Faculty of Law postdoctoral fellow explores access to life-changing treatments

When it comes to improving Canadians’ access to autologous cell-based therapies — using the patient's own cells or tissues to help with a range of medical concerns from muscle regeneration to Type I Diabetes — Nevicia Case’s research is taking a global approach.

This postdoctoral fellow with the University of Alberta Faculty of Law is examining the ethical, legal and societal implications of regenerative medicine and the barriers impacting patient access to these life-changing treatments. 

“Nevicia’s work has been central to broadening the discourse around emerging biotechnologies to include the perspectives of diverse communities and to draw attention to issues of justice, equity, and affordable access to cutting-edge technologies,” says Professor Ubaka Ogbogu. “Nevicia has made the cross-over from clinical science research to policy research in an exemplary manner that truly reflects the multidisciplinary nature of the work we do.”

To understand how our current system can adjust to better facilitate affordable and equitable access to these therapies, as part of her research working under the supervision of Ogbogu, Case has been conducting interviews and surveys with different populations across the country, including patients, clinicians and medical researchers. 

“The challenge with autologous cell-based therapies is that they're often being force-fit into the same regulatory pathway as drugs,” says Case. “There's been this tension created between wanting to have the therapies available for clinical use and making sure there are rigorous clinical trials done first.” 

In the medical world, a number of standards must be met before regulators can accept a drug. However, in the case of cell and gene therapies, these regulatory barriers can have far-reaching impacts, especially when it comes to the efficacy of the therapies and patient access and affordability. 

“Much of the body of knowledge and research activities that we’re aware of in this field are emerging from the Global North,” says Case. “Most of the therapies being developed in these regions are prohibitively costly, with some costing hundreds of thousands of dollars.”

While many drug manufacturers in the Global North (the world's developed countries) are producing treatments that are out of reach for many patients, Case is looking to countries in the Global South (the world’s developing and least developed countries) for more cost-effective ways of bringing gene and cell therapies to the market. 

“Because there are often fewer research resources available in the Global South, scientists are more likely to devise therapies at a much lower cost,” says Case. “We might be able to learn from how these regions are developing therapies and follow similar processes in the Global North. This also serves as a way of moving towards equity in the flow of scientific and regulatory knowledge between the Global South and the Global North.” 

Medicine as Policy 

To drive policy reform, Case, who completed her Master’s in Medical Science at the University of Calgary and Ph.D. in Psychiatry at McGill University, is leveraging the legal experience of her colleagues at the Faculty of Law in tandem with her medical research background.

This past December, Case participated in a panel discussion at a Parliamentary Health Research Caucus event in Ottawa, where she educated a room full of parliamentarians on the issues surrounding access to and affordability of regenerative medicines.

“It’s interesting to see how the research I do is applicable across so many professional areas,” says Case. “That’s something I wanted when I came into the Faculty of Law and, coming from the sciences, it’s refreshing to feel this close to seeing the impact of my research.”

Fighting for systemic changes to how cell and gene therapies are regulated in Canada is no easy task. However, incorporating lessons-learned from researchers and scientists outside the Global North could have massive implications worldwide for patients who require these life-saving stem cell treatments. 

To further this knowledge-sharing, Case is organizing a workshop in Ballito, South Africa, this April. She, along with Ogbogu and other experts in regenerative medicine regulation from throughout the Global South will meet to discuss the global landscape of research and regulatory challenges and how the Global South can be included in its evolution.  

“In terms of developing better regulations in Canada, the wheels turn slowly, but the need is urgent,” says Case. “Numerous cell and gene therapies are being developed in the lab now, with some already in clinical trials and nearing the point where they are ready to go to market. Drawing on diverse voices both in Canada and globally could better inform how Health Canada might be able to design regulations pertaining to cell and gene therapies going forward.”