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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.
