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  1. Book ; Online: Chapter 2: MEDICAL INFORMATION COMMONS: CONCEPTUAL, LEGAL AND ETHICAL CONSIDERATIONS FOR STAKEHOLDERS

    Geary, Janis / Majumder, Mary A / Robinson, Jill Oliver / Guerrini, Christi / Cook-Deegan, Robert

    2022  

    Keywords LNRD ; Commons, Data, Data sharing, Privacy, Ethics, Governance
    Language English
    Size 1 Online-Ressource
    Publisher Edward Elgar Publishing
    Publishing place Cheltenham, UK
    Document type Book ; Online
    Note English
    HBZ-ID HT030380998
    ISBN 9781839105951 ; 183910595X
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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  2. Article ; Online: The

    Sherkow, Jacob S / Cook-Deegan, Robert / Greely, Henry T

    Annual review of genomics and human genetics

    2024  

    Abstract: A decade ago, the US Supreme Court ... ...

    Abstract A decade ago, the US Supreme Court decided
    Language English
    Publishing date 2024-02-29
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2037670-4
    ISSN 1545-293X ; 1527-8204
    ISSN (online) 1545-293X
    ISSN 1527-8204
    DOI 10.1146/annurev-genom-010323-011239
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Lessons from Biomedical Innovation during World War II.

    Cook-Deegan, Robert

    The Hastings Center report

    2021  Volume 51, Issue 5, Page(s) 3

    Abstract: The United States developed penicillin and vaccines during World War II. The partnership of government, industry, and academe was crucial. In an essay, Vannevar Bush credited that partnership with the technological achievements that led to winning the ... ...

    Abstract The United States developed penicillin and vaccines during World War II. The partnership of government, industry, and academe was crucial. In an essay, Vannevar Bush credited that partnership with the technological achievements that led to winning the war. The policies used to address the Covid-19 pandemic closely resemble how penicillin was developed, and similarly produced spectacular success in the form of RNA-based vaccines. But will today's politics of hyperpartisan vitriol and credit-mongering that pit industry against government and academe prevent carrying that success into the postpandemic era?
    MeSH term(s) COVID-19 ; Humans ; Pandemics ; Politics ; SARS-CoV-2 ; United States ; World War II
    Language English
    Publishing date 2021-10-13
    Publishing country United States
    Document type Journal Article
    ZDB-ID 194940-8
    ISSN 1552-146X ; 0093-0334
    ISSN (online) 1552-146X
    ISSN 0093-0334
    DOI 10.1002/hast.1280
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Updating the Bayh-Dole Act: March-in Rights and Transparency.

    Cook-Deegan, Robert / Kesselheim, Aaron S / Sarpatwari, Ameet

    JAMA

    2022  Volume 327, Issue 10, Page(s) 923–924

    MeSH term(s) Drug Costs/legislation & jurisprudence ; Patents as Topic/legislation & jurisprudence ; United States
    Language English
    Publishing date 2022-03-15
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2022.0895
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Breathing fresh air into the debate: Ventilators and the United States' intellectual property problem.

    Tiffney, Theora W / Cook-Deegan, Robert / Ross, Heather M

    Health policy OPEN

    2022  Volume 3, Page(s) 100069

    Abstract: In 2006, the U.S. federal government launched a project to create a cheap, easily produced, and easy to use ventilator that could be stored for long periods of time for pandemic response. Despite successful funding and contracts with two separate medical ...

    Abstract In 2006, the U.S. federal government launched a project to create a cheap, easily produced, and easy to use ventilator that could be stored for long periods of time for pandemic response. Despite successful funding and contracts with two separate medical device companies, not a single ventilator had been added to the stockpile by 2020. The company currently under federal contract for these ventilators is selling its product to private parties, rather than supplying it to the federal government. In the current crisis, government has instead turned to the Defense Production Act to supply ventilators. Inaccessibility of medical equipment is a detriment to Americans' health, particularly during a public health emergency like COVID-19. This persists despite the central role of the federal government in the funding of healthcare innovation. We place the shortage of ventilators in context of the ongoing debate about the federal government's intellectual property powers, as well as the legal recourses available, then discuss why this situation is a strong argument for expanding compulsory licensing powers as a component of federal policy.
    Language English
    Publishing date 2022-04-07
    Publishing country Netherlands
    Document type Journal Article
    ISSN 2590-2296
    ISSN (online) 2590-2296
    DOI 10.1016/j.hpopen.2022.100069
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Bayh-Dole at 40: Accomplishments, Challenges, and Possible Reforms.

    Sarpatwari, Ameet / Kesselheim, Aaron S / Cook-Deegan, Robert

    Journal of health politics, policy and law

    2022  

    Abstract: Over forty years have passed since the enactment of the Patent and Trademark Amendment (Bayh-Dole) Act, which authorized institutions to patent inventions arising from federally-funded research. Although some experts have heralded the Bayh-Dole Act as ... ...

    Abstract Over forty years have passed since the enactment of the Patent and Trademark Amendment (Bayh-Dole) Act, which authorized institutions to patent inventions arising from federally-funded research. Although some experts have heralded the Bayh-Dole Act as ushering in a new era of technological advances, others have been less sanguine about its impact. In recent years, the rising price of prescription drugs and the patenting of COVID-19 therapeutics and vaccines developed with substantial federal government support have rekindled the debate whether companies should receive more restricted rights to such products. In this article, we trace the history leading to the enactment of the Bayh-Dole Act and critically assess its strength and weaknesses as well as unresolved questions concerning its scope. Based on this analysis, we propose reforms to better align the Bayh-Dole Act with public values and health outcomes, including clarifying the scope of government use rights, making it easier to invoke march-in rights for failure to meet health and safety needs, increasing transparency in how patents are licensed, and testing different approaches to foster the development and application of inventions.
    Language English
    Publishing date 2022-07-14
    Publishing country United States
    Document type Journal Article
    ZDB-ID 752966-1
    ISSN 1527-1927 ; 0361-6878
    ISSN (online) 1527-1927
    ISSN 0361-6878
    DOI 10.1215/03616878-10041247
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article: An Elusive Consensus

    Cook-Deegan, Robert

    Issues in Science and Technology

    Abstract: A few months into my medical training, I heard Fred Sanger, the Nobel prize-winning biochemist, describe a miracle-DNA sequencing in his lab-and Ray White, a pioneer in human genetics, excitedly reveal the first genetic markers that would grow into a ... ...

    Abstract A few months into my medical training, I heard Fred Sanger, the Nobel prize-winning biochemist, describe a miracle-DNA sequencing in his lab-and Ray White, a pioneer in human genetics, excitedly reveal the first genetic markers that would grow into a human genetic linkage map [ ]the US Patent and Trademark Office has granted patents on gene editing technologies, but is now-eight years after the critical science was conducted- reviewing a possible "interference," an administrative procedure to sort out competing patent claims on related inventions While the US Congress passes secretive, sloppy funding legislation and patent offices in different jurisdictions craft incoherent policies, a hot debate plays out about whether, when, and under what conditions it might make sense to introduce heritable forms of genome editing into human beings Baylis's book, Altered Inheritance, is a plea for broadening the debate beyond a case-by-case technical assessment of risk and potential benefit
    Keywords covid19
    Publisher WHO
    Document type Article
    Note WHO #Covidence: #884299
    Database COVID19

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  8. Article ; Online: Development of an Open Database of Genes Included in Hereditary Cancer Genetic Testing Panels Available From Major Sources in the US.

    Geary, Janis / Majumder, Mary / Guerrini, Christi / Cook-Deegan, Robert

    JAMA oncology

    2022  Volume 8, Issue 4, Page(s) 1–3

    MeSH term(s) Genetic Counseling ; Genetic Predisposition to Disease ; Genetic Testing ; Humans ; Neoplasms/genetics
    Language English
    Publishing date 2022-02-03
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ISSN 2374-2445
    ISSN (online) 2374-2445
    DOI 10.1001/jamaoncol.2021.7639
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Governing Heritable Human Genome Editing: A Textual History and a Proposal for the Future.

    Walters, LeRoy / Cook-Deegan, Robert M / Adashi, Eli Y

    The CRISPR journal

    2021  Volume 4, Issue 4, Page(s) 469–476

    Abstract: Heritable human genome editing (HHGE) has become a topic of intense public interest, especially since 2015. In the early 1980s, a related topic-human genetic engineering-was the subject of sustained public discussion. There was particular concern about ... ...

    Abstract Heritable human genome editing (HHGE) has become a topic of intense public interest, especially since 2015. In the early 1980s, a related topic-human genetic engineering-was the subject of sustained public discussion. There was particular concern about germline genetic intervention. During the 1980s debate, an advisory committee to the Director of the National Institutes of Health (NIH)-the Recombinant DNA Advisory Committee (RAC)-agreed to provide initial public review of proposals for deliberate introduction of DNA into human beings. In 1984 and 1985, the RAC developed guidelines for research involving DNA transfer into patients. The committee also commented on the possibility of deliberately altering the human germline. We track the textual changes over time in the RAC's response to the possibility of germline genetic intervention in humans. In 2019, the NIH RAC was abolished. New techniques for genome editing, including CRISPR-based techniques, make both somatic and germline alterations much more feasible. These novel capabilities have again raised questions about oversight. We propose the creation of a new structure for the public oversight of proposals to perform HHGE. In parallel with a technical review by a regulatory agency, such proposals should also be publicly evaluated by a presidentially appointed Bioethics Advisory Commission.
    MeSH term(s) Advisory Committees ; DNA, Recombinant ; Gene Editing/history ; Gene Editing/legislation & jurisprudence ; Gene Editing/methods ; Gene Editing/trends ; Genetic Engineering ; Genetic Therapy/history ; Genetic Therapy/legislation & jurisprudence ; Genetic Therapy/methods ; Genetic Therapy/trends ; Genome, Human ; Germ Cells ; Government Regulation ; History, 20th Century ; History, 21st Century ; Humans ; National Institutes of Health (U.S.) ; United States
    Chemical Substances DNA, Recombinant
    Language English
    Publishing date 2021-08-18
    Publishing country United States
    Document type Historical Article ; Journal Article ; Research Support, N.I.H., Extramural ; Review
    ZDB-ID 3017891-5
    ISSN 2573-1602 ; 2573-1599
    ISSN (online) 2573-1602
    ISSN 2573-1599
    DOI 10.1089/crispr.2021.0043
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 7195: Show issues Location:
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    Zs.MG 119: Show issues

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  10. Book ; Online: Chapter 8 The BRCA patent controversies : An international review of patent disputes

    van Zimmeren, Esther / Nicol, Dianne / Gold, Richard / Carbone, Julia / Chandrasekharan, Subhashini / Lane Baldwin, A. / Cook-Deegan, Robert

    2014  

    Keywords Society & culture: general ; Social & cultural anthropology, ethnography ; Sociology ; Society and culture: general ; Social and cultural anthropology
    Size 1 electronic resource (57 pages)
    Document type Book ; Online
    Note English ; Open Access
    HBZ-ID HT021028212
    Database ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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