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LAW AND POLICY OPTIONS

Regulating Cognitive Enhancement Technologies. Policy Options and Problems

ROBERT H. BLANK

Introduction

Rapid advances in cognitive neuroscience and converging technologies have begun to create a vigorous debate over cognitive enhancement (CE). Although there are strong opposing views over the ethics of enhancement, there is little doubt that such endeavors will proliferate in the coming decade. In a highly competitive society where the difference between winning and losing is measured in miniscule degrees, demand for any enhancement edge is inherently strong, driven by the high economic stakes of a thriving enhancement industry. Already, there is evidence of the attractiveness of such techniques by athletes, symphony orchestra members, parents, and students.1 Moreover, we live in an era dominated by forces that create “needs” through captivating marketing of products promising a better life. Marketing of these products through the media and the Internet is already active and, absent regulation, will escalate. Despite the controversy over CE, therefore, it will be alluring to many individuals and democratic governments will be hard pressed to limit its use.

This chapter focuses on the legal/policy dimensions of CE and places enhancement techniques in a social context. Since CE is likely to become more commonplace in the near future, it will increasingly generate a range of policy issues. Importantly, since different interventions involve more or less risk to the user and vary in effectiveness, it is counterproductive to lump all potential new enhancement methods into one category.2 The more intrusive and risky the procedure or drug, the closer the policy attention should be. There is also a need to balance the individual right to self-improvement with the numerous social costs that could arise.

Whereas enhancement technologies are in various stages of research and development and some are likely to have no real enhancement capacity, many observers stress the potential benefits of the research.3 Meanwhile, the media tends to exaggerate the positive effects of CEs and downplay or ignore the negative effects.4 Moreover, active marketing and publicity often promote their use long before potential deleterious effects are apparent. Because the broader policy implications are extensive and touch many areas of human existence, these techniques must be scrutinized as to their impact on the individual and society as a whole. Any such dialogue is likely to increase demands for some government involvement in enhancement techniques.5,6

The move of the CE issue to the policy domain alters the context by bringing to the forefront political considerations and divisions and placing the resolution of these issues in the milieu of interest group politics. With the high potential economic, social, and personal stakes involved, this is unavoidable. Intervention in the brain, including CE, is a particularly controversial policy area because of the rapid succession of advances in knowledge and the shortened lag time between basic research and application.

Although many of specific issues raised by CE are distinctive, fundamentally, the policy dimensions are similar to other areas of biomedical research. At their base, there are three relevant policy dimensions.7 First, decisions must be made concerning the research and development of the techniques. Because a considerable proportion of this research has been funded either directly or indirectly with public funds, civilian and military, it is important that public input be included at this early stage. The growing prominence of forecasting and assessing the social as well as technical consequences of technologies early in the process represents one means of incorporating broader public interests. However, it remains problematic as to how best design assessment processes to evaluate efficacy, short- and long-term safety, and the social impact of brain interventions, especially when there is a ready market and demand for them.

The second policy dimension relates to the individual use of technologies. Although direct governmental intrusion into individual decision-making in the medical arena has been limited, governments have at their disposal an array of more or less explicit devices to encourage or discourage individual use, including tax incentives or disincentives, the provision of services, licensing, and education programs. Although conventional regulatory mechanisms might be utilized to protect potential users or targets of CE applications, it is critical that their efficacy and applicability first be determined. Despite much debate on the potential or actual ethical and social impacts of human enhancement, however, the origin of motivations leading to the desire of individuals to be enhanced or not have been poorly investigated.8

The third dimension of enhancement policy centers on the aggregate consequences of widespread usage. What impact might widespread CE have on

Types of governmental involvement in cognitive enhancement

Figure 15.1 Types of governmental involvement in cognitive enhancement.

society? Will it aggrandize social inequalities or break down barriers? Should it be a high priority for public funding? Policy-making here requires a clear conception of goals, extensive data to predict the consequences of each possible course of action, an accurate means of monitoring these consequences, and mechanisms to cope with consequences deemed undesirable. At a minimum, the government has a responsibility of ensuring safety and quality control standards as well as consumer protection and fair market practices.

Figure 15.1 illustrates the many forms that a governmental response to CE could take from the earliest stages of research to the use of specific techniques. Enhancement policy can be permissive, affirmative, regulatory, or prohibitive. Also, a government could opt to take no action, thus allowing unfettered activity by the private sector. It can make affirmative policies that promote or encourage certain activities, for example, public funding of research or provision of services to facilitate wider use of a particular technique. The question of whether the government ought to be providing such encouragement, and, if so by what means, is debatable. Should public funds be used to pay for enhancement interventions when patients cannot afford them? Should private insurers be required to cover these expenses? Should we even distinguish among therapeutic and enhancement uses of a drug? Moreover, affirmative policies are often redistributive and thus introduce potential conflict between the negative rights of individuals to use their resources as they see fit and the positive rights of recipients of government support. Also, in some instances, the line between encouragement and coercion or mandate is easily breached.

The most obvious examples of regulation are psychoactive drugs including those used for CE.9 Although the research and development phase of all pharmaceuticals is highly regulated by the Food and Drug Administration (FDA) in the United States, control of individual use is problematic, as is potential overuse in the aggregate. A broader regulatory approach would require assessment of the social and ethical ramifications by focusing attention on the various social processes involved in moving a technology along the different axes of regulation. Although regulatory policy might apply only to government-supported activities, it normally consists of sweeping rules governing activities in both the public and private sectors. Regulation can be used to ensure that standards of safety, efficacy, and liability are adhered to, and, unlike professional association guidelines, which can set minimum standards, regulations have the force of law and usually include legal sanctions for violations.5 Moreover, as discussed later, an important regulatory device is price, which can be modified through taxation or license fees. Regulation of enhancement drugs could follow an approach similar to policies on tobacco products based on a combination of taxation, bans on marketing and display, plain packaging with graphic pictures, and limits on where the products can be sold and used. Dubljevic,10 however, doubts such an approach is well-suited to medical drugs like Ritalin (methylphenidate) and Adderall (a combination of amphetamine and dextroamphetamine) that have serious known side effects and that it would be too permissive to sell them over the counter even with sufficient warning.

Another option would be to require enhancement licenses to ensure informed consent and enable better monitoring. Dubljevic10 suggests that a government agency such as the FDA could offer a licensing procedure to pharmaceutical companies to market enhancement drugs for healthy adults. Moreover, in order to use them, citizens would have to pay for and pass a course about known effects and side effects. Furthermore, additional medical insurance and obligatory annual medical tests would be required in order to obtain and renew a license to use them. In addition, the prices could be regulated and an additional tax imposed. According to Dubljevic,10 such a policy could ensure that all citizens have legal access to the drugs, but the imposition of taxes, fees, and requirements of additional insurance would offset any positional advantage gained from their use. A downside with enhancement licenses is that people with low cognitive capacity who might have the most to gain from enhancements might find it difficult to get access if the license requirements were too demanding.11

Last, although far less common than regulation, prohibitive policies could be implemented that reduce the options available for CE. The most straightforward form is to create laws that impose criminal sanctions on a particular research activity or application. A softer type of prohibitive policy is to preclude public funding of specific areas of research and development (e.g., certain types of fetal or human embryo research) or specific enhancement services. It remains to be seen what, if any, areas of cognitive neuroscience are candidates for prohibition, but governments do have that option, as evidenced by bans on electroconvulsive therapy in some jurisdictions. These policies often reflect political motives or a response to the demands of particular interest groups.

Figure 15.2 illustrates a range of possible policy responses to CE. Many of these options have been used by various countries with regards to stem cell research, reproductive and genetic technologies, or past brain interventions. They clearly demonstrate the diversity of policy options as well as the often diametrically opposed positions on the role of the government. Given the history of policy in these related fields, there appears very little likelihood of anything approaching a consensus emerging either on the role of government in enhancement or the preferred policies regarding specific uses. Also, it should be

The role of government in cognitive enhancement. Source

Figure 15.2 The role of government in cognitive enhancement. Source: Adapted from Blank.7

emphasized that policy-making, particularly in the United States, is a gradual process, not manifested in quick, decisive action, and policy on CE, like genetic and reproductive policy, is likely to come in fits and starts in a fragmented, unsystematic manner.

Throughout the policy process, governments have many mechanisms for facilitating expert input. Permanent mechanisms include the use of internal bureaucratic expertise, science advisors, offices of science and technology, and science advisory councils, whereas temporary mechanisms comprise task forces, ad hoc committees, commissions, consultants, conferences, hearings, and issues papers. Their remit can be specific to a particular application, broader in scope across the range of brain interventions, or cover a wider swathe of issues. The United Kingdom’s Academy of Medical Sciences, for instance, has recommended the establishment of regulatory authorities for cognitive enhancers,12 whereas the British Medical Association proposed a permissive system of regulation in which techniques are permitted under license from a regulatory body—the Regulatory Authority for Cognitive Enhancements.13

 
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