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.     

Islamic NGOs and Muslim politics: A case from Jordan

Islamic NGOs have proliferated in an effort to solve basic socioeconomic problems within an Islamic framework. Although legal conditions and government oversight prohibit direct political activities through Islamic NGOs, Islamists utilise these institutions to combat the intrusion of Western values and cultural codes. It is this struggle at the level of discourse and culture that imbues Islamic NGOs with political import, even if these activities are outside the boundaries of traditional politics. This article uses a case study of the al-Afaf Charitable Society in Jordan to examine the relationships among socioeconomic development, political and cultural struggle, and Islam. In an effort to promote early family formation, as encouraged by Islam, al-Afaf provides a variety of services to remove obstacles to marriage. This, in turn, is conceptualised by Islamists as an institutionalised attempt to counter Western values and practices that are seen as inimical to Islam.     

The New Global Threat: Transnational Salafis and Jihad

The ruling to kill the Americans and their allies-civilians and military- is an individual duty for every Muslim who can do it in any country in which it is possible to do it, in order to liberate al-Aqsa Mosque and the holy mosques from their grip, and in order for their armies to move out of all the lands of Islam, defeated and unable to threaten any Muslim. This is in accordance with the words of Almighty God. "And fight the pagans all together as they fight you all together," and "Fight them until there is no more tumult or oppression, and there prevails justice and faith in God."     

Emergent patterns in the regulation of pharmaceuticals: institutions and interests in the United States,Canada, Britain,and France

Although industrialized nations regulate pharmaceuticals to ensure their safety and efficacy, they balance these concerns with those related to the timeliness of the approval process and the burdens involved in meeting regulatory criteria. The United States, Canada, Britain, and France have adopted different approaches to the regulation of pharmaceuticals that place varying emphases on these competing goals and involve the participation of private interests to different extents. The regulatory approval processes and the government-industry relationships inherent within them are compared in the United States, Canada, Britain, and France by analyzing five features that distinguish the U.S. pluralist from the European corporatist approaches to policy development: representation (internal versus external), process (closed versus open), stance (informal, accommodative versus formal, adversarial), institutional power (fragmented versus centralized), and resources. An institutional framework further characterizes these approaches as based on models of managerial discretion and adjudication (United States), consultation (Canada), and bargaining (Britain, France) to clarify the patterns that emerge. While the approach that most effectively supports product safety involves managerial discretion as occurs in the United States, formal mechanisms for negotiation might be incorporated rather than a reliance on the judicial process. In an era of globalization and regulatory harmonization such divergence has significant implications. First, where harmonization in Europe involves the mutual recognition of one country's product licensing decision by the others, differences in evaluative processes remain important. Second, as harmonization leads to a common set of regulatory criteria, the criteria adopted tend to be those of nations with the least stringent regulatory standards, making evident the need for more responsive systems of post-market surveillance to protect the public interest.