Minnesota Legislature Must Hold Hearings on Psychiatric Research Misconduct

By Trudo Lemmens, Raymond DeVries, Lois Shepherd and Susan M. Reverby (this op-ed was originally published on April 28, 2015 in the Minnesota Post)

(The following commentary was also signed by 159 scholars of health law, bioethics, medicine and pharmacy from institutions in the U.S., Canada, Australia, New Zealand, the UK, and other countries. Their names and affiliations are listed in a document attached to the Minnesota Post commentary. Earlier UofT Law blogs already reported on the initiatives and controversies mentioned in this commentary. See here)

As scholars of health law, bioethics and medicine, we are calling on the Minnesota Legislature to conduct public hearings on psychiatric research misconduct at the University of Minnesota.

Respect the weight of 800 years of law in Khadr bail

 

Portrait of Audrey Macklin

 

This oped by law scholar Prof. Audrey Macklin, commenting on Canadian Omar Khadr's release on bail pending his appeal, appeared in the print and online versions of the Globe and Mail today. Read the full commentary online here, or below.

 

Respect the weight of 800 years of law in Khadr bail

By Audrey Macklin, Professor & Chair in Human Rights Law

One Million Dollar Fine Confirms the Shift of Corporate Criminal Liability From the Boardroom to Middle Managers

On April 17, 2015, Justice Tôth of the Quebec Superior Court imposed a one million dollar fine on a corporation found guilty of price fixing in the case of R. c. Pétroles Global inc ("Global Fuels"). This case is important because it affirms that corporations will be penalized for the actions of middle level territory managers, even where there is no evidence that the head office of the company was aware of the misconduct.

 

The Pharmaceutical Industry’s Shift towards Niche Markets and ‘Personalized Medicine’: New Article Reports on Qualitative Study and Critically Analyzes Ethical and Regulatory Challenges

Reports abound of an apparent innovation crisis in the pharmaceutical sector, with some sources citing escalating drug development costs, declining new drug approvals, and an increasingly stringent regulatory environment. Concurrently, commentators refer to the death, or at least the decline, of the blockbuster model of drug development—where large, brand-name pharmaceutical companies rely on a portfolio of drugs that gross more than U.S. $1 billion per year—which has dominated the pharmaceutical sector for decades.

Decreasing the Data Deficit: Improving Canada's Drug Regulatory System

Decreasing the Data Deficit: Improving Canada’s Drug Regulatory System: Paper by Trudo Lemmens & Shannon Gibson now publicly available on SSRN.

 

New Canadian Securities Administrators' rules would discourage takeovers

Financial Post

This week, the Canadian Securities Administrators (CSA) published draft rules under which a takeover bid would have an irrevocable 50 percent minimum tender condition. Once met, the rules would require an additional 10-day right to tender for undecided shareholders.

The bid, however, would also remain open for a minimum of 120 days. The 50 percent condition is laudable, because it offers effective decision-making capacity on the part of shareholders. The 120-day requirement, however, would cause uncertainty in the market, to the detriment of target shareholders, and of bidders.

The CSA proposal seeks to strike a balance that might lessen the prominence of litigation relating to shareholder rights plans or “poison pills.” The bidder must obtain a “majority of minority” approval before it can take up shares; securities of the bidder and its joint actors would not be counted in the 50 percent. The advantage is that a minority of shareholders cannot force the majority to sell control.

The proposal would therefore likely sound the death knell for some pills such as the “just say no” pill, whereby the bidder can remove the pill only via a proxy contest. But it would prevent bidders from being able to corner target shareholders into the undesirable choice of selling into an underpriced offer or being stuck with illiquid shares.

Home care rethink is needed

Home care rethink is needed

Cost-cutting measures at CCACs have fragmented and confused patient care

Hamilton Spectator

Home care in Ontario has been a controversial subject for decades. In 1995, the Mike Harris government implemented Community Care Access Centres or CCACs, and a managed competition model for service providers. This system changed the face of home care, but did it cause more harm than good?

In the 1980s and 1990s, political parties unanimously agreed that reform was needed, as there was no formal home care system and provincial government spending in health care was too high. Each party proposed a new home care model, and after their election the Harris government passed the Home Care and Community Services Act.

CCACs were introduced to better help individuals live independently at home and to provide information about care options through community support agencies. However, the introduction of a competitive procurement process was driven by an effort to cut costs.

National Regulator 4: The Regulatory Leviathan

 NOTE: This article first appeared in the Financial Post, November 20, 2014 

A selection of the shortcomings of the “Cooperative Capital Markets Regulatory System” (CCMRA), a cooperative enterprise between the federal government and five provinces to create a one-stop securities regulator, have been discussed in these pages in recent days. The CCMRA, if adopted, would be a watershed event in the architecture of Canada’s political institutions. And in no way for the better. 

Since the Great Depression, the rise of the welfare state has been associated with a vastly expanded role for government, and this vast expansion has received its expression in the commensurate growth of the administrative state. Government administrators, who exercise powers delegated to them by government, have tentacles into virtually every walk of life, from the TV we watch to how we behave in the workplace to the pedigree of the hamburgers we throw on the barbie in the summer. 

Why National Securities Regulator Plans Should be Chucked

NOTE: the following first appeared in the Financial Post, December 10, 2014

Two weeks ago on this page I presented detailed and extensive criticisms of the Cooperative Capital Markets Regulatory Authority (CCMRA), which aims at creating a one-stop securities regulator for B.C., Ontario, N.B., P.E.I. and Saskatchewan (and whatever other provinces and territories might choose to sign on). In a response to my criticisms, Phil Anisman dismissed my views “tendentious, overstated and often incorrect.” On the contrary, I believe that they are fair, balanced, and accurate. The factual errors are Mr. Anisman’s, not mine. As this debate has already consumed a lot of space, I will limit the scope of my comments here (although a longer and more detailed version is available online at FT Comment).

 

Phil Anisman’s detailed critique of my series of opeds on the Cooperative Capital Markets Regulatory Authority (which aims at creating a one-stop securities regulator for all of B.C., Ontario, Saskatchewan, N.B., and P.E.I., and any other jurisdictions that may sign on) are “tendentious, overstated and often incorrect.” In fact, they are air, balanced, and accurate. The factual errors are his, not mine.

Paper Shannon Gibson & Trudo Lemmens on Pharmaceutical Innovation and Drug Regulatory Changes Available Online: Niche Markets and Evidence Assessment in Transition

Ontario’s new Minister of Health Eric Hoskin argued in a recent Toronto Star op-ed article for a national pharma plan as an essential component of equitable health care. Federal Health Minister Rosa Ambrone appears also supportive of exploring the development of such a plan. The arguments in favour, based on equity and cost containment, are strong. The development of such a plan will only increase the need to ensure the production of reliable drug safety and effectiveness information. Shannon Gibson and I discuss in a recent paper in the OUP journal Medical Law Review (Shannon Gibson & Trudo Lemmens, "Niche Markets and Evidence Assessment in Transition: A Critical Review of Proposed Drug Reforms" (2014) 22(2) Med. L. Rev. 200-220 available online here for people with UofT library access; and here in a pre-print version on SSRN), how the development of niche pharmaceutical products for which often exorbitant prices are being charged, creates additional pressure to adjust existing drug regulatory and funding systems. As pharmaceutical development strategies evolve and drug products become more complex, regulatory and policy responses must be able to evolve along with them.