Evaluating health policy and legal responses : how to reduce barriers and improve access to orphan drugs for rare diseases in Canada

Abstract : Rare diseases are debilitating conditions often leading to severe clinical manifestations for affected patients. Orphan drugs have been developed to treat these rare diseases affecting a small number of individuals. Incentives in the legal framework aimed to recoup the research and development cost of orphan drugs for pharmaceutical companies have been implemented in the United States and the European Union. At the present time, Canada is still lacking a legal and policy framework for orphan drugs. Several problems at the federal and provincial levels remain: lack of research funds for rare diseases, discrepancies on orphan drug policies between provinces, difficulties to access and reimburse these high price drugs. Recommendations and measures are proposed, such as a pan-Canadian (national) scientific committee to establish evidence-based guidelines for patients to access orphan drugs uniformly in all provinces with a disease specific registry, a formal agreement for a centralized Canadian public funding reimbursement procedure, and increasing the role of “guardian” for prices by the Patented Medicines Review Board in Canada. These recommendations and measures will be beneficial for the implementation of a policy framework for orphan drugs in Canada.

Changing patterns of first injection across key periods of the French Harm Reduction Policy: PrimInject, a cross sectional analysis

Background: Monitoring of emerging modes of drug consumption in France has identified new patterns of injection among youths with diverse social backgrounds, which may explain the persistence of high rates of hepatitis C virus infection. The circumstances surrounding the first injection have been poorly documented in the group of heavy drug users and in the context of the French opioid substitution treatment (OST) policy that provides expanded access to high-dosage buprenorphine (BHD). Methods: An Internet survey (Priminject) was conducted from October 2010 to March 2011 with French drug users. Four time periods were compared based on critical dates throughout the implementation of the Harm Reduction Policy in France. Results: Compared with drug users who injected for the first time prior to 1995, the aspects of drug use for users who recently injected for the first time were as follows: (1) experimentation with miscellaneous drugs before the first injection; (2) an older age at the time of first injection; (3) heroin as the drug of choice for an individual’s first injection, notwithstanding the increased usage of stimulant drugs; (4) BHD did not appear to be a pathway to injection; and (5) an increased number of users who injected their first time alone, without the help or presence of another individual. Conclusion: The PrimInject study showed that there is a group of injection drug users that is larger than the group of injection drug users observed in previous studies; therefore, it is necessary to diversify programs to reach the entire spectrum of high-risk users.

Dette publique, développement monétaire international et demande de monnaie : une analyse à partir des tests de cointégration et du modèle à correction d'erreurs

Résumé : Ce document examine l'effet de la dette publique et du développement monétaire étranger (taux de change et taux d'intérêt étranger) sur la demande de monnaie de long-terme. Le déficit budgétaire est utilisé comme mesure de la dette publique. Cette étude est menée sur cinq pays industrialisés: le Canada, les États-Unis, l'Allemagne, le Royaume-Uni et la France. Le modèle multivarié de cointégration de Johansen & Juselius (1990) est utilisé pour établir le lien entre ces trois variables et la demande de monnaie. Ce modèle examine indirectement deux effets: les effets du déficit budgétaire sur le taux d'intérêt et du développement monétaire étranger sur le taux d'intérêt, à travers la demande de monnaie. L'évidence d'une relation de cointégration entre la demande de monnaie et les dites variables est vérifiée pour la plupart de ces pays. Le test d'exclusion des variables de la relation de long-terme nous révèle que toutes ces variables entrent de façon significative dans la relation de cointégration. Ces résultats suggèrent donc aux autorités monétaires, l'importance de tenir compte à la fois du déficit bugétaire et du développement monétaire étranger dans la formulation de la politique monétaire.||Abstract : This paper examines the impact of both public debt and foreign monetary developments (exchange rate and interest rate) on the long-run money demand. The budget déficit is used as a measure of public debt. Five industrial countries are considered, Canada, the United States, Germany, the United Kingdom and France. The multivariate cointegration model of Johansen & Juselius (1990) is used to establish the relationship between this tree variables and the money demand. This model indirectly examines two effects, the effect of budget déficits on interest rates and the effect of foreign monetary developments on the interest rates, both through money demand. Evidence of long-run relationship between the money demand and the defined variables are found for almost every country. The long-run exclusion test shows that ail these variables significantly enter into the cointegration relation. This suggests that, in formulating monetary policies, policy makers should take into account the influence of both budget déficit and foreign monetary developments on the money demand.