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.

Expanding our Constitutional Horizons: A Comprehensive Study of Quasi-Constitutionality in Canada

A number of laws in Canada which uphold rights are referred to as quasi-constitutional by the courts in recognition of their special importance. Quasi-constitutional statutes are enacted through the regular legislative process, although they are being interpreted and applied in a fashion which has become remarkably similar to constitutional law, and are therefore having an important affect over other legislation. Quasi-constitutionality has surprisingly received limited scholarly attention, and very few serious attempts at explaining its significance have been made. This dissertation undertakes a comprehensive study of quasi-constitutionality which considers its theoretical basis, its interpretation and legal significance, as well as its similarities to comparable forms of law in other Commonwealth jurisdictions. Part I examines the theoretical basis of quasi-constitutionality and its relationship to the Constitution. As a statutory and common law form of fundamental law, quasi-constitutionality is shown to signify an association with the Canadian Constitution and the foundational principles that underpin it. Part II proceeds to consider the special rules of interpretation applied to quasi-constitutional legislation, the basis of this interpretative approach, and the connection between the interpretation of similar provisions in quasi-constitutional legislation and the Constitution. As a statutory form of fundamental law, quasi-constitutional legislation is given a broad, liberal and purposive interpretation which significantly expands the rights which they protect. The theoretical basis of this approach is found in both the fundamental nature of the rights upheld by quasi-constitutional legislation as well as legislative intent. Part III explores how quasi-constitutional statutes affect the interpretation of regular legislation and how they are used for the purposes of judicial review. Quasi-constitutional legislation has a significant influence over regular statutes in the interpretative exercise, which in some instances results in conflicting statutes being declared inoperable. The basis of this form of judicial review is demonstrated to be rooted in statutory interpretation, and as such it provides an interesting model of rights protection and judicial review that is not conflated to constitutional and judicial supremacy.

Strategic Diplomacies: Indigenous Governance, International Politics, and Natural Resources in Canada

International Relations theory would predict that central governments, with their considerable material resources, would be unlikely to face a challenge from a substate government. However, substate governments, and particularly Indigenous governments, are pushing back against central government control in both domestic and international spheres. Indigenous governments are leveraging their local mining sectors to realize their interests and express local identities—interests and identities that may not be congruent with those of the central government. Applying the case study of the resource extraction sector in Canada, this thesis asks: under what conditions are substate governments able to challenge the authority of central governments in the international arena? Canada���s reliance on the global extractive resource sector is a major driver of its international policy preferences, but the increased engagement of Indigenous governments in the sector challenges the control of the federal government. Focusing on the resource extraction sectors in British Columbia, Saskatchewan, and Ontario, this thesis argues that there is a mutually reinforcing relationship between Indigenous governments’ international engagement and their domestic autonomy; both challenge the parameters of state authority. Both force the state to respond to claims of control from multiple sites and to clarify convoluted policy environments. A confluence of factors—including increased Indigenous connections to the globalized economy, new Canadian regulatory frameworks, and recent Supreme Court of Canada cases regarding Indigenous lands—have all altered the space in which Indigenous governments in Canada participate in the resource extraction sector and produce overlapping or multilevel governance structures. This thesis demonstrates that Indigenous international engagement entrenches the authority and political legitimacy manifest in Indigenous governments’ insistence on equitable and horizontal negotiations in Canada���s lucrative resource extraction sector. A cumulative process occurs in which domestic and international expressions of political autonomy reinforce each other, produce further opportunities to express authority in both environments, and trouble the state’s capacity to fully realize its international policy preferences.

Comparison of the site distribution of melanoma in New Zealand and Canada

A comparison of the site distribution of cutaneous malignant melanoma in New Zealand and Canada was performed. This series deals with 41,331 incident cases registered between 1968 and 1990 and is the largest to date to evaluate the influence of age and gender on the site distribution of melanoma. Site-specific, age-standardized rates per unit surface area and relative tumour density were assessed by gender and country and differences compared with statistical techniques adapted to this context. The age-standardized rates for all sites were higher in New Zealand than in Canada, the ratio being 3.2 for men and 3.8 for women. Occurrence of melanoma was denser for chronically than intermittently exposed sites in both New Zealand and Canada. The highest incidence rate per unit area was for the ears in men which was more than 5 times the rate for the entire body in each country. For each gender, melanomas were relatively commoner on the trunk and the face in Canada, and on the lower limbs in New Zealand. The variations in the site distribution were similar in each country and consistent with the effect of differential patterns of sun exposure between genders. Our results show that the levels of risk of melanoma between phenotypically comparable populations exposed to different amount of UV radiation vary in a site-specific manner, especially for intermittently exposed sites. This suggests that both environmental conditions and lifestyle factors influence the site distribution of melanoma in these two populations.

Preliminary epidemiological study of latent tuberculosis in Mexican agricultural workers in the Niagara region, Canada

It is well documented that the majority of Tuberculosis (TB) cases diagnosed in Canada are related to foreign-bom persons from TB high-burden countries. The Canadian seasonal agricultural workers program (SAWP) operating with Mexico allows migrant workers to enter the country with a temporary work permit for up to 8 months. Preiimnigration screening of these workers by both clinical examination and chest X-ray (CXR) reduces the risk of introducing cases of active pulmonary TB to Canada, but screening for latent TB (LTBI) is not routinely done. Studies carried out in industrialized nations with high immigration from TBendemic countries provide data of lifetime LTBI reactivation of around 10% but little is known about reactivation rates within TB-endemic countries where new infections (or reinfections) may be impossible to distinguish from reactivation. Migrant populations like the SAWP workers who spend considerable amounts of time in both Canada and TBendemic rural areas in Mexico are a unique population in terms of TB epidemiology. However, to our knowledge no studies have been undertaken to explore either the existence of LTBI among Mexican workers, the probability of reactivation or the workers' exposure to TB cases while back in their communities before returning the following season. Being aware of their LTBI status may help workers to exercise healthy behaviours to avoid TB reactivation and therefore continue to access the SAWP. In order to assess the prevalence of LTBI and associated risk factors among Mexican migrant workers a preliminary cross sectional study was designed to involve a convenience sample of the Niagara Region's Mexican workers in 2007. Research ethics clearance was granted by Brock University. Individual questionnaires were administered to collect socio-demographic and TB-related epidemiological data as well as TB knowledge and awareness levels. Cellular immunity to M tuberculosis was assessed by both an Interferon-y release assay (lGRA), QuantiFERON -TB Gold In-Tube (QFf™) and by the tuberculin skin test (TSn using Mantoux. A total of 82 Mexican workers (out of 125 invited) completed the study. Most participants were male (80%) and their age ranged from 22 to 65 years (mean 38.5). The prevalence of LTBI was 34% using TST and 18% using QFTTM. As previously reported, TST (using ~lOmm cut-off) showed a sensitivity of 93.3% and a specificity of 79.1 %. These findings at the moment cannot predict the probability of progression to active TB; only longitudinal cohort studies of this population can ascertain this outcome. However, based on recent publications, lORA positive individuals may have up to 14% probability of reactivation within the next two years. Although according to the SA WP guidelines, all workers undergo TB screening before entering or re-entering Canada, CXR examination requirements showed to be inconsistent for this population: whereas 100% of the workers coming to Canada for the first time reported having the procedure done, only 31 % of returning participants reported having had a CXR in the past year. None of the participants reported ever having a CXR compatible with TB which was consistent with the fact that none had ever been diagnosed with active pulmonary TB and with only 3.6% reporting close contact with a person with active TB in their lifetime. Although Mexico reports that 99% of popUlation is fully immunized against TB within the first year of age, only 85.3% of participants reported receiving BOC vaccine in childhood. Conversely, even when TST is not part of the routine TB screening in endemic countries, a suqDrisingly high 25.6% reported receiving a TST in the past. In regards to TB knowledge and awareness, 74% of the studied population had previous knowledge about (active) TB, 42% correctly identified active TB symptomatology, 4.8% identified the correct route of transmission, 4.8% knew about the existence of LTBI, 3.6% knew that latent TB could reactivate and 48% recognized TB as treatable and curable. Of all variables explored as potential risk factors for LTBI, age was the only one which showed statistical significance. Significant associations could not be proven for other known variables (such as sex, TB contact, history of TB) probably because of the small sample size and the homogeneity of the sample. Screening for LTBI by TST (high sensitivity) followed by confirmation with QFT''"'^ (high specificity) suggests to be a good strategy especially for immigrants from TB high-burden countries. After educational sessions, workers positive for LTBI gained greater knowledge about the signs and symptoms of TB reactivation as well as the risk factors commonly associated with reactivation. Additionally, they were more likely to attend their annual health check up and request a CXR exam to monitor for TB reactivation.

Identification of Summer Origins of Songbirds Migrating through Southern Canada in Autumn

Stable hydrogen isotopes (δD) in flight feathers were measured to investigate the summer origins of five species of boreal-breeding warblers captured during fall migration at Canadian Migration Monitoring Network (CMMN) stations spread across southern Canada. Mean δD varied among stations and species within stations, but there was broad overlap in δD values. Although isotope ratios indicate that migrants at each station come from a wide range of latitudes, they are unable to provide much longitudinal discrimination. Band recoveries are sparse, but indicate that in general western Canadian warblers move southeast in fall, eastern birds move southwest, and there is a transition zone in the Great Lakes region. Combining knowledge of migratory direction with isotope results increases discrimination of breeding areas. Isotope results support fall migratory movements by Blackpoll Warbler (Dendroica striata) and Northern Waterthrush (Seiurus novaboracensis) that are more easterly than for other species, and in all study species, birds from more northern regions passed through southern Canada later in the season. Migration monitoring stations capture birds from broad areas of latitude, and migrants passing through each province appear to come from largely different portions of the Canadian breeding range, so a few stations placed in each province should suffice collectively to sample birds from most of the boreal forest. Migration monitoring in southern Canada, therefore, has the potential to monitor status of boreal forest birds in Canada that are unsampled by other monitoring programs.

Development of eco-efficient and sustainable urban infrastructure in Asia and Latin America: eco-efficiency and sustainable infrastructure in the United States and Canada

Incluye bibliografía

A comparative study of health care policy in the United States and Canada: what policymakers in Latin America might and might not learn from their neighbors to the North

Includes bibliography

The application of medical informatics to the veterinary management programs at companion animal practices in Alberta, Canada: a case study.

Companion animals closely share their domestic environment with people and have the potential to, act as sources of zoonotic diseases. They also have the potential to be sentinels of infectious and noninfectious, diseases. With the exception of rabies, there has been minimal ongoing surveillance of, companion animals in Canada. We developed customized data extraction software, the University of, Calgary Data Extraction Program (UCDEP), to automatically extract and warehouse the electronic, medical records (EMR) from participating private veterinary practices to make them available for, disease surveillance and knowledge creation for evidence-based practice. It was not possible to build, generic data extraction software; the UCDEP required customization to meet the specific software, capabilities of the veterinary practices. The UCDEP, tailored to the participating veterinary practices', management software, was capable of extracting data from the EMR with greater than 99%, completeness and accuracy. The experiences of the people developing and using the UCDEP and the, quality of the extracted data were evaluated. The electronic medical record data stored in the data, warehouse may be a valuable resource for surveillance and evidence-based medical research.

Educational Systems and Gender Segregation in Education: A Three-Country Comparison of Germany, Norway and Canada

How do institutional settings and their embedded policy principles affect gender-typed enrolment in educational programmes? Based on gender-sensitive theories on career choice, we hypothesised that gender segregation in education is higher with a wider range of offers of vocational programmes. By analysing youth survey and panel data, we tested this assumption for Germany, Norway and Canada, three countries whose educational systems represent a different mix of academic, vocational and universalistic education principles. We found that vocational programmes are considerably more gender-segregated than are academic (e.g. university) programmes. Men, more so than women, can avoid gender-typed programmes by passing on to a university education. This in turn means that as long as their secondary school achievement does not allow for a higher education career, they have a higher likelihood of being allocated to male-typed programmes in the vocational education and training (VET) system. In addition, social background and the age at which students have to choose educational offers impact on the transition to gendered educational programmes. Overall, gender segregation in education is highest in Germany and the lowest in Canada. We interpret the differences between these countries with respect to the constellations of educational principles and policies in the respective countries.

Major and minor element concentrations in the livers of polar bears (Ursus maritimus) from Greenland, Canada and Alaska

To assess geographic distributions of elements in the Arctic we compared essential and non-essential elements in the livers of polar bears (Ursus maritimus) collected from five regions within Canada in 2002, in Alaska between 1994 and 1999 and from the northwest and east coasts of Greenland between 1988 and 2000. As, Hg, Pb and Se varied with age, and Co and Zn with gender, which limited spatial comparisons across all populations to Cd, which was highest in Greenland bears. Collectively, geographic relationships appeared similar to past studies with little change in concentration over time in Canada and Greenland for most elements; Hg and Se were higher in some Canadian populations in 2002 as compared to 1982 and 1984. Concentrations of most elements in the polar bears did not exceed toxicity thresholds, although Cd and Hg exceeded levels correlated with the formation of hepatic lesions in laboratory animals.

Hints to emigrants : in a series of letters from Upper Canada /

Map: Perth, Lanark & Richmond Settlements, district of Bathurst, Upper Canada with part of the adjacent county; Plans: [1]. Township of Drummond, ten miles square. This sketch shows how a township is divided into concessions & lots; [2]. Perth.

France and England in North America: a series of historical narratives,

pt. 1. Pioneers of France in the new world 1880. -- pt. 2. The Jesuits in North America. 1880 - pt. 3. La Salle and the discovery of the Great West 1880. -- pt. 4. The old régime in Canada 1880 -- pt. 5. Count Frontenac and New France under Louis XIV 1880 -- pt.6. A half-century of conflict 1905 -- pt.7 Montcalm and Wolfe 1903. 2 v.

Worker Voice : Employee Representation in the Workplace in Australia, Canada, Germany, the UK and the US, 1914-1939 /

This book informs debates about worker participation in the workplace or worker voice by analysing comparative historical data relating to these ideas during the inter-war period in Australia, Canada, Germany, the UK and the US. The issue is topical because of the contemporary shift to a workplace focus in many countries without a corresponding development of infrastructure at the workplace level, and because of the growing ‘representation gap’ as union membership declines. Some commentators have called for the introduction of works councils to address these issues. Other scholars have gone back and examined the experiences with the non-union Employee Representation Plans (ERPs) in Canada and the US. This book will test these claims through examining and comparing the historical record of previous efforts of five countries during a rich period of experimentation between the Wars. In addition to ERPs, the book expands the debate will by examining union-management co-operation, Whitley works committees and German works councils.

France and England in North America; a series of historical narratives,

Includes various editions of some volumes.