Bioethics and GE3LS Research: Guiding Canadian Bioengineering

What are bioethics and GE3LS, and how do they intersect with biomanufacturing and bioengineering?  

Bioethics is a field that studies the societal implications of biomedicine, with a focus on biotechnology. It looks at the ethical, social, legal, policy and governance aspects of these emerging technologies. GE3LS is the Canadian iteration of the term ELSI: ethical, legal, and social Implications. The history of the term is very interesting. When the Human Genome Project was launched by the National Institutes of Health, there was a recognition that the study of genomics is particularly problematic from an ethical perspective because of the history that we have with eugenics and its abuses in the context of human societies and the suffering it brought. The idea was to set up research fields that would accompany the science and look at the possible societal implications of sequencing the human genome, and a budget was set up for this work right from the beginning.  

“Canada added economic and environmental implications on top of ethics and made the GE3LS program broader in scope, including more disciplines and methodologies than other countries.” 

The ELSI work went along with the science, which was the first time that ethics was given a place side-by-side with, not chasing behind, scientific development. This spread from the US to the rest of the world and many countries have research programs that look at the societal implications of genomics. Canada is unique in its three Es. Canada added economic and environmental implications on top of ethics and made the GE3LS program broader in scope, including more disciplines and methodologies than other countries. Canada also implemented a very unique model, in which in order to get your research funded by Genome Canada, you must include a study of GE3LS that are relevant to your field of study. That put Canada on the international map in terms of our excellence and leadership in GE3LS research. 

“GE3LS research and analysis can identify, analyze, and address issues that might come up when research is applied.” 

What is really important in terms of biomanufacturing and bioengineering is that GE3LS research and analysis can identify, analyze, and address issues that might come up when research is applied for manufacturing, in the health sector, or in any other sector. It can help us with the ethical and social acceptability of new technologies that are being implemented. It can help facilitate implementation and design governance that will ensure that innovation is implemented responsibly, and in some cases, it might even limit certain applications due to GE3LS concerns. It can help us with anything from facilitation to limitation based on the way we have identified and addressed GE3LS issues. 

How potentially disruptive are biomanufacturing and bioengineering for Canada’s future economy? 

Biomanufacturing and bioengineering are both critical to Canada’s future economy. I heard a talk this week from a leading scholar and he said we have lived three big revolutions recently. Early in the 20^th century, we had the revolution in physics with Albert Einstein and the nuclear bomb. Then came the revolution of information technology in the late 20^th century, and now we are living the revolution in biology. Genomics, epigenetics, and gene editing are crossing boundaries that we have not crossed before, giving us better, more efficient, more precise and cheaper tools to do things we could never do before. This opens doors to many applications that we cannot even imagine and it is clearly tied to the future of our economy. 

“Genomics, epigenetics, and gene editing are crossing boundaries that we have not crossed before, giving us better, more efficient, more precise and cheaper tools.” 

Another element is that the world is moving forward and Canada needs to remain competitive in the international scene. If we do not support the research now and the application tomorrow, we will be left behind in this global race to improve agriculture and human health, which also has economic implications. As a bioethicist, I am more interested in the benefits to the public, whether to individual patients, communities, or society. Economic growth is not my mandate or field, but as a researcher, I see the economic implications of doing good for our society everywhere. 

What real-life impacts will biomanufacturing and bioengineering have on Canadian health? 

The implications of emerging genomics and biotechnologies for human health are enormous. We are talking about precision medicine and genomic medicine. We know that the cost of sequencing the human genome came down from billions to $1,000 and is becoming accessible. We are talking about integrating what we have learned about genomics into routine care for every patient, not just for the diagnosis of rare diseases. The implications can be anything from tailoring better drugs for cancer, heart disease, diabetes, and common diseases, to understanding how drugs should be tailored to you as an individual based on your genome. It will help us understand the epigenetic risks that you carry, which was something we did not know about before and did not know how to diagnose, so this is like a second layer of care that we might be able to provide very soon.  

Your family doctor looking at the full sequence of your genome to understand better how to care for you—that is the great hope of precision medicine and genomic medicine. We are not there yet but we are getting there very fast. That is at the level of us as patients. Of course, for children, diagnosis and care of rare diseases, and even diagnosis without care, has proved to be helpful. We hope to be able to come up with new treatments through gene therapy and somatic gene editing to help address rare diseases, some of them very severe, that do not have any other treatment at this time. If we look at the prenatal context, that is where very exciting things are already happening. The identification of cell-free fetal DNA has revolutionized prenatal testing, allowing families to know much more about their fetus much earlier in the pregnancy without risks to the pregnancy that procedures like amniocentesis entail. 

“The identification of cell-free fetal DNA has revolutionized prenatal testing, allowing families to know much more about their fetus much earlier in the pregnancy.” 

Almost at every stage of pre-life and life, we see possible applications for human health and a revolution in the way we care for pregnancies and patients. On top of that, we can address public health issues through genomics technologies such as gene drives, to eradicate mosquito populations to prevent malaria. We can think about the individual patient and the impact on care on that level but we can also think about bioengineering at an environmental population level to address disease at the public health level. 

What are the bioethical implications of genomics research in Canada and how can we best manage them?  

I will start with research and go to implementation. At the research level, some of these studies subject participants to unknown risks, because we are doing something for the first time ever and trying to introduce a new type of intervention. For example, somatic gene editing has never been done before with these tools, and so we have issues around informed consent for research participation. Without participants, we cannot move ahead with understanding the technology and get to the point of implementation and benefit, but how do we inform research participants about risks when we are not sure what they are? That is one possible impact.  

Once we have technologies that we can move to clinical or public health use, we face issues such as safety. This falls in the realm of post-implementation studies and how we assess long-term and on a population level the safety of what we are offering. We face issues of privacy. Genomic information is often seen as different from other medical and personal information. People have great concerns about violations of their privacy when it comes to hacking into their DNA. We face fears of genetic discrimination that many countries have addressed by legislation to prevent such discrimination. We have not found much evidence of such discrimination in Canada, but we still need to be vigilant about this possibility. Overall, we face the possible implications of these profound changes to the way we deliver medical care. We do not know what it is going to look like when you have a chip containing your entire DNA that you could present every time you go to the emergency room or doctor. What does that mean in terms of the quality of your care, privacy, and this information ending up in the wrong hands? We have concerns about genetic information in biobanks being shared by commercial entities and across national borders.  

“We need regulations that are proportionate and would not create excessive burden on researchers or clinical use, but protect us as citizens.” 

These are all relatively novel issues that emerged with these discoveries and the best way to address them is with GE3LS research to identify, analyze, and address through good governance.  

We need regulations that are proportionate and would not create excessive burden on researchers or clinical use, but protect us as citizens at the same time. Where that sweet spot is and what this proportionate limitation is are some of the key questions we face as researchers so that we can recommend to policymakers the right type of governance to allow us to deliver all these benefits while remaining responsible and cautious. 

Who and what would you pitch about improving Canada’s leadership in biomanufacturing and bioengineering?  

I would pitch a federal minister in health or industry, and use my 30 seconds to talk about the importance of research, from basic research all the way to GE3LS. We are focusing so much on the end of the pipeline: “Give us research projects that can deliver in three to five years, show us the economic impact of your research, and show us the social benefits.” It does not always work like that. I would use my time to pitch the importance of basic, fundamental research that often delivers surprises and the most powerful tools economically without us knowing. I would pitch the importance of funding GE3LS research because the best research outcomes, in terms of science, will not serve us Canadian citizens without the right ethical principles and the right governance. Basic research and GE3LS research are where we have to keep funding flowing in order to deliver on the promise of genomics.