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International Journal of Law and Psychiatry publishes article by LML Collaborators

last modified Nov 27, 2019 01:19 PM

Dr Daisy Cheung (LML collaborator based at Hong Kong's Centre for Medical Ethics and Law) and Dr Elizabeth Fistein (LML Affiliate, Cambridge Clinical School) have co-authored an article with others titled, Articulating future directions of law reform for compulsory mental health admission and treatment in Hong Kong . The article explores four possible pathways for law reform in the area of compulsory mental health admission and treatment in Hong Kong. The discussion of each pathway -- abolition, risk of harm, mental capacity and consensus -- takes into account local challenges in implementation, as well as Hong Kong's international commitments for the protection of rights. In outlining these pathways for reform, the authors also provide a blueprint for regulatory change in other jurisdictions that are in the process of reforming their mental health laws.

The paper emanates from an international conference Compulsory Mental Health Treatment in Hong Kong: Which Way Forward?  which was organised in 2017 by the Centre for Medical Ethics and Law (CMEL) in collaboration with Dr Elizabeth Fistein. Academics and practitioners from the United Kingdom, United States, New Zealand, and Hong Kong came together to discuss the philosophical justifications for compulsory treatment, constitutional and human rights, and the use of compulsory powers in practice. The conference report is available here.

The paper is available online, and free to download until 9th Jan 2020.

LML personnel update

last modified Oct 21, 2019 12:48 PM

The Centre for Law, Medicine and Life Sciences is growing!

We are delighted to announce the following appointments:

Jennifer Anderson joined LML in October 2019 as a Research Associate. She will work closely with Dr Jeffrey Skopek (LML Deputy Director) on 'Liability for Harms Caused by the Use of AI in Healthcare', a research project funded by a Wellcome Trust Seed Award. This project will clarify how the law of negligence and product liability might apply to harms caused by the use of black-box algorithms in healthcare and explore whether either of these areas of law should be reformed or supplemented with a sui generis law for AI.

Isabelle Le Gallez joined LML in October 2019, also as a Research Associate. She will contribute to a joint project between LML and The Healthcare Improvement Studies Institute, 'Differential Diagnosis and the Law'. The project is part of a larger research initiative run by Dr Zoe Fritz which is taking a closer look at how diagnosis is made, communicated, and recorded in acute care with the goal of improving the process for doctors and patients. The legal arm of the project will clarify how the law, particularly the law of negligence post-Montgomery, shapes the development and communication of differential diagnoses, and whether the law should be reformed.  

Jacquelyn Veraldi commenced her PhD candidacy with LML in October 2019. Under the supervision of Dr Albertina Albors-Llorens, her project will focus on the interpretation and application of the EU abuse of dominance prohibition in pharmaceutical markets. The 3-year project is generously funded by the Hatton-WYNG PhD Studentship.

Andrew Sagar joined LML in September 2019 as a Research Assistant. Andrew is available to provide research and administrative assistance to members of LML across a broad range of subject areas. He will also supervise Intellectual Property law to undergraduate students.

LML is also pleased to announce the following promotions for current staff:

Stevie Martin (LML PhD Candidate) has been appointed to a Fixed-Term Lectureship in Public Law.

Jeff Skopek (Deputy Director of LML) has been appointed to an established University Lectureship in Medical Law.

Jens Scherpe (LML Member) has been appointed Professor of Comparative Law, and will also act as the Faculty's Director of International Strategy and Partnerships.

Claire Fenton-Glynn (LML Member) has been appointed to a University Senior Lectureship in Law.

 

Recent publications on IP and algorithms

last modified Oct 16, 2019 05:06 PM

LML would like to congratulate our close collaborators at the PHG Foundation on the publication of two reports.

'Regulating algorithms in healthcare: The GDPR and IVDR in practice', details the findings from a 2018 multidisciplinary workshop (of the same name). Attended by Dr Kathy Liddell (LML Director), Dr Jeff Skopek (LML Deputy Director), Prof. Mateo Aboy, Dr Cristina Crespo, and Dr David Erdos; the workshop addressed wider aspects of algorithm regulation. A subsequent workshop, 'Regulating algorithms in healthcare: intellectual property and liability', was convened jointly by LML, the PHG Foundation, and CeBIL.

Prompted by the aforementioned workshops, 'Algorithms as medical devices' is a detailed analysis of the field. It addresses questions such as: when might a digital health tool qualify as a medical device, and how will machine learning systems be regulated as medical devices? It also explores a number of specific challenges that machine learning poses for regulation, including the difficulty of interpretation by humans, and the compliance of such dynamic devices with the change management processes contained by current medical device regulation.

LML has also made significant progress on research in this space, collaborating closely with our partners at CeBIL. 'How does emerging patent case law in the US and Europe affect precision medicine?', was published as a feature patent article in the October 2019 issue of Nature Biotechnology. Written by Prof. Mateo Aboy, Dr Cristina Crespo, Dr Kathy Liddell, Prof. Glenn Cohen, Dr John Liddicoat, Dr Sara Gerke, and Prof. Timo Minssen, the paper investigates how today’s patent law will affect tomorrow’s innovation in the areas of: biomarkers and nature-based products; diagnostics; and algorithms, big data and AI. A further LML paper on regulatory responses to medical machine learning has been accepted for publication.

It is very pleasing that the collaborations and content aired at the 'Regulating Algorithms' workshops have resulted in such high quality outputs. Undoubtedly there will be more to come, with Ms Jennifer Anderson recently being appointed as a Research Associate with LML. Jennifer will work closely with Dr Jeff Skopek on 'Liability for Harms Caused by the Use of AI in Healthcare', a research project funded by a Wellcome Trust Seed Award.

Dr Liddell attends CSaP workshop on 'Real World Evidence' in the life sciences industry

last modified Oct 16, 2019 05:06 PM

On Wednesday 25 September, Dr Kathy Liddell (Director of LML) attended 'What's the value of real world evidence in the context of the life sciences industrial strategy?', a CSaP policy workshop organised jointly with the Department for Health and Social Care, and the Office for Life Sciences.

Attended by delegates from academia, policy, the NHS, regulatory agencies, and private industry, the roundtable workshop facilitated discussion of the opportunities and challenges that policy makers should consider in order to capitalise on the possibilities of real world evidence (RWE). Particular focus was paid to whether real world evidence could support industrial growth through reducing some of the cost and time burdens of clinical research, and provide a sound understanding of the efficacy and safety of medicines and medical technology.

LML members participate in OECD workshop

last modified Oct 16, 2019 05:08 PM

From 17-18 September 2019, Dr Kathy Liddell (Director of LML), Prof. Dianne Nicol (LML Visiting Scholar), and Matt Jordan (Collaborative Research Projects Co-ordinator) attended “Collaborative platforms for personalized health: realizing the potential of genomics and biobanks”.

This workshop, organised by OECD in collaboration with Vinnova (the Swedish Governmental Agency for Innovation Systems), examined the institutional arrangements and business models underlying collaborative platforms in genomics and biobanks for personalised health. Delegates included representatives of major national and international platforms, and a diverse range of experts at the triple interface between IP and data policy, business, health systems.

Prof. Nicol acted as a panellist in the first session titled, 'Connecting genomic data and biobanks with human health – realizing digital opportunities in personalized medicine'. She reflected on issues of consent and public trust, and the concept of the 'walking biobank', where research participants themselves are considered storage units. 

Dr Liddell acted as rapporteur for the third session: 'Business models of genomic platforms and biobanks'. LML's involvement in this session was timely, as we are currently writing up a paper titled, 'Intellectual Property Policies and Business Models for Large, Human Bioresources: a major, empirical survey'. Preliminary findings from this study were presented as part of Dr Liddell's reporting of session three.

LML hosts collaborators from CeBIL

last modified Oct 16, 2019 05:09 PM

Following the hugely successful CeBIL Symposium 2019: Legal Innovation to Support the Development of Antimicrobial Drugs, LML was delighted to host CeBIL colleagues Prof. Timo Minssen and Dr Jakob Wested for an extended visit. Building on the momentum of the Symposium, we consolidated findings and feedback from the event, and planned how the ideas raised might be incorporated into CeBIL's future work on antibiotics. 

It was also an opportune time for Dr Wested, who leads CeBIL's study on orphan drugs, to collaborate with Dr John Liddicoat, LML's Senior Research Associate for CeBIL's study on repurposing known drugs for new medical uses. LML will increasingly be considering the 'orphan drugs' area, as it will be the topic of the 2020 CeBIL Symposium; for which planning is underway.

 

Artificial Intelligence and Liability - Job Opportunity

last modified Jul 10, 2019 05:51 PM

The Centre for Law, Medicine and Life Sciences (LML) seeks to appoint a highly motivated and independent Research Associate to join a two-year research project on artificial intelligence and liability.

The project will focus in particular on the assignment of liability for harms caused by the use of machine learning algorithms in healthcare. There are several ways in which these harms might be addressed, each of which raises legal and normative questions that have received insufficient attention.

More details can be found  here.

The application portal is here.

 

Dr Liddell to Present at Workshop on Medical Ethics and Compassionate Use in the UK

last modified Jun 18, 2019 03:08 PM

On 13 June 2019, Dr Kathy Liddell (LML Director) will participate in a workshop on Medical Ethics and Compassionate Use in the UK.

The workshop, organised by Roche Products Ltd. and facilitated by the Pembroke Corporate Partnership Programme, aims to design a consistent and sustainable approach for responding to requests to supply medicines to patients outside of their approved MHRA licence; either where the product is in development and not yet approved, or for a different indication to the one for which it is already licensed.

Participants from Roche and the University of Cambridge will use compassionate use as a focal point in considering the supply of medicinal products to patients who have a disease with no satisfactory authorised therapies, and who cannot enter clinical trials. Compassionate use will be considered from legal, ethical and philosophical standpoints. 

As part of the day, Dr Liddell will deliver a talk titled 'Legal and Policy Issues for the Compassionate Supply of Drugs'. Other Cambridge academics presenting perspectives include Dr Stephen John and Dr Jacob Stegenga, both from the Department of History and Philosophy of Science.

Register now for Antimicrobial Resistance Symposium

last modified Aug 09, 2019 12:10 PM

LML is delighted to announce that registration has opened for the CeBIL Annual Symposium 2019: Legal Innovation to Support the Development of Antimicrobial Drugs.

Antimicrobial resistance (AMR) continues to expand, raising the risk of a future public health crisis. Numerous conferences have been organised to address the scientific challenges of AMR, such as the need to engineer novel antibiotics. However, science in isolation will not suffice. 

This symposium will explore the complex interactions between law and antimicrobial research and development. Advancing our understanding of this ecosystem will help design a better legal toolkit to promote antimicrobial innovation and limit the impact of resistance on global health.

The CeBIL Symposium is organised by the Cambridge Centre for Law, Medicine and Life Sciences, the Center for Advanced Studies in Biomedical Innovation Law at the University of Copenhagen, and the CeBIL International Collaboration including partners; such as CARB-X, Boston University SIDR, and PORTAL at Harvard Medical School. The Symposium is generously supported by the Novo Nordisk Foundation, the Cambridge Academy for Therapeutic Sciences (CATS), and the Cambridge Infectious Disease Interdisciplinary Research Centre.

Held at the University of Cambridge, an international hub for legal and scientific expertise, we hope the event will mobilise legal, economic, business, medical and scientific experts – early, mid, and late career – who recognise the need to work together to avert the AMR crisis.

The conference programme is available here.

Please visit the University e-sales page to register.

If you have any queries about the conference please contact us via email at lml.law.cam.ac.uk.

Job Opportunity: Research Associate/Senior Research Associate

last modified May 13, 2019 02:04 PM

The Centre for Law, Medicine and Life Sciences and The Healthcare Improvement Studies Institute (in the School of Clinical Medicine) seek to appoint a Research Associate or Senior Research Associate to work on a project exploring the intersection between the law of negligence and the practice of medical diagnosis.

The project will investigate and critically evaluate the scope of a physician's legal duties to record and communicate the uncertainty that is inherent in the process of developing a patient's 'differential diagnosis'. The aim of the project is not only to clarify how the law shapes the development and communication of differential diagnoses, but also assess whether and how the law in this area should be reformed.

For further details about the vacancy, please click here.

LML members to participate in international think tank: "Legal Boundaries and the 'Human' in Humanity"

last modified May 15, 2019 12:41 PM

From 9-11 June 2019, Dr Jeffrey Skopek (LML Deputy Director) and Dr Rumiana Yotova will participate in an international think tank on "Legal Boundaries and the 'Human' in Humanity" at McGill University. 

The think tank is being organized by Professor Bartha Knoppers (McGill) and Professor Hank Greely (Stanford).

It will bring together a diverse group of scholars to examine the future of legal characterisations of the "human" in three domains: the human genome; the human brain; and human cells and body parts.

Dr Skopek will present on "Human Enhancement/Therapies/Eugenics."   Dr Yotova will present on "Gene Editing and the Rights of Future Generations." 

After the event, the group will jointly write a policy forum piece.

Fourth article by LML Research Group published in Nature Biotechnology

last modified May 15, 2019 12:28 PM

An LML Research Group has just published its fourth article in Nature Biotechnology:  'After six years, what has been Mayo’s impact on patent applications related to biotech, diagnostics, and personalized medicine?' (available here), examines the impact of the US Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc. on patent subject-matter eligibility and patent prosecution of biotech related patent applications before the USPTO.

The article was co-authored by Prof. Mateo Aboy, Dr Cristina Crespo, Dr Kathy Liddell, Prof. Timo Minssen, and Dr John Liddicoat. 

This is the fourth publication by this LML Research Group to be accepted by Nature Biotechnology in three years.  They previously published:

Empirical patent studies continue to be a core focus of LML research, and will feature significantly in LML's contribution to the CeBIL research programme.

LML members to participate in CeBIL Retreat

last modified May 15, 2019 12:16 PM

From 20-23 May, several LML members will travel to Copenhagen for a retreat hosted by the University of Copenhagen's Centre for Advanced Studies in Biomedical Innovation Law.

As part of the CeBIL Collaborative Research Program, LML is responsible for a study investigating new uses for known drugs, and it will contribute to a study on synergy and policy solutions.

The retreat will provide an opportunity for LML to present a progress update on the 'New Uses' study and to receive feedback from other members of the CeBIL Collaborative Research Program.

Over the course of the week, the team will also meet with CeBIL's funders from the Novo Nordisk Foundation, and hear reports about CeBIL's societal engagement activities.

Dr Liddicoat embarks on research trip to Copenhagen

last modified May 15, 2019 12:14 PM

Dr John Liddicoat (LML Senior Research Associate) is set to undertake a three-week research visit to the University of Copenhagen.  His research will focus on the repurposing of drugs -- a topic that is of great interest to LML, which is leading the CeBIL study on New Uses.

Over the duration of the trip, Dr Liddicoat will collaborate with the Copenhagen-based members of the CeBIL Collaborative Research Programme in Biomedical Innovation Law to develop two research projects:

  1. The first project will seek to determine the number of repurposed drugs have been authorised by the EMA and FDA.
  2. The second project will seek to determine the number of 'repurposed drug patents' that have been granted in the US and Europe.

Dr Liddicoat will be joined by several LML members who are involved with the CeBIL Research Program for a CeBIL Retreat from 20-23 May.

Dr Liddell teaches Law and Emerging Health Technologies Course at University of Melbourne

last modified May 15, 2019 12:05 PM

Dr Kathy Liddell (LML Director) has recently returned from teaching a course on Law and Emerging Health Technologies at the University of Melbourne, strengthening the already substantial links between the LML and Melbourne Law School.

The postgraduate course examined ways in which law is affecting, and being affected by, the latest advances in medical technology. It covered a variety of fascinating topics, including genomics, precision medicine, gene editing, reproductive technologies, regenerative medicine, and the role of intellectual property law in facilitating medical innovation. It challenged students to think not only about the future of medicine, but also the future of human life itself. Are legal systems dealing with these issues in adequate, legitimate, and strategic ways?

The course was attended by lawyers at varied career stages and by senior medical professionals, which made for stimulating interdisciplinary discussions and debates.  

LML Research Group published in 'Global Genes' edited collection

last modified May 09, 2019 11:41 AM

A chapter authored by Dr Kathy Liddell (LML Director), Dr John Liddicoat, and Mr Matt Jordan has been published in T Minssen, J R Hermann and J Schovsbo (eds.) Global Genes, Local Concerns- Legal, Ethical and Scientific Challenges in International Biobanking (Edward Elgar Publishing, 2019).

The chapter, ‘IP Policies for Large Bioresources: The fiction, fantasy and future of openness’, highlights two fictions:  first, that the idea of 'openness' is clearly defined; and second, that bioresources are committed to openness. The chapter then argues that harmonisation of bioresources' access policies is largely a fantasy, and it challenges the view that bioresources should be working towards the goal of harmonised policies of openness.

With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking. It contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.

More information about the book can be found here.

Dr Imogen Goold Delivers 2019 Baron de Lancey Lecture

last modified May 09, 2019 11:31 AM

On Friday March 8th, the LML hosted the 2019 Baron de Lancey Lecture, kindly sponsored by the Ver Heyden de Lancey Fund.

This year, Dr Imogen Goold (St Anne's College, University of Oxford) delivered her thought-provoking talk 'Should parents have the final say on the medical treatment of their children?'

Dr Goold's talk addressed a question that has received significant media attention following the recent court cases concerning Charlie Gard and Alfie Evans. Namely, who should have the final say over the treatment of a very ill child who is too young to express their own preferences? In describing why this question might be viewed as a 'live issue', Dr Goold cited the emotive public reaction to such cases, which expressed a sense of parents feeling disempowered. Moreover, running in parallel to this strong public response are theoretical debates within the academic literature about the point at which it is appropriate for the courts to step into such situations.

In an energetic Q&A session, Dr Goold engaged with audience questions in a robust and thoughtful way. Interested readers are encouraged to view the lecture. 

Video recording of the lecture is available here and on the University SMS site.

Nature Biotechnology publishes third article from LML Research Group

last modified Dec 17, 2018 11:52 AM

The article, titled 'Was the Myriad decision a 'surgical strike' on isolated DNA patents, or does it have wider impacts?', reveals the results of an empirical investigation about the effects of the US Supreme Court's decision in Association for Molecular Pathology v Myriad Genetics on patent prosecution for nature-based products beyond isolated DNA. The article is co-authored by Professor Mateo Aboy, Dr Cristina Crespo, Dr Kathy Liddell, Dr John Liddicoat and Mr Matt Jordan.

This is the third publication by this LML research team to be accepted by Nature Biotechnology in three years. It follows their 2016 paper 'Myriad's impact on gene patents', a post-Myriad empirical patent landscape analysis, and their 2017 paper 'After Myriad, what makes a gene patent claim ‘markedly different’ from nature?', which identified the types of claim amendments which successfully transformed isolated gene claims from ineligible subject matter into patent eligible inventions following Myriad.

Empirical patent studies have become a core focus of LML research, and will feature significantly in LML's contribution to the CeBIL research programme.

Dr Liddell appointed to steering group for SRI on Reproduction

last modified Dec 03, 2018 02:12 PM

Dr Kathy Liddell (LML Director) has joined a new Strategic Research Initiative on Reproduction as a member of their steering group.

The SRI is funded for three years, and is a University-wide network which aims to encourage interactions among the many Cambridge researchers with interests in reproduction; from clinical medicine and biology to the arts, humanities and social sciences. A launch event will take place in the Pitt Building on Trumpington Street from 2:30 - 5:00 pm on Friday 7 December.

LML is looking forward to being part of this interdisciplinary initiative. LML's involvement is timely, with PhD Candidate Jinal Dadiya's current research focusing on the relationship between reproductive rights and the legal techniques that are used to regulate assisted reproductive technologies. 

LML appoints Senior Research Associate

last modified Oct 31, 2018 04:48 PM

The Centre for Law, Medicine and Life Sciences has appointed Dr John Liddicoat as a Senior Research Associate. Dr Liddicoat will work with Dr Kathy Liddell (Director of LML) to develop a flagship research project on the legal issues surrounding the re-purposing of pharmaceuticals.

The aim of the project is to harness legal expertise in the field of intellectual property to help scientists and clinicians with the challenge of re-purposing known drugs. In particular the project will study the role of law in making re-purposing research economically attractive, efficient and effective – what does the law do to help or hinder re-purposing of pharmaceuticals, and what could it do better? It also intends to build an evidence base for improving legal policy in this area.

This project will be LML's primary contribution to the Collaborative Research Program in Biomedical Innovation Law, headed by the University of Copenhagen. LML will also contribute to a sixth Synergy study. Other key collaborators include the Petrie Flom Center (Harvard), and the University of Michigan. The CeBIL Collaborative Project is supported by a grant from the Novo Nordisk Foundation

More about the CeBIL collaboration can be found here.

Dr Yotova to be published in European Journal of International Law

last modified Oct 30, 2018 02:22 PM

An article co-authored by Dr Rumiana Yotova and Prof. Bartha Knoppers on the right to benefit from science has been accepted for publication in the European Journal of International Law.

The right was first set out in the 1948 Universal Declaration of Human Rights, and later affirmed in the International Covenant on Economic, Social and Cultural Rights. Dr Yotova, together with Professor Knoppers, studied the practice of UN Member States in giving effect to the right domestically. 

The announcement comes ahead of Prof. Knoppers third visit to LML in November 2018. During her stay, Prof Knoppers will deliver a seminar to LLM students on the topic of The Human Cell Atlas: Another Policy Frontier? This will be followed by a lunchtime talk on a recent special issue on genomic data sharing, lead by the Centre for Genomics and Policy at McGill University.

LML research group forthcoming in Nature Biotechnology

last modified Oct 07, 2018 01:46 PM

Nature Biotechnology has accepted a third article from an LML research group for publication. The forthcoming feature article announces empirical results about the effects of the US Supreme Court's decision in Association for Molecular Pathology v Myriad Genetics on patent practice beyond isolated DNA claims. 

The article, co-authored by Professor Mateo Aboy, Dr Cristina Crespo, Dr Kathy Liddell, Dr John Liddicoat and Mr Matt Jordan, is the third publication accepted by Nature Biotechnology in three years. It follows their 2016 paper 'Myriad's impact on gene patents', a post-Myriad empirical patent landscape analysis, and their 2017 paper 'After Myriad, what makes a gene patent claim ‘markedly different’ from nature?', which identified the types of claim amendments which successfully transformed isolated gene claims from ineligible subject matter into patent eligible inventions following Myriad.

Empirical patent studies have become a core focus of LML research, and will feature significantly in LML's contribution to the CeBIL research programme. The announcement of this publication also coincides with the conclusion of the three-year Philomathia Social Sciences Research Programme project 'Realising Genomic Medicine: Intellectual Property Issues beyond the 'Old' DNA Patent Debates. 

 

LML hosts CeBIL Annual Symposium 2018: Precision Medicine, Artificial Intelligence and the Law

last modified Oct 05, 2018 11:17 AM

 

On Friday 7th September, LML hosted the CeBIL Annual Symposium 2018: 'Precision Medicine, Artificial Intelligence and the Law'. This was the first of five annual symposia to be held in Cambridge as part of LML's involvement in the Novo Nordisk Foundation’s Collaborative Research Programme in Biomedical Innovation Law, directed by Prof. Timo Minssen at the University of Copenhagen's Center for Advanced Studies in Biomedical Innovation Law.

Each year, the symposium addresses one of CeBIL's five core research projects. In 2018, the Symposium focussed on 'Precision Medicine, Artificial Intelligence and the Law', reflecting the PMAIL project led by Professor I. Glenn Cohen at the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School, together with Professor Nicholson Price (University of Michigan) and Professor Timo Minssen (University of Copenhagen).

The Symposium tackled some of the challenging legal and regulatory issues raised by black-box precision medicine. 

Professor Cohen opened the first session with a discussion of big data and predictive analytics. He was then joined by Sara Gerke (Research Fellow for the PMAIL project), who gave an outline of plans for future PMAIL research. This was followed by a panel discussion between Professor Chris Lowe, Dr Stuart Hogarth and Dr Richard Dybowski. Professor Chris Lowe encouraged more discussion of key definitions (such as 'black-box', and 'precision') and critical reflection on the extent to which problems are 'new' or rather echoes of familiar, long-running tensions in the practice of medicine. Dr Stuart Hogarth drew attention to the political economy of the emerging precision medicine field, and Dr Richard Dybowski urged legal, ethical and social research to monitor the way that machine learning is being put together at 'the coalface'. Dialogue has led to principles of good practice and good algorithmic 

The second session of the Symposium focused on intellectual property and the black box. Dr Kathy Liddell (Director of LML) commenced the session with a brief outline of three key US Supreme Court cases in this area: MyriadMayo and Alice, which featured heavily in the following presentations.

In particular, this session was an opportunity for LML members Professor Mateo Aboy and Dr John Liddicoat to present the results of some of LML's recent empirical research. Prof. Aboy focussed on the impact of important cases on the grant of patents, and several LML studies that have been recently published or reviewed. For instance he spoke about the magnitude of Myriad's impact on gene-related patents, isolated DNA patents and nature-based products beyond DNA. He also spoke about the magnitude of Mayo's impact on the grant of biotechnological patents, and the implications of that case for patent prosecution timelines. He also introduced current research that the LML group are doing in relation to the magnitude of Alice's impact on biotechnological inventions.

Dr Liddicoat presented recent results from interviews designed to investigate the ways in which Myriad and Mayo have affected the development of diagnostic tests in the US and in Europe. Professor Jacob Sherkow (New York Law School) rounded off the IP session by discussing concerns about surrogate licensing in the US. In the ensuing discussion is was reassuring to learn that 'Oxbridge' tech transfer licensing policies are globally-respected.

The Symposium's third session looked at regulation governing 'the black box' as a medical device. The presentations offered perspectives from academia and public authorities, including the US Food and Drug Administration (FDA) and UK Medicines and Healthcare products Regulatory Agency (MHRA). Dr Alberto Gutierrez (former Director of the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety), Professor Nicholson Price (Michigan Law School) and Stephen Lee (MHRA) offered different models and ideas for regulating black box medicine. Questions of liability in this area are of significant interest to LML, as Dr Jeff Skopek (Deputy Director of LML) was recently awarded a grant by the Wellcome Trust to study liability for uses of AI in the healthcare context.

The final session of the day, facilitated by Dr Tom Ling (RAND Europe), was highly interactive. Dr Ling encouraged audience members to voice what they had found most interesting and illuminating, and to debate ideas and issues drawing on their own backgrounds and perspectives. There was also a panel discussion about the future challenges of black box precision medicine, involving Professor Timo Minssen, Alison Dennis (Fieldfisher), Manuel Corpas (Cambridge Precision Medicine), Dr Victoria Chico (University of Sheffield, and Dr Jonathan Darrow (Harvard Medical School). 

The Symposium was very well-attended, with large numbers attending from the Cambridge biomedical environs as well as international representatives from Australia, Ireland, Belgium, the US, Canada. The audience was wonderfully lively and engaged, and the Symposium exceeded our expectations. 

The second Annual CeBIL Symposium is likely to take place in September 2019.

 

Liddell and Minssen

Workshop on "Regulating algorithms in healthcare: intellectual property and liability" jointly organised by LML, CeBIL and the PHG Foundation

last modified Sep 13, 2018 04:10 PM

On Thursday 6th September, LML co-hosted a workshop titled 'Regulating Algorithms in Healthcare: Intellectual Property and Liability' with the PHG Foundation and the Center for Advanced Studies in Biomedical Innovation Law. The workshop brought together a multidisciplinary group of academics, researchers, policy makers and regulators, to evaluate intellectual property and liability issues arising from use of algorithms and software in healthcare. This is an area of significant interest to LML, as Dr Jeff Skopek (LML Deputy Director) was recently awarded a grant to study liability for uses for AI in healthcare by the Wellcome Trust. LML was represented by Kathy Liddell, Jeff Skopek, John Liddicoat, Mateo Aboy, Cristina Crespo and Matt Jordan.

The first half of the workshop was dedicated to discussion of intellectual property protection for algorithms in healthcare. Prof. Mateo Aboy (Senior Research Scholar with LML) gave a presentation on the patentability of algorithms in the healthcare space and new empirical evidence about the impact of US cases such as Myriad, Mayo and Alice. Dr Enrico Bonadio discussed the relationship between free and open source software (FOSS) and IP. 

Dr Kathy Liddell (Director of LML) facilitated the IP panel, framing discussion in terms of identifying and refining what might be considered to be IP policy problems, assessing the size of any problems, and considering what the responses might be. Prof. Aboy and Dr Bonadio were joined by Prof. Timo Minssen (CeBIL), Iain Mitchell QC, and Andrew Katz (Moorcrofts). Several cross-cutting questions and themes emerged during the morning's session. For example, to what extent are IP policies in this landscape pitted against each other and to what extent are they complementary and capable of being integrated? Are the patent law issues primarily legal uncertainty, or are there problems with legal principles as well?  Supposing it was possible, would it actually be desirable  to increase the use of FOSS in this space as an alternative to IP protection? What are some of the complexities of 'free' and 'open' innovation systems?

The second half of the workshop concerned possible models of liability for algorithms where harm occurs as a result of their outputs. Dr Jeff Skopek introduced Professor Glenn Cohen (Harvard Law School) and Professor Nicholson Price (Michigan Law School). Prof. Cohen gave an account of the increasing role of AI and predictive analytics in healthcare, before focusing on tort law as lens through which one might debate the optimal scheme of liability, and how liability might be apportioned to the relevant actors. Prof. Price presented on medical malpractice and black box medicine, posing the question of how schemes of negligence might set the incentives for bringing algorithms into practice.

Joining the liability session speakers for a panel discussion (facilitated by Alison Hall, Head of Humanities at the PHG Foundation) were Dr Alberto Gutierrez (former Director of the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety), Dr Danielle Belgrave (Microsoft) and John Buyers (Osborne Clarke). They addressed  questions  of liability from the viewpoint of regulators, researchers, and lawyers respectively.

This event was the second in a series of two workshops held by the PHG Foundation on the topic of regulating algorithms in healthcare. The first focussed on the GDPR and IVDR in practice.  The PHG Foundation plans to publish reports on both events.

Dr Skopek awarded Wellcome Trust grant to study liability for uses of AI in healthcare

last modified Sep 04, 2018 12:19 PM

How will legal liability be assigned when an AI system causes harm?  Does the law need reform?  

Dr. Skopek has been awarded a Wellcome Trust grant to explore these questions in the healthcare context.  His project will focus in particular on the liability landscape for harms caused by the use of machine learning algorithms in clinical care.  

Three different types of liability frameworks might apply to these harms—negligence, product liability, and sui generis legislation—each of which raises legal and normative questions that have received insufficient attention.  

The grant will fund a post-doctoral fellow to explore these questions under his supervision.   The job advertisement will soon be posted here.

Job Opportunity: Senior Research Associate

last modified Aug 21, 2018 11:38 AM

Applications are invited for a Senior Research Associate to work with the Centre for Law, Medicine and Life Sciences (LML) at the Faculty of Law. This is a fixed term three-year position with a preferred commencement date between 1 December 2018 and 1 February 2019. The post holder will be employed by the Faculty of Law, University of Cambridge, to contribute to the Collaborative Research Program in Biomedical Innovation Law (the CeBIL Collaborative Project). The CeBIL collaborative research program is supported by a grant from the Novo Nordisk Foundation.

The post holder will work alongside the Director of LML to contribute to CeBIL's fourth study on new medical uses. Accordingly, the post holder will be expected to focus on the legal (and to some extent the ethical and social) issues surrounding the re-purposing of pharmaceuticals, particularly issues arising in patent and regulatory law.

The post holder must have completed a PhD in law (or equivalent) before starting the position (the latest commencement date is 1 February 2019), and at least three years' experience as a postdoctoral Research Associate, or equivalent. The post holder must also have a track record such that they have acquired independent standing as an internationally-known researcher and be capable of full operational responsibility for a major project if required. Broad knowledge of intellectual property law (including patents, copyright, trade marks, database rights, trade secrets) and evidence of a resourceful, quick and entrepreneurial attitude will be important in evaluating the suitability of an applicant. Highly competent knowledge of biomedical patent law is required, and knowledge of the regulatory frameworks governing market authorisations for drugs and diagnostics is also desirable. Experience in socio-legal research (such as interviews, surveys and patent landscaping), and a degree in natural or medical sciences would be advantageous.

Short listed candidates will be invited to attend interviews in Cambridge in September or October 2018. Interviews will be in person or via teleconference.

Fixed-term: The funds for this post are available for 3 years in the first instance.

Further particulars and details of the application procedure are available at http://www.jobs.cam.ac.uk/job/18583/. Online application is available via that site.

If you have any questions about this vacancy or the application process, please contact Dr Kathy Liddell by email k.liddell@law.cam.ac.uk.

Please quote reference JK16540 on your application and in any correspondence about this vacancy.

Quote Reference: JK16540
Salary: £39,992-£50,618
Closing Date: 20 September 2018

The University values diversity and is committed to equality of opportunity.

The University has a responsibility to ensure that all employees are eligible to live and work in the UK.

Nuffield Council on Bioethics publishes Dr Yotova's Report on the Regulation of Genome Editing under International Law

last modified Aug 21, 2018 11:41 AM

The Nuffield Council on Bioethics has published Dr Rumiana Yotova's report on 'The Regulation of Genome Editing and Human Reproduction under International Law, EU Law and Comparative Law'.

Dr Yotova was commissioned to write the 25,000 word report by the Nuffield Council's Working Party on Genome Editing and Human Reproduction to help inform their evidence-gathering and deliberations. The aim of the report was to identify and analyse the relevant legal frameworks governing the research and possible clinical applications of human genome editing on the levels of public international law, EU law, and a comparison between selected domestic jurisdictions. It focused in particular on the legality of genome editing and on the requirements and restrictions imposed by international legal frameworks on the use of the technology.

Dr Yotova's contribution was one of two background papers to the Nuffield Council’s report on 'Genome Editing and Human Reproduction: Social and Ethical Issues' and serves as the basis for Chapter 4, section 2 on International Law and Governance.

In addition to discussing her findings at a research interview conducted by the Nuffield Council, Dr Yotova was also invited to present her report at the stakeholder conference on 'Genome Editing and Human Reproduction: Social and Ethical Issues' organised by the Nuffield Council in London on 23 July 2018.

Dr Palmer discusses developments concerning the legal status of abortion in Ireland and Northern Ireland

last modified Sep 13, 2018 03:41 PM

Dr Stephanie Palmer has written a blog post for the International Association of Constitutional Law (IACL/AIDC) on the repeal of the Eighth Amendment in Ireland, and the recent human rights challenge brought by the Northern Ireland Human Rights Commission against current criminal law provisions on abortion.

Looking first at the Republic of Ireland, Dr Palmer outlines a range of policy influences contributing to the repeal of the Eighth Amendment. Moving on to Northern Ireland, Dr Palmer describes the decision of the UK Supreme Court in In Re Northern Ireland Human Rights Commission’s Application for Judicial Review [2018] UKSC 27 as a pyrrhic victory. While the Northern Ireland Human Rights Commission were thought not to have standing in this case, the judgment indicates that if a 'victim' with standing were to challenge the existing legislation which criminalises abortion, they would obtain a declaration of incompatibility between the national legislation and the ECHR.

Dr Palmer's post can be found here.

The Development of Abortion Rights in a Changing Europe

last modified Jul 16, 2018 02:28 PM

Tickets are now available for the upcoming conference "The Development of Abortion Rights in a Changing Europe", to be held in at the Faculty of Law on September 28 2018. 

The conference, organised by a team headed by Cambridge Law student Helen Jennings, will explore what human rights law has to say on the issue of abortion in 2018, with consideration given to issues including the upcoming referendum on Ireland's 8th Amendment, and the impact of Brexit on abortion law across the UK and Ireland. Discussion will not be limited to the legal framework in Ireland and Northern Ireland, although the issue is currently at the cutting-edge of legal debate there.

The provision of abortion services for women, including the extent to which one can consider abortion a "right", is one of the foremost human rights issues facing citizens of the United Kingdom and Ireland today. To this end, the conference will be entirely focused on the legal frameworks in place, their interaction with human rights law, and the potential of recent legal and political developments and litigation to change the law.

Confirmed speakers include:

  • Lord Kerr
  • Professor Dalia Lienarte
  • Dr Stephanie Palmer
  • Máiréad Enright
  • Benedict Ó Floinn BL
  • Dr Ruth Fletcher
  • Venetia Taylor BL

Tickets and further information are available here.

Dr Kathy Liddell teaches new course on Health Law and Emerging Technologies at Melbourne Law School

last modified Apr 27, 2018 01:58 PM

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Dr Kathy Liddell (LML Director) has recently returned from teaching a new Health Law and Emerging Technologies subject at the University of Melbourne; strengthening the already substantial links between the University of Cambridge's Faculty of Law, and Melbourne Law School.

The subject examined ways in which law is affecting, and being affected by, the latest advances in medical technology. It covered a variety of fascinating technologies including genetic, big data analytics, regenerative, therapeutic, and reproductive technologies. It challenges students to think not only about the future of medicine, but the future of human life itself. Are legal systems dealing with these issues in adequate, legitimate, and strategic ways? 

Classes were highly discursive, and utilised literature and case studies to cover controversial topics such as precision medicine, gene editing, the role of intellectual property law in facilitating medical innovation, the shifting boundaries of human reproduction, and replacement and regenerative technologies  for human organs and tissue.

The course was attended by lawyers of various seniority and senior medical professionals, which made for stimulating interdisciplinary discussions and debates. 

The subject can be taken by JD students, Masters of Law students, Specialist Health Law Masters students (who have two years professional practice in a relevant degree) and as a single subject by students studying at Melbourne University. Contact at Melbourne Law School for more information. 

Health Lae Class Melbourne