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PubMed2004

Apomixis technology development-virgin births in farmers' fields?

Apomixis is the process of asexual reproduction through seed, in the absence of meiosis and fertilization, generating clonal progeny of maternal origin. Major benefits to agriculture could result from harnessing apomixis in crop plants. Although >400 apomictic plant species are known, apomixis is rare among crop plants, and the transfer of apomixis to crop varieties by conventional breeding has been largely unsuccessful. Because apomictic and sexual pathways are closely related, de novo engineering of apomixis might be achieved in sexually reproducing crops. Early consideration of issues relating to biosafety and intellectual property (IP) management can facilitate the acceptance and deployment of apomixis technology in agriculture.

Agriculture↗
PubMed1996

Juridical and sociocultural problems on the definition of a law concerning property, usage and access to genetic resources in Colombia.

The property, usage, and access to genetic resources, is today one of the primary topics in international business, as a result of the strategic importance of the resources for the biotechnology industry. Internationally, the sovereignty that each country has over its natural patrimony is recognized. However, the new laws of international marketing have obligated countries in the process of development, such as Colombia, to adopt and copy a concept of intellectual property on living resources that does not have anything to do with the country's sociocultural identity, and sometimes even does not take into account its material enjoyment. The new juridical movement that treats genetic resources as private property produces a cultural conflict between indigenous populations, Afro-Americans and peasants, because for them the genetic resources are an element of community life. In these communities, knowledge is freely transmitted; it is an understanding that they have to conserve their agricultural customs and the relationship that they have with the environment. They do not recognize the term "property' according to patenting laws. These elements have to be considered, respected, and guaranteed in the laws that recognize the genetic resources in the country. On the other hand, not even countries that are pioneers in biotechnological development can adopt a concept about patents that is in agreement with the particularities that the living materials possess. This is obviously the reason for the numerous discussions on the legal interpretation, as well as complicated debates in court. Confronting that situation, there are countries rich in biodiversity, such as Colombia, but which do not have a proper concept and are not economically strong in the international context. These countries have to copy inadequate protection policies that do not take into account all their rights. This paper describes some of the technical, juridical, and sociocultural difficulties which Colombia has to confront, in order to set a guideline on patenting living organisms, and on the access and usage of the genetic resources.

Breeding↗
PubMed2006

Thais protest US-Thai FTA talks.

On 11 January 2006, thousands of Thai citizens and HIV/AIDS advocacy groups converged in Chiang Mai, Thailand to protest the latest negotiations of the proposed US-Thailand Free Trade Agreement (FTA). The FTA is believed to include intellectual property (IP) provisions that will pose a threat to Thailand's national HIV/AIDS treatment program, which relies on local production of inexpensive generic medicines to treat people living with HIV/AIDS.

Anti-HIV Agents↗
PubMed2003

Biomedical informatics: precious scientific resource and public policy dilemma.

Biomedical informatics includes the application of computers, information networks and systems, and a growing body of scientific understanding to a range of problems. As skill in this field increases and as progress in virtually all modern biomedical science becomes more data intensive, informatics becomes a precious resource. Applications areas include access to knowledge, discovery in genomics, medical records, mathematical modeling, and bioengineering. At the same time, progress in informatics is deeply dependent on resolution of four major public policy issues: digital intellectual property rights, genetic testing protection, medical data privacy, and the role of biomedical data in the context of information warfare and homeland security.

Anatomy, Cross-Sectional↗
PubMed2006

Podcasts--an emerging form of digital publishing.

Podcasting has recently emerged as an important information technology tool for health professionals and consumers around the world. Prestigious journals, international conferences, universities and government agencies among other entities are starting to publish digital informotion via audio and video podcasts. Podcosting is distinguished from other forms of digital audio-video content because it can be subscribed to (using Real Simple Syndication or RSS) and easily accessed from a personal computer. Further, it can be downloaded to a mobile device, such as an iPod where the user is able to listen to or watch it anywhere, anytime. Podcosting is used in new and evolving ways to publish information for healthcare education, patient care, professional continuing education, and in support of healthcare research. In addition to a description of what podcasting is, how podcasts are created, and how they are used, this paper addresses four critical issues that are emerging concerning podcasts. These issues are intellectual property and copyright, podcast preservation, podcast location, and podcast standards. As podcasting matures and new uses are discovered, we will see podcasting incorporated into our education, research and patient care publication paradigm.

Computers, Handheld↗
PubMed2005

Ethico-legal issues in biomedicine patenting: a patent professional viewpoint.

Over the last two decades, the ethical implications of patents for biological materials and processes have been the subject of spirited public debate between the many individuals and groups on which the patent system impacts. Whereas copyright, trade marks, and other species of Intellectual Property Rights (IPR) are widely acceptable, the patent system evokes criticism from many quarters, especially in relation to the legal protection of inventions in the Life Sciences. Some of these criticisms expressed by prestigious public organisations are addressed here from the patent professional standpoint.

Biotechnology↗
PubMed2001

The road not taken.

The annual Janet Doe Lecture was established in 1966 to honor Janet Doe, emerita librarian of the New York Academy of Medicine. The lecture focuses on either the history or philosophy of health sciences librarianship. This lecture addresses three fundamental values of the field, highlighting basic beliefs of the profession that are at risk: privacy, intellectual property rights, and access to quality information. It calls upon readers to make the everyday choices required to keep the value system of health sciences librarianship in place. Robert Frost's poignant poem "The Road Not Taken" provides the metaphor for examining choices in an information economy.

Commerce↗
PubMed2000

Development of biotechnology in India.

India has embarked upon a very ambitious program in biotechnology with a view to harnessing its available human and unlimited biodiversity resources. It has mainly been a government sponsored effort with very little private industry participation in investment. The Department of Biotechnology (DBT) established under the Ministry of Science and Technology in 1986 was the major instrument of action to bring together most talents, material resources, and budgetary provisions. It began sponsoring research in molecular biology, agricultural and medical sciences, plant and animal tissue culture, biofertilizers and biopesticides, environment, human genetics, microbial technology, and bioprocess engineering, etc. The establishment of a number of world class bioscience research institutes and provision of large research grants to some existing universities helped in developing specialized centres of biotechnology. Besides DBT, the Department of Science & Technology (DST), also under the Ministry of S&T, sponsors research at universities working in the basic areas of life sciences. Ministry of Education's most pioneering effort was instrumental in the creation of Biochemical Engineering Research Centre at IIT Delhi with substantial assistance from the Swiss Federal Institute of Technology, Zurich, Switzerland to make available state-of-the-art infrastructure for education, training, and research in biochemical engineering and biotechnology in 1974. This initiative catalysed biotechnology training and research at many institutions a few years later. With a brief introduction, the major thrust areas of biotechnology development in India have been reviewed in this India Paper which include education and training, agricultural biotechnology, biofertilizers and biopesticides, tissue culture for tree and woody species, medicinal and aromatic plants, biodiversity conservation and environment, vaccine development, animal, aquaculture, seri and food biotechnology, microbial technology, industrial biotechnology, biochemical engineering and associated activities such as creation of biotechnology information system and national repositories. Current status of intellectual property rights has also been discussed. Contribution to the India's advances in biotechnology by the industry, excepting a limited few, has been far below expectations. The review concludes with some cautious notes.

Agriculture↗
PubMedDate not supplied

Biotechnologies and genetic resources for food and agriculture.

The article stresses the complimentarity of genetic resources and biotechnologies in ensuring food security. Genetic resources are being lost at an increasing and alarming rate. A small number of crops and farm animals contribute an ever increasing percentage of human food. The conservation and sustainable use of genetic resources have many socio-economic, political, cultural and legal implications. Genetic resources are the raw material to which biotechnology is applied. Biotechnologies are increasingly protected by intellectual property rights, no such incentive for the conservation and sustainable use currently exists. The article discusses the role of the International Undertaking on Plant Genetic Resources, currently being negociated in FAO countries, and of the Code of Conduct on Biotechnology being developed by the FAO Commission on Genetic Resources for Food and Agriculture.

Agriculture↗
PubMed2002

The pharmaceutical industry as a medicines provider.

Rising prices of medicines are putting them beyond the reach of many people, even in rich countries. In less-developed countries, millions of individuals do not have access to essential drugs. Drug development is failing to address the major health needs of these countries. The prices of patented medicines usually far exceed the marginal costs of their production; the industry maintains that high prices and patent protection are necessary to compensate for high development costs of innovative products. There is controversy over these claims. Concerns about the harmful effects of the international system of intellectual property rights have led the World Trade Organization to relax the demands placed on least developed countries, and to advocate differential pricing of essential drugs. How these actions will help countries that lack domestic production capacity is unclear. Better access to essential drugs may be achieved through voluntary licensing arrangements between international pharmaceutical companies and manufacturers in developing countries.

Developed Countries↗
PubMed2004

Will the Australia-United States Free Trade Agreement undermine the Pharmaceutical Benefits Scheme?

The Australia-United States Free Trade Agreement (AUSFTA) contains major concessions to the US pharmaceutical industry that may undermine the egalitarian principles and operation of the Pharmaceutical Benefits Scheme (PBS) and substantially increase the costs of medicinal drugs to Australian consumers. AUSFTA's approach to the PBS excessively emphasises the need to reward manufacturers of "innovative" new pharmaceuticals, instead of emphasising consumers' need for equitable and affordable access to necessary medicines (the first principle of our National Medicines Policy). Several features of AUSFTA may bring pressure to bear on the Pharmaceutical Benefits Advisory Committee (PBAC) to list "innovative" drugs that the committee initially rejected because the evidence for cost-effectiveness was not compelling. Intellectual property provisions of AUSFTA are likely to delay the entry of PBS cost-reducing generic products when pharmaceutical patents expire. We support the many concerned health and consumer organisations who have asked the Senate either not to pass the enabling legislation, or to delay its passage until a fairer deal in terms of public health can be obtained.

Australia↗
PubMed2003

Industrial support of orthopaedic research in the academic setting.

Industry support provides critical resources for researchers in departments of orthopaedic surgery, and affords research that otherwise likely would not be possible. However, in contrast to sponsorship from the federal agencies or most foundations, corporate sponsorship raises ethical, practical, and legal issues for the individual researcher, the department, the academic institution, the scientific community at large, and industry. Most of these issues relate to ownership of intellectual property, confidentiality, disclosure of results, and apparent bias. For the public the issues involve ethical issues, including trust. Academic institutions have evolved approaches for contracts with industry, which minimize, but not eliminate these problems. Given appropriate contracts, corporate sponsorship of research is not only mutually beneficial, but for many departments, critical.

Confidentiality↗
PubMedDate not supplied

Drug registration application in China.

PURPOSE: This article is used to give a brief overview for people who would like to submit a drug registration application in China, or for those who would like to get a broader international drug registration perspective. METHODS: This paper concretely describes the new items in the current drug registration application through introducing following contents: qualification of the applicant, registration classification or type, the procedures for drug registration application review, the intellectual property rights concerning the pharmaceutical (drug substance and product), the process for submitting a drug registration application and the materials required in application for registration. RESULTS: From the paper, we have a comprehensive knowledge of drug registration application in China. CONCLUSIONS: The current Provision for Drug Registration is more reasonable and suitable for China's entry into WTO and further guarantee that safe and effective drugs are available to Chinese people.

China↗
PubMed2006

WTO approves TRIPS amendment on importing under compulsory licensing.

On 6 December 2005, the World Trade Organization (WTO) amended the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement to allow WTO member states to produce, under compulsory licences, lower-cost generic pharmaceutical products for export to countries that lack domestic production capacity to make such products. The amendment makes permanent the previous decision of 30 August 2003, which has not yet proven to be an effective mechanism to encourage the supply of more affordable medicines and other pharmaceutical products to countries in need.

Commerce↗
PubMed2003

Duverney's skeletons.

In 1730, shortly before his death, the Paris anatomist Joseph-Guichard Duverney wrote his will, leaving his anatomical specimens to the Académie des Sciences, of which he was a member. But the will was disputed by Pierre Chirac, supervisor of the Jardin du Roi where Duverney, as professor of anatomy, had performed most of the dissections that produced the specimens. The ensuing debate between Chirac and René-Antoine Ferchault de Réaumur, arguing for the Académie, reveals the tensions surrounding both the concept of intellectual property in this period and the collective enterprise in natural philosophy. The differing roles and audiences of the Académie and the Jardin were central to this debate. In addition, this essay explores the origins and significance of the anatomical specimens themselves and their changing role in instruction and display, as well as the transition from the cabinet of curiosities to the natural history museum.

Academies and Institutes↗
PubMed2006

The negotiation and development of a clinical trial agreement.

A carefully negotiated clinical trial agreement will protect a biotechnology and medical device company in critical areas, including the management and control of data and confidential information, defining publication rights and the ownership of intellectual property. Properly constructed, the agreement can increase a company's value. This article will review the major provisions of a standard industry sponsored clinical trial agreement; the principle areas where there is likely to be differing views that need to be reconciled and interrelated ethical concerns. A form of clinical trial agreement designed for a single site therapeutic trial in the United States follows the article.

Biomedical Research↗
PubMed2006

Vaccine development for an imminent pandemic: why we should worry, what we must do.

The avian H5N1 virus continues to evolve and poses an imminent pandemic threat. Pandemic vaccine development, however, has progressed slowly. For it to succeed, it must be based on a public health perspective that reflects the arithmetic of pandemic vaccine demand, especially by countries without vaccine companies. Clinical trials of H5N1 vaccines have been discouraging, and we must understand why the H5N1 virus is so poorly immunogenic. Antigen-sparing pandemic vaccines will be required, and future trials must identify the most effective adjuvant and determine whether whole virus vaccines will be needed. Problems related to intellectual property and concerns about several regulatory issues must be resolved. Public funding for clinical trials must be provided and firm leadership and coordination exercised by national and international (WHO) public health officials. Vaccination for an imminent pandemic requires a global perspective not only for vaccine development but also for vaccine production and distribution.

Clinical Trials as Topic↗
PubMed2002

WTO ministerial conference adopts declaration on TRIPS and public health.

In November 2001, the 4th Ministerial Conference of the World Trade Organization adopted a Ministerial Declaration on public health and the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (the "TRIPS Agreement"). The declaration represents a modest advance in addressing concerns that strict patent laws, and threats of trade sanctions, will be a barrier to most of the world's people with HIV/AIDS accessing affordable medicines. The full significance of the declaration remains to be seen, as it depends on what political impact it has at the WTO and on its member countries, and what legal impact it will have in the interpretation of the TRIPS Agreement.

Commerce↗