Law Commons^™

Toward A Canadian Right To Repair: Opportunities And Challenges, Anthony D. Rosborough

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This Article draws a picture of the past, present, and future of the right to repair in Canada. It looks to early successes toward automotive right to repair, challenges faced in proposing consumer protection reforms in Ontario and Quebec, and the utility of a proposed copyright “Technological Protection Measure (TPM) exception” allowing circumvention for repair purposes. In light of right to repair priorities identified by Canada’s current federal government, the Article identifies a selection of reforms that could achieve these goals. Such reforms include creating regulations under the Copyright Act governing the use and implementation of TPMs, passing an exception …

Achieving A (Copy)Right To Repair For The Eu’S Green Economy, Anthony D. Rosborough, Leanne Wiseman, Taina Pihlajarinne

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• The Right to Repair is a global movement in favour of rebalancing the relationship between manufacturers and end users of products and devices. As part of the European Union (EU) Green Deal and the Circular Economy Action Plan, EU legislators have made the Right to Repair a key policy aim. To date, however, the EU’s Right to Repair policy focus has been predominantly consumer law–oriented.

• This article sheds light on another key dimension of the Right to Repair—IP (and principally copyright law). It canvasses the ways in which copyright can inhibit repair activities, including curtailing access to repair information and …

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Repair As Research: How Copyright Impedes Learning About Devices, Anthony D. Rosborough, Aaron Perzanowski

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Widespread computerization and ubiquitous smart devices have enabled software-based copyright governance to reach into new domains. Beyond their instrumental utility, these devices are also containers of vast amounts of information in the form of software and technical know-how. Through copyright and anti-circumvention rules, however, this information can be cordoned off and confined to exclusive distribution channels. This can have a significant impact on research. While copyright law traditionally conceives research as the use of expressive works within institutional settings, this paper proposes a broader conceptualization that includes device research, including informal inquiries and DIY activities. Whether for the purposes of …

Zen And The Art Of Repair Manuals: Enabling A Participatory Right To Repair Through An Autonomous Concept Of Eu Copyright Law, Anthony D. Rosborough

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Repair manuals are an essential resource for repairing today’s modern and computerised devices. And though these manuals may contain purely utilitarian and uncopyrightable facts, they often receive copyright protection in their entirety as literary works. This protection can impede community-based efforts toward fostering a culture of participatory repair throughout the EU, including repair cafés and tool libraries. Participatory repair activities provide numerous environmental, social, and economic benefits. This article explores whether directive 2001/29/EC’s exception for “uses in connection with the repair or demonstration of equipment” at Article 5(3)(l) (the “Repair Exception”) may offer an avenue for enabling such non-profit participatory …

Understanding Chilling Effects, Jonathon Penney

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With digital surveillance and censorship on the rise, the amount of data available online unprecedented, and corporate and governmental actors increasingly employing emerging technologies like artificial intelligence (AI), machine learning, and facial recognition technology (FRT) for surveillance and data analytics, concerns about “chilling effects”, that is, the capacity for these activities “chill” or deter people from exercising their rights and freedoms have taken on greater urgency and importance. Yet, there remains a clear dearth in systematic theoretical and empirical work point. This has left significant gaps in understanding. This article has attempted to fill that void, synthesizing theoretical and empirical …

Platforms, Encryption, And The Cfaa: The Case Of Whatsapp V Nso Group, Jonathon Penney, Bruce Schneier

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End-to-end encryption technology has gone mainstream. But this wider use has led hackers, cybercriminals, foreign governments, and other threat actors to employ creative and novel attacks to compromise or workaround these protections, raising important questions as to how the Computer Fraud and Abuse Act (CFAA), the primary federal anti-hacking statute, is best applied to these new encryption implementations. Now, after the Supreme Court recently narrowed the CFAA’s scope in Van Buren and suggested it favors a code-based approach to liability under the statute, understanding how best to theorize sophisticated code-based access barriers like end-to-end encryption, and their circumvention, is now …

Regulation Of Health-Related Artificial Intelligence In Medical Devices: The Canadian Story, Michael Da Silva, Colleen M. M. Flood, Matthew Herder

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Artificial Intelligence (AI) may transform Canadian healthcare. The hope is that AI will enable more accurate and efficient care, thereby solving many access, quality, and safety problems. Yet, despite this tantalizing prospect, there are risks of unsafe AI harming patients, algorithmic bias, and threats to privacy. This work begins analysis of whether applicable Canadian laws are up to the task of ensuring Canadians can benefit from effective health-related AI while minimizing AI-related risks. It focuses on Health Canada’s regulation of medical devices, a ‘first line of defence’ that decides which devices are safe, effective, and thus permitted for trade in …

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

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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 …

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

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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 …

From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham

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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

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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 …

Consultation On How To Implement Canada's Cusma Commitment To Extend The General Term Of Copyright Protection, Carys Craig, Ariel Katz, Lucie Guibault, Graham Reynolds, Bita Amani, Sara Bannerman, Pascale Chapdelaine, Myra Tawfik, Samuel Trosow

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As a group of Canadian Intellectual Property Law scholars, we write regarding the Ministers’ recently launched consultation on extending the term of copyright protection in order to meet Canada’s CUSMA commitments. With this letter, which we jointly submit in response to the call for comments, we wish to express our shared concerns about both the proposed term extension and, more immediately, the inappropriately curtailed nature of this consultation process.

Reasonable Expectations Of Privacy In An Era Of Drones And Deepfakes: Expanding The Supreme Court Of Canada’S Decision In R V Jarvis, Suzie Dunn, Kristen Mj Thomasen

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Perpetrators of Technology-Facilitated gender-based violence are taking advantage of increasingly automated and sophisticated privacy-invasive tools to carry out their abuse. Whether this be monitoring movements through stalker-ware, using drones to non-consensually film or harass, or manipulating and distributing intimate images online such as deep-fakes and creepshots, invasions of privacy have become a significant form of gender-based violence. Accordingly, our normative and legal concepts of privacy must evolve to counter the harms arising from this misuse of new technology. Canada’s Supreme Court recently addressed Technology-Facilitated violations of privacy in the context of voyeurism in R v Jarvis (2019). The discussion of …

Is It Actually Violence? Framing Technology-Facilitated Abuse As Violence, Suzie Dunn

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When discussing the term “Technology-Facilitated violence” (TFV) it is often asked: “Is it actually violence?” While international human rights standards, such as the United Nations’ Convention on the Elimination of All Forms of Discrimination against Women, have long recognized emotional and psychological abuse as forms of violence, including many forms of technology-facilitated abuse, law makers and the general public continue to grapple with the question of whether certain harmful technology-facilitated behaviors are actually forms of violence. This chapter explores this question in two parts. First, it reviews three theoretical concepts of violence and examines how these concepts apply to technology-facilitated …

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

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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, …

Regulating Wave, Tidal And Ocean Thermal Energy, Meinhard Doelle, Theodore Nsoe Adimazoya

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Ocean renewable energy sources hold the potential to contribute to the options of low-carbon energy sources and enhance the efforts by the global community to slow down climate change. In this Chapter, we provide a brief background on the current state of technology and development of wave, tidal and ocean thermal energy and consider their potential as forms of renewable energy as well as the potential negative environmental footprints of ocean renewable energy installation and development. Secondly, we examine the relevant international legal and policy framework governing ocean energy, highlighting in particular, the absence of a global legal instrument that …

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

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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

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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.

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

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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

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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

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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

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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, …

Introduction, Aldo Chircop, Floris Goerlandt, Claudio Aporta, Ronald Pelot

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This chapter introduces a multidisciplinary collection of chapters addressing various aspects of governance of Arctic shipping written by leading international scholars. It investigates how ocean changes and anthropogenic impacts affect our understanding of risk, policy, management and regulation for safe navigation, environment protection, conflict management between ocean uses, and protection of Indigenous peoples’ interests in Canadian Arctic waters. The book is divided in three parts, together providing a multi-faceted and interdisciplinary view on governance of Arctic shipping. The first part addresses conceptual and empirical aspects of risk governance, management, and assessment in the Canadian Arctic. The second part focuses on …

Sustaining Canadian Marine Biodiversity: Policy And Statutory Progress, Jeffrey A. Hutchings, Julia K. Baum, Susanna D. Fuller, Josh Laughren, David Vanderzwaag

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A 2012 Expert Panel Report on marine biodiversity by the Royal Society of Canada (RSC) concluded that Canada faced significant challenges in achieving sustainable fisheries, regulating aquacul- ture, and accounting for climate change. Relative to many countries, progress by Canada in fulfilling international obligations to sustain biodiversity was deemed poor. To track progress by Canada since 2012, the RSC struck a committee to track policy and statutory developments on matters pertaining to marine biodiversity and to identify policy challenges, and leading options for implementation that lie ahead. The report by the Policy Briefing Committee is presented here. It concluded that …

Unscrewing The Future: The Right To Repair And The Circumvention Of Software Tpms In The Eu, Anthony D. Rosborough

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This analysis examines the impact of software technological protection measures (“TPMs”) in the European Union which inhibit the repair and maintenance of products. Using John Deere tractors as a case study, this analysis addresses the growing number of products which incorporate computerisation and TPMprotected software into their design and function. In utilising software integration and TPMs, many product designs now allow manufacturers to retain considerable control over the manner of repair and choice of technician. In response, consumers and lawmakers are calling for legal reforms to make self-repair and servicing easier. Both the competition law and moral implications of this …

Legal Risks Of Adversarial Machine Learning Research, Ram Shankar Siva Kumar, Jonathon Penney, Bruce Schneier, Kendra Albert

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Adversarial machine learning is the systematic study of how motivated adversaries can compromise the confidentiality, integrity, and availability of machine learning (ML) systems through targeted or blanket attacks. The problem of attacking ML systems is so prevalent that CERT, the federally funded research and development center tasked with studying attacks, issued a broad vulnerability note on how most ML classifiers are vulnerable to adversarial manipulation. Google, IBM, Facebook, and Microsoft have committed to investing in securing machine learning systems. The US and EU are likewise putting security and safety of AI systems as a top priority.

Now, research on adversarial …

Politics Of Adversarial Machine Learning, Kendra Albert, Jonathon Penney, Bruce Schneier, Ram Shankar Siva Kumar

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In addition to their security properties, adversarial machine-learning attacks and defenses have political dimensions. They enable or foreclose certain options for both the subjects of the machine learning systems and for those who deploy them, creating risks for civil liberties and human rights. In this paper, we draw on insights from science and technology studies, anthropology, and human rights literature, to inform how defenses against adversarial attacks can be used to suppress dissent and limit attempts to investigate machine learning systems. To make this concrete, we use real-world examples of how attacks such as perturbation, model inversion, or membership inference …

Implementing User Rights For Research In The Field Of Artificial Intelligence: A Call For International Action, Sean Flynn, Christophe Geiger, Joao Pedro Quintais, Thomas Margoni, Matthew Sag, Lucie Guibault, Michael W. Carroll

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Last year, before the onset of a global pandemic highlighted the critical and urgent need for technology-enabled scientific research, the World Intellectual Property Organization (WIPO) launched an inquiry into issues at the intersection of intellectual property (IP) and artificial intelligence (AI). We contributed comments to that inquiry, with a focus on the application of copyright to the use of text and data mining (TDM) technology. This article describes some of the most salient points of our submission and concludes by stressing the need for international leadership on this important topic. WIPO could help fill the current gap on international leadership, …

Ethical Testing In The Real World: Evaluating Physical Testing Of Adversarial Machine Learning, Kendra Albert, Maggie Delano, Jonathon Penney, Afsaneh Ragot, Ram Shankar Siva Kumar

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This paper critically assesses the adequacy and representativeness of physical domain testing for various adversarial machine learning (ML) attacks against computer vision systems involving human subjects. Many papers that deploy such attacks characterize themselves as “real world.” Despite this framing, however, we found the physical or real-world testing conducted was minimal, provided few details about testing subjects and was often conducted as an afterthought or demonstration. Adversarial ML research without representative trials or testing is an ethical, scientific, and health/safety issue that can cause real harms. We introduce the problem and our methodology, and then critique the physical domain testing …

Technology-Facilitated Gender-Based Violence: An Overview, Suzie Dunn

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Technology facilitated gender-based violence (TFGBV) is a complex worldwide phenomenon with devastating results. Research to date shows that victim-survivors of intimate partner violence are tracked by their abusive partners who use technology to monitor their movements and communication. Many women journalists, human rights defenders and politicians face daily death threats and rape threats for speaking out about equality issues or for simply being a woman in a leadership role. Those with intersecting marginalized identities are at specific risk, with Black, Indigenous, and people of colour, LGBTQ+ people, and people with disabilities facing higher rates of attacks and concerted attacks that …