University of Alberta Faculty of Law Blog

Federal Government Proposes Amendments to Canada’s Embryo Research Law

The Federal Government has proposed amendments to the Assisted Human Reproduction Act, the legislation that governs fertility treatment services and embryo research, including many aspects of stem cell research. The amendments, which are contained in an omnibus budget implementation bill tabled before Parliament on April 26, seeks primarily to implement the 2010 Supreme Court of Canada ruling that invalidated several provisions of the law on the basis that the power to enact those provisions belonged to the provinces. The bill also seeks to abolish Assisted Human Reproduction Canada, the beleaguered federal agency charged with the responsibility of enforcing the legislation. Other proposed changes include:

• The licensing regime for research activities permitted by the legislation will cease to exist. This means that scientists will no longer require a license to conduct research on supernumerary IVF embryos, for keeping and handling gametes and embryos, or for transgenics. These activities are, in fact, no longer regulated under the statute. However, they would still be subject to other research regulations, such as the Tri-Council Policy Statement and the CIHR Guidelines for Human Pluripotent Stem Cell Research, or to future provincial regulations.

• The revised statute will maintain the prohibitions on research involving embryos and gametes. This includes bans on creating embryos for research purposes, somatic cell nuclear transfer, buying and selling of human gametes, and possibly, the derivation of gametes from induced pluripotent stem cells. This, in my opinion, is a missed opportunity to revise aspects of the law that are out of touch with scientific realities and public opinion.

•  The provision that bars many experts (persons who are, have applied to be or are affiliated with others licensed to carry out research activities permitted by the Act) from sitting on the Board of Directors of Assisted Human Reproduction Canada will be repealed. Such experts are also barred from sitting on the Stem Cell Oversight Committee, the national research ethics board established to monitor and approve human pluripotent stem cell research protocols. The practice of excluding experts from oversight boards is unique to Canada and to human pluripotent stem cell research, and is primarily aimed at addressing issues arising from conflicts of interest in research ethics oversight. The rule has attracted some criticism, with some commentators (including myself) noting that it is an example of cutting off the nose to spite the face. To exclude experts from oversight activities that sometimes require intimate knowledge of the field seems a bit heavy-handed and ill-informed. A better strategy would be to create comprehensive and stringent rules for managing conflicts of interest. This is the approach taken in most other jurisdictions, including the UK, where the stem cell research regulator is generally regarded as a model of good governance and oversight. One hopes that with the repeal of this provision, CIHR would also amend its rules to address the exclusion of experts from SCOC.

For those interested in seeing what the legislation would look like if the amendments are passed into law, I have prepared a revised version which you can download here.

Common (Public) Nuisance and the Fear of Smallpox

via Health Law in British North America

“The fears of mankind, though they may be reasonable, will not create a nuisance” – Defence counsel, R v Vantandillo, (1815), 4 M & S 72, 105 ER 76 (KB).

In R v Vantandillo, a mother was convicted and sentenced to three months imprisonment for “unlawfully and injuriously” carrying his infant son, who was infected with smallpox, along a public highway. The case is one of many that fall under the “grab bag” common law offence of common or public nuisance. The case also provides some insights on the strict liability quality of public nuisance qua crime. Here’s how:

• A “judgment by default” was entered against the defendant. I am not familiar with the history of this procedure, but I doubt that it means the same thing as a default judgment in the context of civil proceedings. If I were to guess, I would say that a conviction was simply entered against the defendant upon notice of the indictment. Some statements in the case report support this theory. For example, it is reported that “the defendant having suffered judgment by default, appeared to receive the sentence of the Court,” which suggests that an actual trial was dispensed with. Also, at the sentencing hearing, Lord Chief Justice Ellenborough, responding to the defence counsel’s contention that it was entirely possible that the only reason her client presented her child on the street was to obtain medical advice, noted (in a somewhat circular fashion) that even though the “necessity” defence could be proved by evidence, such defence was precluded by the mere fact that the “indictment alleged that [the offence was committed]…unlawfully and injuriously.”
• The defence counsel argued that the mother’s actions were neither unlawful nor injurious to anyone. According to him, since the indictment did not state how the child caught the disease or that he was purposefully inoculated with smallpox by or at his mother’s request, it was perfectly reasonable to assume that the reason why she exposed the child in the streets was to obtain medical treatment (inoculating or procuring the inoculation of a person was also a common law offence, even if commonly relied on at that time as a preventative from smallpox). This act by itself (i.e. the actions of caring mother), he argued, could not be unlawful. On the question of injury, he argued that since the indictment did not show that the child carried some outward manifestation of smallpox (such as sores) as the time of exposure, it cannot be concluded with certainty that there was any injury presented by the situation. He noted that without such outward evidence (as in the case of leprosy, and by analogy to the writ of de leproso amovendo), it would be difficult to distinguish between infected persons who pose an injury to the public and those who do not.

The court rejected both arguments. It surely must not have helped the defendant’s case that the prosecution alleged that “the passage in which the defendant had exposed the child was a cul de sac, extremely narrow; that there was a small school kept there, and that two of the children had caught the disorder and died.”

“Health” and the Distribution of Legislative Powers in the BNA Act, 1867

via Health Law in British North America

Here are some ideas (hypotheses?) emerging from my current research on infectious disease legislation and the advent of state medicine in 19th century Canada:

• Prior to confederation, legislation on the subject of “health” can be grouped under three general headings: quarantine and emigration laws, laws relating to vaccination, inoculation and sanitation, and laws relating to hospitals and health professions. The theme common to these three areas is the prevention and management of infectious and contagious diseases (indeed, it appears as if the fear and threat of diseases provided the impetus for state involvement in the regulation of medicine and health care, but that is a story for another post). These areas, with the exception of quarantine and emigration, emerged from and remained under the legislative and administrative mandates of local authorities until confederation (see my next point for why quarantine and emigration is excepted). More interestingly, at the time of confederation, these two areas had not coalesced into a precise, or (at a minimum) recognizable legislative notion of “health” or “health care”.  One could therefore hypothesize that this situation may account for why health—unlike “quarantine and the establishment and maintenance of marine hospitals”—is not specifically enumerated as a head of power under the British North America Act (BNA Act), 1867.
• In 1853, the Province of Canada legislature consolidated all statutes relating to quarantine and emigration under one enactment, thus repealing a number of quarantine statutes that had their origin in pre-union Canada. This may have contributed to a “vision” of quarantine as belonging to a class of subjects of national interest, despite the fact that early quarantine laws dealt mainly with local measures to prevent the importation of infectious and contagious diseases (especially in Lower Canada and Nova Scotia [see e.g. here, here and here]—Upper Canada entered the 1841 union without any quarantine laws, for reasons I speculated on in an earlier post). The 1853 consolidation specifically repealed the principal Lower Canada legislation dealing with quarantine in the context of importation of diseases, and replaced it with a section which empowered the Governor in Council to issue regulations relating to quarantine measures directed at the “preservation of the Public Health” and preventing the “introduction and dissemination of disease.”

So what are the implications of all this? First, I think there is a strong historical link between infectious disease regulation and the development of “state medicine” or more specifically, state/legal intervention in health/care. Second, the absence of a precise concept of “health” in the legislative context, and the fact that much of what made up that concept was handled by local authorities prior to confederation may account for why the subject of health is missing from the distribution of powers scheme in the BNA Act, 1867. What we find instead is that under the BNA Act, the legislative power over the establishment of health care institutions—one of three major areas of “health” legislation prior to confederation—falls to the provinces. This head of power, along with powers over property and civil rights and matters of a merely local or private nature in the province form the locus of authority that informs the present notion that the provinces occupy more of the field of health governance. Conversely, the responsibility for quarantine legislation may have shifted with the 1853 consolidation.

Interesting side note: Under the 1853 consolidation, any “Lunatic, Idiotic, Deaf and Dumb, Blind or Infirm Person” arriving in Canada must be accompanied by family members. If unaccompanied, and if in the opinion of the Medical Superintendent, “likely to become permanently a public charge,” the Master of the vessel in which such a person arrived in the Province must execute a bond with “two sufficient sureties” in the amount of seventy-five pounds to indemnify the Province for any expenses incurred for his/her maintenance and support within three years of arrival. This suggests that during this period, the maintenance of infirm and mentally ill residents of Canada was paid for by relatives or, in the case of persons without relatives, out of the public purse. What would have been the quid pro quo for the latter arrangement? Perhaps something similar to the Poor Law infirmary system?

Health Law in Lower and Upper Canada, 1791-1841

Consider this: Number of health-related legislation enacted between 1791 and 1841 in Lower and Upper Canada (i.e. during the period of formal existence of both provinces):Lower Canada: 6*Upper Canada: Nil*

via healthlawhistory.wordpress.com

This is cross-posted from my new blog on health law in early Canadian history.

Latest "Legislative Overreach" Analysis from SCC: Reference re Assisted Human Reproduction Act

Earlier today, the SCC issued its long awaited ruling on the constitutionality of several sections of the Assisted Human Reproduction Act, Canada's assisted reproduction and related research legislation. The principal issue in the case was whether the impugned provisions exceed Parliament's legislative authority. The case is a feds appeal from a Quebec Court of Appeal judgment which struck down the provisions for being an intrusion into matters within provincial legislative authority. The SCC decision was a 4/4/1 split, with Justice Cromwell casting the deciding vote to allow the appeal in part, and affirm the Quebec Court of Appeal decision in part.

Below is my diagrammatic representation of how the two opposing judgments dealt with the legislative overreach analysis. Before reviewing each one, try guessing at first glance which of them 1Ls will find more accessible.

You see, the thing about calling gametes "life's essence" is that...

Margaret Sommerville has a piece in Saturday's Globe and Mail that argues against donation of gametes specifically for procreation (which, according to her, some think is distinguishable from procreation for infertility treatment). Here are some nuggets from this piece:

• "Is donor conception the 21st-century version of the wrongs we now recognize we did to some children in the 20th century? Are we repeating in a new context and in new ways the terrible errors and grave injustices that occurred with Australia’s “stolen generation” of aboriginal children, the United Kingdom’s “home children” sent to Canada and other British Commonwealth countries, and the “scoop” of native children from reserves into Canadian residential schools and white adoptive homes, all of which deliberately separated children from their biological families.”
• "I suggest that the first step in dealing, ethically, with the issues I have identified and with other related issues, is to place the future child, and the child’s human rights and our obligations as a society to him or her, at the centre of the decision-making as to what should be required, allowed or prohibited – that is, what we must, may or must not do, respectively – in the use of assisted human reproduction technologies, including gamete donation."

Regarding the first, the analogy is jarring and wrongheaded in many ways I won't go into here. Not because I can't raise specific objections to it, but rather that I suspect my objections might be obvious to anyone who reads that. On the second point, well, it's a great thought, but I wonder if Somerville would recommend we use law to enforce the same for biological (or more to the point, heterosexual) procreation.

The problem I have with philosophical arguments like the ones suggested by this piece is not that they don't make sense, but that they require that nothing else make sense in order to sound legitimate. But hey, confusing statements like the one I just made are the reason G&M favors bioethicists with a clear moral position.

A Few Things From and For the Web

Anonymous Coward over at Bayblab - one of my favorite science blogs - has this interesting post which suggests that homeopathy and alternative medicine are attracting some positive attention in the British Parliament. I know a lot of people who would either enjoy or loathe this development.

This Harvard prof. has a few thoughts on what it really means to be a professor. (H/T Bayblog).

Some interesting recent developments in the world of biomedicine, science, law and policy:

• President Obama has asked his bioethics commission to look into the issues raised by synthetic biology following Craig Venter's recent announcement that his research team has created a synthetic cell. Other scientists say the work is a significant technical achievement, but not groundbreaking. Don't expect that to deter conspiracy theorists, who unfortunately may be writing the script for the next crop of lawmakers seeking to protect us from science gone mad à la embryonic stem cell research.
  
• Three members of the Board of Assisted Human Reproduction Canada, the federal regulatory agency responsible for implementing the provisions of the Assisted Human Reproduction Act, have resigned their posts. Interestingly, they can't say why because of a gag order written into their terms of service. You can read my reflections on the resignations here. One thing I did not mention in that post is that the current membership of the Board certainly does not "reflect a range of backgrounds and disciplines relevant to the Agency's objectives" as expressly required by the Act. Not that it matters - the Board has been largely inactive since its establishment in 2004.
• If you know someone planning to travel abroad for stem cell treatments, ask that they check out this website. A speaker at a regenerative medicine conference I attended last week in Madison, WI suggested that clinics offering unproven and unapproved stem cell treatments may be operating within a new research and innovation paradigm whereby patients receiving these treatments serve as unwitting funders and subjects of research. Or as I like to think of it: the paradigm that killed the right of autonomy.

Autism vaccine linked rejected

So says the Court of Federal Claims in the United States. The court hears cases where claims are being made against the U.S. federal government.  I am not sure if this will end the debate.  This story about how a researcher who tried to show such a link faked the data may also end the discussion, but I also doubt it. (h/t Point of Law)

New HHS rules on freedom to deny medical services on grounds on belief

The US Dept. of Health and Human Services released a rule today which takes the health care provider's freedom to practice according to their conscience one step further. The new rule provides, inter alia, that health care providers or other entities subject to HHS rules (basically those that receive federal funds) shall not "[r]equire any individual to perform or assist in the performance of any part of a health service program or research activity funded by the Department if such service or activity would be contrary to his religious beliefs or moral convictions." For avoidance of doubt, the rule defines "assist in the performance" as follows: "to participate in any activity with a reasonable connection to a procedure, health service or health service program, or research activity, so long as the individual involved is a part of the workforce of a Department-funded entity.  This includes counseling, referral, training, and other arrangements for the procedure, health service, or research activity."

What this means is that in addition to the freedom to choose what medical services to provide, a doctor or other health professional now enjoys the freedom to decide what kinds of medical advice to give to or to deny his/her patients. For example, a doctor who objects to abortion on religious grounds has no obligation to perform the procedure or to provide counseling or a referral to another doctor who can. Put otherwise, health professionals do not have an obligation to provide all material information that a patient should know in circumstances where such information offends their beliefs.

Notice that the rule also extends to research activities. I imagine an embryonic stem cell research laboratory staffed by dissenters who cannot be fired because of this rule.

Read the HHS news release here.
Download the HHS rule.

Finally, A Dose of Good Judgment...

This has just been brought to my attention, via Tim C. and Corey T. Hugely important.

The Canadian Press

MONTREAL - The federal government overstepped its authority when it drafted laws on assisted human reproduction, the Quebec Court of Appeal ruled on Thursday.
In a 53-page judgment, the court said dozens of federal provisions on clinical and research activities are unconstitutional because they encroach on provincial jurisdictions.
Appellate court justices determined that assisted reproduction should be considered a health matter as opposed to a criminal justice issue regulated by Parliament.
They warned that failing to correct to the imbalance could "amount to a Trojan Horse and would reduce substantially the jurisdiction of the provinces." 
The federal law on assisted human reproduction was passed in
2004 and bans human cloning and the buying and selling of human embryos.
It also sets out guidelines for in vitro fertilization and research licensing.
The Quebec government had asked the appeals court to review the law, believing parts of it should be under its control.
The court agreed, ruling 22 articles aimed to regulate "an entire area of medical practice," a task usually left to the provinces.
Quebec's Health Department has often complained that Health Canada was on its turf by controlling elements of the assisted human reproduction industry.
Health Minister Philippe Couillard even tabled a bill last year to create provincial norms for clinical and research activities.

Health Insurance Benefits from STD

The CB Cout of Appeal ruled that a man who contracted Herpes after having unprotected sex with three women can his health insurance benefits.  What amazes, or should I say shocks, me most about this story is that the man became paralyzed from the Herpes virus! Yikes! I knew Herpes was bad - but this is really bad!

Doctors are enemies of humanity?

Somewere between the time the young undergraduates get into medical school and the time they become established members of the medical community, it seems that some doctors lose their humanity and moral compass.  They become agents of the socialist state that dictates who lives and who dies. So it was no surprise to see that doctors, at the ironically named Grace Hospital, assert that they and only they get to decide who lives and who dies even if this goes against the wishes of the patient's family members! (HT: David Kopel at Volokh)

Do doctors really believe that somehow because they spent 4 years in medical school that they get to play God with our lives? These are the doctors who routinely make basic medical errors like leaving sponges inside a patient, amputating the wrong leg, prescribing the wrong dosage and then cry that the pressures of the job should relieve them of any legal or moral culpability (which I am inclined to grant). Yet, when it comes to life and death decisions, these over-worked and stressed out doctors get to pull the plug on someone's life! They can't have it both ways.

Is this what our society has reduced us to? Thankfully, for now, the judge in the case has at least seen the insanity of the physician's demand of immediate pulling of the plug and has granted an injunction.

I wonder how these doctors can sleep at night? It is amazing how throughout history doctors have been at the forefront of state-sponsored barbarism such as eugenics in both this continent and Nazi Germany.  It seems that they never learn.

Doctors need to come to terms with who they really are. We as a society need to do so too. If they want the power of the soul over us, then they need to be prepared to face not only civil but criminal sanctions for every mistake they make. In other words, the trade-off is as follows: you get to be the final arbiter on life and we get to hold you strictly liable in a crimnal sense everytime you make a mistake. After all, if you are so superior to be able to make life and death decision, in a state that has abolished the death penalty, we presume that all your decisions are done with sound deliberation. So when you forget that scalpel in the patient or amputate the wrong leg, that can only mean that you were criminally negligent. After all could a superior being make such a mistake?

Perhaps, the doctors should get out of the life and death game, and just focus on healing people.

HPV Vaccines

The death toll is mounting from the HPV Vaccine that was touted with religous fervor by many as the next wonder drug. Its maker launched a shameless campaign to get state legislatures to mandate its use without adequate time to study its side effects or effectiveness. 

Parents who opposed its usage were labelled as fanatics, ignorant, and unfit. 

As these reports of deaths continue, will sanity prevail or will more children have to be sacrificed on the altar of the leftists public health ideology?

Another reason to be safe

Ladies get it from men who carry it - yes, I am talking about HPV. Now it seems, even men can get it, and the results are not nice: trees will start growing on you.

I am not sure about this

A dentist who is facing sexual battery charges claims that his fondlings were medically necessary.

National Health = Terrorism?

That is what this talking head on FoxNews argues:

PS. Not that I minded the exchange last week about John Carpay, but in case you don't know FoxNews, here is the Simpson's take on it:

Stem Cell Banking: Another Reason to Draw on your Home Equity

A company in California is now offering an embryonic stem cell banking service which allows you to generate stem cells from excess IVF embryos and store them for future use. i.e. when the scientists have figured out whether this technology is for real. Read the full story here. The company, appropriately called StemLifeLine, is certified as a tissue bank and boasts that their service is an investment for the future, the near future. Interestingly too, they are promoting this one based on the hype about stem cells: "With more than a decade of scientific research supporting the future use of embryonic stem cells and several therapies currently under development, personalized therapies using immunocompatible cell lines may be available in the near future."

Of course, tissue banking is nothing new, but this may be the first time tissues are being banked for an unproven and still speculative therapy (I have to investigate this). And with the possibility that couples may want to create embryos solely as a source of cells, this will surely attract more controversy in an area that does not need any more attention than it is getting now.

Also, I believe such cell banking is not allowed under current Canadian regulations. The Assisted Human Reproduction Act (which incorporates parts of CIHR's Guidelines for Human Pluripotent Stem Cell Research) provides that embryos no longer wanted for reproductive purposes may be donated to another couple, used for research, or discarded. No mention of extracting and banking stem cells. Following the Interpretation Act, the use of the word "may" only allows some discretion with respect to the alternatives mentioned in the provision i.e. donated to another couple, used for research, or discarded.   

Gardasil or Not?

Excerpt from this news story in today's National Post:

"Gardasil's best case is a 70% case for cervical cancer reduction, not prevention, whereas condoms and Pap tests are nearly 100% effective, not only against all cervical cancers but against all STDs. Because it has been studied for only five years, Gardasil is not yet able to demonstrate either long-term benefits or side effects and has not been shown to prevent cervical cancer. Its record in preventing pre-cancerous cervical lesions is at best only 46% better than a placebo.

When vaccination for girls was allotted $300-million in the March federal budget, critics alleged pressure from drug manufacturer Merck and physicians' groups with which the company has commercial ties, as well as from Merck lobbyists who had once been advisors to Stephen Harper.

In the run-up to the budget, Merck's "Tell Someone" TV commercial ran night after night through January and February, featuring girls and women musing about "the cervical cancer virus." By means of what appeared to be a public service message, Canadians were suddenly aware about cervical cancer and HPV and its threat to women's health."

It appears as if corporate interests have once again trumped evidence-based decision making and the wise use of your tax dollars. Also easy to see the political appeal of the vaccinations. I wonder what most doctors will recommend - a vaccine with limited effect or continued testing? The answer could be a nice little study that would add to the literature on financial conflicts of interest in the medical setting and on the role of big pharma in designing public health response systems.

Doctor in LA not indicted

Tom Kirkendall has been following the saga of Dr. Anna Pou who was being threatened with prosecution for the last few years (when was Hurricane Katrina?)  Today, the news says that a grand jury refused to indict her. The Attorney General, I suppose, could try to convene another grand jury (if LA law allows that) or just let this matter drop. Medical ethics and criminal law sometimes should stay away from each other.

Manufacturing controversy

I am a reluctant media interviewee. But sometimes, perhaps against my better judgment, I agree to speak to the media in the hope that my doing so will add a balanced perspective and will explain legal and ethical issues to interested members of the public.

This morning, I was contacted by a well-respected media outlet with a request for a live radio interview. The interview was to focus on the story of a Montreal woman (story also here) who has decided to freeze a number of her ova for possible future use by her now seven-year old daughter. The woman decided to take this step after she learned that her daughter has a genetic condition that might mean she is infertile.

The producer I spoke with this morning asked me a number of "pre-interview" questions, the first of which was "is it ethical for this woman to have frozen her eggs for her daughter's use?." I responded that there is nothing inherently unethical about what this woman has done, that it is ultimately a personal decision for her, and that while it does raise potential ethical concerns, these are, in my view, not insurmountable. I was also asked "Does this mean that, if the child goes on to have a child using her mother's eggs, she will be both mother and sibling to the resulting child?" I answered that, genetically speaking, the woman's daughter would be a half-sibling to her own child, but that from a social point of view, it is really a question of how the family chooses to define and shape its relationships. I noted that the separation of biological and social parenting is not novel, adoption being perhaps the most familiar example, and that this is simply a variation on that practice.

I also noted that the woman's daughter may never use the eggs that her mother has cryopreserved. Currently, it is very difficult to obtain donor eggs for use in IVF. But by the time this young girl is ready to raise children (should she choose to do so at all), that may no longer be the case and she may opt to use eggs provided by a different donor. I told the producer that one of the troubling issues surrounding this case is the lack of anonymity that has been granted to the family, particularly the young girl. Hopefully, however, by the time she is ready to try to conceive children, this will all be long-forgotten.

The producer then told me that she would speak to her senior producer and get back to me with the details of the interview. Instead, I got a phone message from her saying that they had decided to forego the story for now. They were hoping to find someone "who saw more of both sides of the issue, or thought that this was more unethical" than I did.

So much for providing a balanced, reasoned perspective. That, it seems, is not of interest. Instead, this media outlet is looking for controversy and would prefer to interview someone who is going to generate sound bites about how outrageous our society has become, how our social values have shifted in a direction that bodes poorly for the future. Not only would they prefer this type of interviewee, but they decided that the story itself is not worth telling unless they can find him or her. Maybe I've been right all along in being reluctant to speak to the media...