Why critiques of SynBio

from NGOs and civil society need to be taken seriously

by: Conor Douglas, PhD

 

Earlier this month a report entitled ‘The Principles for the Oversight of Synthetic Biology’ was released by a collection of NGOs and civil society organizations, which outlines ‘principles necessary for the effective assessment and oversight of the emerging field of synthetic biology’ (2012: 1). The emergence of yet another such a report outlining principles for oversight is not really blog-worthy in-and-of-itself as the grey literature on the governance of SynBio is well stocked with similar outputs. What is blog-worthy about this particular report is that it comes from the NGO Friends of the Earth, and their +100 signatory friends, which includes the ETC Group. Those following the public policy debates on SynBio will be aware of the ETC Group and their critical –and often referenced- position, which came first in their report The New Biomassters – Synthetic Biology and the Next Assault on Biodiversity and Livelihoods.

Unfortunately the headlines that this report is generating tend to centre on the ‘moratorium on the release and commercial use of synthetic organisms, cells, or genomes’ (2012: 3) until a series of conditions are met. Added to this regrettable treatment are the kinds of inflammatory responses science writer Elizabeth Pennisi is reporting: 

…Brent Erickson from the Washington, D.C.-based Biotechnology Industry Organization (BIO) calls the report absurd. “[With] the shrillness of its tone and its lack of objectivity, I don’t ‘think it’s really helpful to policy-makers and the public.” He points out that synthetic biology is in many ways a relabeling and evolution of biotechnology that’s been going on for decades. While he agrees that existing rules and regulations may eventually need upgrading, “it’s not like we don’t have experience in dealing with those organisms,” he points out. “There are a lot of safeguards in place.”

This is a double-whammy shame because 1: Erickson’s response only works to polarize the debate and further incense the civil society signatories of the Principles document; and 2, which is perhaps more important: focusing on the call for a moratorium glosses-over the principles themselves that are the core of the report.

This blogger shall not be so careless; the principles outlined in the Principles for the Oversight of Synthetic Biology are as follows:

I. Employ the Precautionary Principle

II. Require mandatory synthetic biology-specific regulations

III. Protect public health and worker safety

IV. Protect the environment

V. Guarantee the right-to-know and democratic participation

VI. Require corporate accountability and manufacturer liability

VII. Protect economic and environmental justice

 

The importance on focusing on points of convergence

Because, the thing is, many of the scientific, policy, regulatory, and funding actors involved in SynBio want the same thing and support many –if not most- of these principles… well, this is more or less true in the European context anyways. In fact it is important to point out that this Principles documents is the product of American and Canadian lead-author NGOs where things like the precautionary principle don’t get as much play. I would hasten to remind our blog readers out there that I made this point about the differences between Europe andNorth America back in 2010 (see below for previous blogs), and this report only seems to hammer the point home.

While I am sure there may not entirely be agreement on how the NGOs articulate the principles in the remainder of the report (including our respective understandings and operationalizations of the precautionary principle), but at least there is some common ground on some basic ideas….WHICH IS CRUCIALLY IMPORTANT…particularly in a debate that runs the risk of serious polarization.

[Worker] safety, environmental protection, democratic participation, accountability and justice, these are all issues that we in the SYBHEL project are exploring when it comes to SynBio for human health, and as a result we are best-off to listen closely to these critiques and explore important areas of convergence rather than focus on high-profile points of divergence –such as the call for a moratorium- that do nothing but sell papers –or increase webpage hit counts as the case may be-  and entrench extreme positions.

 

A point of disagreement?

While one can find considerable overlap in the principles desired by the NGOs and civil society, and the heterogeneous community surrounding SynBio; questions remain on Principle II that would ‘require mandatory synthetic biology-specific regulations’.

The question of whether or not SynBio requires specific regulations is actually one of the central questions driving the SYBHEL project in general, the policy work-package specifically, and something I also addressed in my previous blog-spot. Indeed the American position is for regulatory parsimony when it comes to SynBio; however, part of the problem with this principle as outlined in the report is its positioning of SynBio as a clearly defined and well delineated singular practice. This is not the case, as SynBio represents a set of different approaches and practices that range from bioengineering, to synthetic genomics, protocell synthetic biology, unnatural molecular biology, and in silico synthetic biology. As a result, if there aren’t practices that are SynBio-specific, how would policymakers go about making ‘synthetic biology-specific regulations’?

What is more, there isn’t particularly good evidence that governmental regulations are uniquely effective in promoting safe, secure, fair and just science and technology. While the Principles report is correct in stating that ‘voluntary self-regulation by practitioners is not a substitute for synthetic biology-specific regulations enacted by governments and international treaties.’ (2012: 4); the report fails to note that the bio-security codes of conduct produced by and for gene synthesis companies set a higher regulatory standard than the code offered by the American government. This is a point that Prof. Stephen Maurer has made quite nicely in his work on self-governance (see his book Regulation Without Government: European Biotech, Private Anti-Terrorism Standards, and the Idea of Strong Self-Governance).

What is therefore required for sensible policy progress on this issue is an overview of the current regulations that could pertain to the entire diverse set of SynBio practices, and a subsequent evaluation of the ability of those regulations to deal with these diverse sets of practices. If and when there are gaps between regulations and practice, then new regulation is warranted. I think everyone would agree on that. We should also note that this review of the existing regulations was a recommendation given by the European Group on Ethics of Science and Technology in their Opinion on SynBio in 2009 (i.e. Recommendation 13 on page 52). This is a massive undertaking there is no doubt, but the European Commission is pretty massive, and doing so might go some way in addressing some commonly held concerns which could work to unify -rather than- splinter public discussion on SynBio oversight and governance.

PREVIOUS BLOG November 24^th, 2012

 

Craig Venter Presentation in Rotterdam – Some Policy Questions Left Unanswered

If you have any interest  in SynBio then it is likely that you are to follow closely the moves of Craig Venter and his various institutes, companies, and centres. The biotechnology powerhouse has not only been a central player in SynBio with his flashy announcement of  the ‘creation of a bacterial cell controlled by a chemically synthesized genome’ (Gibson et al. 2010), but was centrally involved in the sequencing of the human genome.

But of course you know all that.

What you may not know is that on November 22nd The Netherlands Genomics Initiative (NGI)  held its 11th annual ‘Life Sciences Momentum’  in which -among other things- ‘the man himself’ gave a keynote presentation ‘From Reading to Writing the Genetic Code’ as a part of his address as the NVBMB (The Netherlands Society for Biochemistry and Molecular Biology) Speaker of the Year 2011.

The NGI is the financial infrastructure behind the major genomic centres that consolidate and drive research and development in this area in The Netherlands, and the ‘Life  Sciences Momentum’  is an event that offers ‘a platform on which the Netherlands’ Life Sciences sector has the chance to take stock of the current situation, look at best practices, and make plans to move forward.’ (http://www.momentum2011.nl/about.html accessed November 24th, 2012).

While this was a special opportunity to hear one of the fore-runners in the field of SynBio speak publicly, I was somewhat disappointed by the number of policy-related questions that were not only left unanswered, but due to the somewhat hokey format of an interview with a not that informed newspaper science editor (which was no fault of Venter’s), also were left unasked.

In the absence of a proper Q&A at Venter’s talk I thought I would use this format to explore some of the issues that I felt deserved some attention.

To start, it is important to get a feel for the context and content of not only Venter’s presentation, but also of his
co-keynote Feike Sijbesma CEO Royal DSM N.V.  [i.e. a life-sciences juggernaut in its own right yielding  revenues in the area of 9billion plus euros in 2010 from its work in nutrition, pharmaceuticals, performance materials and polymer intermediates  http://en.wikipedia.org/wiki/DSM_(company)].

Basically a thumb-nail sketch of all of the world’s problems were laid-out in front of us: problems related to food shortages, dangers related to climate change, deaths resulting from diseases, scarcities of sources for energy, all major issues facing the entire globe.

SynBio, and its various potentialities and products, was positioned as a (partial) answer to all of these issues.

Very dramatic, very emotive, very rhetorical.

The first thing that struck me was that social and behavioural change needed to alter the current habits that have gotten us into this mess in the first place were largely not discussed. No talk of reducing energy consumption (like riding bikes instead of driving cars); rather, use SynBio microalgae to make better biofuel. No  discussion of altering our throw-away culture that buys and replaces goods in historically unparalleled fashion; rather, develop SynBio to improve materials technology to get us off carbon-based plastics. Forget reducing individual or industrial pollution, or change your diet to eat locally produced organic fruits and veg; instead focus on micro-organisms to deal with those pollutants and engineer foods in ways that goes way beyond conventional GM or plant breeding.

So it was all a very technocratic approach to dealing with the grand challenges our world faces. We were at the NGI annual  event, these guys are in biotech, perhaps I shouldn’t have been (and really I wasn’t) surprised.

One of the other things that struck me was how both speakers were able to brush off any consideration about a future in with synthetic humans (or humans with synthetic genomes). Both speakers claimed that there was no desire to do this, and therefore it should not and will not happen; but Venter did agree that it could be technically possible by 2050. I didn’t understand how they could so easily dismiss all of the discussion around human enhancement  (which would be possible through alterations in the human genome) that is so prominent in much ethical discourse on SynBio?

Even if we ignore this issue of human enhancement (which we should not, which is why I raise it here) and accept this technocratic approach to solving the world’s problems, there were some issues about the details of a SynBio future that were noticeably absent – namely the role of patents and policies related to them.

Venter did take considerable time to explain how his team was able to transplant an entire Mycoplasma mycoides genome (from a digitize genome sequence) into an M. capricolum cell ‘to create new M. mycoides cells that are controlled only by the synthetic chromosome’(Gibson et al. 2010). What he took no time to explain was how and why his affiliated Synthetic Genomics Inc. (SGI) has chosen to apply for patent protection of the self-replicating synthetic bacteria?

According to the Craig Venter Institute (JCVI) websiste,

Over the course of the 15 years it has taken to construct the first self-replicating synthetic bacterial cell, the team at JCVI has had to develop new tools and technologies to enable this feat. SGI has funded the work at JCVI in exchange for exclusive intellectual property rights. SGI has filed 13 patent family applications on the unique inventions of the JCVI team. SGI believes that intellectual property is important in the synthetic genomics/biology space as it is one of the best means to ensure that this important area of basic science research will be translated into key commercial products and services for the benefit of society. SGI intends to provide licenses to its synthetic genomics patents.(http://www.jcvi.org/cms/research/projects/first-self-replicating-synthetic-bacterial-cell/faq/#q11 accessed November 24^th, 2011)

Really? ‘One of the best means’ for ensuring translation? I wonder what some of the other best means might be?

The main reason I sought explanation and discussion on this patent issue is that large parts of the diverse and diffused SynBio ‘community’ are dedicated to working with freely available and freely accessible information on biological parts necessary for the advancement of this bourgeoning field. This dedication has taken its most visible form in the BioBricks Foundation (BBF). In contrast to SGI’s position that, the BBF is

…dedicated to advancing synthetic biology to benefit all people and the planet. To achieve this, we must make engineering biology easier, safer, equitable, and more open. We do this in the following ways: by ensuring that the fundamental building blocks of synthetic biology are freely available for open innovation; by creating community, common values and shared
standards; and by promoting biotechnology for all constructive interests.  (http://biobricks.org/ accessed November 24^th, 2011)

I would have been very interested to hear how Venter thought this difference could (or would) be reconciled? I would have been interested as to what he would tell young SynBio students who use parts found in BBF for the International Genetically Engineered Machines Competition and deposit their results into the BBF?

Further, I would have liked an explanation as to why the SGI thought ‘that intellectual property is important in the synthetic genomics/biology space as it is one of the best means to ensure that this important area of basic science research will be translated into key commercial products and services for the benefit of society’ (http://www.jcvi.org/cms/research/projects/first-self-replicating-synthetic-bacterial-cell/faq/#q11 accessed November 24^th, 2011), particularly when large components of the SynBio community are taking an approach that is diametrically opposed to patenting?

Venter and the JCVI are very clear about their  ‘private, not for profit status’, but that status is conflated by the fact that he is the  Co-Founder, Chairman, CEO, Co-Chief Scientific Officer of SGI.

Findings from ourSYBHEL workshop hosted by the Rathenau Instituut on SynBio, European policy, and governance this past spring in Brussels suggested that the issues surrounding intellectual property are one of the main governance challenges facing SynBio in its attempt to develop applications in human health.

Unfortunately this issue does not seem to be enough of an agenda item to be discussed by one of the main movers-and-shakers in SynBio, at one of the largest genomics-based events in Europe. A failure to discuss –let alone- mention it as such does little to ‘make plans to move forwards’ on policy reconciliation between the open source and IP protection positions that stand to strangle SynBio.

 

PREVIOUS BLOGS

WHY THE NOVELTY OF SYNBIO HEALTH PRODUCTS SHOULDN’T NECESSARILY MATTER FOR POLICY

October 5^th, 2011

Conor Douglas is a Post-Doctoral Researcher at the Rathenau Instituut in The Hague. He is a social scientist, and member of the SYBHEL project team.

The current regulatory discourse surrounding SynBio is trending towards a series of positions that centres on a debate about the novelty of SynBio practices and products. These positions can be crudely summarized as either:

(a) there is nothing ‘new’ or novel about SynBio, and therefore the existing regulatory measures that are in place to deal with the safety of other medicines or genetic modifications, or legal issues surrounding intellectual property, are sufficient for the task at hand;

(b) there is something new, or particular, about SynBio, but the existing regulatory measures are sufficient to address this novelty; or,

(c) there is something novel about SynBio, the existing regulatory measures are insufficient, and as a result some policy actions need to be taken.

The first two positions basically argue that while there may be future risks, this is an emerging techno-science, and as a result the current institutional arrangements, legislation, policy and regulations are sufficient to deal with the current health applications related to SynBio. After all, the European Medicines Agency exists to evaluate the safety (and efficiency) of medical products, and the Advance Therapy Medicinal Products regulation was specifically designed to deal with prospective and emerging health technologies that can be slippery to pin down in one regulatory category or another.

Whereas the third position stresses the miss-match of old policy and new scientific practices.

The problem that I have with this entire discourse is that is hinges on the issue of novelty.

For me, the novelty of SynBio practices and products is of course an important factor when assessing the adequacy of current governance mechanisms, but novelty certainly is not a necessary or sufficient characteristic upon which this assessment should be based.

The reason I don’t find the ‘novelty issue’ to be particularly helpful is that it operates on the assumption that the existing tools that can be drawn-on to govern SynBio (e.g. genetic modification regulations, medicines licensing practices, or legislation for intellectual property claims on biological materials) actually function adequately for the targets they were originally intended for.

Due to the fact that convincing arguments and empirical research have been made about the failure of the current legislation to deal with these ‘older’ scientific issues and products like genetic modification (e.g. Meyer 2011) and/or on the ability of the
existing European patent system to foster responsible innovation in the life-sciences (e.g. Calvert 2008), it doesn’t make a lick of difference whether SynBio practices and products are novel or not.

In fact this novelty discussion might just be a distraction, or misallocation of our intellectual resources, diverting us from tackling the very real issues facing SynBio for human health.

I realize that as I write this blog I too am guilty of being drawn into the novelty debate surrounding SynBio, but at the very least this is done so knowingly and in an attempt to steer the discussion away from novelty and towards the issues at hand….like how two distinctive scientific cultures of molecular biology and computer science are coming to ahead on issues of intellectual property with the Craig Ventres of the DNA world actively pursuing patent protection for biological parts that could be instrumental in SynBio product development, and the Dew Endys of the bio-engineering world constructing open access repositories for similar biological parts.

This is, one of the many, real issues facing SynBio. Let’s think about how it is going to play out, and what kind of policy interventions (if any) are necessary; rather than arguing about whether or not this is something new and specific to SynBio.

 

Bakker van Eeklo by Cornelis van Dalem en Jan van Wechelen (17th century) depicts
wealthy patrons coming to have their heads removed and ‘re-baked’ for their
revitalization. Thanks to Prof. Oscar Kuipers for making the links between this
painting and parts-based approach of SynBio. Image courtesy of wikidpedia: http://nl.wikipedia.org/wiki/Bakker_van_Eeklo

REFERENCES

Meyer, H. (2011) Systemic risks of genetically modified crops: the need for new approaches to  risk assessment. Environmental Sciences Europe. 23:7.

Calvert,J. (2008). The Commodification of Emergence: Systems Biology, Synthetic Biology and Intellectual Property. BioSocieties
3: 383-398.

 

Special Regulation for SynBio? : Differences Between US and Europe.

January 20^th, 2011.

The much awaited report on SynBio from the Presidential Commission for the Study of Bioethical Issues (PCSBI) was released on December 16^th , 2010 (http://www.bioethics.gov/news/ ). For all of you who read the previous blog in this section, I was curious about what would come of this PCSBI report. I asked openly: “when contemplating risks and policy, and exploring social and ethical issues related to synthetic biology, are American bioethical issues the same as everyone else’s ?”

It is clearly not the scope of this blog to try and review all of the similarities and differences between the US and –for instance- Europe when it comes to their bioethical priorities. However, this science policy blogger is particularly interested in the views of the respective ethical commissions and groups with regards to the need for special and specific regulations for SynBio.

In their letter to the President at the outset of the Report the Chair of the PCSBI concluded that  “synthetic biology is capable of significant but limited achievements posing limited risks. Future developments may raise further objections, but the Commission found no reason to endorse additional federal regulations or a moratorium on work in this field at this time. Instead, the Commission urges monitoring and dialogue between the private and public sectors to achieve open communication and cooperation.” (PCBSI 2010: vii).

Later on in the Report when the PCSBI discusses the ethical principles of intellectual freedom and responsibility for assessing an emerging technology like SynBio, they state that “the Commission endorses a principle of regulatory parsimony, recommending only as much oversight as is truly necessary to ensure justice, fairness, security, and safety while pursuing the public good” (PCSBI 2010: 5).

Hmmmm.

I don’t even know how to start to translate that and break-down what parsimonious regulation means, or what they mean by ‘truly necessary’ or their definitions for vague concepts like ‘justice’ or ‘the public good’.

While leaving the latter for another blog, the former reference to  ‘regulatory parsimony’ would seem to support their earlier statement rejecting the need for ‘additional federal regulation or a moratorium on work in this field’.

So that is the American ethics position on special regulation for SynBio, is the European one any different?

Luckily we have the European Group on Ethics in Science and Technologies (EGE) Opinion on Synthetic Biology from 2009 to compare (http://ec.europa.eu/european_group_ethics/docs/opinion25_en.pdf )

On the specific point of existing regulation at the EU level the EGE also feels that much of the existing tools used for genetic modification and genetically modified organisms will also apply to SynBio.

Most of the work in synthetic biology falls within the remit of Directive 98/81 which deals with the contained use of genetically modified micro-organisms. It regulates the contained use of genetically modified microorganisms (GMM) and therefore has environmental and human health protection purposes as stated under Article 1 of the Directive (This Directive lays down common measures for the contained use of genetically modified micro-organisms with a view to protecting human health and the environment.) (EGE 2009: 27-28)’.

However, the EGE doesn’t go quite as far as to suggest ‘regulatory parsimony’. Rather, when it comes to regulations and governance more generally – to which regulation is just one element – the EGE  ‘expresses its concerns on the existing fragmented regulatory framework, which may not be sufficient to properly regulate current and emerging aspects of synthetic biology. It also stresses the need to explore a proper model of synthetic biology governance (soft law, codes of conducts etc.), also taking into consideration potential risks of delocalisation of research trials in countries where regulation may be less stringent than the one proposed in the EU (EGE 2009: 53)’.

Hmmmmmm…‘ delocalisation of research trials in countries where regulation may be less stringent than the one proposed in the EU’, could they be talking about the US? It is well known that the American’s have a much different view on GM than in Europe.

That aside, it would seem that the EGE is indeed suggesting that SynBio is somewhat different, and does indeed require special attention.

This might have something to do with 2009 Nuffield Council’s background paper on SynBio that the EGE references. The EGE notices that ‘under the current regulatory framework, risk assessments of genetically modified organisms (GMOs) compare the altered organism with the natural organism on which it is based, considering the individual traits introduced. Synthetic biology will produce organisms with multiple traits from potentially several different donor organisms. The use of an artificially expanded genetic information system or the insertion of multiple genetic traits or the synthesis of new synthetic biology products, while not excluded per se in the EU biosafety framework may not provide sufficient reliability to the risk assessment and analysis framework (EGE 2009: 29)’.

So while SynBio products will be subject to GM legislation, the very nature of SynBio –and its production of novel organisms- may mean that GM legislation is not enough.

What is perhaps even more interesting than the differences between American and European ethics commissions/groups is that the position of the EGE seems to be in-line with how European citizens feel about SynBio. According to the most recent Eurobarometer (2010) -which regularly takes the pulse of the views of Europeans on matters of science and technology- when asked under what conditions SynBio should be approved  ‘a substantial percentage across Europe (23 per cent) say they don’t know… The remaining respondents, however, are willing to voice a view despite the technology’s unfamiliarity. Some (17 per cent) say that they do not approve under any circumstances and 21 per cent do not approve except under very special circumstances. More than a third (36 per cent) approve as long as synthetic biology is regulated by strict laws and only 3 per cent fully approve and do not think that special laws are necessary. Overall, it seems safe to say that Europeans consider synthetic biology a sensitive technology that demands for precaution and special laws and regulations, but an outright ban would not find overwhelming support (Gaskell et al. 2010: 33, my emphasis)”.

The extent to which these are cultural difference between the biotech-leading American’s and a Europe that favours the precautionary principle is unclear, but the differences are there. In one of their official recommendations the ‘EGE [p]roposes that the EU takes up the question of governance of synthetic biology in relevant global fora (EGE 2009: 53)’.

I wonder if the Americans and the PCSBI would show up to such a global fora?

Stay tuned to this space for more on SynBio policy.

Conor Douglas,  January 20^th, 2011.

Conor Douglas is a Post-Doctoral Researcher at the Rathenau Instituut in The Hague. He is a social scientist, and member of the SYBHEL project team.

References

The European Group on Ethics in Science and New Technologies (2009) Opinion to the European Commission on the ethics of synthetic biology. No 25 17/11/2009.

Luxembourg: Publications Office of the European Union. Also accessible at http://ec.europa.eu/european_group_ethics/docs/opinion25_en.pdf

Presidential Commission for the Study of Bioethical Issues (2010) New Directions: The Ethics of Synthetic Biology and Emerging Technologies. Washington, DC. Also accessible at: http://www.bioethics.gov/documents/synthetic-biology/PCSBI-Synthetic-Biology-Report-12.16.10.pdf

Gaskell, G.  et al. (2010) Europeans and biotechnology in 2010: Winds of change? Luxembourg: Publications Office of the European Union. Also accessible at: http://ec.europa.eu/research/science society/document_library/pdf_06/europeans-biotechnology-in-2010_en.pdf

 

International Risk Governance Council Report to Inform US Presidential Commission for the Study of Bioethical Issues’ Report on SynBio: Thanks, But Are American Bioethical Issues the Same as Everyone Else’s ?

By Dr. Conor Douglas – Postdoctoral Researcher at the Rathenau Instituut and member of the SYBHEL project team

December 8^th, 2010

Two Innogen researchers (Heather Lowrie and Joyce Tait) have recently published a report ‘Risk Governance of Synthetic Biology’ that will be used as background reading for the US Presidential Commission for the Study of Bioethical Issues (PCSBI) that is preparing recommendations for the President concerning synthetic biology, to be published by the end of the year (see the press release from the Innogen website on November 30^th at http://www.genomicsnetwork.ac.uk/innogen/news/latestnews/title,24203,en.html and see below post-script for more information on Innogen and the International Risk Governance Council)

There is no doubt international attention will be given to the synthetic biology report from the US PCSBI that Lowrie and Tait’s report will contribute to. After all The Commission advises the President (i.e. Mr. Obama) on ‘bioethical issues that may emerge from advances in biomedicine and related areas of science and technology’ (see http://www.bioethics.gov/ ), and will deliver the report on synthetic biology to ‘The Man’ himself in about a months time.

But the question has to be asked, when contemplating risks and policy, and exploring social and ethical issues related to synthetic biology, are American bioethical issues the same as everyone else’s ? While the ‘Risk Governance of Synthetic Biology’ report works to identify possible areas of ‘risk governance deficits’ in the hope that such deficits could be avoided if and when knowledge and products resultant from synthetic biology begin to roll out of lab and company doors, it also reflects a certain tension in thinking about risk governance for science. For instance, the Report notes that bio-security risks resultant from synthetic biology are particularly sensitive to the US (Lowrie and Tait 2010: 6). This is not to say that such bio-security concerns are irrelevant in Europe; rather, they are just not the same kind of priority issue as they are in a Post 9-11 America.  And it is these international differences that might stifle the utility of PCSBI’s recommendations for synthetic biology outside of the U.S. of A.

The authors of the report hit the nail on the head when they state that “ [t]he difficulties that arise from piecemeal and divergent national approaches to the regulation of innovative technology in life sciences were very apparent in the case of GM crops, and this experience offers lessons for synthetic biology. However, these lessons are more complex than merely ‘more and earlier stakeholder engagement’ [Tait, 2009b]. “(Lowrie and Tait 2010: 17)

Indeed, they are more complex…and that complexity goes beyond the fact that “[d]ifferent issues arise (i) for the early- stage regulation of fundamental research in synthetic biology and (ii) for the regulation of the products of synthetic biology as they come to trial and market. Ideally, both should be co-ordinated at an international level.” (Lowrie and Tait 2010: 17)

There are numerous reasons for divergent national approaches to the regulation of novel techno-science, which range from differences in how  national economies are organized (i.e. do they care about GM because they are French farmers? VS. do you care about bio-security because your economy is driven by a military-industrial-complex), to how expert advice science policy is sought and delivered (see Jasanoff 2005 Designs on Nature), to relative levels of publics engaging with science and technology ( see Hansen 2010 Biotechnology and Public Engagement in Europe).

I guess my point is that while the idea of coordinated international governance and oversight on issues like synthetic biology could facilitate the regulatory game, it is not only highly problematic to try and execute, but it is also questionable as to its desirability.

This point is particularly salient to the SYBHEL project, and the 6^th work package that seeks to provide policy implications for synthetic biology at the European level. So stay tuned to this site and this blog for more about how that works out. There is no doubt that for things like the licensing of new medical devices or medicines, European-wide regulation is needed for SynBio. However, foreseeing uniform reactions of European countries to those novel medical devices or medicines -that for instance make use of human-made living organisms-  is as unlikely as the applicability of American ethical issues on European soil.

So it will indeed be interesting to see the Presidential Commission for the Study of Bioethical Issues (PCSBI) report concerning synthetic biology. Will it contain ethical issues that are universally relevant for synthetic biology? Will it contain issues pertinent to global health? Or will it reflect an understandably American-centric approach to the field?

I guess we’ll see. Stay tuned.

{end}

Post-Script

Heather Lowrie and Joyce Tait  belong to the Innogen group at the University of Edinburgh is the Centre for Social and Economic Research on Innovation in Genomics that is part of the British  Economic and Social Research Council ESRC, which was formed in October 2002, it is part of the ESRC Genomics Network.Their work on the  ‘Risk Governance of Synthetic Biology’ report  (which can be viewed at http://www.irgc.org/IMG/pdf/IRGC_Concept_Note_Synthetic_Biology_191009_FINAL.pdf ) was made possible by the International Risk Governance Council (IRGC), who ‘is an independent organisation based in Switzerland whose purpose is to help the understanding and governance of emerging, systemic global risks. It does this by identifying and drawing on scientific knowledge and the understanding of experts in the public and private sectors to develop fact-based recommendations on risk governance for policymakers’ (see http://www.irgc.org/ )

Hello all,

for those of you who that had the chance to look through the WP 6 Future Objectives, below are links to articles mentioned there in terms of when to talk to the public (in the case of nano medicine) by Jones 2008, and also included here is the link to the British Market Research Bureau report on which the Jones work refers to:

Hyperlinks for the articles are access only, so people may or may not have access:

For Jones 2008 see : http://www.nature.com/nnano/journal/v3/n10/full/nnano.2008.288.html

The nanotechnology for health care can be freely accessed at : http://files.nanobio-raise.org/Downloads/Nanotechnology%20For%20Healthcare%20-%20D_Battachary.pdf

Hope this helps.

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