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Law, Public Policy and Social License for Next-Generation Regenerative Medicine

Exploring policy issues that affect how regenerative medicine research moves into real treatments 

We are exploring important policy issues that play a critical role in how regenerative medicine research moves into real treatments that can help people while addressing potential risks. 

Our team of researchers are experts in law and public policy research.  Our work has led to peer reviewed publications, presentations, graduate student research, and public facing content. This page contains resources produced by our working group, developed to support our ongoing work and to share insights, tools, and findings with a wider audience. We invite you to explore and make use of the content provided here.

With our work in regenerative medicine policy, we aim to:

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Highlight global innovation and challenges

Create regulatory frameworks that support responsible and inclusive innovation in regenerative medicine, including in the Global South
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Promote trustworthy oversight

Explore the role that professional regulation plays in overseeing regenerative medicine treatments for patients
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Understand the misinformation landscape

Understanding the spread of misinformation in the context of RM and its impact on the state of the science, public understanding and trust in the field

Highlighting global innovations and challenges of regenerative medicine to create a harmonized regulatory framework

There is a need to develop clear and robust regulations to guide the translation of regenerative medicine (RM) research into interventions that improve public health. While regulatory frameworks exists for clinical trials and marketing of RM products, attention is needed to address the specific challenges posed by these emerging technologies. Our work examines RM policy and governance across regions of the Global South to understand the regulatory approaches, innovations, and challenges that RM brings. By focusing on under examined areas in literature, this study aims to contribute to global discussions on RM governance and support the development of inclusive and well suited regulatory frameworks.

Promoting trustworthy oversight of regenerative medicine by understanding the role of professional regulation and its challenges

Groups that regulate professionals, like the ones that oversee doctors, are meant to protect the public. However, because RM is a new and developing field, there can be important questions about what protecting the public really means and requires in this context. Also, who or what is responsible for overseeing a new RM treatment will often depend on whether that treatment is considered to be a drug, a medical device, or a type of clinical innovation, and on whether it is being provided as a part of a research study or in a different context. A challenge is that the boundaries between these different concepts are not always clear. Our work is exploring these and related areas, with the goal of informing future policy to help ensure that the clinical progress of RM is supported by strong and well-fitting systems of oversight.

Understanding the misinformation landscape in regenerative medicine

The field of RM is rife with misinformation - a problem that has resulted in the development and offering of ineffective and harmful RM interventions, a distorted understanding of the science, and the erosion of trust in scientific experts and public health institutions involved in the field. Such issues have only intensified with the use of new media, where misinformation about RM is spread on all popular platforms, including social media, search engines, news and commercial websites, e-commence marketplaces and crowd funding platforms. Countering its effects is a complex and challenging task. In our work, we analyze media contexts to best understand how RM misinformation is portrayed and spread, as well as appropriate policy and regulatory options that may be utilized to combat and manage this phenomenon.

Our Team

Ubaka Ogbogu

Ubaka Ogbogu, LLB, BL, LLM, SJD

Professor and Katz Group Chair in Health Law Read more
Amy Zarzeczny

Amy Zarzeczny, PhD, BA, LLB, LLM

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Tim Caulfield

Timothy Caulfield, BSc, LLB, LLM

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Our funders and collaborators

The working group is funded by the Stem Cell Network