Mediator at UNESCO,
Co-Chair of the Ethics Committee, World Academy of Biomedical Technologies (WABT),
Former Secretary-General of the International Bioethics Committee (IBC), UNESCO
Speech at the ICMCC Event 2008
June 10, 2008
In the 80’s several international organizations starting putting on their agenda issues pertaining to biology, genetics, medicine and related technologies and to their ethical, legal, social and cultural implications. This was not happening by chance. There were at least four reasons for it. Firstly, there was a sense of the increasing economic weight carried by the research in these areas and by their potential applications. Secondly, the huge expectations that progress in these areas represented in terms of health and well-being for humanity as a whole. Thirdly, the social and cultural changes that would be induced by developments in these fields were perceived as being significant. Fourthly, the public attention that advances in these areas have triggered lead decision-makers to give priority to these issues.
In particular the Council of Europe, in Strasburg and the United Nations Educational, Scientific and Cultural Organization (UNESCO) in Paris were very active. After ten years of preparation, the Council of Europe adopted in 1997 the Convention on Human Rights and Biomedicine (Oviedo Convention) that to date has been ratified by 21 European States. However, it should be noted that it has been ratified neither by France, nor by Germany, nor by the United Kingdom.
Over a period of twelve years, from 1993 to 2005, the United Nations Educational, Scientific and Cultural Organization (UNESCO), with a membership of 193 States, elaborated and adopted unanimously three essential international instruments, which are relevant to the theme selected by the International Council on Medical & Care Compunetics for the 2008 Event, namely Patient Empowerment – The Power of Information.
The Universal Declaration on the Human Genome and Human Rights (UDHGHR) was in 1997 the first universal instrument ever covering the challenges raised by genetic research and their applications in the field of human rights. This Universal declaration was endorsed by the United Nations General Assembly in 1998.
The International Declaration on Human Genetic Data (IDHGD) was adopted in 2003. Its purpose is to ensure respect of human dignity and protection of human rights and fundamental freedoms in the collection, processing, use and storage of human genetic data.
Finally, the Universal Declaration on Bioethics and Human Rights (UDBHR), adopted in 2005, is an all-encompassing legal text that aims at providing a universal framework of principles and procedures to guide States in policy-making and guide the actions of individuals, communities, professional and corporate groups.
The Convention of the Council of Europe is a legally binding instrument. It creates obligations on the side of States and foresees sanctions in cases of infringement of its provisions. The Web site connection to download the European Convention is: http://conventions.coe.int/Treaty/Commun/ListeTraites.asp?MA=9&CM=7&CL=ENG.
The UNESCO Declarations are none binding. However, they represent the consensus of the international community on ethical and legal principles pertaining to medicine, life sciences and associated technologies. As such they do carry some weight since they represent the moral commitment of States to abide by these rules.
The UNESCO texts can be accessed on its Web page through the following link: http://portal.unesco.org/en/ev.php-URL_ID=12027&URL_DO=DO_TOPIC&URL_SECTION=-471.html.
I will limit myself to raising the following three issues:
- The right of any patient to access his/her medical records;
- Imparting information to patients, in terms of:
- the conditions required,
- the psychological factor in the relation between a patient and the physician and,
- the cultural sensitivity.
- Access by third parties to medical records and information.
III. RIGHT OF PATIENTS TO ACCESS THEIR MEDICAL RECORDS.
Over a few decades, there has been an increasing awareness that individuals should share responsibility in their state of health. This cannot be simply delegated to the medical profession, since our health depend to a certain extend to our life-style, our eating habits, our hygiene, etc. A corollary assumption is that individuals should give their consent to any medical intervention. Giving consent is not only a legal obligation it creates a moral bond between a patient and a health professional. And consent can only be meaningful if it is supported by adequate information. In these circumstances information is indeed power and information can empower patients to exercise their responsibility over their health. One of the effects of the HIV/AIDS pandemic in the industrialized countries has been this reflection on the links between access to medical records, recognition of one’s responsibility and the possibility to seek for more information on the Net.
The right of patients to access to their medical records has been formally recognized only recently. The European Convention, in its Chapter III dealing with “Private life and right to information“, provides that:
“Everyone is entitled to know any information collected about his or her health”
Equally, in its Section dealing with “Access“, the UNESCO Declaration on Human Genetic Data states that:
“No one should be denied access to his or her own genetic data (ï¿½)”
In most of the countries of the world this right is not put into practice neither by physicians nor by hospitals. In fact, the rule is more often to retain information from the patients and even from other consulting doctors.
In France, even hospitals were reluctant to communicate medical records and information not only to patients but to their general practitioners. The French legislation was changed on March 4, 2002 (Act Nï¿½2002-303) and on September 8, 2003 by an Executive Order instituting a Charter of Rights and Liberties of the Person Admitted (in a health institution). This Executive Order was further consolidated on 21 May of this year. The Charter devotes article 3 to the Right to Information. Article 1 is on Non-discrimination and article 2 is on the Right to Health Care.
The Charter has been integrated in the Code of Public Health that rules and regulates health practices. Hence,
“every person has access to all information concerning his/her health that professionals or health institutions have elaborated whether for diagnostic, treatment or prevention reasons or have been exchanged between health professionals, with the exception of information that have been collected through third parties that are not health professionals”
It is worth noting that that same article states that the information should be provided to the patient within eight days after he/she has filed a request but leaving to the patient forty-eight hours time lag to reflect on his/her request.
Nevertheless, the European Convention, in the same Chapter III considers that:
“the wishes of individuals not to be (so) informed shall be observed”
(same Article 10.2)
The two UNESCO Declarations on the one hand on the human genome and on the other on human genetic data have similar considerations. The first one claims that:
“The right of each individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences should be respected”
(article 5(c) of the UDHGHR)
The second specifies that:
“When human genetic data, human proteomic data or biological samples are collected for scientific research purposes, the information provided at the time of consent should indicate that the person concerned has the right to decide whether or not to be informed of the results”
(article 10 of the IDHGD)
IV. IMPARTING INFORMATION TO PATIENTS
Access to medical records and information is certainly essential, but it is a first step. Because patients rarely understand the content of the records and the purport, scope and implications of the information contained. The four international instruments try to define the conditions under which information should accompany in particular the expression of consent.
The European Convention indicates in Chapter II on Consent that the patients concerned:
“(ï¿½) shall be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks”
The UNESCO Declaration on bioethics has a similar formulation and talks about “adequate information” (article 6.1). It qualifies it further and states that:
“The information should be adequate (and should be) provided in a comprehensible form (ï¿½)”
The UNESCO Declaration on human genetic data goes maybe further when it qualifies in Article 6(d) the required information as: “(ï¿½) clear, balanced, adequate and appropriate“, adding that it should specify the purpose for which human genetic data are being generated from biological samples, and are used and stored. This information should also indicate, if necessary, risks and consequences associated with the entire process.
The Explanatory Memorandum indicated about this article that oral explanations are often essential to the understanding of the written documents, especially as the medical terminology used is not accessible by all. In the case of illiterate persons, oral explanations are indispensable in order to make sure that the information has been understood.
In this respect, the French law mentioned above specifies that it is the patient or the person exercising parental authority who should request access to the medical records (Article R.1111-1). Furthermore, the doctor who has established the medical records can recommend the presence of a third party, to be designated by the patient, when the information is imparted due to the risks that such knowledge can represent. This is merely a recommendation that the doctor can formulate and if the patient opposes it then he/she either consults the medical records in situ, or requests copies to be handed over or requests the mailing of copies (Article R.1111-2).
The French law makes special provisions in the case of psychiatric patients hospitalized by constraint or hospitalized at the request of a third party. In these cases, the psychiatrist can again recommend that access to medical records by the patient takes place in the presence of a third party designated by the patient, but in case of refusal by the patient, the matter is brought to the attention of a District Commission of Psychiatric Hospitalizations for decision (Article L.1111-7).
B. Psychological factor in the relation between a patient and the physician
The “who, what, and when” of imparting information is of crucial importance. First, the knowledge that a patient acquires about his/her condition through information is often an asset in a treatment, inasmuch as that information is geared to reinforce his/her “life-drive“. Indeed, secrecy is pathogenic and, instead of liberating the patient, can lock him/her up in a succession of denials. No matter what seems to be the refusal of a patient to know the truth, the physician should not indulge in a play of mirrors of deception, but put the patient on the track of truth. In the case of a predictive diagnosis, information can at times lead a patient to a destructive behaviour known as “self-fulfilling prophecy“. Obviously such enactment bears heavily on the personal history of a patient. But it can to some extend depend on the way a dramatic diagnosis is communicated.
The way information is imparted is almost as important as the content of the information. The diagnosis of an incurable disease can be “death instilling” depending on the way it is imparted. In fact, the way such information is imparted to a patient in terminal stage reveals a lot about the relationship between a physician and death. This is why oncologists and health professionals working in palliative care units should clarify their own relation to death. In fact, the disclosure of dramatic information should be through a process undertaken by the patient, the health professional guiding the patient in the right direction. Hence, the patient would no longer be passive, but become a partner, taking responsibility in the cure or in the preventive treatment. In such a case, the information becomes empowering and the patient musters up the resources to carry on a treatment. Patient associations, in particular psychiatric patient associations have been very vocal on this matter.
Second, the discourse of a patient is no less important than the cure itself. In matters of disease, an essential factor in taming ailments is to demystify symptoms, pains, fears, etc. by expressing them in ones own words. Recently, at a Conference at the French Academy of Medicine, Dr. Didier Sicard, Chairman of the French Consultative Ethics Committee, wondered whether the clinical relation between a patient and a doctor was not disappearing, in particular because doctors had no longer time to listen to what patients had to say. In his opinion, the relation between a physician and the patient that is essential for therapeutic purposes is fading away. In his view, the time factor is only an excuse, because in ten-minutes a patient can express the sore of his/her body to a physician. Let us keep in mind that the oral contact builds the trust in the relation which in turn does indeed have a therapeutic effect.
Third, there is a trend to hand out to patients written information about their condition with no oral explanation. In such circumstances, there is no guarantee that patients have understood the nature of their condition considering the language that is often used. When they are illiterate, the situation is worse, because they will be ashamed to admit it in front of the physician and will rather rely on relatives or members of their community to provide the written information. Surveys show that the problem is that relatives will only give them scanty information, convinced that complete information cannot be understood by an illiterate person.
C. Cultural Sensitivity
This leads me to the issue of cultural sensitivity in imparting information. We live in multicultural societies, where words are translated in different languages and used as if they were equivalent to all of us, but in fact they have different meanings and connotations. Illness does not mean the same thing for all of us, nor for that matter life or death. Different cultures have various ways of caring for their sick. What information is disclosed and how it is disclosed is a culturally sensitive issue. It can be considered in the best interest of some patients not to inform them about the probable evolution of their illness, although the next of kin should be. Conversely, patients may wish that information were not transmitted to their families. The role played by various family members can be important in this respect, provided that one has the consent of the concerned patient.
I will give two examples to illustrate the point of cultural sensitivity of information of a dramatic nature. In Japan, the literature on this question indicates that it would be the responsibility of the eldest son to transmit such information, subject to certain conditions and abiding by communication rules which, although they are not written, are expected to be followed.
In the countries of the Middle East, depending on the sex of the patient, it is expected that the eldest son will transmit this information to his father or the eldest daughter to her mother or the wife of the eldest son to her mother-in-law. The role played by the eldest daughter in these societies in family decisions, particularly regarding health care and welfare, is much more important then suspected. In Arabic, the eldest sister is specifically designated by the respectful term of “abla”. Incidentally, this is a common feature of societies stretching from the Middle East to the Caucasus and up to Central Asia.
V. ACCESS BY THIRD PARTIES TO MEDICAL RECORDS AND INFORMATION
The access by third parties to medical records and information is a central human rights preoccupation. The international instruments mentioned above have provisions about this issue, in particular inasmuch as third parties could use the information in order to discriminate against the individuals concerned or stigmatize them.
“Everyone has the right to respect for private life in relation to information about his or her health”
(Article 10 on “Private life and right to information” of the European Convention)
“Genetic data associated with an identifiable person and stored or processed for purposes of research or any other purpose must be held confidential (ï¿½)”
(article 7 of the UNESCO Declaration on the human genome)
“(a) States should endeavour to protect the privacy of individuals and the confidentiality of human genetic data (ï¿½).
(b) Human genetic data, (ï¿½) should not be disclosed or made accessible to third parties, in particular, employers, insurance companies, educational institutions and the family, except for an important public interest reason in cases restrictively provided for by domestic law consistent with the international law of human rights”
(Article 14 on “Privacy and confidentiality” of the UNESCO Declaration on human genetic data)
In conclusion, access and communication through the Net of medical records is a welcome and empowering move subject to three conditions:
- That it is appropriate to the local setting (at present mainly industrialized countries);
- That it does not altogether preclude a traditional contact between the patient and the physician and that information is imparted through a face-to-face contact;
- That the health professionals concerned can ensure the reliability and the quality of the system used to transmit e-health records and ensure the security of the data contained.
This latter condition is also important considering the possible cross-border flows of e-records and their transmission to countries where respect for privacy may not be up to the standards and infringements may not be sanctioned.