The Greek Conference - Mykonos, September 2005 Papers

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THE IMPACT OF HUMAN RIGHTS ON MEDICAL LIABILITY

Dr Takis Vidalis*

In 1997 the Council of Europe adopted the European Convention on Human Rights and Biomedicine in Oviedo, Spain1.

The so-called “Oviedo Convention” is not just one of the so many international legal documents of a rather trivial importance. It represents the first major attempt in the legal field, having as purpose to regulate the relationships between physicians and patients under the terms of human rights.

Until then, these relationships were governed traditionally by the rules and codes of medical ethics, from the Hippocratic Oath (attributed to many centuries BCE) to the Declaration of Geneva (WMA 1948, last amendment 1994), the International Code of Medical Ethics (WMA 1949, last amendment 1983), the Nuremberg Code (1947), the Declaration of Helsinki (WMA 1964, last amendment 2000), the Belmont Report (1979) on biomedical research etc.

How can we explain and what are the meaning and the possible consequences of this “legalisation” of medical practice? In this paper, I will try to examine these questions.

The Convention

The Oviedo Convention covers a wide range of topics by using the characteristic terminology of human rights. We can mention, first of all, its general provisions, declaring the protection of

In chapters concerning special topics, the Convention contains detailed guarantees for:

There are also particular provisions for:

Furthermore, there is a chapter relevant to biomedical research and the adequate protection of persons undergoing such research, whether able to consent to or not, in clinical trials (art. 15 - 17).

In the same chapter there is also a provision accepting research on human embryos in vitro for scientific or therapeutic purposes, under strict conditions (art. 18). In addition, there are rules aiming at the protection of living donors in transplantations, stating that the informed consent of the living donor should be preserved more carefully (art. 19 - 20).

Finally, it is worth mentioning that the document contains a general provision declaring the principle of non-commercialization of the human body and its parts (art. 21), which reflects a common ethical standard of the existing national laws in Europe, with regard to traditional medicine and biomedicine.

The Convention is a binding legal text; therefore it demands the monitoring of its application by the Member States that would ratify it, and even the imposition of sanctions in case of infringements (art. 23 - 25).

But, moreover, the Oviedo Convention represents a starting point for the “legalization” of contemporary medicine. Indeed, the Council of Europe has already adopted three additional protocols, which contain special regulation in conformity with the Convention principles, as regards

These Protocols use also the terminology of human rights and have binding legal force as well, if ratified by the European States.

The change of medical practice

The existence of these legal documents in Europe reflects a completely new approach of the physician/patient relationship. As mentioned before, for many centuries this relationship was regulated almost exclusively by rules of medical ethics, that is, by non-legal rules.

According to the traditional formulation of these rules, the physician plays the central role, as the person who accepts the total responsibility of a diagnostic or therapeutic process. In that context, the role of the patient is rather a “passive” one; the patient must comply with the physician’s advices, not because they “agrees” with him but rather because they “trust” him5. In that context, the initial act of selecting a physician is, in fact, the only voluntary initiative of patients, all the rest remaining at the expert’s hands.

This traditional approach of the physician/patient relationship corresponds to a quite simple status of medical liability in the law. Indeed, as only the expert decides for a medical treatment, he/she is the exclusively liable person. And as his/hers initiatives and acts are based upon scientific knowledge, only extreme cases of obvious malpractice can be judged as contrary to medical liability.

Therefore, for evaluating medical liability in particular cases, general provisions of criminal law and the law of torts are quite enough.

Yet the application of these provisions is exceptional: In such a context, what really counts, apart from the specific medical knowledge, are the physician’s moral attitude, the compassion, the sense of devotion and the humane approach of his/hers duties towards their patient.

But, during the last decade, the emergence of a new notion, that of “informed consent” has changed this traditional approach6. “Informed consent” was, in fact, the path for acknowledging patients as active participants, real contributors to their own medical treatment, persons who cooperate with physicians for achieving the best possible result7.

It is not surprising that the first elaboration of this notion comes from the area of biomedical research, where the risks of experimentation are extensive; so the patient’s voluntary participation in every step of the proposed treatment protects not only him but also the physician from the blame of a possible mistake.

After that first indication of change, the next episode was a more and more detailed and extensive elaboration of the medical malpractice theory, particularly in the American legal system8. An increasing number of lawsuits and judicial decisions (not always justified, it is true) expanded considerably the concept of malpractice and the relevant area of medical liability.

The reaction of the medical world was what we call “defensive medicine”, that is a refusal from physicians to take initiatives during a certain treatment, without the consent of the person undergoing this treatment. The message of “defensive medicine” was that physicians don’t accept the whole responsibility for a certain treatment anymore; they don’t want to play the role of the only “active” part in the medical relationship, eventually an authoritarian role of a kind of “guru”. So, the need for a “shared” responsibility between physicians and patients concluded to the dominance of “informed consent”, as the pivotal notion of the modern medical law, and the acknowledgement of both parts as active contributors in the process of treatment.

Informed consent and human rights

Most of all, informed consent was the key to associate medical practice, and medical liability with the whole spectrum of the patient’s human rights. We must note here, that, until the era of informed consent, the protection of several rights (particularly, the right to privacy) was a duty imposed on physicians by their codes of medical ethics9; it was not the natural subject of these rights of the one who cared for their protection, in the first place.

After the acknowledgement of the key -notion, this responsibility has been transferred to the natural subject of rights - the patient. This is a development with an important consequence: Asking the consent for a certain medical act (after previous adequate information of the interested patient about the expectations and the possible implications of this act), the physician has eventually the crucial evidence for the preservation of rights, such as the right of physical integrity, the personal freedom, the freedom of moral and religious beliefs, the right to privacy and so on. Having this evidence, the physician can proceed to commence the treatment safely, that is, without the fear of unexpected legal implications from the course of treatment (although this does not diminish the physician's responsibilities to properly carry out that treatment).

The explicit and, if necessary, written form of the patient’s consent, is now common practice, particularly in difficult and risky therapies. The existence of such forms of informed consent makes clear the limits of medical liability. In other words it makes clear the concrete space under which the physician can develop freely the treatment methods, according to his/her scientific knowledge and personal moral convictions, as well.

In this context, an informed patient may consciously reject available means of therapy, because she may find them contrary to hers human rights: For some, a painful method may violate physical integrity, for others hospitalization may violate personal freedom etc. But, this active role of the patient excludes automatically the blame for medical malpractice, in case of undesirable results; this is the logical cost of the responsibility “sharing” that patients must accept (and sometimes suffer). On the other hand, physicians have no excuse to avoid available means of therapy, fearing the possibility of malpractice, if they have previously properly informed the patient and freely obtain the patient’s consent to proceed. On the contrary, in such a case a physician is certainly liable for malpractice, if he/she does not take all initiatives, that he/she believes necessary for the treatment.

The bond of trust

Is that model of “legalisation” better for the exercise of medicine nowadays? Could we say that, what we lose here, is the traditional bond of “trust” linking the patient with the physician that he/she prefers?

Yet it seems that the original bond of trust in the patient/physician relationship corresponds rather to social conditions of the past. Under these conditions, ordinary people were, in fact, unable to form rational opinions about the situation of their health, due to lack of general education. In addition, physicians possessed limited scientific knowledge and methods of treatment, because the inputs of their information were relatively limited; they did not have the means and the amount of information about developments in their science (besides these developments were much slower than in our time). These two factors justified eventually a strong bond of personal trust, between a patient who knew almost nothing and a physician who seemed to know almost everything.

These factors have deeply changed. Patients are now in place to understand the situation of their health, just because they are educated people. On the other hand, physicians have much more information to control and apply in their practice, a thing which is necessary for the progress of medicine, but creates also uncertainties about the best possible treatment in particular cases.

So, patients, if informed properly about their disease, are now able to balance the burdens and risks of proposed treatments with other important values affecting their life, such as personal freedom, privacy, moral beliefs etc, - in other words values corresponding to their human rights.

In the old model of personal “trust” the responsibility of this balancing of values belonged to the physician (who decided for everything), and lay in the area of medical liability. Now, there is no reason to suppose the same. In this arrangement of mutual responsibilities about the process of treatment, personal trust has not disappeared. On the contrary, it may be strengthened, since physicians perhaps feel safer regarding their liability and a possible blame of malpractice. Moreover, feeling safer, they do not have reasons to exercise “defensive medicine”, focusing on the avoidance of such blames rather than on the patients’ good.

Conclusion

To summarize these comments:

  1. The adoption of legal documents concerning the protection of human rights in the patient/physician relationship is a relatively recent development, corresponding to the new model of “shared” responsibility between the parts in the treatment practice. The key-notion for the allocation of responsibility in every particular case is the patient’s informed consent.
  2. The balancing between the human rights fundamental values and the requirements of a certain proposed treatment, is something that, in the first place, patients themselves should make (and decide accordingly), via the process of informed consent.
  3. The area of medical liability appears, thus, relatively restricted; physicians cannot be found liable for acts (properly carried out) they have done in accordance with the particular content of informed consent. Their responsibility is, of course, to inform patients properly, about the consequences of a certain therapy.
  4. This “legalisation” of medical practice does not necessarily diminish the crucial role of trust in medical practice. It helps rather to clarify the extent of medical liability; thus functions in favor of trust, as physicians have not reasons to exercise “defensive medicine”.

Perhaps, the profound meaning of these developments in medical law is that, as confirmed permanently in so many fields of social life, nobody but the natural subjects of human rights are the best guardian of them. Given that, it certainly would not be fair to ask from physicians playing this role for other people; it would not be fair, consequently, to put to their shoulders an insufferable liability.

*Dr Takis Vidalis, Ph.D./Law, Hellenic National Bioethics Commission , Greece

1 “Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine” (Oviedo, Spain 1997).

2 “Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings” (Paris, France 1998).

3 “Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Transplantation of Organs and Tissues of Human Origin” (Strasbourg, France 2002).

4 “Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research” (Strasbourg, France 2005).

5 In the same sense, see also R. M. Veatch, “Medical Oaths and Codes” (1995), in: S. G. Post (ed.), Encyclopedia of Bioethics, v. 3, 3d ed., McMillan Reference, N. York, 2004, p. 1497.

6 See, in general, T. L. Beauchamp - J. F. Childress, Principles of Biomedical Ethics, 5th ed., Oxford U.P., New York - Oxford 2001, pp. 77 – 80. For a comprehensive history of this term, see R. Faden – T. L. Beauchamp, A History and Theory of Informed Consent, Oxford U. P., N. York 1986.

7 The alternative models of relationships between patients and physicians are presented in: J. F. Childress – M. Siegler, “Metaphors and Models of Doctor –Patient Relationships: Their Implications for Autonomy”, Theoretical Medicine 5 (1984), pp. 17 – 30.

8 See T. A. Brennan (rev. by M. Mehlman), “Medical Malpractice”, (1995), in: S. G. Post (ed.), Encyclopedia of Bioethics, v. 3, 3d ed., McMillan Reference, N. York, 2004, pp. 1460 – 1462.

9 See, for example, the Code of Ethics of the American Medical Association (1847), Chpt. I, Art. I, 2, and, one century later, the WMA International Code of Medical Ethics (1949 – “Duties of Physicians to the Sick”)

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Copyright 2005. Greek Legal and Medical Conference