Research, dual-use and export control An initiative for raising awareness and compliance
Introduction It came as a shock for the life science community in The Netherlands, when the government asked Rotterdam-based virologist Ron Fouchier to apply for an export license before being allowed to submit his article on a mutation of the avian flu virus (H5N1) to Science for publication. It was seen as an undesirable intervention of the state and even as a threat to academic freedom. Probably nuclear scientists and chemists would have reacted differently to this, as in their working fields it is very common to take security measures into account. However, because of a multitude of developments in the past decades many of them will also have lost sight on the laws, regulations and treaties that exist in the field of dual-use research and export control. Philip Sidney B.V., a Netherlands-based multi-disciplinary firm, along with political scientist and ethicist Dr. Koos van der Bruggen have taken the initiative to raise awareness among scientists, researchers, universities, research institutes, companies and other parties involved regarding dual-use nature of specific research. Of course this must lead to an enhanced understanding of the pertinent laws and regulations and the inner workings of mandatory compliance programs.
Issues Dual-use research The concept of dual-use was once developed to indicate that products and technologies had a civil as well as a military application. Nowadays the concept refers more to (civil) products and technologies that can be used for beneficial purposes as well as for malicious purposes. The most important application of the concept of dual-use is related to weapons of mass destruction (WMD). As nuclear weapons are the most important WMD, the concept was first applied in debates about the risk of misuse of nuclear technology. The concept of dual-use in relation to nuclear weapons is most significant because of the regime of arms control. Inspections by the International Atomic Energy Agency (IAEA) are mainly directed at discovering intended or perhaps unintended activities by countries that can be seen as breaching the Non-Proliferation Treaty (NPT). Let s first understand how is the dual-use concept introduced and applied in relation to the life Sciences The most common and authoritative definition is the one in the so called Fink Report (U.S. National Research Council of the National Academies 2004). In this report Dual-Use Research of Concern is defined as: Research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agriculture, plants, animals, the environment, or material. The definition is explained by the list of seven experiments of concern. As the authors of the Fink report are aware, uncertainties are inherent to both threats and expected damage because of which it is useful to involve both intentions and consequences in defining dual-use. Therefore, with all necessary restraint, the following definition can be proposed: A dual-use problem arises when: research, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be misapplied and; there is a recognizable threat and a not negligible chance of such misuse and; there are serious consequences for society and science (public health and safety, agriculture, plants, animals, the environment, or material). Export Control One of the ways in which the governments can regulate these matters is through export control regulations and licensing. On its website, the Dutch government states: Because of international security there are strict rules governing the export and transit of dual-use goods. These are based on the European dual-use regulation. For export to countries outside the European Union (EU), a company needs a permit. This should prevent that dual-use goods after exports end up in arms, or in machines to make weapons. The control has focused inter alia on products that can be used for the development and production of weapons of mass destruction.
These include nuclear, chemical warfare agents or biological weapons and The whole export control system for dual-use goods is based on risk analysis. A company that wants to export dual-use goods, must first specify exactly where the products arrive and what they are used for. The government then checks the combination of goods, and enduser specified end use. The government also evaluates the risk that the goods reach suspected end-users via an alternative route. There should be enough guarantees to ensure that the goods are not used for unintended purposes. These general principles of export control policy have been refashioned into a vast and very complex set of rules and regulations, subject to rapid change. And because of new technological developments as well as growing concerns for safety & security, the number of researchers and scientists that will be confronted with these rules and regulations is also growing rapidly. These developments imply that more knowledge and awareness of export control regulations is a must. Sanctions Apart from general rules on export control, there are specific actions that have been taken against some entities, encompassing states, organizations and (legal) persons by virtue of sanctions and embargo s in place. These sanctions may have been imposed for many different reasons: such as change in the behaviour of a country or regime, in cases where that country or regime is violating human rights, waging war or endangering international peace and security. Sanctions can be based on supranational, international (UN, EU) and/or domestic laws or regulations and they can have a more or less permanent or a more temporary character. Sanctions often do not only relate to military or dual-use products or technologies, but also to more civil products (oil & gas, key technology, industrial sources etc.). Food and medicine are mostly excluded. However, a sanctions policy can also influence scientific cooperation. The field of sanctions policy for many organisations and companies in the field of science and technology is a terra incognita, the more so because also in this field the number of regulations is growing. Again a field where there is a need for more knowledge and awareness. This does not mean that everybody should know all the rules and all the exceptions, but one should at least know why, when and who to turn to if advice is needed in certain cases. Publication and communication Dual-use issues in relation to the life sciences are not limited to the laboratory and to the physical or biological agents as such. The H5N1 debate has shown that dual-use policies may also extend to publication and communication on dual-use research. These policies do not only relate to the publication of project results in scientific journals, but also to presentations at conferences and to the dissemination of information through FTP-servers, e-mail, websites or the social media. In this context there is a link with developments in the field of cyber-security. Here again it cannot be expected that funding agencies, researchers, scientists and other involved parties know all the details of these policies. But at least they need to be aware that these policies exist and that they are relevant vis-à-vis their applied-scientific research and work.
Target groups Based on the above overview of relevant issues, we present a (not exhaustive) list of organisations and groups that will be confronted with one or more of these issues, although not all aspects may have the same bearing on these groups. We distinguish between the following groups. Universities and colleges Central board Faculties and departments (biology, physics, chemistry, medicine, pharmacy) Research groups Primary investigators Umbrella organisations (VSNU, NWO, KNAW) Funding agencies Public funding agencies (NWO, STW) Private funding agencies (KWF, Hartstichting etc.) Companies Private companies in the field of biology, physics, chemistry and pharmacy Umbrella organisations (NIABA, NEFARMA) Professional organisations Scientific unions Unions of laboratory workers Biosafety organisations
Possibilities / What can we offer Given the different issues and the different roles and positions of potentially involved groups and organisations, we have the following to offer: Introductory Seminar We will provide your organization or institution with a one day bespoke seminar. Together with you, we will explore dual-use research, export control, sanctions and communication/publication. Of course: academic discussion will be fostered. The seminar will provide you with the necessary insights regarding fundamental research (exempted from export controls), applied sciences and super- and international regulations. Individual advice / consultancy Together with you, we can set up a risk analysis concerning the peculiarities of your organization or institution: maturity, background, nature, size, type of research, markets et cetera. This will be the starting point to draw up an effective technology control plan that will help you to further your endeavours in the dual-use research realm, with safety and security. Specific courses We can offer specific courses. These courses can be directed at (changing) policies and rules in each of the above presented fields: dual-use research, export control, sanctions policy and communication/publication. To give an example: a course on export control can pay attention to international treaties and cooperation (e.g. Australia group, Wassenaar Agreement, EU-policy) as well as national regulations. Attention will be given to the application of these national and international regulations for companies and research institutes. Another approach can be directed at the involved agents: what is the policy for biological, chemical or nuclear agents, materials and knowledge. An example: what has been arranged for biological agents: Geneva Protocol (1925); Biological and Toxin Weapons Convention (1975); Australia group; Antrax letter (2001) and consequences: biosecurity debates (H5N1); recent developments. Regular updates Because the technological and political developments, regulations and applications in the field of dual-use research, export control, sanctions policy and communication/publication are continuously and rapidly changing, we will monitor these developments for you and inform all parties involved immediately regarding relevant changes. We will inform you about the impact that these changes can have on your organization or institution and your operations. You can opt for regulatory updates and impact analysis on two levels: sector specific or company specific.
We make sure that you never miss any opportunities
Who are we? Philip Sidney B.V. is a Netherlands-based multi-disciplinary firm specialized in preventing and investigating financial economic crimes risks in predominantly the international trade environment. We can show you how to make legislation and regulation work to the best of your advantage and help you define your strategy. Philip Sidney can be your compliance partner for export control and sanction regulations, and help you in setting up risk analysis for your organization. We can help you comply with regulations and while doing so, we make sure that you never miss any opportunities. We can train your employees to stay abreast of and anticipate changes in legislation, and to assess risks. Having served corporates in sectors such as banking, insurance as well as life-sciences, we are in a very suitable position to provide you with end-to-end solutions, fully aligned with your business operations. Koos van der Bruggen Dr. Koos van der Bruggen (1951) studied political science (International Relations) at Radboud University Nijmegen (The Netherlands). He wrote his PhD thesis on criteria for the ethical judgment of nuclear deterrence at the Vrije Universiteit (Free University) Amsterdam. Dr. van der Bruggen has been working at the Rathenau Institute, the Dutch organization for parliamentary technology assessment for more than 15 years. He was involved in research and debates on social and ethical aspects of technological developments (biomedical technology, genetics, and military technology). Furthermore Van der Bruggen has been working at the Royal Netherlands Academy of Arts and Sciences (KNAW), where he was involved in developing a code of conduct for scientists regarding issues of biosecurity and at Delft University of Technology (research on biosecurity and dual-use). He was the secretary of the Committee of Inquiry into the Dutch involvement in the Iraq War of 2003 (Davids Committee, 2009). More recently he has again been working for the KNAW as the secretary of a Committee of the Academy that prepared an advice for government on how to deal with dual-use research. Moreover, he is an independent researcher on peace and (bio)security issues. Van der Bruggen has a national and international network in the field of biosecurity: He organized (with the US Academies of Science) biosecurity workshops in Indonesia and is involved in activities regarding the Biological Weapons Convention. Dr. van der Bruggen has published (in Dutch and English) on just war issues, on issues of ethics and technology and on biological weapons.
Contact To find out more about us, please visit www.philip-sidney.com (also in Dutch, French and German versions) and to contact us, please write to: Mr. Herman Annink Managing Partner herman.annink@philip-sidney.com Mr. Gert Demmink Partner gert.demmink@philip-sidney.com Koos van der Bruggen jjgvanderbruggen@ziggo.nl