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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
• “human dignity and identity” (art. 1),
• the respect of “human integrity” (art. 1),
• the primacy of each and every human being against simple social or scientific
interests (art. 2),
• the equal protection principle (art. 3); and,
• the right to health (art. 3).
In chapters concerning special topics, the Convention contains detailed guarantees
for:
• the informed consent principle (art. 5),
• the protection of persons unable to give consent (art. 6),
• the protection of personal medical data (art. 10),
• the right to be informed: and,
• the “right not to know” (art. 10).
There are also particular provisions for:
• the use of genetic data (art. 11),
• genetic testing (art. 12),
• the modification of human genome (art. 13), which refuse any discrimination
of people on the basis of these data, accept modification of genome only of
the person concerned and not of future generations; and,
• prohibit embryo selection on the basis of sex (art. 14).
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
• human cloning2,
• transplantations3, and
• biomedical research4.
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.
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