Open Access. Powered by Scholars. Published by Universities.®
- Discipline
-
- Health Law and Policy (8)
- Food and Drug Law (5)
- Science and Technology Law (5)
- Medical Jurisprudence (3)
- Administrative Law (2)
-
- Intellectual Property Law (2)
- Internet Law (2)
- Judges (2)
- Law and Society (2)
- Legal Ethics and Professional Responsibility (2)
- Privacy Law (2)
- Public Law and Legal Theory (2)
- Comparative and Foreign Law (1)
- Constitutional Law (1)
- Jurisprudence (1)
- Law and Politics (1)
- Legal History (1)
- Legislation (1)
- National Security Law (1)
Articles 1 - 12 of 12
Full-Text Articles in Law
Judicial Discipline Through The Prism Of Public Law Values: A Critical Analysis Of Bill C-9, An Act To Reform The Judges Act, Richard Devlin, Sheila Wildeman
Judicial Discipline Through The Prism Of Public Law Values: A Critical Analysis Of Bill C-9, An Act To Reform The Judges Act, Richard Devlin, Sheila Wildeman
Articles, Book Chapters, & Popular Press
Bill C-9 is the first legislative reform to the Judges Act in five decades. The goal of the legislation is to enhance public confidence in the administration of justice by modernizing the complaints and discipline system for federally appointed judges. In a previous essay published in Volume ?? of the Advocates’ Quarterly we offered a normative framework for assessment of a complaints and discipline system and identified seven key strengths of Bill C-9. In this sequel, we continue to apply this normative framework and argue that the legislation is marred by five significant weaknesses. We conclude that because the reforms …
Judicial Discipline Through The Prism Of Public Law Values: A Contextual Analysis Of Bill C-9, An Act To Reform The Judges Act, Richard Devlin, Sheila Wildeman
Judicial Discipline Through The Prism Of Public Law Values: A Contextual Analysis Of Bill C-9, An Act To Reform The Judges Act, Richard Devlin, Sheila Wildeman
Articles, Book Chapters, & Popular Press
Bill C-9 is the first significant legislative reform to the Judges Act in five decades. The goal of the legislation is to enhance public confidence in the administration of justice by modernizing the complaints and discipline regime for federally appointed judges. This essay is a contextual analysis of Bill C-9. The authors begin by outlining a conceptual framework which identifies eight public law goods that can guide an assessment of a complaints and discipline system. They then locate Bill C-9 in a historical context by identifying a crisis of legitimacy that had overtaken the Canadian Judicial Council by the early …
On What Basis Did Health Canada Approve Oxycontin In 1996? A Retrospective Analysis Of Regulatory Data, Jessie Pappin, Itai Bavli, Matthew Herder
On What Basis Did Health Canada Approve Oxycontin In 1996? A Retrospective Analysis Of Regulatory Data, Jessie Pappin, Itai Bavli, Matthew Herder
Articles, Book Chapters, & Popular Press
The marketing and sale of oxycodone (OxyContin) by Purdue Pharma has commanded a great deal of legal and policy attention due to the drug’s central role in the ongoing overdose crisis. However, little is known about the basis for OxyContin’s approval by regulators, such as Health Canada in 1996. Taking advantage of a recently created online database containing information pertaining to the safety and effectiveness of drugs, we conducted a retrospective analysis of Purdue Pharma’s submission to Health Canada, including both published and unpublished clinical trials. None of the trials sponsored by Purdue Pharma sought to meaningfully assess the risks …
Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross
Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross
Articles, Book Chapters, & Popular Press
Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.
From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham
From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham
Articles, Book Chapters, & Popular Press
Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Om- nibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, how- ever, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. …
Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens
Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens
Articles, Book Chapters, & Popular Press
Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …
Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder
Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder
Articles, Book Chapters, & Popular Press
Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the …
Denaturalizing Transparency In Drug Regulation, Matthew Herder
Denaturalizing Transparency In Drug Regulation, Matthew Herder
Articles, Book Chapters, & Popular Press
In the arena of pharmaceutical drug regulation, transparency is the favoured focus of many current policy initiatives. Transparency is predominantly understood in terms of information disclosure. Requirements to register clinical trials, publish summary results, share clinical trial data, and disclose physician-industry relationships as well as rationales behind regulatory decision making are each predicated upon this idea that imparting information will both inform and deter unwanted behaviours. In this paper, I argue that understanding transparency qua disclosure has clear limitations and suggest transparency can and should serve an additional function - namely, of enabling standard setting through a more participatory, public …
Warrant Canaries Beyond The First Amendment: A Comment, Jonathon Penney
Warrant Canaries Beyond The First Amendment: A Comment, Jonathon Penney
Articles, Book Chapters, & Popular Press
Warrant canaries have emerged as an intriguing tool for Internet companies to provide some measure of transparency for users while also complying with national security laws. Though there is at least a reasonable argument for the legality of warrant canaries in the U.S. based primarily on First Amendment "compelled speech" doctrine, the same cannot be said for the use of warrant canaries in other "Five Eyes” intelligence agency countries — United Kingdom, Canada, New Zealand, and Australia — where the legality of warrant canaries has yet to be examined in either cases or scholarship. This comment, which provides an overview …
Toward A Jurisprudence Of Drug Regulation, Matthew Herder
Toward A Jurisprudence Of Drug Regulation, Matthew Herder
Articles, Book Chapters, & Popular Press
Efforts to foster transparency in biopharmaceutical regulation are well underway: drug manufacturers are, for example, legally required to register clinical trials and share research results in the United States and Europe. Recently, the policy conversation has shifted toward the disclosure of clinical trial data, not just trial designs and basic results. Here, I argue that clinical trial registration and disclosure of clinical trial data are necessary but insufficient. There is also a need to ensure that regulatory decisions that flow from clinical trials — whether positive (i.e. product approvals) or negative (i.e. abandoned products, product refusals, and withdrawals) — are …
Warrant Canaries Beyond The First Amendment: A Comment, Jonathon Penney
Warrant Canaries Beyond The First Amendment: A Comment, Jonathon Penney
Articles, Book Chapters, & Popular Press
Warrant canaries have emerged as an intriguing tool for Internet companies to provide some measure of transparency for users while also complying with national security laws. Though there is at least a reasonable argument for the legality of warrant canaries in the U.S. based primarily on First Amendment "compelled speech" doctrine, the same cannot be said for the use of warrant canaries in other "Five Eyes” intelligence agency countries — United Kingdom, Canada, New Zealand, and Australia — where the legality of warrant canaries has yet to be examined in either cases or scholarship. This comment, which provides an overview …
Achieving Transparency In Implementing Abortion Laws, Rebecca Cook, Joanna Erdman, Bernard Dickens
Achieving Transparency In Implementing Abortion Laws, Rebecca Cook, Joanna Erdman, Bernard Dickens
Articles, Book Chapters, & Popular Press
National and international courts and tribunals are increasingly ruling that although states may aim to deter unlawful abortion by criminal penalties, they bear a parallel duty to inform physicians and patients of when abortion is lawful. The fear is that women are unjustly denied safe medical procedures to which they are legally entitled, because without such information physicians are deterred from involvement. With particular attention to the European Court of Human Rights, the UN Human Rights Committee, the Constitutional Court of Colombia, the Northern Ireland Court of Appeal, and the US Supreme Court, decisions are explained that show the responsibility …