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Direct to consumer genetic testing and the libertarian right to test
  1. Michele Loi
  1. Correspondence to Dr Michele Loi, ETH Zürich, Department of Biology, Institute of Molecular Systems Biology; loi{at}imsb.biol.ethz.ch

Abstract

I sketch a libertarian argument for the right to test in the context of ‘direct to consumer’ (DTC) genetic testing. A libertarian right to genetic tests, as defined here, relies on the idea of a moral right to self-ownership. I show how a libertarian right to test can be inferred from this general libertarian premise, at least as a prima facie right, shifting the burden of justification on regulators. I distinguish this distinctively libertarian position from some arguments based on considerations of utility or autonomy, which are sometimes labelled ‘libertarian’ because they oppose a tight regulation of the direct to consumer genetic testing sector. If one takes the libertarian right to test as a starting point, the whole discussion concerning autonomy and personal utility may be sidestepped. Finally, I briefly consider some considerations that justify the regulation of the DTC genetic testing market, compatible with the recognition of a prima facie right to test.

  • Predictive Genetic Testing
  • Ownership
  • Political Philosophy
  • Genetic Screening/Testing
  • Rights

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Introduction

The US Food and Drug Administration recently lifted its ban on a large provider of direct to consumer genetic testing (DTCGT)1; for bioethics, it is worthwhile and urgent to examine whether individuals have a moral right to access such tests. Some consumers adamantly argue that they do, using social media to express their views that “genetic information is the property of the individual”, so everyone has a “natural right” to have “access to own genetic information resulting from tests […] paid out of pocket”, and “no one should be able to prevent access”.2 As one such petitioners puts it:It's very simple. If it comes from my body, or is a snapshot of the composition of my body, I should have a right to it.2

Are these consumers simply confused or are they formulating a plausible philosophical argument? If the latter, what kind of argument it is? (That some people think that they have a right to test is no conclusive reason to think they do.) This article aims to answer such questions. It will be argued that these consumers formulate at a distinctively libertarian argument: distinctively libertarian because it relies on the moral concept (or intuition) that persons are full owners of themselves. Clearly, the libertarian argument for the liberty to test is only as plausible as its major premise about a moral right to self-ownership. Following Gerald Cohen, I will point out that the libertarian idea of self-ownership is at least as plausible as any other fundamental ethical belief or intuition (eg, that welfare should be promoted or that persons ought to be treated equally absent a justification for treating them unequally) because it undergirds some strong and fairly widespread evaluative beliefs. I will also argue that the inference from the right to self-ownership to a negative right to have one's genome tested is plausible too. I will only argue for this right being prima facie, that is, a claim that might be defeated by other considerations. The prima facie libertarian right to test does not entail that consumers ought to have access to genetic tests when doing so conflicts with other people's rights. I shall leave open the question whether libertarianism is the only valid account of all moral rights or some moral rights are grounded in other values, such as welfare or equality. While the libertarian right to test does not support the lack of regulation of the DTCGT market in all cases, it shifts the burden of justification on those who require more regulation. In order to violate pre-existing moral rights, regulators must provide cogent arguments, supported by empirical evidence when these arguments rely on factual claims. Merely pointing out that DTCGT may be harmful for some people, or that it is not a means to utility or a vital aspect of individual autonomy, is not sufficient to justify restriction of the negative liberty to access to genetic tests.

The empirical literature has shown that actual or prospective customers of genetic tests are motivated by the perceived entertainment value of such tests or their curiosity.3–5 This has spurred a debate over the concept personal utility, which today remains controversial.6 Alternatively, one may claim that the freedom to know one's genetic constitution contributes to autonomy, even when no life-shaping decision can be grounded on such information,7 a claim that has been contested as well.8

The ‘libertarian right to test’ in the strict sense presupposes no positive value of genetic testing in relation to utility or autonomy. Libertarian claims have been detected in qualitative empirical study,2 but an examination of the argument from the point of view of philosophical ethics is still missing.

Libertarian rights to the genome

The libertarian argument for the right to test can be summarised as follows:

  1. Each person is the rightful owner of her person and powers, and consequently, each is free to use her person and these powers as she wishes, provided that she does not use them aggressively against others.9

  2. A person's genome is part of what a person is. From these two premises, one infers that:

  3. Each person is the rightful moral owner of his or her genome, and consequently, each is free to use her genome as she wishes, provided that she does not use her own person and powers aggressively against others.

  4. Each person is free to have tests performed on her genome as long as the test providers (the legitimate owners of the resources for performing the test) are not forced to perform those tests by aggressive means.

The major premise of the argument states the right to self-ownership, while spelling out its immediate general implications. Most political philosophers use the label ‘libertarians’ to refer to a broad range of political theories—both to the left and the right of the political spectrum—all of which share this premise.10 The second premise is matter of fact: my genome, no less than my arm or my brain, is just part of who I am. Notice that this is not the claim that the genome is all who I am, or that it defines the essence of individual identity. Having the same (ie, a qualitatively similar) genome is not a sufficient condition for individual identity (monozygotic twins share a qualitatively identical genome at least until the first epimutations and somatic mutations take place). Nor is it, it may be safely conceded, a necessary condition for it (it is conceivable that some parts or aspects of a person's genome may change while personal identity is preserved). The point made here is more minimal: my genome, just like my lungs, is a part of my body, since the beginning of my existence, and I am the only person having a moral right of ownership over it.

The third claim follows from combining the first two premises, while the fourth is a particular application of the third. If one has a morally legitimate property right to her money and her genome, she can consensually exchange them for other goods and services, among consenting adults. One is morally authorised to use her genome in ways that do not harm others, such as paying for a genetic test. The libertarian view entails that, in principle, one needs no permission from a higher moral authority to do that.

The libertarian right to test is a negative right, entailing non-interference, not a positive one, requiring the provision of some good or service.11 It is a broader right than the right to know genetic information, in the sense that it is a right that each person has independently of the opportunity to acquire knowledge through the test. Not all exchanges involving genomes must aim at knowledge acquisition. For example, a genetic analysis may be performed for the sake of entertainment or aesthetic value. The right to test, therefore, is best characterised as logically independent of any antecedent right to know. It says a person is at liberty to do whatever she wants to do with her genome and that other agents have a duty not to interfere as long as other people's rights are respected. This holds irrespective of whether the test yields any knowledge.

The content of the right to test can be made more precise by decomposing it into several ‘Hohfeldian incidents’. If A has the right to test, A has

  1. The liberty-right (Hohfeldian ‘privilege-right’) to test: A has no duty not to test her own genome.

  2. The liberty-right not to test: A has no duty to test her genome.

  3. The claim-right that others do not interfere: B has a duty to A not to prevent A from testing her own genome (through the resources over which A has a right).

  4. The power-right to transfer her rights (I, II, III): for example, B may be permitted by A to test A's genome.

  5. The immunity-right from having one's rights (I, II, III, IV) being altered by others. This confers protection from the above rights being modified by others.

Other two important features of a right to test that is distinctively libertarian (in the narrow sense) are that it presupposes a certain view of the function and justification of rights. The two main theories on the function of rights are the will theory and the interest theory. According to the latter, the function of rights is to protect an interest. According to the former, rights define who is entitled to control a given entity or portion or reality.11 The libertarian right to test as characterised here has the function that the will theory ascribes to it. The function of this claim is not that of protecting an interest. It is to characterise a specific person (in our case, the moral owner of the genome) as the sole person who has a legitimate right to control that genome and who can grant that right to others, without having been antecedently granted that right by another human being.

With respect to the justification of rights, the main scholarly distinction is between a status-based versus instrumental justification. According to the former, rights should be respected because it is fitting or appropriate to do so; according to the latter, because of the consequences of respecting them.11 A libertarian right to test is grounded in status: people do not have rights because their having such rights would make the world better in some respect.12 Libertarian rights of self-ownership are not justified by their consequences; rather, people's bodies (including their genomes) begin to exist with full ownership rights attached to them.

The status theory makes sense of the widespread intuition that body parts come to the world with rights attached, whose validity is independent of the consequences of respecting them. Borrowing an example from G. A. Cohen, few egalitarians find it acceptable for the state to conscribe potential kidney donors into a lottery whose losers must yield a kidney to beneficiaries who would otherwise stay in dialysis (ref. 9, p. 70). But if moral rights to parts of the body are justified as means to equal autonomy (or well-being), egalitarians who deny libertarian self-ownership must support the lottery. Conversely, those who object to the lottery of moral grounds appear to recognise self-ownership.

Autonomy versus self-ownership

The libertarian right to test in the strict sense should not be confused with the libertarian position on DTCGT regulation in the broad sense. The libertarian position on DTCGT regulation is the claim that consumers have at least a prima facie right to access to genetic tests, independently of medical recommendations and genetic counselling. This claim may be justified by appealing to different considerations. The libertarian right to test in the narrow sense is a special justification of this broadly libertarian position. It is grounded in conceiving the genome as part of what one owns, in moral terms, in virtue of owning oneself.

To clarify this distinction, I will describe an argument for a broadly libertarian position on DTCGT, which, unlike the narrowly libertarian one, relies on autonomy and utility. Traditionally, bioethics recognises patients' rights to know information relevant to their health. This may include genetic information having clinical utility. The new question is whether individuals have a right to know genetic tests that have no clinical utility (if people have a prima facie right to know their genetic information, then arguably they also have a prima facie right to test in order to obtain it).

A broadly libertarian position that is not libertarian in the strict sense may start from observing that a person's right to know is a means to advancing her interests in autonomy or well-being. An argument could be made that there are ways in which genetic tests with no clinical utility may contribute to autonomy or well-being. For example, it may be argued that genetic information lacking clinical utility opens up new forms of biosocialisation.13 This advances the autonomy of persons by enabling new life-shaping options.7 It has also been argued that DTCGT has ‘personal utility’ in the light of its entertainment value (notice that the term ‘utility’, as used by Bentham, refers to pleasurable mental states such as those entertainment may give rather than an attribute of usefulness of a thing).3 ,4

In response, Bunnik and others have objected that normative uses of personal utility to justify access to direct to consumer (DTC) testing rest on conceptual confusions, for “entertainment value is not the same as utility”, 6 that “there is a difference between perceived utility and actual utility” and that “from the fact that consumers experience satisfaction or pleasure, it does not follow that genomic tests generate valuable life-shaping options”.8

Because of its presuppositions, this debate is orthogonal to a debate grounded in the moral claim of a libertarian right to test. Since the moral right to self-ownership is not grounded in autonomy or utility, someone who favours a prima facie antiregulation position need not engage with the arguments above if his starting premise is libertarian in the narrow sense. But there are other arguments, as we shall see, that she cannot ignore.

The libertarian right to test and policy

Having described and defended the claim of a distinctively libertarian prima facie right to test, it is important to consider how it links to policy and regulation.

Laissez-faire libertarianism would include regulations “to prevent false advertising, fraud, and protections against clear dangers to public health”.14 Consumer protection law is needed to protect the holder of the right to test from fraudulent, deceitful offers. In healthcare systems, gatekeepers have been installed to hinder access to various medical products and services for various reasons, among which preventing harm to uninformed consumers. For example, the safety of drugs must be assessed before they enter the market. Services that invoke genetic pseudoscience, misleading consumers and placing public health at risk, should be contrasted.

Another function of gatekeepers in healthcare is rationing a healthcare service that is entirely or partly subsidised by the state. In socialised healthcare systems, most services are made available on the basis of need or sold below their market price, which creates an imbalance between demand and supply. This makes rationing necessary. In making rationing decisions in socialised healthcare, various kinds of gatekeepers rely on criteria of equity or fairness. If value pluralism is accepted, prioritisation in public (or publicly subsidised) healthcare may rely on non-libertarian moral considerations, such as priority for the worst off, equality or utility maximisation. The libertarianism characterised here is not incompatible with value pluralism and does not entail that only moral claims grounded in self-ownership are legitimate. The libertarian right to test is characterised as a negative right, not a right to obtain genetic tests subsidised by others. It concerns the right people have to use their genome within private markets, not claims on taxpayers’ resources and other resources that the state controls. It is therefore compatible with medical professionals or other supervisory agencies setting priorities to pursue public health objectives and achieving an equitable distribution of resources within socialised healthcare.

Finally, a regulation of the market may also be justified when private exchanges produce negative externalities, that is to say, spillover effects reducing the well-being of parties who are not included in the transaction. It has been argued that DTCGT of unproven validity or clinical utility “represents a drain on the health care system, limiting the resources available for other established health care interventions”.15 Let us assume for the sake of the argument that other patients have a moral right to these established interventions, which can no longer be delivered because DTCGT users have raised the cost of providing standard diagnostic exams. The limitation of libertarian rights of DTCGT users may be justified because a person's right ends where the rights of other people begin. (Ideally, users of DTCGT would be required to pay a tax for their externality; taxation on the ground of negative externalities is coherent with self-ownership.)9 Finally, the accumulation of genetic and other health data by DTCGT companies and their role as monopolistic brokers of such data 16 could raise issues of justice and efficiency. While these issues may justify restrictions to some market transactions, a thorough examination of DTCGT governance in its multifaceted complexity is outside the scope of the present essay.

The core implication of the libertarian right to test for policy is that it is up to supporters of regulation to provide the empirical evidence of deleterious effects of DTCGT on the healthcare patients are entitled to or that it undermines public goods. If consumers have a prima facie libertarian right to test, this shifts the burden of the proof on regulators. Moreover, a fair assessment of the externalities produced by DTCGT market exchanges must also consider positive externalities, for example, advances in science and technology that lead to healthcare improvements and lower prices.

Conclusion

The conceptual analysis of a distinctively libertarian right to test provides an addition to literature in bioethics on DTCGT, where this argument is mostly ignored. The idea of a moral right to self-ownership defines libertarianism in political philosophy. It can be used to charitably interpret the claims of some users of DTCGT services, showing that they reflect (coherent and plausible) libertarian intuitions about self-ownerships. I have not argued for a right to test all things considered since the libertarian right may be overridden by other considerations (ie, concerned consumers causing a drain on the healthcare system). But the idea that all persons have such right shifts the burden of the argument, at least if you find its major premise plausible, that is, that people are the sole legitimate owners of their body and mind. Libertarians offer a plausible argument for a prima facie liberty right in the realm of genetic testing, namely that persons are sovereign over all uses of their own genome that do not harm others. Opponents of this liberty must offer cogent arguments if they want to restrict it.

References

Footnotes

  • Funding Portuguese Foundation for Science and Technology (FCT). SFRH/BPD/87083/2012. COST (European Cooperation in Science and Technology) (http://www.cost.eu). COST Action IS1303 ‘CHIP ME’.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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