In China, there have been numerous reports that doctors or other health care workers have been attacked by patients or members of patient’s families. From 2000 to 2003, there were 502 reports of violence against health care workers in the city of Beijing, in which 90 health care workers were wounded or disabled. From January 1991 to July 2001, in Hubei Province, 568 attacks on health care facilities and workers were reported, and some health care workers were even killed. In Jiangsu Province, from 2000 to 2002, violent events against health care facilities and workers increased by 35% every year, with an average of 177 such events occurring each year. Those acts of violence have been attributed, in part, to the inadequacy of the legal system for handling medical disputes that was in effect prior to 2002.

The question of whether the normative testimony of ethics experts should be admissible under the rules of evidence has been the subject of much debate. Professor Imwinkelried's paper is an effort to get us, for a moment, to change that subject. He seeks to turn our attention, instead, to a means by which bioethics experts’ normative analyses might come before the court without regard to the rules of evidence - a means lying formally outside those rules’ jurisdiction. The court, he argues, may freely consider evidence from expert bioethicists so long as it is performing a legislative rather than an adjudicative function. The rules of evidence apply to the court's efforts to find the facts of a particular case, Imwinkelried argues, but they do not constrain the court's investigations relative to its creative law-making efforts.

The words of Paul Simon capture the essence of what the courts are called upon to deal with when adjudicating matters of health. Wealthier and healthier neighbors living in the upstairs apartment are, all things being equal, not overly interested in raising the floor of their apartment in order to create more space for those in the apartment below. The floor is tangible, measurable and movable, and thus a subject where science can contribute much. However, where to locate the floor is a matter of values and thus largely in the realm of politics.

Resorting to the courts in matters of public policy can be seen as the residual of the inability of the remaining two branches of government, the legislature and the executive, to succeed in allocating resources and regulating the system. When the combination of science (bureaucracy) and politics (legislation) falters, enter the judiciary.

Few things seem more a part of the material world than biological specimens. Yet the processes by which collections of specimens are assembled, translated into information, combined with more information, and distributed are taking research repositories into the virtual realm.

The term “virtual” has a number of meanings, and so a research repository can qualify as virtual in a variety of ways. The term would seem to apply, for example, to (1) constructing a repository by forming a network among institutions; (2) using the Internet or the World Wide Web to solicit specimens and information; (3) integrating web-based technology into the operation of the bank; (4) using the Internet or web-based technology to manage relationships with donors or collection sites and recipients; and (5) digitizing specimens. The all-digital repository would seem the most virtual of all possible repositories, a true cyberbank.

Most now recognize the inevitability of rationing in modern health care systems. The elastic nature of the concept of “health need,” our natural human sympathy for those in distress, the increased range of conditions for which treatment is available, the “greying” of the population; all expand demand for care in ways that exceed the supply of resources to provide it. UK governments, however, have found this truth difficult to present and have not encouraged open and candid public debate about choices in health care. Indeed, successive governments have presented the opposite view, that “if you are ill or injured there will be a national health service there to help; and access to it will be based on need and need alone.” And they have been rightly criticized for misleading the public and then blaming clinical and managerial staffin the National Health Service (NHS) when expectations have been disappointed.

Professor Imwinkelried is surely right: the propriety of bioethicists serving as expert witnesses in litigation is problematic, and, I would add, it should remain problematic. Such testimony most certainly does not belong everywhere it will be offered by lawyers and litigants in an effort to advance their interests. Yet in contrast to some commentators, Imwinkelried and I both see a place for bioethicists serving as expert witnesses, although we differ significantly on how to understand and justify this place. In any event, serious questions regarding the proper place for expert bioethicist testimony in the courtroom do exist, not only for law but also bioethics as well.

The threshold question regarding the prospect of bioethicists serving as expert witnesses would seemingly have to be: “could a bioethicist qualify as an expert witness under the controlling rules of evidence?” Imwinkelried, however, does not perceive any need to even entertain this question as he claims that “technical evidentiary standards are inapplicable when information is presented to a judge to permit the judge to perform… a legislative or law-making function.”

Too many patients are injured in the course of medical care. This truth is as distressing now as it was four years ago when it began an article in this journal’s last similar symposium. Many or most injuries seem preventable. Yet today’s systems of care and of oversight of care too often fail to prevent them, despite generations of increasing legal intervention. Few injuries are litigated, even fewer addressed through medical peer review or state disciplinary authorities. The Institute of Medicine’s (IOM’s) landmark report To Err Is Human brought patient safety to national attention when released in late 1999. Half a decade later, significant reduction of injury remains a distant prospect, despite some apparent progress.

Biobanking activities for genetic research purposes have recently undergone nothing short of a small revolution. Many biobanks have left their traditional home of a small refrigerator in a laboratory to reach the unprecedented proportion of large, sophisticated storage centers containing DNA samples from whole populations. As we turn our attention to research on complex diseases and show great interest in human genetic variation and genetic epidemiology, we need to base our research not only on the DNA of small family cohorts, but on larger sample collections, coupled with geographic location, genealogical information, and environmental and medical data. Population genetic research projects are underway around the world. Setting up such large-scale population biobanks is a challenge for any researcher. Population genetic research projects raise legal, ethical, and social issues that need to be addressed properly in order to maintain the trust of the population, an absolute requirement for the success of such research endeavour.

Over fifteen years after first reporting to the State of New York, the Harvard Medical Practice Study (HMPS) continues to have a significant impact in medical malpractice policy debates. In those debates the HMPS has come to stand for four main propositions. First, “medical injury… accounts for more deaths than all other kinds of accidents combined” and “more than a quarter of those were caused by substandard care.” Second, the vast majority of people who are injured as result of substandard care do not file a claim. Third, “a substantial majority of malpractice claims filed are not based on provider carelessness or even iatrogenic injury.” Fourth, “whether negligence or a medical injury had occurred… bore little relation to the outcome of the claims.”

Medical malpractice researchers have long known that the HMPS provides far stronger support for the first two of these propositions than for the last two; the HMPS was not designed or powered to reach strong conclusions about the validity of medical malpractice claims.

Access to care has become a key and contentious issue in the Canadian health care system. In this article, I explore the role of Canadian courts in determining rights to access public health insurance (Medicare), beginning with a brief overview of the Canadian system and its distinguishing features, and then moving to discuss challenges to governmental limits on publicly-funded Medicare using the Canadian Charter of Rights and Freedoms. I argue that the Canadian courts are not, as is often charged, proactive in this area. I question whether the deference exhibited by courts to governmental limits on Medicare is justified given concerns about the fairness of the principles and processes followed by decision-makers. In sharp relief to the judiciary’s conservative approach to applications for better or timely access to publicly-funded Medicare is the recent Supreme Court of Canada’s decision in Chaoulli v. Quebec (Attorney General) which upheld a right to buy private health insurance for “medically necessary” hospital and physician services.

In the lead article in this symposium issue, Edward Imwinkelried follows other scholars in distinguishing among three types of tasks for ethicists serving as expert witnesses: (1) descriptive (e.g., addressing the existence and content of relevant codes of ethics or guidelines, or the correspondence, or lack of correspondence, between relevant codes or guidelines and the parties’ practices); (2) metaethical (e.g., clarifying concepts, critiquing the logic of a particular argument or position); and (3) normative (e.g., addressing what the standard or practice should be). He finds agreement that the admissibility of descriptive or metaethical evidence rests upon the usual criteria of helpfulness and reliability. He breaks new ground in arguing that normative evidence typically relates to the judge's legislative rather than adjudicative function and therefore need not satisfy the usual standards for admissibility in order to be considered.

Bioinformatics, the integration of information technology and biotechnology, is the primary means to make medical sense out of the map of the human genome, and bioinformatics capabilities continue to expand exponentially. Consequently, the demand for access to human biological samples and medical information has never been greater. This demand is giving rise to ambitious biobanking initiatives - meaning the organized collection of samples and medical information from human population.

I am an academically trained philosopher who has taught and written about medical ethics for three decades, who has done extra-mural ethics consultation in clinical and other settings for two decades, and who has served as an expert ethics witness in the courts for more than ten years. Trained as a traditional academic, none of these three pursuits have come easily. Like most philosophers, my education did not prepare me for such responsibilities. Indeed, regardless of a bioethicist's initial background - i.e., health care, law, theology or philosophy - it is invariably necessary to build upon foundational knowledges and abilities in gearing up for work as a health care ethics consultant.

Edward J. Imwinkelreid has prepared a remarkable overview of the work of the expert ethics witness from the point of view of the law of evidence. My perspective as a philosopher, an ethicist, and an expert witness, stands in contrast with his.

The amount allocated to publicly funded health care for 2005/06 in New Zealand, a small country of some four million people, is $NZ 9.68 billion, or 6.2% of GDP, an increase from the 5.7% of GDP in 2000/01. The Minister of Finance has recently signalled that spending in health and education has outpaced economic growth, and that the present rate of growth in health spending, which has grown at about 7% a year over the last decade, is unsustainable. Despite these big funding increases in recent years, the perception of New Zealanders is that the extra spending has made little difference, at least to hospital services and to people’s ability to access treatment. In surveys, health emerges as a leading concern for New Zealanders. Their concern is apparently less about the quality of services, than about their ability to access treatment - whether they will be able to access timely health care when they or their family members need it.

Repositories of tissues, cell lines, blood samples, and other biological specimens are crucial to genomics, proteomics, and other emerging forms of biomedical research. Creation of these repositories by individual researchers and their affiliated organizations, commercial entities, and even governments has been labeled “biobanking” in the bioethics literature. Biobanking as a metaphor for the collection, transfer, and use of these specimens suggests a framework for the legal response to conflicts that may arise - one embedded in principles of contract law and property ownership with an overlay of legislatively authorized regulation of the “industry.”

The United States is in its fifth year of what is now widely referred to as “the new medical malpractice crisis.” Although some professional liability insurers have begun to report improvements in their overall financial margins, there are few signs that the trend toward higher costs is reversing itself - particularly for doctors and hospitals. In 2003-2004, the presidential election and tort reform proposals in Congress brought heightened public attention to the need for some type of policy intervention to ease the effects of the crisis.

The darling of tort reformers at both the federal and state levels has been legislation to limit, or “cap,” damages awarded to plaintiffs in malpractice cases. Health care provider groups, liability insurers, and the Bush Administration have all seized on the example of California's MICRA law, which since 1975 has capped noneconomic damages in malpractice cases at a flat $250,000, as the path to financial recovery.

The United States Supreme Court has long recognized the value of scientific evidence - especially when compared to other types of evidence such as eyewitness identifications, confessions, and informant testimony. For example, in Escobedo v. Illinois, the Court observed: “We have learned the lesson of history, ancient and modern, that a system of criminal law enforcement which comes to depend on the ‘confession’ will, in the long run, be less reliable and more subject to abuses than a system which depends on extrinsic evidence independently secured through skillful investigation.” Similarly, in Davis v. Mississippi, the Court commented:

In the Netherlands, access to healthcare has been guaranteed by social health insurance legislation. But since the introduction of the Health Insurance Act (“Zikenfondswet”) in the 1960s, the health insurance system has been in a state of flux. Numerous reforms have changed the system gradually, of which the latest is the introduction of a competitive health insurance scheme for the entire population.

Cutting across the various reforms has, however, been the goal of access to healthcare services as defined by international treaty law, including European Union law. In particular the leverage of Community law in strengthening the patient’s right to healthcare is remarkable. Since the European Court of Justice (ECJ) has accepted that healthcare should be considered as a service in terms of the EC Treaty, rights to healthcare have become inextricably linked with the free movement principles and are no longer restricted to the jurisdiction of the country of origin.

On November 2, 2004, California voters approved Proposition 69, “The DNA Fingerprint, Unsolved Crime, and Innocence Protection Act” by a margin of approximately 60 to 40 percent. Given the limited amount of information provided to voters during the initiative process, it is unclear how many of the yea-sayers were apprised of the full implications of this measure. Indeed, by voting “yes” on Proposition 69, California has elected to house the most radical and costly state criminal DNA database in the country. This dangerous expansion of California's database poses tremendous threats to civil liberties and social justice while offering little, if anything, by way of increasing the safety of its citizens.

Prior to November 2, California law required the permanent retention of DNA samples from felons convicted of serious, violent crimes. The new law expands the database to include DNA samples from all felons and individuals with past felony convictions - including juveniles - and, beginning in five years, all adults arrested for any felony offense.

Biobanks hold out the prospect of significant public and private benefit, as genetic information contained in tissue samples is mined for information. However, the storing of human tissue samples and genetic information for research and/or therapeutic purposes raises a number of serious privacy and autonomy concerns. These concerns are compounded when one considers the possibility that a biobank or its owner might go bankrupt. Insolvency impairs the ability of enforcement regimes, and liability-based regimes in particular, to enforce legal norms. The goal of this essay is to develop guideposts for thinking about private and public enforcement of privacy imposed by donors on tissue samples and/or genetic information when a biobank becomes insolvent.