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Team:KULeuven/Law&Patents
From 2011.igem.org
Law & Patents
1. Introduction
The KU Leuven 2011 iGEM team had the unique opportunity to meet the Policy Officer for Governance and Ethics at the Directorate-General for research at the European Commission in Brussels. Alice Uwineza and Bakul Vinchhi represented the team and had an intriguing talk about self-governance, justice, religion, “do-it-yourself-community” and patents. As a part of a good self- governance practice we would like to share the new insights we gained from some of our questions.
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2. Self-Governance
What are the steps taken by the European Commission to promote self-governance to tackle risks in synthetic biology?
Governance is an overarching concept including legal, political and ethical considerations [1]. It may refer to personal conduct or family units but more commonly refers to larger scale activities, i.e., professions, industry bodies, religions and political units (usually referred to as Local Government), up to and including autonomous regions and aboriginal peoples (or others within nation-states who enjoy some sovereign rights). It falls within the larger context of governance and principles such as consent of the governed, and may involve non-profit organizations and corporate governance [2].
Several initiatives have been taken by the EC to deal with synthetic biology and other new Emerging fields in science and technology. One of the main aims of “The Science in Society Program” at the EC is to promote good governance in research, along with promoting high standards of ethics in research and innovation. There are other action lines about gender equality and science education, but the main focus remains on governance and ethics aspects.
One of the initiatives setup within the EC under joint collaboration is a recommendation that was published on responsible research in nanotechnology, called the ‘Nanocode’. This was an initiative of the member states of the EU to promote self-governance in nanotechnology. Currently, there are plans to promote good governance and ethics in an even broader aspect: a general code of conduct for scientists, but also about some specific activities pertaining to synthetic biology.
At the moment there are no hard laws or even concrete policies about synthetic biology, as no particular issues are foreseen. Safety issues are covered by current regulations on Genetically Modified Organisms (GMOs) in Europe. There is a framework for both ‘contained use’ and ‘deliberate release’ of genetically modified organisms. The current point of view of the European commission is that there is no need to act specifically on synthetic biology and introduce new legislation at the EC level.
However, the field of synthetic biology is followed very closely and any potential risks that could appear with advanced and sophisticated synthetic biology are monitored as there may be a need to change or add some new regulations. The biosafety regulations all over Europe, but also across the world, in the context of GMO’s are based on the fact that a traditional organism is compared to a natural host organism and the further away you move from that traditional natural organism the harder it is to assess the possible new risks. Therefore it will be very hard to compare a completely new, synthetic organism to another organism and assess the risks. This is a potential risk that will have to be addressed by policy in the future. But at the moment the EC’s opinion is that the GMO framework is sufficient to cover synthetic biology.
Governance of synthetic biology
The EC funds research projects that look into the ethical, legal and social aspects of synthetic biology, and more generally funds activities that promote exchange of information about this field. For example two years ago they had a discussion on synthetic biology in a network that is called the NEC forum, the Forum of ‘National Ethics Council’s, a network funded by the EC. In this network the members of the National Ethics Councils of the member states come together to exchange information, opinions and best practices.
Last year, initiated by the European Commission, synthetic biology was also discussed at a global summit of Bioethical advisory bodies. This global summit is coordinated by WHO as the EC works closely together with WHO and UNESCO on exchanging information about this field proactively: scientific, legal, social and ethic aspects are here of importance. The purpose of promoting these activities is to stimulate the idea that the member states themselves can follow up on these activities as there is already an existing formal governance structure. However, it is the purpose that the member states act themselves on soft-law and other kinds of activities, as these issues need to be addressed on a national level. Furthermore a funding instrument called the ‘Mobilization and Mutual Learning Action Plan’ exists at the moment, an ambitious project that attempts to bring together all stake holders and try to let them work on a joint agenda. More specifically if they think that a new technology is emerging, that can cause new controversies, they can talk about the societal ramifications.
Currently the European Commission has an idea to fund a big project in the area of synthetic biology, in which research conducting bodies themselves submit proposals. For example an interesting issue to be tackled is to find ways in which synthetic bio fuels could best be developed in a technically feasible, economically viable and socially acceptable way. The EC wants to set up a framework to support such projects.
The results do not necessarily have to go in a code of conduct. The idea is to create a base, trying to create certain awareness about the societal aspects of synthetic biology and indeed also stimulate an early engagement of society with the field. One of the good things that have come out of the long protected debate about GMOs is that the EC has gained a lot of knowledge on how to organize those type of interactions with society. It is not easy as there is always a certain limitation to what can be done by the EC.
We, the K.U.Leuven iGEM 2011 team, remarked that we also had a debate on synthetic biology and found it difficult to rise the awareness of those people: synthetic biology is really technical. It is indeed a big challenge: the earlier you have this engagement and the earlier you start interaction with the public, the more vague it is. At this stage what one can say about synthetic biology is limited. Therefore it is definitely difficult to really get the attention of citizens: you have to speak about the impact on their daily life, on changes to their daily practice and the gain for them. This was also a lesson that was learnt from the earlier debates on GMOs.
The challenge at the moment is indeed the question “Whether it’s already the right time to reach out to the public?” To address this the EC has been in touch with more professional stakeholders, policy makers, NGOs, and the National Ethics Councils as they are professional representatives of society, are easier to identify, have some more knowledge on this field and can spend some more time in looking into what happened in this field.
Intrinsic vs. Extrinsic Objections
Intrinsic objections involve claims that state that ‘developing and using a certain technology is inherently wrong regardless of the results of doing so’. The others are “extrinsic objections” involving claims that this technology (or action) is not inherently wrong but can be wrong if it causes or contributes to morally unacceptable situations or outcomes [3].
The K.U.Leuven 2011 iGEM team remarked that they learned a lot about extrinsic objections like environmental impact, agriculture; while the people have a lot of intrinsic objections. What is the scope of governance here? What are the consequences, Benefits, Risks? And, how is the European Commission handling this?
The intrinsic objections have been also addressed during the GMO debates. One of the mistakes that was made during the GMO debate was to totally focus on risks. The evaluation made by the people is based on a broader set of issues than just risks alone. The lesson that was learned was that it is a bad idea to inform people what the risks are and use their reaction to decide which direction is more favorable to pursue. The value judgment of the citizens plays an important role and they have intrinsic objections either from a religious, spiritual or from a philosophical perspective. There were many societal groups that have a problem with biotechnology, because they thought that it was meddling with nature or they were playing God and some even thought it was wrong to interfere with life at such a fundamental level.
Obviously the same type of objections could arise with synthetic biology, as at the moment so little is known about synthetic biology, there is no real active debate on either the extrinsic or intrinsic objections on this matter. However it is particularly difficult for the EC to deal with such matters because Ethics as such is really an area of concern that is not so much within the mandate of EC to address. Ethics fall under the commission mandate as subsidiary, which means that the member states themselves should make their own regulations on these topics.
In a certain sense the EC doesn’t touch this area of intrinsic objections, at least not in a formal way. These kinds of objections were also central in the agricultural and GMO debate. There is also a big objection from people towards the development of an organic form of agriculture and who perceive GMOs as a big threat to their livelihood.
In the end it turns out to be a political debate as it is tied to deeper fundamental values and viewpoints like:, “What is the good life?”. It is not up to EC or to the member states to decide this. In any Western Society, there is a general recognition that it’s up to each individual to decide “What his or her own good life is?” It’s even very hard for a country to regulate these intrinsic concerns because they touch upon religion and philosophy, and obviously people have freedom of religion in the Western World. So it’s up to them to decide how (s)he thinks about synthetic biology, which raises some important questions.
“How do you promote good governance in such tough situations?”
It’s obvious that every scientist has to abide by the legislation, not only safety legislation, but everybody must also respect the charter of human rights. But how to relate these to synthetic biology? Because all these fundamental declarations don’t go into the details of the technology, they state that you have to respect human dignity in terms of the biomedical fields. There are declarations about patient (informed consent) and data protection but all these declarations don’t really relate to the matter of whether it’s allowed or not to create a synthetic organism.
There is no real concrete ethical principle for this nor is there any global consensus. However, there are some issues that are covered at global level, for instance there is the UN declaration against Human Cloning. There are some issues where a consensus is reached, but these are scarce, mainly on the core topics, like the use of human stem cells.
There are some groups that are in favor of Human Cloning but by and large the human society is against the idea of human cloning so it’s easy to have a concrete guideline in opposition to that. Stem cell research in contrast is not allowed in certain countries, whereas in other European countries it is.
