Health Law and Policy Commons^™

Optimizing The Data Available Via Health Canada's Clinical Information Portal, Alexander C. Egilman, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast repository of data that have been submitted to support market authorization of drugs and medical devices. Health Canada has released data from more than 160 submissions for drugs, biologics, vaccines and medical devices. The regulator is currently in its third year of a 4-year phase-in schedule to release clinical data proactively from submissions for all new active substances, new clinical indications, generic drugs and higher-risk devices that are approved, withdrawn or rejected. Substantial clinical data submitted by the industry sponsor of the application, …

Legislative Options To Address Institutional Objections To Voluntary Assisted Dying In Australia, Ben P. White, Lindy Willmott, Eliana Close, Jocelyn Downie

Articles, Book Chapters, & Popular Press

Voluntary assisted dying is being considered by parliaments and law reform bodies across Australia. Although individual conscientious objection is routinely considered in these deliberations, an institution’s desire to object to providing voluntary assisted dying has received very little attention. After briefly considering the concept of institutional objection in voluntary assisted dying, this article examines the available (albeit limited) Australian evidence on this practice. Institutional objection is happening in Victoria (where voluntary assisted dying is lawful) and is likely to occur in other Australian states. The article proposes that regulation is needed and presents three models for parliaments and law reformers …

Factors Affecting Access To Administrative Health Data For Research In Canada: A Study Protocol, Cynthia Kendell, Adrian Levy, Geoff Porter, Elaine Gibson, Robin Urquhart

Articles, Book Chapters, & Popular Press

In Canada, most provinces have established administrative health data repositories to facilitate access to these data for research. Anecdotally, researchers have described delays and substantial inter-provincial variations in the timeliness of data access approvals and receipt of data. Currently, the reasons for these delays and variations in timeliness are not well understood. This paper provides a study protocol for (1) identifying the factors affecting access to administrative health data for research within select Canadian provinces, and (2) comparing factors across provinces to assess whether and how they contribute to inter-provincial variations in access to administrative health data for research.

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

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. …

Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder

Articles, Book Chapters, & Popular Press

Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and repurposed pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying …

In The Name Of Public Health: Misoprostol And The New Criminalization Of Abortion In Brazil, Mariana Prandini Assis, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores the criminal regulation of misoprostol as a controlled drug in Brazil as a new form of abortion criminalization. A qualitative analysis of Brazilian case law shows how the courts use a public health rhetoric of unsafe abortion to criminalize the distribution of misoprostol in the informal sector. Rather than an invention of the local bench, this judicial rhetoric reflects global public health discourse and policy on unsafe abortion and the double life of misoprostol as both an essential medicine and a controlled drug. In contrast to previous studies, the article shows that abortion criminalization is not the …

An Abortion Law Preformed, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article engages the transcribed testimony of Carolyn Egan and Janice Patricia Tripp in R v Morgentaler as a critical moment of lawmaking. There is something revealing, often amusing, and sometimes devastating, when a lawyer asks a non-lawyer, in this case, a social worker: “What is the law?” The article focuses on those moments in their testimony when Egan and Tripp answered questions about the 1969 abortion law that made the law itself, its rules and procedures, the subject of examination, and in doing so, constructed new meanings of the law and social action in relation to it in the …

Securing Safe Supply During Covid-19 And Beyond: Scoping Review And Knowledge Mobilization, Matthew Bonn, Natasha Touesnard, Brianna Cheng, Michael Pugliese, Emilie Comeau, Claire Bodkin, Thomas D. Brothers, Leah Genge, Matthew Herder, Candis Lepage, Ayden Scheim, Dan Werb, Sheila Wildeman

Articles, Book Chapters, & Popular Press

Background

Safe supply is defined as the legal and regulated provision of drugs with mind and/or body altering properties that have been typically accessible only through the illegal drug market. In response to the coronavirus disease 2019 (COVID-19) pandemic and related social/physical distancing measures, efforts have been made to scale up and increase access to safe supply programs in an effort to reduce overdose and other drug- and drug policy-related risks. However, it remains unclear whether these efforts taken thus far have meaningfully mitigated the barriers to safe supply experienced by People Who Use Drugs (PWUD), both during and beyond …

Does “No, Not Without A Condom” Mean “Yes, Even Without A Condom”?: The Fallout From R V Hutchinson, Lise Gotell, Isabel Grant

Dalhousie Law Journal

In R v Kirkpatrick, the Court of Appeal for British Columbia held that consent to sexual activity cannot be established where a man proceeds with unprotected vaginal intercourse when his sexual partner has insisted on a condom. While this finding should be uncontroversial, it is in fact contrary to the Supreme Court of Canada ruling in R v Hutchinson. In this comment we argue that the approach taken in Kirkpatrick is correct and consistent with the landmark decision in R v Ewanchuk. We urge the Supreme Court of Canada to reconsider its majority judgment in Hutchinson in order to fully …

Faith And/In Medicine: Religious And Conscientious Objections To Maid, Daphne Gilbert

Dalhousie Law Journal

Across Canada, health care institutions that operate under the umbrella of religious traditions refuse to offer medical assistance in dying (MAiD) on the grounds that it violates their Charter-protected rights to freedom of religion and conscience. This article analyses the Supreme Court jurisprudence on section 2(a) and concludes that it should not extend to the protection of institutional rights. While the Court has not definitively pronounced a view on this matter, its jurisprudence suggests that any institutional right to freedom of religion would not extend to decisions on publicly-funded and legal health care. MAiD is a constitutionally-protected option for individuals …

Dispute Settlement Under The African Continental Free Trade Area Agreement: A Preliminary Assessment, Olabisi D. Akinkugbe

Articles, Book Chapters, & Popular Press

The African Continental Free Trade Area Agreement (AfCFTA) will add a new dispute settlement system to the plethora of judicial mechanisms designed to resolve trade disputes in Africa. Against the discontent of Member States and limited impact the existing highly legalized trade dispute settlement mechanisms have had on regional economic integration in Africa, this paper undertakes a preliminary assessment of the AfCFTA Dispute Settlement Mechanism (DSM). In particular, the paper situates the AfCFTA-DSM in the overall discontent and unsupportive practices of African States with highly legalized dispute settlement systems and similar WTO-Styled DSMs among other shortcomings. Notwithstanding the transplantation of …

Biosimilars: The Quest For A Rational Regulatory And Intellectual Property Approach In Canada, Elizabeth S. Dipchand

LLM Theses

Biologics and biosimilars represent the promise for more effective treatments of many diseases. International treaty obligations influenced heavily by the biopharmaceutical industry and advanced through the international trade agenda may lead to an imbalance between incentivizing innovation and the public interest. Canada’s implementation of its obligations into national patent and regulatory laws encourages aggressive biologic patent protection strategies that, coupled with linked regulatory assessments, may establish compounding layers of exclusion that disproportionately disincentivizes both the biologics innovation and biosimilar development. This comparative analysis addresses the progression of international obligations and the way in which they have been implemented into Canada’s …

Covid-19 Provincially Incarcerated Individuals - A Policy Report, Adelina Iftene

Articles, Book Chapters, & Popular Press

This document is the result of an investigation into the impact of the COVID-19 pandemic on provincially incarcerated individuals and the Nova Scotia government’s responses relating to its prison population. It was supported by the Nova Scotia COVID-19 Health Research Coalition. In this memorandum, we describe the results of the investigation and propose solutions to better prepare for the second wave of COVID-19 or an alike pandemic situation.

The Opioid Crisis As Health Crisis, Not Criminal Crisis: Implications For The Criminal Justice System, Haley Hrymak

Dalhousie Law Journal

The criminal justice system’s response to the opioid crisis exacerbates risks faced by people using drugs and is harmful to public health. Interviews with 11 interviewees including defence counsel, probation officers, and public interest lawyers and advocates revealed three key challenges of working in the criminal justice system during the opioid crisis. First, there is a lack of understanding of addiction within the criminal justice system. Second, as a result of the opioid crisis, fentanyl trafficking sentencing decisions in British Columbia emphasize the need for lengthier prison sentences, which disproportionately affects people who use substances. Third, the conditions on bail …

Maid Legislation At A Crossroads: Persons With Mental Disorders As Their Sole Underlying Medical Condition, The Halifax Group, Melissa K. Andrew, Jennifer A. Chandler, Jocelyn Downie, Colleen M. M. Flood, Arthur Frank, Mona Gupta, Kwame Mckenzie, Tanya Park

Reports & Public Policy Documents

Legislation permitting medical assistance in dying (MAiD) came into force in Quebec in December 2015, and in the rest of Canada in June 2016. The Quebec and federal MAiD laws contain detailed eligibility criteria as well as procedural safeguards. In particular, Quebec’s MAiD legislation requires that to be eligible for MAiD, a person must be “at the end of life,” whereas the federal legislation requires that a person’s “natural death” must have become “reasonably foreseeable.” At the time the two laws were introduced, legal experts warned that some eligibility criteria would require further clarification and could even face Charter of …

End-Of-Life Decision Making: Policy And Statutory Progress (2011-2020), Jocelyn Downie, Mona Gupta, L. Wayne Sumner, Joshua Wales

Reports & Public Policy Documents

In 2009, the Royal Society of Canada (RSC) identified a series of urgent scientific and public policy questions. It established a series of five Expert Panels to study the issues and provide recommendations for next steps. It is now timely to revisit the findings of these Expert Panel Reports. What impact have they had? Have their recommendations been implemented? What are the next steps in terms of policy options?

To answer these questions, the RSC is establishing Policy Briefing Committees (PBC) to:

• describe the context, findings, and recommendations of the report;
• track policy developments in relation to the panel’s findings …

From Discovery To Delivery: Public Sector Development Of The Rvsv-Zebov Ebola Vaccine, Matthew Herder, Janice Graham, Richard Gold

Articles, Book Chapters, & Popular Press

The discovery and development of the Ebola rVSV-ZEBOV vaccine challenge the common assumption that the research and development for innovative therapeutic products and vaccines is best carried out by the private sector. Using internal government documents obtained through an access to information request, we analyze the development of rVSV-ZEBOV by researchers at Canada’s National Microbiology Laboratory beyond its patenting and licensing to a biotech company in the United States in 2010. According to government documentation, the company failed to make any progress toward a phase 1 clinical trial until after the WHO Public Health Emergency of International Concern freed substantial …

International Economic Law In The Global South And Covid-19, James Thuo Gathii, Olabisi D. Akinkugbe, Nthope Mapefane, Ohio Omiunu, Titilayo Adebola

Articles, Book Chapters, & Popular Press

The COVID-19 pandemic has disrupted all facets of human relations on a magnitude not witnessed in the post-World War II era. Due to the interdependence of countries in the international system, it is not surprising that the unfolding public health crisis has had significant ramifications for the functioning of the global economy as well. In responding to this global health crisis, and the associated fallouts, the academic community has a crucial role to play in finding solutions to the hydra-headed problems we all face.

Driven by this sense of urgency and responsibility, AfronomicsLaw put out a call for contributions in …

Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015, Andrea Macgregor, Audrey D. Zhang, Joshua D. Wallach, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Thirty days after a novel therapeutic agent, a new molecular entity, or original biologic is approved, the US Food and Drug Administration (FDA) must publicly disclose its approval package, including scientific reviews completed by FDA disciplines (eg, pharmacology, statistical, and medical reviewers) and any available assessments by agency leadership.1 Although reports of internal disagreement have surfaced,2 it is unclear how often such disagreements occur. Disagreements document differing points of view or engaged discussion and may, thus, capture important scientific debates or signal challenging decisions within the agency. We sought to determine the frequency of disagreements within the FDA regarding approval …

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

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 …

Editorial, Lucie Guibault

Articles, Book Chapters, & Popular Press

1 This issue marks the tenth month into the COVID-19 pandemic. Since March 2020, we have learned to live with the more or less strict public health measures put in place to ‘flatten the curve’ of infection from the virus. Words like ‘social distancing’, ‘mask wearing’, and ‘lockdowns’ have taken an entirely new meaning. In spite of these measures, the human toll is huge, most clearly among frontline workers and vulnerable people. While the curve is far from flat in most countries, the pandemic has brought to light the long time unacknowledged persistence of systemic inequalities: figures show that poorer, …

Covid-19 Vaccines As Global Public Goods, Jason W. Nickerson, Matthew Herder

Articles, Book Chapters, & Popular Press

Vulnerable: The Law, Policy and Ethics of COVID-19 confronts the vulnerabilities that have been revealed by the pandemic and its consequences. It examines vulnerabilities for people who have been harmed or will be harmed by the virus directly and those harmed by measures taken to slow its relentless march; vulnerabilities exposed in our institutions, governance, and legal structures; and vulnerabilities in other countries and at the global level where persistent injustices affect us all. COVID-19 has forced us to not only reflect on how we govern and how we set policy priorities, but also to ensure that pandemic preparedness, precautions, …

Fighting For Deinstitutionalization In Nova Scotia: Emerald Hall Human Rights Case, Sheila Wildeman

Articles, Book Chapters, & Popular Press

Those who have not been following the human rights complaint, MacLean v Nova Scotia, should start paying attention now. The case will be heard at the Nova Scotia Court of Appeal in November. People First Canada, CACL and the Council of Canadians with Disabilities will intervene.

At stake is whether institutionalization counts as discrimination - and what, if anything, human rights can do to respond.

Beth MacLean, Joey Delaney and Sheila Livingstone, all persons labeled with intellectual disabilities, brought the complaint to the Nova Scotia human rights commission in 2014. The Disability Rights Coalition [DRC] joined in the complaint.

MacLean, …

End-Of-Life Care For Federally Incarcerated Individuals In Canada, Adelina Iftene, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In this article, we review the current legislation, policies, and practices related to end- of-life care for federally incarcerated individuals as set out in statutes, guidelines, and government reports and documents that were either publicly available or obtained through Access to Information requests from the Parole Board of Canada and Correctional Service of Canada (CSC). Based on this review, we describe the status quo, identify gaps, and offer reflections and raise concerns regarding end-of-life care for federally incarcerated individuals. We conclude that there are significant information gaps about the number of people seeking end-of-life care and about how CSC is …

Reducing Unnecessary Caesarean Sections: Scoping Review Of Financial And Regulatory Interventions, Newton Opiyo, Claire Young, Jennifer Harris Requejo, Joanna Erdman, Sarah Bales, Ana Pilar Betrán

Articles, Book Chapters, & Popular Press

Background: Caesarean sections (CS) are increasing worldwide. Financial incentives and related regulatory and legislative factors are important determinants of CS rates. This scoping review examines the evidence base of financial, regulatory and legislative interventions intended to reduce CS rates.

Methods: We searched MEDLINE, EMBASE, CINAHL and two trials registers in June 2019. Both experimental and observational intervention studies were eligible for inclusion. Primary outcome measures were: CS, spontaneous vaginal and instrumental birth rates. We assessed quality of evidence using Grading of Recommendations, Assessment, Development and Evaluation (GRADE) method.

Results: We identified 9057 articles and assessed 65 full-texts. We included 16 …

Covid-19 In Canadian Prisons: Policy, Practice And Concerns, Adelina Iftene

Articles, Book Chapters, & Popular Press

Correctional Service of Canada and the provincial prison systems have a duty to provide incarcerated individuals with health services that are comparable to those in the community, but they have failed to do so during the COVID-19 pandemic. There are inherent practical difficulties to implementing health care in prisons. In addition, prison demographics include a higher proportion of populations that are vulnerable to disease. These factors together mean that the prison response to COVID-19 must involve depopulation and the implementation of guidelines provided by public health agencies in all institutions. So far, the measures taken have been insufficient, as is …

Assisted Dying And Evidence-Based Law-Making: A Critical Analysis Of An Article’S Role In New Zealand’S Referendum, Ben White, Lindy Willmott, Jocelyn Downie, Andrew Geddis, Colin Gavaghan

Articles, Book Chapters, & Popular Press

Aim: To critically analyse the reliability of an article which claims to be evidence that the End of Life Choice Act 2019 provides a “potential hotspot for family, community and social discord that may not be easily remedied” should the legislation receive public support in New Zealand’s September 2020 referendum.

Method: The subject article was reviewed multiple times by all authors and critiqued against three criteria: a reliability pyramid developed to weigh evidence about assisted dying; principles that guide the conduct of social science research; and the use of reliable and current social science literature to support factual claims.

Results: …

Assisted Dying For Prison Populations - Lessons From And For Abroad, Jocelyn Downie, Adelina Iftene, Megan Steeves

Articles, Book Chapters, & Popular Press

No abstract provided.