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  1. Article: Realising the right to participate in pandemic prevention, preparedness and response and beyond.

    Lee, Tsung-Ling

    BMJ global health

    2023  Volume 8, Issue 1

    MeSH term(s) Humans ; Pandemics/prevention & control ; Influenza, Human/epidemiology
    Language English
    Publishing date 2023-01-25
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2059-7908
    ISSN 2059-7908
    DOI 10.1136/bmjgh-2023-011689
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Navigating equity in global access to genome therapy expanding access to potentially transformative therapies and benefiting those in need requires global policy changes.

    Lee, Tsung-Ling / Sawai, Tsutomu

    Frontiers in genetics

    2024  Volume 15, Page(s) 1381172

    Abstract: In December 2023, the US Food and Drug Administration and the UK Medicines and Healthcare Products Regulatory Agency granted the first regulatory approval for genome therapy for sickle cell disease. This approval brings hope to those suffering from this ... ...

    Abstract In December 2023, the US Food and Drug Administration and the UK Medicines and Healthcare Products Regulatory Agency granted the first regulatory approval for genome therapy for sickle cell disease. This approval brings hope to those suffering from this debilitating genetic disease. However, several barriers may hinder global patient access, including high treatment costs, obtaining informed consent for minors, inadequate public health infrastructure, and insufficient regulatory oversight. These barriers reflect the structural inequalities inherent in global health governance, where patient access often depends on social and institutional arrangements. This article addresses concerns around informed consent, treatment costs, and patient access, and proposes corresponding policy reforms. We argue that these discussions should be framed within a broader global context that considers social and institutional structures, global research priorities, and a commitment to health equity.
    Language English
    Publishing date 2024-04-04
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2606823-0
    ISSN 1664-8021
    ISSN 1664-8021
    DOI 10.3389/fgene.2024.1381172
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Legal preparedness as part of COVID-19 response: the first 100 days in Taiwan.

    Lee, Tsung-Ling

    BMJ global health

    2020  Volume 5, Issue 5

    MeSH term(s) Betacoronavirus ; COVID-19 ; Communicable Disease Control/legislation & jurisprudence ; Communicable Disease Control/organization & administration ; Communication ; Coronavirus Infections/epidemiology ; Disaster Planning/legislation & jurisprudence ; Health Policy/legislation & jurisprudence ; Humans ; Pandemics ; Pneumonia, Viral/epidemiology ; SARS-CoV-2 ; Taiwan/epidemiology
    Keywords covid19
    Language English
    Publishing date 2020-05-19
    Publishing country England
    Document type Journal Article
    ISSN 2059-7908
    ISSN 2059-7908
    DOI 10.1136/bmjgh-2020-002608
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: The legal personhood of human brain organoids.

    Kataoka, Masanori / Lee, Tsung-Ling / Sawai, Tsutomu

    Journal of law and the biosciences

    2023  Volume 10, Issue 1, Page(s) lsad007

    Abstract: Research using three-dimensional neural tissues derived from human pluripotent stem cells-known as 'human brain organoids'-has progressed rapidly in recent years. Although related ethical issues have been intensively discussed, legal issues have only ... ...

    Abstract Research using three-dimensional neural tissues derived from human pluripotent stem cells-known as 'human brain organoids'-has progressed rapidly in recent years. Although related ethical issues have been intensively discussed, legal issues have only been sparsely examined compared with the related ethical issues. In this paper, we explore a fundamental issue concerning the legal status of human brain organoids: whether they can be considered legal persons. We clearly distinguish between two types of legal personhood: 'natural person' as a human legal person and 'juridical person' as a nonhuman legal person. By examining natural and juridical personhood separately, we point out the bias and confusion in the remarks on the legal personhood of human brain organoids and provide a more comprehensive picture of the problem.
    Language English
    Publishing date 2023-04-03
    Publishing country England
    Document type Journal Article
    ZDB-ID 2756090-9
    ISSN 2053-9711
    ISSN 2053-9711
    DOI 10.1093/jlb/lsad007
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  6. Article ; Online: Legal preparedness as part of COVID-19 response

    Lee, Tsung-Ling

    BMJ Global Health

    the first 100 days in Taiwan

    2020  Volume 5, Issue 5, Page(s) e002608

    Keywords covid19
    Language English
    Publisher BMJ
    Publishing country uk
    Document type Article ; Online
    ISSN 2059-7908
    DOI 10.1136/bmjgh-2020-002608
    Database BASE - Bielefeld Academic Search Engine (life sciences selection)

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  7. Article ; Online: Conditional Approvals for Autologous Stem Cell-Based Interventions: <i>Conflicting norms and institutional legitimacy</i>.

    Lee, Tsung-Ling / Lysaght, Tamra

    Perspectives in biology and medicine

    2018  Volume 61, Issue 1, Page(s) 59–75

    Abstract: Demands from patients, health-care professionals, and industry to streamline the market approval process for promising new therapies has prompted the introduction of programs that can provide more rapid access to stem cell-based products before evidence ... ...

    Abstract Demands from patients, health-care professionals, and industry to streamline the market approval process for promising new therapies has prompted the introduction of programs that can provide more rapid access to stem cell-based products before evidence of safety and efficacy has been demonstrated in clinical trials. These products may be approved for marketing under "conditional authorizations," while uncertainty around safety and efficacy is reduced through the collection of clinical data in observational trials or registries. The rationale for conditional approval programs assumes that patients with unmet medical needs will benefit with rapid access to novel stem cell therapies. It also assumes that data gathered in actual clinical contexts is inherently better at reducing uncertainty than conventional clinical trial methods of demonstrating safety and efficacy. These assumptions may be overly optimistic and do not account for the broader societal burdens of prematurely releasing high-cost therapies with uncertain safety risks and benefits on to health-care markets. This essay focuses on the introduction of conditional approval programs for autologous somatic stem cell therapies and argues that these programs may conflict with, and potentially undermine, the normative commitments of regulatory agencies charged with promoting population health and protecting vulnerable groups from harm and exploitation. It concludes with suggestions of how programs designed to accelerate access to potentially helpful but experimental interventions could be reconfigured to be more equitable.
    MeSH term(s) European Union ; Humans ; International Agencies ; Japan ; Patient Participation ; Social Justice ; Stem Cell Transplantation/economics ; Stem Cell Transplantation/ethics ; Transplantation, Autologous/economics ; Transplantation, Autologous/ethics
    Language English
    Publishing date 2018-05-24
    Publishing country United States
    Document type Journal Article
    ZDB-ID 80373-x
    ISSN 1529-8795 ; 0031-5982
    ISSN (online) 1529-8795
    ISSN 0031-5982
    DOI 10.1353/pbm.2018.0027
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    In stock of ZB MED Cologne/Königswinter

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  8. Article ; Online: The World Health Organization was born as a normative agency: Seventy-five years of global health law under WHO governance.

    Gostin, Lawrence O / Meier, Benjamin Mason / Abdool Karim, Safura / Bueno de Mesquita, Judith / Burci, Gian Luca / Chirwa, Danwood / Finch, Alexandra / Friedman, Eric A / Habibi, Roojin / Halabi, Sam / Lee, Tsung-Ling / Toebes, Brigit / Villarreal, Pedro

    PLOS global public health

    2024  Volume 4, Issue 4, Page(s) e0002928

    Abstract: The World Health Organization (WHO) was born as a normative agency and has looked to global health law to structure collective action to realize global health with justice. Framed by its constitutional authority to act as the directing and coordinating ... ...

    Abstract The World Health Organization (WHO) was born as a normative agency and has looked to global health law to structure collective action to realize global health with justice. Framed by its constitutional authority to act as the directing and coordinating authority on international health, WHO has long been seen as the central actor in the development and implementation of global health law. However, WHO has faced challenges in advancing law to prevent disease and promote health over the past 75 years, with global health law constrained by new health actors, shifting normative frameworks, and soft law diplomacy. These challenges were exacerbated amid the COVID-19 pandemic, as states neglected international legal commitments in national health responses. Yet, global health law reforms are now underway to strengthen WHO governance, signaling a return to lawmaking for global health. Looking back on WHO's 75th anniversary, this article examines the central importance of global health law under WHO governance, reviewing the past successes, missed opportunities, and future hopes for WHO. For WHO to meet its constitutional authority to become the normative agency it was born to be, we offer five proposals to reestablish a WHO fit for purpose: normative instruments, equity and human rights mainstreaming, sustainable financing, One Health, and good governance. Drawing from past struggles, these reforms will require further efforts to revitalize hard law authorities in global health, strengthen WHO leadership across the global governance landscape, uphold equity and rights at the center of global health law, and expand negotiations in global health diplomacy.
    Language English
    Publishing date 2024-04-11
    Publishing country United States
    Document type Journal Article ; Review
    ISSN 2767-3375
    ISSN (online) 2767-3375
    DOI 10.1371/journal.pgph.0002928
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  9. Article ; Online: Mapping the Ethical Issues of Brain Organoid Research and Application.

    Sawai, Tsutomu / Hayashi, Yoshiyuki / Niikawa, Takuya / Shepherd, Joshua / Thomas, Elizabeth / Lee, Tsung-Ling / Erler, Alexandre / Watanabe, Momoko / Sakaguchi, Hideya

    AJOB neuroscience

    2021  Volume 13, Issue 2, Page(s) 81–94

    Abstract: In 2008, researchers created human three-dimensional neural tissue - known as the pioneering work of "brain organoids." In recent years, some researchers have transplanted human brain organoids into animal brains for applicational purposes. With these ... ...

    Abstract In 2008, researchers created human three-dimensional neural tissue - known as the pioneering work of "brain organoids." In recent years, some researchers have transplanted human brain organoids into animal brains for applicational purposes. With these experiments have come many ethical concerns. It is thus an urgent task to clarify what is ethically permissible and impermissible in brain organoid research. This paper seeks (1) to sort out the ethical issues related to brain organoid research and application and (2) to propose future directions for additional ethical consideration and policy debates in the field. Toward (1), this paper first outlines the current state of brain organoid research, and then briefly responds to previously raised related ethical concerns. Looking next at anticipated scientific developments in brain organoid research, we will discuss (i) ethical issues related to in vitro brain organoids, (ii) ethical issues raised when brain organoids form complexes or have relationships with other entities, and (iii) ethical issues of research ethics and governance. Finally, in pursuit of (2), we propose research policies that are mindful of the ethics of brain organoid research and application and also suggest the need for an international framework for research and application of brain organoids.
    MeSH term(s) Animals ; Brain ; Ethics, Research ; Humans ; Organoids/transplantation ; Policy ; Research Personnel
    Language English
    Publishing date 2021-03-26
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2576262-X
    ISSN 2150-7759 ; 2150-7740
    ISSN (online) 2150-7759
    ISSN 2150-7740
    DOI 10.1080/21507740.2021.1896603
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    In stock of ZB MED Cologne/Königswinter

    Zs.A 6886: Show issues Location:
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    ab Jg. 2022: Lesesaal (EG)

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  10. Article ; Online: Pandemic preparedness and response: exploring the role of universal health coverage within the global health security architecture.

    Lal, Arush / Abdalla, Salma M / Chattu, Vijay Kumar / Erondu, Ngozi Adaeze / Lee, Tsung-Ling / Singh, Sudhvir / Abou-Taleb, Hala / Vega Morales, Jeanette / Phelan, Alexandra

    The Lancet. Global health

    2022  Volume 10, Issue 11, Page(s) e1675–e1683

    Abstract: In response to the COVID-19 pandemic, several international initiatives have been developed to strengthen and reform the global architecture for pandemic preparedness and response, including proposals for a pandemic treaty, a Pandemic Fund, and ... ...

    Abstract In response to the COVID-19 pandemic, several international initiatives have been developed to strengthen and reform the global architecture for pandemic preparedness and response, including proposals for a pandemic treaty, a Pandemic Fund, and mechanisms for equitable access to medical countermeasures. These initiatives seek to make use of crucial lessons gleaned from the ongoing pandemic by addressing gaps in health security and traditional public health functions. However, there has been insufficient consideration of the vital role of universal health coverage in sustainably mitigating outbreaks, and the importance of robust primary health care in equitably and efficiently safeguarding communities from future health threats. The international community should not repeat the mistakes of past health security efforts that ultimately contributed to the rapid spread of the COVID-19 pandemic and disproportionately affected vulnerable and marginalised populations, especially by overlooking the importance of coherent, multisectoral health systems. This Health Policy paper outlines major (although often neglected) gaps in pandemic preparedness and response, which are applicable to broader health emergency preparedness and response efforts, and identifies opportunities to reconceptualise health security by scaling up universal health coverage. We then offer a comprehensive set of recommendations to help inform the development of key pandemic preparedness and response proposals across three themes-governance, financing, and supporting initiatives. By identifying approaches that simultaneously strengthen health systems through global health security and universal health coverage, we aim to provide tangible solutions that equitably meet the needs of all communities while ensuring resilience to future pandemic threats.
    MeSH term(s) COVID-19/epidemiology ; Global Health ; Humans ; International Cooperation ; Pandemics/prevention & control ; Universal Health Insurance
    Language English
    Publishing date 2022-09-27
    Publishing country England
    Document type Journal Article ; Review ; Research Support, Non-U.S. Gov't
    ZDB-ID 2723488-5
    ISSN 2214-109X ; 2214-109X
    ISSN (online) 2214-109X
    ISSN 2214-109X
    DOI 10.1016/S2214-109X(22)00341-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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