The last half century has been characterized by a growth in the regulation of clinical research nationally and internationally. Each area of research on human subjects has been the subject of a vast academic literature and extensive public policy debate, from issues of informed consent to that of regulatory structures. Professor Bernard Dickens has provided an outstanding contribution to this debate internationally through his many innovative and incisive papers in this area. This paper provides an English lawyer’s perspective upon the increasing regulation of clinical research practices and asks – does regulation equate with effective rights protection? From Nuremberg onwards, there has been concern to ensure that research practices are ethical and in accordance with legal principles. So, for example, there have been statements such as the Declaration of Helsinki, which was initially produced in 1964. In the European context in particular, notably influential statements have been the European Convention on Human Rights, which has been followed by the Council of Europe Convention on Human Rights and Biomedicine and, more recently, a Draft Additional Protocol on medical research.

With progress in genetic research advancing as it is, a host of novel theoretical and practical challenges are thereby being raised. From a bioethical perspective, it is easy to get the feeling that, because of this rapid progress, many fundamental concepts that should be in place arent yet in place. This lack may be felt especially in relation to human gene modification. with the Human Genome Projects (HUGOS) potential to yield innumerable applications, one of the things that should be in place is a set of fundamental conceptual guidelines demarcating the kinds of genetic modifications (I will use this term to stand both for various kinds of genetic therapies and enhancements) that should count as ethically acceptable and legally permissible. In this paper, my goal is to articulate such guidelines, specifically for the set of all possible human germline (rather than somatic) modifications.

This article explores decision making about social-ethical values issues by members of the public in the context of the recent Canadian federal election, held in late June 2004. All of these issues are sensitive and controversial, and I hesitated to address them in an article that I dedicate, with respect and admiration, to my friend and fellow medical lawyer-ethicist, Bernard Dickens. Over the years Bernie and I have discussed, debated and disagreed on many of them. It speaks to his tolerance, reasonableness and wisdom that those occasions were for me always ones of learning and respect, colored by his inimitable sense of humor. I hope that Bernie feels that, in some small measure, this article reflects those same characteristics, ones that he has modeled for so many of us over the years of his distinguished career.

On October 14, 2003, the Supreme Court announced that it would not review a Ninth Circuit Appeals Court ruling that enjoined the federal government from punishing doctors who recommend medical use of marijuana to their patients. The Ninth Circuit case, Conan v.Walters, drew a fine line in distinguishing betweendispensing information and dispensing controlled substances, and held that [p]hysicians must be able to speak frankly and openly to patients under the First Amendments. Although unauthorized use and distribution of marijuana is prohibited, the court found that a doctor s recommendation does not itself constitute illegal conduct that doctors should be free to recommend the use of medical marijuana if based on sincere medical judgment, without fear of retaliation by a government probe or prosecution.

On February 2,2004,U.S. District Judge Federico Moreno issued the final order and judgment authorizing a settlement between the HMO CIGNA Healthcare and the physicians who treated patients covered by CIGNA, ending the companys involvement in the larger class action In re Managed Care Litigation, which stil includes eight other HMOs. The settlement, estimated by plaintiffs experts to be worth 1.3 billion, mandates changes in the companys business and disclosure practices, establishes a non-profit foundation dedicated to the promotion of high quality health care, and guarantees at least 70 million in payments to the physicians. Similar in scope to the settlement approved between the physician class and Aetna Healthcare in October 2003,the settlement could potentially set a new standard for transparency and physician involvement in billing practices; however, much depends on the outcome of the remainder of the class action, which is set to go to trial later this year.

Though in existence for over thirty-five years, due to the increasing panoply of possible tests. Newborn screening programs are drawing public attention. Many jurisdictions have mandatory newborn screening programs for treatable disorders. Disorders are detected through tests on blood spots drawn from a newborn’s heel soon after birth and verified through a diagnostic test with follow-up. Unbeknownst to most parents, these blood spot cards are also stored thereafter. Indeed, while dried blood spots (DBSs) are primarily used for screening for health problems, experience demonstrates that they can be made useful in various contexts unrelated to screening.

Newborn dried blood spots have taken on a new life as a result of developments in genetics and the increasing ability of bioinformatics to link DNA information with clinical data. Additionally, storage and secondary uses have been documented to occur without parental consent.

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science (CIOMS), and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions (See Table 1). Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also requires limiting the risks of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.

Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved.

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the appeals court reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws.

In recent years, shared decision-making has become entrenched in the medical literature and the law as the ideal method for involving patients in decisions related to their health care. Shared decision-making represents a compromise between the opposed extremes of paternalistic interactions that limit patients’ control of their health care, and “informed choice” interactions that require physicians to provide technical expertise only, leaving patients to make all treatment decisions on their own. An implicit goal of shared decision-making is to improve medical care by promoting joint participation of patients and physicians in clinical consultations. The model of shared decision-making may, however, inadequately address the health care needs of lower literate patients, a significant portion of the general population.

As shared decision-making is widely held as a clinical ideal, we highlight the difficulties that physicians might have in implementing shared decision-making with lower literate patients.

On December 30, 2003, the FDA announced that it will publish a rule banning sales of ephedra - a dietary supplement often utilized for weight loss, increased energy, and enhanced athletic performance - because it poses an unreasonable health risk.The ban will be issued under the auspices of the Federal Food, Drug, and Cosmetic Act and the Dietary Supplement Health and Education Act of 1994 (DSHEA), in response to a process that began in June of 1997, when the FDA first proposed a mandatory warning statement on dietary supplements containing ephedra. FDAs analysis of the scientific evidence has led it to conclude that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury and are therefore adulterated under Section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act?