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Regulatory Challenges at the Intersection of Cellular and Medical Device Therapies in Europe: The Case of the Bioartificial Pancreas


Regenerative medicine solutions for type 1 diabetes are a rapidly developing field of medical technology. So far, these solutions have been principally cell-based treatments and, at present, in Europe, are regulated under the European Union regulations for Advanced Therapy Medicinal Products (ATMPs). But now, new, emerging technology combining cellular therapy with medical devices is under development. The potential of this novel hybrid model to create a bioartificial pancreas is tantalising. However, incorporating medical devices creates a further layer of complexity to an already challenging product development process. Moreover, it raises important questions about how bioartificial organs should be regulated.

This article seeks to expose the complexity of the legal and regulatory landscape relating to such products, focusing on the laws of the European Union and, where appropriate, bringing in examples from other jurisdictions. We set out the role of the European Medicines Agency (EMA) and review the classification of existing ATMPs and those proposed for type 1 diabetes to highlight the potential consequences and effects of nomenclature and classifications. We argue that emerging hybrid regenerative medicine solutions at the intersection of cellular and medical device therapies, in which medical devices are integral to and facilitate the cell therapy mechanism of action, are not satisfactorily accounted for in the existing legal paradigm regulating regenerative medical therapies. We suggest that these functional hybrid products, currently in their infancy, may yet have far-reaching implications for the interface of law, regulation and technology. For example, they are likely to challenge the conventional discourse related to a market in (bioartificial) organs. We recommend that the EMA, national competent authorities for medical devices, national transplantation authorities and those responsible for overseeing translational clinical research respond to this by developing the existing regulatory framework in such a way that captures the essence of these hybrid products as a single entity. Issuing guidance on updated regulations to researchers engaged in this emerging technology will be key to the success of its translation into human therapies.


Published: 2023-11-21
Pages:114 to 133
Section: Symposium: Regulatory Futures and Medical Devices
How to Cite
Cronin, Antonia, Rebecca Thom, and VANGUARD Consortium. 2023. “Regulatory Challenges at the Intersection of Cellular and Medical Device Therapies in Europe: The Case of the Bioartificial Pancreas”. Law, Technology and Humans 5 (2):114-33.

Author Biographies

King's College London
United Kingdom United Kingdom

Dr. Antonia Cronin is a Consultant Nephrologist at Guy’s and St. Thomas’ NHS Foundation Trust and Honorary Reader in Medical Ethics and Law at King’s College London. She has a special interest in emerging biotechnology related to organ donation and transplantation and its implications for public policy, regulation and the law.

She is co-leader of the ethical and legal issues work package of the EU Horizon 2020 funded VANGUARD project. The project aims to generate a vascularised and immune-protected bio-artificial pancreas that can be transplanted into non-immuno-suppressed patients by combining advanced tissue engineering strategies. The ambition of the VANGUARD project is to produce a therapy in the form of an Advanced Therapy Medicinal Product (ATMP), which can be translated into man in order to cure type 1 diabetes.

St George's Hospital
United Kingdom United Kingdom

Dr Rebecca Thom is a general internal medicine and nephrology consultant at St George's hospital in London. She has an interest in medical ethics and law with research specialising in mental capacity and advanced cellular biotechnologies.

Open Access Journal
ISSN 2652-4074