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.

National Regulator 3: Where are the Efficiencies?

Note: the following was first published in the National Post, Nov. 20, 2014

A shiny bright “Cooperative Capital Markets Regulatory System” (CCMRA), a cooperative enterprise between the federal government and five provinces to create a one-stop securities regulator, is set to hit the show room floor next September. Regrettably, instead of a Porsche Carrera, it looks much more like a Ford Edsel.

For some years now, the federal government has been hell bent for leather to supplant Canada’s existing 13 securities regulators (10 provincial and three territorial) with a single pan-Canadian regulatory body. In 2011, however, the Supreme Court of Canada ruled that that the federal government’s constitutional authority in the securities law domain is limited to matters of systemic risk affecting the country as a whole. As discussed in this space yesterday and the day before, the CCMRA is thus an attempt to marry the respective constitutional authorities of provincial and federal governments in a single entity. To date, five provinces (B.C., Ontario, Saskatchewan, N.B., and P.E.I.) have signed on. They will all adopt common legislation that will be administered by a common regulatory authority called the “Capital Markets Regulatory Authority” (CMRA). In like fashion, the feds will adopt the “Capital Markets Stability Act” and delegate their power to administer this statute to the CMRA.

National Regulator 2: A Category 5 Blizzard of Red Tape is Headed for Canada's Market Players

Note: the following first appeared in the National Post, Nov. 19, 2014

Many are still unaware that a major proposal to reform our securities regulatory system is now on the table. The “Cooperative Capital Markets Regulatory System” (CCMRA) will replace the securities regulators in five provinces (Ontario, B.C., Saskatchewan, N.B., and P.E.I.) with a new regulator to be called the “Capital Markets Regulatory Authority” (CMRA). Each participating province will adopt a common statute (the “Provincial Capital Markets Act”) and delegate its authority to administer the statute to the CMRA. The federal government will adopt the “Capital Markets Stability Act” (CMSA) and also delegate its authority to administer that statute to the CMRA. In theory, this is supposed to reduce the burden on capital market actors by replacing five distinct regulatory authorities with one. The reality is far different. As discussed Wednesday in this space, business is going to be hit with a category 5 blizzard of red tape that will make Hurricane Katrina look like a zephyr.

The Grand Regulator: Be afraid, very afraid

The following first appeared in the National Post, November 17, 2014

Anyone in the business community who draws breath will be aware that for some time now the federal government has been on the warpath to eliminate the provincially-based system of securities regulation and substitute a single national regulator. Unfortunately for the feds, in 2011 the Supreme Court ruled that the federal government does not have the constitutional power to enact a comprehensive scheme of securities regulation. The Court, however, did suggest that the feds have the power to enact securities laws designed to address nation-wide systemic risks, and to collect securities market information on a national basis.

Following this decision, the federal government and Ontario spearheaded an effort to get as many provinces as possible to sign on to a common piece of legislation known as the “Provincial Capital Markets Act” (PCMA) and to delegate their respective authorities to administer this statute to a common regulator – the Capital Markets Regulatory Authority (CMRA). Under the cooperative agreement (known as the “Cooperative Capital Markets Regulatory System, or CCMRA), the federal government is to adopt a statute called the “Capital Markets Stability Act,” which will deal with those matters within the feds’ constitutional capacity. They will also delegate their authority to administer the statute to the CMRA.

Presidential Elections in Brazil: a choice of development models

Yesterday, Brazil decided to re-elect its President, keeping Dilma Rousseff for another 4 years in power. The margin of victory was really small (51.6%). The wealthy regions (south and southeast) have largely favoured Dilma's opponent, Aecio Neves, while the poorest regions (north and northeast) have strongly supported Dilma.

While the elections clearly show a divided country, those who have followed the debates and scrutinized the policy proposals know that the results reflect more than a division based on income levels. The outcome of this election shows a country divided over two very different development projects. 

Attack Ads, Copyright, and Collusion: Have Canada's Major Broadcasters Violated the Competition Act?

Canada's first (and the world's first) competition act: the Combines Act of 1889
Originally posted on Prof. Katz's blog

Last week reports emerged that the Government is considering a new copyright exception for political advertising. The reports suggested that the exception would permit the use of news content by political parties without authorization. While most of the media coverage of this story focused on the copyright issue and the phenomenon of attack ads, documents that Sun Media obtained from the CBC (under an Access to Information request) reveal an even more interesting and more important story, both politically and legally. These documents, offering a rare glimpse behind the scenes of Canada's major media organization, reveal a picture of a concerted action between the majority of Canada's news outlets, action that might run afoul the Competition Act. 

First jail sentence in Canada for foreign corrupt practices

Nazir Karigar, a former agent of an Ottawa high-tech company  was sentenced on May 23, 2014 to a penitentiary term of three years for conspiring to bribe several Indian government officials in the first Corruption of Foreign Public Officials Act (the “CFPOA” or the “Act”) case to go to trial. The conspiracy to bribe had as its purpose the winning of a tender for a multi-million dollar contract to sell facial recognition software to Air India, a state enterprise. Facial recognition software may play an important role in preventing the boarding of planes by unauthorized persons.

Sophisticated bribery schemes result in jail sentences

Superior Court Justice Hackland ruled that Karigar “had a leading role in a conspiracy to bribe Air India officials in what was undoubtedly a sophisticated scheme to win a tender for a Canadian based company.” The Court issues the following warning: “Any person who proposes to enter into a sophisticated scheme to bribe foreign public officials to promote the commercial or other interests of a Canadian business abroad must appreciate that they will face a significant sentence of incarceration in a federal penitentiary”.

European Medicines Agency's Proposed Data Release Policy: Promoting Pharma's Control Over Data

[Note: this Blog was originally written for and appeared as Guest Blog in PLoS' Blog "Speaking Of Medicine" (May 30, 2014) Reproduced here with permission]

Things were looking good recently in Europe for data transparency, a necessary, albeit not sufficient, tool to promote integrity of pharmaceutical data. The European Court’s Vice-President overturned in November 2013 two lower court interim suspensions of EMA’s data access decision in relation to Abbvie’s drug Humira and Intermune’s Esbriet, which had stalled EMA’s data release approach. Shortly after, Abbvie withdrew the Humira lawsuit. Then in April 2014, the European Parliament approved the new Clinical Trials Regulation that introduced a requirement to register all clinical trials and make all clinical study reports in relation to EMA approved drugs publicly available. These developments put EMA again in the driver’s seat for the further implementation of its promised prospective data release policy.

Understand The 'Law' Behind The Schoolgirl Kidnapping And Dare To Redefine It

By Anver Emon

This article was first posted on The Huffington Post on May 12, 2014.

Boko Haram, the group behind the horrific kidnapping of more than 300 schoolgirls in Nigeria, says its goal is to implement Islamic law - also known as Sharia. Meanwhile, in the small Southeast Asia nation of Brunei, the Sultan has declared Sharia law that calls for punishing adultery, abortions and same-sex relationships with flogging and stoning.

Both draw upon historical tradition that they believe reflects how things ought to be.

Boko Haram draws upon a legal tradition that permitted war captives (e.g. women and children) to be treated as slaves and sold as chattel. The legal context of this rule had to do with designating certain classes of people as protected in warfare, namely women, children and the elderly. Those who could not fight or posed no military threat were to be protected and not targeted in battle. But once the opponent was defeated, all that was theirs became part of the Muslim imperial coffers. Those who were protected in war subsequently became treated as the spoils of war, and thus relegated as slaves who could be sold. When Boko Haram, therefore, invokes Islamic legal rules to frame their abduction of schoolgirls and to justify their sale to others as wives, they are drawing upon a historical tradition about the economics of warfare and conquest.

Ten Cases that Changed the World

So what are the ten cases that have had the biggest impact, not just on the law, but on our collective life more generally?  The world is a big place so I am going to try to focus on cases that have had the greatest impact on our own lives which means that there will  be more focus on jurisdictions that we interact with most—thus not the legal world in its true sense.  But unlike many of the articles and materials I’ve looked at, I don’t want to only consider cases in our home legal system. 

I sat down to sketch a few ideas about the cases that seemed to stand out to me in terms of large scale impact.  Here are some preliminary thoughts:

Of course, I must include Donoghue v Stevenson—the case with the marauding gastropod which not only has intriguing facts but which also began the slow displacement of contractual obligations as the dominant means of organizing  relations, forcing contract to ‘share the field’ with more generalized duties of care.  The fallout continues….as Lord Buckmaster predicted.