Protecting traditional knowledge: the San and hoodia.
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Humans↗
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Results for “Intellectual Property”
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CIPIH report: main recommendations.
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Developing Countries↗
Ethical conflicts in university-based research.
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Conflict of Interest↗
Withholding of data among academic geneticists.
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Communication↗
Data withholding in academic genetics: evidence from a national survey.
CONTEXT: The free and open sharing of information, data, and materials regarding published research is vital to the replication of published results, the efficient advancement of science, and the education of students. Yet in daily practice, the ideal of free sharing is often breached. OBJECTIVE: To understand the nature, extent, and consequences of data withholding in academic genetics. DESIGN, SETTING, AND PARTICIPANTS: Mailed survey (March-July 2000) of geneticists and other life scientists in the 100 US universities that received the most funding from the National Institutes of Health in 1998. Of a potential 3000 respondents, 2893 were eligible and 1849 responded, yielding an overall response rate of 64%. We analyzed a subsample of 1240 self-identified geneticists and made a limited number of comparisons with 600 self-identified nongeneticists. MAIN OUTCOME MEASURES: Percentage of faculty who made requests for data that were denied; percentage of respondents who denied requests; influences on and consequences of withholding data; and changes over time in perceived willingness to share data. RESULTS: Forty-seven percent of geneticists who asked other faculty for additional information, data, or materials regarding published research reported that at least 1 of their requests had been denied in the preceding 3 years. Ten percent of all postpublication requests for additional information were denied. Because they were denied access to data, 28% of geneticists reported that they had been unable to confirm published research. Twelve percent said that in the previous 3 years, they had denied another academician's request for data concerning published results. Among geneticists who said they had intentionally withheld data regarding their published work, 80% reported that it required too much effort to produce the materials or information; 64%, that they were protecting the ability of a graduate student, postdoctoral fellow, or junior faculty member to publish; and 53%, that they were protecting their own ability to publish. Thirty-five percent of geneticists said that sharing had decreased during the last decade; 14%, that sharing had increased. Geneticists were as likely as other life scientists to deny others' requests (odds ratio [OR], 1.39; 95% confidence interval [CI], 0.81-2.40) and to have their own requests denied (OR, 0.97; 95% CI, 0.69-1.40). However, other life scientists were less likely to report that withholding had a negative impact on their own research as well as their field of research. CONCLUSIONS: Data withholding occurs in academic genetics and it affects essential scientific activities such as the ability to confirm published results. Lack of resources and issues of scientific priority may play an important role in scientists' decisions to withhold data, materials, and information from other academic geneticists.
Communication↗
Commercial molecular diagnostics in the U.S.: The Human Genome Project to the clinical laboratory.
Molecular diagnosis is the detection of pathogenic mutations in DNA and RNA samples to aid in detection, diagnosis, subclassification, prognosis, and monitoring response to therapy. Principles underlying nucleic-based diagnosis originate from localization, identification, and characterization of genes responsible for human disease. Clinical molecular genetics is now part of the mainstream of medical care in the United States. All commercial clinical reference laboratories now have a molecular genetic diagnostic unit, many of which are in contractual agreement with third party payers to provide services. Gene discovery provides valuable insight into the mechanisms of disease processes and gene-based markers will enable clinicians to study disease predisposition, as well as improved methods for diagnoses, prognosis, and monitoring of therapy. The broad range of mutation spectrum and type performed in the clinical laboratory requires the use of multiple technologies rather than a single typing platform. Platform choice depends on such diverse factors as local expertise, test volume, economies of scale, R&D budget, and royalties. Test validation is a major hurdle and positive control samples are often not readily available. Oversight and the regulatory environment for clinical molecular genetics laboratories in the United States are evolving rapidly. Several government agencies and private organizations are currently involved in revision of specific laboratory standards, including the Secretary's Advisory Committee on Genetic Testing (SACGT), Food and Drug Administration (FDA), Center for Disease Control (CDC), College of American Pathologists (CAP), American College of Medical Genetics (ACMG), and the individual states.
DNA Mutational Analysis↗
Addressing the concerns of rural communities about access to plants and knowledge in a sui generis legislation in Cameroon.
This article assesses the traditional systems of accessing and using plant genetic resources as well as the benefit sharing and systems of sanctioning infringement in the context of biodiversity related activities in specific areas in the Northwest province of Cameroon. The article also addresses the type research and development activities using plant genetic resources and associated traditional knowledge in the context of Cameroon, the current laws regulating such activities and the extent to which these activities and laws affect and/or protect the customary biodiversity rights of rural communities. The article uses these assessments to suggest the context under which a sui generis legislation for the protection of the biodiversity rights of rural communities can be established in Cameroon.
Biodiversity↗
Piggy-back. A son with more than one father.
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Humans↗
Ten years of bacterial genome sequencing: comparative-genomics-based discoveries.
It has been more than 10 years since the first bacterial genome sequence was published. Hundreds of bacterial genome sequences are now available for comparative genomics, and searching a given protein against more than a thousand genomes will soon be possible. The subject of this review will address a relatively straightforward question: "What have we learned from this vast amount of new genomic data?" Perhaps one of the most important lessons has been that genetic diversity, at the level of large-scale variation amongst even genomes of the same species, is far greater than was thought. The classical textbook view of evolution relying on the relatively slow accumulation of mutational events at the level of individual bases scattered throughout the genome has changed. One of the most obvious conclusions from examining the sequences from several hundred bacterial genomes is the enormous amount of diversity--even in different genomes from the same bacterial species. This diversity is generated by a variety of mechanisms, including mobile genetic elements and bacteriophages. An examination of the 20 Escherichia coli genomes sequenced so far dramatically illustrates this, with the genome size ranging from 4.6 to 5.5 Mbp; much of the variation appears to be of phage origin. This review also addresses mobile genetic elements, including pathogenicity islands and the structure of transposable elements. There are at least 20 different methods available to compare bacterial genomes. Metagenomics offers the chance to study genomic sequences found in ecosystems, including genomes of species that are difficult to culture. It has become clear that a genome sequence represents more than just a collection of gene sequences for an organism and that information concerning the environment and growth conditions for the organism are important for interpretation of the genomic data. The newly proposed Minimal Information about a Genome Sequence standard has been developed to obtain this information.
Bacterial Vaccines↗
The impact of economic globalisation on health.
The analysis of the impact of economic globalisation on health depends on how it is defined and should consider how it shapes both health and health policies. I first discuss the ways in which economic globalisation can and has been defined and then why it is important to analyse its impact both in terms of health and health policies. I then explore the ways in which economic globalisation influences health and health policies and how this relates to equity, social justice, and the role of values and social rights in societies. Finally, I argue that the process of economic globalisation provides a common challenge for all health systems across the globe and requires a broader debate on values, accountability, and policy approaches.
Bioethical Issues↗
Coauthorship in physics.
In a large and detailed survey on the ethics of scientific coauthorship, members of the American Physical Society (APS) were asked to judge the number of appropriate coauthors on his or her last published paper. Results show that the first or second coauthors are more appropriate than later coauthors about whom there is equal and considerable doubt. The probability of any third and subsequent coauthors being judged as inappropriate is 23% for the APS guideline, 67% for the tighter guideline of the International Committee of Medical Journal Editors, 59% if the guideline requires "direct contributions to scientific discovery or invention". Only 3% of respondents report having personally rejected an undeserving scientist who expected to be an author on the last published paper. Respondents seem to be divided into two non-overlapping populations--those who report no inappropriate coauthorship and those who have a more graduated view.
Authorship↗
Strengthening the United States' database protection laws: balancing public access and private control.
This paper develops three arguments for increasing the strength of database protection under U.S. law. First, stronger protections would encourage private investment in database development, and private databases have many potential benefits for science and industry. Second, stronger protections would discourage extensive use of private licenses to protect databases and would allow for greater public control over database laws and policies. Third, stronger database protections in the U.S. would harmonize U.S. and E.U. laws and would thus enhance international trade, commerce, and research. The U.S. should therefore follow the European example and develop two tiers of protection for databases: 1) protection for creative databases under copyright law; 2) protection for non-creative databases through a special type of sui generis protection. In order to balance private control of data and public access to data, sui generis protections should define a "fair use" exemption that permits some unauthorized extraction of data for private, educational, and research purposes, provided that such extraction does not adversely impact the economic value of the database.
Access to Information↗
Can drug patents be morally justified?
This paper offers a few elements of an answer to the question to what extent drug patents can be morally justified. Justifications based on natural rights, distributive justice and utilitarian arguments are discussed and criticized. The author recognizes the potential of the patents to benefit society but argues that the system is currently evolving in the wrong direction, particularly in the field of drugs. More than a third of the world's population has no access to essential drugs. The working of the patent system is an important determinant of access to drugs. This paper argues that drug patents are not easily justified and that the 'architecture' of the patent system should be rethought in view of its mission of benefiting society.
Human Rights↗
Gene co-ops and the biotrade: translating genetic resource rights into sustainable development.
The 1992 Convention on Biological Diversity marks a basic change in the international status of genetic resources. Prior to the Convention, these resources were considered to be the "heritage of mankind.' Although the intent of this open access regime was to ensure the widespread availability of genetic resources for agriculture and industry, commercial use of the resources provided no additional economic incentive for conservation by source countries. The Biodiversity Convention corrects this policy failure by establishing that states have sovereign rights over their genetic resources, thereby enabling market incentives to complement various multilateral mechanisms that might directly fund biodiversity conservation. A number of obstacles face countries that are translating this broad right to regulate access into specific policies, laws, and regulations designed to meet conservation and development objectives. A review of these obstacles and of trends in technological development suggest that nations and developing country institutions should take a set of actions to develop access legislation and Material Transfer Agreements, establish biodiversity "cooperatives' and intermediary institutions to facilitate information exchange, develop minimum standards for access legislation, and require that prior informed consent of local communities be obtained by all biodiversity collectors.
Animal Population Groups↗
Legal issues in sharing the benefits of biodiversity prospecting.
The National Cancer Institute (NCI) is the US Government's principal agency for research on the prevention, diagnosis and treatment of cancer. A critical component of the Institute's mission is the identification and development of new and promising treatments for cancer and AIDS. For many years these efforts have included a program to investigate natural products for potential new therapeutic agents. In 1986, with the advent of new screening techniques, the National Cancer Institute stepped up its exploration of natural products and began world-wide collections of plants in tropical and subtropical regions. In recognition of the principles of the Biodiversity Treaty, NCI appreciates that continued access to the natural products of these countries depends on the Institute's ability to recognize the contributions of these source countries and their indigenous peoples, and to provide them adequate incentives to conserve their natural resources for the purposes of drug discovery. Accomplishing this goal presented several legal issues for the National Cancer Institute. As an agency of the US government, the NCI has an adjunct statutory mission to facilitate the transfer of technology developed through the Institute's programs into the private sector for further development and commercialization, and NCI operates under a national policy to use the patent system to transfer Federally supported research to the private domestic sector. Reliance on patent law may limit the Institute's ability to recognize the rights of source countries and their indigenous people and provide compensation for their contributions. However, other legal instruments, such as contracts, can serve as interim measures to provide compensation to source countries and indigenous populations. The National Cancer Institute's Letter of Collection agreement (LOC, formerly the "Letter of Intent'), is an example of an alternative means that "fills-in the gaps' created by patent law and through which source countries may share in the benefits of natural product development.
Conservation of Natural Resources↗
Medicinal plant genetic resources and international cooperation: the Brazilian perspective.
Brazil is a gene rich country, host to 24% of known primate species, between 10 and 15 million species of insects, and 22% of the world's higher plant species. The debate over how and by whom these resources should be protected has intensified over the last few years due to a growing awareness of the links between sustainable utilization of natural resources, conservation of biodiversity, and economic development. Within this context the pharmaceutical exploitation of natural products for drug development has a prominent place. For a significant portion of Brazilian society, fair cooperation is welcome and can facilitate drug discovery. Nevertheless, the complexity of the consequences of patenting and utilization of natural resources calls for a thorough cost/benefit analysis in order to promote policies that can ensure significant and long term benefits for the country.
Brazil↗