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Control over One’s Own Genes

Methods for whole genome sequencing reveal sensitive information on the state of a person’s health. The Freiburg jurist Prof. Dr. Silja Vöneky thus stresses the importance of establishing legal provisions on the national and international level.


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Sequencing a person’s complete genome opens up new possibilities for the individual diagnosis of health risks.  Legal standards must ensure that the increase in sensitive information does not violate the basic rights of patients and test subjects. ( © ~lonely~ /


Sequencing a person’s complete genome opens up new possibilities for the individual diagnosis of health risks. In the past ten years, the cost of so-called whole genome sequencing has dropped dramatically – from approximately three billion dollars to 1000 dollars. In addition, it now takes only a few days to carry out the procedure. The sequencing of complete genomes is thus also becoming a part of routine clinical patient care in Germany, particularly in the area of cancer medicine. Legal standards must ensure that the increase in sensitive information does not violate the basic rights of patients and test subjects, demands Vöneky, a member of the German National Ethics Council.


  • Clear Minimum Requirements

Since a genome reveals vital aspects of a person’s identity, genetic information is protected on an international level by several UNESCO declarations. The International Declaration on Human Genetic Data from 2003 and the Universal Declaration on Bioethics and Human Rights from 2005, for instance, require that persons who undergo genetic testing be provided full information on the procedure and that they freely give their informed consent. Patients also have the right to be informed of the results or, if they so desire, the right not to be informed of them. These rights are protected under the Basic Law for the Federal Republic of Germany as well as under international human rights agreements. At the same time, it is always necessary to weigh the risks and benefits of genetic analyses. “The UNESCO declarations establish clear minimum requirements in this regard,” says Vöneky.


  • Dealing With Incidental Findings

One controversial question is how to deal with unintended findings that are not related to the actual goal of a genetic test. “Individual countries have a certain amount of leeway in how they are allowed to deal with these incidental findings, as long as there are legitimate reasons for their legal regulations and they do not interfere with human rights,” explains the Freiburg law professor. However, the UNESCO International Declaration on Human Genetic Data calls for those conducting the test to again seek the consent of the patient if the purpose of the test changes, and this is the case with incidental findings. In the event of doubt or legal loopholes, the UNESCO International Declaration on Human Genetic Data recommends handing the matter over to an independent and multidisciplinary ethics commission for a decision.


  • A Focus on Human Rights

The International Covenant on Economic, Social, and Cultural Rights from 1966 recognized the right to the highest attainable standard of health as well as the right to partake in the benefits of scientific progress as human rights. This implies that it is the task of government to promote medical research. A UNESCO declaration from 1997 even requires countries to provide adequate infrastructure for research on the human genome. Another point to consider is the general freedom of research. Although this right is not as firmly and unconditionally fixed in international law as it is in the German Basic Law, protecting the private sphere and the autonomy of the patient or the test subject is always the main focus of international regulations, as Vöneky points out.
The German National Ethics Council has set itself the task of finding a solution to this problem that takes into account the international and constitutional guidelines as well as additional ethical aspects. In Vöneky’s opinion, the council should formulate draft regulations that more clearly delineate how patients or test subjects can be provided full and neutral information about all – known – chances and risks. As demonstrated by examples from other areas – such as the new requirements for providing advice on financial products – the quality of the information provided in complex decision-making situations is the decisive factor for enabling an individual to truly make a responsible decision. Quality control measures could include specifying parameters for the information to be provided and requiring full documentation of consultation sessions. Even more importantly, the information should be provided by an independent consultant, thus ensuring that individual aspects of these complex questions are not – whether consciously or unconsciously – swept under the carpet before the patient or test subject provides his or her consent.


  • Genes on the Internet

Since genetic tests always also reveal information about other related persons, it is up to debate whether individuals have the right to, for instance, make their own gene sequences freely available on the Internet – something which has already begun to happen. Can person A decide to post his or her genome on the Internet if this also affects B and C? “The UNESCO declarations are very strict on this point – researchers often find the guidelines too narrow,” says Vöneky, “but the individual rights of the persons in question should not be restricted to an unreasonable extent.”


  • Legal Certainty in Germany

In Germany, genetic analyses performed by doctors are regulated by the Genetic Diagnostics Law of 2009. It guarantees patients control over their own genetic data as well as consultation from medical specialists. “Due to the asymmetry of knowledge and the great uncertainty and significance of the results of genetic testing, it is justified to have such high requirements,” says the Freiburg law professor.
However, the Genetic Diagnostics Law does not make explicit reference to genetic research. This area is under the jurisdiction of international regulations – as long as they do not come into conflict with the protection of human dignity, which is emphasized more strongly in the German Basic Law than in international human rights agreements. It is always possible to achieve higher protection standards through national legislation than through international agreements, says the professor. For example, the sequencing of the genomes of children and others who are not in the position to give their legal consent may be legitimate under international law but still violate German Basic Law. This is the case for genetic analyses that have no direct benefit for the individual, such as those performed within the context of research projects. “In order to create legal certainty for scientists,” explains Vöneky, “I consider it by all means prudent to establish legal regulations for genetic diagnostics in the area of research as well.”



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 Prof. Dr. Silja Vöneky
Silja Vöneky has served as professor of public law, international law, and legal ethics at the University of Freiburg and director of the Institute of Public Law, Department 2: International Law and Comparative Law, since 2010. Her research interests include international laws of war, international environmental law, international law of the sea, and legal ethics. Since writing her habilitation thesis on the foundations and limits of democratic legitimation for ethics committees, she has also begun focusing on biolaw and medical law. From 2005 to 2011 she served as head of the independent Max Planck research group “Democratic Legitimation of Ethical Decisions – Ethics and Law in Biotechnology and Modern Medicine” at the Max Planck Institute for Comparative Public Law and International Law in Heidelberg. On the suggestion of the federal government, she became a member of the National Ethics Council in 2012, where she serves as head of the work group on bio-security. Since 2013 Vöneky has also been a member of the executive board of the Competence Network for Law on Civil Security in Europe (KORSE) at the University of Freiburg.


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