Bioethics Blogs

Whose lifestyle benefits? Regulatory risk-benefit assessment of enhancement devices

Nearly everyone would agree that a device or drug that relieves pain, or alleviates symptoms of depression confers a benefit – plausibly, a substantial benefit – on its user. No matter what your goals are, no matter what you enjoy, you are likely to agree that your life will go better if you are not in pain and not depressed: whether you’re a painter, a footballer, a Sudoku-enthusiast or a musician, you will be better able to pursue your projects and engage in the activities you love. It is unlikely that you will even question whether pain relief or alleviation of depression indeed constitute benefits.

This general consensus with respect to medical benefits makes it relatively straightforward for regulators to conduct risk-benefit assessments of medical products when they decide whether a particular product can be put on the market. A very small risk of a mild rash or gastrointestinal upset, for example, will be considered reasonable in the context of effective pain relief, as long as patients or consumers are informed. Even as the risks get more significant, substantial pain relief will be considered a large enough benefit to out-weigh a range of negative side effects in many cases.

So far, so straightforward.

However, a new class of consumer devices, promising enhancement effects, create a challenge for this sort of risk-benefit assessment, were a similar approach to be adopted. Whilst there is a general consensus that pain relief is a benefit, and that the size of this benefit can be substantial, it is much harder to say how beneficial a small improvement to ‘healthy’ working memory is, for example.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.