Shifting priorities at the Health Protection Branch: challenges to the regulatory process

Abstract: The Health Protection Branch (hpb ) of Health Canada has recently undergone considerable policy and organizational renewal, with numerous and broad‐ranging implications for the evaluation of drug product safety and efficacy. From a public‐health perspective, however, the criteria used to develop organizational and policy change at the hpb have provided a sub‐optimal basis for reform, due primarily to the many forms of market failure to which the regulation of pharmaceuticals is subject. For example, thepartnership andefficiency criteria that guided policy renewal have led to the transfer of important responsibilities to partners, with the potential for either a conflict of interest or inadequate information, for which the legal basis is not always clear. The resulting realignment of the hpb's roles and responsibilities may be characterized as leading to a shift from a comprehensive approach to public‐health protection to one based on strategic risk management, with responsibilities dispersed among government, industry, academia and consumers. The rebalancing of goals in the redesign of the regulatory process suggests a change in the role of the state in the context of public‐health protection and highlights issues of concern to the public interest that may not be fully recognized as deregulation occurs in other sectors of the economy. Sommaire: La Direction générale de la protection de la santé (dgps ) de Santé Canada vient de subir un vaste remaniement de politiques et d'organisation qui entraîne de nombreuses et profondes répercussions sur l'évaluation de la sûreté et de l'efficacité des produits pharmaceutiques. Cependant, du point de vue de la santé publique, les critères auxquels on a fait appel pour modifier les politiques et l'organisation de la dgps n'ont permis qu'une base de réforme sous‐optimale, à cause surtout des nom‐breux genres de défaillance du marché qui affligent la réglementation des produits pharmaceutiques. Par exemple, les critières depurtenariat etd'efficacité qui ont guidé le remaniement des politiques ont amené le transfert d'importantes responsabilites à des partenaires moyennant le risque de. conflit d'intérêts ou d'informations inadéqaates, sans pour autant assurer une base juridique Claire. On pourrait donc dire que cette réorientation des rôles et responsabilités de la dgps fait que l'on passe d'une approche globale en matière de protection de la santéà une gestion stratégique du risque, la responsabilité en étant dispersée parmi le gouvernement, l'industrie, les milieux universitaires et les consommateurs. Le rééquilibrage des objectifs dans le remaniement du processus de réglementation suggère une évolution du rôle de l'État en ce qui concerne la protection de la santé publique; il met aussi en relief des questions d'intérêt public qui n'ont peut‐être pas été reconnues alors que la déréglementation prend lieu dans d'autres secteurs économiques.     

From Participatory Reform to Social Capital: Micro‐Motives and the Macro‐Structure of Civil Society Networks

Although a wide‐ranging literature explores the favorable effects of social capital, it is only relatively recently that systematic attention has been directed to the manner in which social networks emerge and the consequent implications for civic engagement and collaborative governance. This article employs advanced social network statistical models to examine civic network emergence following a participatory reform in Los Angeles. Findings suggest that the reform fostered a number of favorable network attributes supportive of democratic participation. At the same time, subtle but ubiquitous effects of socioeconomic sorting had the unintended and undesirable effect of elevating higher‐status actors within the emergent civic network. These findings suggest that macro‐level policy interventions are required to foster the development of ties that promote cross‐talk among socioeconomically distinct community groups.     

The Penal Voluntary Sector in England and Wales: Adaptation to Unsettlement and Austerity

This article draws on some findings from research which investigated penal voluntary sector adaptation to the mixed market in criminal justice services. The article firstly reprises the main trends for aligning state relationships with the voluntary sector from the 1980s to the present. We then outline some findings about adaptive experiences, situations and practices of the voluntary sector in criminal justice resettlement in the light of considerable upheaval. The research found that service providing voluntary sector organisations (VSOs) either outwardly comply with, or, in a minority of cases, actively embrace, competitive marketised models of service delivery. Secondly, the sector has normalised commercial approaches to organisational efficiency as well as aligned with bureaucratic practices common to the statutory sector. Despite charges that they are effectively co‐opted by both state and market interests, many have reported conflicts between prioritising long‐term financial viability with their founding ‘ethos and values’. We conclude that while many VSOs have successfully adjusted to market and bureaucratic norms, aspects of that repositioning have been at a cost to their traditions of relative autonomy, localism and distinctiveness, to the possible detriment of a vigorous civil society.     

“He said,she said”: Sexual harassment in the fractured criminal justice work place

This article addresses the critical problem of sexual harassment in criminal justice agencies. The authors assess empirically the incidents of sexual harassment in criminal justice organizations, and discuss why sexual harassment is more prevalent in criminal justice agencies than in other public agencies.     

The State of American Federalism, 1993-1994

National political energies in 1993–1994 were focusedon major initiatives promised by the Clinton administrationduring the 1992 presidential campaign, especially health-carereform and crime. From the perspective of the states, federalgovernment action in these (and other) policy areas raised seriousquestions about preemption and mandates. The administration'sofficial pronouncements on federalism have suggested a strategyof decongestion and decentralization. Thus far, its actionshave fallen short of empowerment, taking instead the path ofregulatory waivers. Frustrated with the federal government,states and localities continued to engage in policy experimentation.     

Attributional style,depressive features,and self-esteem: Adult children of alcoholic and nonalcoholic parents

Undergraduate adult children of alcoholics (ACOAs; N=57) were compared to children of nonalcoholic parents (CONAs; N=100) on measures of the Beck Depression Inventory (BDI), selfesteem, and attributional style. ACOA status was determined using the Children of Alcoholics Screening Test (Jones, 1981). ACOAs were found to have significantly higher scores on the BDI and to have significantly lower self-esteem, as measured by the Index of Self-Esteem, than CONAs. ACOAs were also more likely to have a depressive attributional style, in that they perceived failure as more internal, stable, and global than CONAs. Further, females had significantly higher BDI scores than males.Received B.A. from West Virginia University. Research interests: adult children of alcoholics and human sexual behavior.Received Ph.D. from West Virginia University. Research interests: the impact of popular culture on adolescents and the impact of parental conflict on children.Received Ph.D. from University of Massachusetts. Research interests: adolescent suicide risk.     

The State of American Federalism, 1994-1995

Federalism, as a concept and as a reality, received assistancefrom a variety of sources during 1994–1995. Opinion pollsrevealed a public strongly supportive of shifts in the balanceof power between federal and state governments. The new Republican-controlledCongress, bent on devolving authority to the states, busieditself with an ambitious legislative agenda. The DemocraticPresident pursued his principles of federalism and intergovernmentalrelations by supporting the unfunded mandates bill and by increasingthe use of the administrative waiver. The U.S. Supreme Courtbolstered federalism with its rulings in cases such as Lopez,a state challenge to the federal Gun-Free School Zones Act.The new mood in Washington, D.C. was complemented by state leadersanxious to take on the challenges of a rebalanced federal system     

Building sustainable capacity in the public sector: What can be done?

Effective government performance is central to the creation of market-oriented economies, secure and productive populations, and democratic political systems in developing countries. Capacity building to improve public sector performance is thus an important focus of development initiatives. Several implicit assumptions underlie most such efforts: that organizations or training activities are the logical site for capacity-building interventions; that administrative structures and monetary rewards determine organizational and individual performance; that organizations work well when structures and control mechanisms are in place; and that individual performance improves as a result of skill and technology transfer through training activities. Each of these assumptions is called into question by the findings of research carried out in six developing countries and reported in this article. Our studies indicate designing interventions that most constructively address sources of poor performance must follow from an assessment of a relatively broad set of variables, including the action environment in which all such activities take place. We also found that effective public sector performance is more often driven by strong organizational cultures, good management practices, and effective communication networks than it is by rules and regulations or procedures and pay scales. Our case studies further indicate that individual performance is more affected by opportunities for meaningful work, shared professional norms, teamwork, and promotion based on performance rather than it is by training in specific skills. In this article, we describe a framework or conceptual map that emphasizes that training activities, organizational performance and administrative structures are embedded within complex environments that significantly constrain their success and that often account for training or organizational failure. When it was applied in the six case study countries, the framework proved useful in identifying capacity gaps and providing a tool for the strategic design of interventions that are sensitive to the roots of performance deficits. This allows us to conclude that the assumptions underlying many capacity-building initiatives may focus attention on interventions that do not generate the highest payoffs in terms of improved performance.     

Diversity in the American States: Updating the Sullivan Index

The index of socioeconomic and cultural diversity among theAmerican states formulated by John L. Sullivan for 1960 is recreatedfor 1980. Comparisons are made between the index for the twotime periods, and changes among the states are examined overtime. Significant differences continue to exist between northernand southern states, mainly because of cultural rather thansocioeconomic factors. The diversity index remains a relativelypowerful predictor of policy variation among the states and,as such, might be considered as a substitute for geographicregion in comparative state policy research.