The need for a legitimate regulatory regime in bioethics: a global and European perspective.

• Author: Reichel, Jane

ABSTRACT

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?

1. INTRODUCTION

   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. When it comes to ethical issues directly related to biobanks, there are merely soft law documents and no binding legal rules at the global level. (5) National legislators, neither parliaments nor other rulemaking bodies entrusted with delegated legislative powers, cannot single-handedly regulate cross-border matters. The regulatory framework applicable in the area of bioethics in international biobanking thus consists of basic principles laid down in public international law, an abundance of non-binding soft law documents, as well as scattered regional and national legislative acts to be applied within the respective legal order.

   At the administrative level, ethical issues related to medical research are normally handled within each state in accordance with national law. The procedure varies between states, but basically researchers gather consents from sample donors in standardized forms, which are then reviewed by the competent ethical review committees in the region or the state where the research is being conducted. If the samples are collected in several states, the procedure has to be repeated in each state. On the other hand, if a sample is collected in one state and sent to another, the consent given in the sending state can be considered sufficient, if the receiving state agrees to respect the rules of the sending state.

   The focus of this Article is on the international and European administrative rules connected to research on human biological samples in an international context. The administrative burden on international research in the present system often becomes quite onerous, and from the point of view of researchers, there is a need for a foreseeable and transparent internationally applicable regulatory framework on ethical issues. The question is who can regulate this field and how. The ethical and moral values involved in medical research often have a strong connection to the legal, moral, and cultural landscapes of the nation state or region, and it is difficult to find a common denominator acceptable on a global scale. Without the democratic legitimacy of national parliaments, and the lack of a legitimate and competent legislator at the global level, it may be questioned whether soft law is the only possible way forward. However soft the "law" is on its surface, internationally enacted declarations and guidelines often have normative qualities in practice. This article analyzes the form and status of the rules applicable in the field and by which bodies they have been adopted. This analysis takes into account the developing theories on global administrative law, examining what roles the classic administrative rights of transparency, participation, and accountability can have in the current regulatory framework for international biobanking, with its multitude of actors, legislators and rule-makers at different levels. (6)

2. THE DEVELOPMENT OF A GLOBAL ADMINISTRATIVE LAW AND ITS REGULATORY LIMITS

   A central issue for administrative regulations in a globalized context is determining the optimal level for enacting the regulations, and, if an international level is considered necessary, what requirements can be imposed on the globalized regulatory process. The question of the legitimacy of the administrative regulatory powers outside the nation state is central to such discussions. Professor Carol Harlow argues that the legitimizing principles "of any Western administrative system are found in the twin ideals of democracy and the rule of law." (7) How can these ideals be achieved in a globalized context?

   This topic is first discussed from a global perspective and then from the EU perspective. EU regulation is not typical of global administrative law, because the EU itself has evolved into an organization with clear supranational features, with its own legislative, administrative and judicial bodies. From a national perspective, it is still clear that the sources of law deriving from EU law differ from purely national legal sources. The aim of this Article is not to give an exhaustive account of all relevant procedures, but rather to depict the overall regulatory background for further discussions on legitimacy and accountability from the perspectives of researchers and donors.

   1. Administrative Regulation through Public International Law

      There is no single set of legislative rules or procedure for the international community. Public international law builds on the premise that no state can be bound to follow rules it has not consented to, i.e. consensual rulemaking. The same concept is true for non-governmental organizations and private enterprises, which cannot be forced to enter into agreements that they do not accept. On the other hand, the era of globalization has brought about a new legal reality with an outspoken need for workable administrative regimes allowing states, NGOs, commercial actors, and individuals around the globe to cooperate, for example, in research projects. Global administrative regimes may thus answer to a practical need of resolving common problems. (8) In areas such as medical research and biobanking, there is further a need for these global administrative regimes to be reliable from a legitimacy perspective, in order for the public not to lose its confidence in the research conducted. Without public faith in the research conducted, there is a risk that fewer donors will consent to donate their samples, which would be detrimental for medical research in general.

      Drawing on the terminology established by Professor Fritz Scharpf in connection to the EU, one could differentiate between in-put legitimacy and out-put legitimacy. (9) In a classic nation state setting, legitimacy can be derived through the process of enacting rules (in-put legitimacy), for example, through the direct or indirect participation of a democratically-elected...