All issues > Volume 14 > Issue 1 > Editorial Introduction

We are delighted to present the Spring Issue of this Volume 14 with a bold, fresh look. In addition to a variety of changes to our website (https://script-ed.org/) undertaken in the past year, we have launched thoroughly amended Author Guidelines (https://script-ed.org/submission-guidelines/author-guidelines/) and wholly redesigned the templates for our Articles and Book Reviews. This was the first revision to the templates since SCRIPTed’s founding in 2004. We believe these new templates afford a modern look and continue our committed effort to making SCRIPTed a professional, highly regarded journal in the fields of intellectual property, information technology and medical law.

In this issue, in addition to a wide selection of book reviews, authors look at several pressing, topical issues in biotechnology and information technology. Jeff Kosseff explores how policymakers in the US have struggled to maintain free expression on the Internet while minimising defamation and other harmful online speech. Focusing on the concept of “intermediary liability”, i.e. whether online platforms should be held legally responsible for user-generated content, Kosseff examines the US experience with relatively broad intermediary liability immunity, as seen under Section 230 of the Communications Decency Act of 1996. He argues that while broad immunity often prevents lawsuits against online platforms, many of the largest US intermediaries voluntarily block objectionable and harmful content due to consumer and market demands.

Two groups of authors explore current topics in novel biomedicine. Marton Varju and Judit Sándor carry out a comparative assessment to explore the regulatory environment for the procurement of stem cells throughout Europe. They find that the relevant national regulatory regimes share common regulatory frames, yet exhibit considerable differences in terms of the regulatory approach followed, the biological level regulated, and the context in which technologies for stem cell procurement are regulated. Varju and Sándor suggest that this variety indicates that legal regulation may resort to different means (generic or specific) so as to secure a connection between rules and the technology that is regulated. To improve “regulatory connection”, they recommend “inter-systemic regulatory learning and borrowing”, namely that countries consider engaging in borrowing from other regulatory systems covering both generic and specific instruments of technology regulation.

In an Analysis, Tsung-Ling Lee and Tamra Lysaght analyse the European Medical Agency’s (EMA) two-year pilot programme known as the “Adaptive Pathways” (AP) scheme, which was launched in response to calls for faster access to innovative biomedicines. Lee and Lysaght situate the AP scheme within a broader regulatory approach that seeks to accelerate the approval process for novel biomedicines. They urge caution for such an approach. Using the recent market authorisation of a stem cell product as a case study, they scrutinise the legal and ethical merits of the AP scheme, including by drawing attention to how it will grant conditional marketing approval to medicinal products with limited clinical benefits. In response to the identified weaknesses, Lee and Lysaght propose procedural safeguards which are in keeping with the EMA’s public health missions.

Finally, Julia Hӧrnle provides a case comment on the European Court of Human Rights case of Bărbulescu v Romania. The Court held that an employer’s monitoring of their employee’s instant messenger account and the disclosure of these communications (to the Applicant’s colleagues) containing highly private, sensitive information was justified and therefore not a breach of Article 8 of the European Convention on Human Rights. Hӧrnle argues that the Court under-engaged with the requirements of the proportionality test in the context of employment monitoring, and failed to answer the difficult question to what extent an employer’s strict “no private use of the internet” rule is compliant with Article 8(1). This deference effectively means that the Court gave very little guidance on the question of when monitoring is proportionate and therefore justified by Article 8(2). She expressed the hope that a future court would be more willing to engage in the proportionality issues raised by employment monitoring cases.

In sum, we are extremely pleased with both the look and contents that comprise this Issue 1 of Volume 14 of SCRIPTed. We hope you are as well.