On today’s show, we go one-on-one with Borden Ladner Gervais’ (BLG) Jeff Graham to discuss his article in our latest issue of Biotechnology Focus Magazine, Genetic Discrimination: Creating a New Canadian Law, plus we look at the week that was and the top stories on the Canadian biotech scene.
Hello this is Shawn Lawrence, senior writer for Biotechnology Focus, and your host for Biotechnology Focus Podcast.
We start today’s show with our weekly rundown of the top stories in Canadian biotech this week, and our first story takes us to Vancouver, BC, with AbCellera Biologics Inc., a biotechnology company specializing in the rapid discovery of monoclonal antibodies from natural immune cells, successfully completing its antibody discovery partnership with Kodiak Sciences. Through this collaboration, AbCellera applied its antibody discovery platform to perform ultra-deep screening of immunized animals and identified hundreds of antibodies against an undisclosed target. Multiplexed single cell binding assays were used to enrich for antibodies with high affinity and desired properties, resulting in the generation of multiple lead antibody families with picomolar affinity and potent blocking activity. Dr. Victor Perlroth, chairman and CEO of Kodiak Sciences said that AbCellera has outperformed Kodiaks expectations while adding that AbCellera’s technology platform leverages the many benefits of in vivo selection and maturation while avoiding the inefficiency of traditional hybridoma approaches. In all, AbCellera screened over one million antibody-producing single cells with its platform and delivered relevant antibody sequences covering a diverse functional and sequence space. Under the terms of the agreement, Kodiak has now executed its option to advance selected candidates for clinical development with AbCellera eligible to receive downstream payments. Other financial terms were not disclosed.
Retaining and growing talent is a challenge for many Canadian biotech and life science companies, and there is a real need for new programs that are able help train and develop Canadian talent and help them become qualified workers with industry experience. In response to this need, Toronto-based Clinical immuno-oncology company Trillium Therapeutics says it is launching an industry postdoctoral fellowship program that will help young research scientists make the transition from their academic training to rewarding careers in the biopharma industry. In a press release Dr. Niclas Stiernholm, president and CEO of Trillium Therapeutics stated that as part of Trillium’s commitment to help grow the Canadian biotechnology industry, Trillium wants to provide an environment in which bright scientific minds will be challenged and nurtured. “We believe this will help drive the development of tomorrow’s innovative cancer therapies,” he said. “We take great pride in establishing an official industry-sponsored postdoctoral fellowship program here in Canada, enabling outstanding Ph.D. graduates to prepare for a career in the biopharmaceutical industry,” he added. Under the program, Trillium will annually accept up to four postdoctoral fellows for an initial one-year term, with the possibility of an extension for an additional one or two years based on project needs. Through the program,pPostdoctoral fellows will be paired with mentors in a state-of-the-art laboratory environment, conducting independent research that is commercial and translational in nature. The postdoctoral projects will be focused on cutting-edge research in immunology or oncology research, with the goal of elucidating disease biology or the mechanism of action of a novel drug candidate or target. Individuals will work independently but as part of cross-functional teams made up of scientists and research associates. Additional information on the program can be found at: http://trilliumtherapeutics.com/Contact/Careers/IndustryPostdoc
Borden Ladner Gervais (Canada’s largest law firm) released their annual Life Signs report earlier this year, which looks at legal trends in the Canadian Life Sciences sector. The report includes contributed articles from multi-disciplinary BLG professionals and as well from Canada’s national and regional life sciences associations. Jeff Graham, BLG’s National Life Sciences Group Leader, is here with us today to discuss genetic discrimination and Canadian law, just one of areas explored in this report. Welcome to show Jeff!
Question: Let’s delve right in with the questions Jeff, what is genetic testing?
Answer: Genetic testing, which involves the analysis of a person’s chromosomes, genes, or gene products (proteins) to identify the presence of specific traits, can have many benefits. It allows people to learn about their parentage and ancestral origins, and is helping scientists to map pre-historical routes of human migration. It can be used to diagnose genetic conditions (diagnostic testing) or to identify a predisposition to a genetic disease (predictive testing). This information can help people initiate appropriate treatment early and adopt lifestyles that will minimize the possible harm of a genetic condition. It can also guide the selection of pharmacologic therapies and identify patients who are candidates for gene therapy, an approach that uses various techniques to replace, correct, suppress, or eliminate a mutated gene.
Question: From a public policy perspective why is genetic testing important?
Answer: The possibility of improving outcomes and cost-effectiveness by tailoring therapy to a patient’s genetic profile has prompted consider able commercial activity and government funding in the emerging field of “personalized medicine.” Although, at present, relatively few tests for genetic conditions are widely recognized as reliable, and while a positive test result does not necessarily predict the onset or severity of an illness, it is recognized that genetic testing will continue to open up new areas of medical knowledge and new options for treatment. New tests are being developed at a rapid pace and these will increasingly become available.
Question: What risks are created for Canadians as a result of this powerful technology?
Answer: Genetic information can, however, also be used for purposes other than for which it was intended, including potentially discriminating against individuals. For example, a genetic test could reveal a person who is otherwise in good health has a higher risk of one day requiring advanced health care or being unable to work because of an inherited condition. This information could affect how decisions are made in such matters as insurance and employment, among other things. If an applicant for insurance has a higher risk for a certain disease, then that applicant presents a higher risk to the insurer of having to make payments for health coverage or life insurance. This may affect the terms of any policy offered to the applicant. Similarly, an employer may be less willing to hire a job applicant who is genetically at high risk of developing an illness or genetic condition for fear the applicant will not be as productive as someone with a more favourable genetic profile.
Question: Are the risks you have described real?
Answer: Although the long-term ethical and legal consequences of genetic testing for employment matters, insurance contracts, and preventive medicine and treatment are not yet fully known, cases of alleged genetic discrimination have been emerging in different parts of the world, prompting calls from concerned citizens for government action here in Canada.
For example, the U.S. Council for Responsible Genetics has noted that in one reported case, genetic testing indicated that a young boy had Fragile X Syndrome, an inherited form of intellectual disability. The insurance company for the boy’s family subsequently dropped his health coverage, claiming the syndrome was a pre-existing condition. In another case, a social worker lost her job within a week of mentioning that her mother had died of Huntington’s disease and that she had a 50 per cent chance of developing it.
Question: So what is being proposed as new law in Canada?
Answer: In the lead up to the last Canadian Federal election, the previous Government of Canada introduced the “Protection Against Genetic Discrimination Act”. However, the Bill died when the House of Commons was dissolved in June 2015. After a new Canadian government took office last fall, a Senate Bill was introduced and passed entitled “An Act to prohibit and prevent genetic discrimination” (the “Senate Bill”). It was then introduced in the Canadian House of Commons where it is currently being deliberated. Whether the Senate Bill ultimately receives Royal Assent in its current form or in a modified form, it seems quite reasonable to expect federal legislation protecting against genetic discrimination will be enacted in Canada.
The Senate Bill proposes criminal sanctions for actions such as when one person requires another to undergo a genetic test or disclose the results of one as a condition of (a) providing goods or services to that individual; (b) entering into or continuing a contract or agreement with that individual; or (c) offering or continuing specific terms or conditions in a contract or agreement with that individual.
The rationale for the use of the criminal law power is to attempt to bolster this federal effort to extend the protection beyond the ambit of traditional federal authority as reflected in the above noted statutes.
In addition, the Bill proposes amendments to several statutes of the Government of Canada – the Canadian Human Rights Act, the Privacy Act, the Personal Information Protection and Electronic Documents Act and the Canadian Labour Code.
The proposed amendment to the Canadian Human Rights Act would deem discrimination on the basis of a predisposition to a disability, as inferred from genetic test results, to be discrimination on the ground of disability. This Act applies to the federal government and First Nations governments, as well as to federally regulated businesses and industries, such as banks and telecommunications companies, in matters of employment and the provision of goods, services, facilities and accommodation.
The proposed amendment to the Privacy Act and the Personal Information Protection and Electronic Documents Act would specify information resulting from genetic testing is among the types of personal information protected by these Acts. The Privacy Act protects personal information collected, used and disclosed by federal government institutions listed in the Act, as well as any parent Crown corporation and any wholly owned subsidiary within the meaning of the Financial Administration Act. The Personal Information Protection and Electronic Documents Act protects personal information that is collected, used and disclosed by private sector organizations in the course of commercial activities. It also protects information on employees who work for a federally regulated business. Under these statutes, the consent of the person is generally required before the person’s personal information can be shared with third parties.
The proposed amendments to the Canada Labour Code would protect employees from being required to undergo or disclose the results of genetic tests and provide employees with other protections related to genetic testing and test results.
Question: What is the status of the legislative proposals?
Answer: The Bill is scheduled to begin Second Reading later this month. Once second reading is completed it is expected that the Bill will be referred to House of Commons Health Committee for consideration. Depending on the ultimate position of the Government, it could become law by the end of 2016 or early 2017.
Question: Are there any opposing views?
Answer: While the health and life science sectors have been supportive of the legislative proposals outlined above the insurance sector has not.
The current position of the Canadian insurance industry is that while companies will not require genetic testing of applicants for insurance, they will ask whether the applicant has been genetically tested in the past, and they will require disclosure of those test results where they exist. This position is generally justified on the basis there exists a good faith obligation under most provincial laws for an insurance applicant to disclose to the insurance company all information that might have a bearing on the company’s assessment of risk. The insurance industry has expressed concern insured persons who learn, after taking a genetic test, they are at high risk for a genetic disease could knowingly take out policies for large amounts of additional coverage without insurers being aware of any increased risk. Disclosing the results of genetic testing would therefore help ensure both parties negotiating an insurance contract would have the same knowledge about the health risks of the applicant.
Question: Anything further to add?
Answer: No thank you for allowing me to provide some insights into this important development.
With that we’ve come to the end of this week’s program. We hope you enjoyed it. A big thanks to our production manager Laskey Hart for putting the show together and to the rest of the Biotechnology Focus team. You can find past episodes online at www.biotechnologyfocus.ca and we’re always looking for your feedback, story ideas and suggestions so we’d love to hear from you. Simply reach out to us on twitter: @BiotechFocus or by email firstname.lastname@example.org.
For all of us here at Biotechnology Focus, thank you for listening.