The regulation of nutrigenetic testing: a role for civil society organisations?

• Author: Hogarth, Stuart

Introduction

In March 2005, Pharmacogenetics Reporter ran a story describing how the nutrigenetic biotechnology company, Sciona, was moving its operations from the United Kingdom to the United States. (1) The report suggested that the move was largely motivated by the failure to create a consumer market for its testing services in the UK and the expectation that the US would provide a far more receptive market. In the UK, Sciona had been the subject of criticism from scientists, nutritionists, the Human Genetics Commission and civil society organisations (CSOs). The Sciona controversy sparked a review of the regulatory framework for consumer genetics in the UK. This paper uses the Sciona controversy and the resulting policy debate as a case study to discuss the role of CSOs in the regulation of commercial genetic testing services.

As genomics research advances, the appropriate regulation of genetic testing becomes increasingly important. This issue has troubled clinicians, patient groups, policy makers and regulators for over ten years. In Canada, the US, Europe and Australia, high-level committees have considered the issue and made their recommendations in weighty reports. (2) Analysis of the policy issues requires an understanding of the concerns the regulation is supposed to address as well as the regulatory space, including the regulatory framework and the actors involved.

Concerns raised regarding genetic testing can be broadly categorized as consumer harms and social costs. Consumer harms range from the fear of a 'new eugenics' based on discrimination and stigmatisation, to fears that tests of limited predictive value will mislead consumers, either providing false reassurance that they are genetically predisposed to good health or causing undue alarm and expanding the ranks of the 'worried well' relying on expensive and potentially harmful medications, diets or other interventions for questionable reasons.

The potential social costs of genetic testing include a negative impact on the nation's health, if by focusing on genetic risks well-established environmental factors, such as exercise, diet, pollution and smoking, are neglected or minimized. In the case of tests marketed directly to the public, there is a fear that busy family doctors will be further burdened by patients who have been tested commercially and then seek either reassurance or action as a consequence of the test results, especially if the testing company has not provided adequate counselling or advice.

The regulatory challenges include ensuring that consumers have full opportunity to give informed consent, assuring quality of lab procedures to promote accurate testing, policing promotional claims to halt misleading advertising, protecting privacy of genetic data, and requiring premarket review of tests to evaluate fitness for purpose (that is, can the test diagnose or predict disease with the accuracy that the test developer claims?).

As a result of these concerns, a debate has developed about how best to regulate the practice of genetic testing to prevent harm and maximize benefits. The debate is fairly sophisticated in that a range of regulatory mechanisms are generally advanced--from statutory licensing and use of existing consumer protection law to voluntary codes of conduct, best practice guidelines and consumer education. Much of the debate has revolved around the relative importance of these different mechanisms. (3) To caricature, regulatory hardliners view a robust regulator as essential to good regulation--an entity with 'command and control' authority to oversee compliance. Conversely, regulatory libertarians posit industry self-regulation coupled with education of consumers and healthcare professionals as the crucial mechanisms.

Regulatory Theory and the Role of CSOs

The debate over regulation of genetic testing is underway when regulation itself is undergoing change. The concept of 'responsive regulation' developed by Ayres and Braithwaite has been particularly influential. (4) One core concept is that where state intervention is required it should be the minimum necessary to achieve the desired outcome; consequently, it should target the highest risks and reward good practice with a light touch. The central idea in responsive regulation is to decrease reliance on the traditional 'command and control' mode of regulation, which focuses on "regulation by the state through the use of legal rules backed by (often criminal) sanctions." (5) Advocates of responsive regulation suggest that the state is not always the most effective regulatory agent; other actors can often perform regulatory functions more effectively and more efficiently. This prescriptive policy agenda is linked to a theoretical analysis that suggests regulation is a 'de-centred' process involving a range of public and private actors from trade associations to public interest groups. (6) Scott's concept of 'regulatory space' is helpful:

The chief idea of the regulatory space metaphor is that resources relevant to holding of regulatory power and exercising of capacities are dispersed and fragmented. These resources are not restricted to formal, state authority derived from legislation or contracts, but also include information, wealth and organisational capacities. The possession of these resources is fragmented among state bodies, and between state and non-state bodies. (7) In understanding the distribution of resources and exercising of capacities, a functional definition of regulation may be of assistance. Regulation may be seen as encompassing three broad tasks: information gathering, standard setting and enforcement. (8)

Regulatory theorists who promote the concept of responsive regulation have suggested a significant role for public interest groups; that is, third parties who are neither the regulator nor the regulated body but who represent a broadly defined public interest and who act as honest brokers, ensuring that a more flexible approach to regulation does not lead to the capture of the regulator by the regulated industry. (9)

In a similar vein, others have described the capacity of a range of CSOs--from professional bodies to churches and non-governmental organisations (NGOs)--to carry out the three regulatory functions enumerated earlier. (10) As information gatherers, CSOs can provide intelligence and analysis useful to both state regulators and regulated industries in the development of policy and commercial strategies. They may also have useful data on compliance with, and enforcement of, regulations. As standard setters, they may provide technical expertise and a democratic legitimacy to the official regulatory process and they may also highlight the importance of factors that have been placed outside the official regulatory process, particularly by the normative framing of issues that might otherwise be treated as strictly scientific or economic. As enforcers of standards, they can mobilize public opinion through direct action and media campaigns, but they can also use the legal system to enforce compliance with regulations. (11)

CSOs draw much of their power from the fact that they may be trusted more than government or industry, and thus claim to bring democratic legitimacy to fora where a democratic deficit may exist. But they are also vulnerable to accusations that they lack democratic accountability, act for narrow interests rather than a broad...