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Key Documents

Policy papers and regulatory issues

Displaying 101-120 of 136 key documents

Key Drivers of Genomics: Forecasts for 2015

Source: UK Economic and Social Research Council | January 2002

This paper attempts to forecast the directions that genomics research and design will take up until 2015. Although not focusing explicitly on the developing world, it articulates some pertinent issues in an accessible, easily digestible way.

It identifies ten political, social, economic, and technical drivers of genomics over the next decade, and offers different scenarios for each. The drivers include: social attitudes; social mobilisation; demand; functionality of genomics technologies; governance of knowledge; business forces; and regulation. From a developing-world perspective, it appears likely that the more pessimistic scenarios may proliferate.

The paper implicitly highlights the contestations, differing values, and widely different contexts in which genomics research must be conducted, and how appropriate technologies are brought to the marketplace.

Report of the International Bioethics Committee on Ethics, Intellectual Property and Genomics

Source: UNESCO | January 2002

This report arose from a realisation of the need to clarify international intellectual property law in light of recent advances in genomics, most visibly the mapping of the human genome. It is the result of a working party convened by UNESCO in 2001.

The report hinges on the following key issues:

  • The broad shift away from publicly funded pure science;
  • The intimacy of the study of the human genome to individual and groups of people
  • Refocusing of research priorities away from the greatest human need to the greatest achievable profit;
  • "Premature protection" brought about by rapid and blanket acquiring of patents while the study of the genome is still in its infancy and poorly understood;
  • A lack of equity in benefit sharing, whereby developing countries do not accrue the correct benefits for the utilisation of genetic material sourced from their countries.

  • The report acknowledges the strengths and the weaknesses of current legislative frameworks surrounding bioethics and endorses the creation of an inter-agency committee on bioethics, and for closer links between governments, scientists, institutes and corporations engaged in genomic research. It also acknowledges the potential for genomics to widen the technology and the knowledge gap and calls for closer relationships between institutions like WHO and UNESCO.

     

    Statement of the WHO Expert Consultation on New Developments in Human Genetics

    Source: Human Genetics Programme, World Health Organisation | 2000

    In 2000 the World Health Organisation (WHO) undertook a consultation exercise involving both invited experts in human genetics and staff members, to review WHO’s activities in human genetics, identify challenges and priorities for WHO, and assess the future role of the organisation in genetics.

    The paper briefly outlines WHO's role as a leader in health-related issues, and emphasises its need to provide policies on human genetics quickly and decisively. It includes a short statement that underlines the importance of applying knowledge from the human genome in an ethical way, with "due regard to autonomy, justice, education, and the beliefs and resources of each nation and community".

    Priority recommendations for WHO include:

  • Developing its capacity to offer a global response to the ethical, legal and social issues posed by the revolution in human genetics
  • Convening a public, high-level meeting to consider these issues and to stimulate global dialogue
  • Ensuring the establishment of a genetic resource centre
  • Encouraging all nations to set up genetic services and prepare for future needs.
  • Developing international norms and standards for genetic testing and other health-related gene technologies
  • Considering the implications of the use of experimental transgenic animals, possible hazards from zenotransplantation to humans, and relevant issues arising from the development of these and other genetically modified organisms
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    Human Genome Patents and Developing Countries

    Source: Commission on Intellectual Property Rights | 2002

    The UNESCO Declaration on the Human Genome and Human Rights (1997) outlines the principle that human genome sequence information should be freely available to all countries. This report, by Sivaramjani Thambisetty, attempts to clarify what access really exists and questions to what extent national patent systems should be allowed to impinge on this international consensus.

    The report discusses:

  • The possibility and implications of patenting of human genetic material taken from developing countries
  • Patenting and informed consent of participants in genetic research
  • The relevance of community consultation and consent
  • Benefit sharing with the research participant
  • Patent laws in developed countries with respect to informed consent and benefit sharing
  • Post-grant control over use of a patent
  • Developing countries and patent protection for human genetic material

    The author suggests that merely making the human genome sequence available on the Internet satisfies the principle only in letter and not in spirit, and concludes that the relevance and implementation of UNESCO’s Declaration should now be reviewed. The report was commissioned as a background paper for the UK Commission in Intellectual Property Rights.
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    Reed Elsevier: Statement on Open Access

    Source: Reed Elsevier | March 2004

    This is the written evidence given by Britain's largest science and technology publisher to a UK parliamentary inquiry on scientific publications.

    In the statement, Reed Elsevier defends the traditional 'user-pays' model of scientific publishing.

    It argues that by introducing an 'author-pays' model, open access "risks undermining public trust in the integrity and quality of scientific publications that has been established over hundreds of years". Furthermore, the financial viability of open-access models of scientific publishing has yet to be proven, it says.

    Nature Publishing Group: Statement on Open Access

    Source: Nature Publishing Group | March 2004

    This is an extract of a letter from Richard Charkin, chief executive of Macmillan publishers, which was submitted as written evidence to a UK parliamentary inquiry on scientific publications.

    In the letter, Charkin argues that the 'author-pays' model used by open-access journals "potentially undermines the integrity of the world's highest quality journals, with unwelcome consequences for the scientific community, and for the wider public".

    The publisher estimates that it costs £10,000-30,000 to publish a research paper in Nature. "Such an amount would be hardly affordable to most research scientists, and so journals such as Nature would be forced to reduce editorial criteria, and publish more, lower quality papers, and/or favour wealthy authors that were in a position to afford such a fee," the statement says.

    Bethesda Statement on Open Access Publishing

    June 2003

    This is a statement of principle that was drafted at a meeting in April 2003 at the headquarters of the US-based Howard Hughes Medical Institute.

    The statement spells out significant concrete steps that all relevant parties — including scientific research organisations, scientists, publishers and librarians — can take to promote the rapid and efficient transition to open-access publishing.

     

    Signed by more than 20 senior figures, the document includes statements from working groups on institutions and funding agencies, libraries and publishers, and scientists and scientific societies.

    2003 Statement: Access to Scientific Information

    Source: The InterAcademy Panel on International Issues | December 2003

    This statement, released by the InterAcademy Panel on International Issues (IAP), voices the support of more than 50 scientific academies worldwide for greater access to scientific publications.

    "Most scientists and research laboratories in developing countries cannot afford ... journal subscriptions, or have to pay for access to the databases that exist in more economically advanced nations," it says. "All nations must have access to the accumulation of scientific knowledge in order to work toward a better future for all people."

    The statement makes five main recommendations: 1) that electronic access to journal be made available immediately upon publication for scientists in developing nations; 2) that journal content be prepared for electronic distribution to facilitate ease of use; 3) that journal content be archived collectively, either by private or government organisations; 4) that governments and publishers work together to raise awareness of the availability of free access to scientific journals; and 5) that scientific databases obtained by intergovernmental organisations be made freely available.

    Budapest Open Access Initiative Statement

    February 2002

    This declaration was signed by key players in the open-access movement at a meeting organised by the Open Society Institute in Budapest in February 2002.

    It calls for barriers to open-access publishing to be removed, with the aim that research articles from all academic fields be made freely available on the Internet.

    Other individuals and organisations are now invited to sign the declaration to pledge their support and help ensure a transition to open-access publishing. More than 3,000 individuals and 200 organisations have added their name to the initiative.

    Comments and Inputs from the Scientific Community on the Draft Declaration and Action Plan for the World Summit on the Information Society

    Source: CERN, UNESCO and ICSU (in cooperation with TWAS and ICTP) | May 2003

    This document - compiled on behalf of the international scientific community - suggests amendments to the Draft Declaration of Principles and Draft Plan of Action Plan for the World Summit on the Information Society, the first stage of which was held in Geneva, Switzerland in December 2003.

     

    The document underlines the central role of science in the information society, and says that information and communications technologies "provide an historic opportunity to reduce the scientific divide: they improve and increase the transfer of scientific knowledge between developed and developing countries".

     

    It specifically urges the Summit to "promote electronic publishing, affordable pricing schemes and appropriate open source initiatives to make scientific information affordable and accessible on an equitable basis in all countries".

    Message from the Founders: Why PLoS Became a Publisher

    Source: Public Library of Science | October 2003

    This statement, published in the first issue of the open-access journal PLoS Biology, outlines the philosophy behind the journal – the first to be published by the Public Library of Science.

     

    PLoS Biology has been launched to demonstrate that high-quality journals can flourish without charging for access, say the founders of the initiative, Patrick Brown, Michael Eisen and Harold Varmus. The aim is to cause a revolution in science publishing.

     

    The statement also explores the financial 'producer pays' model adopted by PLoS, and refers to examples of the recent surge of awareness and support for open-access publication, both within the scientific community and in the public at large.

    Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities

    October 2003

    This declaration was made at a meeting on Open Access to Knowledge in the Sciences and Humanities held in Berlin, Germany in October 2003. It aims to promote the Internet as a "functional instrument for a global scientific knowledge base", and says that "content and software tools must be openly accessible and compatible".

    It has been signed by more than 20 international research and cultural heritage organisations, including seven large German research organisations.

    The signatories encourage their researchers and grant recipients to publish their work according to the principles of the open-access paradigm, and encourage the "holders of cultural heritage" to support open access by providing their resources on the Internet.

    [The declaration is available in English, French and German.]

    International Response to the HIV/AIDS Epidemic: Planning for Success

    Source: Bulletin of the World Health Organisation | 2001

    Peter Piot - executive director of UNAIDS - weighs up the policy strategies for making an international concerted effort to shift the course of the global HIV/AIDS epidemic, following commitments made at the June 2001 UN General Assembly Special Session on AIDS.

    Simultaneously combining prevention and care strategies at multiple levels, eradicating social ills such as stigma and discrimination of HIV-infected individuals, and combining public and private finance, will be needed to avert this global catastrophe.

    AIDS Vaccines for the World: Preparing Now to Assure Access

    Source: International AIDS Vaccine Initiative (IAVI) | July 2000

    This IAVI policy document advocates the need to ensure global access to future HIV vaccines. It starts from the premise that true access cannot be assumed for people living in the poorest nations or who belong to high risk groups.

    IAVI's five-point action plan demands that any future vaccine be introduced simultaneously in both the industrialised North and developing South, that the necessary infrastructure be created to administer and monitor vaccines, and that vaccine development and distribution is funded by partnerships between the private and public sector.

    Biotechnology R&D: Policy Options to Ensure Access and Benefits for the Poor

    Source: Food and Agriculture Organisation | June 2003

    This FAO 'working paper' - which was prepared as background material for the 2003 issue of The State of Food and Agriculture - discusses concerns that private sector dominance of biotechnology research and the extensive patenting of new discoveries prevent poor farmers from benefiting from biotechnology.

    The authors, Carl E. Pray and Anwar Naseem of Rutgers University, United States, provide a focused overview of the status of crop biotechnology research worldwide and analyse the influence of intellectual property rights (IPRs) on diffusion of the technology. They explore the idea of an optimal degree of 'appropriability' that maximises the total social value of biotechnology research and which yields a socially desirable distribution of the benefits.

    The paper then describes various policy measures that could focus more biotechnology research on the problems of the poor, in both the public and private sectors and through public private partnerships. Specific recommendations include that groups are developed to lobby for the interests of the poor, and that "more efficient" biosafety regulations and stronger IPRs are established to encourage privately funded research. 

    A related paper - The Economics of Agricultural Biotechnology Research - provides more detail on the economic determinants and impacts of agricultural research, and surveys public and private research in both developed and developing countries since the green revolution.

    The release of genetically modified crops into the environment

    Source: The Plant Journal | January 2003

    These two highly informative papers - which offer overviews of current status and regulations and of ecological risk assessment - are an excellent overview of the current status of GM crops in commercial production, as well as those that have been approved for release. The regulatory mechanisms surrounding the release of GM crops in different countries are compared, followed by a balanced discussion of the issues surrounding risk assessment and its role in decisions involving GM technology.

    The first paper contains a comprehensive list of over 40 transgenic crops approved for commercial release, and discusses legislation in the United States, Argentina, Canada, China, the European Union, Australia, Japan and other countries. The authors caution against "the regulation of risk turning into the risk of regulation", which would lead to a situation in which only a few multinational companies could afford to tackle excessive regulatory processes.

    The science of risk assessment is addressed in the second paper, concluding with the socio-economic context of judgements surrounding GM technology. The various concerns regarding the environmental release of transgenic crops are thoroughly discussed, including the likelihood and possible consequences of the invasion of existing ecosystems, outcrossing, horizontal gene transfer, 'superpests' and secondary ecological impacts on biodiversity and other agricultural practices.

    The authors emphasise that the plants developed by traditional breeding offer the most appropriate reference point against which the potential impact of a GM crop should be judged, and that these judgements must be made on a case-by-case basis.

    Migration of Highly Skilled Persons from Developing Countries: Impact and Policy Responses

    Source: International Labour Office | November 2001

    This paper summarises a research project that looked at the impacts of high skilled emigration on developing countries and the policy options of developed countries. The authors say that while there is little doubt that skilled emigration at the levels estimated will create challenges for certain developing countries the impact of increased international mobility of skilled workers may not necessarily be negative.

    They emphasise that "brain exchanges" between countries characterise all advanced economies, forming one component of the flow of goods and information in a globalising economy. A central challenge is therefore for developing countries to engage appropriately in the exchange of skills taking place in the global labour market, and to maximise on the benefits of skilled migration.

    The authors recommend that developed receiving countries should play an active role in addressing the issue, for example by encouraging temporary and return migration, controlling recruitment from at risk countries, incorporating mechanisms that encourage developing country economic growth, and assisting with diaspora arrangements. They conclude that the best means of addressing developing country skill shortages over the long run is to improve education, training and targetted economic deveopment.

     

    Research and Policy Issues in High-Skilled International Migration: A Perspective with Data from the United States

    Source: Institute for the Study of Labor | September 2001

    This article notes that while highly-skilled migration is eliciting much debate, its effects — both positive and negative — have not been well studied or measured (particularly when compared with international migration in general). Simple models of "brain drain" and "brain gain" — which dominate most policy discussions — do not fully capture the complexity of the movement of people and knowledge across borders.

    Data from the United States — as the world's largest educator of foreign students — is used to provide insights into the magnitude and direction of some of the possible effects of highly-skilled migration. The author warns that economic and knowledge creation should not be the only component of policy making on immigration policy, and that freedom of movement — as a human right — should also be considered.

    In conclusion, both sending an receiving countries should be concerned with the potential effects of highly-skilled migration, and much research needs to be done to better understand its impacts. While the paper does not explicitly explore policy options, it describes how the magnitude of the effects of such migration will be significantly affected by aspects of a country's immigration, education and technology policies.

     

    Human capital flight and growth in developing countries

    Source: Stanford Institute for Economic Policy Research | April 2002

    The author challenges the assumption that the emigration of highly skilled people is detrimental to their country of origin, and suggests that some developing countries — if not the majority of them — have in fact benefitted from this brain drain. He explains that the main reason for this is that migration prospects increase the expected return to education and, hence, foster domestic enrollment in education.

    This concise article gives a brief overview of the current status of the brain drain, the feedback effects of this migration. It then asks whether there is an "optimal" brain drain, such that a country's stock of human capital can actually be increased. The author suggests that this could be achieved by designing specific incentives to return migration to those countries negatively affected by the brain drain, and to promote international cooperation aimed at furthering brain circulation.

     

    Review of the TRIPS agreement: fostering the transfer of technology to developing countries

    Source: Third World Network | 1999

    Carlos Correa presents a detailed analysis of the Trade-Related Aspects of Intellectual Property Rights (TRIPS), examining the motives behind developing countries calling for a review of the agreement.

    The report also discusses issues related to the implementation of the agreement and to the 'in-built agenda', and looks at the interface between TRIPS and the Convention on Biological Diversity and proposals for enhancing the transfer of technology to developing countries.

    The author suggests the development of a comprehensive approach to address developing countries' concerns relating to transfer of technology, possibly including the review of various WTO agreements, and concludes that the improvement of conditions for access to and effective use of foreign technologies will require a broad approach beyond the TRIPs Agreement.