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.

Criminal law as a preventative tool of environmental regulation: compliance versus deterrence

The effective enforcement of environmental law is an issue which continues to engender considerable academic debate. The conclusions that may be drawn from such debate will have implications not only for the future of environmental law but also the wider regulatory reform agenda. This article commences with several noncontentious propositions. First, any regulatory regime ought to place considerable emphasis on preventing harm; within the context of environmental law, this view is encapsulated by the preventative principle. Secondly, one may be tempted to treat the criminal law as a purely reactive or curative mechanism were it not for the deterrent effect associated with the imposition of criminal sanctions. Therefore, the initial premise is that if environmental law is to become more preventative in scope, policymakers ought to consider how the deterrent effect of environmental criminal law may be bolstered. Academic publications and official reports are replete with assertions that the fines imposed by the courts for environmental crime are lamentably low. A preoccupation with the level of fine may lead one to overlook the fundamental importance of the likelihood of apprehension as an essential ingredient of the deterrence formula. Mainstream criminological discourse provides clear evidence that the probability of apprehension has a greater influence on deterrence than severity of sanction. In this context, the enforcement style adopted by the relevant enforcement agency is crucial; in particular, whether the style adopted augments the perception that apprehension is more probable. This article proceeds to argue that many of the assumptions on which the compliance style is based may be questioned, if not totally undermined. It is contended that a transition from compliance-orientated enforcement towards an approach more focused on deterrence has the potential to enhance the deterrent, and by extension the preventative effect, of environmental criminal law.

Contemporary Accounts of Moral Progress

This chapter lays out several alternative understandings of moral progress found in the contemporary literature of analytical moral and political philosophy. None of these amounts to a theory of moral progress, but each is suggestive of some of the building blocks for constructing such a theory. Among the accounts considered are those offered by Peter Singer, Ruth Macklin, Philip Kitcher, and Peter Railton. A taxonomy of types of views is provided, utilizing the following distinctions: monistic (reductionist) versus pluralistic, static versus dynamic, and better norm compliance versus functionalist, where the latter are grounded in the idea that managing problems of cooperation is constitutive of morality. Each of these understandings is shown to be inadequate because it is unable to accommodate the full range of types of moral progress or, in the case of functionalist views, because it betrays an impoverished conception of what morality has come to encompass.