Academic journal article Missouri Law Review

The Need for a Legitimate Regulatory Regime in Bioethics: A Global and European Perspective

Academic journal article Missouri Law Review

The Need for a Legitimate Regulatory Regime in Bioethics: A Global and European Perspective

Article excerpt


Bioethics in global biobanking touches upon several internationally accepted fundamental rights and values, namely the sample donor's right of privacy, the patient's right to health, and--at least implicitly--scientific freedom. From the perspective of fundamental rights, however, there are very few internationally applicable rules as to the enforcement of these rights at the administrative level. Instead, the combination of the practical need for common rules and the lack of political will and/or legislative competence within the international community or the European Union (EU) seems to have paved the way for soft law. Further, the role of courts in the area of bioethics and biobanking, nationally as well as internationally, is limited. The implementation of administrative rules at the national or regional levels is carried out by research committees and research funding institutions, usually with limited or no right to appeal to the general court system. Consequently, the traditional mechanisms of political and judicial control to a large extent are unavailable. The question raised here is whether the theories connected to global administrative law can be of any guidance in developing a legitimate regulatory regime for international biobanking. Can principles of participation, transparency, and reasoned decisions be of relevance in this area of law?


Globalization and general technical developments have brought about changes in medical research. It is now possible to collect blood, tissue or other biological samples from large populations of individuals and use them for a series of different research projects in the quest of developing new treatments for diseases and for improving health. After they are collected directly for research purposes or during the course of medical treatment, many millions of samples are stored away in freezers ("biobanks") for future purposes. Medical research using these biobank samples is a typical example of an area where globalization is noticeable, since this research, both in academia and in the pharmaceutical industries, is often conducted across national borders. Samples of human biological material are sent from a research lab in one country to a research lab in another.

On the technical side, methods for freezing and storing samples and other safety assessments are largely regulated by detailed international standards, as developed by the Organization for Economic Co-operation and Development (OECD) and the EU among other organizations. (1) On the ethical side of biological and medical research--bioethics--there are several questions that are not as easily resolved in an international legal context. On one hand, research conducted on humans can be regarded as sensitive from an ethical aspect. On the other hand, there is an enormous public demand for medical achievements, and the public at large is usually willing to contribute to this by donating samples to qualified and reliable researchers. (2) The starting point in this Article is that if researchers are to be considered reliable and gain and retain the trust of the public, a clear legal and ethical framework for medical researchers to act within must be established.

From an integrity perspective, the law as it stands today often sets certain limits as to what can be done with the human body, even a blood or tissue sample, as well as the personal information that may be retrieved from the sample. (3) Several international documents, conventions, and even non-binding declarations state that the donor must give some form of informed consent in order for the research conducted on the sample to be deemed legitimate. (4) For the sample donor to be informed, he or she has to be provided with information on how the sample may be used in the future. Beyond this basic point, however, member states of the international community, or even of the European Union for that matter, have been unable to establish universally accepted ethical standards or common administrative procedures for researchers acting globally. …

Search by... Author
Show... All Results Primary Sources Peer-reviewed


An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.