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ProfessorJane Nielsen

Professor

Law

Orcid identifier0000-0002-3005-0047 (opens in a new tab)⁠
  • Professor
    Law
  • +61 3 6226 2322 (Work)
  • +61 3 6226 7623 (Fax)
  • Faculty of Law, Law, 2.17 Faculty of Law Building, Sandy Bay Campus, TAS

RESEARCH SUMMARy

Expertise:
Jane’s research expertise lies in the areas of health and medical law and regulation, genomic data sharing, and issues pertaining to intellectual property protection of health innovation. Jane has undertaken a considerable amount of research in these areas, much of it funded by competitive grants, that has responded to and influenced important issues of health policy on both a national and international scale. Jane’s specific research projects include work on the return of raw genomic data to individuals, reforming the regulation of innovative health technologies, and the legal issues associated with genomic data sharing.

Areas of Research Expertise:
Intellectual Property Law, particularly Patent Law
Regulation of bioprinting
Health Regulation
Data Ownership
Tort Law
Competition Law

Collaboration
Jane partners with a number of organisations in undertaking various research projects in which she is currently involved. This includes:

LINEAGE project - Law, sociology and ethics in data governance for genomics, is led by University of Sydney and includes a number of other institutions.
Returning raw genomic data: patient autonomy or legal minefield?: Zero Childhood Cancer, the Childrens’ Cancer Institute, Sydney Childrens’ Hospital, the Garvan Institute, International Cancer Genome Consortium, UNSW, Deakin University, PROFYLE (Canada)

Reforming the regulatory environment for innovative health technologies: Sydney University

Genomic data sharing: issues in law, research, ethics and society: Melbourne University, Sydney University, Deakin University

Jane has also worked with many other national and international collaborators during the course of her research career, including researchers from Australia, the United States, Canada, Europe and the United Kingdom.

Awards:
Dean’s Commendation Award for an Outstanding Doctoral Thesis. (2005)

Current projects:
Jane’s work on returning raw genomic data investigates legal and ethical obligations around the return of data to patients and research participants.

The project investigating the reform of innovative health technologies encompasses investigation of a broad array of regulatory mechanisms to determine whether there are better ways to regulate research, translation and delivery of new medical technologies.

The work on genomic data sharing encompasses a range of issues arising from the data sharing ecosystem, including institutional arrangements, protections, legal obligations, ethical issues and practical impediments. The LINEAGE project is similarly investigating data sharing of clinical data within the Australian regulatory environment.

Research Appointments
Associate Investigator in the Ethics, Policy and Public Engagement Program of the Australian Centre of Excellence for Electromaterials Science (2015 – present)

Research Invitations
-‘The Intellectual Property Landscape in Bioprinting’, invited speaker, International Conference on BioFabrication, October 2021 (online)
-‘Regulating Innovative Medical Technologies’, invited speaker, 14th Annual International Electromaterials Science Symposium, February 2020, Canberra
-‘Reforming the Regulatory Environment for Innovative Health Technologies’, invited speaker, 13th Australian Peptide Conference, September, 2019, Port Douglas
-‘Institutional and Other Arrangements: Impacts on Data Sharing’, invited presentation, Centre for Law and Genetics Data Sharing Workshop, Hobart, April 2019
-‘IP and Commercialisation’, invited speaker, The Centre for Law and Genetics 25th Anniversay Public Forum, April 2019, Hobart
-‘Patentability and Bioprinting: Where to From Here?’, invited speaker, QUT Bioprinting Workshop, December 2017, Brisbane

FUNDED PROJECTS

  • GRANT
    Attracting and Retaining Criminal Lawyers in Tasmania
    1 Jan 2024 - 13 Apr 2026
    People funded by this grant:
    • Maker Y,
    • Nielsen J,
    • Prichard J,
    • Boocock J
    Project Total: $47,186; The purpose of this study is to understand the factors influencing the supply of lawyers in criminal practice in Tasmania and provide recommendations for attracting and retaining lawyers in a sustainable manner. Through survey and interview research with a range of stakeholders, the team will work with Tasmania Legal Aid and the Law Society of Tasmania to understand issues that exist with the supply of criminal lawyers around Tasmania and barriers to lawyers getting into, or staying in, criminal law practice, and to identify options for stakeholders to address those barriers and promote a sustainable supply of lawyers to meet demand. Funded by: Law Foundation of Tasmania - Grant ($47,186); University of Tasmania.
  • GRANT
    Ethical governance for clinical and genomic data
    1 Jul 2022 - 31 Aug 2028
    People funded by this grant:
    • Newson A,
    • Nielsen J,
    • Otlowski M,
    • Eckstein L,
    • Nicol D
    Project Total: $4,999,986; This program of work will produce a comprehensive national genomic data governance framework for managing the generation and exchange of clinical and genomic datasets. The overarching aim of the project is to create a framework that takes into account the ethical, legal and social issues associated with the production and use of clinical and genomic datasets, in order to achieve more effective implementation and use of datasets. Funded by: Medical Research Future Fund - Genomics Health Futures Mission 2021 Stream 3; University of Sydney; University of Adelaide; University of Tasmania.
  • GRANT
    Posthuman Genetic Legacies
    21 Jun 2021 - 6 Jun 2022
    People funded by this grant:
    • Kratz S,
    • Sutherland B,
    • Hutmacher D,
    • Nielsen J
    Project Total: $21,100; Posthuman Genetic Legacies is a practice-led research project that investigates avenues of producing an alternative (non-human) and ongoing genetic legacy via biotechnological intervention. The study draws on established practices in biological art to consider the feminist potential of cell culture and genetic engineering technologies to acquire biological offspring when conventional reproductive pathways are compromised or traditional conceptions of motherhood are undesirable. The project also aims to test the proposition that posthuman and new materialist philosophies, that disrupt binary categorisation and a human centred perspective, may offer a conceptual space for rethinking the anguish of situational childlessness. Through a range of boundary-challenging artistic examinations, existing regulatory and ethical issues will be examined to highlight the legal frameworks that govern access to reproductive technologies as well as ownership, use and patenting of biological material. Funded by: Australian Network for Art and Technology - Synapse ($21,100); University of Tasmania.
  • GRANT
    Returning raw genomic data: patient autonomy or legal minefield?
    30 Jun 2020 - 30 Jun 2024
    People funded by this grant:
    • Nielsen J,
    • Otlowski M,
    • McWhirter R,
    • Gill A,
    • Tyrell V
    Project Total: $388,026; This project will seek to answer the following question: Does the Australian legal framework provide sufficient clarity for clinicians, researchers, the public health system and those making requests, to deal with requests for the return of raw genomic sequence data to patients and research participants? It incorporates an interview-based component that will then be used to consider how requests for raw genomic data by patients and medical research participants are likely to be treated from a legal perspective. It will produce a set of recommendations and best practice protocols. Funded by: Medical Research Future Fund - Grant-Genomics Health Futures Mission ELSI scheme ($388,026); University of Tasmania.
  • CONSULTANCY/CONTRACT RESEARCH
    Assessment of Commonwealth, State and Territory legislation and regulations as it applies to the collection and use of health-related genomics information in the clinical and research setting
    20 Nov 2019 - 31 Dec 2020
    People funded by this grant:
    • Nicol D,
    • Chalmers D,
    • Otlowski M,
    • Nielsen J,
    • Eckstein L
    Project Total: $299,424; The purpose of this Project is to undertake an assessment of the relevant Commonwealth, State and Territory legislation and regulations as it applies to the collection and use of health-related genomics information in the clinical and research settings, with a specific focus on current and emerging ethical, legal and social issues. This Project will deliver an evidence-based assessment of the relevant legislation and regulations and how these apply to the current and emerging ethical, legal and social issues identified, including any differences between jurisdictions. This project is intended to provide a high-level overview of the key issues and related legislative environment. It does not include development of recommendations or options to Government. Funded by: Department of Health, Disability and Ageing (Cth) ($299,424); University of Tasmania.
  • GRANT
    Reforming the Regulatory Environment for Innovative Health Technologies
    14 Jun 2018 - 13 Jun 2025
    People funded by this grant:
    • Nicol D,
    • Nielsen J,
    • Eckstein L,
    • Stewart C
    Project Total: $628,576; Funded by: Australian Research Council - Grant-Discovery Projects ($628,576); University of Tasmania ($21,000).
  • GRANT
    Genomic Data Sharing: Issues in Law, Research Ethics and Society
    1 Jan 2018 - 31 Dec 2024
    People funded by this grant:
    • Nicol D,
    • Otlowski M,
    • Critchley C,
    • Eckstein L,
    • Nielsen J
    Project Total: $614,454; Funded by: Australian Research Council - Grant-Discovery Projects ($614,454); University of Tasmania ($10,400).
  • CONSULTANCY/CONTRACT RESEARCH
    Genetic Diagnostic Testing - Impacts
    1 Jan 2016 - 31 Dec 2017
    People funded by this grant:
    • Nicol D,
    • Nielsen J
    Project Total: $34,432; To provide advice to IP Australia on whether a comprehensive economic analysis of the impact of the High Court's decision in D'Arcy v Myriad Genetics Inc on the cost of genetic testing in Australia, is warranted. Funded by: IP Australia ($34,432); University of Tasmania.
  • GRANT
    Delivering on the Commercial Promise of 3D Printing: Identifying Legal Barriers
    1 Jan 2014 - 31 Dec 2014
    People funded by this grant:
    • Nielsen J
    Project Total: $10,000; Funded by: University of Tasmania - Grant-Research Enhancement (REGS); University of Tasmania ($10,000).
  • GRANT
    The Innovation Pool in Australian Biotechnology: Assessing Optimal Strategies for Fostering Innovation through Patenting and Patent Pooling
    1 Jan 2009 - 31 Dec 2013
    People funded by this grant:
    • Nicol D,
    • Nielsen J,
    • Critchley C
    Project Total: $412,000; The Australian biotechnology industry is characterised by many small players that use patents to manage commercialisation of their research. A side effect in such industries that build on complementary innovation is the fragmentation of rights. This can increase transaction and coordination costs and slow or stifle innovation. Patent pooling is a potential tool to free up inherent problems in traditional patent management, but there is a risk of anti-competitive conduct. We propose to: assess how the current Australian biotechnology industry is working; examine whether patent pooling is a feasible/desirable option; and make recommendations regarding the need for regulatory changes to increase benefits and reduce costs of patent management. Funded by: Australian Research Council - Grant-Discovery Projects ($412,000); University of Tasmania.