The Genetic Discrimination Crisis

Posted By Jennyfer Pelletier

What is genetic discrimination?

Canadians are at risk of facing genetic discrimination. This type of discrimination occurs when an individual is treated unfairly due to differences in their genetic information. Genetic sequencing tests can be used to identify genetic mutations in an individual’s DNA that are associated with diseases including “prostate cancer, certain breast and ovarian cancers, kidney diseases, Huntington’s ALS and cystic fibrosis“. The genetic information obtained from these tests is beneficial as it can open up the possibility for treatment and even prevent the emergence of diseases in the first place. It is important to note that a mutation does not mean someone will necessarily develop a certain disease; it often only indicates a higher risk of developing that disease.

Genetic discrimination tends to arise in insurance and employment contexts where a person may unjustly be refused employment or insurance based on the faulty assumption that they will actually develop the disease. Genetic sequencing tests are becoming increasingly accessible and are often recommended by doctors when family members have been diagnosed with a disease linked to genetic mutations. However, Many Canadians opt not to have genetic tests “for fear that the results will impact their insurability or their present or future employability“. Consequently, they do not have the information necessary to take any available preventative steps. Some conditions, such as Hemochromatosis, can be easily treated. Unfortunately, 80 percent of those affected are unaware and many who are tested and diagnosed are denied insurance.

Fears of genetic discrimination are not unfounded. Indeed, instances of genetic discrimination have been documented in Canada and are continuing to grow. Teresa Quick’s story is just one example. At 27 years old, Teresa opted for genetic testing for the BRCA 1 gene mutation because both her mother and grandmother died from cancer. A mutation in this gene would indicate a higher chance of developing breast or ovarian cancer. Teresa tested positive for the mutation and opted for a preventive double mastectomy to greatly reduce her chances of developing the disease (Angelina Jolie also famously underwent this procedure after testing positive for the BRCA 1 gene, and reduced her chances of developing breast cancer from 87 to under 5 percent). When Teresa applied for critical illness insurance to cover her mortgage in case she fell ill, the insurance provider denied coverage due to her family history with cancer. A genetic counsellor commenting on Teresa’s situation explained that it is not uncommon for applicants with a history of certain cancers linked to mutations, like the BRCA gene, to be denied insurance.

In the employment context, genetic discrimination may interfere with someone’s employment or promotion prospects, or result in the termination of their job. For example, a 24-year old man was fired from his job after his boss found out he had tested positive for the Huntington’s gene even though the disease usually manifests itself during middle age or even later.

Genetic discrimination is also causing controversy in other circumstances. For example, in 2012, a boy in California had to leave school, a few weeks into sixth grade, because of his DNA test results. Colman had genetic markers for cystic fibrosis. Children with this disease cannot be in proximity of each other, as they are more vulnerable to infections. Since two siblings with cystic fibrosis already attended the school, Colman was forced to leave even though he did not actually suffer from the disease. His parents filed a claim against the school district alleging genetic discrimination.

In Canada, there have also been examples of genetic discrimination with regards to adoption and child custody.

Is your genetic information protected?

In 2008, the United States adopted the Genetic Information Non-discrimination Act (GINA), a federal law meant to prevent genetic discrimination by health insurers and employers. However, the Act does not include life insurance, disability insurance, or long-term care insurance. Furthermore, the law does not protect people from genetic discrimination where an employer has fewer than 15 employees. GINA also does not alter the provision of the Americans with Disabilities Act, “under which an employer, after a conditional offer of employment, lawfully requires an individual to sign an authorization to disclose all of his or her health records“. Since there is no practical way to separate genetic and non-genetic information in health records, it is likely that many employers will receive genetic information. Due to its shortcomings, it is unclear whether GINA will assuage fears of discrimination.

In Canada, on the other hand, there are no existing legislative provisions specifically prohibiting genetic discrimination. Hence, any third party who obtains access to someone’s genetic test results may use it against them. When the Global Genome Project began, Canada took a “wait and see” approach to the potential need to safeguard genetic information. Twenty-five years later, Canada is the only G7 nation that has yet to protect genetic information. However, Bill S-201, An Act to prohibit and prevent genetic discrimination, has recently reached a second reading in the Senate.

This bill intends to create a new Genetic Non-Discrimination Act that would “prohibit anyone from requiring someone to take a genetic test or to disclose the results of a genetic test”. Furthermore, it would prohibit the use of genetic test results as a condition to provide services or enter into a contract with someone. Although there were concerns that the legislation would be unconstitutional by infringing on provincial powers, Legislature relies on the federal criminal power and aims to prohibit misconduct. Insurers have argued that Bill S-201 would make their business model unviable. However, research commissioned by the Office of the Privacy Commissioner of Canada concluded that prohibiting the use of genetic information “would not lead to a significant economic impact on the industry“. The Bill would also amend the Canada Labour Code, the Canadian Human Rights Act, the Privacy Act and the Personal Information Protection and Electronic Documents Act. A contravention of this Act would constitute a criminal offence with severe penalties, including a $1-million dollar fine and up to five years of imprisonment. Overall, this Bill seems to implement broader protection that fills many of the gaps in the United State’s legislation.

Conclusion

Genetic discrimination is a real obstacle to increasing the well-being of Canadians. According to Dr. Ronald Cohn, a senior scientist at the Hospital for Sick Children, “33 per cent of families refused to participate in a study that could have life changing diagnostic implications for their seriously ill children, citing genetic discrimination“. Hence, it is important for Canada to enact legislation that will properly protect its population from genetic discrimination in all contexts so that it may benefit from advancements in genetic testing and medicine.

Administering care without consent in F.D. c. Centre universitaire de santé McGill (Hôpital Royal-Victoria)

Posted By Jennyfer Pelletier

On January 4th 2015, the appellant was hospitalized due to convulsions caused by alcohol withdrawal. The appellant, 49, is a married father who has been struggling with an alcohol consumption problem for many years. During his hospitalization, the Court of Quebec authorized a motion for confinement in an institution to last until May 21st 2015.

At the end of January, the appellant’s situation improved and, while he remained in the hospital, he left the emergency unit. On February 10th 2015, Dr. Tourian, the appellant’s psychiatrist, stated in a report that the patient required housing in a care unit that would be equipped to manage his condition and potential deterioration. The appellant, however, manifested a desire to go home. Dr. Tourian believed the appellant was inapt and incapable of providing consent. Consequently, a month later, he instituted a motion at the Superior Court seeking an authorization for care that would authorize the hospital and the appellant’s psychiatrists, or any delegated physician or nurse, to administer medications and place the appellant in a care unit.

Superior Court

On March 18th 2015, the Honourable William Fraiberg found that the appellant was incapable of providing his consent pursuant to article 16 of the Civil Code of Quebec (CCQ). He allowed the respondents, the appellant’s psychiatrists as well as other doctors and nurses, to put in place a treatment program that would last 36 months.

Court of Appeal

The appellant appealed on three grounds: 1) the trial judge erred in refusing to postpone the hearing, 2) the trial judge appeared partial and 3) the trial judge erred in granting the authorization as the requirements set out in articles 16 and 12 of the CCQ were not satisfied. On July 6th 2015, the appellant was successful on all three grounds and the Court of Appeal ordered a new trial.

This summary will focus on the third ground of appeal as it relates to substantive health law. This ground of appeal illustrated the court’s interpretive framework when dealing with a request for authorization of care without consent. The Court of Appeal held that a motion for authorization to administer care is examined while keeping in mind the following:

  • Every person is inviolable and is entitled to the integrity of his person (article 10 CCQ)
  • No person may be made to undergo care except with his consent (article 11 CCQ)
  • No one can force a person capable of giving consent to receive care, even if that care is in their best interest and its refusal may lead to their death
  • Where a person is capable of providing consent, no one can intervene in their choice of treatment
  • The use of article 16 requires a judge to determine whether he or she is in the presence of a person who is incapable of giving consent and is refusing treatment

The Court of Appeal then elaborated on a two-step test to determine if the requirements of articles 16 and 12 of the CCQ are satisfied. The first step requires determining whether the patient is competent pursuant to article 16 of the CCQ. There is no presumption of inaptitude to consent simply because someone is subject to psychological or psychiatric treatments. To conclude that a patient is incompetent, a judge must find that the patient is (1) inapt to consent and (2) is categorically refusing treatment.

(1) To determine whether a person is inapt to consent, the following questions should be asked:

  • Does the person understand the nature of their condition?
  • Do they understand the goal of treatment?
  • Do they understand the risks of treatment, as well as the risks of not following the treatment?
  • Is their capacity to understand affected by their condition?

(2) To determine that someone is categorically refusing treatment:

    • There must be proof that the person is refusing the treatment for which the authorization is sought
    • If a treatment has not been offered yet, there cannot be a categorical refusal

If one of these two conditions is not met, the judge must reject the request.

If both conditions in the first step are met, the judge proceeds to the second step. Pursuant to article 12 of the CCQ, the judge must ask the following questions:

  • Is the treatment required, and if so, is it sufficiently described?
  • Do the benefits outweigh the negative consequences?
  • How long should the authorization be granted for?

Whether treatment is required must be determined in the sole interest of the patient while taking into account, as far as possible, any wishes they may have expressed.

In the present case, the Court of Appeal held that, even if the trial judge concluded that the appellant was inapt, he could not find that the appellant is categorically refusing treatment as it was revealed, through Dr. Tourian’s testimony, that the appellant has been taking the prescribed medication. Dr. Tourian testified that anti-psychotics were not required for the moment, but could be in the future. However, the court referred to recent jurisprudence stating that it is not in the tribunal’s power to act in a preventive manner. Hence, the analysis attempts to protect patients’ autonomy by providing a rigid framework and clearly defined parameters.

TPP vs. Healthcare in Canada

Posted By Jennyfer Pelletier

The Trans-Pacific Partnership (TPP) is a free trade initiative agreed upon by 12 countries including Canada, the U.S. and Australia, for which negotiations concluded on October 5th 2015. The preamble states that the Agreement seeks to “liberalise trade and investment, bring economic growth and social benefits”, raise living standards and “reduce poverty and promote sustainable growth”, among others.

Participating countries began negotiations in 2008 with the intention of concluding the agreement in 2012. However, many contentious issues, including intellectual property concerns, prolonged negotiations. Pharmaceutical companies in the U.S. strongly lobbied in favour of the TPP. The Huffington Post reported that the Pharmaceutical Research and Manufactures of America (PhRMA) “spent over $110 million lobbying the U.S. Congress to support the TPP” as they knew the Agreement would increase their profits.

How might the TPP impact healthcare in Canada?

Many health professionals and organizations, such as Doctors Without Borders, have expressed concern regarding the TPP agreement. The released text of the TPP contains provisions that would “force governments to extend existing patent monopolies beyond current 20-years terms”. Furthermore, Doctors Without Borders claims that the agreement will “redefine what type of medicine” is patentable and will even grant patents for “modifications of existing medicines”. Hence, the TPP will increase the protection of brand name drugs. The agreement also limits generic competition by prohibiting regulatory authorities from using data related to the safety and efficacy of a drug in order to authorize a competing drug to enter the market, even if there is no patent on the first drug. If a participating country breaches a provision of the TPP, an international tribunal could theoretically require that country to pay the pharmaceutical corporations compensation for any lost profits caused by the breach. In a market that generates billions of dollars of profits, the stakes are high.

Some critics also argue that the increased protection of patents for brand name drugs and, consequently, the lack of generic competition, will allow pharmaceutical companies to make more profits and cause drug prices to rise. The Council of Canadians has said that the extension of patents under the TPP will delay “the release of more affordable generic drugs and [add] $2 billion to [their] annual public health care bill”. Already, 23% of Canadians are unable to take their drugs as prescribed, and an increase in cost would aggravate this problem. A decrease in drug compliance has adverse effects on health and increases the rates of hospitalization. In Australia, some critics even went so far as to say that the cost benefits derived from the TPP might be negated by the “costs associated with these poor health outcomes”. Overall, the provisions on intellectual property in the TPP may negatively impact the Canadian healthcare system, as well as healthcare systems around the world, by increasing the costs of drugs and thus, the costs associated with poor health such as increased hospitalization and increased absences from work.

Are there any possible solutions?

Canada possesses a regulatory system that serves to keep drug prices under control. The Patented Medicine Prices Review Board (PMPRB) is an agency that “sets a price based on what the same drug costs in other countries”. The maximum price in Canada is the median of prices in other countries including the U.K and the U.S. This system is meant to ensure that Canada will not be paying the highest cost for a drug. However, this power may be jeopardized if Alexion Pharmaceuticals succeed in an ongoing Constitutional challenge, in which they have argued that the Federal Government has no authority to force the company to lower the price of its drug.

This system has also been criticized as being ineffective in certain situations. For one, certain drugs are not available in all the comparative countries. If a drug is only offered in the U.S., which effectively has no price control system, then it can be sold for a high cost and the PMPRB cannot change it. Similarly, the PMPRB cannot lower prices of a drug that is expensive worldwide. Hence, if the TPP causes the global inflation of pharmaceutical prices, this system will remain powerless to help Canadians.

Can we draw any possible solutions from the TPP itself? The preamble of the text specifically addresses health concerns, stating that countries may protect “public health” and have an “inherent right to adopt, maintain or modify health care systems”. The intellectual property chapter provides that the commitment to the Declaration on TRIPS and public health will be maintained. While this chapter also specifies that countries may adopt “measures necessary to protect public health”, it requires that these measures be consistent with the provisions in the chapter. Article 18.6(a) mentions promoting access to medicines for all. However, the article then suggests that the protection of public health is required in the case of national emergencies and “public health crises”, such as HIV/AIDS. It is unclear from these provisions exactly what will be deemed an emergency or a public health crisis, and thus, it is uncertain what countries will be able to do with the rising costs of medication. Countries may be deterred from regulating in a manner that would lower costs, unless there is a clear epidemic, due to the potential of having to pay large compensation damages for breach of the TPP.

The impact of the TPP on healthcare remains to be seen. However, many critics have argued that its provisions on intellectual property threaten to inflate the costs of medication. Neither the PMPRB nor the text of the TPP appear to provide a clear solution should this problem arise. Hopefully, participating countries will remember and uphold their commitments to access to medicines, which can be found in previous trade agreements (Doha Declaration, TRIPS Agreement).