Precision Medicine: Drowning in Regulatory Soup?

Journal of Law and the Biosciences, 2016

23 Pages Posted: 11 Jun 2016

See all articles by Dianne Nicol

Dianne Nicol

University of Tasmania

Tania Bubela

University of Alberta - Faculty of Public Health

Donald Chalmers

University of Tasmania - Faculty of Law; University of Sydney - Centre for Values, Ethics and the Law in Medicine

Jan Charbonneau

Massey University

Christine Critchley

Swinburne University of Technology

Joanne Dickinson

University of Tasmania

Jennifer Fleming

The University of Sydney

Alex Hewitt

University of Tasmania

Jane Kaye

University of Oxford - Faculty of Law

Johnathon Liddicoat

University of Cambridge - Faculty of Law; University of Tasmania

Rebekah McWhirter

University of Tasmania

Margaret Otlowski

University of Tasmania - Faculty of Law

Nola M Ries

University of Technology Sydney (UTS)

Loane Skene

University of Melbourne - Law School

Cameron Stewart

The University of Sydney Law School

Jennifer Wagner

Geisinger Health System Inc. - Bioethics Research

Nik Zeps

The University of Western Australia

Date Written: May 10, 2016

Abstract

Precision medicine is promoted as having the capacity to deliver more personalized healthcare, tailored to an individual’s genetic characteristics, health status and family history. Various sectors of the healthcare industry are involved in precision medicine, including the clinic, the research lab and the diagnostic and pharmaceutical industries. One consequence is that the defined regulatory spaces within which each of these sectors operate are becoming diffuse, resulting in a risk of regulatory overlap, omission and confusion: a ‘regulatory soup’ that could drown the promised advances in precision medicine. In this essay, we explore the challenges involved in modernizing the current regulatory landscape for precision medicine. We outline some of the major technological advances in the field, including genome sequencing, pharmacogenomics, genomic analysis, gene editing and biobanking. We then consider the regulatory ‘soup’ within which these technologies are positioned. We finally explore a range of issues that need to be addressed to ensure that regulation is effective in the future. We conclude that an effective regulatory framework for precision medicine does not necessarily require new laws. It does, however, require careful consideration of how existing laws and other regulatory instruments are applied and interpreted to ensure that new innovations are facilitated, harms are minimized and measured decisions are made about the allocation of limited healthcare funds.

Keywords: precision medicine, pharmacogenomics, direct-to-consumer genetic analysis, regulation

Suggested Citation

Nicol, Dianne and Bubela, Tania and Chalmers, Donald and Charbonneau, Jan and Critchley, Christine and Dickinson, Joanne and Fleming, Jennifer and Hewitt, Alex and Kaye, Jane and Liddicoat, Johnathon and McWhirter, Rebekah and Otlowski, Margaret and Ries, Nola M and Skene, Loane and Stewart, Cameron Lloyd and Wagner, Jennifer and Zeps, Nik, Precision Medicine: Drowning in Regulatory Soup? (May 10, 2016). Journal of Law and the Biosciences, 2016. Available at SSRN: https://ssrn.com/abstract=2782488

Dianne Nicol

University of Tasmania ( email )

French Street
Sandy Bay
Tasmania, 7250
Australia

Tania Bubela

University of Alberta - Faculty of Public Health ( email )

11405 - 87 Ave.
Edmonton, Alberta T6G 1C9
Canada
(780) 492-9335 (Phone)

Donald Chalmers

University of Tasmania - Faculty of Law ( email )

Private Bag 89
Hobart
Tasmania, 7001
Australia

University of Sydney - Centre for Values, Ethics and the Law in Medicine ( email )

Medical Foundation Building
K25, Level 1 92-94 Parramatta Rd
Camperdown New South Wales, 2006
Australia

Jan Charbonneau

Massey University ( email )

Private Bag 11 222
Palmerston North, Manawatu 4442
New Zealand

Christine Critchley

Swinburne University of Technology ( email )

Cnr Wakefield and William Streets, Hawthorn Victor
3122 Victoria, Victoria 3122
Australia

Joanne Dickinson

University of Tasmania ( email )

French Street
Sandy Bay
Tasmania, 7250
Australia

Jennifer Fleming

The University of Sydney ( email )

University of Sydney
Sydney, NC NSW 2006
Australia

Alex Hewitt

University of Tasmania ( email )

French Street
Sandy Bay
Tasmania, 7250
Australia

Jane Kaye

University of Oxford - Faculty of Law ( email )

St. Cross Building
St. Cross Road
Oxford, OX1 3UJ
United Kingdom

Johnathon Liddicoat (Contact Author)

University of Cambridge - Faculty of Law ( email )

10 West Road
Cambridge, CB3 9DZ
United Kingdom

University of Tasmania ( email )

French Street
Sandy Bay
Hobart, Tasmania 7001
Australia

Rebekah McWhirter

University of Tasmania ( email )

French Street
Sandy Bay
Tasmania, 7250
Australia

Margaret Otlowski

University of Tasmania - Faculty of Law ( email )

Private Bag 89
Hobart
Tasmania, 7001
Australia

Nola M Ries

University of Technology Sydney (UTS) ( email )

15 Broadway, Ultimo
PO Box 123
Sydney, NSW 2007
Australia

Loane Skene

University of Melbourne - Law School ( email )

University Square
185 Pelham Street, Carlton
Victoria, Victoria 3010
Australia

Cameron Lloyd Stewart

The University of Sydney Law School ( email )

New Law Building, F10
The University of Sydney
Sydney, NSW 2006
Australia
61 2 9351 0250 (Phone)
61 2 9351 0200 (Fax)

HOME PAGE: http://sydney.edu.au/law/about/staff/CameronStewart/index.shtml

Jennifer Wagner

Geisinger Health System Inc. - Bioethics Research ( email )

100 North Academy Ave.
Danville, PA 17822-4910
United States

Nik Zeps

The University of Western Australia ( email )

35 Stirling Highway
Crawley, Western Australia 6009
AUSTRALIA

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