Kathleen Liddell

Consent, confidentiality, and the Data Protection Act

Overly strict interpretation of the law is hampering epidemiological research. Here, one research team shows why regulators and organisations holding data should adjust their approach

The phantom menace of gene patents.

In this, the second of two Commentaries, Sibylle Gaisser, Michael M. Hopkins and colleagues discuss a survey demonstrating that European health-care systems are ill prepared for the commercial reality of gene patents.

Drug-resistance mechanisms and tuberculosis drugs

The Health Innovation Challenge Fund (HICF-T5-342 and WT098600), a parallel funding partnership between the UK Department of Health and Wellcome Trust.

Should healthy volunteers in clinical trials be paid according to risk? Yes

Eleri Jones and Kathleen Liddell argue that objections to paying according to risk are paternalistic, but John Saunders (doi:10.1136/bmj.b4145) thinks that it would lead to people being exposed to unacceptable danger

Myriad's impact on gene patents

Three years later, the landmark Myriad decision on gene patents has led to some striking and unforeseen implications.

The Origins and Structure of the TRIPS Agreement

The essays in this volume focus upon the Trade-Related Intellectual Property Agreement, which is an important element in the constitution and practice of the World Trade Organisation (WTO). Known to all as the TRIPS Agreement, it reached its twentieth anniversary in operative effect on January 1, 2015. It is unlikely that the text of the TRIPS Agreement will be substantially amended by the Member states of the WTO for at least another decade or two. Our contributors therefore take its current terms as a continuing authority in international law for its immediate future. They do so, however, questioning how far the Agreement was adequate for its own time and how far it remains so in a world that has been changing so extraordinarily during the intervening 20 years and doubtless will continue to do so for the twenty to follow.

After Myriad, what makes a gene patent claim 'markedly different' from nature?

Examining the types of claim amendments that have transformed isolated gene claims from patent-ineligible into eligible subject matter provides clarity into the threshold of eligibility for gene-related patents.

Informed Consent for Research Using Biospecimens, Genetic Information and Other Personal Data

While human subjects research once consisted primarily of research on people, advances in biobanking, genetics and big data have transformed the research landscape. Personal data and biospecimens are increasingly at the centre of research, giving rise to difficult questions about whether and how to apply legal and ethical principles - such as informed consent - that were developed for research on people. The first part of this article explores questions about consent that arise in the context of authorising research on personal data and biospecimens, focusing on the legal and ethical basis of the consent requirement, the use of specific versus broad consent, and the significance of anonymisation. The second part of the article looks at issues of consent that arise beyond the individual’s decision to participate, focusing on the return of individualised research results, community consent, and the ownership of biospecimens. This article is intended to be an encyclopaedia entry. It is forthcoming in the eLS.

Precision Medicine: Legal and Ethical Challenges

On 7 and 8 April 2016, the Centre for Medical Ethics & Law (University of Hong Kong) together with the Centre for Law, Medicine and Life Sciences (University of Cambridge) hosted a conference at the University of Hong Kong on the legal and ethical challenges facing the realisation of precision medicine. The aim of precision medicine is to revolutionise disease treatment and prevention by utilising personal variation in factors such as an individual’s genetic information, biochemistry, environment and lifestyle. Genomic data, for example, can be used to determine predispositions to particular diseases, predict the efficacy and safety of different treatment options, and help develop drugs that are targeted to the causes of diseases rather than their clinical manifestations. In these and other ways, scientific and technological advances have the potential to bring about an unprecedented tailoring of health care to the individual characteristics of patients. In order to realise the potential of precision medicine, however, we must rethink components of the legal and ethical foundation on which it will be built. The reason for this is that our current legal and ethical frameworks were built with a very different generation of medical products and practices in mind. At this conference, world experts convened to identify and explore the challenges that precision medicine brings to the fore. Part I of this report provides a summary of the presentations that were given at the conference. Section A of this part focuses on challenges in the implementation of precision medicine and is divided into two categories: implementation at the level of health care systems, and implementation at the level of clinical treatment. Section B addresses challenges in the development of precision medicine and is likewise divided into two categories: development at the level of foundational research, and development at the level of translational medicine. Part II categorises and summarises the key challenges that were explored in the roundtable discussions that followed the four categories of presentations, as well as some of the broader questions that emerged out of the conference.