The regulation of cognitive enhancement devices: refining Maslen et?al.'s model

摘要

De Ridder, Vanneste, and Focquaert address concerns relating to the definition of a CED and the distinction between treatment and enhancement.1 They raise a number of problems with the treatment-enhancement distinction and suggest that we need to ask ‘whether we are prepared to change the definition of health used by the Medical Devices Directive'. There are in fact three questions raised here. The first is whether our proposal requires a robust characterization of the treatment-enhancement distinction, the second is whether our suggestions, as we intended them, actually involve changing the definition of heath implicit in the MDD (there is no explicit definition), and the third is whether the mere inclusion of CEDs within the MDD will have the de facto effect of changing the implicit regulatory concept of ‘health' or ‘treatment'. Fitz and Reiner broadly support our proposals and endorse our central claim, viz. that the regulatory framework for medical devices should be extended to include CEDs.12 Nevertheless, they raise a concern about the ability of CED users to evaluate the risks of CEDs, saying that ‘evidence that consumers are in a strong position to evaluate the risks associated with CED use is lacking' (p. 323). Johnson, Gillett, and Snelling suggest that the most convincing argument in favor of our position is based on the regulatory assessment of risk, which they believe should be the sole consideration in pre-market assessment.14 We suggest here that our respective proposals are not as different as they may have seemed, as we proposed that risk should be the primary regulatory concern. However, we diverge from the position advocated by them in our contention that objective improvements to cognitive capacities are amenable and relevant to assessment. Further to their concerns regarding individuals' abilities to weigh risks, Fitz and Reiner emphasize the remaining problem of ‘do-it-yourself' (DIY) users who, in constructing devices from scratch, will be afforded no protection by the regulation of direct-to-consumer devices. One of their proposals, with which we agree, is to bolster our recommendations with additional attempts at ‘active harm reduction'.18 They suggest that members of the professional community could join together to create an ‘inclusive online community', where information could be gathered and disseminated with professional oversight. We are broadly sympathetic with much of what they propose and would support the creation of an inclusive online community, were there to be sufficient expert interest in creating and maintaining it. Indeed, we are currently exploring how expert advice could be dispensed via existing fora, such as Reddit.19De Ridder, Vanneste, and Focquaert raise the concern that the societal benefits of enhancement might be lost if devices are in fact effective but regulated. In relation to this, we emphasize that the regulation we advocate is not akin to prohibition. To the extent that our proposals would prevent devices from being placed on the market, this would be limited to very dangerous devices or devices making implausible claims—hardly the sorts of devices that would confer net societal benefits. The important point that many other commentators on our model appear to overlook is that the effectiveness of brain stimulation techniques as a type of intervention does not guarantee the effectiveness of particular token devices claiming to be of this effective type. Regulation would assess devices at this case-by-case level. De Ridder, Vanneste, and Focquaert raise concerns about the misuse of resources, which assumes a position markedly different from that which we set out in our paper. They argue, persuasively, that resources should be directed to the most important causes and that enhancements might not be of a high enough priority to warrant use of our limited resources. We agree that limited resources need to be allocated carefully, but our proposal does not threaten such allocation: the devices that would be prohibited under our proposal are ones that would certainly not warrant significant investment of public resources, and our proposal leaves open how resources should be allocated among those that would be permitted. Perhaps De Ridder and collaborators assumed us to be advocating the inclusion of CEDs under the healthcare funding arrangements, but this is not what we envisaged. The extension to the scope of the MDD, as we recommend it, has no direct implications for the distribution of healthcare resources. Relatedly, the authors ask whether the regulation of CEDs requires new regulations regarding who can use them. Again, the answer is for the most part no: our proposals merely affect what can be placed on the market for consumers to purchase. The only exception should be restrictions governing the use of CEDs on children or vulnerable adults through contraindication labeling and the criminal law. I