Physicians are required to respect their patients’ medical choices, even when patients make choices that would undermine their health or wellbeing. The doctrine of informed consent requires that physicians respect all competent patients’ decision to refuse treatment and inform them about all relevant treatment alternatives. This means that physicians are not permitted to deceive or coerce patients or perform any medical procedures without a patient’s consent. In most cases, public officials also respect people’s self-regarding choices about their bodies and health even if their choices are dangerous. For example, officials do not legally prohibit people from getting bad tattoos, drinking alcohol, refraining from exercise, free-solo mountain climbing, becoming obese, or working as commercial fishermen even though these choices are often imprudent, dangerous, or unhealthy.
Yet for intimate and personal bodily choices that involve pharmaceuticals, physicians and public officials prohibit patients from making self-regarding medical decisions about their own bodies. In Pharmaceutical Freedom (forthcoming) I argue that patients’ rights to make important and intimate medical decisions don’t lose their moral force when patients leave their doctors’ offices. Patients have rights of self-medication as well.
Rights of self-medication refer to the rights to purchase and use unapproved treatments, prohibited drugs, and pharmaceuticals without a prescription. Existing premarket approval requirements for new pharmaceuticals and prescription drug laws violate patients’ rights of self-medication. Instead, public officials and private healthcare providers should certify drugs and provide information about the risks, side effects, and benefits of using drugs. They should not act as gatekeepers for potentially beneficial therapeutics.
Physicians and officials adopted the doctrine of informed consent relatively recently. Patients haven’t always had the legal authority to choose or refuse a recommended course of treatment. Legal protections for patients’ rights to consent to medical care developed throughout the twentieth century after courts found that performing medical procedures against a patient’s wishes was a form of assault. Yet medical paternalism persisted as recently as the 1960s; for example, researchers in one study found that almost ninety percent of oncologists reported that they routinely withheld cancer diagnoses from patients, and some substituted alternative diagnoses. Today patients and physicians recognize that paternalistic deception and medical battery are morally unacceptable. The rejection of medical paternalism over the course of the twentieth century was an ethical triumph for the healthcare profession.
Unfortunately, as patients gained the authority to make medical decisions in clinical contexts, they lost the authority to make medical choices with respect to drugs. In the nineteenth century, people recognized that patients had rights of self-medication. Yet in response to a series of devastating drug disasters throughout the twentieth century, including the deaths caused by use of Elixir Sulfanilamide in the 1930s and Thalidomide in the 1960s, public officials implemented safety and efficacy testing requirements and prescription requirements for therapeutic drugs. Initially these regulations aimed to prevent adulteration, inform patients, and make self-medication safer and more effective. But existing pharmaceutical regulations prevent self-medication entirely in cases where a patient’s judgment about whether to use a drug departs from her physician’s judgment or a regulator’s.
For the same reasons that the rejection of medical paternalism in clinical contexts has been such an achievement over the past century, the increasing acceptance of paternalistic pharmaceutical regulations has been an injustice. The same moral considerations in favor of respecting patients’ rights to make treatment decisions weigh against the paternalistic pharmaceutical regulations that developed during the same time period. And existing policies that prohibit self-medication cannot be justified without undermining these justifications for informed consent.
Specifically, the doctrine of informed consent is justified by an appeal to three kinds of moral considerations. First, a practice of respecting medical autonomy likely promotes good health outcomes on balance by fostering greater trust between patients and health workers and protecting patients from abuse. Second, patients are generally in a better position to know whether a treatment decision is in their overall interest even if physicians are in the best position to know how a decision will affect a patient’s health. Third, and most importantly, people have bodily rights and rights to make intimate and personal decisions even if those choices are unhealthy or imprudent.
These three kinds of considerations, medical outcomes, overall wellbeing, and patients’ rights, are also reasons to support patients’ rights of self-medication. Consider first the claim that respecting patients’ choices is likely to have good health effects on balance even if it means that in some cases patients will make unhealthy choices. Similarly, even if in some cases patients would make unhealthy choices when exercising rights of self-medication, rescinding prohibitive pharmaceutical regulations might nevertheless have good health effects on balance. For example, existing approval requirements harm patients’ health in two ways—by deterring innovation and by delaying access to potentially beneficial therapeutics. Even though some unapproved drugs are genuinely dangerous, it is also dangerous to enforce policies that undermine drug development in light of the ways that pharmaceutical innovation has increased income and life expectancy over the last century. And while people may consent to use dangerous drugs, they cannot consent to policies that cause them to suffer or die while waiting for potentially beneficial treatment.
The public health case in favor of prescription requirements is also weaker than it may initially seem. Prescription requirements raise the price of obtaining treatment, which could prevent people from accessing necessary drugs like birth control or inhalers because it is prohibitively expensive to obtain a prescription. Prescription requirements may cause people to take more medical risks than they would without a physician’s endorsement of their choices. For example, people may be more likely to use addictive opioids if the drugs were prescribed by a trusted physician. On the other hand, prescription requirements cannot effectively prevent people who are addicted to dangerous drugs from using drugs obtained through black markets or drug diversion. Even in these cases public health officials should focus on “smart legalization” paired with harm reduction initiatives and access to treatment for addiction instead of a prohibitive and paternalistic approach to drug use.
It is unlikely that providing patients with unrestricted access to pharmaceuticals would have good health effects in all cases though. After all, just as the doctrine of informed consent entitles patents to refuse life-saving treatment, rights of self-medication would give patients access to drugs deadly drugs. But like rights of informed consent, even if rights of self-medication did not promote people’s health in all cases, public officials and physicians should not narrowly focus on promoting health anyhow. Rather, physicians and officials should focus on the “whole patient,” not specific medical conditions, meaning patients’ overall wellbeing should take priority over medical outcomes. And since competent and informed adult patients are generally the experts about their overall wellbeing, physicians and officials should defer to them about their treatment. Prohibitive pharmaceutical regulations deprive patients of this deference and thereby prevent them from acting in their interests by forcing them to comply with regulators’ and physicians’ judgments about what they should do.
For example, when officials at regulatory agencies such as the Food and Drug Administration consider approval for a new drug, their decision is informed by a judgment of whether the risks and side effects associated with the drug are acceptable in light of the drug’s benefits. But whether a drug is acceptably risky is not a medical or a scientific judgment – it is a normative judgment that may vary from person to person. Even when officials are medical experts they are not experts about people’s values. This is why public officials cannot effectively determine whether the risks of a drug outweigh the benefits for an entire population, as all people have different values in addition to different medical conditions.
Similarly, physicians are also poorly equipped to know whether a treatment is in a patient’s overall interest when they prevent patients from using prescription drugs. Imagine a patient who decides that it is in his overall interest to use a prescription stimulant as a cognitive enhancement. The prescription drug system empowers his physician to override this judgment on the grounds that the drug is medically risky, even though the patient is in the best position to judge whether the risks are acceptable in light of the potential benefits. Furthermore, even people who are not interested in using drugs that regulators and physicians would recommend against may nevertheless have an interest in the freedom to do so, especially if they judge existing policies are offensively paternalistic.
But most importantly, even if respecting a patient’s medical autonomy wouldn’t promote her overall or medical interests, it would still be wrong to prevent her from making decisions about her own health and body. It is disrespectful to use force or coercion to paternalistically prevent someone from making a self-regarding choice, especially when that choice is an intimate and personal one. Moreover, several rights that are widely acknowledged as especially urgent and foundational rights, in addition to rights of informed consent, support rights of self-medication in at least some cases. For example, patients with progressive or terminal illnesses have defensive rights to preserve their own lives, and approval policies that prevent them from trying potentially beneficial therapies outside the context of a clinical trial violate these rights.
In practice, rights of self-medication only require that patients have legal access to pharmaceuticals, meaning that public officials are not entitled to legally prohibit patient’s from using unapproved or unprescribed drugs by threatening patients or their providers with legal penalties. One may object that laws that prohibit people from providing unapproved or unprescribed drugs do not violate patient’s rights of self-medication. But we would not accept this conception of bodily rights in other contexts. For example, a law that banned people from providing abortions would restrict the right to terminate a pregnancy even if it women seeking abortions were not threatened with legal penalties. Officials can violate a person’s right by prohibiting others from providing the necessary means to exercise her right. On the other hand, rights of self-medication do not entail a right to access any medication at low cost; they only include rights to self-medicate without government interference.
Some people may worry that they could be harmed by a policy that affirmed patients’ rights of self-medication, but if public officials respected that right, not much would need to change for people who support the current system. Public officials could still certify drugs as safe and effective, as could private certification services. Insurance companies could refuse to reimburse patients or providers for uncertified or unprescribed drugs in order to incentivize safer drug use. And patients who were uncertain about which drug to use could ask their physicians for advice.
To the extent that officials are worried that children or people who otherwise lack the capacity to make informed decisions may access dangerous pharmaceuticals, some drugs may legitimately be available “behind the counter,” which would enable pharmacists to assess a person’s competency before providing access. Such a system could also be used to track the distribution of deadly drugs and drugs that could be used in crimes. Addictive drugs may also be restricted to behind the counter access in order to enable addicts to voluntarily join registries that restrict their access.
On the other hand, respecting rights of self-medication would have some revisionary implications. People who currently lack effective treatment options and judge that they would benefit from a path to accessing beneficial drugs would benefit from having more options. People who disagree with their physicians about whether a treatment is promising would be permitted to take their health in their own hands and access drugs without a prescription. People would not be required to pay a physician and a pharmacist just to access birth control, insulin, or inhalers.
The foregoing argument for rights of self-medication also contributes to the growing chorus of arguments against the criminalization of recreational drugs in favor of a more respectful and effective harm-reduction approach. Rights of self-medication also include rights to use deadly drugs and enhancements. Though these kinds of drug use do not primarily serve a medical purpose, the arguments in favor of self-medication appeal to the idea that we should not focus too narrowly on medical uses and the health effects of drugs; instead officials should consider people’s overall wellbeing and bodily rights.
In summary, self-medication is a basic right and should be treated like other intimate and personal bodily rights, such as the rights to make medical decisions that are protected by the doctrine of informed consent. It is easy to overlook the harm of existing pharmaceutical regulations because their harmful effects are less obvious than the vivid dangers of risky drug use. When people die because costly approval policies deterred innovation or because a promising therapy was awaiting approval it appears as if they died from their diseases and not a lack of access. Yet the harms associated with pharmaceutical regulation are actually more morally objectionable than the harms associated with risky pharmaceutical use because informed adults can consent to the risks of using unapproved or unprescribed drugs but no one consents to the dangers of drug regulation.
For most patients, rights of self-medication needn’t change how they make medical decisions. After all, rights of self-medication do not preclude patients from consulting with physicians or using only government-certified drugs. But if patients had rights of self-medication they would be free to make intimate and personal decisions about their bodies that reflected their values rather than the values of a physician or public official. The evolution of informed consent requirements throughout the twentieth century and recent patient advocacy movements on behalf of rights to use medical marijuana, rights to die, and rights to use unapproved therapies, demonstrate that reform is possible. Today officials and health workers now recognize patients’ rights to make treatment decisions. Going forward, they should acknowledge that these rights include rights of self-medication too.