several associations between HLA profiles and suicidal behavior.     

Embedded Activism 2.0: Re-shaping the Space for Civil Society in Russia and China

Abstract

NGOs have been seen as an integral part of civil society and a necessary feature of democratic transition. It has been argued that depoliticised NGOs in China ‘embedded’ in existing political structures would eventually bring about democratic changes through incremental actions, as they did in post-Soviet Russia. Both countries, however, recently witnessed the shrinking of political and legal space for public participation, especially for foreign-funded civil society organisations. This article analyses the impact of the NGO laws on civil society in Russia and China to update the embedded activism hypothesis. It draws on empirical data to describe the strategies that the NGOs use to adapt and how the future of the sector is perceived by young people in both countries.     

The Role of Forms of Traumatic Exposure in Relational and Physical Aggression Perpetrated by Incarcerated Men and Women

The relationship between history of trauma and violence is well studied. However, the relationship between trauma and relational aggression is not. And yet relational aggression is of considerable relevance to the criminal justice system. This study was designed to extend the literature on trauma and violence by including a measure of relational aggression and testing for sex differences. The sample was comprised of incarcerated men (N = 125) and women (N = 141). Data were collected from inmate interviews and inmate completion of a battery of instruments. Regression analyses revealed that of three types of trauma, only a history of interpersonal nonsexual trauma predicted the perpetration of both relational aggression and physical aggression while incarcerated, although no sex differences emerged. Results provide guidance for intervention efforts.     

Private Law and Housing Justice in Europe

This article explores the different meanings of the right to housing in Europe in public and private relations with housing providers. In light of the fundamental right to housing's meaning in the case law of the European Court of Human Rights and the Court of Justice of the European Union, we offer a new reading of the CJEU judgments that have hitherto been heralded as extending the social dimension of EU (private) law. We submit that the emphasis on economic and procedural rights risks further ‘economisation’ of housing relations in Europe. While the possibilities to grant direct horizontal effect to the right to housing in EU law currently offer limited potential to counter this trend, private law provides part of the framework for a further balancing of social and economic elements in housing cases. Accordingly, we call for a debate on the specific aspects of horizontal relationships in the complex system of housing justice.     

Islamic Terrorism and the Question of National Liberation,or Problems of Contemporary Chechen Terrorism

Scholars have analyzed various causes of contemporary Chechen terrorism in Russia and have offered multiple explanations as to why this terrorism persists. Most commonly, these scholars accuse Russia of suppressing a Muslim struggle for national liberation in Chechnya because of Russia's own interests in Chechen territory or its lucrative oil resources. This work analyzes various instances of Chechen terrorism, 1991–2002, to conclude that the dynamics of terrorism do not support the claims of various scholars, journalists, and Chechen terrorists that Chechen rebels are fighting a war of independence and that the Russian government's failure “to let Chechnya go” instigates future acts of terrorism.     

Gender inequality in Russia's rural formal economy

Gender inequality in Russia's rural formal economy is examined using quantitative and qualitative data. Rural women continue to be underrepresented in farm managerial positions, and gendered income differences remain the norm. Rural women are underrepresented because they continue to have responsibility for most of the housework and child care. The traditional division of labor inside the household continues to dominate, thereby affecting women's career trajectories and earning potential. Value change about gendered roles in the formal economy has been minimal.     

CORPORATE TAX CUTS AND FOREIGN DIRECT INVESTMENT

Accurate policy evaluation is central to optimal policymaking, but difficult to achieve. Most often, analysts have to work with observational data and cannot directly observe the counterfactual of a policy to assess its effect accurately. In this paper, we craft a quasi‐experimental design and apply two relatively new methods—the difference‐in‐differences estimation and the synthetic controls method—to the policy debate on whether corporate tax cuts increase foreign direct investment (FDI). The taxation–FDI relationship has attracted wide attention because of mixed findings. We exploit a quasi‐experimental design for Russian regions, which were granted autonomy to reduce corporate profit tax in 2003, enabling them to simultaneously experiment with different tax policies. We estimate both the average and local treatment effects of two types of tax cuts on FDI inflows. We find that, on average, relative to the absence of tax cuts, nondiscriminatory tax cuts on direct investment profit increase FDI, but discriminatory tax cuts on selected government‐sanctioned investment projects do not. Yet for both types of tax cuts, local treatment effects vary dramatically from region to region. Our research has important implications for the design of tax policy and fiscal incentive, and the assessment of fiscal policy reforms.