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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.

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.

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 a harmonized national approach to oversight of facilities providing MMAC-H therapies based on existing standards, such as Canadian Standards Association (CSA), was also voiced. Facilities providing MMAC-H therapies should also participate in collection of long-term data to ensure patient safety and efficacy of therapies. Harmonization across provinces of the procedures and practices involving administration of MMAC-H would be preferred. Participants felt that devices used to process MMAC-H are adequately regulated under existing MDR. Overly prescriptive regulation will stifle innovation, whereas insufficient regulation might allow unsafe or ineffective therapies to be offered. Until a clear, balanced and explicit approach is articulated, regulatory uncertainty remains a barrier.

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.

“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.

Advances in pharmacogenomic research and increasing industry interest in personalized medicine have important implications for the way that orphan drug policies are interpreted and applied. Concerns have been raised about the potential impact of pharmacogenomics and new genomic technologies on our understanding of how disease categories are delineated, and subsequently, how the concept of rare disease should be defined for the purposes of orphan drug policies. This article considers whether orphan drug legislation can be drafted in a way that will maximize benefits and minimize concerns relating to the impact of pharmacogenomics on orphan drug research and development. After reviewing the issues that may arise at the intersection of orphan drug policies and pharmacogenomics, this article will discuss the potential impact of pharmacogenomics at two critical points: orphan designation and approval of the drug product. At each of these points, the relevant aspects of current US orphan drug legislation are examined, focusing on the extent to which recent amendments may address concerns that have been raised previously. This analysis will then provide the foundation for a critical review and recommendations regarding the proposed new Canadian orphan drug framework.

This chapter begins by the development challenges of the region and of small island developing states. It surveys the issues from the perspective of the small island countries of the Pacific. The chapter examines the World Trade Organization (WTO) which has accommodated the special needs of developing countries and small economies. Although many of the region's countries are not presently members of the WTO, the WTO regime affects nonmembers indirectly as well as current and prospective members. The chapter focuses on regional trade agreements in the South Pacific, again considering attempts to address the development needs of small island countries in the region. As Small Island developing states, the Pacific island countries face particular challenges in economic development. They also suffer from a degree of inherent disadvantage in international trade, which is increasingly emphasized as a driver of development. The development challenges facing the countries include economic, political, social and environmental factors.

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 surrounding FOP, shelf, and menu labelling. We outline recommendations, emphasizing FOP, shelf, and menu labelling as part of a standardized, coordinated and multi-pronged strategy supported by a robust, evidence-based nutrition profiling system. Recommendations for monitoring adherence to regulations and participation of stakeholders to avoid conflict of interest in policy development, implementation and evaluation are included. Within a comprehensive strategy, these recommendations can help to improve the nutrition information environment for Canadians.

A b s t r a c t Objective 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. Methods 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. Results 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. Conclusion 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.

The regulation of stem cell-based therapies is challenging in many respects. Growing interest in these innovative therapies has led some to question FDA’s regulation of them, arguing that it is too restrictive and impedes both innovation by providers and access by patients. At the same time, others urge rigorous standards and enforcement, given significant risks to patients of physical harm or exploitation. This chapter examines attempts to craft specific provisions for additional flexibility in regulating cell and tissue therapies. After noting current US proposals and recent regulatory reforms in Japan, it focuses on the discussion and consultations regarding Australia’s exemption for autologous cell and tissue therapies and the hospital exemption in Europe’s regulation for advanced therapies. The Australian experience illustrates the potential for unintended negative consequences of an unduly broad exemption. One very relevant lesson from the hospital exemption is that adding flexibility to the regulatory framework involves a trade-off between limited short-term access to new treatments and broad longer-term access. Another is the importance of considering how a proposed new exemption would relate to existing forms of flexibility and whether greater gains would come from improving those existing mechanisms.

In Canada, tax incentives have been recently introduced to promote physical activity and reduce rates of obesity. The most prominent of these is the federal government's Children's Fitness Tax Credit, which came into effect in 2007. We critically assess the potential benefits and limitations of using tax measures to promote physical activity. Careful design could make these measures more effective, but any tax-based measures have inherent limitations, and the costs of such programs are substantial. Therefore, it is important to consider whether public funds are better spent on other strategies that could instead provide direct public funding to address environmental and systemic factors. (Am J Public Health. Published online ahead of print June 16, 2011:e1-e7. doi:10.2105/AJPH.2011.300201).

Modern environments promote overeating and sedentary behaviour, and the resulting epidemic of chronic disease is a major public health challenge of the early 21st century. Governments and experts around the world are sounding the alarm about the medical, economic and social costs of escalating rates

Few areas of recent research have received as much focus or generated as much excitement and debate as stem cell research. Hope for the therapeutic promise of this field has been matched by social concern associated largely with the sources of stem cells and their uses. This interplay between promise and controversy has contributed to the enormous variation that exists among the environments in which stem cell research is conducted throughout the world. This variation is layered upon intra-jurisdictional policies that are also often complex and in flux, resulting in what we term a 'patchwork of patchworks'. This patchwork of patchworks and its implications will become increasingly important as we enter this new era of stem cell research. The current progression towards translational and clinical research among international collaborators serves as a catalyst for identifying potential policy conflict and makes it imperative to address jurisdictional variability in stem cell research environments. The existing patchworks seen in contemporary stem cell research environments provide a valuable opportunity to consider how variations in regulations and policies across and within jurisdictions influence research efficiencies and directions. In one sense, the stem cell research context can be viewed as a living experiment occurring across the globe. The lessons to be gleaned from examining this field have great potential for broad-ranging general science policy application.

The recent approval by the United States Food and Drug Administration of a clinical trial involving a product derived from human embryonic stem cells, along with recent concerns about unproven stem cell therapies being offered to patients, highlight the importance of regulation at the critical stage of beginning human trials of novel therapies. The regulations governing therapeutic products (drugs and related products) are one part of the broader legal framework, but will play an increasingly prominent role as we move into clinical translation. The classification of products as drugs or biologics, on one hand, or minimally manipulated cell and tissue products for homologous use, on the other, will determine the requirements that will apply, including whether use in clinical trials requires approval. Product regulation works alongside other parts of the legal and policy framework, notably research ethics review and legal responsibilities of medical professionals, that play important though limited roles. Three key developments and challenges currently facing product regulation and related areas will affect stem cell research in this phase: regulatory reform, fragmentation, and capacity.

The International Health Regulations, the principle document governing the response to public health emergencies that pose an international threat, were revised in 2005 and became binding international law on June 15, 2007.[1][1] These new regulations, unanimously approved by the World Health

The regulation of stem cell-based therapies is challenging in many respects, given their unique safety, efficacy, and quality issues. At the same time, public interest in these innovative therapies has led some to question FDA's regulation of them, while others urge strict regulation and stronger enforcement. Within the context of this broader debate, this article examines recent attempts in other jurisdictions to craft specific provisions allowing additional flexibility in regulating cell and tissue therapies: Australia's exemption for autologous cell and tissue therapies, and the hospital exemption in Europe's regulation for advanced therapies.

Tissue engineering is a promising biotechnology that uses advances in cell science, surgery, and engineering to create products that can be implanted into human patients to replace organs and tissues or to help restore or improve their function. Tissue engineered products contain living cells, scaffolds made from natural or synthetic materials, and chemical signals that help to guide the cells' development. An engineered skin substitute is already approved and on the market, and engineered tracheas, corneas, and blood vessels are entering clinical trials. Tissue engineering raises a number of legal and ethical issues, one of which is considered in this article: to what extent would existing human tissue legislation in Canada apply to the activities and products of this new technology, and what implications would this have? The key terms defining the scope of application of human tissue statutes are examined to see whether and when tissue engineering materials (cells, tissues, and organs donated for use in tissue engineering) and tissue engineered products, along with the processes of procuring material and implanting the final products, will fall within the statutes' scope. The article then considers how the applicability of human tissue legislation in this context might affect the law governing these products and processes, focusing on provisions involving consent to donation and prohibitions on compensation and sale. The analysis reveals that there is considerable uncertainty and variability in the law, which could have a chilling effect on the development of this technology and leave those involved unprepared to deal with legal issues that arise. As human tissue statutes are revisited and reformed across the country, and as larger debates continue about the use of human tissue in biotechnology, it would be useful to work toward greater consistency in key definitions and to consider and clarify how the legislation will apply to tissue engineering and other new technologies.

A valid consent for treatment must fulfill three basic requirements. First, consent must be given voluntarily without undue influence, coercion or misrepresentation. Second, the person giving consent must be competent and if the patient herself is not competent, the person giving consent in her place must have the legal authority to do so. Third, the consent must be specific to the treatment and those providing it. In addition to these requirements, consent must be informed, which means that the patient must have received sufficient information to make an informed decision. The paper discusses these requirements and how to determine what information must be provided to the patient to ensure that a fully informed decision can be made. All information that a reasonable person in the patient's circumstances would need to make a decision must be provided. This information includes the risks of the procedure, the consequences of declining treatment, alternatives, success and failure rates, recommendations, and any actual or potential conflicts of interest. A physician is responsible for ensuring that this information is provided, and that the patient understands the information. If a patient claims that she has not been properly informed, in a lawsuit she will have to show that a reasonable person in her position would have made a different decision if adequately informed, which is often difficult. However, the consent process is not just concerned with avoiding liability. The education process to inform the patient's choice regarding treatment is a key aspect of the relationship between physician and patient. It highlights the primary importance of good communication and respect for the patient's right to autonomy.

In an ongoing dispute, FDA asserts that autologous cultured stem cells used in treatments for orthopedic conditions are drugs and biological products subject to licensing and good manufacturing practice requirements, while the company providing the treatments claims FDA has no authority over its activities. This article uses the dispute as a focal point to explore current issues relating to the regulation of innovative stem cell-based products, including the impact of regulation on access to new treatments, the role of other oversight mechanisms, the particular challenges of autologous stem cell products and the scope of existing flexibilities in the regulatory framework.

Stem cell therapies offer enormous potential for the treatment of a wide range of diseases and conditions. Despite the excitement over such advances, regulators are faced with the challenge of determining criteria to ensure stem cells and their products are safe and effective for human use. However, stem cell-based products and therapies present unique regulatory challenges because standard drug development models do not wholly apply given the complexity and diversity of these products and therapies. As a result, regulatory requirements are often unclear and ambiguous creating unnecessary barriers for research. In order to better understand the barriers that might affect Canadian stem cell researchers, we sought feedback from stakeholders regarding areas of uncertainty or concern about existing regulatory oversight of cell therapies. A selection of Canadian researchers and clinicians working in the area of stem cell research were interviewed to assess certain key questions: 1) whether current regulatory requirements are easily accessible and well understood; 2) whether regulatory requirements create important challenges or barriers; and 3) whether there is a need for further guidance on the issue. The results of this survey are summarized and compared to issues and concerns experienced in other countries, as reported in the literature, to identify challenges which may be on the horizon and to provide possible solutions for regulatory reform.

Stem-cell research represents a patchwork of patchworks. Understanding this can help the research community to manage it effectively

Human gene patents continue to stir social controversy, including the possibility that they might adversely affect public access to useful technologies. It has been suggested that a compulsory licensing policy might be used to alleviate the adverse effect of patents in this context. We suggest, however, that it is unclear whether existing international policies and licensing practices will permit compulsory licensing to be used in a way that would address common concerns. Indeed, given the minor role that genetic technologies have in most health care systems, it would be difficult to justify compulsory licensing. At a minimum, policy makers need to be more realistic about the potential effects of international trade agreements on the development of biotechnology policies.

In the years following the cold war there have been many attempts to reconceptualise security. One product of these attempts is the concept of 'human security'. This chapter shares some of the findings of research undertaken to fill this gap and specifically explores the ways in which this new way of thinking about security might relate to the norms and principles of international law. It examines some of the implications of rethinking security for international law, with a particular focus on international law's response to conflict. A human security approach to small arms and light weapons entails giving primacy to the impact of these weapons on affected individuals. Examining international law through the lens of human security should not be understood as an alternative intended to displace other established approaches, such as human rights or humanitarian approaches to conflict and other issues. Keywords: cold war; human security; international law

An appropriate legal regime protecting privacy of personal information is an important element in assuring public confidence in telehealth initiatives while at the same time avoiding undue restrictions or difficulties for those implementing these technologies. In Canada there are several sources of legal protection of personal information but there is increasing emphasis on legislation. A bill recently passed by the Canadian House of Commons is expected have a significant impact on the way personal information, including health information, is handled in the private sector.

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.