Barriers and Enablers for Continuous Improvement Methodologies within the Irish Pharmaceutical Industry

This study aims to investigate the barriers that exist when implementing continuous improvement methodologies, such as Lean Six Sigma (LSS), within the Irish Pharma industry. The main finding of this study is that 45% of participants perceived that a highly regulated environment could be a barrier to continuous improvement implementation, while 97% of respondents utilised Continuous improvement (CI) methods, such as Lean, Six Sigma, and LSS, within their organisations. While the International Conference of Harmonisation integrates CI into its Pharmaceutical Quality Systems (PQS) regulations, the highest motivation for CI implementation amongst the Irish Pharma industry is to improve Productivity and Quality. The main obstacles highlighted for CI implementation in Pharma attributed to stringent regulatory regimes were fear of extra validation activity, a compliance versus quality culture, and a regulatory culture of being “safe”. Another relevant finding presented in this paper is that participants CI LSS tools are very strongly integrated into the pharma industries corrective and preventative action system, deviations, and internal audit systems. Limitations of the research are that all the data collected in the survey came from professionals working for multinational Pharmaceutical companies based in Ireland. The authors understand that this is the first research focused on the barriers and status of CI initiatives in the pharmaceutical industry. The results of this study represent an important step towards understanding the enablers and obstacles for the use of continuous improvement methodologies in pharmaceutical manufacturing industries on a global scale.

Interaction Between Media Culture and Legal Culture and Their Impact on the Media Regulation System in Bulgaria

The article discusses the democratic changes in the Bulgarian society and the new regulatory system from the perspective of media and legal cultures. The article analyzes legal phenomena as such, as well as the social environment in which they have emerged and developed during the years of democratic transition. Law is a social regulator and has to serve the public interest. In Bulgaria, however, it has always been subject to the political will of the majorities and could not fulfill its function to provide the necessary basis for the establishment of democratic regulatory culture, management culture and culture of independence within the media.

Beyond Legislative Veto Power: The Transformative Effects of the Early Warning System for Subsidiarity Control Ten Years Down the Line

The majority of European Union (EU) studies tend to be critical of the Early Warning System (EWS) for subsidiarity control, deeming it as ineffective in blocking unwanted EU legislation. Against this background, the aim of this paper is to identify and discuss several transformative effects of the EWS connected with the quality and democratic character of the EU governance, beyond the tool’s legislative veto power. A critical review of the EWS’ interpretations as an accountability mechanism, Europeanization engine, parliamentary autonomy enhancing tool, platform of politicization of Europe, as well as an instrument improving the Commission’s regulatory culture reveals that —although flawed by design— the modus operandi of the EWS has in fact contributed to reinforcing the input legitimacy of the EU. The argument is also made that the EWS should be viewed as a sort of ‘reality-check’ for the EU’s legislative moderation, thus enhancing the ‘perceived output legitimacy’ of the EU policy-making. The paper, however, concludes that although the positive effects of the EWS ought to be recognized and valued, the mechanism in its current form has exhausted its democratic potential and needs to be complemented with new forms of representative politics in EU affairs.

Publisher Correction: Country-level conditions like prosperity, democracy, and regulatory culture predict individual climate change belief

A Correction to this paper has been published: https://doi.org/10.1038/s43247-021-00134-6

Country-level conditions like prosperity, democracy, and regulatory culture predict individual climate change belief

Decades after the scientific community agreed on the existence of human-made climate change, substantial parts of the world’s population remain unaware or unconvinced that human activity is responsible for climate change. Belief in human-made climate change continues to vary strongly within and across different countries. Here I analyse data collected by the Gallop World Poll between 2007 and 2010 on individual attitudes across 143 countries, using a random forest model, to show that country-level conditions like environmental protection, civil liberty, and economic development are highly predictive of individual climate change belief. Individual education and internet access, in contrast, are correlated to climate change awareness, but much less to belief in climate change’s anthropogenic causes. I also identify non-linear pattern in which country-level circumstances relate to individual climate change belief. The local importance of most predictors varies strongly across countries, indicating that each country has its relatively unique set of correlates of climate change belief.

Introducing the new culture section of BJPsych Bulletin

SummaryThis editorial launches the new culture section in the journal. Without any unchallengeable definition of ‘culture’, potential contributors may consider submissions under four headings: the arts and humanities relating to practice; regulatory culture; becoming a cultured practitioner; and psychiatry's cultural context. A new article type, ‘Cultural reflections’, has been created, and submissions may reflect any appropriate methodology, including those from the arts. Peer review (from methodologies outside psychiatry if appropriate) will assure quality. Our objectives are to establish BJPsych Bulletin as the ‘journal of record’ for cultural studies relevant to psychiatric service delivery and demonstrate equivalent quality between them and scientific studies.

Views from Below: Inspectors’ Coping with Hybrid Accountabilities

Regulation of long-term care service provision is a case of hybrid accountabilities. How do inspectors who are responsible for the implementation of regulations handle the uncertainties arising from hybrid accountabilities? While the prevailing scholarly consensus is that hybridity creates tensions that have a negative impact on the quality of regulation, this article shows that different accountabilities can reinforce each other. However, situations in which inspectors can develop a positive stance toward hybridity and integrate competing logics are rare. Hybrid professionalism among inspectors requires training, education, and resources as well as a joint regulatory culture with inspectees—preconditions that are hardly present in recent institutional settings of long-term care regulation.

Making transnational markets: the institutional politics behind the TTIP

The Transatlantic Trade and Investment Partnership (TTIP) may not bear fruit in its current incarnation, but it certainly teaches us crucial lessons regarding the institutional dynamics of market integration beyond the state. I argue that the TTIP’s so-called ‘regulatory cooperation’, in principle a mere mechanism for ‘discussion’ and ‘exchange’ between regulators, would have had a profound impact on the regulatory culture across the Atlantic. I make this argument in three interrelated steps. First, building on insights from constitutional law and political science, I outline an analytical framework for the study of rule-making institutions beyond the state. Second, I analyse the TTIP through the lens of this framework, illustrating the mechanisms through which its model for regulatory cooperation could reform the regulatory culture in the EU. Third, I argue that this change in the EU regulatory culture would have been neither an accident, nor a result of a US-led hegemonic project. Instead, the TTIP’s regulatory cooperation is a part of the EU’s internal political struggle, intended ultimately to re-balance not only powers between the legislative and the executive in the EU, but also within the EU’s executive branch itself.