Through the Looking Glass at Health Canada, Part I

Posted By Richard Maundrell, Associate Professor, Lakehead University

In 1994 changes to the Food and Drugs Act made Health Canada responsible for the regulation of natural health products and homeopathic medicines (NHP’s). Since then, thousands of NHP’s have been approved by Health Canada as safe and effective. I argue that Health Canada’s criteria for efficacy in relation to NHP’s in particular are inadequate and that its certification of NHP’s is a betrayal of the trust that health care consumers have placed in a bureaucracy that is responsible for the regulation of prescription medicines. In Part One of this two-part blog series, I explain what homeopathic medicine is and why it is pharmacologically implausible. In Part Two, I look at Health Canada’s certification process and the problems with its criteria for efficacy in application to NHP’s.

Part I

A decade has passed since Parliament revised the Food and Drugs Act to include natural health products (NHP’s) within the regulatory ambit of Health Canada. The legislation applies to products that had been available in the marketplace for years, but which had escaped regulation because they were neither foodstuffs nor prescription medicines. These products included vitamins, minerals and herbal remedies as well as homeopathic and traditional medicines. Initially, the changes seemed to be a promising development for consumer protection, because they required manufacturers of NHP’s to prove the medicinal claims they used to market their products. Properly executed, the regulation might have helped to rid the drug store shelves of products sold on the basis of misleading, exaggerated or outright fraudulent claims of medicinal properties. Unfortunately for Canadian healthcare consumers, that is not how things worked out. Just how misguided Health Canada’s policies have been in this area is evident in its regulatory policies concerning homeopathic medicines.

What is Homeopathy?

While homeopathy is often confused with herbal medicine, it is actually a distinct mode of alternative medical treatment conceived and developed in the late 18th century by Samuel Hahnemann (1755-1843). Unlike modalities of alternative medicine that have emerged from traditional folk practice, homeopathy is based on theoretical principles. Its pharmacology is based on Hahnemann’s “Law of Similars”: the principle that a substance which produces the symptoms of a disease in a healthy person will be effective in treating a disease involving those same symptoms in someone who is ill. Thus a common homeopathic treatment for nausea is extracted from the root of the Carapichea ipecacuanha plant, which is known to cause nausea and vomiting in otherwise healthy subjects. Hahnemann developed this “fighting fire with fire” approach using “provings”: an experimental method that tests the effects of potential medications on healthy subjects rather than sick ones. Medicines developed in this way would invite obvious concerns about toxicity if not for the other founding principle of homeopathy, the “law of infinitesimals,” which asserts that the smaller a dose of medication the more powerful its effect.

Consistent with the law of infinitesimals, homeopathic medications are prepared through an elaborate process of dilution in which the “mother tincture” is mixed at a ratio of one part active ingredient to 100 parts solvent (usually water). From its initial dilution the preparation can be diluted again any number of times, each by a factor of 100. Thus a 1:100 or “1C” solution becomes a 2C solution by being diluted again by a factor of 100, yielding a ratio of medicinal ingredient to diluent of 1/100 x 1/100 or 1:10,000. Homeopathic medications are often 20C, which means that they are the product of a series of twenty dilutions, each by a factor of 100. Aside from dilution, the preparation of homeopathic medications involves “succussion” or rhythmic shaking so as to impart the “pharmacological message” of the original substance to the molecules of the diluent.[1]

Is Homeopathy Medicinally Effective?

According to conventional science, homeopathic preparations will quickly become biologically and medicinally ineffective as the dilution process proceeds. At 30C, for example, one part active ingredient will remain in 1060 parts solvent. The chances that a single molecule of active ingredient will remain in a standard dose of 30C homeopathic medicine is one in a billion, billion, billion, billion.[2] In the face of the basic implausibility of Hahnemann’s principles, homeopaths have continued to search for a scientific grounding for their beliefs. In the 1980’s, biochemist Jacques Benveniste claimed that he had observed reactions in human basophil samples to homeopathic-scale dilutions of the anti-IgE antibody.[3] To explain his observation, he hypothesized the notion of “the memory of water”: the idea that water is somehow capable of retaining the chemical properties of substances that are immersed in it. However, Benveniste was unable to replicate these results when asked to do so under properly blinded conditions by an investigative team from the journal Nature.[4] This lack of replication has traditionally been the barrier preventing pre-clinical research in homeopathic ultra-dilution from acceptance as genuine science.[5] The homeopathic community has an onerous burden of proof to establish that homeopathic medicines should be considered anything but placebo treatments.

Hahnemann practised medicine in a time prior to the advent of scientific medicine and the germ theory of disease when blood-letting was still a common mode of treatment for many illnesses. If his treatments were ineffective, they were probably not noticeably less so than what his peers were offering.[6] However, in light of the progress medical science has made since Hahnemann’s time, as well as the scientific implausibility of homeopathy’s theoretical tenets, we might reasonably expect regulatory agencies like Health Canada to demand substantial evidence of efficacy in homeopathic medications. After all, extraordinary claims demand extraordinary evidence. Compelling evidence of efficacy in homeopathic medications, however, remains elusive.[7] In a report to the British House of Commons in 2010, an investigative committee examining published research on homeopathy stated that “systematic reviews and meta-analyses conclusively demonstrate that homeopathic products perform no better than placebos.” That finding was echoed by a similar study carried out for the Australian government in 2013. While noting the paucity of high-quality clinical studies on homeopathic treatments, its authors concluded: “the available evidence is not compelling and fails to demonstrate that homeopathy is an effective treatment for any of the reported clinical conditions in humans.”

Meta-analyses cited by the British and Australian studies filter out low quality studies and reserve the greatest significance for the results of randomized clinical trials (RCT’s). The effectiveness of a medication is most accurately measured across subject populations that, for comparison purposes, have been randomly assigned to treatment and control groups. Random distribution reduces the probability that extraneous differences between subjects might be mistaken for therapeutic effect. The use of controls enables the application of statistical methods to arrive at a picture of therapeutic effect that is as precise as possible in research on human subjects. RCT methodology has been refined continuously since its introduction, most importantly with the introduction of placebo controls and double-blinding that enables researchers to tune subject and researcher expectations out of their data.[8] The RCT became the most trusted method available to medical research because it provided the most effective means of eliminating confirmation bias from the interpretation of clinical outcomes: the very common and natural human tendency to assign undue significance to evidence that supports one’s beliefs and to discount evidence that counts against them. It is principally on the grounds of RCT data that regulatory agencies like Health Canada approve prescription drugs.

Health Canada holds NHP’s to a much lower set of standards than those which it applies to prescription drugs. Those who drafted Health Canada’s policies on the regulation of homeopathic medicines must know that they are too dilute to be pharmacologically effective, and yet Health Canada’s guidelines for the approval of homeopathic medicines stipulate 12C as the minimum allowable potency (in the homeopathic sense of the term ‘potency’). Given that homeopathic medicines commonly have a potency of 20C, the vast majority of homeopathic medicines meet this criterion.

There is no known causal mechanism by which a 12C solution, diluted as it is to one part in 10-24, can have biological effects, medicinal or otherwise. At 12C dilution, it has become a significant possibility that not even a single molecule of the original substance remains. Unless we have reason to believe that water really does have a memory, a solution that contains no medicinal ingredient can have no medicinal effect. The same facts that make homeopathic products safe for non-prescription use explain why such products can have no medicinal benefits beyond placebo. This leads one to wonder what Health Canada’s certification of an NHP as “effective” actually means. This will be the subject of Part II.

[1] Simon Singh & Edzard Ernst, Trick or Treatment: The Undeniable Facts about Alternative Medicine, (New York: W W Norton,2008) at 98.

[2] Singh & Ernst, supra note 1 at 99.

[3] Elizabeth Davenas et al, “Human Basophil Degranulation Triggered by Very Dilute Antiserum Against IgE” (1988) 333 Nature 816.

[4] John Maddox, James Randi & Walter W Stewart, “High Dilution Experiments a Delusion” (1988) 334 Nature 287.

[5] AJ Vickers, “Independent Replication of Pre-clinical Research in Homoeopathy: A Systematic Review” (1999) 6:6 Research in Complementary Medicine 311.

[6] Steven Bratman, The Alternative Medicine Sourcebook: A Realistic Evaluation of Alternative Healing Methods, 2d ed (Los Angeles: Lowell House, 1999) at 104.

[7] Edzard Ernst, “Homeopathy: What Does the Best Evidence Tell Us?” (2010) 192:8 Medical Journal of Australia 458. (This article is a review of all systematic reviews conducted on homeopathy in the Cochrane Database of Systematic Reviews, which is generally considered the most reliable source of evidence.)

[8] Marcia L Meldrum, “A Brief History of the Randomized Controlled Trial: From Oranges and Lemons to the Gold Standard” (2000) 14:4 Hematology/Oncology Clinics of North America 745.

Herd Susceptibility: A New Mass Tort?

Posted By Chris Laliberté

“I noticed that her fingers and her mind were not working together and she couldn’t do anything.
‘Are you feeling all right?’ I asked her. ‘I feel all sleepy,’ she said.
In an hour, she was unconscious.
In twelve hours she was dead.”
–Roald Dahl

I am ten years old. Ashley, the babysitter, wakes me up, serves me breakfast, and walks me to the end of the snow-laden, car-free driveway. My bus driver, Mary-Ann, greets me with a knowing smile, but the downward curve in the wrinkles at the corners of her eyes betrays the concern behind her cheer. Mary-Ann loved every kid who rode that bus like her own grandchild, and one of us had taken ill.

While I run around at recess, snooze through long division, and blast my way through StarFox, my parents spend every night in the hospital with my younger brother, Jonah. My parents wring their hands and pace beside Jonah’s hospital bed as every day, his tiny seven year-old body grapples with scarlet fever. Thankfully, with the help of the team at Hôtel Dieu Hospital, my brother survives.

Jonah was the same age then as Roald Dahl’s daughter, Olivia, when measles encephalitis stole the light from her eyes, and from her father’s life. Neither Dahl nor my parents had a proven and effective vaccine available to protect their child against such terrifying diseases; both, having witnessed the devastation wrought upon their beloved children, would have accepted such help without question.

To know a loved one, especially a child, is at the mercy of a deadly pathogen—a force over which medical professionals have only limited control after infection—induces the worst kind of fear, the fear that this intrusion on your loved one’s health could cause them permanent harm. That the risks adopted by another parent could introduce such a threat to a vulnerable child poses more than an ethical dilemma—I propose that the endangerment of others through the disruption of herd immunity raises a possible cause for legal action in the doctrine of negligence.

Herd Immunity & the Duty to Vaccinate

In large part, vaccines owe the success of their inoculative effects to the herd immunity principle. Contagions require viable hosts for the infection to spread; in a vaccinated community the immunized population creates a barrier that protects those who, for health reasons, cannot receive vaccinations themselves.

The success of herd immunity depends on immunizing the greatest possible proportion of the population. While most can accept vaccines without issue, a small percentage of people cannot due to various health-related reasons, including pregnancy, allergies, or compromised immune systems. Every person able but unwilling to accept vaccinations therefore increases the risk of exposure for this vulnerable minority. In effect, this risk implies a moral duty to vaccinate.

A Legal Right to Refuse Treatment…

The issue proves more complex when trying to establish a legal duty. All persons in Canada retain a right to refuse medical treatment. This right is entrenched in arts. 10-18 CCQ in Quebec, and under legislation such as s.10(1) of Ontario’s Health Care Consent Act in the Common Law provinces. To force anyone to accept vaccinations would violate this right to bodily integrity.

Further, since opting out of vaccinations poses no substantial or immediate risk to the child’s well-being, it seems unlikely that Courts would deprive parents of their authority over their child’s medical care, a right confirmed in B(R) v Children’s Aid Society of Metropolitan Toronto. Under ordinary circumstances, s. 7 of the Charter protects a right to personal autonomy, including a parent’s “right to choose medical treatment for their infants.” A Court would therefore likely not force a parent to have their child vaccinated.

The entrenchment of and need to protect these rights causes me to question both the ethics and the effects of bringing criminal negligence charges against parents who refuse to vaccinate their child, as some have suggested. Assuming an identifiable party at fault for an outbreak, innocent families who have suffered could find a more reasonable and, arguably, effective recourse in civil action.

…and a Legal Wrong to Cause Harm

While many might consider this refusal an omission, I would consider the exercise of any right, even one of refusal, an action. The importance of this distinction lies in the need to first establish a duty to act before an omission constitutes negligence. This step does not exist in claims based on actions, as actions carry the “legal duty to refrain from conduct that a reasonable person would know […] might constitute an unreasonable risk of harm to others.” It is therefore much simpler to sue on an action rather than an omission since the right to act in a certain way does not protect against the risks incurred by the action.

Harvard Law professor Arthur L. Caplan and his co-writers recently laid out a roadmap for success in a hypothetical civil suit, and the same criteria could satisfy the Canadian test for negligence. Caplan argues that, in the case of a rare disease like the measles, “epidemiological analysis could link the two children with a high degree of confidence” to provide a reliable case for causation.

With causation established, a civil action grounded in the tort of negligence relies on proof of a failure to take reasonable precautions by the party at fault. A failure to account for the foreseeable possibility of an unvaccinated child contracting measles and exposing peers to the disease could prove a breach of duty of care, and strengthen the case for prima facie tortious negligence.

In terms of damages, plaintiffs could make arguments for pain and suffering as well as the quantifiable medical costs incurred.

Conclusion

Parents who exercise their right to refuse vaccinations for their child retain the right to do so pursuant to legislation that protects the integrity of the person and allows patients to refuse medical treatment. The exercise of this right, however, should not release parents who refuse to vaccinate from the duty to take reasonable care to protect herd immunity and the health of those who lack the option to vaccinate. A failure to take these reasonable precautions could cement a prima facie claim of tortious negligence against the parents at fault.

Both the moral and legal situations surrounding the right to refuse vaccinations prove as clear to some as they are nebulous to others. No reasonable person, however, can ignore the fact that measles, whooping cough, and other formerly scarce diseases continue to mount a resurgence in direct correlation with the lowest vaccination rates in decades. We have forgotten the threat these diseases pose, the reason we sought their eradication. As more tragedies like the recent Disneyland outbreak unfold, I hope more parents will remember Roald Dahl’s plea after the death of his daughter:

“It is not yet generally accepted that measles can be a dangerous illness.
Believe me, it is. In my opinion parents who now refuse to vaccinate
their children are putting the lives of those children at risk. […]
It really is almost a crime to allow your child to go unimmunized.”

Mandatory Labeling of Genetically Modified Foods: The Phantom Risks of “Frankenfood” [Part II of II]

Posted By Maryam Sabour

Mandatory labeling of GM foods continues to be hotly debated. On the one side, proponents for labeling argue it is a consumer’s “right to know”. They advocate that the precautionary principle should be used as a basis to implement the labeling regulation, as the long-term risks of GM foods are unknown. On the other side, Health Canada’s official stance on GM foods is that they are safe for consumption and no study has provided evidence of health risks. In Part I, the scope and purpose of labeling in Canadian legislation was discussed. It was found that labeling GM foods could give consumers an erroneous impression of GM products, with labels coming off as warnings rather than information. In this final section, we will take a closer look at the notion of consumer perception and risk. We will go beyond the consumer level to consider the societal consequences associated with GM labeling.Consumer Perception of Risk: Perceived vs. Actual Risk

If mandatory labeling regulations were in place for GM foods, would it enhance the consumer’s choice on decision-making? To answer this it is important to assess the perceived risk vs. the actual risk of consuming GM foods and which risk is behind the encouragement of regulation of GM food labeling. Perceived risks of GM foods relate to the uncertainty of the long-term consequences of consumption. That is, labeling for perceived risks is labeling for unknown risks. Actual risks are based on empirical data and scientific judgment. When focusing on perceived risk, much of it is fear based thus, “the factual basis of that fear needs scrutiny”, in other words, the actual risks must be considered. GM breeding processes are “tested or vetted for human and environmental safety which means that GM crops are better characterized than conventionally bred crops”. Thus to regulate GM labeling to reduce fear, when there is no risk, only reinforces fear. Just as the detailed scientific explanations of GM breeding processes are outside the scope of this paper, it is also unknown to the average consumer. Thus, a “genetically modified” label would not inform a consumer any better of the inherent risk (or lack thereof) associated with GM products. Therefore mandatory labeling does not provide valuable information to consumers; in fact it may be more harmful than helpful by creating uncertainty and confusion.

As a result, when considering risk assessment, it is imperative that the assessment is based on “peer-reviewed, pure or paradigm science, not junk science; phantom risk, and not public opinion.” Stephen Breyer emphasizes the importance of regulations focusing on areas where there is a “real scientific basis for their validity”. Breyer illustrates how there is a serious “knowledge gap” between the public and experts which lead the public to overestimate certain risks and “this incongruity leads to the expenditure of valuable public resources in the wrong order of priorities.” In terms of GM foods, due to lack of understanding of the GM process, there “perceived risks” has led to low consumer confidence. This consumer skepticism is what is influencing policy makers and thus these misconceptions and uneducated public perceptions are driving politicians towards regulation of GM labeling. Going back to Breyer’s concept however, more deference should be paid to scientific experts when conducting a risk assessment. Consequently, “the appropriate approach on a regulatory issue should not be determined by “policy by polling” but by what is most likely to enhance the public welfare in the long run.”

Consequences of Regulation: Societal Impact

Proponents of mandatory labeling argue that the precautionary principle provides a valid basis for governments to implement the Regulation. At the first reading of Bill C-517, it was argued that it is impossible to expect consumers to know all the risks associated with different food products. As a result, it is the role of the government to set the basic rules and principles for proper risk management. Although I do agree that the government plays the primary role in risk management, I do not agree that the precautionary principle is a valid basis for implementing mandatory labeling. The mandatory labeling of GM foods does not adequately minimize risks: if GM foods are unsafe, then labeling them will not effectively reduce the harm. Rather, if GM foods are actually harmful, then the genetic engineering techniques used to make them should be reconsidered. Simply labeling potentially harmful products does not minimize risk.

Aaron Wildavsky provides a valid argument against the precautionary principle. He argues that trial and error is the best way to manage risks in a technologically advanced society such as ours because the precautionary principle considers perceived risk rather than actual risk. Thus, the function of regulation should be to balance technological progress and technological precaution. By enforcing mandatory labeling requirements on GM foods, technological progress is stifled and the potential future benefits to human health and society are lost.

The precautionary principle also lacks a cost-benefit analysis, which is the cornerstone of any risk analysis. The mandatory labeling of GM foods would create significant costs for producers, which in turn leads to higher prices for consumers. These include: separating GM from non-GM foods, accidental contamination of non-GM crops by GM crops, added labeling and storage costs for farmers as well as separating equipment for planting and harvesting to avoid contamination.

The benefits of mandatory labeling would be that consumers have the option of choosing between GM and non-GM foods in order to defer potential risks associated with GM foods. However, as consumers are not well informed about the process of genetic modification, the information would be invaluable and would likely further dilute the abundance of information on food labels.

In contrast, GM crops help improve global food security and the health of farmers by reducing the use of pesticides. The establishment of mandatory labeling requirements would discriminate against this technology and stifle its advancement. In considering the potential benefits of GM foods, governments should avoid mandatory labeling because the advantages outweigh the alleged risks.

Concluding Remarks

The current safety measures enforced by the Canadian government to evaluate GM foods are sufficient. Mandatory labeling should not be imposed as no actual risk has been found to date by the scientific community. Regulations of GM foods should not be swayed by public perceptions as they are based on misconceptions and do not reflect the actual risks associated with GM foods. Deference needs to be given to scientific experts. Rather than misleading consumers with mandatory labeling, governments should strive to correct the misconceptions surrounding GM products by raising awareness of their benefits. “The history of technology shows that many innovations after strong initial rejection are subsequently widely diffused…especially with regard to risk reduction.” As public perceptions shift, establishing consensus at a global level will become more feasible.

Mandatory Labeling of Genetically Modified Foods: The Phantom Risks of “Frankenfood” [Part I of II]

Posted By Maryam Sabour

In 2011, a private members’ bill was introduced that would have amended the Canadian Food and Drugs Act. The amendments included mandatory labeling of genetically modified (GM) foods and would have held the Minister of Health responsible for publishing a list of all foods that have genetically modified components. This bill died with much controversy over these so-called “frankenfoods”.

GM foods first hit the Canadian market in 1994, and today about “70% of all the items in grocery stores that are packaged, bottled or frozen have some GM ingredients.” Non-governmental organizations promote statistics such as “80% of Canadians want labeling of GM foods,” but this phrasing begs the question of whether the average Canadian knows what GM means and understands the associated risks.

Labeling legislation exists to ensure that consumers have the necessary information readily available to assess the risk for themselves; thus, lawmakers must consider whether GM foods present enough risk to mandate a label for this information. I argue that the Canadian government should not implement regulation for mandatory labeling of genetically modified foods. In Part I of this two-part blog series, I analyse the purpose and scope of labeling in Canadian legislation. In Part II, I conduct a risk assessment on a consumer level, emphasizing the effects of consumer skepticism and the public’s perception of risk versus actual risk. I will then analyze the risk on a societal level to illustrate the reasons why the precautionary principle proves an ineffective approach in consideration of the social and economic consequences mandatory labeling of GM foods would entail.

Mandatory vs. Voluntary Food Labeling: Scope and Purpose

Labeling is the primary means of communication between producers and consumers”; it helps consumers make informed decisions when selecting one product over another. For the purposes of my argument, I will divide labeling into two categories: mandatory and voluntary (or social). Mandatory labeling is used to either mitigate the risk incurred from using products or to preclude misrepresentations about products.[1] Conversely, social labeling makes voluntary positive claims about credence goods to promote a socio-economic, cultural or ecological trait associated with a process related to the good.[2] Social labeling includes environmental labels (e.g. rain forest friendly), social labels (e.g. no child labour), green labels (e.g. recyclable), and agriculture labels, under which “non-GM products” currently fall categorized as “no GMO”.[3] A change in regulations to require mandatory labeling for GM foods would presume a material and substantial risk associated with the consumption of GM foods. To date, however, no empirical data exists to substantiate this claim.

A mandatory label to distinguish GM foods from non-GM foods would not improve consumer protection beyond the precautionary protocols already in place. Under Canadian legislation, Health Canada is responsible for developing policies and standards related to the health and safety of labeling under the Act. Genetically modified foods are considered “novel foods” under the Food and Drugs Act Regulations and must follow stringent safety requirements. The safety requirements take an ex ante approach of risk assessment as outlined under Division 28 of Part B of the Food and Drugs Regulations (Novel Foods). Manufacturers and importers of GM food in Canada must submit data to Health Canada for a pre-market safety assessment. Only after rigorous assessment and approval will Health Canada class the food as safe for consumption. Labeling requirements are only necessary for special changes that consumers must know, such as major compositional or nutritional changes. As a result of the safety measures in place to screen products before they enter the market, no risks can be associated with GM food and there is no need to distinguish between GM and non-GM food. Labeling is therefore not required.

Not only are GM labels unnecessary given the safety precautions undertaken by Health Canada, but forcing companies to label foods containing GM components would actually contradict current legislation. Section 5 of the Food and Drugs Act states: “no person shall label….any food in a manner that is false, misleading…or is likely to create an erroneous impression regarding its character, value…merit or safety”. Forcing companies to label foods as “genetically modified” would give an erroneous impression to consumers because it seems to warn rather than inform. The label would give consumers the impression that there is a risk associated with the consumption of the product, even though no such risk has been scientifically proven. Studies conducted so far have not provided evidence of health risks, and Health Canada’s official stance on GM foods is that they are safe for consumption.

In Part II, I will consider whether mandatory labeling regulations would in fact enhance consumer choice. As no empirical data has ever suggested that risks exist with consuming GM foods, creating associations with risk – by labeling, for instance – is misleading. A short contrast of the perceived risks against actual risks will emphasize the potential consequences of mandatory labeling for GM foods. A wider approach is also taken in evaluating the effects of labeling GM foods by considering the broader societal impacts and exploring the notion of the precautionary principle. Finally, a recommendation is made for reducing consumer skepticism and encouraging informed public perception.

[1] Stan Benda, GM food labels: is it the need to know or the right to know – label what and why? (PHD Thesis, Osgoode Hall Law School, 2009) [unpublished].

[2] Ibid at 354.

[3] Ibid at 355.

Genetic Privacy and Bill S-201

Posted By Jey Kumarasamy

An individual’s genetic information can be used for diagnosing medical conditions, measuring the probability of developing or transmitting a genetic disorder, and personalizing treatment. Given the increase in genetic testing, the collection and use of genetic information continues to grow in prevalence.

Aside from the more apparent medical and research purposes, genetic information could also be used to make decisions related to insurance coverage or employment. Insurance underwriting requires the disclosure of relevant information in order for the insurer to properly assess risk.

The rise in genetic testing has prompted privacy concerns. Arguments for the right to a reasonable expectation of genetic privacy include the right not to have others know, and the right “not to know” about oneself. Proponents for allowing the use of genetic information by insurers argue that it is no different from other vital classification tools used for risk assessment, and that it allows for fair market prices.

Legal limitations

Legal responses to these concerns have varied. The US, in 2008, prohibited the use of genetic information for making employment or health insurance underwriting decisions. In Germany, genetic information may only be requested for life insurance policies that exceed a specified amount. Similarly, there is now a voluntary moratorium in the UK, set to expire in 2017, under which genetic information may only be used for life insurance policies over a specified limit (£500,000, or £300,000 for critical illness policies), and only if the genetic test and illness have been approved by an independent government committee.

At present, Canada lacks any similar federal prohibition or moratorium. The Canadian Life and Health Insurance Association (CLHIA) has stated that although an insurer would not require genetic testing, the insurer may request disclosure of genetic information from previously completed tests. This may soon change due to Bill S-201, An Act to prohibit and prevent genetic discrimination, which was introduced in October 2013. The Bill specifically addresses the use and disclosure of genetic information.

Bill S-201

Once in force, the Bill would prohibit anyone from requiring an individual to undergo a genetic test as a prerequisite to providing goods or services, or entering/continuing a contract (in whole or in part). Similarly, it would also prohibit requirements to disclose results from previous genetic tests. Under this Bill, therefore, employees or insurance underwriters would not be permitted to demand genetic information, save for one exception: an insurer may require the disclosure of genetic tests results for policies that exceed $1,000,000 or that pay a benefit of more than $75,000 per annum, if it is expressly permitted in an applicable provincial statute. Note that this still would not allow insurers to require new genetic tests – it would only apply to previous tests. Additionally, these prohibitions would not apply to medical professionals and researchers if it is for the purpose of medical care or research.

If convicted on indictment for contravening one of these prohibitions, one could face a fine of up to $1 million and/or imprisonment for a term not exceeding five years (or $300,000 and/or twelve months for a summary conviction).

The Bill also amends the Canada Labour Code and the Canadian Human Rights Act to expressly include genetic testing and genetic information.

Conclusion

As access to personal genetic information continues to improve, protection for genetic privacy proves to be a growing and pressing concern. While Bill S-201 would address many of the commonly raised issues regarding the use and disclosure of genetic information, it remains to be seen whether these provisions will become law, and if they provide the optimal solution.

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If you are interested in issues related to genetic privacy, be sure to attend our upcoming event, “Patenting Genetic Materials: Biotechnology and Intellectual Property Law