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TITLE:  ETHICAL GUIDELINES URGENTLY NEEDED FOR COLLECTING, PROCESSING,
        USING AND STORING HUMAN GENETIC DATA
SOURCE: UNESCO, Press Release No.2002-93
        http://www.unesco.org/bpi/eng/unescopress/2002/02-97e.shtml
DATE:   Nov 25, 2002

------------------ archive: http://www.gene.ch/genet.html ------------------


ETHICAL GUIDELINES URGENTLY NEEDED FOR COLLECTING, PROCESSING, USING AND 
STORING HUMAN GENETIC DATA

Paris/Montreal, November 25 - Human genetic data is everywhere. Its 
presence in biological samples (of blood, tissue, saliva and sperm etc.) 
provides answers to questions from police and courts of law about paternity 
or the identity of sex offenders. Scientists are also using it to detect 
diseases we may be programmed to get, thus raising the hope for new cures

Genetic data use has produced spectacular results. Montreal University's 
magazine Forum reported (January 29, 2001) that 76 people on death row in 
the United States had been cleared of their crimes since 1987 after looking 
at their genetic imprint. But many are worried about the risks involved in 
some of these promising uses. Jacques Testart, the "father" of the first 
French test-tube baby, said in his book Des hommes probables: (Of Probable 
Men) "It is unclear whether modern societies can avoid new abuses, such as 
genetic racism which would be science-based, replacing racism based on skin 
colour or ethnic origin."

In this fast-developing field, the need for ethical guidelines is obvious 
and UNESCO, which drew up the Universal Declaration on the Human Genome and 
Human Rights (adopted in 1997) has since 1993 encouraged debate on the 
issue through its International Bioethics Committee (IBC), which has 
produced two reports - Confidentiality and Genetic Data (June 2000) and 
Human Genetic Data: Preliminary Study by the IBC on its Collection, 
Treatment, Storage and Use (May 2002).

The IBC's Drafting Group has for the past few months been drawing up an 
international instrument on human genetic data. The entire Committee will 
discuss the outline of the text for the first time at its 9th session in 
Montreal (Canada) November 26 to 28. Further consultations will follow and 
a final version will be presented for adoption to UNESCO's General 
Conference next autumn.

---

We may not always realize it, but the use of human genetic data is becoming 
an ever larger part of our lives, and not just where medicine is concerned. 
Some countries - such as Iceland today, Estonia soon and Latvia and Tonga a 
bit later - have undertaken genetic data censuses of their populations. 
Genetic databanks are springing up all over the place, ever more numerous 
and bigger. Their number is unclear, since nowadays even very small 
hospitals have a stock of processed genetic data or at least a collection 
of DNA samples waiting to be processed. There are thought to be about 50 
databanks with more than a million items each.

Why collect so much? So we can see the structure of genetic sequences in 
given populations and variations among individuals and different 
populations (genetic polymorphism), the scientists reply. Both basic and 
applied research require such data to help explain developments or open the 
way to new treatments. To understand diseases, such as diabetes for 
example, scientists need samples from families where they occur 
particularly often. They may also choose to look at samples from groups 
that are unaffected by it.

Doctors are prescribing more and more genetic tests nowadays, not just when 
taking decisions regarding reproduction. Tests on adults are increasing and 
the results are swelling the mass of data kelp by hospitals and research 
centres. These tests are mainly used to study genetic mutations that can 
trigger diseases. For example, genetic factors are involved in 5 to 10% of 
cases of breast cancer, which affects nearly one woman in 11, and the 
mutant BRCA1, 2 and 3 genes have been identified as the culprits. While 
their presence does not guarantee getting the disease, it represents a 
significantly increased. In the United States, thousands of women have 
asked their doctors for such screening.

Industry is naturally interested in human genetic data as well. The legal 
battle between several European institutions, including France's Institut 
Curie, and the US firm Myriad Genetics shows this. It concerns screening 
for breast cancer and ovarian cancers both of which are linked to the 
presence of the BRCA1 gene. The Europeans are challenging Myriad's patents 
that give it an unofficial monopoly. The Europeans also say that because 
the firm refuses to grant manufacturing licences, all DNA samples will have 
to be sent to the Myriad Genetics headquarters in Salt Lake City for 
processing, providing the company with a unique databank about people at 
high risk.

The interest of the pharmaceutical industry is going to grow, since some 
people react badly (or not at all) to some drugs (20% of high blood 
pressure patients, for example) and firms hope to discover all the genetic 
differences between people that explain this. Perhaps one day we will have 
genetic tests so we can receive optimal treatment. If customized medical 
treatment is to become possible, it will be thanks to the genetic databanks 
currently being built up.

Moreover, genetic studies of entire populations are underway. They involve 
the collection of vast quantities of data assembled to show up the 
incidence of certain genetic traits, and also for non-medical uses by 
police and the courts. Even governments are increasingly interested in such 
data and some have already started a genetic census of their population, 
from which they can gain vital information that can help them improve their 
public health policies. If such a census finds a strong presence of a 
genetic mutation causing cardio-vascular disease, for example, a prevention 
programme can be launched and priority given to treatment, notably by 
funding research.

---

The stock of human genetic data is sure to continue increasing. So we have 
to think about possible misuses. At all stages - whether collecting, 
processing, using or storing - ethical problems arise and some of the 
abuses that would threaten human rights and human dignity can easily be 
imagined.

At the collecting stage, there is the problem of consent, which is not new 
to the medical profession. "Free, informed and express" consent is not 
always self-evident. Suppose researchers in rich countries decide to obtain 
raw genetic data from people living in countries with less developed 
economies and legal protection systems, with no legislation about genetic 
data or even basic information about it, what kind of consent can they give?

There is also the issue of withdrawing consent and the right of a donor to 
be informed or not (dealt with in article 5c of the Universal Declaration 
on the Human Genome and Human Rights). Some people might not want to have 
their genes tested or know the results. Someone whose father has developed 
Huntingdon's chorea, a neurological disease that affects one person in 
every 10,000, has an even chance of developing it too. A test for it exists 
but those taking it might want to avoid at all costs the trauma of a bad 
result for them and their families. Might they be practically obliged to 
take such a test if they wanted to take out life insurance, for example? 
The insurance company might ask them either to produce negative test 
results or to pay a much higher premium.

At the processing stage, confidentiality is the major problem. Should the 
samples or data be tagged with the person's name? If so, how will 
confidentiality be maintained? Some data (such as police specimens but also 
genetic tests) needs to be identified or identifiable in this way, yet 
everything must be done to respect confidentiality. Quite apart from 
possible abuses, we have to recognize the dilemmas. Anybody taking a test 
must be able to rely on confidentiality but family members could invoke 
their right to access the test results because they might be affected by 
the data. This dilemma could be particularly hard to resolve if the first 
symptom of the disease in question were blindness, for example, and one of 
the relatives of the person tested were an air traffic controller 
responsible for other people's lives.

We should be able to take for granted the reliability and quality of 
processed data in view of the professional standards practitioners, but 
there is a special risk when it comes to research concerning behaviour 
genetics. Just as some scientists once believed they could identify 
criminals by the shape of their skulls, some today might be tempted to 
track down genes for such things as crime, alcoholism or violence. The 
media are usually keener on this kind of shortcut than scientists, but some 
studies have already proved controversial. In fact the problem is less with 
the data itself than with its interpretation, but the danger of looking for 
"high-risk" individuals or hunting for "bad genes" is too great to be 
overlooked.

At the using stage, the first question is what for? The IBC Drafting 
Group's outline only spells out the purposes of medical and scientific 
research, health care, forensic medicine and the needs of the judiciary in 
civil or criminal proceedings. The use (even just the collection) of 
genetic data to discriminate against a section of the population is not 
acceptable, any more than is use or collection for eugenic purposes.

But "racial" discrimination is not the only kind of discrimination and 
genetic data can be used to discriminate in other ways. For example, a bias 
against employing certain people might be presented, at least ostensibly, 
as based on very sound motives. An oil company might ask its workers to 
take a test to identify those running a particular risk of falling ill 
because of contact with solvants. Such screening fits nicely into 
preventive medicine in the interest of the employee. But the test - 
suggested or imposed, the line is a thin one - can put some candidates for 
a job at a disadvantage. Employers more interested in productivity than 
health or justice might exclude employees sensitive to certain products 
from services where these substances are used in order to reduce financial 
losses due to sick leave.

Some people suspect the members of the insurance industry of wanting to 
introduce such discrimination. Genetic tests are a godsend for insurers 
because they can enable them to weed out "bad customers". The great 
temptation is to ask life insurance applicants to be screened for certain 
illnesses and penalize (through higher premiums) those who refuse or who 
turn out to be at risk for certain illnesses. This means that some will be 
lucky in the genetic lottery - with little likelihood of being ill and thus 
benefiting from low premiums - while others will lose out. As well as being 
likely to develop illness, insurers will treat them as pariahs.

This may not yet be the case, mainly because tests are only available for a 
few illnesses and those that are available are not always reliable and 
produce only strongly indicative results (except in the case of 
Huntingdon's chorea) with no proof that a person will develop the disease. 
However, except in a few countries where restrictions have been imposed 
(Austria, Belgium, Norway, the Netherlands and parts of the United States), 
the danger does exist. In some countries there is no legislation about such 
practices and in some cases insurers have decided themselves not to use 
genetic testing for the time being. Though their moratorium is, in general, 
very short term, usually five years only. They may use genetic tests in the 
future, especially once tests become more accurate.

When speculating about possible scenarios, we can imagine what might happen 
in education. At first, it would obviously be in children's interest that 
school doctors took genetic samples. The next step would be to try to use 
the data to steer children through their schooling. After the "crime gene", 
would there be a hunt for the one for mathematics? Schools eager to score 
high could even devise an admissions policy that favoured "geniuses," who 
would be defined as those able to prove they had the "best genes."

There is also the problem of the time element in collecting human samples 
as collections might come to be used for new ends. If genetic research was 
needed on lung samples from victims of a century-old flu epidemic, who 
would give permission for the samples to be used in a way not originally 
intended and obviously not authorized at the time? This possibility is 
considered in the outline the Drafting Group will present in Montreal. The 
text proposes to allow such use without consent on condition that the 
samples are of undeniable interest for medical and scientific research or 
for public health and that the anonymity of the data providers is made 
irreversible.

The Drafting Group thinks that as a rule one purpose should not exclude 
another. Human genetic data collected for scientific and medical research, 
health care, forensic medicine and judicial purposes in civil or criminal 
proceedings "can be used for another purpose", the Group's version says, 
"as long as prior, free, informed and express consent of the person 
concerned is obtained again." Use of genetic data implies expected 
beneficial results. At the collection stage, the problem of "shopping" for 
genetic data in poor countries by researchers and firms in rich countries 
has been raised. This issue of fairness reappears at the results stage. If 
genetic data gathered from a group of people is used to the advantage of 
the acquirers in the form of tests and new drugs, should the "donor" 
population not also benefit from this?

There are also difficult issues at the storing stage. What kind of human 
genetic data management can ensure adequate protection of human rights and 
basic freedoms? Which samples should be kept and which discarded, 
especially in the case of those collected in a criminal investigation or 
lawsuit?

Cross-linking data presents the storage aspect of the purpose problem 
already mentioned. Since one purpose should not entail another, cross-
linking, in some case must not be allowed. The Drafting Group's version 
says that "human genetic data collected for scientific and medical research 
and health care shall not be cross-linked with data collected for judicial 
purposes in civil or criminal proceedings." There can be no question of 
using data gathered for medical purposes, or even in a national genetic 
census, to track criminals.

---

The very technical issues raised by genetic data that the IBC will consider 
in Montreal are very complex, largely because such data groups both medical 
and personal information. On the one hand, people's genetic traits can 
determine or predispose them to many illnesses, on the other, as each 
person's genetic imprint is unique, forensic scientists and the law can use 
it for identification purposes. All this data is sensitive yet long-lasting 
(remaining relevant throughout a person's lifetime). It also provides 
information about siblings, descendants and more broadly about the 
population group the person belongs to.

In view of this complexity, the IBC Drafting Group chose at its first three 
meetings to take a practical approach. It opted for a non-binding 
instrument - a declaration rather than a convention - the better to adapt 
to a constantly changing environment and to reach consensus more easily. 
The discussions in Montreal should allow for further progress.

****

Contact:
Pierre Gaillard
Bureau of Public Information, Editorial Section
Tel. +33 (0)1 4568-1740 
During the IBC meeting: +33 615 695 372
e-mail: p.gaillard@unesco.org



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