Law Commons^™

'The Perfect Shouldn't Be The Enemy Of The Good' — What Canada Can Do Today, Tomorrow & Next Week To Enhance Equitable Access To Covid-19 Biopharmaceutical Interventions, Matthew Herder

Reports & Public Policy Documents

There is overwhelming evidence of inequitable access to a range of COVID-19 targeting biopharmaceutical interventions, including not only vaccines but also anti-viral drug therapies, diagnostic tests, and various materials that are incorporated into these products. As recently explained by Yamey et al. in the British Medical Journal, inequitable access is baked into every phase of the biopharmaceutical system—from production and allocation to affordability and deployment. Yet, it is still possible to improve access to these critically important biopharmaceutical interventions in low and middle-income countries (LMICs). Intellectual property (IP) rights are one crucial site where policy intervention can make an immediate …

Recommendations On Mature Minors, Constance Macintosh

Reports & Public Policy Documents

Recommendation: The Committee should remove the requirement from the Criminal Code that candidates for Medical Assistance in Dying (MAID) be at least 18 years old. This is for the following reasons, elaborated upon below.

1.The MAID regime should always turn on the actual capacity of any person requesting MAID

2.The MAID regime’s approach to consent and capacity should be consistent with Canadian law on health care decision-making by minors

3.The MAID regime will likely be found unconstitutional if it maintains an age-based bar

4.The vulnerability of youth may require a different approach but does not justify an age-based bar

5.Removing …

Permissive Regulation: A Critical Review Of The Regulatory History Of Buprenorphine Formulations In Canada, Abhimanyu Sud, Meghan Mcgee, Barbara Mintzes, Matthew Herder

Articles, Book Chapters, & Popular Press

Suboxone (buprenorphine-naloxone) is an opioid product approved in the US and Canada for the treatment of opioid use disorder. The drug is considered an important response to the opioid overdose epidemic with consistent calls for wider prescribing and deregulation. The history of Suboxone regulation in Canada has not been critically examined. Part of the rationale for doing so stems from the US regulatory experience, with documented irregularities, or what some have called abuses, that support profit-making by Suboxone's manufacturers. This regulatory analysis allows us to determine how opportunities to address health crises through drug innovation are managed at a federal …

Reducing Barriers To Accessing Administrative Data On Sars-Cov-2 Vaccination For Research, Andrew Mcrae, Patrick Archambault, Patrick Fok, Hana Wiemer, Laurie Morrison, Matthew Herder

Articles, Book Chapters, & Popular Press

Public trust in scientific research, especially research regarding vaccines, has proven fragile during the COVID-19 pandemic. To counter abundant misinformation about SARS-CoV-2 vaccines, rigorous, ongoing evaluations of vaccine safety and effectiveness by independent Canadian researchers are important. However, researchers' efforts to conduct timely, national studies of vaccine effectiveness have been hindered by barriers to data sharing that have made it difficult to integrate patients' vaccination status into SARS-CoV-2 clinical and epidemiological studies. Here, McRae et al discuss how a risk-averse data-sharing culture has led to missed opportunities to conduct robust, timely, pan-Canadian SARS-CoV-2 clinical and vaccine effectiveness studies, and outline …

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, …

Steering And Rowing In Health Care: The Devolution Option?, Colleen Flood, Joanna Erdman, Duncan Sinclair

Articles, Book Chapters, & Popular Press

Publicly funded health care systems are often the subject of heated policy debates. All too often (particularly in Canada), these debates focus on the prohibitive costs, the resultant taxation levels, and the questionable efficiency and outcomes associated with a publicly funded system. Moreover, the institutionalization of the system and the entrenchment of its many stakeholders make effecting change particularly difficult. In this article, the authors begin with an assessment of the drawbacks of the Canadian health care system in the federal-provincial context and its resulting gaps in governance (steering), in management (rowing), and in overall accountability (apart from that offered …