Academic journal article Health Law Journal

Reconciling Private Benefit and Public Risk in Biotechnology: Xenotransplantation as a Case Study in Consent

Academic journal article Health Law Journal

Reconciling Private Benefit and Public Risk in Biotechnology: Xenotransplantation as a Case Study in Consent

Article excerpt

1. Introduction

All major technological advances have the potential to fundamentally change the social, economic, political and legal landscapes of those who adopt the benefits of innovation. While these advances may represent significant changes in knowledge or modes of behaviour, they nonetheless develop gradually. This progressive implementation is the cumulative effect of a multitude of discrete individual decision-making processes. Research is initiated into what appears to be a promising line of inquiry or may be a serendipitous by-product of other projects. Investment underwrites this activity, originating in either the public or private sector, for motives of either public health and welfare or profit and return on investment. The end-users of technology, the ostensible intended beneficiaries, accept or reject the applied products of research, either through a considered analysis of the benefits to be gained by adopting a new technology or in the hope that whatever the outcome, it is better than the current alternat ive. Thus, while appearing organic, technological development actually take place within the context of a multitude of decisions at the individual and aggregate levels, from the decision to invest initial resources in research and development, to the decision to commercialize, to the decision to adopt the products of commercialization. Each of these decisions is, at least in part, a reaction to not only a perceived need for technology to address a problem or improve productivity or standard/quality of life, but also to the acceptance of the fundamental changes that will occur as a result of implementation.

While these general thoughts apply to all new technologies, they take on heightened meaning with respect to biotechnology. Research and development in this field along with the concomitant commercialisation of the products of biotechnological innovation, present a unique challenge that we have not had to address in the past technological revolutions that we have weathered. Advancements in biotechnology have the potential to alter not just our environment but our physical embodiment as well. In altering not merely our social, cultural, economic or political environments, but the physical foundations of life itself, the decision to adopt a particular biotechnology may be irrevocable and the results irreversible. There can be no turning back from a decision to alter our biological destiny.

While biotechnology promises to change many aspects of our lives in terms of our relationship with nature and our physical environment, it is in the area of health care that we are most likely to feel the impact of irreversible innovation. To date, this impact has been subtle: we now manufacture, for example, some medications using genetically-modified microorganisms, we provide genetic tests, and we conduct research using our emerging knowledge of the human genome. But the potential of modem biotechnology stretches far beyond these early applications. For example, researchers are working on ways to match medications against a person's genetic make-up in order to reduce adverse reactions and maximize positive ones (pharmacogenetics (1)) and there has been some limited success (but also failure) in inserting non-mutated genes into the bodies of those suffering from genetic diseases (gene therapy). We may also soon have the ability to insert animal organs into human beings in order to replace diseased human org ans. This is called xenotransplantation: the transplantation of an organ or tissues across species.

In each of the above examples, the health benefits to individual recipients of the products of biotechnological innovation are self-evident, although far from uncontroversial. (2) The appropriate balance between the benefits and risks of medical intervention in each individual case is a decision typically made within the confines and confidentiality of a doctor-patient relationship. …

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