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Genome editing refers to a set of novel techniques for manipulating the genome that can achieve much greater precision than pre-existing forms of genetic engineering. The best known and most consequential of these techniques is CRISPR-Cas9. Genome editing is set to have major implications for innovation across biomedicine, agriculture, and industrial biotechnology because genetic manipulation is now more exact, cheaper, and easier. The techniques have already become critical tools in research that has diffused across the world. In addition to its scientific and economic implications, gene editing carries with it a host of ethical, regulatory and policy issues that are of high interest to both OECD and non-OECD countries. Questions of intellectual property, the ethics of manipulating the human germline, and the potential health risks are among the most prominent.
Genome editing is an emerging concept at the convergence of bio- and nanotechnology, which calls, for a broad discussion among scientists, policy makers and the public at large, to define the boundaries in which this promising technology can be developed.
The genome editing project of the OECD Working Party on Biotechnology, Nanotechnology and Converging Technologies (BNCT) aims to produce a forum conducive to evidence-based discussion aross countries on the many issues of shared concern. The initiative aims to help guide policy at the national and international levels and promote -- where appropriate -- cooperative governance approaches.
The Policy Issues
Genome editing approaches are already used in different stages of clinical development to treat diseases, although at this stage only on somatic cells (that cannot be passed on to the next generations). Just like the use of stem cells, genetic engineering of plants, the development of three parent babies or the use of synthetic biology - to name a few - genome editing invokes a serious debate because of ethical concerns and safety implications. The fear exists that a negative perception will negatively impact the enormous positive potential of genome editing.
On the other hand, in the discussion, one should also consider whether not treating a genetic defect for which genome editing may bring a solution, is to be preferable. The genetic defect may indeed also be transferred to the next generation, and some of these defects, such as Huntington’s disease or cystic fibrosis have an outcome that is sure.
In addition, it should be considered that it is extremely difficult to stop progress in this field and ban knowledge. It is part of human nature that when new insights are being generated they will be used.
The controversy over these results suggests that there is a critical need for fuller policy discussion concerning the full impact the development of genome editing may have now and in the future for health and wellbeing. Among other things, there must be agreement on best practices to use these technologies and on boundaries of use, akin to agreements on human cloning1 or the use of synthetic biology.
Next to the safety and ethical issues that are driving the debate, other policy issues should also be addressed. A major issue that arises is on intellectual property rights. A major patent fight already started on the ownership of the patent covering the CRISPR technology, and in view of the expected impact of this technology a number of questions arise, around the appropriate conditions and incentives for the various scientific and economic actors to develop the invention into actual cares.
Genome editing has received increasing prominence over recent years both in the academic press and in the wider media. It refers to techniques in which specialized enzymes which have been modified, can insert, replace, or remove DNA from a genome with a high degree of specificity.
Currently three systems for gene editing have been described, using respectively Zinc-Finger Nucleases (ZFN), Transcription Activator-Like Effector Nucleases (TALENs), or Clustered Regularly Interspaced Short Palindromic Repeats – CRISPR-associated protein-9 nuclease (CRISPR-Cas9) system. These systems enable the rapid introduction of targeted genetic modifications in existing genomes (Esvelt and Wang, 2013; Sander and Joung, 2014). These techniques can be applied in a wide range of higher organisms (plants, animals), accelerating their genetic manipulating considerably (from many months to a few weeks in the case of mice) and facilitating the manipulation of non-model organisms.
Recently, one of the most discussed of these techniques, the CRISPR/Cas system, was named as by the journal Science as the Breakthrough of 2015. Amongst the reasons for interest in CRISPR/Cas is the ease of use of this technique as well as its low cost as compared with similar techniques. Even modestly equipped labs are able to work with CRISPR. It has been used in China to edit genomes of non-viable human embryos. It has also been successfully used with organisms of commercial importance such as crop plants and farm animals raising the possibility of new methods for the control of pests and diseases as well as improving the efficiency of plant and animal breeding. There are numerous other potential applications, which are being explored.
Many thanks to all Speakers, Delegates and Canadian Co-Organisers, who made this BNCT workshop such a success!
[I would like to] congratulate you on this excellent workshop! it was extremely well organized and executed. I want to highlight that it was very informative and stimulating, and I think the choice of speakers and participants was spectacular. The diverse format (keynotes, panels, breakouts) really contributed to keeping everyone engaged throughout. And the notion of putting people to work and then reporting back was – of course – very useful. The questions for the group discussions were helpful and the facilitators did a great job [...]. So well done! It was a pleasure to participate. Thank you for inviting me. Looking forward to the outcomes.
BNCT Members and Members of the BNCT Gene Editing Steering Group can now download the workshop presentations by following this link.
Welcome to the BNCT Gene Editing Project webpage. This webpage wsill be frequently update with the latest news and developments of the BNCT Project on Gene Editing. Members Project Steering Group are invited to access the private sections of this webpage, in order to download project information and participate in discussion fora.
Please save the date for the Workshop on 'Gene Editing in an international Context: Scientific, Economic and Social Issues across Sectors', to be held on the 29th and 30th September 2016 in Ottawa, Canada.