The Centre for Law and Genetics has released its second annual report. It outlines the CLG’s recent achievements, project updates and new research directions and collaborative efforts. This year it also includes a list of CLG-authored publications, which will be continued in future reports.
View the 2016-2017 Annual Report.
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Dr Lisa Eckstein and Professor Don Chalmers, recently published an article in the Journal of Law and Medicine that was prompted by concerns that arose after the French Biotrial (more about that here, here and here) that “left one person dead and five hospitalised.”
The article looks at the initiation and monitoring process involved in giving clinical trials the green light. Ultimately, Australian Regulation in the clinical trial space and the responsibilities as delegated between DSMBs, HRECs, and the TGA is remarkably the “light touch”.
Dr Eckstein also wrote this on DSMBs a few years prior.
L Eckstein and Chalmers, ‘Is Australia Well Equipped to Deal with Future Clinical Trials? ‘ (2016) 24 Journal of Law and Medicine 337.
Journal of Law and Medicine Vol 24 (2016) at 337
On November 13-14 2016, the CLG hosted its second workshop for the year, centered around current issues in genome editing. This issues were triggered by an increase in genetic manipulation using CRISPR/Cas technology. This has caused an explosion of research using the technique and simultaneously caused for calls that this technology requires reconsideration of the regulatory and ethical frameworks.
The conference covered genome editing and its translation into clinical practice (focusing on somatic editing of cells), the intellectual property tensions and advantages, and the well-known concern regarding germline editing. The main focus was appropriate management of genome editing in the clinic and the role of germline research/translation – if at all.
The Centre was again proud to host many international and national experts from diverse fields, that came together to discuss the issues in genome editing holistically. (See who came, the agenda and view the presentations).
There are many conferences being held internationally in this area, many focused on the problems of germline manipulation. Perhaps due to the diversity of expertise, the conversation here focused on the most promising and likely uses of CRISPR and the barriers of using this technology in non-germline, that is, somatic cell, research and treatment.
Thank you to all our guests.
Notification of publications from this workshop will be available here.
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The Centre for Law and Genetics hosted a small, targeted workshop with international and national experts and key players in the Material Transfer Agreement (MTAs) area. This workshop canvassed the original concerns borne of material transfer agreements. The key concern is that MTAs are stalling and impeding research. Research has been conducted in the US, Canada and Australia in this area to date.
The Centre for Law and Genetics currently holds an ARC Discovery Grant to investigate the use of material transfer agreements. Our key questions concern whether the issues that have been identified over time are persisting, and if so, what might be done to reconcile them and whether the problems that emerged at that time are now emerging in the context of data. (The transfer of data is quite common and becoming increasingly formalised by use of data transfer agreements, material transfer agreements and in other agreements.) This workshop is one of the final phases of our research in this area.
Experts presented (view slides) on aspects of their research in relation particularly to human tissue transfer but also touched on synthetic biology and natural resources. Special guests who could provide different supplier and user perspectives from Addgene and the Walter and Eliza Hall Institute also attended.
While attention in this area has calmed in recent years, the problems endure. The workshop participants discussed why this was so and the potential ways that this might be countered.
The Centre is grateful to all the guests who attended the event, for their contributions and enthusiasm in the area. Outputs from this workshop will be made available on our website.
Professor Dianne Nicol was invited to participate in an OECD workshop on ‘Gene Editing in an Internation
al Context: Scientific, Economic and Social Issues across Sectors‘ held in Ottawa, Canada on the 29th and 30th of September 2016. At the workshop, she presented on innovation pathways and roadblocks in genome editing, using her previous research on innovation in the biopharmaceutical industry to provide salutary lessons. She concluded that what is needed is a cautious approach, fostering innovation by: regulating and governing; propertising and sharing; and communicating and consulting wisely.
The workshop covered genome editing accross its many applications. The scientific, economic and social issues were considered in relation to: Agriculture, Aquaculture and Bio-production; Environmental Applications, and; Applications in Human Medicine. She recounted examples of the studies mentioned at the workshop that are capitalising on the power and potential for genome editing and its applications within but also outside health in Australia to the CLG earlier this morning with much excitement.
The CLG is hosting an upcoming workshop on genome editing later this year. Workshops such as the OECD Gene Editing in an International Context are a perfect springboard on which to delve into the more specific issues arising in respect of human applications of CRISPR, and the way forward. Many of these contentious issues are not new; older methods of gene editing have been discussed at length in the past and as far as embryo research is involved, this is also not new. However, the sheer volume of use of CRISPR technology by scientists and industry, the multitude of potential applications, the new promises and the feeling that this technology may actually deliver, brings questions into reality where answers must be provided to ensure safety to the public while supporting innovation. There are also important follow on questions for example in relation to commercialisation which impact upon the usefulness of the technology.
Also in September, Dianne Nicol presented on intellectual property issues in genomics in a number of other forums, including the annual European Policy on Intellectual Property Conference in Oxford, UK and an invitation only workshop ‘The Future of Genomic Medicine Patents in Europe and the US’ in Cambridge, UK. Dianne discussed her empirical, policy and doctrinal research findings over the five or so years at these events.
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A new collaborative CLG publication, discussing the future of biobanking has recently been published in BMC Medical Ethics, and is available open access – ‘Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era‘.
This special issue of the journal came after a HeLEX, Translation in Healthcare conference that has already been mentioned a number of times on this blog. This paper began as an idea from a workshop on the sustainability of biobanks jointly run by CLG Professors Dianne Nicol, Don Chalmers and from HeLEX, Professor Jane Kaye. Many of the authors attended that workshop, and others were invited to illustrate the global experience of biobanking, and important innovative ideas in the field.
In discussing the future of biobanking, the paper outlines the concept of a ‘walking biobank’, a much more interactive, ongoing and potentially cost effective model of biobanking. This is one of the exciting new concepts developing in the biobanking academic community, and the group discussed it at some length, particularly in the context of tightening of biobanking funding in a number of countries in the world.
Group of Diverse Multiethnic People Teamwork
Earlier this month, Dr Rebekah McWhirter presented at two meetings in Edinburgh: the 13th World Congress of Bioethics, and a Satellite Symposium hosted by ELSI2.0 and EuCelLEX.
The Congress took place 14-17 June, hosted by the International Association of Bioethics, and examined the contribution of bioethics to individuals, public interests and public goods. McWhirter presented work on the challenges and implications of sharing (or not sharing) Indigenous genomes in research.
The Satellite Symposium was held on 14 June at the University of Edinburgh. McWhirter’s presentation “Exclusion of indigenous peoples from genomics: when ELSI goes awry” examined the effect of ELSI research on the practice of genomic research with Indigenous communities in Australia. This symposium had a particular focus on the ethical and legal issues associated with gene editing technologies, and these discussions raised some interesting questions for the CLG’s gene editing workshop to explore further in November.
On her recent trip to the UK, Professor Dianne Nicol met with colleagues at the Centre for Law, Medicine and Life Sciences at Cambridge University which enabled her to present on some work of the CLG’s Material Transfer Team. In particular, she presented some results from empirical work from interviews conducted with Australian university technology transfer offices.
The presentation was attended by a small group of interested people – academics including Dr Kathleen Liddell (Director of the Centre for Law Medicine and the Life Sciences), post doctoral researcher, John Liddicoat (who also holds an adjunct position with the Centre for Law and Genetics) and Dr Jennifer Molloy Coordinator of OpenPlants as well as Cambridge professionals implementing these types of agreements.
The presentation was followed by in-depth and detailed discussion about material transfer agreements, particularly for transfer of synthetic biology and the reliance on material transfer agreements as a tool for protecting intellectual property especially where patents are not utilised. The group shared their experiences relating to the usefulness and purposes of MTAs as well as outlining their involvement with standard agreement and simplification of the transfer process. As aforementioned, the CLGs Material Transfer Team, has interviewed professionals in similar positions in Australian Universities, and this enabled an informal comparison of views from those in similar positions in different jurisdictions. Professor Dianne Nicol would like to extend her thanks to those who attended and participated in this discussion, and to her Cambridge hosts for the opportunity to present.
The Ethics Review Equivalency (ERE) Task Team of the Global Alliance for Genomics and Health (GA4GH) Regulatory and Ethics Working Group met in Montreal, Canada in early May for a two-day workshop. The group, recently published a paper in the ethics review equivalency area, considering the background and to map the current approaches to a solution: reciprocity, delegation and federation. CLG Director, Professor Dianne Nicol is a member of the task team.
The purpose of this meeting was to outline the process for moving forward by assess the evidence already collated and turn the members of the task group’s minds to solving some of the key issues. In light of this, the group took the first steps and begun creating an Ethics Review Mutual Recognition Framework that would assist in large-scale international data-intensive research.
An area of interest to the group was the concern that accepting another institution’s ethics review decision opened up the potential that the receiving institution be held liable for a decision that they did not make. This is one of many of the concerns raised and flagged for further consideration.
Longer term, the group hopes to create a framework to promote efficient practices for ethics review enabling easier collaboration in the case of cross-jurisdictional projects and data sharing.
Last week the paper ‘Precision medicine: drowning in regulatory soup?’, published in the Journal of Law and the Biosciences became available online. This paper, led by Professor Dianne Nicol and co-authored by 16 others from cross-disciplinary backgrounds including law, health science, social science, bioethics and epidemiology, is written in response to the ‘confusion, veritable ‘regulatory soup’ that could drown the promised advances in precision medicine’. Many of these authors came together and met in Hobart, Australia in late 2014, to discuss the more general question of how the challenges of regulating for ‘precision’ or ‘personalised’ medicine might be addressed.
The ideas for this paper were first voiced as part of a discussion that was conducted at this meeting. They have been developed into a comprehensive review of the current state of affairs, and inter-play between regulations in respect of delivery of personalised medicine. As the title suggests, the regulation in this area is not coherent and is a ‘soup’ – that is a broad collection of separate regulations that derive from different basis and legal instruments – that all are relevant to delivery of personalised medicine. As such, this article sets out important considerations and existing regulations. Highlighting that navigating the sets of laws is a primary problem.
The authors suggest that regulation for this area ‘need not – and probably should not- result in new, highly targeted laws’ (at p 12). Also stating that the high level ethical principles should stand and not be modified to address these specific problems. However they reiterate the question of whether we are ‘drowning in the regulatory soup?’. And further, many of the individual regulations are subject to specific concerns of their own.
The conclusion suggests that modernisation of the precision medicine regulation is fraught with challenges, but is essential to ensure patients safety (and to society) and to concurrently allow development in medical treatment. In light of this they put forward five recurrent elements that must be taken into account in any creation of regulation (at 23):
(i) appropriate consideration of safety, efficacy, and patient need;
(ii) cost effectiveness;
(iii) consistency/equivalency across geographical, technological and institutional borders; (iv) respect for cultural differences; and
(v) genuine engagement with all relevant stakeholders.
These considerations should be taken into account by policy and law makers. They will also feed directly into the development of frameworks and regulations as well as reform thereof, where the authors and the CLG are involved.
Read the paper.