In November 2018, Chinese biophysics researcher He Jiankui shocked the world with the announcement that he had created the world’s first gene-edited infants. A storm of condemnation followed.
“The fact that you can now edit genes more precisely than ever before raises some classical issues that have been coming up since the in vitro birth of Louise Brown, the first ‘test tube baby,’ in 1978,” says Bartha Knoppers, PhD, LLB’78, BCL’81, director of the Centre of Genomics and Policy, based in McGill’s Faculty of Medicine.
In response, she and CGP colleague Erika Kleiderman, BSc’10, outlined these “classical issues” in the January 2019 Canadian Medical Association Journal ; they included the potential for eugenic manipulation, the possibility of future health risks to children unanticipated by the gene-editing, a general concern about regulatory frameworks, and the potential for a chilling effect on less controversial gene-editing research.
“Bad cases make for bad laws, and Dr. He’s is a bad case, so we shouldn’t be rushing to create policies based on his example,” says Knoppers – while noting that the issue also opens opportunities for defining policies governing the use and potential abuse of genetic research in general. The article concludes by calling for discussions “to reorient our models of governance of emerging biotechnologies.”
Indeed, the CGP has been prompting – and leading – important discussions and debates since being established in 2009. In the process it has earned an international profile, emerging in the vanguard of explorations into the legal, social, and ethical implications of the ever-growing body of genomic research and knowledge.
“Initially, our expertise lay in comparative international legal research, such as looking at examples of what genetic privacy or discrimination policies existed in other countries and trying to find models to implement in Quebec and Canada,” says Yann Joly, DCL’09, the CGP’s research director. “But as research has become more interdisciplinary and methodologies more sophisticated, our research approaches in turn have become increasingly multidisciplinary.”
Among the projects carried out by the CGP’s team of over 50 researchers – primarily based at McGill, but also at other universities locally, nationally and internationally – are investigations into policies and technologies concerning data-sharing. For instance, genetic information is assuming an increasingly important role in personalized medicine, where therapies are targeted for an individual’s particular genetic make-up – and as a result, concerns with protecting this information are also on the rise.
“We need to explore how to best integrate genetic information into health care, with attention to such issues as where there are needs for additional privacy and ethical safeguards to protect against genetic discrimination,” says Knoppers.
With this goal in mind, in 2013 Knoppers worked with international colleagues to launch the Global Alliance for Genomics and Health (GA4GH), which creates the tools for secure data sharing to bring the fruits of genomic research into health care systems. Five years later, the GA4GH boasts institutions and researchers from 71 countries, offering them access to genomic data within a regulatory and ethical framework that ensures that individual genetic information remains secure.
Genetic discrimination is a focus of CGP research, led by Joly’s extensive investigations into the phenomenon. “We’ve looked at all the studies undertaken on this issue, especially in the field of insurance,” says Joly. The findings: so far the incidence of discrimination has been quite small, with the only cases concerning rare monogenetic conditions such as Huntington’s Disease – but in such cases, genetic discrimination is well documented. And while the incidence elsewhere may be small, genetic discrimination has gained a high profile in news reports, leading to a debate that is not particularly well-informed.
“We need to get more information about what we are facing, to find the best means to protect groups more at risk,” Joly says.
In December 2017, Canada’s federal government passed the Genetic Non-Discrimination Act, but a year later the Quebec Court of Appeal ruled that it was non-constitutional, infringing on provincial authority. “This important court decision provides a unique opportunity to engage society in a public debate that would be conducive to finding a solution that is more responsive to the problem,” says Joly, who notes that the original federal law did not adequately address many aspects of genetic discrimination.
To further research into genetic discrimination, Joly and his collaborators are building a Genetic Discrimination Observatory, an internet platform for acquiring and sharing data on incidences of such discrimination and initiatives to prevent it. “The observatory will help us learn more about how genetic discrimination manifests itself, opening possibilities for research and policy-making,” says Joly.
The initiative is timely given that a growing number of countries are considering the possibility of implementing compulsory genetic databases to increase the efficiency of surveillance and forensic measures. Recently Joly and two CGP colleagues published in the prestigious journal Science outlining the dangers these databases could pose to human rights and individual privacy.
“You can’t just invent policies: you have to understand the science and any underlying issues,” Knoppers says. While CGP researchers come from across disciplines – the centre includes members with backgrounds in law, science, medicine and philosophy, among others – they all work closely with scientific research teams in such wide-ranging areas as epigenetics, rare diseases, pediatric care, artificial intelligence, bio banking and food safety.
“At McGill we’re often embedded in the original scientific grant proposals for such research, so we’re there from the start, not as an afterthought,” Knoppers says. “And we’re also involved with designing policies concerning governance, intellectual property, access to data, and consent, so we are providing practical tools as well as research.”
Knoppers, who holds McGill’s Canada Research Chair in Law and Medicine, was recently honoured with the 2019 Henry G. Friesen Prize International Prize in Health Research, awarded by the Friends of Canadian Institutes of Health Research. She has 38 books, 465 articles and 100 book chapters to her credit, and Knoppers remains busy – most recently on building a human cell atlas, which would map out the role of different cells and tissues in human health, while also considering the full range of policy-related issues.
“This project is another huge international collaborative endeavour providing open-access tools for scientists founded on the human right of everyone to benefit from science,” she says. “The centre is truly global – that’s our niche.”
