While the socio-ethical and legal issues surrounding clinical genetics have long been the subject of international interest, the thorny questions of genetic research and biobanking are more recent. Add to this the fact that national guidelines and laws usually precede international policymaking, and the delay in international approaches is understandable. In that regard, the United Nations Educational, Scientific and Cultural Organization’s 1997 Universal Declaration on the Human Genome and Human Rights is unique in its prospective guidance on genetic research. Also, it is in the very nature of international normative instruments to be general, except on specific issues considered to be in the interest of humanity, such as research into human reproductive cloning or access to AIDS drugs.

The term, “bioethics” was coined in 1970 by American cancerologist V. R. Potter. In the few decades since, the field of bioethics has emerged as an important discipline. The field has attained a remarkable degree of public recognition in a relatively short period of time. The “right to die” cases such as In re Quinlan placed bioethical issues on the front pages. Although the discipline is of recent vintage, the past quarter century has witnessed a flurry of scholarly activity, creating a substantial body of bioethical literature. Moreover, the bioethics movement has manifested itself in institutional expressions. Universities and medical schools have added courses in bioethics to their curricula. In 1974, federal legislation and regulations mandated that federal grantees conducting human subjects research establish institutional review boards to safeguard subjects’ welfare, and even absent a legislative mandate numerous hospitals created ethics committees. Centers and institutes, devoted exclusively to the study of bioethical issues, have been founded.

Medical science brings innovations in patient care at an astounding pace today - new chemotherapeutic agents, coated stents, and minimally invasive surgery are just few recent examples. For physicians, though, the specter of malpractice liability can overshadow the marvel of practicing in this era. Many physicians are working in a volatile liability environment; they face spiraling costs for malpractice insurance, have difficulties purchasing liability coverage at any price, and see record payouts in a growing number of claims against their colleagues. The American Medical Association (AMA) has declared that at least 20 states are currently in a malpractice “crisis,” with another 24 states showing early signs of an impending crisis.

There have been two comparable periods of instability in the last thirty years, but these predecessor crises differ from the current one in important ways. First, while physicians mainly experienced dwindling options for obtaining coverage in the mid-1970s (i.e., availability) and exorbitant prices in the mid-1980s (i.e., affordability), the current crisis appears to have elements of both availability and affordability.

Biomedical research has always relied on access to human biological materials and clinical information, resources that when combined form biobanks. In the past, it appears that investigators sometimes used these resources with relatively little oversight, and without the consent of the individuals from whom these materials and information were obtained. Several developments in the last ten to fifteen years have converged to place greater emphasis on the role of individual consent in the creation and use of biobanks. The most important by far is the power of information technology, which has transformed our lives in almost every domain. In the research setting, it is now easy to abstract information from electronic medical records. Computers make it possible to analyze enormous datasets and have contributed in essential ways to the dramatic increases in our understanding of genomics and other areas of biomedical science.

Medical indemnity is not usually the stuff of high political and social drama in Australia. When the biggest medical defense organization went into voluntary liquidation in 2002, this all changed. Newspapers carried stories on an almost daily basis about the actual or possible negative impact of the “crisis” on doctors, hospitals, and communities. Doctors became increasingly vocal in their criticisms and expansive in their claims. Their political organization, the Australian Medical Association, lobbied powerfully and successfully for government intervention to address the problem of dramatically escalating premiums for some doctors. This, combined with a broader public relations campaign about public liability insurance, resulted in significant changes in the law at both the federal and state level - not just in the area of medical negligence but in relation to most personal injury litigation.

The genesis of and reasons for current medical indemnity problems in Australia have been the subject of much speculation and little rigorous analysis.

In The Abuse of Casuistry Jonsen and Toulmin describe one view of moral reasoning as follows:

Whether or not all moral reasoning resembles “strands to a rope,” bioethics testimony certainly does. Bioethics testimony is eclectic, a composite of many loosely woven strands. Rarely, if ever, is bioethics testimony “a chain of unbreakable deductions.” Rarely is it “pure” ethics, much less pure normative ethics.

Professor Imwinkelried has boldly attempted to justify the admissibility of normative ethical expertise in the face of a legal evidentiary rule requiring a scientific basis for expert testimony. Because ethical testimony is inherently unscientific, Professor Imwinkelried prudently focuses his analysis on circumstances where evidentiary requirements are less strict; those involving the legislative rather than adjudicative function of courts and those in which substantive law overrides normally rigorous evidentiary requirements. While both proposals may have merit and are thoughtful and creative, Professor Imwinkelried ultimately fails to provide sufficient doctrinal support or persuasive rationale for his arguments.

Professor Imwinkelrieds argument for the admissibility of “expert” normative ethical testimony has two parts. The major proposition is that, when courts are engaged in legislative functions, they should be permitted to consider all sources of information. The assumption that apparently underlies this proposition is that nothing limits courts’ exercise of legislative powers.

It is often thought that there is a “crisis” or something akin to this in the field of medical malpractice in the USA and from time to time, as will be shown, there are suggestions that a similar situation could exist in the UK. This paper will examine what might be meant by the expressions “malpractice” and “crisis” in relation to the UK. It will be argued that there is no evidence to suggest that anything as dramatic as a crisis exists, and that what current concerns exist about medical malpractice and litigation are not based upon an existing or impending crisis. Further, it will suggest that evidence points to medical litigation had reached a plateau, and that, due to a number of factors, if there were a serious problem it is likely to be on the wane.

We have a thriving biotechnology industry in the United States. There are over 1,450 biotechnology companies developing diagnostic and treatment technologies in medicine, creating more nutritional foods, and innovating new industrial processes. Yet this $28.5 billion sector of the economy is not without controversy. The “bio” in biotechnology comes from living, biological entities - people, plants, animals, and even bacteria. In the realm of biobanking, people are the source of the raw material for the discovery of genes for research, diagnosis, and therapy, raising a host of issues about rights and responsibilities, fiduciary duties and societal obligations.

Is it possible to use the courts - or rights instruments - to advance fair access to health care? This article examines this question within the context of the Norwegian public health care system - one special example of the Scandinavian welfare system. In particular, it asks four basic questions: What are the normative justifications for rights to health care? What were the political processes and concerns leading up to the current Patients Rights Act in Norway? What kind of legal status do these rights have? How can rights to access be implemented?

Patient rights do not only concern the right to access to health care; they also include the right to information, the right to participate in decision-making, and informed consent. This article examines only the former aspect, the use of the legal system to secure access to prioritized specialized health care services.