Papers by Barbara von Tigerstrom
Journal of law and medicine, 2016
“Special” or “expanded” access schemes permit the use, outside of clinical trials, of drugs or de... more “Special” or “expanded” access schemes permit the use, outside of clinical trials, of drugs or devices that have not yet been licensed or approved for marketing in a particular jurisdiction. Special access raises important and difficult questions, reflecting tensions between competing interests and values. This article explores similarities and differences between special access schemes in the United States, Canada, and Australia, focusing on areas closely connected with the controversies highlighted in the literature and where the comparison can provide insights for regulatory reform. These jurisdictions differ particularly with respect to how the regulations can be used to protect clinical trials and product development processes, whose authorisation is needed for special access use, and how ethical concerns, such as informed consent, are addressed. The requirements for data collection and reporting are similar, with all three countries appearing to be uncertain about the utility of information collected from special access use.
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International Law Issues in the South Pacific, 2017
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The growth of actions for violation of privacy presents a significant risk for defendants and an ... more The growth of actions for violation of privacy presents a significant risk for defendants and an opportunity for civil claims to provide a mechanism for accountability. However, several key issues that would determine the scope of liability remain unsettled. In most cases, courts have concluded that the existence of statutes dealing with personal information does not exclude the possibility of civil actions, which is important given the limits of statutory remedies. Negligence claims in this context may face issues regarding the duty of care, particularly where the defendant is a public authority, and proof of injury, given that recovery for harms such as stress or economic loss is limited. Therefore, the availability of statutory or common law privacy torts, which do not require proof of actual damage, is very important, but the elements of these torts are evolving and may be difficult to prove against an organization where the main perpetrator of the violation is an individual emp...
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Canadian Yearbook of international Law/Annuaire canadien de droit international, 2021
The current international framework that purports to regulate the spread of communicable disease ... more The current international framework that purports to regulate the spread of communicable disease in the context of maritime traffic is a fragmented, internally inconsistent, and inadequately enforced patchwork of treaties (including the International Health Regulations (2005)) and customary international law. The COVID-19 pandemic has tested the current framework and revealed it to be inadequate to deal with a major global health emergency. States have imposed or failed to impose varying control measures, the effects of which have been witnessed on board passenger vessels around the world. The cruise industry, in particular, has a significant global economic impact; therefore, appropriate, enforceable international regulation is necessary to ensure the adequate control of future communicable disease outbreaks.
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Journal of Travel Medicine, 2020
As countries modify or lift travel restrictions implemented in response to the COVID-19 pandemic,... more As countries modify or lift travel restrictions implemented in response to the COVID-19 pandemic, some variation in approaches is to be expected, but harmonization is important to re-establishing international travel. Despite challenges, the International Health Regulations (2005) and WHO recommendations can provide a balance of consistency and flexibility.
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Alberta Law Review, 2012
This article examines the potential use of taxes to increase the price of sugar-sweetened beverag... more This article examines the potential use of taxes to increase the price of sugar-sweetened beverages in an attempt to curb consumption, improve public health, and generate revenue that can be used to support other public health initiatives. In doing so, it first considers the arguments for and against such a tax, including economic, political, and health considerations. This article then proceeds to look at how the tax could be implemented, addressing the various models of taxation that could be used as well as questions of jurisdiction surrounding what level of government may implement those models.
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International Law Issues in the South Pacific, 2017
... has a land mass of some 7.7 million square km and a population of some 19 million of which 90... more ... has a land mass of some 7.7 million square km and a population of some 19 million of which 90 per cent is of European extraction; the Cook Islands occupies only 240 square km with a * The editors would like to acknowledge the assistance of Danie Benkman (LLB student ...
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Medical Law International, 2016
Authorities responsible for regulating medicines and other medical products continue to expand op... more Authorities responsible for regulating medicines and other medical products continue to expand opportunities for direct participation of patients and their representatives in regulatory processes. For example, patient representatives can participate as members of scientific committees and provide input in various ways. This article examines the current framework and recent initiatives for such participation in the US Food and Drug Administration and European Medicines Agency. It draws from scholarship on public and patient participation in other contexts to describe and clarify the purposes and roles of patient involvement and to identify issues needing attention in the development of these initiatives, including systemic factors that may impede the ability of patient representatives to fulfill their roles effectively. It also considers convergent efforts to engage patients in research and development that could alleviate some of these difficulties and provide an opportunity to rethink the goals and methods of patient involvement in a larger context.
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Canadian Journal of Diabetes, 2013
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Canadian Journal of Diabetes, 2013
Regulatory measures, including taxes and subsidies on food and beverage products, food labelling ... more Regulatory measures, including taxes and subsidies on food and beverage products, food labelling requirements, regulation of food content and regulation of food marketing, have been proposed to encourage healthier eating and prevent obesity. The objective of this article is to explore the extent to which international trade agreements affect governments' choices to use such regulatory measures. It reviews key provisions of relevant World Trade Organization (WTO) agreements and their implications. Some insights can be gained by examining 2 recent developments in the WTO regarding tobacco control: a current dispute involving Australia's plain packaging law and its effect on trademarks, and a recent decision involving the United States law banning flavoured cigarettes. This decision said that the ban did not restrict trade more than necessary to fulfil its legitimate health objective, but it was discriminatory because it banned imported products (clove cigarettes) while exempting domestic products (menthol cigarettes) with similar characteristics. The conclusion we can draw from this decision is that WTO member states probably enjoy a significant degree of latitude in developing food regulations as part of an obesity prevention strategy, so long as those do not disproportionately affect imported products and therefore raise questions of discrimination. The approach taken in this case encourages the adoption of public health policies that are consistent with strong scientific evidence, but may restrict governments' ability to make political compromises, which could frustrate some proposals. The ongoing development of WTO law will continue to affect policy choices in public health.
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Canadian Medical Association Journal, 2008
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Cytotherapy, 2017
In Canada, minimally manipulated autologous cell therapies for homologous use (MMAC-H) are either... more In Canada, minimally manipulated autologous cell therapies for homologous use (MMAC-H) are either regulated under the practice of medicine, or as drugs or devices under the Food and Drugs Act, Food and Drug Regulations (F&DR) or Medical Device Regulations (MDR). Cells, Tissues and Organs (CTO) Regulations in Canada are restricted to minimally manipulated allogeneic products for homologous use. This leaves an important gap in the interpretation of existing regulations. The purposes of this workshop co-organized by the Stem Cell Network and the Centre for Commercialization of Regenerative Medicine (CCRM) were to discuss the current state of regulation of MMAC-H therapies in Canada and compare it with other regulatory jurisdictions, with the intent of providing specific policy recommendations to Health Canada. Participants came to a consensus on the need for well-defined common terminology between regulators and stakeholders, a common source of confusion and misinformation. A need for ...
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Regenerative medicine, 2017
There are widespread concerns with the ways in which 'unproven' stem cell therapies are a... more There are widespread concerns with the ways in which 'unproven' stem cell therapies are advertised to patients. This article explores the potential and limits of using laws that regulate advertising and promotion as a tool to address these concerns. It examines general consumer protection laws and laws and policies on advertising medical products and services, focusing on the USA, Canada and Australia. The content of existing laws and policies covers most of the marketing practices that cause concern, but several systemic factors are likely to limit enforcement efforts. Potential reforms in Australia that would prevent direct-to-consumer advertising of autologous cell therapies are justified in principle and should be considered by other jurisdictions, but again face important practical limits to their effectiveness.
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Canadian journal of public health = Revue canadienne de sante publique, Jan 9, 2017
Greater availability of low nutritional quality foods and decreased consumption of nutrient-dense... more Greater availability of low nutritional quality foods and decreased consumption of nutrient-dense foods have negatively impacted the nutrient profile of the Canadian diet. Poor diet is now the leading risk factor for chronic disease and premature death in Canada. To help consumers choose healthful foods, nutrition labelling is one policy tool for communicating relevant nutrition information. However, there are notable shortcomings with current nutrition labelling systems, which make it difficult for Canadians to navigate the complex food environment. Government action on nutrition labelling systems, including front-of-package (FOP), shelf, and menu labelling, is required. In May 2016, we hosted a consensus conference with experts from research, policy and practice to review available evidence, share experiences and come to consensus regarding the next best steps for action on nutrition labelling in Canada. In this paper, we examine the evidence, opportunities and challenges surround...
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Constitutional Forum / Forum constitutionnel
EQUALITY RIGHTS AND THE ALLOCATION OF SCARCE RESOURCES IN HEALTH CARE: A COMMENT ON CAMERON V. NO... more EQUALITY RIGHTS AND THE ALLOCATION OF SCARCE RESOURCES IN HEALTH CARE: A COMMENT ON CAMERON V. NOVA SCOTIA
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Health Law Journal, 2009
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Health Law Review, Sep 22, 2011
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Health Law Review, Mar 22, 2004
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Papers by Barbara von Tigerstrom