Legal Aspects of Genetic Data Banking in Germany
- Juergen Simon, M.D. and Susanne Braun, Ph.D.
Institut fur Rechtswissenshaften, Universitat Luneburg,
D-21332 Luneburg, GERMANY
E-mail: simon@euroacademy.com
Eubios Journal of Asian and International Bioethics 12 (2002), 171-6.
1. Introduction
In the last few years there was an important expansion of human DNA sampling and data collecting in order to exploit and study genetic information that is collected. In the coming years the storage and use of such genetic information will be of increasing importance. Actually the German government discusses the use of genetic data in the Labour Law, for research and insurance purposes1.
As in other countries a lot of databanks already exist in Germany and genetic testing commerce has become an important market with a global total turnover of US $ 1,3 million. The potential benefits seem to justify the establishment of genetic databanks but the possibility of misuse imposes a responsibility of proper management and protection of the subjects' interests. The availability of personal genetic information poses many problems concerning privacy, confidentiality of the data and informed consent, because genetic data are highly specific information, revealing facts not only about the examined person but about the members of his or her family and having therefore a great impact on a person's life or lifestyle. Therefore genetic research has to be conducted with sufficient safeguards to protect individual interests, without obstructing legitimate medical research activities of potential benefit to society. New forms of discrimination have to be avoided when insurance companies or employers could use genetic data as a reason for denying insurance cover or turning down a person for a job. The European Parliament stated: "The use of and access to personal genetic information should be debated with a view to legislation, which should particularly focus on protecting the individuals' personal integrity on the requirement to obtain his consent Member States should protect individuals' right to genetic confidentiality to ensure that genetic profiling is used for purposes beneficial to individual patients and society as a whole; there should be an exception to this general principle of confidentiality where genetic fingerprints held in DNA databases are used to identify and convict criminals" .
In this paper, the different reasons for genetic data banking, the social perception and the quality management of databanks will be discussed. Then the legal aspects concerning genetic data banking in Germany are examined.
2. Reasons for genetic data banking and status of collections
There is a wide range of application fields of genetic data banking. Above all, the medical sector is the most important area. The origin of diseases could be detected and new diagnosis and therapy methods could be more efficiently developed by constructing genetic profiles. The genetic data registration of entire populations or groups makes the construction of genetic profiles possible. Furthermore the use of genetic fingerprinting in criminal cases, on the legal basis of 81 a, c and completed by 81 e, f, g Criminal Procedure Code, has been operationalised and developed through court rulings. Also genetic data could be used for certification of parentage. A clear distinction exists between legislation and policy that relates to criminal databanks and that which relates to medical databanks. The further remarks will focus on the medical sector
Concerning the status of collections several types have to be distinguished. In anonymous collections the biological materials were originally collected without identifiers and are impossible to link with their sources. In anonymized collections, biological materials were originally identified, but have been irreversibly stripped of all identifiers and are impossible to link to their sources too. In identifiable collections, biological materials are unidentified for research purposes, but can be linked to their sources through the use of a code. In identified collections, identifiers, such as a name, patient number, or a clear pedigree location, are attached to the biological materials.
3. Social perception of genetic data banking in Germany
The German Ministry for Education and Research states in its report upon human genome research in Germany that the genetic epidemiology is still underdeveloped without starting any public debate. In Germany since about 30 years a population screening will be made. These screenings were offered and can be voluntarily done. Screening is a kind of test performed for the systematic early detection or exclusion of a hereditary disease, the predisposition to such a disease or to determine whether a person carries a predisposition which may produce a hereditary disease in offspring. this genetic screening has to be distinguished from genetic testing because the implications are different and it does not necessarily lead to the prevention or treatment of diseases, whereas genetic testing is carried out on patients who for whatever reason have taken the initiative and seek advice. But it is only the beginning of population studies in Germany. For instance in the databank of the Berlin enterprise InGene data of more than 3000 volunteer donors have been registered since the 1rst of April 2001. This number should increase up to 40,000 per year. Seven hospitals and about twenty physicians collect data, results of blood tests, medical data and a large questionnaire of 23 pages. Clinical history, living habits, social surroundings and environmental conditions have to be respected too.
For InGene the human phenotype is the starting point of research. From this base, populations and later on gene profiles should be established. The detection of new disease related genes should be possible. This "direct and accelerated revelation of clinical relevant genetic factors" will be important for further medical development" and a contribution to a future personalised medicine. The necessary votes of the ethic committees exist, authorising InGene to transmit data and sample to third persons this means DNA and serum samples as well as the above mentioned clinical questionnaires.
With this project, private enterprises try to realise a small version of what has been funded by private organisations, or the government in Iceland or with the governmental supported gene databank in Estonia. This Estonian example of a central health databank, supported by a commercial exploitation enterprise, is widely accepted on the international level. Personalised medicine should better contribute to the individual provision and insofar economize costs. Therefore a working group at the World Medical Association is actually elaborating ethical guidelines organising the development and function of genetic databanks. Especially these guidelines will be made for governments planning national gene databanking.
In Germany large-scale projects such as in Estonia would not be accepted and are not planned because there is no social consensus for this kind of project, being mostly understood as a tendency of eugenics and related to fears of the transparent human being. The possibilities of electronic data processing associated with the fear of a total transparency of the citizen impedes extensive governmental data storage and data exploitation in Germany. Since the beginning of the 1980s, legislation, jurisdiction and science have intensively discussed this subject under data protection aspects with the result that the respect of the fundamental rights is the essential leading principle of the whole biopolitics and particularly for genetic data banking.
4. Management, quality control and security issues
Many DNA banks are concerned how to obtain valid informed consent, safeguard the privacy of samples and data and avoid potential misunderstandings with depositors. The value of a collection is proportional to the amount and quality of the information attached to it. The full benefits for which the subjects gave their samples will be realised through maximizing collaborative high quality research but the multiplicity of actors and of rules that regulate them (public versus private, hospitals, research centers, laboratories ) make the situation very difficult to comprehend. Rules for exchange and sharing of information should exist, but the status of collections often are not known and most laboratories have no written policies or agreements regarding this activity.
Because of the sensivity of the results security mechanisms to ensure confidentiality and long-term conservation of genetic information are absolute conditions and have to be implemented. This should include maintaining the quality of genetic examinations (validity and exactness), the employees and the procedure of genetic examinations. Genetic examinations should only be made by physicians and indications should be made by human geneticists or special physicians to guarantee adequate information, consultation and essential protection of concerned and third persons. There has to be a safeguard against unauthorised access to genetic data banking as well as safeguards against the use of the databank for anything other than their overriding purposes.
5. Legal aspects of genetic data banking in the medical area
In Germany no special law of genetic data banking exists. Information can only be used according to the constitutional principles especially the fundamental rights and the data protection regulations.
5.1. The fundamental rights of concerned persons
Strong legal positions of the concerned persons, especially the donors of the information, are needed. The Constitutional situation depends on the kind of data banking system whether it is a governmental or a private one, because fundamental rights are only defensive rights against the State and cannot be applied between privates.
First of all human dignity, the highest value of the German Constitution (GG) and protected by the "guarantee of eternity", in Art 79 III GG, has to leave unimpeachable, Art. 1 I GG. Every human being has a dignity in the sense of a social claim of value and respect because of his being as a human. The principle of human dignity is based on the idea of human beings focusing at the same time on the inherent value and a common relation element. A legal argument as Art. 1 I GG is not necessary for these inalienable and inviolable rights, but is responsible for the qualification of human dignity as a legal notion and is open for legal interpretation. The content has to be determined with view to Art. 1 I S. 2 GG, the obligation for all governmental authorities, to respect and protect the dignity. But it is difficult to explain the notion of human dignity. Following a kind of negative definition, human dignity is affected, if the single human being is degraded to an object, to a mere mean, to a replacable unit. It is not compatible with human dignity to accept a treatment calling a persons' subject quality into question. The State is not only obliged to omit actions that are an offence of human dignity but as well to act in a defensive way so to avoid offences and attacks of human dignity from third parties. So all bioscientific developments will be accompanied by the question of whether they are compatible with human dignity or if there will be an offence of human dignity which has to be restricted by the State. However, we should avoid a general emotional appeal to human dignity in the form of a knock-down-argument. The other constitutional provisions have to be interpreted within the light of the human dignity, being at the same time a concretisation of the notion of human dignity. At the beginning of the discussion about genetic testing in Germany, Benda, the former president of the Federal Constitutional Court, supposed it would be an intrusion of human dignity in the case of a total storage of individual hereditary factors. The storage of single genetic characteristics seems not to be an offence against human dignity, although associated with intensive effects for of the concerned person
The use of personal data like the name of the patient or their symptoms related with a gene databank should not violate the general personality right, which has been derived by the Federal Constitutional Court from Art 2 I GG in connection with Art. 1 I GG. "The task of this right is to guarantee the closer personal sphere and its basic prerequisites". Art. 2 I GG guarantees expressively the general freedom of action, an active element, whereas the general personality right is a more passive element, including the respect for the sphere of inner personality, the intimate and private sphere as the preservation of their basic prerequisitions. But Art. 2 I GG could be restricted. Concerning the general personality right the Federal Constitutional Court developed the "sphere theory" as a marking point for these restrictions: The basic sphere, an inviolable domain of private life style, is absolutely protected and every action of executive organs will be prohibited. Beyond this sphere, the domain of private life style being in a social relation could be restricted if there is a predominant interest of the public and a strict respect of the principle of proportionality.
These contents of the general personality rights will be essential especially with regard to the developments of modern biotechnology and the associated dangers for the personality and individuality. Therefore the general personality right will be an adequate criterion for a judgement about the legal aspects of gene data collection and storage in relation with the fundamental rights. Even if the Court has not yet developed concrete criterions if genetic data belong to this absolutely protected sphere, it has to be supposed that the decision, if the individual would like to know the genetic details of his future health, belongs to this inviolable essential content.
A part of this general personality right is the right of informational self determination guaranteeing the individual person a free decision over which personal data shall be given to whom, at which time and for which purposes these data can be used. The person has to know about the probable consequences for herself when using these information. This right is not limited to the automatic data processing. Another part of the right of informational self determination is the right not to know, especially of the family members of the examined person who do not want to know about their genetic constitution. It is not necessary to argue directly with the basic fundamental right of human dignity, because the general personality right is based on Art. 1 I and so it is directly related to the principle of human dignity. For the individual it is important to have the freedom to develop his own personal identity without being burden with a foreknowledge. Consequently governmental instruction concerning data storage would be forbidden in principal as well as any sanction in the case of refused consent. An exception could be the protection of the right of life of third persons and the preservation of serious health damages.
If the individual should know his hereditary factors or perhaps fatal or later appearing diseases against his will, there are convincing arguments to deny a global intrusion of human dignity but there will be an offence against the general personality right. So much the more if the disease could appear in the near future people may not have the capacity to actually avoid or cure the disease. The typical uncertainty related with the storage of genetic data, if the stated disease risk will be realised, would be another burden. Because the corresponding diagnosis could only be statistically-epidemiologically interpreted for a group of persons. The individual has to live with the uncertainty. This could be a threat especially in case of risks of fetal disease whose intensity could vary from individual to individual and even lead to an existential conflict. Only a right not to know could avoid the probable loss of impartiality, frankness and finally freedom towards the own future. Meanwhile this meaning is widely accepted, generally recognizing the necessity of informed consent. The individual must have the possibility to chose the right not to know his hereditary factors even if healthy disadvantages are related with his decision, even if the genetic data storage would only or mainly be made to discover endogenous health risks for preventive aims and to instruct later on the preventive or therapeutically indicated participating obligations. The right not to know includes the free decision of the individual life style. It has to be the individuals choice, which concrete health diagnosis would threaten the individual so to ignore further information. A restriction of the right not to know, for instance in cases of severe diseases, would not be compatible with the right of self determination. It would be different if the citizen defends his right not to know his hereditary factors against the interest of the State or other private persons or if he voluntary offers material or information about his genetic constitution. This would be an expression of his personality. A prohibition would contradict the right of life, physical integrity or free personality development if it aims at a defence of disease risks or supporting research.
Finally, the right of the person whose genetic data are collected and stored could collide with the freedom of research protected in Art. 5 III GG. There are no particular reservations or limitations mentioned in Art. 5 III GG, but the so called "constitutional immanent barriers" as other constitutional values have to be respected and the colliding values have to be assessed.
5.1.1. Collision of the right to know and the right not to know
In case of an increasing correlation between genetic characteristics of an individual and certain diseases, more and more negative stigmatizing social prejudices towards the concerned person or groups of persons will be expected. In principle everyone has the right to keep secret his genetic diagnosis instead of revealing it. A situation demanding an intensive protection exists. But there will be problems if in case of a genetic diagnosis the right to know of the examined person collides with the right not to know of the same person or another person, for instance a family member. If a person is positively tested for Huntington Disease and her grand father already had this disease then it will be sure that one parent would be carrier of this disposition as a connecting link and would get this disease. This is a constellation of private family relations which cannot be solved with regular legal measures. The prohibition not to disseminate the test result or not to tell genetic data to any person cannot effectively be established inside a family community. An international study about the handling with genetic data with 1400 patients from USA, Canada, France and Germany found only about 500 persons demanded for a right not to know, and many patients wanted an information for the whole family even if single members do not agree.
It has be to asked if the right not to know can be guaranteed even in such a constellation. So among others a restrictive access to genetic examinations could be possible. But this would mean that genetic testing is not available for anyone. The contradictory legal positions and interests have to be assessed and criteria have to be developed, who and under which conditions could make genetic testing. The right to know would be more important if the concerned subject would be of a higher value, for instance if a testing result would be of great influence for life styling whether by a therapeutic treatment or a prophylactic life style of the concerned person. At the same time the other person has so much the more the right not to know. A result free of contradiction would not be possible. Anyhow, the necessary genetic testing must be accessible for those persons whose serious disease could be efficiently treated. But the concrete criteria for this access in the individual cases does not exist and it seems very difficult to define them.
5.2. Regulations of the Federal Data Protection Law
The collecting, storage and use of genetic information has to be done according to the regulations of the Federal Data Protection Law (BDSG). This means on the one hand the law protects the individual and its right of informational self determination and on the other hand it is possible to control the databanks by this law.
The Federal Data Protection Law is very complex, since the applicable law depends on the status of the data collecting and storing institution (public, private, federal, state), it contains different permissions for collecting, storing, using, transferring for own and other purposes and there are numerous exceptions in other laws. With respect to the principles of 3 a BDSG to collect personal data only if it is really necessary and to use anonymous data if possible, the special purpose of this law is the protection of the individual, so that the use of his data would not violate his general personality right, 1 I BDSG. Data are single facts about personal or material relations of an identified or identifiable person. Single facts in turn are information about the physical or mental situation, which can be discovered by genome analysis. Data procession and uses are only permissible to the extent that they are authorised by the law or another legal provision or if the concerned people has consented, 4 I BDSG. This consent has to result of the free decision on the base of an intensive information about the intended purpose of the collecting, storage and use, 4 a BDSG.
The law does not relate specifically to the protection of personal genetic data, nevertheless the general regulations may apply to the collection, storage and use of personal genetic data qualifying them as personal data in the sense of 3 IX BDSG. 28 III No 1, 2 BDSG allows the use and transfer for danger preventive or criminal procedure purposes, despite the initial purpose.
Referring to the second aspects of the BDSG, the controlling of databanks it has to be stated that controlling authorities exist to supervise the respect of data protection regulations, 38 VI BDSG. In case of defiance of the rules, the authorities can sanction the databank. Furthermore non-public databanks in the sense of 2 IV BDSG are obliged to indicate their activity starting to the controlling authority, 4 d BDSG. If they forget this indication, they have to pay a fine, 43 I No 1, 2, III BDSG.
Insofar the Federal Data Protection Law establishes as well a certain control mechanism for databanks.
The Data Protection Law of the States include all public authorities of the respective states. The law has to be applied in public hospitals or the state or the municipalities. The provisions are subsidiary to special provisions in other laws. In most state hospital laws exist containing special data protection rules.
6. Result
The survey and the reflections about the social perception and the legal aspects of genetic data banking in the medical sector showed that above all the above main problems focus on the confidentiality, privacy and discrimination. Every breach of confidentiality could impact insurability, destroy family relationships and causes stigmatisation or discrimination. Therefore transparency of the activities of genetic data banking is necessary for the individual related with intensive information (existence, ownership, application and group of persons covered by the databank) maintaining at the same time a status of anonymity concerning the concrete data. It is obvious that the sampling, storage and examination of body material without knowledge and consent of the concerned person would be an offence against the right of informational self determination. Even the already formulated consent declarations are often not enough determined or temporarily limited, these have to be discussed. There may be a need to create documentation and report obligations disregarding the principle of appropriation. But it must be clear for the concerned person to know who, how far, for which purpose and where his genetic data will be used. Additionally the person must be able to revoke the consent.
Furthermore a data protection level and system has to be established in Germany corresponding to the particularity of genetic data transforming "informational" self determination rights and preserving at the same time the right not to know, especially because the right to data protection has finally been recognized as a fundamental human right in Art. 8 of the EU Charter of fundamental rights and because these prerequisites are not realised by the existing Federal Data Protection Law. The regulations of this law contain more or less general clauses and undetermined legal notions needing interpretation for each single case. The Data Protection directive of the EU established new measures concerning the handling of patients' data in medicine and health care, and forbidding the collection of data about health and sexual life, Art. 8 I. Those data are protected. Art. 8 III foresees several exceptions if the data are really necessary and an obligation to keep the identity of the concerned person secret. These exceptions have to be interpreted when transferring the directive into national law. Till now such a transfer into German law doesn't exist. In 1999 the central ethic committee of the German Medical Association gave a statement concerning the use of patients data in medical research and in health policy. Anyhow, an informed consent will be necessary requiring the individual to be provided with information regarding the purpose of the research, whether information obtained is to be coded, deidentified or identifiable, privacy protections, that the result of the research may be commercialised, whether samples will be stored for future research purposes and that the consent may be withdrawn at any time. The committee demanded for a better protection of the general personality right concerning the use of patient data for medical research. Ethical and legal problems arise if the concerned person cannot consent and consent cannot be sought from the person's legal representative. Then an ethical justification will be necessary. But if a great number of data should be collected it will be to difficult and expensive to ask each patient for his consent if the storage or use will be made for another than the initial purpose, or if data should be collected from different origins, or information about a patient should be permanently collected or data should be stored for a long time. In these cases the interests of both sides, the databank and the patient or other concerned persons have to be intensively assessed. A total prohibition of collection, storage and use of personal data certainly cannot be justified because essential functions of health policy would be destroyed especially if the citizen is legally obliged to finance the health system. In the contrary any derestriction in the data protection field could be a risk for the general personality right. This problematic and difficult situation can only handled if concrete legal measures will be defined, incidently contributing to a better social perception of genetic data banking. Actually in Germany a draft Genetic Testing Law exists, containing special data protection regulation: "Genetic data should only be collected, stored or used for the purpose of genetic examination and only so far as the collection, storage or use corresponds to the informed consent of the concerned person". This draft could be the first step towards a new regulation concerning genetic data banking.
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