Benedikt Burger, Claudia Langer, and Veronika Krizova, Privacy law in the U.S. and in Europe in emerging fields of biotechnology
Comment by: Paul Schwartz
Workshop draft abstract:
Biotechnology is one of the key technologies of our days. Its rapid evolution opens new opportunities for healthcare and bio-engineering. But as the progress of biotechnological medical research and therapy advances, so do the threats to privacy. Genes as the basic biological component of biological sample tissues contain sensitive information about donors or patients. While an individual may profit, for example, from his participation in research projects or from therapies, the protection of privacy requires him/her to remain in control of his/her data.
Only if the legal framework keeps track with the rapid development and solves the conflict between the researchers need for information and the individual’s right to privacy, biotechnology can bring benefits to individuals as well as the society in general without reducing the protection of an individual’s privacy.
The paper illustrates this intersection on three controversially discussed examples: human tissue engineering, biobanks, and organ donation and transplantation.
Human tissue engineering constantly consumes human tissue samples for the research for new and promising therapies and cures for diseases. By taking tissue samples which doctors/researchers then prepare as human tissue engineered products (HTEPs), they provide treatment while simultaneously collecting the patients’ clinical data. Furthermore, HTEPs are worldwide exchanged among researchers in international projects. The projects have to face the challenge of different national laws on patients’ privacy rights. But also single patients travel internationally for innovative therapies. Such medical tourist destinations are regularly countries where their privacy rights do (almost) not exist. Specific privacy rules on medical tourism and the international tissue exchange are necessary to ensure the individuals’ rights. The paper will present how informed consent is a way to serve both the patients’ and the researchers’ needs in a globalized world.
After the collection of tissues, biobanks may be installed to maximize scientific research in interdisciplinary and international projects. Genetic data is used as an input to perform either research which may help to understand diseases and to develop of new drugs. The nature of research does not allow precise information about its progress and findings. The level of information an individual can get at the time of his consent is therefore inevitably low. New models like open or broad consent are introduced to solve this conflict – and reduce an individual’s protection even further. The paper will present alternatives that will balance the scientific needs and an individual’s protection.
Organ donation and transplantation has been one of the first medical fields that drew attention of lawyers and the general public due to the controversial nature of the method in respect to personality rights. Many attempts have already been made to find the best compromise for a legal regulation of issues regarding i.e. consent, incentives and benefits for donors or the privacy of data collected, stored and shared. But there still seems to remain uncertainty as to what approach is the most sensible yet effective one. As the medical law and medicine itself evolves, new fields of research and innovations bring new challenges for legislation. At the same time, they help to introduce new legal solutions. New areas such as stem cell research or the use of biobanks for scientific and commercial purposes can also represent potential elements of a new legal framework for organ donation and transplantation while they can thrive from the variety of approaches to the existing problems in more traditional fields of medicine.
The goal of this paper is to show the interrelation between specific aspects of biotechnology and privacy. It will focus on the comparison between U.S. and European Privacy Law and show the different ways of regulation as well as commonalities in order to maximize potential benefits of international research.