Regulation of cognitive enhancement devices: commentary

Maslen et al. (2013) have provided us with a comprehensive overview of the current legislation regulating non-clinical cognitive enhancement devices (CEDs) in the European Union and have proposed a specific model whereby CEDs would be regulated in the same way as medical devices. An alternative model would be to require manufacturers to quantify risks only. Irrespective of the purported 'benefits' of a product, this would allow the consumer freedom of choice to use the product at their will and allow the periodic review of worthwhile indications and unexpected adverse events. Although this departs from the standard Cochrane-type assessment, it takes into account the facts that (i) the evaluation of clinically used cognitive enhancement techniques may not be as rigorous as one might expect, (ii) variations and case-by-case use might be widespread, and (iii) independent variables of significance and useful endpoints may not be obvious ab initio. We consider cerebrospinal fluid diversion techniques which are widely used clinically to enhance cognition in patients with normal pressure hydrocephalus despite any large-scale clinical studies demonstrating substantial benefit, and the real risks of paralysis and death from these invasive procedures. The risks of CEDs which have been available for some time need to be kept in perspective: are the risks really more than using conventional cognitive enhancement techniques such as imbibing too caffeinated drinks? Furthermore, the loss of Europe as a market for CEDs which do not comply with the proposed regulatory model implies a potential gain in the market for other parts of the world. This could impact on the ability of companies in Europe being able to compete in an evolving market demand for CEDs. Legislation to regulate CEDs should be guided by the principle of 'do no harm' and allow for innovation and competition.