Law Commons^™

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we conducted a retrospective analysis of Purdue Pharma’s submission to Health Canada, including both published and unpublished clinical trials.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 …

The Politics Of Regulating And Disciplining Judges In Nigeria, Olabisi D. Akinkugbe

Articles, Book Chapters, & Popular Press

The disciplining of judges is a sensitive and complex challenge. In Nigeria, the complexity is heightened because the process is complicated by socio-political factors and public views about the motivations for disciplining some judges, including claims of political interference by the ruling government. This Chapter argues that both judicial discipline and the work of the National Judicial Council (NJC) – the body responsible for judicial regulation in Nigeria – are caught up within Nigeria’s peculiar socio-politics, a reality that a strictly legal analysis will miss. The Chapter analyzes contemporary challenges and controversies associated with the complaints and discipline procedure in …

The Politics Of Regulating And Disciplining Judges In Nigeria, Olabisi D. Akinkugbe

Articles, Book Chapters, & Popular Press

The disciplining of judges is a sensitive and complex challenge. In Nigeria, the complexity is heightened because the process is complicated by socio-political factors and public views about the motivations for disciplining some judges, including claims of political interference by the ruling government. This Chapter argues that both judicial discipline and the work of the National Judicial Council (NJC) – the body responsible for judicial regulation in Nigeria – are caught up within Nigeria’s peculiar socio-politics, a reality that a strictly legal analysis will miss. The Chapter analyzes contemporary challenges and controversies associated with the complaints and discipline procedure in …

Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

Articles, Book Chapters, & Popular Press

Policy Points

• The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
• Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
• Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …

Toward A Principled Design Of Provincial Cap & Trade Systems: Lessons From Nova Scotia's Proposal To Meet The Carbon Pricing Requirement In The Pan-Canadian Framework For Climate Change, Meinhard Doelle

Articles, Book Chapters, & Popular Press

This article explores the Cap & Trade System proposed by the province of Nova Scotia in response to the call in the Pan-Canadian Framework on Clean Growth and Climate Change for all provinces to implement a carbon pricing mechanism. The proposed C & T system itself and the way it has been developed offers insights into ongoing debates in the governance of climate mitigation. The first debate is about the strength and weaknesses of various carbon pricing mechanisms, most notably the carbon tax and cap and trade systems. The second debate is about the relative importance of carbon pricing and …

Let My People Go: Human Capital Investment And Community Capacity Building Via Meta/Regulation In A Deliberative Democracy - A Modest Contribution For Criminal Law And Restorative Justice, Bruce P. Archibald

Articles, Book Chapters, & Popular Press

Globalization and the new information economy are putting great stress on western high-wage economies of which Canada is an exemplar. As individuals and together as a society, Canadians are being forced to become more flexible and strategic in adjusting to changing employment opportunities and economic challenges. Meanwhile, governments have shifted from being purveyors of welfare to being supervisors of both markets and decentralized/ privatized public services. Key roles for the government in this new political environment are the sponsorship of mechanisms for autonomous, individual human capital investment as well as for community responses to these emerging economic and social challenges. …

High Seas Fisheries: Troubled Waters, Tangled Governance And Recovery Prospects, David Vanderzwaag, Boris Worm

Articles, Book Chapters, & Popular Press

Global fisheries are in a perceived state of crisis. Despite growing technological effort and an unprecedented global expansion of fisheries, total landings (85-100 million MT per year) have stagnated and probably entered a period of slow decline. This trend may destabilize ocean ecosystems and undermine world seafood supplies, which provide the major source of protein for 2.3bn people, and international cooperation to address this issue has been slow. This is particularly true for highseas fisheries that occur in international waters encompassing some 61% of the world's ocean. These have been plagued by a fragmented and weak legal framework, poor enforcement …