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PubMed2001

DNA patents and scientific discovery and innovation: assessing benefits and risks.

This paper focuses on the question of whether DNA patents help or hinder scientific discovery and innovation. While DNA patents create a wide variety of possible benefits and harms for science and technology, the evidence we have at this point in time supports the conclusion that they will probably promote rather than hamper scientific discovery and innovation. However, since DNA patenting is a relatively recent phenomena and the biotechnology industry is in its infancy, we should continue to gather evidence about the effects of DNA patenting on scientific innovation and discovery as well the economic, social, and legal conditions relating to intellectual property in biotechnology. We should give the free market, the courts, researchers, and patent offices a chance to settle issues related to innovation and discovery, before we seek legislative remedies, since new laws proposed at this point would lack adequate foresight and could do more harm than good. However, we should be open to new laws or regulations on DNA patents if they are required to in order to deal with some of the biases and limitations of the free market.

Biotechnology↗
PubMed2004

Regulatory reforms and GCP clinical trials with new drugs in India.

Current Indian drug regulations do not allow for toxicology testing and clinical trials in India with compounds or molecules discovered abroad, except for treatments of tropical, cancer and cardiovascular diseases as part of global studies. The number of GCP Phase II/III trials by foreign sponsors has increased dramatically since 1995, attesting to the potential of India for lower cost trials and reduction in drug development costs and time, due to rapid patient recruitment. However, there have been problems with regard to intellectual property protection and adherence to informed consent guidelines. Starting in 2005, a series of regulatory reforms and patent protection will be instituted that are designed to address many of these concerns; the nature of these reforms are presented and discussed. However, sponsors need to pay close attention to informed consent and other ethical issues in Indian trials, which enroll mainly poor and uneducated patients.

Clinical Trials, Phase II as Topic↗
PubMed2006

"Studies on biodiversity of Vietnam and Laos" 1998-2005: examining the impact.

The impact of the University of Illinois at Chicago-based Vietnam-Laos International Cooperative Biodiversity Group (ICBG) Program "Studies on Biodiversity of Vietnam and Laos", which has been in operation for the period of 1998-2005, touches on five major areas of endeavor: (a) biodiversity inventory and conservation; (b) studies on medicinal plants; (c) drug discovery and development; (d) economic development; and (e) issues on intellectual property rights and benefit sharing in natural products drug discovery and development. Highlights are presented and the significance is discussed.

Biodiversity↗
PubMed2004

Virtual university governance.

There is a need to establish collaboration alliances or partnerships if we are to provide global Health Informatics educatics education. Agreements need to make provision for the existing diversity between country educational systems as well as variations in funding, legislation and political systems and a number of other issues including intellectual property and copyright. Four virtual University governance models were identified, 1) evolution of existing universities, 2) newly created organisations collectively delivering one type of program eg MBA, 3) a consortium of partners using a common portal and 4) a commercial enterprise. Collectively IMIA academic members need to be in a good position to respond to the global changes in higher education and minimise the risk of failure when establishing a virtual University to collectively deliver Health Informatics education. Others have undertaken a similar path in the past, some successful others not so, we need to learn from these experiences.

Accreditation↗
PubMed2005

The conducting and reporting of rural health research: rurality and rural population issues.

Rurality and rural population issues require consideration when conducting and reporting on rural health research. A first article focused on the planning stage of the research. The objective of this article is to explore conducting and reporting issues that require attention when undertaking rural health research. The privacy of participants, the collection of data, the cultural traditions of Indigenous communities, the dissemination of results, and giving something back to the community, are all aspects of conducting and reporting rural health research that require attention. Procedures such as identifying the characteristics of the population, attention to safety issues when collecting data, the use of local liaison persons and acknowledging the ownership of intellectual property, increase the quality of the research outcomes. They are issues that are relevant to both qualitative and quantitative research methods. Procedures are available to address issues of particular concern in developing appropriate methods for rural health research. While we have concentrated on Australian issues, and possible solutions, rural localities in many other countries may face similar issues. In any rural setting, paying attention to issues that may affect the conducting and reporting of rural health research will hopefully result in studies that support the continued improvement of health in rural communities.

Australia↗
PubMed2003

Conceptualization and measurement of health-related quality of life: comments on an evolving field.

This article summarizes personal views on the rapidly evolving field of functional health assessment and comments on their implications for advances in assessment methods used in rehabilitation medicine. Topics of strategic importance included (1). a new formulation of the structure of health status designed to distinguish role participation from the physical and mental components of health for purposes of international studies; (2). applications of item response theory that offer advantages in constructing better functional health measures and cross-calibrating their underlying metrics; (3). computerized dynamic assessment technology, well proven in education and psychology, which may lead to more practical assessments and more precise score estimates across a wide range of functional health levels; and (4). intellectual property issues involved in standardizing and promoting readily available assessment tools, ensuring their scientific validity, and achieving the best possible partnership between the scientific community and those developing commercial applications. Promising results from preliminary attempts to standardize and improve the metrics of functional health assessment constitute grounds for optimism regarding their potential usefulness in rehabilitation medicine. Someday, all tools used to measure each functional health concept, including the best single-item measure and the most precise computerized dynamic health assessment, will be scored on the same metric and their results will be directly comparable. To achieve this goal in rehabilitation medicine, we have much work to do.

Activities of Daily Living↗
PubMed1999

Breaking out of the ivory tower: from academia to clinic.

This paper considers the relationship between academic research and industry in terms of the commercial exploitation of product or process driven programmes originating in academic institutions. The commercial exploitation of pharmaceutical research is the only practical means of achieving the desired end-point of all research programmes in the pharmaceutical sciences-achieving patient benefits. The requirements for generating intellectual property rights (IPR), types of IPR likely to be encountered, time scales, costs, potential partnerships and commercial routes for exploitation are discussed. The ability to link up with industry to exploit new pharmaceutical products or processes is exemplified through two models. Model 1 involves out-licensing of IPR generated wholly within an academic setting and is illustrated by reference to the development of Ametop Gel, a novel percutaneous anaesthetic preparation. Model 2 involves a partnership with industry in a risk-sharing format, with both partners contributing expertise to the project. This latter model is illustrated by reference to a new controlled and sustained release intravaginal ring delivery system for oestrogen replacement therapy.

Clinical Trials as Topic↗
PubMed2005

The gap between law and ethics in human embryonic stem cell research: overcoming the effect of U.S. federal policy on research advances and public benefit.

Key ethical issues arise in association with the conduct of stem cell research by research institutions in the United States. These ethical issues, summarized in detail, receive no adequate translation into federal laws or regulations, also described in this article. U.S. Federal policy takes a passive approach to these ethical issues, translating them simply into limitations on taxpayer funding, and foregoes scientific and ethical leadership while protecting intellectual property interests through a laissez faire approach to stem cell patents and licenses. Those patents and licenses, far from being scientifically and ethically neutral in effect, virtually prohibit commercially sponsored research that could otherwise be a realistic alternative to the federal funding gap. The lack of federal funding and related data-sharing principles, combined with the effect of U.S. patent policy, the lack of key agency guidance, and the proliferation of divergent state laws arising from the lack of Federal leadership, significantly impede ethical stem cell research in the United States, without coherently supporting any consensus ethical vision. Research institutions must themselves implement steps, described in the article, to integrate addressing ethical review with the many legal compliance issues U.S. federal and state laws create.

Ethics, Medical↗
PubMed2002

Patents and innovation in cancer therapeutics: lessons from CellPro.

This article discusses the interaction between intellectual property and cancer treatment. CellPro developed a stem cell separation technology based on research at the Fred Hutchinson Cancer Center. A patent with broad claims to bone marrow stem cell antibodies had been awarded to Johns Hopkins University and licensed to Baxter Healthcare under the 1980 Bayh-Dole Act to promote commercial use of inventions from federally funded research. CellPro got FDA approval more than two years before Baxter but lost patent infringement litigation. NIH elected not to compel Hopkins to license its patents to CellPro. CellPro went out of business, selling its technology to its competitor. Decisions at both firms and university licensing offices, and policies at the Patent and Trademark Office, NIH, and the courts influenced the outcome.

Biomedical Research↗
PubMed2003

Protecting innovation in bioinformatics and in-silico biology.

Commercial success or failure of innovation in bioinformatics and in-silico biology requires the appropriate use of legal tools for protecting and exploiting intellectual property. These tools include patents, copyrights, trademarks, design rights, and limiting information in the form of 'trade secrets'. Potentially patentable components of bioinformatics programmes include lines of code, algorithms, data content, data structure and user interfaces. In both the US and the European Union, copyright protection is granted for software as a literary work, and most other major industrial countries have adopted similar rules. Nonetheless, the grant of software patents remains controversial and is being challenged in some countries. Current debate extends to aspects such as whether patents can claim not only the apparatus and methods but also the data signals and/or products, such as a CD-ROM, on which the programme is stored. The patentability of substances discovered using in-silico methods is a separate debate that is unlikely to be resolved in the near future.

Computational Biology↗
PubMed2005

Animal breeding and disease.

Single-locus disorders in domesticated animals were among the first Mendelian traits to be documented after the rediscovery of Mendelism, and to be included in early linkage maps. The use of linkage maps and (increasingly) comparative genomics has been central to the identification of the causative gene for single-locus disorders of considerable practical importance. The 'score-card' in domestic animals is now more than 100 disorders for which the molecular lesion has been identified and hence for which a DNA test is available. Because of the limited lifespan of any such test, a cost-effective and hence popular means of protecting the intellectual property inherent in a DNA test is not to publish the discovery. While understandable, this practice creates a disconcerting precedent. For multifactorial disorders that are scored on an all-or-none basis or into many classes, the effectiveness of control schemes could be greatly enhanced by selection on estimated breeding values for liability. Genetic variation for resistance to pathogens and parasites is ubiquitous. Selection for resistance can therefore be successful. Because of the technical and welfare challenges inherent in the requirement to expose animals to pathogens or parasites in order to be able to select for resistance, there is a very active search for DNA markers for resistance. The first practical fruits of this research were seen in 2002, with the launch of a national scrapie control programme in the UK.

Animal Diseases↗
PubMed2000

Global trade and health: key linkages and future challenges.

Globalization of trade, marketing and investment has important implications for public health, both negative and positive. This article considers the implications of the single package of World Trade Organization (WTO) agreements for public health research and policy, focusing on three themes: commodities, intellectual property rights, and health services. The main aims of the analysis are as follows: to identify how trade issues are associated with the transnationalization of health risks and possible benefits; to identify key areas of research; and to suggest policy-relevant advice and interventions on trade and health issues. The next wave of international trade law will need to take more account of global public health issues. However, to become more engaged in global trade debates, the public health community must gain an understanding of the health effects of global trade agreements. It must also ensure that its own facts are correct, so that public health is not blindly used for political ends, such as justifying unwarranted economic protectionism. "Healthy trade" policies, based on firm empirical evidence and designed to improve health status, are an important step towards reaching a more sustainable form of trade liberalization.

Commerce↗
PubMed2003

Shackling the shoulders of giants. A report on excerpts from the National Academies' Symposium on the Role of Scientific and Technical Data and Information in the Public Domain, Washington, DC, September 5-6, 2002.

This paper informally summarizes a two-day symposium held at the U.S. National Academy of Sciences in Washington, D.C., September 5-6, 2002. The issue was to what extent the progress of science and societal capacity for continued technological innovation are threatened by excessive protection of intellectual property. Excessive protection creates disadvantages not only for scientists and inventors but also for educators/students and for librarians/clientele. Speakers from a variety of disciplines and institutions agreed unanimously that scientific and technological progress is, indeed, under serious threat. Various opinions were expressed about the degree of threat, currently and prospectively, as well as what counter-measures are best suited to resist undue restrictions on creative uses of scientific and technical data and information. This summary is based entirely on the author's notes from the symposium, and the commentary offered is his alone. My apologies to the speakers if this paper does not accurately reflect the primary intent of their presentations. The "Suggested Readings" offered at the end are not specific to the speakers' statements but rather are offered as a general resource to aid further research. The definitive record of the symposium is planned to be available from the National Academies Press as a Proceedings publication in the summer of 2003.

Copyright↗
PubMed2005

Sticking to the knitting: CIHR, innovation and Canadian biotech.

The novel proposal outlined by Glenn Brimacombe suggests that the federal government directly participate in funding incremental venture capital investment in Canadian biotechnology, with the goal of facilitating commercialization of Canadian biotechnology and health sciences intellectual property. In this way, they suggest, the economic development benefits of the Canadian current investment in health sciences will be increased. The proposal is based on two premises that need further evaluation: (1) the biotechnology sector in Canada presently underperforms in terms of value creation; (2) this underperformance is due to inadequate venture capital investment. It is the author's view that, although several measures do suggest relative system underperformance, this is likely due to structural differences rather than inadequate venture capital investment. The absence of large, integrated, global biopharmaceutical firms based in Canada, the large number of very small biotech firms and the absence of a clear federal policy mandate supporting technology transfer and underinvestment in public sector funded basic research may all be contributory factors. Given the Canadian biotech sector's current efficiency at creating value from limited public investment in basic science, increasing the core CIHR budget might be an even better investment opportunity for limited incremental funding.

Biotechnology↗
PubMed2003

Ethical issues at the university-industry interface: a way forward?

This paper forms an introduction to this issue, the contents of which arose directly or indirectly from a conference in May 2001 on Corruption of scientific integrity?--The commercialisation of academic science. The introduction, in recent decades, of business culture and values into universities and research institutions is incompatible with the openness which scientific and all academic pursuit traditionally require. It has given rise to a web of problems over intellectual property and conflict of interest which has even led to corporate sponsors' suppressing unfavourable results of clinical trials, to the detriment of patients' health. Although there are those who see the norms of science developing to recognise the importance of instrumental science aiming at specific goals and of knowledge judged by its value in a context of application, none justifies the covert manipulation of results by vested interest. Public awareness of these problems is growing and creating a climate of opinion where they may be addressed. We suggest a way forward by the introduction of nationally and internationally-accepted guidelines for industrial collaboration which contain proper protections of the core purposes of universities and of the independence of their research. Some codes suggested for this purpose are discussed. We note that some universities are moving to adopt such codes of conduct, but argue the need for strong support from the government through its funding bodies.

Academies and Institutes↗
PubMed1997

Withholding research results in academic life science. Evidence from a national survey of faculty.

OBJECTIVES: To identify the prevalence and determinants of data-withholding behaviors among academic life scientists. DESIGN: Mailed survey of 3394 life science faculty in the 50 universities that received the most funding from the National Institutes of Health in 1993. PARTICIPANTS: A total of 2167 faculty responded to the survey, a 64% response rate. OUTCOME MEASURES: Whether respondents delayed publication of their research results for more than 6 months and whether respondents refused to share research results with other university scientists in the last 3 years. RESULTS: A total of 410 respondents (19.8%) reported that publication of their research results had been delayed by more than 6 months at least once in the last 3 years to allow for patent application, to protect their scientific lead, to slow the dissemination of undesired results, to allow time to negotiate a patent, or to resolve disputes over the ownership of intellectual property. Also, 181 respondents (8.9%) reported refusing to share research results with other university scientists in the last 3 years. In multivariate analysis, participation in an academic-industry research relationship and engagement in the commercialization of university research were significantly associated with delays in publication. Odds ratios (ORs) and 95% confidence intervals (CIs) were 1.34 (1.07-1.59) and 3.15 (2.88-3.41), respectively. Variables associated with refusing to share results were conducting research similar to the Human Genome Project (OR, 2.09; 95% CI, 1.75-2.42), publication rate (OR, 1.02; 95% CI, 1.01-1.03), and engagement in commercialization of research (OR, 2.45; 95% CI, 2.08-2.82). CONCLUSIONS: Withholding of research results is not a widespread phenomenon among life-science researchers. However, withholding is more common among the most productive and entrepreneurial faculty. These results also suggest that data withholding has affected a significant number of life-science faculty and further study on data-withholding practices is suggested.

Biological Science Disciplines↗
PubMed2006

Affordable antiretroviral drugs for the under-served markets: how to expand equitable access against the backdrop of challenging scenarios?

BACKGROUND: Threats by enforced Intellectual Property (IP) rights to equitable HIV treatment access by poor populations are impending. India and China's policy directions in the field will be crucial in ultimately affecting the affordability and accessibility of antiretroviral (ARV) therapy in the under-served markets. These directions, together with the exploitation level of IP-bound flexibilities and the evolutionary modelling in partnerships and trade agreements between research-based and generic pharmaceutical industry, will also affect the outcomes of self-sufficiency efforts now at their beginning in the developing world as far as domestic manufacturing of generic ARV drugs is concerned. AIMS: This paper explores key issues, implications and interaction dynamics across these challenging scenarios while attempting to provide equitable solution glimpses into the near future. RESULTS: Access-oriented long-term drug policy strategies entitled to pass muster of governments, research-based as well as generic industries in both developed and developing countries are needed if equitable access to affordable ARV treatments by poor people has to be achieved despite enforced IP rights. Predictable dynamics between western multinationals and transitional country generic corporations let regard IP-bound Voluntary License flexibilities as a fitting measure into just mentioned needs especially if substantial incentives to generic corporations are concurrently secured. Efforts to equitably expand ARV drug access through exploiting IP opportunities should encompass attainment of self-sufficiency in domestic drug manufacturing whenever basic requirements are in place in the developing world as a whole. A credible industrial potential would act, indeed, as a boosting factor for drawing branded drug producers into technology transfer agreements, the terms of which would let all contractors enjoy substantial advantages. These perspectives consistently bind up with the foreseeable long-term trade and drug policy directions of India and China according to frontier crossing implications of their key IP management trends as well as their multifaceted penetration strategies of both the wealthy and under-served markets worldwide. As coherent with these perspectives, more disbursement by wealthy country governments and donors to basic infrastructure development in sub-Saharan African nations with stable governments in place is urged both as a priority for improving Africa's economy and a prerequisite for allowing domestic industrial plants to take off. Aiming at the targets just underscored, WHO's brokering role in negotiated agreements between wealthy and developing country-based firms as well as its technical guidance in setting international standards have always to be sought if equitable and appropriate end results are to be attained. CONCLUSION: Overall insights in this paper would mean that, while research-based corporations are to be praised whenever waiving, on humanitarian purposes, part of their profits, the trade and profit rules cannot basically be given up if long-term sustainable results are the goal to look for. Only negotiated agreements securing all contracting parties lasting advantages may ensure shifting of such a goal from mere vision to a really sustainable attainment.

Anti-HIV Agents↗
PubMed1995

Research on the human genome and patentability--the ethical consequences.

The genome is one of the primordial elements of the human being and is responsible for human identity and its transmission to descendants. The gene as such ought not be appropriated or owned by man. However, any sufficiently complete description of a gene should be capable of being protected as intellectual property. Furthermore, all utilisations of a gene or its elements that permit development of processes or new products should be patentable. Ethics, in the sense of moral action, should come into play from the very first stages of research into the human genome. Protection of intellectual and industrial property is of purely legal concern and need not provoke ethical consideration. By contrast, the use of the results of, and in particular the commercialisation of products deriving from, research into the human genome, ought to be subjected to ethical consideration and control. Considering the economic and societal stakes of such research, ethical analysis ought to be at an international level if mistakes and unforeseen risks of conflict are to be avoided.

Base Sequence↗