Policy recommendations for front-of-package, shelf, and menu labelling in Canada: Moving towards consensus.

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.

Regulating the advertising and promotion of stem cell therapies.

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.

Workshop to address gaps in regulation of minimally manipulated autologous cell therapies for homologous use in Canada.

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.

Access to Experimental Treatments: Comparative Analysis of Three Special Access Regimes.

"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.

Revising the Regulation of Stem Cell-Based Therapies: Critical Assessment of Potential Models.

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.

Orphan drug incentives in the pharmacogenomic context: policy responses in the US and Canada.

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.

How do international trade obligations affect policy options for obesity prevention? Lessons from recent developments in trade and tobacco control.

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.

Regulation of stem cell-based therapies in Canada: current issues and concerns.

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.

Using the tax system to promote physical activity: critical analysis of Canadian initiatives.

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.

The Food and Drug Administration, regenerative sciences, and the regulation of autologous stem cell therapies.

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.

The stem cell research environment: a patchwork of patchworks.

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.

Product regulation and the clinical translation of stem cell research.

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 challenges of regulating stem cell-based products.

Appropriate regulation of stem cell-based products is essential to ensure public safety and trust while minimising unnecessary barriers to product development, but presents numerous challenges. Weaknesses of existing legal frameworks include variation between jurisdictions and poor fit between product categories and new technologies. The new European Regulation on advanced therapy medicinal products is an important attempt to provide a consolidated regulatory framework for novel products. Others can learn from issues encountered in its development, including definition of product categories, ethical concerns, and the application of regulations to small-scale production. Several aspects of the Regulation will be useful models, but some larger questions remain unresolved. As reform efforts move forward, harmonisation and sharing of expertise will be vital to effective regulation.