Team:KULeuven/Law&Patents

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Self-Governance, Legal Aspects, Justice & Religion

1. Introduction

The K.U.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.

2. Self-Governance

What are the steps taken by the European Commission (EC) 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.

3. Legislation

Is there a need for a new legislation for synthetic biology?

As it is seen in Figure 1 there is a continuum between genetic engineering and purely synthetic biology as a result of this there will definitely be pressure on the legislation in the coming years as the field of synthetic biology matures. However currently the GMO legislation encompasses all aspects of synthetic biology.

Figure 1: Observe the hazy boundary between Genetic Engineering and Synthetic Biology. Source: de Lorenzo, Bioessays 32: 926–931, 2010

Important regulation areas from the European Group on Ethics 2009 report on Ethics of synthetic biology[1] have been listed here -

- Risk Assessment and risk management


- New Medicinal Products


- Medical Devices


- Gene therapy, cell therapy and tissue engineering


- Clinical Trials


- Cosmetic Products


- Data Protection


- Biological Risks


- Occupational Health


- Patents

4. Religion

“Does the commission face opposition from major representing institutions of religions across Europe?”

Religious groups, like any other group in the society, express their views on these topics. The EC is also involved in the debate; the commission has an independent advisory body called ‘European group on Ethics’ (EGE). Its advice has no direct legal impact but nevertheless the EC takes notice of their opinions. This EGE groups 17 people and it’s very trans-disciplinary: it is composed of scientists, ethicists, lawyers, social scientists and people with a religious background.

This body advises on specific developments, with a focus on science and technology. Thy also gave their opinion on synthetic biology called the “Ethics of synthetic biology”.This was actually the first major international document on the Ethics, Legal and Social aspects of synthetic biology. One of the things they asked the commission to do was to stimulate a proper dialogue about this field.

Religious organizations can also voice their opinion via a platform, independent of the EC, for dialogue between different religions. In this way they can participate in European debates and like any societal group they are free to express their voice and raise issues either directly to policy makers or via the media.

5. Do It Yourself Community

The 'do it yourself community' is a new development that is seen now in synthetic biology. It can be said that there is a continuum between biotechnology and synthetic biology from the scientific, policy, legislative, and even from the ethical side. But what is really the new element is the idea of informal networks doing scientific research without any oversight and control.

Biotechnology research is much regulated, much institutionalized, there is a full gamut of bio-safety regulations that labs need to conform. So far we haven’t had any major incident in the field of the life sciences, thanks to this extensive regulations. But nowadays people start to experiment with life in their backyard. Up to this point it seems to be fairly innocent, but the open source nature of synthetic biology can be a dangerous new development. This is really limited but obviously it raises issues about bio-safety and bio-security and it’s not only the innocent amateur that does this. This concern of amateur scientists comes about with the field of synthetic biology and can also be stated back to the GMO area. The idea of having this advanced LEGO to play with raises the question about “What to do with biosafety legislation?” One enters a whole new situation where it will be a big challenge for formal regulation and for policy makers to deal with these concerns.

“How many years do you think it will take for such a legislation and what is the right time?”

That is indeed a hard question and even for those at the forefront of synthetic biology research it is tough to make a fair estimate. Even for people with a minor background in molecular biology this can be a quite daunting assessment to make.

Can a contest like iGEM exist for students? Luckily it’s between universities, so we have people looking out for us, but competition exists between students, so regardless of the university it can already be something between students in the backyard?

That is true and indeed it might be possible that in the course of the iGEM competition some regulations are not properly addressed or respected, not so much out of bad intention but out of unawareness. The bigger question is how to implement such a thing? You can have the rules and policies in the legal system but how can you make sure that its implemented in day-to-day life? It is at least clear at the moment that for such a new dynamic development, which in theory can affect so many individuals, that a formal legislation will not be very effective and efficient. The best approach of dealing with such an ever-changing community would indeed be to focus on raising the awareness and to focus on self-governance. It is necessary to have role models like Drew Endy. The students of the iGEM competition must be aware that the competition does not take place in vacuum but they are doing this in society where there is a potential for certain risk and they have a certain responsibility to avoid potential hazards from occurring.

The K.U.Leuven iGEM team commented that the students are stimulated to work on Human Practices and there are special prizes for teams that took bio-safety issues into account in their designs. However, the concern was that students from the third year bachelor are carrying out synthetic biology experiments, as even professionals do not have a complete idea about this discipline. Institutionalizing courses in all science and engineering curricula that reflect on the positive and negative ramifications of science, its implicit value and impact on society could solve this. It would be very interesting to take the interdisciplinary approach of synthetic biology a step further by including specialists from ethics, law, philosophy and governance.

A hurdle of implementing such a practice in the iGEM competition is that it’s hard for the instructors, who are scientists themselves, to realize the impact of the specific projects on society. They are not trained specialists in the other aspects, therefore it is hard for them to take a step back and think about the impact on society. It’s also a challenge as research funding is highly competitive. The scientists have to focus on high quality research and publish their results in high impact journals. Moreover there are also no economic incentives or rewards for taking up their societal responsibility.

The big question that arises is “How could ethical, societal, legal aspects be integrated formally into the system and day-to-day scientific activities?” There was consensus in our meeting that it must be stimulated by the leading professors and prominent scientists of the universities who must also realize that it is in their own interest to have a good connection with the society and must act as role models encouraging other research groups. However, since professors search for people who are really good at fundamental research, its not easy for them to realize upfront the economic benefits they could have from such an interdisciplinary approach. Though not impossible, this is very difficult as it would a fundamental change to the system of universities and research labs, it is in a sense dependent on the goodwill of role models and their proactive initiatives.

It was interesting to learn that in Europe: the Netherlands, UK and some Scandinavian countries are really taking a lead on this. For example in the ‘Center for Society and Genomics’ scientists and social scientists work together. There are projects where researchers team up with an ethicist, who questions the actions and possible outcome of the research. It’s instrumental that research group leaders take the lead in making this happen.

If a group leader, in contrast, states that a researcher cannot spend any minute on these non-essential activities, then obviously this is not going to work. Therefore it’s important that the educated societies and the professional representatives of a community take the lead in making this happen on an individual basis.

It is very interesting to look at the biomedical field in which the scientific society takes a lead. Another counter-intuitive way is that publishers ask for a certain declaration. For example biomedical publishers always ask for a statement ‘if the research has been conducted in line with certain ethics criteria’ so that patients are being properly informed about the consequences.

In the case of synthetic biology it’s a bit abstract and difficult, but one could think of indirect ways in which the mentality can be changed. It’s necessary that scientists can see that it is in their own interest to adhere to these issues. For example, it would be good to make it impossible to publish in high-impact journals without adequate proof that they considered certain ethics and standards. This would stimulate such an activity enormously within the synthetic biology community. There are also research projects funded by the EC in which the grant is awarded based on to the inclusion of ethical, legal and social aspects in the project.

6. Justice

When you have this powerful way of distributing goods and making new kind of things, how to answer the questions about the ‘Justice’ aspect, like: “Who should get the benefit?”, “Who should win or lose?” and "What about ownership?"

These are very fundamental and political questions. It is not within the scope of the EC to answer such questions but it’s a matter for the member states to hammer out a consensus about this together with the European Council. But in our market economy it is the market that decides who will be the winner and who will get the benefits and this is certainly not always in accordance to global justice or solidarity criteria.

Synthetic biology entails several of these discussions in it. As mentioned earlier for example with bio-fuels, the discussion about food vs. energy related applications and whether or not is just to cut forestland's. The GMO issues have a long history of discussion about equitable sharing of generic resources, for example, in Brazil the rain forest is very rich in biodiversity and harbors a very interesting potential for pharmaceutical companies to see which exotic genes they can find there. Should there be some kind of reward for a country for finding a commercially useful gene? Should there be some reward for this find in monetary terms if this provides to be a market success? These were all questions also raised during the GMO debate. In pure synthetic biology these questions are also important as now entirely new and synthetic things are created.

Open-Source vs. Patents

In the field of synthetic biology a big question is the one about Intellectual Property Rights (IPR) and patents and whether an open source or patent approach should be used. This is going to be crucial in the way this field will be defined in the future and in the way its research will be carried out in the future.

The K.U.Leuven iGEM team wondered if this issue was not already raised with the GMO debate? It turns out that for GMOs patents are indeed used. But synthetic biology raises new issues: in the GMO debate era there was no such movement like the BioBricks. This idea of having genetic parts available to everybody is completely new. The biotechnological community finds open-source a big hurdle, as our market model is based on which IPR portfolio there can be protected to control a certain monopoly on products. The new developments in synthetic biology lead to a totally different market model in which everybody could produce new applications and copy already existing ones.

The K.U.Leuven iGEM team wondered if something entirely new is created out of open source Bio-bricks, is it then possible to patent this new application? It was interesting to learn that in order to get a patent there has to be a, what is called, ‘intuitive step’ in the application. A patent application using open-source BioBricks would be turned down because all underlying steps are publically available. Even an unskilled person could make the same thing, so it’s necessary to include an inventive step, which can only be performed by experts.

Our discussion got even more intriguing as GMOs are created from little pieces of DNA that exist in nature and that are put together. The big difference with BioBricks is that one can look-up in a database which bio-bricks already exist. The patents of GMOs are based on sequences that have not been declared to be publicly in advance of the patent application, so this is different to the BioBrick concept and can be patented. BioBricks have been declared to be publicly available, nobody can patent those sequences anymore and it would go against the open-source philosophy.

We wondered why people would invest money into BioBricks, if they cannot get profit out of it? As entrepreneurs are asking themselves, “How can I make the money out of it?” All this boils down in being inventive and creating a new kind of market model. For instance it often happens in pharmaceutical companies that as soon as a patent expires they find often a new way to administer the medicine and so even though the substance itself is no longer covered by patent law the device is patented. In this way they still can make money from their invention and create certain market monopoly.

At the moment there are people that strive to cover various types of medicine with special laws because of their high public value. In the interest of these important public applications non-profit models are interesting, but again that is for the Craig Venter's of this world who have a very particular viewpoint on these things. However, there is going to be a big debate or whether you got for a public model of research for bio-bricks or whether it goes for the private patent type approach. At the moment BioBricks are a relatively small but rapidly evolving field, compared to all the private investments that are being made on GMOs. Therefore it is very difficult to extrapolate whether the open-source model would succeed in a ten to twenty years time frame.

7. Europe vs. US

The K.U.Leuven iGEM had a question addressing the BioBricks standard. “The BioBricks originally evolved from the MIT in the USA, is the European Union helping scientists to come up with a different competing standard? As BioBricks are just a standard that everyone is following willingly as there is no alternative. Moreover a lot of universities take part in the iGEM competition and use BioBricks to increase their visibility, as it is prestigious to be associated with the MIT. But is there a possibility that European Universities come up with a different standard? Is it possible that the European Union will miss the train again, like they did with the GMOs?”

The EC is certainly trying and that's their sole motive in funding research on synthetic biology and biotechnology in general. A lot of activity is currently ongoing at the EC on talking with the US on standards. It is not a feeling that the EU is missing the boat but obviously it is clear that the US is the most important player and leading the way. So it is important for the EU also to have an initiative not competing with the US but having, an agreement with the US in terms of a common standard.

The K.U.Leuven iGEM team commented that the European groups fiercely compete score generally really high and thought that right now Europeans are the ones creating it for America. This led to another interesting discussion that this is indeed a pity for Europe as Europeans have an excellent basic knowledge, but, like in many fields, often the final products that make the money are made in the US. The students again wondered, “Why is it like that?” The explanations that were given are that the Americans have more access to venture capital. The Europeans are really good at having this research infrastructure but we are not so good in bringing the idea into a product. It is also more expensive to get a patent in Europe. Also the US has one language and in Europe although there is a European patent office, the patent application has to be translated into all the different languages of the European Union so the system is slower and more expensive to go through.

Indeed the private funding for research in Europe is much smaller than it is in the US and this private funding is also more focused on a marketable product. So the focus on indeed having a return of the investments made is higher in the US than it is in European research initiatives. Getting access to venture capital to start a scientific business is usually easier in the US than it is in Europe because there are more venture capitalists interested in giving the money there.

On the lighter note it is also interesting to find that Americans are also better at selling their own argument, even in plain discussions, whether it concerns business or science itself. It may be because they are much better trained in presenting what they do and transmit it correctly.

Is there a possibility that our iGEM team to participate in some of the EC projects to raise awareness among policy makers about the ongoing iGEM activities and involving them early in this discussion?

This is possible in an indirect way. The EC funds projects, but doesn’t organize debates themselves. It is a really positive evolvement that the K.U.Leuven iGEM team is in contact with the Rathenau Institute and they are involved in one of the projects that is funded by the EC. The presence of iGEM teams and research groups would be welcome in their project.

It is also important to note that there is not so much regulatory activity on synthetic biology ongoing in EU because of the position of the EC. At the moment the member states cover synthetic biology with the legislation on GMOs. Currently the EC is monitoring bio-safety regulations, talking to the US in relation to global standards et cetera.

In many of the conferences in Western Europe there is an ongoing debate on life sciences. For instance he UK has an ongoing dialogue on synthetic biology not really on policy but more generally about creating an early awareness on the theme.

8. Conclusion

It was an intellectually enriching experience for the students of the K.U.Leuven iGEM team to learn about these developments and initiatives on synthetic biology at the EC. This activity was a result of the good self-governance initiative from our team to reach out to policy makers and people involved in the future policy making on synthetic biology in the EU.

References

[1] EGE 2009, Ethics of synthetic biology

[2] Wikipedia, Self Governance

[3] M.J. Peterson. 2008.“Ethical Evaluation of New Technologies: Genetically Modified Organisms and Plants.” International Dimensions of Ethics Education in Science and Engineering."

Disclaimer: "The views expressed are purely those of the writers and may not in any circumstances be regarded as stating an official position of the European Commission".