(2017) 14:1 SCRIPTed 1–163

Issue DOI: 10.2966/scrip.140117

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  • Glimpse
    Laurence Diver

    The sun glints between the spires of New College on the skyline of Edinburgh’s Royal Mile (film, 2002).



  • Twenty Years of Intermediary Immunity: The US Experience
    Jeff Kosseff, pp. 5-36
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    Policymakers worldwide have long debated how to maintain free expression on the Internet while minimising defamation and other harmful online speech. Key to these debates has been intermediary liability: whether online platforms should be held legally responsible for user-generated content. To inform this continued debate, this article examines the US experience with relatively broad intermediary liability immunity. Enacted two decades ago, Section 230 of the Communications Decency Act of 1996 provides robust immunity to websites, Internet service providers, social media providers, and other online platforms for legal claims arising from user content. This article examines the scope of the immunity that Section 230 provides to US platforms and examines the primary criticisms of this approach. This article analyses court opinions involving Section 230, and examines the content moderation policies and practices of the leading US online platforms. The article concludes that Section 230 has fostered the growth of social media, user reviews, and other online services that rely primarily on user-generated content. Critics of Section 230 raise valid concerns that the broad immunity often prevents lawsuits against online platforms. However, my research concludes that many of the largest US intermediaries voluntarily block objectionable and harmful content due to consumer and market demands.

    Keywords: intermediaries, liability, immunity, defamation, United States

  • Generic or Specific? The Frames of Stem Cell Procurement Regulation in Europe
    Marton Varju and Judit Sándor, pp. 37-80
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    The procurement of stem cells, which is a crucial source-material in biomedical research promising the development of novel therapies in regenerative medicine, is subject to regulation using generic and technology-specific provisions throughout Europe. The relevant national regulatory regimes, while they share common regulatory frames, exhibit considerable differences as a matter of the regulatory approach followed, the biological level regulated, or of the context in which technologies for stem cell procurement are regulated. This variety indicates that legal regulation may resort to different means so as to secure a connection with the technology regulated. It is proposed that for improving “regulatory connection” states should consider engaging in regulatory borrowing from other systems covering both generic and specific instruments of technology regulation.

    Keywords: stem cell regulation, legal regulation of stem cell procurement, regulatory connection, frames of regulation, national diversity, regulatory mixity, regulatory borrowing


  • Adaptive Pathways Regulations for Stem Cells: Accelerating Access to Medicine or Deregulating Access to Markets?
    Tsung-Ling Lee and Tamra Lysaght, pp. 81-99
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    In response to calls for faster access to innovative biomedicines, the European Medical Agency ran a two-year pilot program known as the “Adaptive Pathways” (AP) scheme. Under this approach, evidence is gathered and evaluated iteratively for license adaptation to reduce uncertainties rather than in an accumulative phased trial process. With the European Medicines Agency (EMA) aiming to mainstream the AP scheme, the regulatory approach of accelerating the approval process for novel biomedicines is in need of critical evaluation and should be viewed with some caution. Focusing on the recent market authorisation of a stem cell product, we scrutinise the legal and ethical merits of this programme. We draw attention to how the AP scheme will grant conditional marketing approval to medicinal products with limited clinical benefits. In response to the identified weaknesses of the AP scheme, we propose procedural safeguards which are in keeping with the EMA’s public health missions.

    Keywords: adaptive pathways, stem cell regulations, adaptive licensing, conditional marketing approval, Holoclar, EMA

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