Biotechnology as an intellectual property.

Recent advances in biotechnology have created many public policy and legal issues, one of the most significant of which is the treatment of biotechnological industrial products, particularly under the patent system. Patents represent one of several types of intellectual property; their ownership confers the right to exclude others from benefitting from the tangible products of a proprietary subject matter. Intellectual property law and its protections will play a major role in the rate at which biotechnology develops in the United States. In this article biotechnological intellectual property issues are reviewed in the context of their underlying legal requirements. The implications of other factors, such as international competition, research funding, and gene ownership, are also considered.

KIE: Legal ownership of industrial products of biomedical research is discussed as a question of intellectual property rights. Attention is focused on the major role played by the U.S. patent system in establishing such rights, as illustrated by the case of products of recombinant DNA research. Trade secret, copyright, and trademark protections are also considered, as are policy issues such as international competition in the development of biomedical technologies and financing arrangements.

Genome research: fulfilling the public's expectations for knowledge and commercialization.

This article provides a historical perspective for the patenting of gene sequences and describes the fundamentals and evolution of patent law. It summarizes federal technology transfer law and policy and assesses the impacts of patenting on academic research. The patentability of gene sequences is then considered along with potential impacts that published sequence data may have on obtaining patent protection for downstream products. Industry's position on gene patenting is summarized and perspectives from the emerging public record on these issues are presented. The article discussing points at which the filing of patent applications and the licensing of patents may be appropriate. It concludes that technology transfer policies for genome research must be adopted carefully so that they remain viable in a time of rapid technological change.

Australian pathways and solutions for dealing with older impaired doctors: a prevention model.

Our ageing medical workforce poses many challenges, not the least of which is acknowledging the contributions of ageing practitioners who continue to practise safely and competently while ensuring that those who are incompetent by virtue of impairment are identified, assessed and either rehabilitated or encouraged to retire. Hitherto, there has been little attempt to review approaches to impairment on a national basis in Australia, let alone with a focus on older doctors. Information regarding pathways for dealing with impairment was obtained from the websites and confirmed by representatives of regulatory bodies of every state or territory in Australia. Using a prevention model we outline the current Australian regulatory processes, address some of the barriers and suggest some solutions to dealing with the older impaired doctor. Much of the focus in dealing with the older impaired doctor is tertiary prevention based, that is, reducing the negative influence of established impairment. There is some uniformity in the way that Australian regulatory bodies deal with impairment that espouses the dual goals of protecting the public and rehabilitating the doctor. The approach is typically individualized and multi-levelled, beginning with assessment followed by rehabilitation where appropriate. A range of secondary and primary prevention measures is proposed for dealing with the problem of the older impaired doctor. These include educating the medical community, encouraging early notification and facilitating career planning and timely retirement of older doctors. This will have benefits both in protecting the public as well as preventing an undignified and humiliating end to often-unblemished careers in medicine.

Neuropsychological complications of IDDM in children 2 years after disease onset.

OBJECTIVE: To compare the neuropsychological profiles of children with IDDM with a community control group at two time points: 3 months after disease onset and 2 years after the baseline assessment. RESEARCH DESIGN AND METHODS: A total of 123 children (age 3-14 years) with recent IDDM onset were compared with 129 community control subjects, stratified for age and sex, on standardized measures of general intelligence, attention, speed of processing, memory, learning, executive skills, and behavioral adjustment soon after diagnosis and 2 years later. Exclusion criteria were premorbid evidence of central nervous system disease or trauma, or English not spoken in the home. RESULTS: There were no differences between children with IDDM and control subjects on any measure at the initial assessment 3 months after disease onset. Two years later, children with IDDM tended to show a less positive change, relative to control subjects, in their standardized scores on measures of general intelligence, and significantly so on the vocabulary (P < 0.01) and block design (P < 0.05) subtests. Multivariate group differences were also apparent on speed of processing (P < 0.05) and learning (P < 0.01) subtests, reflecting smaller developmental gains in the children with IDDM when compared with control subjects. CONCLUSIONS: The findings are consistent with previous reports, suggesting that IDDM is associated with an increased risk of mild neuropsychological dysfunction. The skills most affected in this cohort were information processing speed, acquisition of new knowledge, and conceptual reasoning abilities. Clinicians and educators should be made aware of the risk of specific neuropsychological deficits in children with IDDM.

Children hospitalized with child abuse and neglect: a case-control study.

A case-control study of 45 hospitalized abused children was conducted to reassess the risk factors for child abuse when confounding by social class was minimized. Cases were matched for age, sex, family structure, and social class with children admitted to hospital for an acute illness. Abused children were more likely to have younger parents, fewer siblings, and to have been separated from their mothers during the first year of life. Their parents were more likely to have been abused as children and to have a poor relationship with the child's other parent. The families of abused children had encountered more stressful life events in the preceding 12 months. Other previously recognized "risk factors" were not shown to have a statistically significant association with child abuse. Because child abuse is more prevalent in lower socioeconomic families, the association with many of these factors has been accepted as implying a causal relationship. Matching procedures which attempted to eliminate confounding by social class and family structure cast doubts on some previously held beliefs about the risk factors for child abuse.