Law Commons^™

What Is The Purpose Of The Orphan Drug Act?, Matthew Herder

Articles, Book Chapters, & Popular Press

The Orphan Drug Act (ODA) [1], first enacted in the United States in 1983, was set up to encourage the development of drugs for rare diseases. At that time, drug therapies for such diseases were rarely developed. Three decades later, a growing proportion of industry research and development (R&D) [2] and regulatory drug approvals [3] target diseases affecting fewer than 200,000 persons in the United States, the prevalence-based threshold of rare disease under the ODA.

In a new article published in PLOS Medicine, Aaron Kesselheim and colleagues document an embedded trend: within the …

Pereira's Attack On Legalizing Euthanasia Or Assisted Suicide: Smoke And Mirrors, Jocelyn Downie, Kenneth Chambaere, Jan L. Bernheim

Articles, Book Chapters, & Popular Press

In a paper published in Current Oncology, University of Ottawa palliative care physician Jose Pereira states that the, “laws and safeguards [in countries in which euthanasia or assisted suicide have been legalized] are regularly ignored and transgressed in all the jurisdictions, and that transgressions are not prosecuted.” He purports to demonstrate that the safeguards and controls put in place in the permissive jurisdictions are an “illusion.”

In the present paper, we expose problems with the evidence base provided and relied upon by Pereira. It should be noted that we provide only examples of each of the categories of mistakes made …

Confusion Worse Confounded: A Comment On 'Withdrawl Of Clinical Trials Policy By Canadian Research Institute Is A 'Lost Opportunity For Increased Transparency', Jocelyn Downie, Francoise Baylis

Articles, Book Chapters, & Popular Press

According to a recent BMJ article on CIHR's decision to "disappear" its policy on clinical trial registration, "Ian Graham, CIHR's vice president Knowledge Translation and Public Outreach, stated the CIHR policy was removed 'as the overlap [with Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)] will cause confusion and inconsistent application of the requirements.'"

Ironically, this explanation is itself confusing and inconsistent with previous decisions made by CIHR. There are at least three areas in which CIHR policy/guidelines overlapped with TCPS 2 (registration and results disclosure of trials, research involving Aboriginal People, and research involving human pluripotent …

Canadian Parliament Must Act On Assisted Human Reproduction, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In the past three months, three members of the Board of Directors of Assisted Human Reproduction Canada (AHRC) have resigned. Their resignation letters include the following statements: '[that following requests for information about the Agency's spending and budget] there was much reluctance and procrastination in providing information, and that when the information was provided, there were inconsistencies in what I received and what was originally presented. This raises concerns in my mind about the prudence and diligence in managing public funds'; 'I have encountered difficulties as a board member in receiving satisfactory replies to concerns and questions I have raised …

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, …

The Manitoba College Of Physicians And Surgeons Position Statement On Withholding And Withdrawal Of Life-Sustaining Treatment (2008): Three Problems And A Solution, Jocelyn Downie, Karen Mcewen

Articles, Book Chapters, & Popular Press

The College of Physicians and Surgeons of Manitoba (CPSM) recently issued a Statement on Withholding and Withdrawl of Life-Sustaining Treatment (2008). The College should be given enormous credit for trying to provide guidance with respect to physicians' obligations in an area of great confusion and controversy. Unfortunately, however, there are some very serious flaws in the Statement. In this paper, we describe three major problems with it that we believe make the case for the claim that the Statement must be revised. We then provide a revised statement that, if adopted, could represent significant progress as it would provide: greater …

Health Care Ethics Experts In Canadian Courts, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In this paper, I will first describe the traditional approach to the use of experts in Canadian courts. Then I will consider whether, on this approach, health care ethics experts should be permitted to testify in Canadian courts. I will argue that they should be permitted to testify but caution should be exercised by the courts, the parties, and the experts themselves. The objective of the paper is to highlight the strengths and raise some concerns about the weaknesses of a practice that appears to be growing, so that the potential harmful consequences might be anticipated, problems with the practice …