4 - Regulatory responses to developing biotechnologies

Summary

Along with any general provisions on experimental procedures or medical research, specific regimes to regulate a particular developing biotechnology are often introduced. This occurred with IVF, gene therapy and xenotransplantation, for example, and I chart here the regulatory landscape, history and development of these schemes, and highlight how they were devised as these biotechnologies were scientifically developing. Regulatory theory per se is not my concern, nor is the ethics of these biotechnologies, and I am not claiming that these are directly comparable; rather, I explore the regulatory responses to these advances because they raise similar issues with regard to questions of harm, risk and safety, and what it means to be human. One key difference is that unlike the former biotechnologies, no clinical genetically engineered solid organ xenotransplant has yet occurred. There is thus an opportunity to reflect on the experiences of regulating IVF and gene therapy and learn lessons from how their regulatory schemes were developed and implemented. I focus on how those schemes evolved prior to, at the time of, and in the decade post-clinical introduction; for IVF from 1978 to1988 and gene therapy from 1990 to 2000. This is not a comprehensive comparative account of how IVF and gene therapy were regulated; rather, I identify trends in regulatory approaches. For xenotransplantation, I explore regulatory responses from the 1990s when (unfulfilled) claims were made that clinical solid organ xenotransplants were imminent, and trace the development of solid organ xenotransplant regulation to date.

One of my aims is to consider whether there is a way of determining how to regulate a developing biotechnology which ‘best . . . balance[s] the needs of doctors and scientists with the concerns of the public at large so as to maximise beneficial outcomes for society as a whole’. This is important because existing legal frameworks have demonstrated four problems with regard to genetic science:

[t]hey can't seem to adapt to evolving science, and indeed the adaptive/reactive model is itself problematic; regulation has been introduced on an ad hoc basis focusing on a rather arbitrary selection of issues and creating different regulatory bodies to oversee connected areas of scientific research; the regulation is essentially technology-led; and the regulatory frameworks do not reflect any single ethical theory.