SynBio-August-Webinar

08_August_Maximising Impact_SynBio FSP monthly seminar date clai

 

 

[Image appears of an A on the main screen and then the image changes to show Dr Aditi Mankad talking to the camera and the participant bar can be seen in at the top of the screen]

 

Dr Aditi Mankad: Today. Thank you for joining this month's edition of the SynBio Seminar series. Before we get started, I would like to acknowledge that I am joining you today from the inner north of Brisbane, which is traditionally the lands of the Jagera and Turrbal people, whose traditional lands and hunting grounds lay around the Brisbane River and Moreton Bay, extending towards Toowoomba in the west. 
I would like to pay my respects to their Elders past, present and emerging, and I would like to extend that acknowledgement to the traditional owners of the many lands on which people are joining this meeting from today. 

 

Today's presentations will focus on some of the complementary areas of investigation that take place in parallel with the biophysical science investigations within the Synthetic Biology Future Science Platform. I'll explain a little bit about how the session will work today. We ask that all attendees remain on mute throughout the presentations. And during the presentations audience members can send questions via the Chat function by replying to “Everyone”. Each presenter will answer questions at the end of their presentation, and we’ve allowed about five minutes for each presenter. Any unanswered questions will be directed to the speaker for response after the seminar, and we can send through the responses to the questioner via email afterwards.  

 

[Image continues to show Aditi continuing to talk on the main screen and participants can be seen in the participant bar at the top of the screen]

 

So, I will introduce myself. My name is Aditi Mankad. I am a Senior Scientist and Team Leader in CSIRO. My team looks at social and economic issues related to biosecurity and biotechnology, and I am also the Maximising Impact Application Domain Leader within the SynBio FSP, which houses the FSP's social and economic sciences capability. So, this application domain critically enables and informs the synbio based research and development through shared impact pathways. 

 

Our first speaker today is Michelle Rourke, who is a CSIRO SynBio Future Science Research Fellow at Griffith University's Law Futures Centre, where she researches the global regulation of access to genetic resources for the Australian Synthetic Biology Community. Michelle was also a virologist in the Australian Army for ten years, researching the intra-host genetic variation and evolution of Dengue virus and Ross River virus. The title of her presentation today is “The Nagoya Protocol on Accessing Genetic Resources – Some Challenges for Synthetic Biology Research”. 

 

[Image continues to show Aditi continuing to talk on the main screen and participants can be seen in the participant bar at the top of the screen]

 

Our second speaker today is Dr Lucy Carter who is a Senior Research Scientist with CSIRO Land & Water. Lucy uses her background in bioethics and social science to address complex problems in agriculture, health, and biosecurity. As a member of the Maximizing Impact Domain of the SynBio FSP she helps to design and facilitate stakeholder engagement processes with diverse stakeholders to include, to include these perspectives in science decision-making. And the title of Lucy’s presentation today is “Public Engagement in Synthetic Biology: What’s Possible and How Do We Get There?”. So, we have some really exciting talks coming up. So, I’ll now give up the floor for Michelle.

 

[Image changes to show Michelle Rourke on the main screen talking to the camera and Aditi and Lucy can be seen in the participant bar at the top of the screen]

 

Michelle Rourke: Thanks Aditi. I will share my screen and hope that that’s working. How did we go?

 

[Image shows Michelle listening on the main screen and Aditi answering in the participant bar at the top of the screen]

 

Dr Aditi Mankad: It’s just coming up. Yep perfect.

 

[Image shows Michelle talking on the main screen and then the image flicks to Aditi listening on the main screen and the participant bar can be seen at the top of the screen]

 

Michelle Rourke: Excellent. OK. So, thanks everyone for having me today. I want to talk to you about the genetic resources you use in your research.

 

[Image changes to show an A on the main screen and then the image changes to show a new slide on the main screen showing a photo of a building and text appears: The Nagoya Protocol on Accessing Genetic Resources: Some challenges for Synthetic Biology Research, Michelle Rourke, CSIRO Synthetic Biology Future Science Fellow, m.rourke@griffith.edu.au]

 

I work on time [3:51] known as Access for Benefit Sharing which is short for Access to Genetic Resources and the Sharing of Benefits Associated with Their Use in Research and Development. So, if anyone’s heard of the United Nations Convention on Biological Diversity and its Nagoya Protocol, they’re the two big international agreements that outline how nation states are able to regulate Access and Benefit Sharing or ABS. And a lot of the research that we do on ABS at Griffith University’s Law Futures Centre can be fairly theoretical but at its core it’s about where a lot of people on this call are getting their genetic resources from that they use day to day in their research, and whether they’re obtaining those in accordance with international and national laws. So, I’ll walk through what all of this means shortly.

 

[Image changes to show a new slide on the main screen showing a photo of a building on the left, Michelle can be seen talking in the participant bar at the top, and text appears on the slide: Scope, Background on Access and Benefit Sharing (ABS), Scope of ABS, The “Digital Sequence Information” (DSI) Problem, The “Parts Agenda”, Synthetic Biology and Fragmentation of Genetic Resources, DOI: 10.10002/ppp3.10184]

 

OK, a lot of what I talk about today is covered in an open access article that was published in a journal called Plants, People, Planet earlier this year. That’s a DOI and I can paste a link in the Chat box when I’m finished talking. A quick disclaimer, any opinions I express today are my own and none of what I say can be considered legal advice. But I’ll start with a background on what this regulation is known as Access and Benefit Sharing and what it applies to and then start to talk about how some of the unique aspects of synthetic biology interact with that regulation. So, we’re looking at the problems that synthetic biology poses for the regulation. And more importantly for our purposes how the regulation may pose problems for synthetic biologists.

 

[Image changes to show a new slide on the main screen showing a pipeline diagram showing Inputs entering one end of the pipeline, Research and Development inside the pipeline, and Outputs coming out the end of the Pipeline, and text appears on the slide: The “Innovation Pipeline”]

 

OK, when lawyers or policy people are talking about ownership rights over genetic resources, they’re quite often talking about intellectual property rights, and while that’s a related issue that’s not precisely what we’re talking about today. If you think of the research and development process as what is often framed as a very simplified pipeline, the patents and other intellectual property rights that are applied to the outputs of research that, they’re applied to the outputs of research, patents and intellectual property rights if they’re considered new and useful, but I want to talk about the other end of the pipeline, the types of rights that can apply to the raw inputs used in research and development, and specifically I want to talk about those inputs that come from nature.

 

[Image changes to show a new slide on the main screen showing a photo of different insect specimens, and Michelle can be seen talking in the participant bar at the top, and text appears on the slide: Who Owns Nature?]

 

So, up until the early 1990s one of the fairly well-established norms of scientific research was that biological resources belonged in the public domain. So, scientists could, and would, undertake these huge bioprospecting missions, travelling the world collecting all sorts of seeds and animals and insects, and they’d amass these vast personal and institutional collections of biodiversity.

 

[Image changes to show a new slide on the main screen showing a map of the world with the Global North areas highlighted in blue and the Global South areas highlighted in red, and Michelle can be seen talking in the participant bar at the top, and text appears on the slide: The North-South Divide, Biodiverse countries of the Global South, Technologically advanced countries of the Global North]

 

And the natural world was sort of considered a free for all or what some called the “Common heritage of mankind” because usually colonial powers of the Global North figured that they could take whatever they wanted from biodiverse nations of the Global South. So, bioprospecting is a tradition that is steeped in colonialism and some of these attitudes are still quite prevalent. So, in the post-colonial era we start to see a lot of formerly colonised nations pushing back on the unfairness of having their genetic heritage taken in the name of science, and then major companies and industrial nations reaping all of the rewards. And the cases of what the Global South term not bioprospecting but biopiracy are especially [7:28] when researchers collect species used in traditional medicine, isolate the active compound, and include it in pharmaceuticals or cosmetics that they then patent, but not return any of the benefits back to the indigenous communities that have developed and maintained that traditional knowledge.

 

[Image changes to show a new slide on the main screen and Michelle can be seen talking in the participant bar at the top, and text appears on the slide: Convention on Biological Diversity, Adopted at the Rio Earth Summit, 1992, 1. “The conservation of biological diversity”, 2. “The sustainable use of its components”, 3. “The fair and equitable sharing of the benefits arising out of the utilisation of genetic resources”.]

 

So, it’s against this background that in 1992 Rio hosts the United Nations Earth Summit. This event is probably best known for the adoption of the United Nations Convention on Climate Change, and it was also where the Convention on Biological Diversity was adopted. So, this is a binding international treaty that has near universal acceptance. So, every country except for the United States is party to this Convention. There are three key objectives, the conservation of biological diversity, the sustainable use of its components, and also the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources.

 

So, this third objective is the regulation, this is where that regulation access and benefit sharing is coming from. This third objective is the reason I have a job, and it’s the reason I’m talking to you today. And it creates this transaction where you’ve got access to genetic resources in exchange for benefits and those benefits are then supposed to be channelled back to the country of origin, into conservation and sustainable use initiatives to conserve that biological diversity for future generations.

 

[Image changes to show a new slide on the main screen and Michelle can be seen talking in the participant bar at the top, and text appears on the slide: Convention on Biological Diversity, Article 15 – Access to Genetic resources, 1. “Recognising the sovereign rights of States over their natural resources, the authority to determine access to genetic resources rests with the national governments and is subject to national legislation”, 2. “Each Contracting Party shall endeavour to create conditions to facilitate access to genetic resources for environmentally sound uses by other Contracting Parties and not to impose restrictions that run counter to the objectives of this Convention”.]

 

And it does this by creating a new type of ownership right. So, the Convention says that states have sovereign rights over the genetic resources that originate in their territory. So, this is a real shift in international law. Genetic resources are no longer considered the common heritage of mankind. They’re not a free for all anymore. They’re in effect the property of the nation state and the nation state can determine how they want users to access their genetic resources by implementing domestic laws and policies.

 

[Image changes to show a new slide on the main screen and Michelle can be seen talking in the participant bar at the top, and text appears on the slide: Convention on Biological Diversity, Article 15 – Access to Genetic Resources, 4. “Access, where granted, shall be on mutually agreed terms and subject to the provisions of this Article”, 5. “Access to genetic resources shall be subject to prior informed consent of the Contracting Party providing such resources, unless otherwise determined by that Party”]

 

So, the CBD gives countries some guidelines about what those laws should look like. It says that the user of genetic resources must have the prior informed consent of the provider and that the provider country and user should make a legal agreement or a contract about how those genetic resources are going to be used and part of the terms of the agreement should include the sharing of benefits.

 

[Image changes to show a new slide on the main screen showing a diagram depicting the flow of information in an ABS transaction, and text appears: Bilateral Access & Benefit-Sharing (ABS), Sovereign Provider of Genetic Resources, Contract, Access, Prior Informed Consent (PIC) User of Genetic Resources, Benefits, Mutually Agreed Terms (MAT)]

 

So, this diagram which should be popping up, there we go, it’s supposed to give you an idea of what the ABS transaction looks like. So, you as the user of genetic resources on the right, you approach the provider of the genetic resources and ask for consent to access their resources. You come to an agreement about how you’re going to use them and what benefits you’ll share. And every country implements these laws in a slightly different way through their domestic laws. So, this means that the details around precisely what this transaction will look like differs across different jurisdictions. So, there’s more on that to come.

 

[Image changes to show a new slide on the main screen and Michelle can be seen talking in the participant bar at the top, and text appears on the slide: What are Benefits?, Monetary, Access fees, Upfront payments, milestone payments, royalties, Joint ownership of intellectual property, Non-monetary, Sharing of research results, Collaboration, cooperation and participation, Knowledge and technology transfer, Capacity building, Contributions to the local economy, Favourable licensing terms]

 

When we say benefits we’re talking about a bunch of different options, perhaps paying a fee for access, sharing research data including, including some of the scientists from the provider country in the research, and on any associated publications for instance. You could train those scientists or if you come up with a fairly lucrative product through your research and development, perhaps paying royalties to the country of origin or including scientists from the country of origin in any patent applications.

 

[Image changes to show a new slide on the main screen and Michelle can be seen talking in the participant bar at the top, and text appears on the slide: Convention on Biological Diversity, Genetic Resources (definition), “Genetic resources means genetic material of actual or potential value”, “Genetic material means any material of plant, animal, microbial or other origin containing functional units of heredity”]

 

OK, so that was the Access and Benefit Sharing transaction. And now we’ll talk about what it applies to, what genetic resources. And according to the Convention, genetic resources are any genetic material of actual or potential value and then genetic material is defined as “any material of plant, animal, microbial, or other origin containing functional units of heredity”. And you can see that these definitions are really quite broad and flexible.

 

Parties to the Convention have decided not to include human genetic resources but some countries do include human genetic resources in their domestic access and benefit sharing laws. The main point to take from this is that countries can regulate access to whatever they want, and they can also choose not to regulate access if they want as well.

 

[Image changes to show a new slide on the main screen showing the cover of the Nagoya Protocol on the left and Michelle can be seen talking in the participant bar at the top, and text appears on the slide: Adopted by the Conference of the Parties to the CBD in 2010, Clarifies Article 15 of the CBD, Includes “derivatives”, Entered into force on 12 October 2014, 130 parties]

 

So, let’s have a quick look at the Nagoya protocol. This is the agreement that most people are actually familiar with but it’s really just a supplementary agreement to the Convention that aims to clarify the Access and Benefit Sharing transaction that we just went through but it also introduces a series of new obligations including monitoring and compliance measures. It applies the Access and Benefit Sharing transaction to traditional knowledge of indigenous peoples, and locals, local communities, and it also expands the definition of genetic resources to include derivatives of genetic resources. So, biochemical compounds that aren’t DNA or RNA, they’re also included in this really already quite broad definition of genetic resources.

 

[Image changes to show a new slide on the main screen showing the ABSCH webpage with a world map showing countries that are parties to the Nagoya Protocol highlighted in purple and Michelle can be seen talking in the participant bar at the top]

 

So, the Nagoya Protocol came into effect in 2014 and as of last week it has 130 parties. This map is old because more often than not whenever I try to access this website, I have all sorts of issues. But my point here is that some countries are party to the CBD and the Nagoya Protocol. Some countries like Australia are party only to the CBD and some countries like the US, no sorry only the US are party to neither, unless you also want to count the Vatican, they’re not party to either. And I also want to reiterate that because Access and Benefit Sharing rules are being established and enforced at the domestic level it means that you’ve got a real legal patchwork of requirements to navigate if you want to access genetic resources from different jurisdictions.

 

[Image changes to show a new slide on the main screen showing a “Pandemic Influence Preparedness Framework” book on the left and an “International Treaty on Plant Genetic Resources for Food and Agriculture” on the right]

 

And there are also a couple of other international agreements to be aware of if you work with influenza viruses or plant genetic resources for food and agriculture. They’ve got their own specialised agreements and rules.

 

[Image changes to show a new slide on the main screen showing an article entitled “Rethink the expansion of access and benefit sharing” and Michelle can be seen talking in the participant bar at the top]

 

OK, I should just say that Access and Benefit Sharing hasn’t really worked to generate enough benefits to have any real impact on biodiversity conservation. I don’t think that’s a particularly controversial statement. We’ve had a paper that came out about this last year if you’re interested and it highlights that Access and Benefit Sharing has been around for nearly 30 years now. As you would all be aware, the world continues to suffer from massive biodiversity loss but what Access and Benefit Sharing laws have undoubtedly achieved is to make scientists’ jobs more difficult. So, the burden is on you as an individual to make sure that you are using genetic resources in accordance with the laws of the country from where those resources originate.

 

I don’t want frame this simply as an administrative burden though. There are some positive ways to look at it. One way to look at it is that it, it formalises some of the benefit sharing that you may already be doing as part of your research with partner countries. So, collaboration, data sharing, and training activities, a lot of you are already doing that sort of stuff. I have found that many scientists that for them Access and Benefit Sharing still isn’t even on the radar, but this needs to be taken seriously from the planning stages of your research. So, some journals now have a section in the authorship agreement where you have to declare ABS compliance in the same way that you would declare human research ethics approval. And some countries have introduced pretty harsh penalties. So, I have heard of research materials being confiscated, projects being shut down, or journal articles being retracted, and obviously there’s the reputational damage that can come from that. And some countries have included fines and imprisonment as potential penalties for ABS breaches.

 

[Image changes to show a new slide on the main screen showing data relating to the Ross River virus clone below the text heading “Digital Sequence Information” (DSI), and Michelle can be seen talking in the participant bar at the top]

 

OK, so let’s get into the synthetic biology stuff. Access and Benefit Sharing was designed to make sure that those scientists accessing physical genetic resources from biodiverse countries were sharing some of the benefits, but this form of regulation assumes that we’re dealing with physical, and whole genetic resources, or at least a large enough chunk of a genetic resource that it could be traced back to a country of origin. And now with the DNA, the ease of DNA synthesis there’s a good chance you’re not accessing physical genetic resources at all. You’re downloading the genetic sequence data off of GenBank, and you’re synthesizing material from that. And this presents a problem for those countries that spent a long time and a lot of money setting up ABS frameworks to regulate the physical resources.

So, using open access genetic sequence data in your research is considered by many biodiverse countries to be a digital loophole where users get what they want but the provider countries don’t get any of the benefits of synthetic biology. On the other hand, if genetic sequence data were to be captured in this Access and Benefit Sharing transaction, this would threaten the open access principles and the norms of publishing sequences in online databases like GenBank. This has been an active area of debate at the Convention and also associated international bodies since 2016 under the placeholder term Digital Sequence Information or DSI. And this is a term that includes nucleic acid sequence data and possibly a whole lot more including amino acid sequences and maybe even traditional knowledge.

 

[Image shows an inset text box appearing on the slide showing text: Synthetic biology is “poised on the boundary of the informational and the material”]

 

And as a field poised on the boundary of the information, the informational and the material, synthetic biology is an area of modern scientific practice that is highly exposed to this new DSI policy conundrum. And there are other aspects of synthetic biology that highlight the mismatch between how the laws are written and how the science is actually being done.

 

[Image changes to show a new slide on the main screen and Michelle can be seen talking in the participant bar at the top, and text appears on the slide: Types of Synthetic Biology (McLennan, 2018), The Construction Approach, Building entirely synthetic organisms including minimal organisms, Metabolic Engineering, Altering biological processes in organisms, The Parts Agenda, Standardised interchangeable biological parts combined to create new devices and systems]

 

So, to try and demonstrate this mismatch in clear terms I looked at what Alison McLennan, who is a Fellow SynBio FSP member from the University of Canberra, I looked at what she calls the Parts Agenda, as distinct from the Construction Approach and Metabolic Engineering in synthetic biology. And if you’re sitting there thinking that these categories don’t fully capture the entire field of synthetic biology, just remember that these are just conceptual divisions designed to make thinking about regulation a bit easier.

 

And I used the Parts Agenda as a case study to show the problems of applying ABS laws to synthetic biology. It was a nice fit for a few reasons, including the fact that it kind of embodies those foundational principles of synthetic biology, at least as defined by [18:19] like standardisation and abstraction. And then the Parts Agenda also began with this ethos of openness and sharing which is potentially threatened if DSI, Digital Sequence Information gets caught up in Access and Benefit Sharing laws.

 

[Image changes to show a new slide on the main screen showing the Registry of Standard Biological Parts website and Michelle can be seen talking in the participant bar at the top]

 

So, if you’re familiar with the BioBricks Foundation and iGEN, you probably already have a good sense of what the Parts Agenda is about. Essentially, it’s an approach to synthetic biology that fragments genetic resources into their smallest functional units to create standardised interchangeable bio parts, and those parts are the building blocks for assembling biological diverse, devices, sorry. Those devices are then also theoretically interchangeable and can be used to engineer higher order synthetic systems, and as we’ve already covered the bio parts, these bio parts are both physical and digital. They exist in physical form in the lab, and they exist in digital form on repositories like this one, or in CAD software. And even if these bio parts are highly modified, they still have a natural genetic resource as a progenitor. And so, if you trace them back far enough, they could be subject to Access and Benefit Sharing Laws.

 

[Image shows a basic device diagram appearing over the top of the website]

 

So, let’s say you’ve got the most basic of basic devices constructed of bio parts here. So, you’ve got a Promoter, a Ribosome Binding Site, the Protein Coding Sequence, and also a Terminator. That’s four parts derived from genetic resources that theoretically need to be traced back to their country of origin for the purposes of sharing benefits. On top of that you’ve got the expression vector, maybe used a shuttle chassis, and then you’ve got the chassis itself or the host organism. Already we’ve got several different components that could have their natural origins in several organisms from multiple jurisdictions. And like I said this is the simplest device that you could devise.

 

Are you going to negotiate a separate ABS contract for each and every component? And if you were to do that, how would you quantify the contribution that each component makes to your invention so that you know what type of benefits to share and how much? These are all the problems that Access and Benefit Sharing, that whole regulatory world, hasn’t fully grappled with yet.

 

[Image changes to show a new slide on the main screen showing a flow chart of the ABS model from genetic resources through to uses, and Michelle can be seen talking in the participant bar at the top]

 

The ABS model assumes a clearly identifiable provider and user party agreeing about the use of a distinct sample, so a leaf or an insect, but how can this happen, how can this work when we’re talking about fragmented and abstracted bio parts. I don’t want to worry everyone. To my knowledge this hasn’t started happening yet, but I would think really hard about any protein coding sequences that you might be using or if you’re altering whole organisms. Are the natural properties of a particular part or organism materially contributing to the functioning of your device or product? If, for example, you’ve sourced a plant species from an arid country because that species has a gene that confers drought tolerance and then you’re looking to perhaps use that gene to create drought tolerant properties in another organism, then perhaps you’d want to make sure that you’ve got the prior informed consent of that hypothetical country before you carry on with that research.

 

These problems exist throughout the bio sciences, but they’re magnified for synthetic biology. This is something that the negotiators of the CBD and Nagoya Protocol didn’t fully grapple with and so this is the purpose of my research for the Synthetic Biology FSP. This is an area in flux especially with the impending regulation of digital sequence information.

 

[Image changes to show a new slide on the main screen showing Acknowledgements, and Michelle can be seen talking in the participant bar at the top, and text appears: Griffith Law School Law Futures Centre Biodiversity Hub, Charles Lawson, Fran Humphries (QUT), Elizabeth Englezos, Todd Berry, CSIRO Synthetic Biology FSP Maximising Impact Domain, Aditi Mankad, Alison McLennan (UC), Frank Sainsbury (Griffith)]

 

So, I work at the Law Futures Centre and with the Maximising Impact Domain feeds into the ongoing negotiations at the Convention and also the related international bodies. And we want to make sure that these international laws take into account the complexities of synthetic biology and other modern scientific practice.

 

[Image changes to show a new slide on the main screen showing a photo looking up at a building, and Michelle can be seen talking in the participant bar at the top, and text appears: Thank you, DOI:10.1002/ppp3.10184]

 

So, the paper goes into a lot more detail using specific examples from plant synthetic biology. There’s that DOI again if you want more information and my thoughts are currently with everyone in lockdown at the moment and thanks very much for having me.

 

[Image shows the same slide on the main screen and Aditi can be seen talking in the participant bar at the top of the screen]

 

Dr Aditi Mankad: Thanks very much Michelle. Right on time, well done. So, very interesting talk indeed and I think it’s raised a few interesting questions as well. So, we have about five minutes to cover some of these. So, the first one is a good one from Thomas. What have been the implications for the US in not signing onto the Nagoya Protocol? Do they have an unfair advantage or on the contrary has it limited their access to international genetic resources?

 

[Image shows the same slide on the main screen and Michelle can be seen talking in the participant bar at the top of the screen]

 

Michelle Rourke: This is such a good question. So, I did some work in America for about a year and every time I spoke to people over there about the CBD they said, “Well it doesn’t affect us because we’re not signatory to this”. But as I was talking about, individual countries will implement whatever laws they want to regulate access to genetic resources. So, any scientists in the US who need to access genetic resources from another country will still need to abide by the, the laws of that, that country, that provider country. So, in terms of accessing it doesn’t really affect them in, in any different way to how it affects all of us. And also, they’re still allowed to, even though they haven’t signed on, they’re still allowed to exercise their sovereign rights over whatever genetic resources they want. So, the Federal Government could if it wanted to regulate access. There are some rules in America about accessing genetic resources from natural, from forests, and nature reserves, and stuff like that as well. So, you still have to be very careful if you’re getting stuff from the US.

 

[Image shows the same slide on the main screen and Aditi can be seen talking in the participant bar at the top of the screen]

 

Dr Aditi Mankad: Great thank you. Thomas just let us know in the Chat if that does not answer your question.

 

[Image changes to show Aditi talking on the main screen and the participant bar can be seen at the top of the screen]

 

So, the next, I might combine a couple of questions here, so it’s more about Australia and their kind of role, or lack thereof in the Nagoya Protocol. So, one question is, “Is it helpful to elaborate that Australia has signed but not ratified the Nagoya Protocol?”. And another question from Rachel is about the status of Nagoya in Australia including how it might interface with indigenous community considerations.

 

[Image changes to show Michelle talking on the main screen and the participant bar can be seen at the top of the screen]

 

Michelle Rourke: Oh yes, so Australia has put in place a bunch of laws. So, there’s the Federal laws for accessing genetic resources and also a few states and territories have put in place some laws. Typically, with the Convention and the Nagoya Protocol, the rights that it puts in place for, or that it talks about for indigenous people and local communities tend, when they’re put into domestic law, it tends to reflect that country’s existing protections for indigenous property, and traditional knowledge. Queensland has just put in some really novel approaches to accessing traditional knowledge of indigenous communities in Queensland and they’re considered one of the forerunners in the world for that type of regulation. Did I get both of those?

 

[Image changes to show Aditi talking on the main screen and the participant bar can be seen at the top of the screen]

 

Dr Aditi Mankad: Oh yes, and sorry the other bit was kind of is it helpful to elaborate that Australia has signed but not ratified the Nagoya protocol?

 

[Image changes to show Michelle talking on the main screen and the participant bar can be seen at the top of the screen]

 

Michelle Rourke: Yeah, thank you. So, by signing we’re essentially, but not having yet ratified, we’re still showing that we intend to abide by the rules. So, even though we haven’t put it into domestic laws as yet, by signing it we’re saying, “Yes, we essentially agree to this and we’ll follow, if not the letter of the law, the vibe of it”.

 

[Image changes to show Aditi talking on the main screen and the participant bar can be seen at the top of the screen]

 

Dr Aditi Mankad: OK, so this is an interesting point raised by Olly. So, it’s around whether it’s worth discussing or recognising that the purpose of natural history collections need not, need not be bio prospecting and that, you know, it’s not the full story to characterise the creation of natural history collections as being just about accumulating information for commercial gain.

 

[Image changes to show Michelle talking on the main screen and the participant bar can be seen at the top of the screen]

 

Michelle Rourke: No, that’s right and, and some countries, so if we want to talk about a distinction between commercial and non-commercial research, I completely understand that. There are definitely collections of biodiversity that were never intended to be used for commercial gain. But some countries don’t make that distinction, and even if you’re just using a particular genetic resource for taxonomy purposes or to display it, they may still regulate the use of those genetic resources.

 

[Image changes to show Aditi talking on the main screen and the participant bar can be seen at the top of the screen]

 

Dr Aditi Mankad: OK, thank you. We have a couple more that I’ll just run through. So, Kirrell asked, “How is the issue of… how does the issue of national ownership differ from general IP rules, for instance the percentage of identity that defines what is similar and what is not?”.

 

[Image changes to show Michelle talking on the main screen and the participant bar can be seen at the top of the screen]

 

Michelle Rourke: Yeah OK. There’s a couple of different issues here. So, I said that IP is a related issue and that’s for a number of different reasons. So, people, some countries will use the intellectual property system as check that Access and Benefit Sharing has happened in accordance with the law, and the rules for intellectual property about how new, how novel something needs to be doesn’t necessarily apply to Access and Benefit Sharing because they’re two separate sets of laws. So, this is one big problem that the whole Access and Benefit Sharing Regulation has, is how different does one sample need to be from another sample before you can consider them two separate samples for the purposes of Access and Benefit Sharing. They, they still haven’t worked that out and again it’ll be down to the country of origin to determine how you treat that on a case by case basis.

 

[Image changes to show Aditi talking on the main screen and the participant bar can be seen at the top of the screen]

 

Dr Aditi Mankad: And it kind of relates to Andrew’s question, are the sequences protected as is, or can unscrupulous folk simply change an amino acid or base to get around things, is it different to where patents protect the sequence base?

 

[Image changes to show Michelle talking on the main screen and the participant bar can be seen at the top of the screen]

 

Michelle Rourke: Yeah, so, yes unscrupulous researchers could certainly do that. So there’s, at the moment there’s only about 19 countries I think that are, that have actually started to regulate digital sequence information. Everybody else is sort of waiting for the Convention to make a call on whether we want to include digital sequence information as a genetic resource or not. And yeah, there are tonnes of loopholes in the Access and Benefit Sharing. So, my warning would be that if, if you do intend to, especially if you intend to commercialise your product, make sure you’re not looking for easy loopholes because when it comes time to patenting, if it becomes clear that you’ve tried to skirt the laws, that could be a problem for you trying to commercialise something.

 

But also like I said there’s positive ways to look at this that aren’t just looking at it as an administrative burden. It’s a way of making sure that the benefits of science are distributed more fairly, and you get to participate in that. So, yeah, I definitely don’t want to frame this as just a negative thing. It is, it is an administrative burden that’s for sure but there are, there are good things about it too, and particularly the protection of indigenous knowledge. I think that is one of the strong points of this type of regulation.

 

[Image changes to show Aditi talking on the main screen, and then the image changes to show Michelle listening, and then changes back to show Aditi talking again, and the participant bar can be seen at the top of the screen]

 

Dr Aditi Mankad: Thanks Michelle. And just a final comment from Claudia, just to say, worthwhile flagging that historical collections made prior to Nagoya aren’t subject to it.

 

[Image changes to show Michelle talking on the main screen and then laughing and the participant bar can be seen at the top of the screen]

 

Michelle Rourke: There’s, OK, there’s a, sorry I know that was a comment not a question but some historical collections yes, some no, it will depend again on where the sample’s from and whether they want to exercise their sovereign rights over them or not. So, just be careful people. Check your material and your transfer agreements.

 

[Image changes to show Michelle talking on the main screen and then laughing and the participant bar can be seen at the top of the screen]

 

Dr Aditi Mankad: Thank you and I did notice a couple more questions coming through so we will get those answered and sent to those who asked them. Thank you so much Michelle. There was a lot of conversation around that. So, thank you. And now I will pass the mic on to Lucy.

 

[Image shows Aditi listening and then talking on the main screen and then the image changes to show a new slide on the main screen and the participant bar can be seen at the top of the screen, and text appears on the slide: Global research aspirations and commitments, Work with publics, stakeholders and communities to consider their concerns and aspirations in our science planning and decision making, Innovations that are responsive to societal needs, Reflexivity as foundational to responsible innovation (RI/RRI scholarship), Synthetic Biology in Australia, Synthetic biology as a field will find more pathways to socially acceptable innovation if it develops methods for upstream public collaboration rather than post-facto deliberation, ACCOLA pg 99-100]

 

Oh, so you’re still on mute Lucy.

 

Dr Lucy Carter: How’s that.

 

Dr Aditi Mankad: Great.

 

[Image continues to show the same slide and Dr Lucy Carter can be seen in the participant bar talking]

 

Dr Lucy Carter: Thank you. And it’s gone, it’s swapped a slide so I’m on the first slide but let me just do some scene setting if I can. So, my presentation is a slight departure from the usual science talk in that I’m hoping to share some ideas that sit more comfortably in philosophy of science and ethics spaces. I’m using this opportunity to raise some challenging questions and to ask for your ideas on how we might address what I’m calling the engagement gap.

 

So, the engagement gap is where, as a global SynBio research community, we’ve totally committed to public participation in science. We’ve committed to engaging with publics and we’ve made significant effort to do that, yet we’re still working out how we might make good use of the information that we do collect and the lessons that we learn along the way through engagement. It’s where the value of that engagement effort is yet to be realised and in that we haven’t yet translated the knowledge and used it in a way that we aspire to do so.

 

So, I’m using the reference “we” a lot in this presentation. For most part I’m referring to the global and national SynBio research community. At some points in the presentation it does make sense to refer to a more concrete “we”, so I might use examples from our own work in the Maximising Impact domain or the broader FSP. But it’s becoming obvious that this is a grand challenge, something that’s been a struggle in the UK, and in parts of the US, and closer to home also in our own CSIRO partnerships.

 

[Image continues to show the same slide on the screen and Lucy can be seen talking in the participant bar at the top of the screen]

 

So, I’m going to apply a broad definition to public engagement in the context of synbio. The question I’m asking is, “How do we facilitate and enable public participation in science as a research community who’s committed to responsible science and research impact?”. Engagement here is more than the practice of science communication. There’s really a rich scholarship on engagement in the applied social sciences and humanities. So, I’m referring to the study of engagement as a science practice as well as engagement as the goal that we aspire to in synbio. So, in those senses it’s not always something only that’s done by others.

 

So, broadly speaking in the FSP and in CSIRO also we see ourselves as leaders in responsible science. We acknowledge the value of transdisciplinary science and we welcome dialogue. There’s a bit of evidence to back this up. We’ve got at least two FSPs, the SynBio Future Science… the Synthetic Biology Future Science Platform, and the Responsible Innovation Future Science Platform that take this quite seriously. Aspirations to work with diverse stakeholders are embedded in our research strategies and our impact pathways and they guide us in our approach to science in general.

 

[Image continues to show the same slide on the screen and Lucy can be seen talking in the participant bar at the top of the screen]

 

There are various ways to articulate this vision and there’s lots of scholarships from different research fields that tells us it’s a good idea. The ACOLA Report is a fairly accessible reference that outlines the rationale for seeking broader collaboration as a goal and more broadly the Responsible Innovation literature explains quite nicely through the concept of collected stewardship of innovation and the importance of reflexivity in science. So, I’m going to keep coming back to this concept of reflexivity quite a bit in this presentation and for this purpose I’m going to interpret it as a continual reflection and learning, or a professional self-awareness. Jack Stilgoe calls it, “Being able to hold up a mirror to our own activities, commitments and assumptions”, and I’m going to keep coming back to this throughout the talk. Here we go.

 

[Image changes to show a Spectrum of Engagement table comparing the intention and process on the vertical side of the table with the increasing impact on decision-making on the horizontal side and Lucy can be seen in the participant bar talking, and text headings appear: Spectrum of Engagement, Increasing Impact on Decision-Making, Inform, Consult, Involve, Collaborate, Empower, The aspiration is to involve, Often we consult (sort of). Reflexivity]

 

So, let me just change that, so here’s a fairly famous spectrum of engagement. You might have come across this spectrum before. These are simply different ways of communicating engagement, engagement styles you might call them, and the further you go down the far right side of the spectrum, the more impact there is on the decision making that occurs. The aspect that I’d really like to highlight in this spectrum is the bottom row which reflects our part of the public participation bargain. So, the extent to which we use and act upon the data that we collect. That, the process row, the row above, we might call our goal, or our aspiration, and the bottom row, we might refer to as the action row. So, generally speaking, and I am making some generalisations, in the SynBio research community globally we’ve got an aspiration to involve. I don’t think that’s controversial. Sometimes we might hear of aspirations to collaborate but often when that does happen in both cases for involving or collaborating, as an aspiration, there isn’t much detail about how we might do that, that action component.

 

Often in applied research we just get to consulting. So, we don’t actually get as far as involving or collaborating. Reflexivity happens when we manage to get further down that spectrum because it demands that we take action with the information that we gather but there are fairly substantial challenges for the SynBio community to move our engagement down, further down the spectrum, and I’ll talk about those in the next slide.

 

[Image changes to show a new slide and Lucy can be seen talking in the participant bar at the top of the screen, and text appears on the slide: Engagement practice in (synbio) science, Tends to be bound by discipline or domain, drawing from past experience, Likely to be informed by risk management approach; GM legacies; imagining publics as hostile or ignorant, Often focussed at project-level, Not to be confused with outreach/education which occurs in pockets, at small scale, and is often one-way communication, How do we move past these limitations?, How do we utilize our capability and resources to add value to our science]

 

So, I’m going to make some generalisations here that might ruffle a few feathers. On the whole, we take a domain or disciplinary approach to informing the way that we engage with the public. So, generally if you’re a social scientist you might be wanting to test theory or concepts, or gather empirical data, or analyse that data. If you come from bioscience you might want to approach engagement with a goal to improving science literacy. You might want to communicate your innovation to others, or you might seek to understand public perspectives about the innovation that you’re working on. But a large driver of the way that we can see the engagement in synbio has been our previous experience, and some say quite a poor track record in the way that we engage on the topic of biotech and GM in the early 2000s.

 

So, there is to some extent a preoccupation with not repeating the mistakes of the past, and that’s legitimate, and sometimes that gets us into the trap of imagining publics as hostile or ignorant. And perhaps now we’re seeing a type of overcompensation effect where inclusion and participation is held up as the goal but we haven’t quite yet stepped back and considered how we might be able to achieve that in an organisational sense. Another influencing factor to our approach to engagement is our adoption to, to apply, or adoption of a risk management approach to synbio where the goal can be to minimise risk, or mitigate, or manage risk. Yet none of these legacies are useful in reaching our goal of inclusion of diverse perspectives and incorporating broader societal concerns into our science planning.

 

[Image changes to show a new slide showing an Environmental Science and Policy article on the right of the screen, Lucy can be seen talking in the participant bar at the top, and text appears on the left: Responding to the engagement gap, Institutional reflexivity (Smith et al., 2021; Macnaghten and Chilvers, 2014; Wynne 1993, Knowledge engagement (Harley et al., 2019), Problem of scale? (Lovbrand et al., 2011)]

 

There’s emerging scholarship in articulating this problem and looking at ways to address it, especially in the context of gene drive for invasive species control. Gene drive is a great example to scrutinise engagement science and practice because it’s disruptive in that it aims to make systematic changes, not just to biological systems, but also to socio ecological systems. Another example that I think fits well into this disruptive technology category might be synbio derived protein foods, in that that application you’re affecting food systems changes. So, the shift is also there potentially disruptive.

 

These applications raise challenges for the science community and this slide shows just a couple of examples of the literature in that space. Sarah Hartley and colleagues and others before her in other contexts have suggested that a shift from viewing engagement as public engagement where you can fall into the trap of not quite knowing who that public might be, and instead to think about engagement as knowledge engagement where your interactions with communities, publics, and stakeholders are based on knowledge exchange, that approach might then more easily lead you to achieving the transdisciplinarity goals where science knowledge is viewed as one type of knowledge across many different types. And I think also to some extent that might help break down some of the hierarchies and laws that science tends to build up in the way that it communicates and conducts research. So, there are multiple ways of doing engagement better and the trick I think for us, or the challenge for us is to find the strategies that best fit.

 

[Image changes to show a new slide showing a diagram showing linked circles on the left representing an ideal project, linked by a series of arrows labelled “Contributes to”, What happens next”, “Leads to”, to a star symbol at the end representing Good research impact, and text headings appears: Good science practice, Good research governance, Science scholarship; capabilities built, Informing new research programmes, Informing government and industry, Enhanced understanding of stakeholder perspectives, New research partnerships]

 

So, here’s a bit of a thought experiment. Say you’ve got an ideal project. So, this ideal project is fully integrated in that perhaps it’s interdisciplinary in its design, it’s sufficiently resourced, it’s implemented as close to responsible science principles as possible, and that project then is replicated in that, in the sense that you’ve got multiple of these ideal projects then delivered, and they lead to a host of outcomes. Science scholarship is the most obvious one, a building of capabilities, you might be in a position to inform new research programmes, or new partnerships, and you might have an enhanced understanding of stakeholder perspectives. That’s what we might call good science practice.

 

But what happens next, that’s the challenge. So, good science practices including how and with whom we engage is not sufficient to meet the engagement goals. We also need to reflect on how the knowledge and perspectives shared through engagement are taken into consideration and translated into actions that reflect that output. That might, we might call that bit good research governance and it’s only after that point that we might be able to achieve research impact. So, this is a challenge across many domains of science, not just synbio.

 

[Image changes to show a new slide on the main screen and Lucy can be seen talking in the participant bar in the top of the screen, and text appears on the slide: What might be needed to add value to our science?, Knowledge synthesis – across any program of work, what are our key research findings?, Knowledge translation and brokering – what does this information mean for how we plan our science?, How best do we incorporate this information?, Embedding and responding – How do we adapt our science and respond to our contributors?, How do we meet our commitment to use the knowledge collected?, What are the unique organisational structures we have available?, What do we already do well?, Creating partnerships, Increasingly more diverse and inclusive engagement processes, Value transdisciplinarity (ie integration of different knowledge systems beyond academia), Experiment with interdisciplinarity]

 

So, what might be needed to add value to our science. There are a couple of ideas around this. One of them is to use a kind of a step wise process in synthesizing, translating, and embedding the knowledge that we gather through public engagement. So, in a synthesis step we might ask across programmes of work what are our key research findings. And then we try and make sense of that. So, what does this information mean for how we plan our science and how best do we incorporate this.

 

And then there’s got to be this kind of final embedding step I think in asking ourselves how we adapt our science and respond to our contributors. And how do we meet that commitment to use the knowledge that we collect. And that might lead us then to think about what kind of structures are available or instruments are available in our organisation to be able to make that or realise that goal. So, I think we’ve got a lot of good things that we do in the FSP and CSIRO more generally and we have a lot of experience in, for example, creating partnerships with industry and government that might help us meet these goals. We’re increasingly more diverse and inclusive in our engagement processes. I think we generally value transdisciplinarity, or the integration of different knowledge systems before, beyond academia and we’re also pretty good, I think, experimenting with interdisciplinarity.

 

[Image changes to show a new slide on the main screen and Lucy can be seen inset in the participant bar at the top of the screen, and text appears on the slide: Some tough questions to finish, As a science community, what exactly are we seeking from public engagement?, If we are opening up to ‘co-shaping’ of science directions, where’s the entry point?, Who might drive the process (of translating, embedding), how, and at what point?]

 

So, I’m going to now finish up by leaving you with some tough questions. So, three questions, “As a science community, what exactly are we seeking to achieve from public engagement?”. You can ask this question on a range of levels. You can ask it at a project level, and if it is support for the development of a particular technology or application, and for some projects this might actually be OK, there are some risks to doing this. If it’s an instrumental outcome that we’re after in the process of engagement, so an acceptance of a technology, in many ways this transactional process is easier to map out but you have to be prepared for a worst possible scenario. These types of processes don’t actually build trust and they can ignore power, and they’re incredibly risky especially in the context of disruptive technologies like genetic technologies.

 

If we’re seeking a more normative or substantive quality to engagement then what’s our entry point for affecting this and what institutional structures or instruments might we use to facilitate the co-shaping of science directions. Is it a governance committee, is it a reference group? So, what are the mechanisms available to us that might allow us or enable us to co-shape our science in the future? And I think the final question that’s often ignored but it’s absolutely critical, a great plan is not, not worth much if we can’t actually implement the plan. So, we’ve got to intentionally resource the vision and there’s a lot of experimentation involved I think when we get to this point. So, I don’t think it’s going to be clear how an embedding process might work until we test drive a selected process and then we can identify the challenges and bottle necks that pop up but it’s got to be resourced and we’ve got to have kind of dedicated people, for example, working on the task, on the challenge.

 

[Image changes to show a new slide on the main screen and Lucy can be seen talking in the participant bar at the top, and text appears on the slide: Thank you, Synthetic Biology FSP, CSIRO Land and Water, Dr Lucy Carter, +61 418 227 978, lucy.carter@csiro.au, Acknowledging colleagues who help refine my thinking, Aditi Mankad, Liz Hobman, Bruce Taylor, Samantha Stone-Jovicich, Simon Fielke, Walter Okelo, Andrea Walton, Justine Lacey, Llana Williams, Michaela Cosjin, Erin Bohensky, Rod McCrea]

 

So, I didn’t, so I had an acknowledgement slide up front because I always forget the acknowledgement slide at the end. Here, I’m acknowledging a whole group of people that helped me kind of refine and, and make clear the language that I used in this presentation. So, thank you to a whole range of people there on that list and I’m going to hopefully successfully stop sharing but still remain in the meeting.

 

[Image changes to show Lucy listening on the main screen, and then the image changes to show Aditi talking on the main screen and the participant bar can be seen in the top of the screen]

 

Dr Aditi Mankad: Thanks very much Lucy and I would encourage any biophysical scientists who kind of are curious about engaging with social scientists around their work to add some questions. So, I’ll get the ball rolling just as a clarifying question. What’s the difference between public stakeholders and communities for clarity?

 

[Image changes to show Lucy on the main screen talking and Aditi can be seen listening in the participant bar at the top of the screen]

 

Dr Lucy Carter: That’s a good question. Thanks Aditi. And I don’t have an easy answer. So, there are different ways to categorise stakeholder groups. Even among social scientists if you ask this question you’ll get different answers. It really does depend on the approach that you are using. So, are you trying to manage risk, or are you seeking to engage to make your science better? Most commonly, differentiated by a level of influence, these stakeholder groups might be, the level of influence in relation to the decision that’s being made or their level of interest, or their closeness to the outcome for example.

 

But oftentimes communities are identified in terms of their geographical position to a problem, but we know that that can be quite a simplistic way of identifying communities because attachment to an issue can manifest in a number of ways. So, for example you can care deeply about the Great Barrier Reef, but you might not live anywhere near it. So, they’re, they’re roughly I think in my opinion, and people on the call will have different opinions about this, but they are to some extent arbitrary categorisations that are useful for particular approaches to data collection but are less useful for thinking about deliberative engagement.

 

Dr Aditi Mankad: OK, thank you.

 

[Image changes to show Aditi talking on the main screen and Lucy can be seen listening in the participant bar at the top of the screen]

 

We have a question from Alison, or a comment really, “An approach that has been successfully used in the medical research sector is the inclusion of patients in the development, design, and evaluation of research applications. This has led to authentic engagement that has driven innovative research”.

 

[Image changes to show Lucy talking to the camera on the main screen and Aditi can be seen listening in the participant bar at the top of the screen]

 

Dr Lucy Carter: Yeah, totally, totally. Alison I would just agree with you so much. I think the Health sector are masters at research translation and they’ve been doing this for years. There are research institutes set up just for translating, you know, from lab to clinic, to health prevention for example. I think it helps if you have a service mindset, and a general commitment to social justice. I think that helps the Health sector in, in managing translation really well. So, I think we could learn a lot from the Health sector’s approach to public engagement and research governance more broadly. So yeah I, I just totally agree with that. They… we’ve got a lot to learn I think from that sector.

 

[Image changes to show Aditi talking on the main screen and Lucy can be seen listening in the participant bar at the top of the screen]

 

Dr Aditi Mankad: Thanks Lucy. And another comment from Andrew, “Unfortunately some publics actually are hostile and/or ignorant like the framing of knowledge exchange because that brings the discussion into a more factually based domain where an informed discussion or consultation can take place”.

 

[Image changes to show Lucy talking to the camera on the main screen and Aditi can be seen listening in the participant bar at the top of the screen]

 

Dr Lucy Carter: Yeah, I agree. Sometimes publics are hostile. I don’t know if I’d say publics are ignorant, I think that’s a philosophical position I won’t agree with. But I think the point I’m trying to make is that we do ourselves a disservice if we label all publics as hostile even in contested spaces. I think that’s where we go wrong. I think there are good reasons, justifiable, perhaps not justifiable but understandable reasons why we do that, why we make those assumptions particularly in the synbio space. But I think it doesn’t help us and we know now even from our own work in the Maximising Impact Domain, that generally there is support for synbio applications, generally. I mean, you know, there’s a lot of caveats with that but we know that it’s, we can’t label publics or groups of individuals as hostile because it doesn’t put us in the right position to do things like that knowledge exchange. I do agree with that, with that conceptualisation of engagement. I think it’s really helpful to look at that as a starting point.

 

[Image changes to show Aditi talking on the main screen and Lucy can be seen listening in the participant bar at the top of the screen]

 

Dr Aditi Mankad: Great thank you. It doesn’t look like there are any other questions. OK, so we might then wrap it up. There was one unanswered question I think from Michelle’s presentation which she has subsequently answered within the Chat to Christine, if Christine’s still on the line.