Should Canada mandate the vaccination of schoolchildren?

Posted By Jessica Walsh – Jan. 28, 2014

Vaccines have been saving lives since the late 18th century. Thanks to vaccines, smallpox has been eradicated and diseases like polio and measles may soon be eliminated.  

Vaccines stimulate the production of antibodies to provide immunity against diseases through the injection of weakened or killed infectious organisms. They also create herd immunity: when enough people in a community are immune to a disease due to vaccination or prior illness, the disease cannot easily spread. With herd immunity, even unvaccinated individuals may be protected given the lower possibility of disease transmission.

Vaccination in Canada

Despite these benefits, Canada, as a country, does not have a general vaccination policy. The federal government seems reluctant to enter into the debate, preferring to leave vaccination as a matter of provincial health jurisdiction. The Canadian Public Health Agency highly recommends that parents vaccinate their children against preventable diseases. However, only three Canadian provinces mandate children to be vaccinated before entering the school system.

Ontario and New Brunswick require vaccination against diphtheria, tetanus, polio, measles, mumps, and rubella, while Manitoba demands vaccination against measles. In each of these provinces, legislation allows parents to receive exemptions from vaccination on medical, religious or ethical grounds.  In the case of a disease outbreak, an unvaccinated child may be quarantined or asked to stay home.

If an exemption is not granted, parents may face fines as a consequence for not vaccinating their children. For example, in Ontario, parents can be penalized with a fine of up to $1000 for failure to vaccinate. Children may also be suspended from school in Ontario for up to 20 days for failing to produce their immunization record. In 2013, about 900 high school students in Ottawa were suspended for not providing proof of immunization or special exemption.

The Global Perspective

Vaccination policies vary internationally. All American states require children to be vaccinated before entering school. There are exemptions available on religious, medical and ethical grounds, which vary depending on the state. Some countries, like Australia, provide financial compensation to parents for vaccinating their children. Slovenia has an extremely stringent vaccination policy with exemptions only available for medical reasons.

The Debate Over Compulsory Vaccination

The debate over compulsory vaccination hinges on the competing interests of public safety versus personal liberty. Some vaccine opponents simply view the mandatory injection of a foreign substance into their bodies as an unacceptable infringement on their personal liberty by the state. Other opponents regrettably cling to a discredited 1998 study that mistakenly linked the Measles, Mumps and Rubella vaccine to autism in children to promulgate the view that vaccines are unsafe.

Yet vaccine supporters, such as the Canadian Public Health Association, argue that vaccines are among the safest tools of modern medicine and that side effects are rare. The World Health Organization has even produced a myth-busting webpage to counter misinformed opinions on vaccination.

Still, there is a difference between deciding to vaccinate oneself or one’s children and deciding to mandate vaccination for all children of a province. According to the Canadian Medical Association Journal’s Erin Walkinshaw, there is little interest in Canada to implement a strict mandatory vaccination policy. If more legislated policies like Ontario’s were adopted, it seems critical that there be wide room for exemptions to still provide parents with a degree of choice. As well, some Canadian health officials do not believe there is much to be gained by introducing more mandatory vaccination schemes since most children in Canada already get immunized.

However, compulsory vaccination schemes for schoolchildren should not be ruled out for other provinces. At a time when countries like the UK have seen decreasing vaccination rates and the return of diseases like measles, government legislation of vaccinations could be an important step by provinces to manage public health risks. At the very least, the provinces must continue to educate the Canadian public about the safety and importance of vaccines to counter growing misinformation.

Are Human Genes Patentable?

Posted By Jey Kumarasamy – Jan. 15, 2014

The recent US Supreme Court decision in Association for Molecular Pathology v. Myriad Geneticsdealt with one primary issue: are human genes patentable? The court ruled that isolated genes cannot be patented. However, synthetic DNA that cannot be found in nature (cDNA) is patentable.

HISTORY

In 1991, scientists at UC Berkeley found that a gene mutation along human chromosome 17 increases the risk of breast and ovarian cancer. As gene sequencing was still a demanding and time consuming process, identifying the specific gene was seen as a challenge and a global search began. A team led by Mark Skolnick, a scientist at the University of Utah, identified the BRCA1 gene and won the race. His collaborators included, Patricia Tonin from McGill University, Johanna Rommens from the Hospital for Sick Children in Toronto, and Jacques Simard from Université Laval.

The Utah team had already founded Myriad Genetics and filed for a BRCA1 US patent. Myriad Genetics invited their fellow collaborators to join the patent claim, but some researchers, such as Patricia Tonin, declined the offer. In 1995, Myriad Genetics identified the BRCA2 gene and filed another US patent. BRCA1 and BRCA2 US patents were granted to Myriad Genetics in 1997 and 1998, respectively.

Myriad Genetics’ developed BRACAnalysis, a patented diagnostic test, and insisted that only their test could be used when screening for BRCA gene mutations. They aggressively enforced their BRCA-related patents to ensure exclusivity. This ultimately led to a law suit against Myriad Genetics, filed by AMP (Association for Molecular Pathology), along with researchers at several universities, and individual patients.

US SUPREME COURT RULING

The Supreme Court held:

“a naturally occurring DNA sequence is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring”[1]

Advances in technology have made DNA mapping and isolation considerably faster than in 1994, when Myriad Genetics filed for a US BRCA1 patent. For instance, the Human Genome Project took 10 years to complete. It began in 1990 and was the first attempt ever to sequence the entire human genome. Today, a similar project would take a few days. Further developments in technologies such as, nanapore sequencing, may soon make it just a matter of hours. Therefore, gene isolation is no longer as challenging as it was when the BRCA genes were first identified.

Furthermore, Professor Eric Lander’s amicus curiae brief may have influenced the Court to invalidate Myriad Genetics’ patent claims on isolated genes. Lander, a Professor of Biology at MIT, provided scientific evidence that isolated DNA fragments of the human genome do occur in nature. DNA fragments may be found, for example, in dying cells, and in fetal DNA circulating in maternal blood. These fragments may contain segments from the entire human genome, but more specifically, Lander states:

“inspection of the publicly available DNA sequence data from two of these studies confirms that (as expected) the isolated fragments of fetal DNA in maternal blood cover the BRCA1 and BRCA2 genes and therefore include many of the isolated DNA fragments covered by Myriad’s patents.”

This may have diminished the significance of isolating a gene in the eyes of the Court.

IMPACT ON BIOTECHNOLOGY

A study published in March estimates that 41% of the genes in the human genome are patented in the US. However, many of these patents involve cDNA, and therefore may be unaffected by the Court’s ruling. Another study suggests that recent gene patent claims tend to avoid being similar to the ones struck down in AMP v. Myriad Genetics. Perhaps the patentability of cDNA may be sufficient to ensure profitability in the biotechnology industry.

Meanwhile, Myriad Genetics has already filed five patent infringement lawsuits against companiesthat have begun offering genetic diagnostic tests for BRCA gene mutations, based on their patents covering cDNA and methods-of-use related to the BRCA genes. Since the Court held that cDNA is patentable, and was not asked to rule on the validity of the method patents related to the BRCA genes, Myriad Genetics claims that these patents are still valid and that they maintain exclusivity over screening tests for BRCA mutations. Some of the companies being sued have proceeded to countersue Myriad Genetics and to seek a declaratory judgment.

(Part II of the series will discuss gene patentability in Canada)

 

[1] AMP v. Myriad Genetics, 569 U.S. 12-398 (2013) at p.4