This multi-disciplinary symposium is aimed at critically reflecting on the ethical, regulatory and conceptual issues surrounding the provision of autologous stem cell and cell-based products as 'innovative therapies'. Interventions with autologous stem cells are being marketed directly to patients, typically over the Internet across geographical boundaries, for a wide range of serious illnesses and conditions. The global proliferation for these interventions and the possible harms they pose to patient populations vulnerable to exploitation. They have generally emerged from private clinics exploiting weaknesses in regulatory systems across different geographical jurisdictions and misinterpreting porous distinctions between clinical practice, research and innovation. They may also be indicative of a wider global trend to facilitate innovation by reducing legal and regulatory constraints over the use of novel medicines in the marketplace, rather than enabling more effective regulation, and demand critical attention to more clearly define the scope and obligations associated with responsible innovation.
The symposium will focus on six original research papers with oral commentaries from scholars with internationally-recognised expertise in the empirical, normative, sociological and legal analysis of biomedical innovation, health technologies, and stem cell science.