Open Access. Powered by Scholars. Published by Universities.®
- Keyword
-
- Pharmaceutical Policy (3)
- Transparency (2)
- WTO (2)
- ABS (1)
- Access and benefit sharing (1)
-
- African Continental Free Trade Area Agreement (1)
- Apotex Inc v Sanofi-Synthelabo Canada Inc (1)
- Appellations of origin (1)
- Biodiversity (1)
- Biologics (1)
- Biologics Price Competition and Innovation Act (1)
- Biosimilars (1)
- Canada (1)
- Capabilities approach (1)
- Critical legal studies (1)
- Critique (1)
- Crown prosecutors (1)
- Cultural homogenization (1)
- Delinking (1)
- Developing countries (1)
- Disciplinary proceedings (1)
- Disciplinary proceedings involving Crown prosecutors and government lawyers (1)
- Dispute Settlement Mechanism (1)
- Doctrine of Non-Obviousness (1)
- Drug Regulation (1)
- Drug Safety (1)
- Embeddedness (1)
- Environmental labelling (1)
- Extraprofessional misconduct (1)
- FAO (1)
- Publication
- Publication Type
Articles 1 - 9 of 9
Full-Text Articles in Food and Drug Law
Twenty Years After Krieger V Law Society Of Alberta: Law Society Discipline Of Crown Prosecutors And Government Lawyers, Andrew Flavelle Martin
Twenty Years After Krieger V Law Society Of Alberta: Law Society Discipline Of Crown Prosecutors And Government Lawyers, Andrew Flavelle Martin
Articles, Book Chapters, & Popular Press
Krieger v. Law Society of Alberta held that provincial and territorial law societies have disciplinary jurisdiction over Crown prosecutors for conduct outside of prosecutorial discretion. The reasoning in Krieger would also apply to government lawyers. The apparent consensus is that law societies rarely exercise that jurisdiction. But in those rare instances, what conduct do Canadian law societies discipline Crown prosecutors and government lawyers for? In this article, I canvass reported disciplinary decisions to demonstrate that, while law societies sometimes discipline Crown prosecutors for violations unique to those lawyers, they often do so for violations applicable to all lawyers — particularly …
Dispute Settlement Under The African Continental Free Trade Area Agreement: A Preliminary Assessment, Olabisi D. Akinkugbe
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
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 …
Memorandum Re: Health Canada's 'Draft Guidance' On Section 21.1(3)(C) Of The Food And Drugs Act, Matthew Herder, Trudo Lemmens
Memorandum Re: Health Canada's 'Draft Guidance' On Section 21.1(3)(C) Of The Food And Drugs Act, Matthew Herder, Trudo Lemmens
Reports & Public Policy Documents
In 2014 Parliament enacted a number of amendments to the Food and Drugs Act, R.S.C. 1985, c. F-27 [hereinafter the “F&D Act”]. Known as “Vanessa’s Law,” these amendments were intended to enhance the regulation of pharmaceutical drugs and thereby protect Canadians from harm by giving the regulator, Health Canada, new powers to, inter alia, recall drugs, require active post-market surveillance, and improve the transparency of information around pharmaceutical drugs. Vanessa’s Law explicitly recognized that “new measures are required to further protect Canadians from the risks related to drugs and medical devices.” (emphasis added) (Bill C-17, An Act to Amend 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 …
When Everyone Is An Orphan: Against Adopting A Us-Styled Orphan Drug Policy In Canada, Matthew Herder
When Everyone Is An Orphan: Against Adopting A Us-Styled Orphan Drug Policy In Canada, Matthew Herder
Articles, Book Chapters, & Popular Press
Putting aside whether diseases that affect only small numbers of people ("rare diseases") should be prioritized over diseases that are otherwise orphaned, in this paper I argue that a new approach to rare, orphan diseases is needed. The current model, first signaled by the United States’ Orphan Drug Act and subsequently emulated by several other jurisdictions, relies on a set of open-ended criteria and market-based incentives in order to define and encourage drug therapies for rare, orphan diseases. Given a) the biopharmaceutical industries’ growing interest in orphan diseases, b) progress in the sphere of personalized medicines enabling more and more …
Intellectual Property, Traditional Knowledge, And Biodiversity In The Global Economy: The Potential Of Geographical Indications For Protecting Traditional Knowledge-Based Agricultural Products, Teshager W. Dagne
PhD Dissertations
The relationship between international regimes regulating intellectual property, traditional knowledge and biodiversity has received much attention in recent times. Of the many complex and controversial issues in contemporary international legal discourse on this matter, the protection of traditional knowledge (TK) stands out as a significant challenge. Choices abound in the search for modalities to regulate rights to use and control TK systems and their underlying biodiversity. In recent times, the protection of geographical indications (GIs) has emerged as an option for protecting TK. Despite the considerable enthusiasm over it, there is appreciable research dearth on how far and in what …
Demythologizing Phosita: Applying The Non-Obviousness Requirement Under Canadian Patent Law To Keep Knowledge In The Public Domain & Foster Innovation, Matthew Herder
Articles, Book Chapters, & Popular Press
The Supreme Court of Canada recently revised the doctrine of non-obviousness in a pharmaceutical “selection patent” case, Apotex Inc. v. Sanofi-Synthelabo Canada Inc. Although cognizant of changes to the same doctrine in the United States and the United Kingdom, a critical flaw in how the doctrine is being applied in Canada escaped the Court’s attention. Using content analysis methodology, this article shows that Canadian courts frequently fail to characterize the “person having ordinary skill in the art” (PHOSITA) for the purpose of the obviousness inquiry. The article argues that this surprisingly common analytical mistake betrays a deep misunderstanding of innovation, …
Book Review Of Passion: An Essay On Personality , Richard F. Devlin Frsc
Book Review Of Passion: An Essay On Personality , Richard F. Devlin Frsc
Articles, Book Chapters, & Popular Press
Passion is a cogently structured, compel Jingly argued and seductively enthralling masterpiece which, in years to come, will undoubtedly stand out as an inspirational source for many who seek social transformation. Unger's style, in this essay at least, is lucid and inviting. Substantively, Passion demonstrates not only the depth of his penetrating intellect but also his command of an array of' disciplines. Unger's polymathy is all the more impressive when we remember that ours is an era in which idiosyncratic specialization is the norm.