Genome Editing for everyone?
Effectivity and potential applications of current methods of genome editing: The worldwide hype on CRISPR-Cas and the many promises concerning its possible applications require critical assessment. For example, the simplicity of the CRISPR-Cas system is said to in the future enable any individual with basic molecular-biologic knowledge to make experiments on organisms which until recently were too complicated, prone to errors and time-consuming.[i] [ii] For which organisms can this method be effectively used at all? Are there side effects, and if yes, can they be estimated? What is the potential of genome editing for implementation in complex ecosystems, as it is considered with respect to gene drives and microbiome manipulation? Which competing methods do exist? What is the success rate compared to other technologies? What will be the costs, and how much experimental effort is necessary to achieve reliable results? Who has access to this technology? Is theoretical knowledge found in the Internet sufficient for making successful experiments without being specially trained in this method?
Regulation and biosecurity: The possibilities offered by genome editing are concerning regulators worldwide. As DNA sequences can be edited purposefully and exactly (without the method leaving traces), it will become difficult to identify and track organismsl,genetically modified in this way as well as products that would contain so modified genetic material.. Furthermore, currently it is debated if cis-gene-modified organisms must be understood as being genetically modified.[iii] The Bundesamt für Verbraucherschutz und Lebensmittelsicherheit has announced a decision on this for the end of 2015, which shall be taken up during the retreat week and in the context of which future scenarios shall be evaluated. Concerning the regulation of cis-genetics, there is seemingly no Europe-wide legal concept. If, however, for example gene drives or microbiome editing will become legal in one country, this would inevitably affect also the neighbouring states, as the biosphere does not know any political borders. Horizontally working genome editing, for example, does not only allow for changing a desired microbiome for therapeutic applications in patients, but it may also have further consequences for the environment and fellow humans. The possibilities to manipulate existing ecosystems by way of releasing gene drives or editing whole microbiomes raise questions concerning evolutionary effects and the stability of the ecosystem, as long-term effects cannot be estimated. [iv] Should these technologies be easily implementable in a decentralised way, physical containment may no longer suffice. Thus an assessment of the differences and common grounds of jurisdiction and the practical regulation of this technology in the European neighbouring countries is highly relevant. One of the crucial issues of the retreat will thus be how further measures of securing experiments on genome editing could look like.[v]
Intellectual property and responsibility: CRISPR-Cas9 was developed by Emanuelle Charpentier, Max-Planck-Institut für Infektionsbiologie in Berlin, Zhang, Broad Institute MIT, Boston, and Jennifer A. Doudna, University of California, Berkeley, California. Currently Doudna, Charpentier and Zhang together with a number of institutes and companies quarrel about patent claims for this technology. Currently (November 5th, 2015), the top 3 claimants are Harvard University with 60 patents, the Massachusetts Institute of Technology with 45, and the Broad Institute with 40 patent applications.   As the molecular tools come from discovering a natural mechanism, it should be assessed in how far it is an invention at all, and if yes, who is the inventor. Tellingly the pioneers of this technology, Doudna and Charpentier, consider themselves the `discoverers´ and not the `inventors´ of the CRISPR method.[vi] Furthermore, how should the question of intellectual property and responsibility for side effects be dealt with if genome editing will be used for microbiome editing? Might influencing the human microbiome even violate the dignity of man and individual self-determination? In case of the horizontal implementation of genome editing, such as in case of gene drives, which is hardly controllable, will there be a danger for public safety and the health of citizens?
Who will be able to make use of genome editing, and who will actually do so? Will it result in social imbalances? Is the access to knowledge and materials of genome editing organised in a socially and economically just way? How could a fair utilisation of the appropriate resources be guaranteed on a globalised market? Could the possibilities of genome editing be politically misused? The difficulty to predict any horizontal implementation of genome editing and its technological controllability inevitably results in one of the most important questions which generally comes along with any progress of life sciences: How are we supposed to handle our knowledge?[vii]