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Abstract

In the ﬁrst part, the entry explores theoretical foundations and historical evolution of patient’s freedom, analyzing the transition from a paternalistic model of medicine to a paradigm that is centered on patient’s beliefs and preferences , within which freedom of treatment is expressive of patient’s self-determination.

The second part ﬁrstly underlines the difference between the individual point of view (i.e., what a single and autonomous person can ask to another in a free market society) and the systemic point of view (to what extent a public health-care system has to recognize individual choices). In the individual perspective, the entry distinguishes a positive freedom of treatment (the freedom to ask for speciﬁc treatments and drugs, which are consistent with subjective preferences , values, and plans of life) from a negative freedom (that of refusing treatments or drugs proposed by healthcare providers, both in general and with speciﬁc regard to a single treatment). Finally, the freedom of treatment is analyzed in a systemic perspective, in order to discuss what are the treatments that can be requested from a competent patient (with speciﬁc regard to demands of alternative medicines and to unproven or off-label treatments) and whether the health-care system has a duty to give them to the patient.

Introduction

The issue of freedom of treatment is likely to generate public debates generally focused on patient’s autonomy, on his or her values and desires, on doctors’ duties, and on the family’s and patient’s expectations. From a legal and bioethical point of view, however, the question leads us also to broader considerations about the role of evidence-based medicine, as such recognized by the legal system, and alternative or complementary methods of care. Furthermore, it imposes an analysis of the relationship between one and the other and of fundamental rights which are interwoven.

Many questions can arise from such a relationship, and many of them can help us to sketch the limits of the freedom of treatment and to understand its meaning. Among the many, it is possible to ask to what extent patient’s wishes are to be met, without fostering illusions, or to what extent it is possible to derogate from scientiﬁc parameters, still remaining within the horizons of science. Again, one shall ask to what extent the discretion of the single physician can justify the use of unapproved drugs or unlicensed devices and ﬁnally (but the list could be much longer than this) whether there is a difference between the right to therapies and the freedom of therapies: in other words, the freedom of a patient of experimenting new drugs on himself or herself implies a duty for the health-care system to allow such a choice.

From Patient’s Autonomy To Freedom Of Treatment

It is well known that in the last decades, a progressive shift has occurred, in Western bioethics, from a paternalistic model of medicine to a more cooperative relationship between physician and patient. This cooperative model, based on the ideal of respecting patient’s autonomy through his or her informed consent about therapies, has become even more centered on patient’s beliefs and preferences . Contemporary Western medicine is more and more expressive of patient’s self-determination, instead of being conceived as the outcome of the patient–physician alliance.

More speciﬁcally, in the last forty years, we have witnessed one of the most radical changes in the history of the Hippocratic tradition, insofar as the principle of beneﬁcence has been progressively replaced by the principle of autonomy. Unlike the principle of beneﬁcence, the autonomy principle recognizes the individual capacity of taking decisions about medical care and requires that the patient with decisional autonomy be accorded authority over what is to be done and over treatments he or she accepts or refuses (Beauchamp and Childress 1979). As a proof of such evolution, one can consider the fact that in the ﬁrst edition of Reich’s Encyclopedia of Bioethics (Reich 1978), there was no entry on autonomy; the entry was added in the second edition (1995), where it was deﬁned by focusing on three elements: agency, independence, and rationality. Agency is “awareness of oneself as having desires and intentions and of acting on them,” independence is “the absence of inﬂuences that so control what a person does that it cannot be said he or she wants to do it,” and rationality is interpreted as the capacity of “rational decision making.”

However, the concept of autonomy has been progressively expanded, so as to include not merely the so-called decisional autonomy (its ﬁrst meaning), but also the executive autonomy, i.e., the patient’s capacity to execute self-management tasks. In other words, autonomy has been perceived not only as the capacity to understand information and make decisions about treatments and cares but also as the capacity to act according to what has been decided. Of course, contemporary Western medicine has undoubtedly acknowledged the principle of autonomy as the respect of patient’s right to his or her views and the permissibility of actions based on such beliefs (Beauchamp and Childress 1979, p. 58). But if the minimal and original content of such a respect was the recognition of patient’s independence, of his or her freedom from any form of coercion and from other interferences, in recent years patient’s autonomy has been shifted more resolutely toward the idea of self-determination.

What is at stake is not the mere consent to options and alternatives proposed by the physician, nor the involvement of the patient in the decision-making process, but his or her right against the state or against any other form of interference, coercion, or manipulation of individual’s efforts to make decisions and execute these decisions. In other words, it is not simply the patient’s ability to accept or refuse treatments that is to be considered, but more speciﬁcally his or her preferences , which are signiﬁcant because they make explicit the values that are rooted in one’s plan of life and action: from a simple noninterference, autonomy has become a more demanding recognition of individual preferences : and beliefs.

From Autonomy To Freedom Of Health

Such a change is both due to a progressive refusal of medical paternalism and to a more and more signiﬁcant consolidation, in Western countries, of liberal paradigms. According to Mill and Kant, indeed, autonomy’s minimal content is freedom from any form of coercion, that is, no one should interfere with the plans and the liberty of another, provided such a plan or action does not harm other people. And this respect of individual freedom is defensible as an obligation that binds both individual and organizations. Kant defended this principle by afﬁrming the categorical imperative of treating others (and oneself) never merely as a means, but always as an end in himself or herself: for this reason, acting only with concern to what we consider the best for a person is not sufﬁcient for respecting his or her autonomy; we shall discover and take seriously the individual’s values and plans, his or her objectives, and his or her desires, if we want to consider him or her as an end in himself or herself (Miller 1995, p. 247).

Accordingly, the right to health seems to be shifted, more and more evidently, into a partially different freedom of health. If the right to health operates as an obligation for governmental intervention and regulation in the ﬁeld of health-care services, the freedom of health operates rather as a restriction on such intervention. And such a freedom not simply requires the right to obtain certain health-care goods and services, or the right to refuse unwanted medical treatments, but the right to choose what treatments are required or preferred and what are more consistent with the individual plan of life.

Strictly speaking, the language of rights in the ﬁeld of health care has been transferred, in many cases, to claims for speciﬁc treatments based on the right to respect for one’s private and family life under, for instance, Article 8 of the European Convention on Human Rights (ECHR) (see R (Burke) v General Medical Council (2004) EWHC 1879 (Admin)) or based on the right of information disclosure (which in many legal systems is already recognized as a patient’s fundamental right). In this second hypothesis, indeed, patient’s autonomy is interpreted as correlative to the physician’s duty of giving information not only about the risks and beneﬁts of a treatment but also about alternative treatment options and their possible beneﬁts and risks (Maclean 2009).

What Is The Freedom Of Treatment?

The freedom of treatment is, simply stated, the freedom of a patient to choose whether and how to be treated, whether and how to take speciﬁc drugs, and whether and how to opt for treatments that are not yet recognized by the scientiﬁc medical community and even for treatments that are totally or partially outside of the paradigms of scientiﬁc Western medicine.

Such a deﬁnition is evidently too generic and vague. On the one hand, and above all, positive and negative freedom should be distinguished; on the other hand, it is to be explained whether such a freedom is to be considered, and to what extent, a patient’s right. It is not immediately evident, indeed, whether such a freedom is to be intended only in a negative sense, as a right not to be interfered with (the right to refuse treatments is an example of such a negative freedom), or also as a positive right, a right to be provided with some speciﬁc drugs or treatments. And, additionally, whether the alleged positive freedom is to be intended in a purely formal meaning, as a freedom to choose whatever is consistent with one’s personal plan of life, or in a more restricted meaning, as a freedom to opt between alternatives proposed by the doctor, all of them are allowed by the national health-care system.

It is true that although many health-care laws recognize negative patient choice, rarely it does encompass a positive right to choose treatments and care options. Only recently, and in just few countries (see, for instance, Lord Darzi’s report for the UK), it has been recognized that the enforcement of the right to health does not require merely the provision of services and treatments that are in the best interest of the patient and the respect of their consent of those treatments. Such a right also requires that patients can inﬂuence and shape therapies for themselves and that they can ask for personal ways of treating them, which may be irrespective of protocols. Signiﬁcantly, the report concludes that “a health service without freedom of choice is not personalised” (UK Department of Health 2008, p. 38), thereby requiring that patients should be free to set their goals and receive appropriate support to achieve their goals as partners with health-care professionals.

The pivotal issue, in order to clarify the freedom of treatment’s meaning and its limits, is that it is an aspect of the individual right to health: however, the right to health and the freedom of treatment do not completely overlap each other. The reason is that any health-care system requires rules and standardized practices and a general coordination of actions and services that cannot be totally committed to individual options and choices. In this perspective, in order to deﬁne whether and how the patient has a positive freedom to choose treatments and drugs, it is useful to separate the individual point of view (i.e., what a single and autonomous person can ask to another in a free market society) from the systemic point of view (what a public and organized health-care system shall provide and to what extent has to be supportive of individual choices).

The Individual Freedom Of Treatment

If we consider the single patient’s freedom of treatment, we have to notice that such a freedom is two-faceted: it has both a positive and a negative meaning, and it can be interpreted as freedom from treatments, as well as freedom to (ask for) treatments.

The Freedom From Treatment

In its negative meaning, the patient’s freedom is that of refusing treatments or drugs proposed by health-care providers, both in general and with speciﬁc regard to a single treatment. The patient’s freedom includes the right to self-determination, the right to live his/her own life how she/he wishes, and the right to do with his/her body what she/he wants, even if it will damage his/her health or lead to his premature death. For that reason, the freedom of treatment can be interpreted, in this ﬁrst meaning, as a freedom from any treatment that the patient does not give consent. According to this principle, the American Medical Association’s code acknowledges that the “patient’s right of self-decision can be effectively exercised only if the patient possesses enough information to enable an informed choice. The patient should make his or her own determination about treatment” (AMA 2014, p. 8.08). The AMA requires physicians to disclose “all relevant medical information to patients” in order to enable them to make medical decisions based upon their personal beliefs and life plans. Under this standard, physicians shall respect patient’s decisions even if they do not conform with what is presumed to be his or her best interest. This kind of freedom is nowadays broadly accepted: Article 6 of the Universal Declaration on Bioethics and Human Rights (2005) states that “Any preventive, diagnostic, and therapeutic medical intervention is only to be carried out with the prior, free, and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.”

Accordingly, when patients decide to refuse recommended treatments, even if they are urgent or medically necessary, physicians shall recognize their right to refuse. Of course, physicians have to explain consequences of the refusal, and reasonable alternatives should be explained and offered to patients, but no coercive treatments can be allowed and practiced (Stanton-Jean et al. 2014).

The Freedom To Treatment

The positive meaning of the freedom to treatment is much more controversial, and it represents its more recent aspect. According to a general principle of respect of personal autonomy, and the physician’s responsibility for the administration of any therapeutic treatment being understood, it can be justiﬁed and allowed to give any kind of substance or drug to a competent patient at his or her request. In other words, provided the patient is aware and informed, and provided his or her capacity and autonomy, the respect of his or her freedom requires to allow the physician to give any kind of treatment, even if there is no evidence of the beneﬁts that can be achieved through this choice. From that point of view, it is the freedom to ask whatever is assumed by the patient as desirable and consistent with his or her values, plans of life, goals, and beliefs. But what is at stake is what are the treatments that can be requested and whether the doctor has a duty to give them to the patient.

The ﬁrst question is about the distinction between the freedom to ask for treatment not yet validated and not approved by the scientiﬁc community, but that according to the available data may be considered as hypothetically beneﬁcial, and the freedom to ask for treatments that are entirely beyond the horizon of the evidence based medicine, such as homeopathy, mesmeric therapies, and chiropractic treatments. Usually, the ﬁrst hypothesis is that of the recognition of the right to off-label drugs, or to the compassionate use of treatments, and of the recently alleged “right to try” for terminally ill patients who have no alternative according standard protocols: this question will be addressed in a speciﬁc section below. But, from a patient’s point of view, the freedom of treatment should have no limits. Even without considering the hypothesis of active and direct euthanasia, if a patient has the right to give consent or to refuse consent to any kind of treatment, according to the respect of his or her personal autonomy, there is no reason to deny his or her freedom to choose whether and how to be treated, whether and how to follow physician’s prescriptions, and whether to resort to Western evidence-based medicine or to alternative practices and therapies. In other words, if we start from a principle of individual autonomy, both positive and negative freedom of treatment do not have any justiﬁed limit.

Possible Limits To The Individual Freedom Of Treatment

There are, in fact, other perspectives less prone to the interpretation of personal autonomy as independency and self-determination; these paradigms, which follow theories such as those of Taylor, criticize the idea of a disembedded and disembodied self and develop a relational and dialogical account of autonomy (Keller 1997). Pivotal, in these perspectives, is the idea that the moral agent is an “encumbered self,” who became autonomous within a network of relationships, which have to be considered in the decision-making process: self-esteem, self-trust, and respect are necessary conditions of autonomy, but are at the same time highly dependent on the system of relationship within which the person lives.

This different approach becomes particularly evident when considering autonomy from a global perspective. Many Asian cultures start from a non-individualistic point of view, which conceives autonomy as a collective pertinence more than as an individual’s right. Autonomy, in these perspectives, has to be interpreted as the possibility, for the whole group that is involved and affected by the sickness, to take part in the decision-making process and in the therapeutic alliance (Cheng-the Tay and Lin 2001). The disclosure of information itself that is somehow the premise of any exercise of the freedom of treatment has to be performed by taking into account such different conceptions of autonomy: while Western countries generally underline the importance of a wide disclosure of information, which is inspired to the principle of truth telling, other cultures prefer indirect forms of disclosure, to other members of the patient’s family group, or forms of disclosure accompanied by religious and nonreligious rituals (Aldrich 2013). In these perspectives, in other words, it is much harder to afﬁrm that the freedom of treatment is to be interpreted as the main outcome of individual autonomy and self-determination: rather, it can be perceived as the collective freedom of a group to ask for (or to refuse) speciﬁc treatments in order to respect collective values and lifestyles.

The biggest problems may arise when the patient is a minor or when he or she is a psychiatric patient. In such cases, the freedom of treatment becomes problematic insofar as the autonomy of these people is questionable. With regard to children, it is usually assumed that parents can make decisions for them, but that states may intervene to protect the well-being of minors who are not old enough to decide for themselves. In these situations, laws and courts have to balance the parental right to choose alternative therapies or even to refuse treatments for their children, according to their fundamental religious freedom, their right to privacy, and their right to raise children as they desire, with the children’s constitutional right to health and the state interest in protecting them. However, in a global perspective, it is to be stressed that some states have religious exemptions in their civil codes, or religious defenses to crimes, which, for instance, can shelter parents from misdemeanor violations if they treat their children through prayer, in accord with the beliefs of a recognized religion, instead of conventional medicine (Neerukonda 2011, p. 369). Anyway, independently (at least in part) to the fact that the patient is a minor, his or her freedom of choice should be taken into account to the extent he or she can clearly communicate his or her decisions, can understand the information about his or her condition, can appreciate the consequences of his or her choices, and can weigh out the relative risks and beneﬁts of the options.

Similar problems can arise for psychiatric patients, whose freedom of choice about treatment has to be balanced with their concrete capacity of exercising personal autonomy, and cannot be simply presumed as for any adult person. Although no diagnosis in which consciousness is retained is invariably predictive of incapacity, it is undoubted that many psychiatric diseases are predictors of incapacity and thus not consistent with a right to exercise freedom of treatment: patients with Alzheimer’s disease and other dementias have high rates of incompetence, as well as patients with schizophrenia, depression, bipolar disorder, lack of insight, etc. (Appelbaum 2007). At the same time, and similarly to the assessment of children’s capacity, even if legal standards vary considerably among jurisdictions, patient’s freedom of choice derives from the concrete ability to communicate, to understand relevant information, to evaluate consequences, and to reason about therapeutic alternatives and cannot be simply excluded for psychiatric patients.

The Freedom Of Treatment Within The Health-Care System

A signiﬁcantly different question is whether and to what extent the health-care system has to provide those treatments that the patient can ask; in other words, the question is whether the local health-care system has to grant, by the provision of drugs and treatments and devices, those choices that the patients can make. In so doing, the freedom of treatment could be interpreted more as a right to choose treatments, rather than a mere positive freedom to decide whether and how to be treated; it would be not simply the freedom to ﬁnd, in a free market society, those treatments that are most desirable for the patient, but it would be translated in a positive right to ask for speciﬁc treatments, to which shall correspond a duty for the physicians to provide them. In that hypothesis, the question would be what options should be provided by the national health-care system, in order to grant the individual freedom of treatment.

Freedom Of Treatment And Alternative Medicine

A possible answer can be that a health-care system can only provide these treatments whose efﬁcacy has been proven under a paradigm of scientiﬁc rationality. Such an answer is certainly wise and broadly shared, but there are some signiﬁcant exceptions that are to be considered.

First, even within Western health-care systems, the link between a disease and a therapy that is scientiﬁcally recognized is seldom questioned. If one thinks about the hypothesis of voluntary sterilization, now allowed in many countries, it is hard to afﬁrm that the idea of medicine as scientiﬁc answer to speciﬁc diseases is the sole shared paradigm of medical practice. Indeed, in such a case, a speciﬁc medical practice is carried out without any clinical necessity, but merely on the base of patient’s desires. This is because the prevailing deﬁnition of health is nowadays centered on the personal experience of well-being, not only in the sense of absence of speciﬁc pathologies but rather on the capacity of achieving personal objectives and of functioning in social contexts; according to such a deﬁnition, it is difﬁcult to afﬁrm that scientiﬁc and evidence-based medicine can be the unique appropriate answer to the patient’s needs. On the contrary, it is possible that alternative and nonscientiﬁc medicine can be more consistent with the individual’s perspective and objectives.

Accordingly, besides monopolistic health-care systems (within which nonconventional therapies are excluded and the patient’s freedom is reduced to the negative right to refuse treatments or to the individual freedom of choosing alternatives outside the national system, in the free market), there are more inclusive systems, such as those of India or Pakistan or Bangladesh, and even more integrated systems, such as those of China and Nepal, where scientiﬁc paradigms and traditional medicine coexist, and a concrete possibility of choice is recognized to the patients (Stepan 1985). In other words, while in Western countries patient’s freedom is mainly the freedom to refuse therapies or the freedom to look for alternative therapeutic options by leaving the national health-care system, in other countries such a freedom can be exercised more broadly by asking for treatments that are not supported by scientiﬁc evidences, but that are consistent with the paradigms of traditional medical practices.

The Claim For Unproven And Off-Label Treatments

Second, and remaining within the horizon of scientiﬁc medicine, the demand for off-label or unproven treatments should be considered: in other words, the freedom to ask for treatments that lack precisely those evidences, which are fundamental for a scientiﬁc approach to medicine. It is well known indeed that under the system currently dominant in evidence-based medicine, drugs undergo three phases of clinical testing before national health institutions approve them for marketing. Phase 1 trials usually are designed only to study the metabolism and toxicity of a drug and the effects of different doses: this phase just provides preliminary information about toxicity and generally few data about efﬁcacy. Only phase 3 trials are larger and designed to provide conclusive information about efﬁcacy, assessing the risks and beneﬁts of a drug in treating a speciﬁc pathology.

The question is whether, in the name of individual’s freedom of treatment, at least those patients who have no other therapeutic options should have access to drugs and treatments that have not yet received any regulatory approval. For instance, should a patient who had exhausted other treatment options be allowed to be treated with a drug with only tier 1 approval? In this case, two contrasting needs are to be considered: on the one hand, the need of patients with serious diseases who do not respond to standard and approved therapies and who ask for more therapeutic options and, on the other hand, the society’s need to a drug regulatory system based on scientiﬁc standards, such to grant public health through the provision of safe and efﬁcacious drugs and such to avoid misleading experimentations. Some scholars indeed argue that allowing patients to access to investigational drugs could jeopardize not only their condition but even more the general development of medical knowledge, by subtracting outcome data to standard trials (Caplan 2007).

Such a right is still recognized, at least in part, in some countries. For instance, the FDA’s current policy on off-label use of drugs allows patients to access phase 3 drugs, provided that the patient’s disease has no satisfactory approved therapy and that the potential beneﬁt for the patient justiﬁes the potential risks. Furthermore, the availability of an unapproved drug has not to interfere with the drug’s trials and development (Food and Drug Administration 2009). But one more signiﬁcant example has been the “Ebola case,” with regard to the possibility of providing drugs still in phase 1 or even less. The WHO, in its report of the panel discussion on “Ethical considerations for use of unregistered interventions for Ebola viral disease,” stated that it is “ethically acceptable to offer unproven interventions that have shown promising results in the laboratory and in animal models but have not yet been evaluated for safety and efﬁcacy in humans as potential treatment or prevention” (WHO 2014, p. 7). Many criteria should guide the provision of such treatments, including informed consent, freedom of choice, preservation of dignity, involvement of the community, and risk–beneﬁt assessment. But the point is that when the patient’s condition and the public health are at risk, it is ethically legitimate to derogate to scientiﬁc standards of evidence-based medicine and provide unapproved drugs and treatments.

A partially different situation is whether a patient can ask for a treatment that is not currently object of any trial. Such a situation often occurs for rare diseases, for which there is no ongoing trial nor there will be in the next future. In these cases the patient demand for a treatment or a drug whose toxicity is not yet adequately known, because phase 1 has not begun, should be evaluated. With regard to these situations, a further evolution of the concept of freedom of treatment is to be noticed, at least for terminally ill patients. Some states in the USA (at the moment, Colorado, Michigan, Louisiana, Missouri, and Arizona) have recently adopted rules that recognize what has been called the “right to try,” that is, the right to have access to investigational drugs even without petitioning the FDA to obtain it. Such a new right, highly questioned from many scholars (Chapman 2014), can represent a further evolution of the freedom of treatment, because it can bolster a more libertarian conception of personal self-determination, according to which any individual decision about treatments (positive or negative) is in principle legitimate and cannot be limited by the public institutions, provided it does not harm other people.

Conclusion

Freedom of treatment is a multifaceted concept. It is based on the idea of patient’s autonomy, increasingly recognizing patient’s beliefs and preferences . As much as contemporary Western medicine is focused on patient’s well-being and on his or her capacity of achieving personal objectives and of functioning in social contexts, autonomy becomes self-determination, and freedom of treatment seems to be one fundamental feature in medical practice and within the doctor–patient relationship.

Anyway, freedom of treatment has multiple meanings, and some of them are more broadly accepted than others. In its negative form, it can be perceived as freedom from treatments, that is, the freedom to refuse and to withdraw the consent to any treatment or drug, even if they are necessary and lifesaving. This negative meaning is probably the oldest version of the freedom of treatment, and it hails from the WWII experience and the Nuremberg Code. This is also why, at least in its fundamental aspects, it is broadly accepted.

The positive form of such a freedom, that is, the freedom to (ask for) treatments, is much more questioned. It can be the freedom to ask for nonconventional treatments, i.e., for treatments that are not accepted within the paradigm of evidence-based medicine. But it can also be the freedom to ask for unproven treatments that are only hypothetically consistent with the scientiﬁc paradigms. In both cases, the right of a competent person to choose how to be cured and to ﬁnd in the free market those services and substances that he or she requires (if they are allowed, of course) is often not questioned. But it is much more disputed whether the health-care system should provide these alternatives to patients and to what extent.

It is reasonable to assume that any health-care system can provide only little alternatives (among those possible), because of the scarcity of resources and the necessity to provide those treatments whose efﬁcacy has been demonstrated. Health-care systems are necessarily based on protocols and focused on practices that are accepted by the scientiﬁc community. Accordingly, even if the freedom to be treated with unproven drugs is gaining consensus among courts, and although the “right to try” has been recognized as an aspect of the right to health by few North American states, it is hard to imagine that it would be generally accepted as a universal principle.

Anyway, some forms of cooperation between evidence-based medicine and alternative medicine are possible, and they are already carried out by some countries. In these cases, freedom of treatment can be interpreted as the freedom to choose between a limited (although wide) number of therapeutic options.

In this perspective, the freedom of treatment is not only a multifaceted concept but a progressively expanding one.

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