Personal Genome Medicine: The Legal and Regulatory Transformation of US Medicine

 

Personal Genome Medicine: The Legal and Regulatory Transformation of US Medicine

Michael J. Malinowski

Drawing from the history of U.S. medicine, Professor Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercialization of personal genome sequencing and testing sectors, as well as to assess their impact on the future of U.S. medicine.

“In the roughly 30 years that I have been researching and writing about these important topics, I have witnessed an explosion in the use of these emerging technologies far beyond anything I could have imagined when I began my career,” said Professor Malinowski, a Yale Law School alumnus who has been an LSU Law faculty member since 2002. “In 2017, when the U.S. Food and Drug Administration approved direct-to-consumer genetic health risk testing that does not meet evidentiary science clinical standards—with medical professional involvement wholly optional—it was a jolting deviation from the U.S. legacy of protecting and promoting the evidentiary-science base of medicine. ‘Personal Genome Medicine’ represents the culmination of my scholarship on this issue to date, and my hope is that it will elevate and advance the conversation in a meaningful way.”

CELH Seminars

CELH Seminar: 'The Suffragettes and Civil Liberties'

Tuesday, 10 October 2023 - 5.15pm

CELH Seminar: 'Substantive Bargain as the Basis of Consideration in Contract: the argument based in case evidence, doctrinal coherence, and principle, and a discussion of the limited role of nominal consideration'

Tuesday, 24 October 2023 - 5.15pm

CELH Seminar: 'The Judicial Finances of Gilbert Rothbury, a Clerical Royal Court Justice (1295-1321)'

Tuesday, 7 November 2023 - 5.15pm

CELH 2023 Annual Lecture: Professor Rebecca Probert

Tuesday, 21 November 2023 - 5.15pm

CELH Seminar: 'Proof by Witnesses in the English Common Law Courts in the Thirteenth Century'

Tuesday, 28 November 2023 - 5.15pm

HONG KONG BETWEEN “ONE COUNTRY” AND “TWO SYSTEMS”: ESSAYS FROM THE YEAR THAT TRANSFORMED THE HONG KONG SPECIAL ADMINISTRATIVE REGION (2019 – 2020)

 

HONG KONG BETWEEN “ONE COUNTRY” AND “TWO SYSTEMS”: ESSAYS FROM THE YEAR THAT TRANSFORMED THE HONG KONG SPECIAL ADMINISTRATIVE REGION (2019 – 2020)

Larry Cata Baker

Hong Kong Between “One Country” and “Two Systems” critically explores the battle of ideas that started with the June 2019 anti-extradition law protests and ended with the enactment of the National Security and National Anthem Laws a year later. At the center of these battles was the “One Country, Two Systems” principle. By June 2020, the meaning of that principle  was highly contested, with Chinese authorities taking decisive steps to implement their own understanding of the principle and its normative foundations, and the international community taking countermeasures. All of this occurred well before the 2047 end of the 1985 Sino-British Joint Declaration (中英联合声明) that had been the blueprint for the return of Hong Kong to China. Between these events, global actors battled for control of the narrative and of the meaning of the governing principles that were meant to frame the scope and character of Hong Kong’s autonomy within China.  The book critically examines  the conflict of words between Hong Kong protesters, the Chinese central and local authorities, and important elements of the international community. This decisive discursive contest paralleled the fighting for control of the streets and that pitted protesters and the international community that supported them against the central authorities of China and Hong Kong local authorities.  In the end the Chinese central authorities largely prevailed in the discursive realm as well as on the streets. Their victory was aided, in part by the COVID-19 pandemic of 2020.  But their triumph also produced the seeds of a new and potentially stronger international constitutional discourse that may reduce the magnitude and scope of that success. These essays were written as the events unfolded. Together the essays analytically chronicle the discursive battles that were fought, won and lost, between June 2019 and June 2020. Without an underlying political or polemical agenda, the essays retain the freshness of the moment, reflecting the uncertainties of the time as events unfolded. What  was won on the streets of Hong Kong from June to December 2019, the public and physical manifestation of a principled internationalist and liberal democratic narrative of self-determination, and of civil and political rights, was lost by June 2020  within a cage of authoritative legality legitimated through the resurgence of the normative authority of the state and the application of a  strong and coherent expression of the principled narrative of its Marxist-Leninist constitutional order. Ironically enough, both political ideologies emerged stronger and more coherent from the conflict, each now better prepared for the next.  

Unsettling Territories: Tradition and Revolution in Law and Society - Call for papers

 

2024 Law and Society Association Annual Meeting 
- call for papers

The deadline for the Call for Submissions is October 24, 2023 at 5:00 p.m. ET (USA and Canada). The Program Committee welcomes any scholar studying sociolegal activities to submit an individual paper or session proposal. We recommend scholars interested in proposing a session with a creative format to consult with the Program Committee and the LSA Executive Office (melissak@umass.edu) in advance of submitting their proposal. 

 

Property Meeting the Challenge of the Commons

Editors:

 

• Ugo Mattei,
• Alessandra Quarta, 
• Filippo Valguarnera, 
• Ryan J. Fisher

• Copyright: 2023
• This book explores the challenge that the commons present to the private-public dichotomy in a wide variety of national legal systems representing the West European legal tradition as well as post-socialist and post-colonial experiences. It presents national reports from 13 jurisdictions, ranging from Belgium and the South Africa to the US. Constituting the outcome of the 20th General Congress of the International Academy of Comparative Law, held in Fukuoka, Japan in July 2018, it offers a valuable and unique resource for the study of comparative law.

La Cultura Juridica - Digital Library - Bibliothèque digitale

 

La Cultura Juridica - 

Digital Library - Bibliothèque digitale

• Setsuo Miyazawa "For the Liberal Transformation of Japanese Legal Culture: a review of the recent scholarship and practice"

• Sergio Stone "Law and Legal Culture in Venezuela in Revolutionary Times (1999-2009)"

• Richard J. Ross "Communications Revolutions and Legal Culture: An Elusive Relationship"

• Remo Bodey "Politics and Culture from the Twentieth Century to the New Millennium"

• Paulino Rueda Romero "La Estética del derecho"

• M.H. Hoeflich "Roman law in American Legal Culture"

• Justice Services Branch (British Columbia) con la contribución de Rodney MacDonald "Legal culture"

• José Ramón Narváez "Cultura Jurídica. Ideas e Imágenes"

• Jo Carrillo "Links and choices: popular legal culture in the work of Lawrence M. Friedman"

• Jan M. Smits "Legal Culture as Mental Software, or: How to Overcome National Legal Culture?"

• International Encyclopedia of Social and Behavioral Sciences "Legal Culture and Legal Consciousness"

• Herman Nébias Barreto "Legal Culture and Argumentation in the Vice-Reign of Peru from the 16th to the 18th centuries"

• Ghislaine Lydon "Islamic Legal Culture and Slave-Ownership Contests in Nineteenth-Century Sahara"

• Georgina López González "Cultura jurídica e imaginario monárquico: las peticiones de indulto durante el 2o Imperio Mexicano"

• David Nelken "Using the concept of legal culture"

• Carlos Petit "Oralidad y escritura, o la agonía del método en el taller del jurista historiador"

• Carlos Antonio Wolkmer "Pluralismo jurídico. Fundamentos de una nueva cultura del derecho" (vista limitada)

• Carlos Antonio Wolkmer "El humanismo en la tradición de la cultura jurídica Latino Americana"

• Bregvadze, Lasha. "Legal Culture between Localism and Globalism: Collisions of Plural Legal Regimes and Cultures in Post-Soviet Georgia"

• Barbara M. Young Q.C. "Change in legal culture: Barriers and new opportunities"

• Ali Acar "The concept of legal culture, with particular attention to the turkish case"

Indiana Journal of Global Legal Studies

Published by: Indiana University Press

• “I Wish There Was a Treaty We Could Sign”: An Inquiry into the Making of the Global Pact for the Environment

  “I Wish There Was a Treaty We Could Sign”: An Inquiry into the Making of the Global Pact for the Environment (pp. 7-80)

  Marie-Catherine Petersmann

  
  
• Twists & Swirls: Caregiving & Sexualization—Femininity Construct in Gendered Migration from Nigeria to Italy

  Twists & Swirls: Caregiving & Sexualization—Femininity Construct in Gendered Migration from Nigeria to Italy (pp. 81-138)

  Christiana Essie Sagay

  
  
• US-Chi/na Transnational Law in a Time of Trade Crisis

  US-China Transnational Law in a Time of Trade Crisis (pp. 139-204)

  Carrie Shu Shang

  
  
• Torn Between Institutionalisation & Judicialisation: The Demise of the EU-US Privacy Shield

  Torn Between Institutionalisation & Judicialisation: The Demise of the EU-US Privacy Shield (pp. 205-244)

  Elaine Fahey and Fabien Terpan

  
  

 

Developments and Issues in Consumer ADR and Consumer Ombudsmen in Europe

CHRISTOPHER HODGES

This policy brief outlines major developments and issues in consumer dispute resolution systems in Europe that were highlighted at the conference CONSUMER ADR: Delivering Fairness and Justice for Consumers, Business and Markets held at Wolfson College, Oxford on 18 and 19 March 2019.

The principal findings include:

• There is considerable evolution in the alternative dispute resolution (ADR) schemes in some countries. A notable feature is that many of the ADR schemes are placing increased emphasis on integrating mediation into their pre-existing arbitration-style procedures.
• Many countries continue to find it a challenge to get more businesses, especially small and medium-sized businesses (SMEs) to adopt ADR schemes. Equally, many consumers are either unaware of ADR or imagine it to be an advisory service rather than an independent dispute resolution service.
• There is a clear division between EU Member States that have sophisticated CDR schemes ― and, despite the differences between States, are improving their mechanisms ― and those States that have very undeveloped Consumer Dispute Resolution (CDR provision).
• The national landscapes of ADR bodies continue to present problems, notably lack of full coverage and low consumer confidence in the current system.
• Ombudsmen are the leading model of CDR, since they typically operate as part of the system of market regulation as well as the national system of dispute resolution.There is increasing realization that ‘consumer ADR’ is something specific and should have its own architecture.

Delivering Dispute Resolution: Recent review on the resolution of disputes in England and Wales

 

Delivering Dispute Resolution: Recent review on the resolution of disputes in England and Wales

Christopher Hodges

This Report summarizes the main points of two recent reviews on the resolution of disputes in England and Wales. One is a study by Professor Christopher Hodges and the other is a Report for the Welsh Government chaired by Lord Thomas of Cwmgiedd, former Lord Chief Justice of England and Wales. There are strong similarities between their conclusions.

 

• The justice system has broken down in England and Wales. There are too many individual, competing, and overlapping options, which confuse potential users. The system needs to be reconstructed as an integrated single entity.
• Many major dispute resolution pathways are inadequate in delivering justice and should be reviewed. An adversarial system inherently involves levels of cost and delay that defeat people’s desire or ability to reach just resolution of their disputes.
• Experimentation with digitized procedures offers opportunities to modernize processes, with considerable benefits. 
• But digitization can exclude a significant number of people and small businesses, who need personal assistance during, after, and especially before starting any formal process.
• Every dispute resolution pathway should be reviewed against its ability to provide satisfactory answers to three questions:

1. How do people identify and access information, advice, support, and assistance in solving their problems?
2. How do we ensure that dispute resolution pathways are simple, cost-effective and deliver justice to people and organizations?
3. How do we identify systemic problems, and address them so as to reduce risk of future recurrence?

 

Judged against these criteria, dispute resolution is best delivered through online platforms and modernized Ombuds or Tribunals, which are overseen by principles-based regulatory authorities, and which feed back extensive data on issues that can then be addressed by relevant interventions.

Reducing Online Harms through a Differentiated Duty of Care: A Response to the Online Harms White Paper

 

Reducing Online Harms through a Differentiated Duty of Care: A Response to the Online Harms White Paper

Damian Tambini

LSE media expert and Government adviser Damian Tambini argues that social media companies have a 'duty of care' to protect users from harms caused by content published on their platforms, in response to the government's policy proposals in its White Paper on Online Harms.

He argues that the government is correct to propose a new institution, Ofweb, with the power to regulate online content in order to combat the significant harms caused by hate speech, foreign interference in democracy, images of self-harm, and terrorist content online. Yet he also warns of the potential dangers in the approach of the White Paper, which could inhibit freedom of expression if the harms are not clearly defined.

The policy brief proposes a detailed distinction between harmful but legal content and illegal content, and that illegal content should be met with sanctions including civil fines.

Tambini tackles the central legal and constitutional problem regarding a new code of conduct for legal harms such as political speech that interferes in the democratic process – so-called ‘fake news’. He finds that such censorship-like functions would not accord with the European Convention on Human Rights free speech test on proportionality, legality (parliamentary oversight), and necessity in a democratic society.

Therefore, Parliament must decide if new offences and categories of content require new laws and liabilities and set standards for blocking or filtering the most dangerous content. Given the dynamic nature of online harms, the process for introducing new laws to reflect harms should be more efficient and evidence-based, with advice from the new regulator.