European governance challenges in bio-engineering : STOA
workshop report
Citation for published version (APA):
Slagt, R., Est, van, R., & Stemerding, D. (Eds.) (2011). European governance challenges in bio-engineering : STOA workshop report. European Parliament, STOA.
Document status and date: Published: 01/01/2011
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1 European Technology Assessment Group
ITAS DBT FCRI ISI IST ITA TC Rathenau
ETAG
Making Perfect Life
Bio-engineering (in) the 21
st
Century
STOA Workshop Report
European Governance
Challenges in Bio-engineering
Deliverable No.6 of the STOA Project “Making Perfect Life”
Commissioned by STOA and carried out by ETAG
Contract No. IP/A/STOA/FWC/2008-096/LOT6/C1/SC3
Ref.: Framework Contract No. IP/A/STOA/FWC/2008-096/LOT6
Report edited by:Robert Slagt (Slagtekst)
Dr. ir. Rinie van Est (Rathenau Instituut) Dr. Dirk Stemerding (Rathenau Instituut) Rathenau Instituut, The Hague
15 November 2011
Contact:
Dr Leonhard Hennen (Co-ordinator)
Institute for Technology Assessment and Systems Analysis; Karlsruhe Institute of Technology
c/o Helmholtz-Gemeinschaft Ahrstr. 45, D-53175 Bonn
Leonhard.Hennen@kit..edu
European Technology Assessment Group
Institute for Technology Assessment and Systems Analysis (ITAS), Karlsruhe
Danish Board of Technology (DBT), Copenhagen
Catalan Foundation for Research and Innovation (FCRI), Barcelona
Fraunhofer Institute for Systems and Innovation Research (ISI), Karlsruhe
Institute Society and Technology (IST), Brussels
Institute of Technology Assessment (ITA), Vienna
Rathenau Instituut, The Hague
2 Project Description
Contract number IP/A/STOA/FWC/2008-96/LOT6/C1/SC3 The project is being carried out by:
Rathenau Instituut, The Hague (Project Co-ordinator) together with the Institute of Technology Assessment, Vienna; Fraunhofer Institute for Systems and Innovation
Research, Karlsruhe; and the Institute for Technology Assessment and Systems Analysis (ITAS), Karlsruhe, as members of ETAG.
Project Leader:
Dr.ir. Rinie van Est, Rathenau Instituut
Members of the European Parliament in charge: Malcolm Harbour
Vittorio Prodi
STOA staff in charge: Vittorio De Crescenzo
3
FOREWORD
A living cell with synthetic DNA is already a reality. Smart implants and stem cells are on their way to the clinic. Scientists also work on other cutting edge technologies, from robots that can act like humans to building supercomputers resembling the human brain. In many ways, technology and biology are increasingly intertwined.
What is the impact of these developments and our vision of the ideal future of Europe? Can the EU foster innovation in these fields while at the same time managing social and ethical concerns in our society? These and other questions were addressed during the conference “Making Perfect Life”, hosted by STOA on the 10th of November 2010 in the European Parliament in Brussels.
To inform and stimulate further political debate in the European Parliament, the STOA “Making Perfect Life” team has now prepared a final report, highlighting the governance challenges arsing from a number of specific developments in four fields of 21st century bio-engineering: the rise of whole genome sequencing, the market introduction of neurodevices, the growing possibilities to capture psychological and physiological states of users by information technology, and the needs for standardisation in synthetic biology. We welcome you at the STOA workshop of today, in which European policy makers will meet with scientific experts, regulators, stakeholders and other relevant communities, to discuss the European governance challenges in 21st century bioengineering!
4
PROGRAMME
13.00 Registration 13.30
Welcome address by Malcolm Harbour (STOA Vice Chairman) 13.40
Introduction: Bio-engineering in the 21st century: major themes and issues Rinie van Est, Rathenau Instituut
14.00
Privacy, data protection and policy implications in whole genome sequencing Bärbel Hüsing, Fraunhofer Institute for Systems and Innovation research 14.30
Market development and regulation for neurodevices in Europe Ira van Keulen, Rathenau Instituut
15.00 Coffee Break 15.30
Monitoring mental states through information technology: issues of privacy and autonomy
Michael Rader, Institute for Technology Assessment and Systems Analysis (KIT) 16.00
Standards for synthetic biology: towards a European bio-economy Helge Torgersen, Institute for Technology Assessment (OAW) 16.30
Governance challenges in 21st century bio-engineering: implications for EU policy-making
Dirk Stemerding, Rathenau Instituut
Comments: Herbert Gottweis, University of Vienna Paneldiscussion with Members of Parliament Moderator: Frans Brom, Rathenau Instituut 17.30
Closing remarks by Vittorio Prodi (STOA Panel Member) 17.45
5
Workshop Introduction and Conclusions
BIO-ENGINEERING NEEDS NEW FORMS OF GOVERNANCE
European laws lagging behind major developments in biosciences
European policy makers need to start up active ‘bio-politics’ to keep control on the fast moving developments in bio-engineering. That is the main conclusion of the European STOA-project ‘Making Perfect Life’, which was coordinated by the Rathenau Instituut. Their report was presented on October 11 at the European Parliament in Brussels. According to the researchers there is an evident need for new forms of governance of current and future developments in bio-engineering.
The STOA project ‘Making Perfect Life. Bio-engineering (in) the 21st century’, which took
three years to realize, focused on four areas where biology and technology are becoming increasingly intertwined: body, brain, intelligent artefacts and living artefacts. The possibilities to intervene in both the body and the brain are growing, while simultaneously there is an increasing capability to create artefacts which have life-like and intelligent qualities.
“The main message of this report is that biosciences are transforming into ‘bio-engineering’. The increasing interplay between biology and technology implies we urgently need to start a much broader political and public debate on the growing amount of bio-ethical issues which is coming our way,” said project coordinator Rinie van Est of the Rathenau Instituut.
In the STOA-workshop, in which seventy scientists and politicians participated, researchers presented four case studies showing the huge developments European citizens will be experiencing over the next decade in DNA-research, brain science, artificial intelligence and synthetic biology. In certain fields of bio-engineering stricter regulations are needed at very short notice.
“Within the next five to ten years we can expect a wave of innovations which we can’t handle within the current legal framework,” Van Est indicated. “Current legislation is incomplete to regulate the socio-technical dynamics which are coming our way. This means we are entering a new phase: to adjust the rules where they are under pressure or make new regulations where they are missing. The ball now lies in the court of politicians.”
‘Regulatory wasteland’
Dirk Stemerding, researcher at the Rathenau Instituut, gave a broader overview of the governance challenges European policy makers on bio-engineering will be confronted with in the next decade. “We are faced by many new discoveries on the one hand. The second problem is: where do these discoveries fit in with the current patchwork of established regulations?”
Stemerding distinguishes two serious challenges for politicians. The first is to keep the current legislative framework flexible enough to fit in new discoveries. Another serious problem is posed by what he calls the ‘regulatory wasteland’: products and procedures in bioengineering for which no rules actually exist.
“There are many uncertainties ahead: the speed and the direction of new developments; the influence new applications can have on socio-political values such as privacy; and the fact that we don't know whether the current framework is adequate.” For Stemerding it is
6 evident that the European Union should adopt a more active strategy: “We need to move beyond bio-ethics, into the sphere of real bio-politics.”
Closer communication needed
For the Austrian political scientist Herbert Gottweis, the STOA report and workshop showed that politicians need to get a better overview of what is going on in bio-engineering. “The need for action is evident, especially in the field of whole genome research and the engineering of the brain.”
Moreover, Gottweis said, citizens expect politicians to take care of medical and ethical dilemmas, which will affect their lives. “The communication on the new technologies needs to become a lot better. For many, bio-banks and whole genome screening are rather mysterious concepts.”
European policy makers too were impressed by the governance challenges they are being faced with in 21st century bio-engineering. “I am dizzy from all the information I heard
today and the huge task which lies ahead of us,” European Parliament member and STOA board member Vittorio Prodi said. “At the same time, we are very pleased by this report. We now have the framework and the methodology to start developing new policies. We owe this to European citizens: to convince them that our dignity as a human being isn’t threatened by developments in bioengineering. So let’s go to work fast. We need to make decisions.”
7
Presentation:
Bärbel Hüsing, Fraunhofer Institute for Systems and Innovation research
NEW DNA DATA RESEARCH INTERFERES WITH
PERSONAL PRIVACY
Technologies for DNA sequencing are developing at such a high pace that in the next decade the whole international framework for privacy and data protection needs to be revised, says senior researcher Bärbel Hüsing from the Fraunhofer Institute for Systems and Innovation Research. “The big question at the moment for many people is: how do we deal with the DNA material and other personal data which will become available to us in the coming years?”
In her case study presentation, Hüsing focused on the impact of whole genome sequencing, which has developed at a tremendous pace over the last two decades. “In 1991, one PhD student would take about three years to sequence one gene. Twenty years later, he is able to sequence a complete individual genome within a matter of weeks. At the moment this process will cost about 50.000 euro, but in about five years time this will be much lower: a mere one thousand euro.”
According to Hüsing, larger quantities of genetic information will become available to researchers and citizens both faster and cheaper, which poses both advantages and threats. “Whole genome sequencing is a unique identification method, for instance to analyse family ancestry and reveal if someone has a hereditary risk to develop a certain disease. But all this DNA information can be stored, re-analysed and misused as well, possibly leading to discrimination and stigmatization.”
Handling personalised medicine
Another issue is that, as science keeps making giant steps ahead, these raw DNA data on a person can be used for unexpected discoveries we cannot foresee now, which affects confidentiality. “With the expected increase of data exchange and internationalization the biomedical field needs to adapt a code of conduct on how to share these data. What level of confidentiality is needed here? How are we going to handle bio banking and personalised medicine?”
In the current debate on DNA and privacy Hüsing distinguishes two groups. The libertarians defend the individual autonomy and demand a stricter data protection. The communitarians focus on the collective interest of curing illnesses and want a more open and transparent medical research culture. The German researcher pleaded for establishing better frame conditions so citizens know their DNA is dealt with in a responsible way.
“The debate is on, but we need to widen it more. In the future a huge quantity of quality DNA data will arrive at our doorstep. How will we handle them? And who will be making the decisions to reassess these data: the doctor or an independent monitoring body? The public awareness on this issue needs to be raised. We need more safeguards and high quality standards. My personal view is that more international harmonization of regulations by the European Union is desirable.”
Discussion
In the ensuing discussion, STOA board member Vittorio Prodi pointed out the necessity to regulate both the storage of DNA data and human samples. “These samples could still be used after someone has died, and the deceased person’s will must be respected. It makes clear that in the future we will be confronted with a huge amount of data about ourselves.”
8 Another important question, which was raised, is: which data are personal data? Bärbel Hüsing indicated that a former STOA report on direct to consumer genetic testing, published in 2009, sees it as a legitimate desire that citizens can acquire data about themselves and their families. “But the quality control is not yet in place. We need a neutral body to provide unbiased information on the pros and cons of obtaining this knowledge”.
STOA board member Malcolm Harbour pointed out that the challenge for the future is how difficult data control will become because of a cheaper and more accessible DNA technology. “So the key question will be: if we have the raw data on a person, what should we analyse or not?”
9
Presentation:
Ira van Keulen, Rathenau Instituut
REGULATORY VACUUM IN GROWTH MARKET OF
NEURODEVICES
The fast growing market for neuromodulation devices poses new governance challenges to the European Union, says Ira van Keulen, senior researcher at the Rathenau Instituut. “We have found regulatory issues about the use and the definition of neurodevices. For example, when they are used for non-medical reasons, like gaming or performance enhancement, can they get around the medical device regulation? This is an odd situation.”
Although the market for neurodevices is still relatively small, with an annual output of 4 to 5 billion euros, it is now growing at a pace of 18% per year at the moment and is expected to grow even more in the coming decade. The advantage of stimulating the brain electronically instead of chemically is that they don’t affect the whole body like drugs do. Also, introducing them into the market is less time consuming than pharmaceuticals because of different and less stringent pre-market EU regulations. Besides new molecular knowledge has not resulted in new effective psychopharmaceuticals. Big pharmaceutical companies like Pfizer are therefore now investing in the neuromodulating industry.
In her presentation, Van Keulen focused on three important upcoming devices for neuromodulation: EEG neurofeedback, transcranial magnetic stimulation (TMS) and deep brain stimulation (DBS).
Starting with DBS, Van Keulen showed an impressive video of a serious tremor case. A woman who was shaking intensely, suddenly stopped: her doctor had switched on a DBS-device which ended her tremor directly.
At the moment about 75.000 people worldwide are using DBS-devices. “The limitation of DBS is that it doesn’t cure a disease, but it only treats the symptoms,” Van Keulen explained. “Also, a 10-40% of the patients experience side effects from DBS which can be quite severe, such as depression or hypersexuality.”
Shift towards psychiatry
At the same time DBS, which started off in 1997 as a highly specialised treatment for people suffering from Parkinson’s disease, is currently being used for depression and compulsive disorders. “There is now a clear shift in DBS towards psychiatric indications.” The same goes for TMS: manipulating the brain with magnetic fields is now increasingly being used in therapy for severe depression and bipolar disorders, besides Parkinson’s disease and epilepsy, mostly in private clinics. “What happens is that certain parts of the brain – 3,5 cm below the skull at the deepest - are ‘switched off’. The technology, which started in 1985, is quite safe as long as it is done by skilled professionals.”
The third form of brain manipulation, EEG neurofeedback, uses video displays or sound to give moment-to-moment information to patients on the state of their physiological functioning. “As a patient you actually see what is happening in your brain. It is being used for ADHD patients and many other medical indications like epilepsy, autism, insomnia and addiction, but the effect has not yet been robustly proven.”
Game or medical device?
Researchers expect all three techniques, and especially DBS treatment, will be used a lot more over the next five to ten years in treatment. According to Van Keulen, the focus in the public debate is now on the safety and performance of the devices. One of the most important problems found in the case study are definition problems. For example, there
10 is a lack of clarity on the classification, especially with EEG neurofeedback. Also, the intended use of the devices is sometimes very narrowly described by manufacturers or very broadly. This results in either off-label use or introduction of neuromodulating therapy in private clinics while their efficacy and efficiency are not proven yet. Some neuromodulating devices are already offered for non-medical purposes, for example to enhance your cognitive performance or gaming. It is unclear whether these devices can completely bypass medical device regulation.
“There is a modest debate going on now if we should regulate these devices like pharmaceutical drugs. But the industry says this will slow down the process of bringing them onto the market and patients will miss out on new therapies. But what we see now is that in practice there is some regulatory vacuum when it comes to EU regulations on the use of especially non-invasive neurodevices. But also when it comes to governance, there are some issues. For example, harmonization of reimbursement policies in the EU is lacking and each therapist using EEG neurofeedback is making his own protocol. There is no standardization. This is a situation which needs to be addressed by policy makers.”
11
Presentation:
Michael Rader, Institute for Technology Assessment and Systems Analysis (KIT)
BIOCYBERNETICS: KNOWING WHAT THE SYSTEM KNOWS
OF YOU
The vast amount of personal data used in biocybernetics will require more extensive regulations in the future, says Michael Rader, former senior researcher at the KIT-ITAS Institute in Karlsruhe. “The use of data in health care is largely covered but we are lagging behind in new developments. The main question is: who will have access to all the data?”
Biocybernetics deals with computer applications where vital data of the user are collected to enable the computer system to adapt to the person who is using it. “This type of artificial intelligence began to develop in the 1990’s,” Rader explains. “It’s about creating a situation where the computer system seems to ‘understand’ the person who is using it.”
Computers are already being used to measure physiological functions, such as blood pressure and stress, visual attention and skin reactions. The next step is to register neurophysiological behaviour like emotions and brain activity.
An interesting example of biocybernetics is ambient intelligence, or creating electronic environments that are sensitive and responsive to the presence and activities of people. In an ambient intelligence world, devices work together to support people in carrying out their everyday life activities. “The system reads your mood, so to speak.”
Examples of ambient intelligence are helping the disabled or elderly to live more independently in their homes. Some progress has already been made to help them communicate better. Other envisaged applications include education, monitoring humans in safety-critical situations and gaming. “Through this, computers can become sensitive partners. For example through games that can give biofeedback to young patients to motivate them.”
Pioneering phase
The main problem now is that this application is still very much in the pioneering phase, according to Rader. “There are already applications of adaptive bio cybernetics in gaming and for medical use it is still in the early stages. But daily applications are still far away. For example: it’s difficult to recognise biosignals when there are several people in a room who make different noises and movements.”
However, if ambient intelligence would move forward in developing applications, this will raise a new problem: what to do with the huge amounts of data that are required? “The advertising sector will have a huge interest in developing adaptive systems which can read people’s actions and minds. But all of the computers in the world have many different owners. So how do you control all these very intimate data? Who will be able in the future to turn the system on or off? We will need a system of licensing here and procedures to control the data. We have enough experience to develop them, but at the moment we are lagging behind.”
12
Presentation:
Helge Torgersen, Institute for Technology Assessment (OAW)
SYNTHETIC BIOLOGY: TOWARDS EUROPEAN
STANDARDS?
With synthesized biological building blocks becoming more widely and cheaply available, new questions are arising as to biological objects can be completely standardized, says Helge Torgersen, researcher at the Institute for Technology Assessment in Vienna. “Most experts say safety standards for Synthetic Biology are all right, but new developments will make some rethinking necessary.” The Austrian researcher directly pointed out to the STOA workshop participants that the topic of his case study was “much further into the future than the three other topics. I will talk about standard genes and ‘bioparts’, which is only a small part of synthetic biology.”
Torgersen began by explaining that synthetic biology (SynBio) can actually have two forms: the design and construction of new artificial biological parts and systems, as well as the redesign of existing natural biological systems. “This means that the question is SynBio genetic engineering? should be answered by yes and no. There is a big overlap between old and new biotechnology.”
For modern students, Torgersen indicated, SynBio is a fascinating world as it has some similarities with computer science. “They see it as a new way of programming or gaming. So for the youth it’s very attractive.” There is also a strong quest for “open source” instead of patenting.
Sudden take-off possible
At the moment SynBio is still in a “lagging phase”, according to Torgersen. “We are now in the phase of standardizing the building blocks. We need exact descriptions of bioparts. But once this is done, within five or ten years SynBio can develop very fast: we may have a sudden take-off.”
At the same time, the scientific challenges in synthetic biology are considerable. “Many bioparts are still undefined and incompatible with others, the circuitry is unpredictable and the endless variability can always crash the system: organisms grow, multiply and change as they like.”
As to the options for European policy makers, therefore, Torgersen sees three options: business as usual; increase monitoring or: taking precautionary actions. “Most experts say that the existing safety standards for SynBio are okay. But: new developments can make rethinking of these standards necessary. There are no special laws yet on SynBio. And with the ‘patent sharks’ from big business, we definitely need to sort out intellectual property questions. So, a wider public debate will play an important role in the coming years when practical applications appear.”
13
PARTICIPANTS LIST
Organisation Last name First name
Dr. A. Energy Consultant SPRL Antonelli Roberto
ARCHES Aroulmoji Vincent
European Science Foundation Berghmans Stephane IEO - European Institute of Oncology Blasimme Alessandro
European Commission/JRC Bock Anne-Katrin
APCO Worldwide Boeynaems Francis
C. von Bonhorst MD Bonhorst, von Carlos
Bioethics Institute Gent Bonte Pieter
Utrecht University Bos Colette
ULB Bourdeau Philippe
Rathenau Instituut Brom Franciscus
Bird & Bird LLP Carbonnelle Nicolas
IRCCS Casa Sollievo della Sofferenza Chiarelli Pasquale
Heales Coeurnelle Didier
Studio Dann Cortier Henk
IRCCS Casa Sollievo della Sofferenza Crupi Domenico Francesco Flemish government, cabinet minister Lieten De Caesemaeker Bart Center for Science, Technology and Ethics De Tavernier Johan
COCIR Deneve Olivier
Eindhoven University of Technology Dignum Marloes
University of Twente Doodkorte Daniel
Rathenau Instituut Douglas Conor Merrick
Williams
Independent scholar Dutoit Dominique
n/a Dutoit Dominique
European Commission Economidis Ioannis
Rathenau Instituut Egmond, van Constance
Rathenau Instituut Est, van Quirinus Cornelis
Amgen Fandel Marie-Hélène
14 Fondation Fourmentin Guilbert Fourmentin Eric
Rathenau Instituut Geesink Ingrid
IRCCS Casa Sollievo della Sofferenza Giuliani Francesco Centre for Social Marketing, NGO Gomelskaya Veronika
University of Vienna Gottweis Herbert
Medical University of Lodz Gurdala Mikolaj
Fraunhofer ISI Hüsing Bärbel
Rathenau Instituut Keulen, van Maria Theodora Elisabeth Liaison Agency Flanders-Europe Knops-Gerrits Peter-Paul
Europolitics Kugyela Tamas David
Fraunhofer ISI Kukk Piret
Europaen Parliament Majoch Martyna
Bird & Bird LLP Martens Marc
Centre for ethics in medicine, University of Bristol Meulen, ter Rudolf
Maastricht University Mitzschke Andreas
Utrecht University Innovation Studies Moors Elisabeth
European Commission Naneva Christina
Univ. of Amsterdam Neicu Maria
Brandenburgische Technische Universität Cottbus Ninkovic Dejan Ministry of Health, Welfare and Sport Olthof Gerrit
NL Ministry of Defence Pelt Willem
European Commission Poireau Michel
EC Puolamaa Maila
Rathenau Instituut Rerimassie Virgil Germaine
Rathenau Instituut Schuijff Mirjam Jeanette
Freelance jourmalist Slagt Robert Christopher
Rathenau Instituut Stemerding Dirk
ARCHES Toffanin Renato
Istitute of Technology Assessment, Austrian Academy of Sciences
Torgersen Helge Michael Universidad de Guadalajara Valenzuela Zapata Ana Guadalupe European Academies Science Advisory Council Vanthournout Sofie
Institut national de la santé et de la recherche médicale Velizara Anastasova
European Commission Verachtert Barend
15
KU Leuven Vinchhi Bakul Jitendra
LIS Consult Vriend, de Hubrecht
German Ethics Council Weber-Hassemer Kristiane Andrea European Science Foundation Weehuizen Rifka Maria Ministerie van VWS Wijngaard, van den Johannes
