Prof. Ubaka Ogbogu co-authors report on ethical, legal questions of gene therapies

Expert panel reviewed safety, accessibility and affordability of treatment

Sarah Kent - 03 November 2020

Associate Professor Ubaka Ogbogu, a health law scholar at the University of Alberta Faculties of Law and Pharmacy and Pharmaceutical Sciences, has co-authored a new expert panel report on the issues surrounding somatic gene therapies in Canada.

Somatic gene therapies involve putting genes into a patient’s somatic cells (those that do not transfer DNA into the eggs or sperm, such as bone marrow cells) in order to treat diseases.

Ogbogu was one of four scholars selected for the multidisciplinary panel by the Council of Canadian Academies, an organization dedicated to gathering specialists to assess scientific topics that impact decision-making in Canada. The expert panel studied the scientific, clinical, policy and ethical challenges surrounding the approval and use of novel, cutting-edge gene therapies.

Requested by the National Research Council of Canada, the report will inform a national strategy for the clinical adoption of gene therapies.

“Four gene therapies have been approved for use in Canada,” said Ogbogu. “With many more in development, gene therapies typically address previously untreatable conditions and are considered to be revolutionary and life-changing. However, they are also expensive — the latest, which treats eye disease, costs $850,000USD per treatment — and complex to produce.”

The report, “From Research to Reality: the Expert Panel on the Approval and Use of Somatic Gene Therapies in Canada,” explores the issues surrounding the approval and use of these gene therapies in Canada, including their safety, accessibility and affordability.

“The main findings of the report are that these challenges can be addressed through better national coordination on all decisions, policies and processes relating to the adoption of gene therapies, strengthening public investment in gene therapy, and creating regulatory systems that are nimble enough to accommodate the rapid pace of developments in the field of gene therapy,” said Ogbogu.

The Expert Panel

“The expert panel provided an opportunity to share my academic research, learn from other experts, and exchange knowledge and ideas,” said Ogbogu. “Most importantly, it was an opportunity to work with a high-level group of people to produce work that has direct and immediate impact.”

The report is the culmination of eight months of reviewing evidence, workshops, interviews and deliberations.

Alongside Ogbogu’s expertise in health law, the panel included scholars working in discovery research, clinical medicine and healthcare innovation.

“A health law perspective (was) needed to inform the panel’s deliberations on how existing legal and regulatory frameworks apply to gene therapies and on whether changes to these frameworks are needed to address the challenges associated with gene therapies,” said Ogbogu.

This is the second time Ogbogu has served on a Council of Canadian Academies expert panel, having previously worked on the expert panel on medical assistance in dying, which ultimately recommended amendments to the Criminal Code that are now tabled in Parliament.