 So welcome to this webinar. My name is Adela Square, I work at SOAS University of London and I'm very glad to have this opportunity to share some ideas we were able to interact with you. Since I can't use the camera at the moment but hopefully you will find the presentation interesting and the way to interact with you all, I'll take it through the chat form. So just a few words to start. What we are going to do today, I'm going to talk for about 20 minutes about a piece of research that I conducted recently to tell you about the context of it and how it fits the broader research and also what we do at SOAS. But just a few words to introduce ourselves if you like. So as I said, my name is Adela Square. I work at SOAS as a senior lecturer of public policy management, public financial management where I convene programs with the same title and I also currently act as the actor of the settings, the distance learning provider of various programs here at SOAS. I will be happy to spare a few words about what we teach at SOAS later if you like. But otherwise, I'd like to move towards this presentation, which is about the regulation of emerging technologies and the responses to the rise of CRISPR gene editing in the US and the European Union. I'm going to put some of you here taking part to the webinar online. As you know, we can interact through the chat. And if you do not mind, I'll be also very happy if you'd like to spare a couple of words here in the chat line about yourself, how you are related to SOAS, if you have any particular interest towards regulation of emerging technologies or gene editing in particular. Oh, great. Thank you, Charles, for the first question, which I think is quite sensible. What is this CRISPR all about? So it's a new technique of genetic editing started in 2012. And as I will say just in a couple of slides, it holds great promises to change the way in which genetic editing is done with respect to the past. But self, it's an acronym and in a couple of slides, I will clarify what it means. Okay. Well, just a time if you don't mind, adjust the progress with the slides and to share with you what we did and what we think about regulation of emerging technologies. But as I said, please we'll free them in a while to drop something here in the chat. If you have any questions at any stage, if you like, as I said, to share with us, why is it you are interested in this topic or SOAS more generally. I'd like to provide you some anticipation of what is it we are taking out of this session, some driving questions, which are basically what are emerging technologies? Why do emerging technologies need regulation at all and how are they regulated? And then in particular, I'd like to focus on this particular technique of gene editing and to look so far, we looked at two particular areas, the US and the European Union, although I can spare a couple of words more about other areas in the world like China and what they're doing with the CRISPR. And then if you like, I'd like to open up a couple of thoughts about how does it matter in terms of the public policy and how our policymakers are reacting to the emergence of new technologies in various fields. Emerging technologies is a very broad concept, very loosely, if you like, we are talking about area scientific inquiry, which are advancing very, very fast. Because of these, they bring about a massive amount of novelty into the industries with potentially disrupting effects. And they also pose, however, new sorts of questions and uncertainties, hazards, dangers to workers in production, consumers to the environment more generally as a substance is charged into the environment. So we're talking about the use of artificial intelligence, for instance, things tend to reach nowadays, it is employed within financial markets or various other kinds of transactions, autonomous vehicles from Google car or other ways to test the self driving vehicles, not just cars, but also boats, for instance, or drones, of course. We're talking about nano materials, they're not too new by themselves, they've been around a couple of decades, but scientific advance is coming out with more and more molecular, which are then discharged into the environment. And of course, we must be safe about their side effects. And of course, also genetic engineering, where I specifically am concerned with this CRISPR technology. So the emerging technology by itself is a very broad area, covers many areas from physics to chemistry and so on. Generally, they do pose relatively similar issues for the for the policymakers in the form of deciding how is it we can regulate these emerging technologies. Now I'd like to make a small digression towards public policy and regulatory policy, if you like. And the biggest point is that by and large theories we have about the regulation are not quite fit to emerging technologies. Many theories of the regulation are really about the asymmetry of information between the producer of something and the consumers of the regulators. The basic idea is that the producer, they know it better, the technology they're using, the potential side effects, they may tend to do not to disclose it fully, completely, and to take advantage of their information asymmetry. And therefore regulation steps in, in order to overcome this information asymmetry. But the point of emerging technology sometimes is that even the same designers produce researchers of the new technology, they may not really know completely quite well what are the side effects and consequences of the technology. And so it's a, it's a, it's an arena where all stakeholders, they may not have a full complete information. That means the regulatory problem is not really the one to overcome information, information asymmetry. Well, thank you for imagining the meanwhile from this comment from Schabchenko, who's learning not having particular interest in gene editing. But yeah, you're right, there is a stream of new innovations, which sooner or later come to impact our daily lives. And of course, they raise quite a number of concerns more generally in terms of regulation. Another instance related to artificial intelligence, intelligence, which comes to my mind is a face recognition technology, for instance, and all related to the concerns towards privacy or discrimination and so on. Talking one more line about regulation of public policy, I should also say that typically this has been started in terms of a stage approach so that as a new product or service comes to the market, there is a rising of a concern from the side of consumers and policymakers when they design a regulatory response. But again, this kind of approach seems to be rather too static and not fit the turbulence that we observe in the case of emergent technologies. So for instance, more than one century ago, as cars, the very early cars appeared on the roads at the very beginning, they were completely unregulated. And so they couldn't drive whatever they want, that without any particular line to fall on the road and so on. It became apparent as the power of machines grew over time that they were a source of danger to pedestrians, for instance. In a sense, the progress was a social law that regulators had all the time to see what was going on and then to agree on pieces of legislation and regulation. In the case of emergent technologies, the stream of innovation as Cepchenco just suggested is so fast. It may take a couple of months in between the announcement of a new discovery or a new design of a technological solution to marketable products, if not to consumers, to other firms and businesses. And so regulators, they may not have the speed, the resources, the capacity to cope with the fast changing environment. Think about the stream of new molecular, which are used in industry, in the food processing, and the resources which are required in order to analyze properly the other effects. So we started the conceptually for an argument that instead other areas of literature could be more fit to make sense of emerging technology. So coming from political science, there are arguments that sometimes policymakers, they just muddle through. It's an expression coming from political science, according to which political scientists just have to make sense along the way of what happens and to provide incremental solutions, as if they're not really able to design solutions to problems, but they just exhaust along the way through a series of steps. And another argument is that in any case, whatever new technologies coming out, regulators and filmmakers do not really start from scratch, because most of the time they rely on existing regulations, many new stream of products from other fields of technology. And so the first immediate response is to look at the technology we already have and to see whether it works, or in the case, if it's just to adjust it as it is, rather than producing anything new. And Charles Lindblum, in particular, is one of the main references in this area, together with Milken, who argued the role of uncertainties in different sorts of uncertainties in a strategy. I anticipate the main line of argument, which is in the regulatory problem followed by the regulatory solution, what we may observe is like a continuous cycle of adjustments and the flow of information from the development of emerging technology, the launching of the very early applications, then the first response to apply existing regulation, but then there is the appraisal as to whether this is working or not, and then an adjustment to regulation. Now, regulation, technology development that they feed to each other, because as new rules passed, these do affect the trajectory of technology development. So, for instance, they may provide incentives or not to invest into a given technology. Otherwise, investors and researchers can reorient their efforts towards different areas, depending on whether they anticipate some path of technological development could be blocked because of the banning of a new technology, for instance, or raising up barriers to Henry in different ways. And so the basic line is that we may expect a process of neutral adjustment in between technology and the regulation to catch up with each other and to mutually influence with each other. This is the general context where we looked at one particular technology. I should say this work is part of a collective effort with other colleagues based at the National University of Singapore, Sun and Fraser University in Vancouver, each of us are looking at different areas of emerging technologies. So, with other colleagues, we looked at this CRISPR, so I'm not an expert in biochemistry, of course, but as far as I know, it's an acronym of a clustered, regularly interspaced, short, palindromic repeats. Just a little bit of background, it was noticed since the 70s that curiously in some bacteria, there were some parts of the DNA which were all similar to each other, they were like repeated. And the question was like, why is it that it is the A that we have these sequences of the genome which look the same, repeated over and over. And then later in a hypothesis that these could originate from a reaction of the pachyrion to an attack to an attack of viruses as an immunotherapy response, loosely said. But in any case, out of this particular feature of the DNA, it was like about 10 years ago that some research took off, which eventually resulted in 2012 in different laboratories at the same time, especially in the US, so they discovered that a certain molecular could be used in order to modify pieces of the genome in a very precise, accurate way. To put it very short, the key word here is very accurate way. As understood in the past, the sort of genetic engineering that we may have had since the 70s, the 80s, was a little bit rough in a sense. Scientists could bombard pieces of DNA with x-rays, for instance, and try to mix them up with other pieces of DNA and sort to provide kind of a hybrid with the strings alien DNA inserted into another genome. This resulted in a very tentative way of creating properties, for instance, desired properties in food, in plants, and so on. And this, of course, also related to some general public concern towards genetically modified food. And as you know, in the part of the world, when we talk in Europe, European Union directives stimulated the spirit of the time to be pretty much against the use of GMO food, for instance. However, CRISPR holds important promises. According to the scientists, that's not like genetic engineering as we did in the past. Methodorically, they talk like scissors, where you can precisely insert the pieces of DNA that you want from bacteria to plants, to animals, and so on, and so on. In such a way as to be better able to engineer the organism that they try. Not unsurprisingly, this resulted very soon in disputes about patents for this method, which has been going on since recently. And in a number of startups, typically spin-offs from the original laboratories, who started the two search, which started to search for the very early applications of this technique. And some of these startups, they have a considerable value in the stock market because of the promises they hold. And that they are moving the early steps to go through a process of testing and approval of some drugs, some treatments in particular. This is the generic context from the side of the technology, but our concern is the one around the regulatory response. And what we did is just so far to have a look at the comparison between the regulatory response in the US and the European Union, especially because of the difference. And I make a long story short because here we went into reviewing the documents of the debate, which took place within the US Congress, for instance, of the European Parliament and the Policies of Scientists and the civil organizations and so on. But just to summarize very concisely, we can easily make a dramatic difference between the reaction in the US and the European Union. First of all, as I said earlier, existing regulatory institutions do count. So in the US, they have since long ago a so-called coordinated framework, which means the joint working of the Environmental Protection Agency, the Food and Drug Administration and the Department for Agriculture. In the US, they have different competencies depending on which kind of genetically modified organisms we are talking about. But in the past, they provided the regulatory scrutiny and response to the emergence of genetically modified organisms. And this is where the US started, basically. But actually, the reaction was to call, starting from under the Obama administration, for a review of a coordinated framework, starting from a national strategy to modernize the regulatory system. A few years ago in 2017, there was an update to the coordinated framework, which basically, to some extent, opened up the doors to this technique, provided new ways of viewing and documentation and so on. But general attitude, which has been reinforced more recently also under the President Trump, is to have these regulatory agencies work collaboratively with the industry in order to review the new stream of products. And just very shortly, that's quite different from the which emerged in the European Union. The basin is different, of course. As I said earlier, here European Union directives, to be more hostile in a sense towards a genetically modified organism and definitely food, with the directives getting back to 2001. There have been a debate for a while, especially in the European part, but no action was really taken also from the side of the European Union Commission for years. Until just a couple of years ago in 2018, a step, a decisive step was taken, but not from policymakers really, but from the European Court of Justice. There was a case which started in France that called the European Court of Justice to make a pronouncement that basically is to whether the existing EU directive could be applied to the emerging CRISPR-modified products, organism. And you know how it is, the lawyers there in the European Court of Justice basically ruled that even things as they are and existing European Union directive applies also to CRISPR-modified genetic organism. There was a reaction from the side of scientists and industry against this ruling along the lines that it's not like the previous genetic technique. The CRISPR, as I said earlier, provides different ways to more precisely intervene into the genome and because of these, the claim that instead the older regulation of about 20 years ago is inadequate, a new regulatory response should come out. There are additional arguments in favor to this claim like that you can't really stop technological advancement. If you make obstacles to commercialization or even in some cases of testing of this new technique, other parts of the world in the case will progress in this direction. Just to give you one more example of how the controversy is, of course that then the worst genetically modified organism in the European Union could also include from other particular cases also the import of genetically modified modified organism. From what I read recently it seems that the CRISPR genetic technique is so precise that if a DNA stream is modified in this technique, later on it seems to be quite hard for analysts to detect whether this modification has occurred because of an intervention or just incurred naturally as it may always happen that a little bit of genetic modification happens in organisms. So there could be always the possibility one day in the future that the CRISPR modified organic material could be imported without the possibility for the control agencies and the laboratories to detect whether the genetic modification just happened by chance in nature or was it intendedly made by scientists. So this is the sort of scenario that we've been analyzing. I don't want to keep the presentation longer than about 25 minutes and so I hope that's fine. I'll leave it at this stage. Just to share with you that the way in which we went on was to map out all the various sources of uncertainties surrounding CRISPR technology which affected the state uncertainty which means understanding what is this technology about, effect uncertainty which means what are the consequences, the effects of this technology and the response uncertainty which means what is the right thing we should do as policymakers and the regulators. And these are the traditional ways in which we identify stages of the policy cycle like the definition of the very policy problem, the possible alternatives, the appraisal of the possible options available. And just as a way to visualize the different arguments this is the way in which we can just easily thoroughly conceive what we believe took place in a place like the US where basically the adjusting of regulatory responses took place strongly in anticipation of future tendency of the development of the industry and the technology and the delivery of products. And so the regulation, regulatory adjustment was in a sense anticipatory, an extent proactive to the trajectory of technology development. On the other hand what we could observe in the European Union context so far at least was a very reactive stance. So the coming up of CRISPR applications appearing in the market just triggered a regulatory response which wasn't just a minimal form of adjustment which is just an extension to how you get existing regulatory institutions, the EU directive specifically on GMO hood applies also to CRISPR products. And so kind of a more reactive stance which especially the European Court of Justice took so far in the absence of a pro-regulatory policymaking initiative on the other hand. Well just a few final lines if you like because we've been interested in CRISPR as a fascinating issue area by itself but then of course we are interested in recommendations if you like thoughts about how generally countries can cope with emerging technologies. Definitely existing institutions provide a solid baseline. We believe it could be fairly rare that technologies are so new to call for a dramatic novel effort to regulate it. By and large regulators, policy makers can just make use the resources they already have in institutions and agencies and so on and to see whether they can fit the emergence of a new technology. But on the other hand the listening to science experts and forecasting the future trends of industry technology development seems to be quite important. And as you probably know in some countries in other areas like innovation in financial technology regulators came out with some solutions provisioning solutions like sandbox which means providing some limited scope for innovators to test new products or new solutions and are closed and regulatory scrutiny and to see whether they work or not before deciding which sort of technology could be needed before scaling up products and solutions to a proper market level. One final thought if you like is that however inaction does not really seem to be the preferred option. Technology and investors may be left without any clue as to what regulation could be in the future or in incentives to pursue and an argument I believe could be made that in nowadays a global market for talents, for capital, for entrepreneurship, it could be easier for resources to move around and to shop around from one country to another one depending on the most favorable local conditions. And so if policymakers and regulators do not provide the appropriate environment you may just lose or lag behind with respect to advancements that in other parts of the world or in other countries could instead take place. Well that's all I believe. I tried to be fairly very sympathetic. The best an academic can be to some extent but also as an interesting area I tried to convey the interest that we shared with the colleagues in research in this area and the impact they can have on public policy. Well thank you very much for your patience and attention as you've been with us all this time and on the other hand we have the possibility to take questions to share reflections if you like around the CRISPR in particular or the most appropriate response from the side of policymakers and regulators if you'd like to use that chat to share your ideas with us. Well thank you for the comments Charles. Definitely this is something we will follow very very closely in the future I believe as well. Well thank you for this comment Chef Tschenko, I don't know your first name. Well that's a quite an appropriate comment. Thank you Katia. That's quite an appropriate comment because generally there's an argument in policy science that there is a regulatory leg so that the regulators typically come later with respect to the advancement of technology and new products and services appearing up in the market and as I said earlier the pace of innovation nowadays is such that if the regulators do not pay attention just in months or a couple of years time definitely they can be far behind the new products and services appearing in the market. So a close collaboration and cooperation between scientists and businesses and the regulators possibly policymakers seems to be quite relevant. If you like if you do not have any questions or if you want anything else in them in a while just to convey to you better the picture of the state of affairs around this crispy technology for instance. So far there have been two international conferences about this technology where scientists convened discuss what are they able to do and what are the dangers that threats which are posed and at the end of 2018 there was the second conference which was in Hong Kong and probably you may have read from the press this particular particular happening. The scientists appeared on the stage at a certain point and reported to the public that he had just conducted a CRISPR intervention on obviously and that after that after they had been successfully implanted they gave birth to twin girls they are in China and he had performed a CRISPR modification of their DNA because apparently the intention was to make these girls these two persons more resistant to attacks of viruses especially the HIV virus. Now this announcement came to the scientific community as a shock because by and large there are very strong ethical concerns and caution before intervening in the DNA of humans. As you understand there is intervention as a way of testing on bacteria, on plants, on animals but humans it's a spatial case of course and so the scientists could carry out an intervention to deliberately modify a DNA and to bring these up to the very giving birth of humans. This came as quite a surprising because of apparently having not followed a number of ethical rules we should have been followed and then because of the uncertainty as to what could be the consequences of this DNA modification on humans. A lot of controversy followed followed up during the last year the last bit of news I read just last month is that apparently this scientist has been condemned by a court in China for not having followed the proper procedural and ethical rules before this intervention but this as you can see clearly opens up quite dramatic concerns around limits and strict regulations and forms of prevention or before the use of such technique could be implemented in uncontrolled or even dangerous ways. Well that's another interesting question and by and large there is not. In some fields if you take finance which are affected by dramatic technology development in the area of impact for instance there we may think that some entities like the bank for international segment for instance they can provide some forum where central bankers for instance convene and the largest stakeholders of the financial industry and they come to coordinate each other to find the common frameworks for regulation. The final sector is really the first one to my mind where you can really have a venue for such a scale of international coordination in other areas like this genetic editing instead. At the level of scientist academia there is a lot of circulation of ideas and the sharing of common practices and the principles agreement on principles for carrying out research. There are some conventions that a number of countries could agree on that for instance I guess it dates back to the 90s that the so-called obiado convention precisely about the limitations the use of humans for geneating editing but then we are talking about the large massive international conferences which may take quite considerable time before organizing really coming to an agreement for many areas of technological innovations I believe they do really lack any practical forum or venue to coordinate and harmonize regulations across the world. Thank you Czech for this question so constraints in developing this technology I do not know which kind of constraints we have in mind particularly but in terms of know-how and the resources from what I understood that this technology is even relatively easy and cheap to implement possibly I'm talking about experts of course in biotech but it seems that the investment which is needed in terms of the performing and crisper interventions is relatively affordable so the barrier to entry in a sense to the to the research and then to the industry applications is not really too high so that's not quite a constant in a in a sense a constant could be of the of the of a regulatory sort so if for instance a certain technology or products or services of the technology they do have a strong limitations they have to go through a approval process or they're just a band then of course in that case these would account as a constant in a particular country at least before the the technology is developed and actually and actually implemented you're welcome but as I said earlier then it's possible always to shop around countries so for instance I just mentioned the already mentioned a few times the limitations within the european union to perform a genetic editing one of the startups which I mentioned earlier in this in this field is based for instance in switzerland and so you may not need to go too far where you can find other jurisdictions where it could be more tolerable to perform certain certain kinds of activities okay good well I can't see anyone anyone else tapping and so therefore I thank you very much for the participation and for your for your interest and I'd be happy to to be contacted if you like you can see my email there if you have any any other question or any literature you'd like to to read about or more generally if you are interested in the in the courses that we do at SOAS so as I said I convene the programs on public policy management public financial management which the the cover number number of areas within public policy but of course regulatory policies just an instance of the various areas of concern that we also cover and so if you'd not already studied with us you may take it please into into account or to let others know about the kind of research and work that we do here oh great chance good to know please feel free to be in touch of course so how much do we need to develop this technology okay and this may I mean think about different lines of answer and the technology is already is already around in terms of a lot of research effort in many laboratories in in the world and they already delivered the very early instances of applications so far it may look like something fairly trivial like for instance take as I read modifying the DNA of mushrooms so that they do not get brown despite being on the shelves for so long what does it mean that a mushroom may look fresher for a longer time they keep look like a white for instance if they are shampignon for example what is the impact of that is it just a commercial interest to extend the shelf life of a product so this could be the case of course it is very simple example but this just gives an idea of the way which a researcher is being converted into some practical application quite quite soon so a lot of effort is going on and and as I said the main promise and possibly the most available applications however at the moment are around the area of treating illnesses especially genetic illnesses and we just read something promising so far but I believe we may stay wait some time before we can really see any product drug or treatment delivered to the market well yes illnesses is one of the most promising promising areas of application so another question what to take notice if you're with the scientists well I should say any professional scientist is a pretty much a way I believe nowadays of implications of dangers hazards of using these techniques and by and large as anticipated in the scientific sphere that's one where efforts to coordinate internally are present especially in terms of ethical and conduct guidelines in order to ensure as much safety as possible and careful testing of this of this technique so as in the position of policymakers for instance or policy advisors policy professionals I believe an important point could be the one of open up a channels of communication with the scientists in that respect of possible I should say there is a lot of variety across the scientists with the some of them more inclined or just better in the extent to which they are able to communicate what they do in more practical terms that also non-scientists can understand so that can be an issue of communication and possibly policy advisors policy consultants professionals they could play an important role as a broker to bridge the gap in between expertise and knowledge and some formulation of policy problems in way regulators policy makers and the public can understand without falling into the risks of either ignoring dangers and hazards or to spread out the alarmism around the technologies which may not deserve just to have to be cast into the into a negative light if you use the appropriate tools to to to use. Well thank you for this additional question Charles the role of uncertainties first first and the risk therefore is quite crucial here starting from the very mapping of what could be the consequences of using this technology by changing DNA here and there and the answer is that on a case by case this goes for analysis and it's not quite known at present and the risk is clearly there but even knowing what kind of risk is difficult may just to tell you one more more more example of the sort of risks which are which are faced today's you may find it quite curious but apparently recently in the US it started the commercialization of CRISPR kids CRISPR kids it means it's a set of tools starting from molecular and other things where apparently companies promise to sell this set of tools to individuals with the promise that in this way they're able to set up a CRISPR laboratory at home as if in their kitchen I'm not in the position to say whether this is this works or not what is it that they are selling but in principle it could pose the threat that individual would adjust by these kids and that just out of their personal knowledge and understanding of a biochemistry just to play around with the bacteria or something else and to induce genetic modifications on their own in a pretty much uncontrolled way and believe it or not this raised up recently the concern from the side of some regulators and I read for instance in California the position of policymakers regulators the legislators actually in California were concerned to pass pieces of state legislation to prevent individuals to biohack themselves so the idea that in individuals would even for instance take blood cells out of themselves to modify these cells in some in some way and to put them back into their body with the possibly completely unknown to their to their health or or even to the health of the others I know it sounds as if we are talking about the science fiction here and the possibility is just the domain of unknown that we are dealing with but this gives the idea of this hope of uncertainty we are dealing with and the potential threats and dangers of this emerging technologies thank you thank you Katia for this other comment and in fact this is true if if i go back to the hearing in the congress a US congress of various scientists who had been invited in the last years to talk to the congress and to specific committees about this technology to help policymakers understand what is it about the dangers a number of them they mentioned precisely this possibility that foreign countries basically first the procedural countries could set up laboratories and to design basically an organism which could handle illnesses or other forms of bioattacks towards enemies and with a related concern about what could be done in order to prevent the use of a new sort of bio weapons discharged into into the environment so you precisely touch upon one of the sources of concern that the experts brought to the attention of our policymakers very recently okay well i feel we can bring this this session to to the end probably it has been for more than 45 minutes so far and well thank you so much again for your participation and attention i hope you found the topic and the specific about this technology interesting and to feed to you some ideas and some more readings to do to to know more about directions that policymakers may take along along these lines feel free to be in touch with me if you have any other questions and thanks for being touched for the next webinar i hope in some time in the future have a nice day