Key speech - parallel session 8 - GENETIC DATA. Georg Apenes, Privacy Protection Commissioner of Norway.
Dear colleagues - ladies and gentlemen, The decoding of the human genome reached a preliminary climax earlier this year when scientists, in charge of Project HUGO, declared that a draft of the entire, human genome had just been assembled.
The compilation of findings from sub-projects coordinated in this impressive and world-wide undertaking may be subject to some adjustments and corrections in the future. But in essence the mapping is finished. It was celebrated in June all over the world by scientists and the medical community. But also by politicians and government officials - which means those who are in charge of the efforts of trying to meet great and quickly growing expectations connected to health, welfare and lifespan.
But compared with the reception of previous, spectacular discoveries and inventions within the field of medicine, we were this time able to notice some doubts in the comments as to the undivided blessings of the opening of this new frontier in the history of man - a new reality enabling us to carry rationality a great step further: To regulate, administer, plan and control a better, common future.
Genetics will some time in the not-so-distant future really make it possible to 'Plan For Success'. Some of the underlying questions might, for instance, be whether such Plans are designed by individuals in their search for a better health - and a better Self - for themselves and their kin, or the lawmakers and governments wanting to raise the quality of their nations, or simply whether the motor is the search for profit by the multinational, pharmaceutical conglomerates.
Many people noticed, though, that president Clinton in his public statement from the lawn of the White House, stressed the ambiguity of the new era entered. Without mentioning his name, he indirectly referred to the problem so often and so strongly articulated by the Finnish philosopher Georg von Wright: Rationality and wisdom do not always mean the same.
This mixture of optimism and fear of the unknown, not-intended, maybe, negative side-effects of the new insight, was also reflected in many of the letters to the editors in papers and magazines, in the commentaries and talk-shows in radio and TV in the weeks following the breaking of the news : "The genetic genie is out of the bottle, and like nuclear power, it can be used for good or evil" one reader wrote, and another expressed himself like this: "Deciphering the gene code is an exiting step forward in biochemistry. Will the achievement bring us happiness or disaster? Fortunately, we are already aware of the challenges. A danger foreseen is half avoided".
This seemingly rather modest ambition, was voiced by Mr. Bao in Shanghai to 'TIME Magazine' and may possibly reflect the famous Chinese, pragmatic, experience-oriented wisdom. Personally I would like to express my concerns of the other half - the dangers we do not see - maybe because we do not like to see them, and therefore do as Lord Nelson did when he put the field-glass on his blind eye?
When the mapping of the human genome now seems to be concluded successfully, the next step will be to embark on the even more challenging, but also promising task, to read the map drawn to see, and eventually to prove, how millions of quantitative elements in each genome, relate to each other. Eventually the geneticists hope to be able to prevent or to cure diseases or malfunctions And to prolong the average lifespan at least 50 percent. Or to promote and strengthen certain wanted or needed features in plants, animals or human beings. Although the accumulation of positive knowledge in this area seems to accelerate, we may still have some years ahead of us before the practical possibility of wide-scaled, human engineering is integrated in our health services.
Even those who, with minimal reservations and loudly enthusiasm hailed the event in June, admit that these new possibilities may be used for purposes that a majority in our culture today regard as negative and harmful. These personalities are eager to calm themselves and their surroundings down by suggesting that we must now embark on a large-scale and intense discussion on the ethical implications of the new discoveries.
As opposed to the scientific break-through manifested in Hiroshima, the advent of genetics has been well advertised. There has been very little secrecy surrounding the research. Governments and the pharmaceutical industry have willingly funded the work. We know much more about what we are approaching this time compared with the nuclear technology break-through a couple of generations ago.
To me it is obvious that genetics represents a challenge to traditional concepts of privacy. I can think of no other more intimate information about an individual than the pathologic potentiality of her or him laid down in the genetic layout embodied in her or his cells? Still, it puzzles me that both the European directive and the national legislations I am familiar with within the field of personal data protection, tend to regard and to treat genetic information as just another category of traditional, medical information like blood-type, indicated blood-pressure or body temperature.
However, before we start on the proposed discussion on how to optimise the future blessings, and at the same time, avoid a maximum of dangers, I think it is necessary to try to pinpoint what, if anything, sets genetic information in a category of itself . In short: -What is so special about genetic information?
I think that the general public as well as academics, politicians and legislators already regard, or very soon will do so, genetic information as very sensitive information, belonging to the most intimate realm of the private sphere. The main reason for this, may be the popular conception that genetic information on the individual carry knowledge of some sort of determinating rails which sooner or later will lead the individual to certain, unavoidable harms, problems - or advantages, like being able to smoke 40 cigarettes a day for 60 years without developing lung cancer.
From a strictly scientific point of view, we know that this is not quite true. We know that manifestations very often will be the results of the interchange of environmental exposure and genetic characteristics. Thus, as we see it today, nobody can with 100 % certainty predict the medical biography of anybody.
I think we also should keep in mind the probability of finding in the future, links between genes and certain types of behaviour. To my knowledge, there are scientist who claim they have found the genes determining dyslexia and genes which activate the production of certain proteins which again substantially increases our ability to remember. Will we find ' violence genes', and will they be used as excuses in court? Or will we look for and find common, graphic features in the genetic profile of convicted rapists - features that may be used for future, preventive searches for potential rapists among non-criminals ?
At the conference in Kalundborg, Denmark on bio-informatics this spring, representatives of IBM told the participants about the companies work on building the biggest computer in the world - just to be able to handle the enormous quantities of genetic data. This information was, by the way, confirmed by Mr. Stanca of IBM yesterday.
What we, in the nearest future, will be able to do, is also to measure the statistical probability of developing a disease or a condition. But most people will probably regard specific, genetic knowledge on themselves as being very sensitive - no matter whether their examination reveal risk estimates of one to 10 or one to 100. We have reasons to believe that empiric data in the future, with increasing certainty, will be able to connect genetic findings and the probability of defined conditions.
Now: What is so special with nominative genetic information? What is it that sets them apart from traditional, personal information on individuals ? My answer is this: The knowledge about the genetic make-up of an individual, also reveals or gives strong indication on dispositions to be expected in the biological lineage the individual belongs to.
When we learn today that a person has suffered a heart attack, we know something about this patient. But if it is added that the person in question was the carrier of familiar hyper cholesterol, we immediately will also know that his or her parents, brothers and sisters as well as children, with statistical certainty, may be carrying the same genes. To me, it is obvious that we here encounter a privacy-problem which we will be forced to face in the nearest future.
The questions are many: Will it be possible to preserve fundamental privacy values as expressed in the Council of Europe convention 108 and the European Directive? Will it be possible to keep and maintain those rights granted the individual according to those legally binding documents just mentioned, and the national legislation derived from them, enabling the individual to protect her or his privacy interests? Put simply and bluntly: How can anybody be expected to be able to check the quality of genetic findings from another subject - but pointing to her- or him-self - when the very site of this, maybe vital, knowledge is unknown? How can anybody, under such circumstances, maintain their interest in proper quality or influence the use of the information for defined purposes or prevent unwanted dissemination of sensitive, personal information? These, and other classic means, are tools developed for the purpose of ensuring the autonomy of the data subject and strengthen the notion of self determination within the private sphere. It is difficult enough today when data collected for specific purposes are connected to a specific data subject from the very beginning. Under such circumstances it will be relatively easy to institute legal obligations for the collector and rights for the subject as done in the present generation of data protection and privacy legislation.
The problems start when findings from person A, also tell us interesting things on B, C and D. Should they be informed? Under what conditions should it be a legal obligation to try to contact the ignorant rest of the alphabet in order to give them certain facts so that they themselves can decide to seek counselling for change of lifestyle, medication or, more dramatically - to reconsider a planned pregnancy or a planned future? Would Ronald Reagan have been campaigning for the presidency of the United States if he himself had known he would eventually develop Alzheimer's disease? Would he have been supported by voters if they knew what was to come? Or would steered leakage of a secret have spoiled his chances of winning the election?
We must also take into consideration the fact that apparent social lineage may not always also express the biological. One of the speakers on our international meeting in Ottawa a few years ago, talking about genetics, stated that one of the consequences of the rapid development of genetic knowledge and its consequent application into society, will be the "reconstruction of the nuclear family". Of course not in the strictest sense, but for diagnostic as well as therapeutic purposes, the positive knowledge of biological contexts will be of greatest importance. Thus the social father will not do; the biological must be located and genetic information collected from him. It also follows from this that we can not, like in my own country, Norway, in the future demand anonymity in connection with human insemination and artificial procreation. Not for ethical reasons only, but also for socio-medical reasons. We can hardly go on with open eyes, denying access to sources of genetic knowledge of vital importance to individuals. And, as all cattle-breeding farmers have known for generations, the identity of the bull is of direct, economic significance !
In point 26 in the preamble of directive 95/46, it is made clear that the principles laid down in the directive is not only connected to identified but also to identifiable persons. It also is quite clearly stated that, when deciding whether we are dealing with identified or identifiable persons, all reasonable measures enabling the users to find out the identity from the information available, should be taken into consideration. This must mean that extraordinary, unusual or costly methods are excluded. But what causes our concern in this matter is the use of good, public records containing nominative data linking persons to persons within the framework of time and space. In none of the countries inside or outside the European Union and Economic Space for whom the directive is binding or represent authority in their own development of privacy legislation, is there a tradition of concealing genetic facts like who is the son of who, who is the sister of who and so on. Although family threes sometimes may have some branches which, regarded strictly biologically, may be grafted, it is assumed that most of the social lines run parallel with the biological lines. But when this general rule does not apply, we must accept surprises in the future when the tracing of biological identity unavoidably may spin off some surprises of which, again, some will be tough news to a number of individuals.
In politics and social formations historically things like biological fatherhood did not play a major role in the legal or administrative developments of society. Now this age of relative innocence may soon be over. It may be of little interest who fathered the prince, but the genetic heritage he left behind can be of decisive value from a curative or therapeutic point of view.
If, as I have already stated, genetic information differ from most other, personal information in that it gives information on the relatives of the tested subject, it can be expected that we are approaching several crossroads in data-protection. One can be described like this: Should the person or institution carrying out the collection of genetic information be obliged to seek the informed consent also from the relatives? Or: Should the collector, depending on his findings, actively inform those who may be in a risk zone? If so: How much time and how much resources should we expect - or force - the geneticist to devote to this obligation?
To which extent should the answer to this last question be relative to the possibility of preventing or delaying the manifestation of a malfunction or disease? Not to mention the delicate, and already heavily debated question, of the very definition of 'handicap', 'maladity' or 'decease'? Are sexual inclinations, for instance, genetically determined? Or alcoholism? In some years time the geneticists may indeed reach upon a shared conception of the role of genetics in human behaviour.
Who should decide whether a finding in person A can be treated adequately in person B, C and D? Who will have the responsibility if such information is not given? Can I sue the doctor or the hospital who found indications in my brother, my father or my son if they did not take proper steps to pass this information on to me ? What about the responsibility - morally, legally and financially - of the public authorities and the government if they do not provide instruments and legislation ensuring the transference of vital information to data subjects who, for all legitimate reasons would want to know? And what about the interest of the insurance industry to have access to very interesting, nominative data ?
Or, approaching our subject from another angle: Can we expect to have the resources which will be necessary when great number of people have concerns for their future health based on the presence of certain, genetic constellations in a close or more remote relative? And what do we know about the expected, mental reactions which may spring to the surface when anybody all of a sudden get information concerning welfare, life and death that he was totally ignorant of seconds before?
Again we may very well put the question: Is it a logical consequence of the right to privacy not to be informed ?As stated in the directives preamble, point 41, everybody should be able to enjoy the right of insight in information gathered on themselves. As it is argued in the text, the reason for this is to enable the data subject to check the quality or accuracy of the information as well as the legality.
When it comes to genetic data, the whole machinery leading to intelligible conclusions today are so sophisticated and demands such skill and expertise such a right may be meaningless. Who will take the time and effort to go for a second opinion in order to be able to challenge the objectivity or quality of the suggested findings? In my opinion it is not very realistic to expect this to happen very often.
And the automatic handling and processing after collecting the samples, which is still some years ahead of us, will focus on the rights of any data subject to have the process explained to her or him in a way which most laymen can understand. Will this very central provision in the directive be possible to realize at all? I doubt it.
Now, some comments on a situation where information is collected by one for his legal and obvious purposes, but others are interested in the data, or the conclusions drawn from them, for other reasons. From a current, very vivid debate in Norway, I am able to report a keen interest from the insurance industry in the results of genetic tests their customers, on their own initiative, may have undergone.
In a recent green-paper the majority of a royal commission concluded that the insurance company should have a legal right to demand to share such genetic information. The majority could see no, qualitative difference between traditional, medical information and genetic data. With very few exceptions, this position was met with very strong opposition. Spokesmen from all the political parties rejected the idea, and there are no indications that this spreading to a third party of highly sensitive data, will come into force - in the nearest future. But what about the day after tomorrow - in 10-15 years or maybe less? In an ideological area dominated by strong individualism as well as the disintegration of solidarity as an important thread in our social web, people with good test-results will refuse to pay the same premiums as those with bad. When marketing has been developed into a question of addressing 'one-to-one', who can then, in the long run, expect a virtual dictionary of very potent, nominative information to be banned from trade and commerce, social planning and social development? Here I think the Icelandic experience gives us food for thought. The DeCode-companies offer to the government, the parliament and the entire, Icelandic population was so fascinating, so full of promises of health to the individual, prestige to the nation and money to the treasury, that the establishing of the suggested, centralized health-data-base was hailed almost unanimously. Some of you may recall the objections and critical remarks from a privacy point of view, raised by the international meeting of data protection commissioners in Santiago de Compostela in September 1998. Two months later the Alting passed the new law with overwhelming majority.
What can be done ? I am afraid very little, and the main reason for my pessimism is that people in general may very well not share the fears and concerns of the privacy advocates. Still problems of the 'spin-off' information or 'surplus' information derived from genetic testing, seems to have been obvious to some national legislators. Thus the new Swedish law states in paragraph nine that processing of information on genetic dispositions need the explicit permission (concession) of the Swedish Data Inspectorate. An interesting approach is one developed in the United States and described in the American Journal of Human Genetics in 1995. In their presentation Charles L. Early and Louise C. Strong explain how a 'Certificate of Confidentiality' works. This certificates are issued by the Department of Health and Human Services to researchers and means that he has not the right nor the duty to reveal data which could damage data subjects financial and social standing or employability. The purpose is to prevent in general discrimination based on genetic data as well as their use for litigation.
The role of the data protection commissions will be to ensure that the legislators and the government agencies make their decisions well informed also of the implicit challenges to privacy that genetics represent. If their arguments and their standing are good, some politicians will listen to them. Whether they will develop majority support, is an open question.
Georg Apenes