Legal and ethical status of stem cells as medicinal products

The realisation of the full potential of products based on stem cells in a clinical setting demands robust scientific evidence, underpinned by legitimate regulatory requirements to ensure their safety and efficacy. This review examines the legal aspects of the use of stem cells in the laboratory and in the development of new therapies and pharmaceutical products. UK and European legal and regulatory documents and directives are used as the framework for discussion of the current status and future prospects.