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.

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.

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.

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?