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.     

EU–Russian Relations and Turkey's Role as an Energy Corridor

This article analyses the impact of EU–Russian relations on Turkey's role as a corridor for the transit of energy supplies to Europe. While the European Union (EU) has inherent leverage in its collective purchase of most Russian gas exports, market power has shifted in Russia's favour. Russian efforts to build new pipelines and widen downstream access have stimulated EU interest in diversifying energy imports and transit routes. In this sense, the EU has recognised Turkey's potential value as a secure and independent route for importing non-Russian energy supplies, which may in turn have an impact on Turkey's EU accession process.     

A retrospective study of drugged driving in Norway

The National Institute of Forensic Toxicology, Oslo, receives blood and urine samples from all Norwegian drivers apprehended on suspicion of driving under the influence of alcohol or drugs. In 1983 we received samples from 1446 drug-suspected drivers, out of which 445 underwent toxicological analysis. The drugs found most frequently were tetrahydrocannabinol (THC) (n = 199), diazepam (n = 166) and amphetamine (n = 102). A cautious interpretation of the data indicate that about 200 of the 445 subjects selected for toxicological analysis drove under severe influence of drugs. Because of the high percentage of submitted cases not analysed for drugs, this figure represents a minimum estimate. Compared with the results from 1978, we found a several-fold increase in detections of THC and amphetamine in 1983. The number of diazepam detections did not increase in a similar way, but we estimated that the diazepam detections would have increased 3-fold if we had analysed as frequent for this drug in 1983 as in 1978.     

Study of cathepsin A, B and D activities in the skin wound edges. Its application to the differential diagnosis between vital and postmortem wounds

The aims of the authors in this paper has been to check the diagnostic ability of the Cathepsin A, B and D concentrations in the skin wound edges to the differential diagnosis between vital and postmortem wounds. We have studied 56 domestic pigs grouped in seven experimental series consisting of 8 animals in each, according to the time (0, 5, 15, 30 min and 1, 3 and 6 h) after the injury. The enzymatic activities were investigated following the methods by Bowen and Davison Biochem. J., 131 (1973) 417-419, Suhar and Marks J. Biochem., 101 (1979) 23-30 and by Anson (modified by Yamamoto, Eur. J. Biochem., 95 (1979) 459-467) for Cathepsin A, B and D, respectively. For the differential diagnosis between vital and postmortem wounds, our results showed that the most useful markers studied are the Cathepsin A and D activities, Cathepsin D that of the first one.     

A simplified procedure for simultaneous detection of salivary proteins and its application in paternity testing

An alternative simplified procedure for the genetic analysis of salivary protein complex (SPC) which eliminates the need for a specific concentrated parotid sample is proposed. After the technique is applied isoelectric focusing and protein detection is carried out by silver staining. The chance of exclusion of non-fathers for these systems in our population is 0.161711 for Pr, 0.07948 for Db, 0.07836 for Pa and 0.00995 for PIF. The total exclusion rate for these systems is 0.30042.     

Overprovision and the licensing (Scotland) act 1976

This paper examines Scottish licensing law, in particular the granting of licenses to supply alcoholic liquor. Any application for a license must be granted unless one or more of four conditions are fulfilled. One of these, that the award would lead to overprovision, is the central concern of this study. The paper does not investigate why the consumption and distribution of alcohol are regulated nor why regulatory control takes the form it does. ¹ The starting point is rather that regulation exists and takes a particular form. Attention is focused on the operation of this regulatory control and with how it might be improved.In the next section, some of the key features of the licensing law and its appeals are reviewed, establishing the importance of evidence of the presence or otherwise of overprovision. Section II discusses the use of density of licensed premises as a measure of provision, indicates the problems, and argues that a measure might be refined and validated by entering it in an equation explaining the retail price of alcoholic beverages. Section III examines empirically the relationship between price and licensing density.