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Mordini Bioterrorism

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Conclusions of the International Conference on Ethical Implications of Research into the Prevention of Bioterrorism
Emilio Mordini, MD


Centre for Science, Society and Citizenship, Via Sistina 37 – 00187 Rome – IT


Email: e.mordini@bioethics.it


Summary
This policy paper assesses and analyses key arguments raised during the CONFERENCE ON THE ETHICAL IMPLICATIONS OF SCIENTIFIC RESEARCH ON BIOWEAPONS AND PREVENTION OF BIOTERRORISM held in Brussels on 3-4 February 2004, and organised by DG Research, Directorate E "Biotechnology, Agriculture and Food" in the context of an EC funded research project on the "Bioethical Implications of Globalisation" (BIG) co-ordinated by the Centre for Science, Society and Citizenship, Rome.
This paper first discusses the political context, then revises some arguments on the ethics of biowarfare, and finally analyses the ethical implications of four highly debated issues: global collaboration against terrorism, response to bioterrorism, dual use technology, and sensitive medical experimentation. It is in the nature of a policy paper that some points are asserted and not thoroughly defended. More substantial argumentation and evidence for the opinions expressed in this text may be found in longer publications which will follow it.
The opinions expressed are those of the author. They do not commit either the European Commission or the Consortium of the BIG Project. They do not yet represent a point of consensus among meeting participants, although they reflect the contents of the debate.

1. Asymmetric Warfare
This paper was completed a month after the events of 11 March 2004 in Spain. In the aftermath of the brutal Madrid attack, at least one consideration can be made: this scenario tragically resembles the scenario of a civil war. At a first glance this definition seems contradictory: civil war means “non international” armed conflict, while current terrorism is by definition “transnational”. Yet the contradiction is only apparent. Terrorist war is a civil war precisely because is not either a war between nations or within a single country, but because it is global. The nature of the war on terrorism is relevant to this paper because it implies some crucial ethical consequences that – I hope - will be clear in reading.
 
Ancient warfare resulted from local and regional conflicts involving different communities (ethnic, religious, cultural, political, geographical). Then, in the post-Westphalia order, wars were mostly matter of state entities. The two world wars in the 20th century introduced some major changes. They were still conducted between coalitions of nation states but they gave one of the greatest impetuses to global collaboration and international change. The devastation of the second world war, the Jewish Holocaust and the violence inflicted on occupied populations by the Germans and the Japanese prompted a profound reconsideration of the relationship between nations, human rights and international peace and generated the quest for a collective global governance of world affairs.


From 1945 to 1989, the Cold War Order - based on the bloc system - produced a second wave of globalisation. Borders were extended beyond the nation state to cover groups of nations. This provided a framework for the development of a system of multilateral agencies regulating global economic relations and for the emergence of a first core of global civil society in Western Europe (D.Gress, BIG Expert Meeting, Rome, Jan 24-26, 2003).
The Cold War introduced a new kind of warfare, the “imaginary war” (G. Oates, 1994, The Imaginary War: Civil Defence and American Cold War Culture. Oxford University Press, New York), played through propaganda, nuclear deterrence, “weaponisation” of military spending, and local/regional wars. As Mary Kaldor says, “the end of the Cold War probably meant the end of wars of the modern type – wars between states and groups of states” (M.Kaldor, 2003, Global Civil Society. An answer to war. Polity-Blackwell, Oxford-Cambridge).


The key feature of post Cold War warfare is the evident US supremacy, making this nation the only remaining global superpower. In the 1990s, the concept of 'asymmetric conflicts' begun to gain favour among military analysts, who asserted that, when forces in confrontation do not possess the same level of military power, they adopt dissimilar tactics (T.V.Paul, 1994, Asymmetric Conflicts: War Initiation by Weaker Powers. New York: Cambridge University Press). In such cases, the military objectives are no longer the systematic pulverization of enemy lines but rather, in many cases, the erosion of popular support for the war within the society of the enemy. In asymmetric wars the distinction between war and peace blurs and the battlefields and frontlines become indefinable. Asymmetric wars are global in their essence, even when they are concentrated in specific world areas. Needless to say that true regional conflicts between nations will continue to ignite. Yet they should not be confused with asymmetric wars, which always involve a number of non state actors and global players (“military outsourcing”, non-governmental organisations (NGOs), international aid agencies, volunteers, media, etc.) that can hardly be understood in local terms. Asymmetric wars are characterised by unconventional tactics and practices, they are the mature product of the information society. The use and management of media hype is part of the strategy, and media - including new electronic media - are turned into a sort of “binary weapon” in which two elements (the attack and information on the attack) are assembled to multiply effects.


War on terrorism is an asymmetric war. Its battlefield is not a specific world area (even if it can be concentrated in some crisis areas such as Afghanistan and the Middle East) but it is a virtual battlefield: the global civil society. Global Civil Society is the concept used by scholars to describe the array of networks through which individuals and groups participate in global decision making. By compressing time and space through air travels and new forms of information and communication technology, modern technology has been the prerequisite to creating a global civil society (J.Urry, BIG Expert Meeting, Rome, Jan 24-26, 2003). The end of the cold war enabled the political conditions necessary for freeing the requisite economic forces.


Global civil society is a combination of networks, organisations, and movements that have learned how to n egotiate, or re-negotiate, business, social contracts, and political bargains at a global level. Global Civil Society includes: NGOs; civic networks; transnational business; religious networks; scientific networks; and other similar groups. They are a global nation without a world state, but with a myriad of overlapping international organisations and agencies (F.Fabbri, BIG Expert Meeting, Rome, Jan 24-26, 2003). They are drawing a new form of global citizenship different from any past cosmopolitan experience. Streets, squares, and agora of their global polis are those places that the French sociologist Marc Augé calls “non-lieux” which actually are – according to Guido Martinotti (G.Martinotti, BIG Expert Meeting, Rome, Jan 24-26, 2003) - “nos-lieux”. John Keane’s visionary description of global civil society deserves a full quotation: “[…] this civil society resembles a kaleidoscope of sometimes overlapping or harmonious, sometimes conflicting and colliding groups, movements and non governmental institutions of many different, often changing colours. Perhaps it is better speaks of global civil society as a dynamic space of multiple differences, some of which are tensely related or even in open conflict. It resembles the inner structures and dynamics of global cities like New York, London, Berlin, Paris or Sidney: a complex and dynamic three-dimensional landscape of buildings of all shapes and sizes, sought-after and down-market areas, organisations of all descriptions, cheerfulness and cursing, public generosity and private thuggery, millions of people on the move, using many forms of transport, in many directions” (J.Keane, 2003, Global Civil Society?, Cambridge University Press: Cambridge UK, p.175).


Willing or unwilling, fundamentalist and terrorist networks are an essential element of this global kaleidoscope. Terrorist networks have been often categorized as the "uncivil society". In the words of UN General Secretary Kofi Annan, the forces that made possible the emergence of a global civil society also facilitate the transnationalization of "uncivil" elements. Most scholars have depicted two sides to globalisation. Mobility has been described as the border line between those who are free to move and those who are forced to move. The first ones are those who enjoy the positive elements of globalisation and are beneficiaries of the technological revolution. The second are those who suffer from globalisation, such as economic migrants, asylum seekers, displaced persons, etc. (D.Grondin, BIG Expert Meeting, Rome, Jan 24-26, 2003). They easily become segregated groups and soon plunge into a phenomena of re-tribalisation and fundamentalism, and end up forming a global outcast. According to this diffused narrative, they are the field in which terrorism grows up (W.Winslade, BIG Expert Meeting, Rome, Jan 24-26, 2003).


Few would doubt that such a global outcast exists, but “uncivil society” is not so much its consequence as its parasite. Terrorists pretend to be delegates of world outcasts, but their networks are sophisticated global enterprises that exploit at the best all opportunities offered by globalisation. Terrorist networks have been shaped by the same technological and economic forces that are shaping the new global order (e.g., electronic networks of exchange of capital, knowledge, commodities, and information). Post-modern terrorists share our civil, political and social rights; they drink what we drink; they publish in the same scientific journals where we submit our papers; they invest their money in the same stock markets where we invest; and they enjoy reading Tom Clancy’s books from which, unfortunately, they may get the idea of commandeering commercial aircraft and slamming them into the World Trade Center (T.Clancy, 1994, Debt of Honor, Berkley Books, New York). They are not the absolute Evil, they are simply one of our – even if unwelcome - global neighbours. The “dark side of globalisation” is just a nice slogan. Whether one likes it or not, terrorist networks are as part of the global civil society as NGOs and civic networks. This makes  the “war on terrorism” the first global civil war in history.
 
2. Ethical Implications of Biowarfare
Standard definitions of biowarfare focus on the deliberate use of biological agents, toxins, and their components for hostile use against humans, animals and plants. While chemical agents were extensively used in World War I, biological weapons have never been used successfully in large-scale combat during the 20th century. Japan was the only nation in World War II that made confirmed use of biological weapons, and it used relatively crude means. While Japan used biological weapons against some 12 Chinese cities, the total number of deaths does not seem to have exceeded 10,000 – many of which were caused under controlled conditions by experiments using human beings as live subjects (J.Miller, S.Engelberg, W.Broad, 2001, Germs: Biological Weapons and America's Secret War, Simon and Schuster).
Other nations confined their efforts to experimentation. No nation is known to have used germs successfully against the personnel of another after the World War II. Charges of germ warfare were made by the Chinese against United Nations forces in the Korean War (1950–53), but no substantiation was offered. Iraq admitted in 1995 that it equipped shells and warheads during the Persian Gulf War with anthrax. None of these weapons was used[1].
 

After World War I bioweapons were prohibited in war (1925 Geneva Protocol) and their development, production and possession was then totally banned (1972 Biological and Toxin Weapons Convention;1996 4th Review Conference of the Geneva Protocol). The underlying logic behind the ban was that because biological weapons were effective, low cost and easy to produce, they were a technology that, once brought into existence, could enable a large number of states to acquire the ability to threaten or carry out destruction on a scale that could otherwise be matched by only a few major powers. Bioweapons were not a good deterrent for major powers but they could easily become the last resource for weak and vulnerable states; according to a well-known definition, the "poor man’s nuke". (J.F.Lacronique, Clinical trials in biodefense research, BRUSSELS, 3-4 February 2004).
Ethical implications of biowarfare were initially discussed in the context of nuclear warfare (P.Viminitz, Nuclear Warfare, in R.Chadwick, ed: Encyclopedia of Applied Ethics, Academic Press:San Diego, 357-365). The morality of bioweapons, as well as of any other weapon of mass destruction, was highly debated in the 1960s and 1970s, and there was substantial agreement among ethicists about their intrinsic immorality. Most arguments came from the Human Rights instruments as the notion of a “crime against the humanity”. The Roman Catholic Church was among the first transnational organisations to condemn any possible use of weapons of mass destruction (Encyclical of Pope John XXIII Pacem in terris 11 April 1963, 112). Roman Catholic moralists applied the traditional categories of jus ad bellum and jus in bello. The former aims at clarifying when force may be used and limiting the resort to force, while the latter,the just-war tradition, seeks also to curb the violence of war by imposing some moral standards for the conduct of armed conflict. Most Christian Churches and world religions followed.


Biowarfare ethics 
Early debate on the ethics of biowarfare coincided with the growing debate on nuclear deterrence. Ethical arguments with respect to the immorality of bioweapons highlighted the following issues (J.P.Zanders The coexistence between research policy on certain weapons and disarmament, Brussels 3-4 Feb, 2004):
1. The threat or use of bioweapons would generally be contrary to the rules of international law applicable to armed conflict, and in particular the principles and rules of humanitarian law;
2. Bioweapons cause unnecessary suffering to combatants;
3. Bioweapons are incapable of distinguishing between civilian and military targets;
4. Bioweapons violate principles protecting neutral states because of the diffusive nature of infectious diseases;
5. There is not a proportional response to a bioweapon attack; and
6. The danger of accident in developing and retaining bioweapons (even for defensive reasons) is still greater than the danger of deliberate military use. Accidental or unauthorized uses, computer error, irrational rogue actions, terrorist attack, criminal syndicate utilization of weapons are irrational and unpredictable, but likely, scenarios.


In the 1970s and 1980s bioweapons were not in the limelight of the public debate. Yet the public disregard towards biotechnology and genetic research was probably also due to the fear raised by the possibility of such a technology being exploited to produce bioweapons. The “Sorcerer's Apprentice” syndrome that surrounded early biotechnology is well illustrated by science fiction novels and movies of the 1980s.


In the 1990s two major events contributed to change this scenario. The first one was the end of the Cold War with its geo-political consequences. The second was the tumultuous development of biotechnology. In the 1990s the life sciences began a revolutionary period. Scientific understanding of living systems and how to manipulate them has been expanding exponentially, fuelled by advances in computerization, the global dispersion of scientific expertise as well as biological databases, and substantial economic investment in biomedical and agricultural research and product development.
 
Sooner or later almost every new technology has been exploited not only for peaceful purposes but also for hostile ones, and this is likely to be the same for biotechnology. Genetic technology is likely to make it possible to introduce changes into organisms and agents that make them more infectious, resistant to antibiotics or vaccinations, and easier to distribute. There are thirty different bacteria, viruses, and fungi on the NATO list of biological weapons threats, and there are additional agents on other lists. With sufficient effort many of these could probably be modified so as to evade existing vaccines and antibiotics. Yet the military potential of the biotechnological revolution remains still largely unexplored.


In the summer of 1997, JASON (a group of academic scientists, which consults on technical matters for the U.S. government and its agencies) addressed the problem of next-generation bioweapons threats (S.M.Block, 2001, The growing threat of biological weapons, Am Scientist, Vol. 89, 1:28-37). The JASON study explored a wide range of future possibilities open to genetically engineered pathogens. Several broad classes of unconventional pathogens were identified by JASON. These include "binary" bioweapons, which (by analogy with chemical weapons) are two-component systems in which each part is relatively safe to handle but which become deadly in combination, and "designer" variations on genes, viruses and complete life forms, including chimeras that mingle existing components. Even the technology that allows the repair or replacement of defective genes might be subverted to introduce pathogenic sequences. "Stealth" viruses could be fashioned to infect the host but remain silent, until activated by a trigger. New zoonotic agents might be developed specifically for bioweapon purposes by modifying existing pathogens to seek human hosts. Finally, detailed knowledge of biochemical signalling pathways could conceivably be used to create "designer diseases." Microbiology is thus just a part of the landscape.
 

The new constellation of 21st century bioweapons may also include biological agents such as: 1) Overproduction of host inflammatory mediators to produce toxic shock; 2) Knocking out genes that regulate key cell processes such as cell proliferation, which could therefore produce cancer and leukaemia; 3) Small molecules that disrupt molecular circuits in immune response, blood clotting system, higher brain function; and 4) Agents that can provoke acoustic disruption, bone pain, airway modulation, ultrasonic skin heating (J.P.Zanders The coexistence between research policy on certain weapons and disarmament, Brussels 3-4 Feb, 2004). Biotechnology can therefore profoundly alter not only the nature of weaponry but also its goals. As biotechnology advances bioweapons will not have only the potential to kill people, but they will be able to interfere with the fundamental biological processes of cognition, development, reproduction, and inheritance.
Humans are not the only potential target for future biological weapons. Both crops and animals have been subjects of biological weapons research. Bio-weapons against crops and animals could prove a very effective way of conducting war by causing famines and destabilising economies. Moreover, they may be easier to disguise as a ‘natural’ event. Attacks on  crops and livestock could also be combined with attacks on human beings. Anti-crop biological weapons have been proposed in the ‘war against drugs’. The USA is assessing the effectiveness of the Fusarium fungus - including a genetically engineered version - against the coca plant, and the United Nations Drug Control Program is carrying out field trials of the non-genetically-modified (GM) version of this fungus. The UK, meanwhile, is co-funding a United Nations project in Uzbekistan to develop another fungus (Pleospora papaveracae) to attack opium plants (P.Rogers, S.Whitby, M.Dando, 1999, Biological warfare against crops, Scientific American, June, pp 62-69). These projects clearly show that know-how to develop anti-crop biological weapons is already available. The application of sophisticated genetic knowledge of different crop species and varieties could greatly increase the gravity of these weapons (J.P.Dudley, M.H.Woodford, 2002, Bioweapons, bioterrorism and biodiversity: potential impacts of biological weapons attacks on agricultural and biological diversity, Rev Sci Tech,21(1):125-37). Also bioweapons against livestock are in progress (B.Biolatti, R.Ciliberti, Bioweapons against livestocks, Brussels 3-4 Feb, 2004). Weaponising biological pathogens against livestock is a far easier process than creating bioweapons against humans.

At least two sets of factors account for this:
- there are many more agents that are lethal and highly contagious to animals than is the case with humans; and
- livestock has become progressively more disease prone in recent years as a result of genetic selection and intensive antibiotic programmes. Disease risks are still higher in countries where control on steroid programmes and intensive husbandry are lenient.
 

Political analysts think that asymmetric warfare concentrates on the use of unconventional weapons such as new generation bioweapons (A.H.Cordesman, A.A.Burke, 2000, Asymmetric and Terrorist Attacks with Biological Weapons, Washington DC, The Center For Strategic and International Studies). In particular, security experts are warning of the danger of biological attack against population centres by terrorist groups or individuals. A clearly perceptible escalation in the use of "unconventional" terrorist weapons is believed to be the most important signal of this increasing risk. According to Richard Betts, (R.K.Betts,1998, The New Threat of Mass Destruction, Foreign Affairs, January/February:27) some of the most important implications of Weapons of Mass Destruction (WMD) have not yet registered with the public. Betts asserts that the nature of the potential use of WMDs is changing. Rather than being weapons of deterrence, as they were during the Cold War, they are increasingly becoming the weapons of choice of non-state groups. It is believed that these groups will use these weapons to attempt to intimidate legitimate governments. In other words, security experts suggest that non-state actors and terrorist networks, are likely to use WMD to maximize their kill ratios and send a larger and more fearsome message to their perceived enemies.


Biotechnology, although sophisticated, is not beyond the capacity of non state actors. The dissemination of biological substances does not call for sophisticated devices. They work through inhalation or ingestion and can easily be spread by crop-spraying equipment in the open or by aerosol in a confined space. Alternatively, depending on their nature, they can be introduced into the drinking water supply or the food chain. Biological weapons can be carried undetected across frontiers if need be, either in small initial cultures from which the desired quantity could be grown or in quantities that are already sufficient for a full-scale massacre.


New Biowarfare Ethics 
Beyond the general reasons for the ethical rejection of bioweapons, new generation biological agents are ethically incompatible with respect to:
1. As with any bioweapons, new generation bioweapons are incapable of distinguishing between civilian and military targets. More importantly, however, they may be used to target mainly civilians because the threshold at which the civilian medical system can be overwhelmed by a biological attack appears to be lower than expected (C.Penn, Human disease and biodefence research: potential benefits but risks of misuse, Brussels 3-4 Feb, 2004): 
- in the case of biowarfare it is likely that military forces will be vaccinated against dangerous biological agents, but it is unlikely that the entire civilian population can be vaccinated against any possible bioweapons - as a consequence, victims will be chiefly amongst civilian populations;
- stealth, or conditionally inducible, viruses can be introduced over years and then used to blackmail policy-makers and governments;
- those civilians who will most suffer from a biological attack will be from the most deprived groups and populations, that is to say those who are less likely to be reached by vaccination campaigns and other public health measures; this will also include the disabled , people suffering form chronic medical conditions and others in poor health;
- in the case of biowarfare it is likely that hospitals and health services will be overwhelmed by people who panic about infections and, consequently, many other legitimate patients will not be treated; and
- collateral damage among civilians will also include people suffering from the side effects of vaccines, antibiotics, and other drugs used to counteract bioweapons, especially vulnerable populations such as infants, pregnant women, elderly people, immune compromised people (AIDS and cancer patients, patients who undergo to any immunosuppressive therapy, etc.).
2. New generation bioweapons produce destruction that largely outweigh military objectives and may provoke disproportionate collateral damage (J.E.Stig Hansen, Bioweapons, Brussels 3-4 Feb, 2004):
- the potential for person-to-person transmission of contagious illnesses can disrupt social life and disorganise human communities;
- the transnational dimension of contagious illnesses can disrupt economic, commercial and cultural relationships between countries and raise serious problems of international collaboration (e.g., should a nation with limited availability of a vaccine stockpile offer its scarce resources to a neighbouring country under attack while there is the concrete risk that the infection spreads also into its own territories?)
- anti-crop and anti-livestock bioweapons my produce famines, serious economic losses and destabilisation that will harm the weakest and most disadvantaged groups and populations; and
- bioweapons, such as anti-crop fungi, may persist long-term in the soil altering the ecosystem and causing disease in other plants and economic destabilisation in vast geographical areas.
3. New generation bioweapons may produce inhumane harm; they can be even used for genocide (C.Penn, Human disease and biodefence research: potential benefits but risks of misuse, Brussels 3-4 Feb, 2004):
- smallpox-like agents may cause disfigurement and deformity;
- future bioweapons can remove immunities and compromise healing capabilities;
- they could induce sterility;
- they could induce dementia-like diseases;
- they could produce long term tailored diseases similar to AIDS that could combine serious initial lethality with crippling long-term effect lasting decades; and
- by exploiting knowledge on the genetic makeup of different populations and consequently by targeting weapons at specific ethnic groups, new generation bioweapons could be used to carry out ethnic cleansing and genocide.
4. New generation bioweapons may target future generations (J.E. Stig Hansen, Bioweapons, Brussels 3-4 Feb, 2004):
- dormant biological agents such as genetically modified anthrax spores can persist undetected for decades in the environment and produce long term effects on future generations;
- bioweapons which use transforming viruses or similar DNA vectors carrying Trojan horse genes (retrovirus, adenovirus, poxvirus, HSV-1), can produce inheritable (germline) effects; and
- Non microbiological agents used for altering fundamental biological processes of cognition, development, and reproduction can produce inheritable modification.


3. Ethical Implications of Global Collaboration against Terrorism
According to a European Commission Staff Working Paper, policies to counter biological threats should address: 1) surveillance and outbreak investigation; 2) risk assessment and crisis management; 3) scientific research on the prevention of potential bio-agents and novel therapeutics; and 4) networking between national and international security agencies (European Commission Staff Working Paper, Report of the R&D Expert Group on Countering the Effects of Biological and Chemical Terrorism, SEC(2002) 698). In turn, a document issued by the US National Research Council Of The National Academies points to: “(1) the risk that dangerous agents that are the subject of research will be stolen or diverted for malevolent purposes; and (2) the risk that the research results, knowledge, or techniques could facilitate the creation of “novel” pathogens with unique properties or create entirely new classes of threat agents” (Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology, Development, Security, and Cooperation, Policy and Global Affairs - National Research Council Of The National Academies, 2003, Biotechnology research in an age of terrorism: confronting the dual use dilemma, The National Academies Press, International Standard Book Number 0-309-09087-3, Washington, D.C.).
The Communication from the Commission to the Council and the European Parliament on Cooperation in the European Union on Preparedness and Response to Biological and Chemical Agent Attack – Health Security (COM-2003-320 final) establishes the general policy of the EU defence against biological agent attacks:


“The European Union is a border-free space in which products, services and people can circulate without hindrance. It is essential in such a space that appropriate arrangements be put in place to ensure prompt notification and exchange of information in case of threats and attacks, action at source be undertaken to stem the spread of disease and environmental contamination, mutual assistance be provided for diagnosis and management of cases, access to special laboratory services and expertise for epidemiological investigations be secured, and public health responses be put into effect. This, in turn, requires sharing of knowledge and good practice, laboratory facilities, equipment and products, experts and intervention personnel across the Member States of the EU, as well as good co-ordination and interoperability of preparedness and response plans.”


This statement – which corresponds to the philosophy of the BICHAT programme (EU Health Security Committee, 17 Dec 2001) - implies some key principles with important ethical components:
1) The existence of a European border-free space is a point-of-no-return: freedom of mobility is a basic right of all EU citizens;
2) Response to biological threats - which might question the right to the free exchange of people, knowledge, goods and information within the EU area – requires more rather than less European integration; and
3) Preparedness for a biological attack is a global enterprise that requires a multilateral effort for information exchange, consultation-coordination, resource sharing, and links with third countries and international organisations.

 
Ethics of global collaboration in the war on to terrorism
 
1. A biological attack because of its extreme gravity, vastness and urgency, must be considered too difficult for the rulers of individual States to solve with any degree of success. To face the challenge we need more rather than less globalisation, more rather than less Europe (J.Solana, A Secure Europe in a Better World: European Security Strategy, document adopted by the European Council on 12 December 2003).
2. War on terrorism should be based on principles of mutual responsibility and solidarity that are not in contradiction with basic individual rights. Individuals have rights — to life, health, security and liberty, as well as freedom of movement, of scientific research and information. The best strategy to counteract terrorism is to promote human rights and license intervention when necessary to enforce such rights. Transnational consultation, reinforced links between different agencies, and resource sharing among states perhaps deserve to be monitored from the human rights perspective, but they must not seen suspiciously as though they were a threat to individual rights (C.Patermann, Introduction to the meeting, Brussels 3-4 Feb, 2004).
3. National and supranational bodies that run the war on terrorism must have as a special aim the recognition, respect, safeguarding and promotion of human rights. Public national and transnational authorities must have the essential purpose to create world conditions in which global civil society, its networks and organisations, can carry out their tasks, fulfil their duties and claim their rights with greater security (E.McNelly, Bioterrorism, 3-4 Feb, 2004).
4. The European Civil Society – made up by a complex tissue of civic, scientific, cultural, and religious networks coming from 25 different nation states - is an invaluable good because it is one of the key components of the global civil society. Promoting the development of the global civil society is the best policy to promote also global health and security (J.Solana, A Secure Europe in a Better World: European Security Strategy, document adopted by the European Council on 12 December 2003).
 
4. Ethics of Preparedness and Response to Bioterrorism in EU
Preparedness and response to bioterrorism imply a difficult interplay between different rights and values, such as: individual liberty, common good, right to security, right to life and health, protection of personal data, freedom of expression and information, non discrimination and equality before the law, freedom of movement and residence within the European Union.

 
The Charter of the Fundamental Rights of the European Union (Nice Treaty) consider liberty and security as basic rights and cites them under the same article (art.6) of the Chapter II (Freedoms): “Everyone has the right to liberty and security of person”. Health rights are considered both under art.2 “Everyone has the right to life” (which is part of the Chapter I “Dignity”) and art.35 “Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities” (which is part of Chapter IV “Solidarity”). Freedom of information and Freedom of sciences are considered in art.11 “Everyone has the right to freedom of expression. This right shall include freedom to hold opinions and to receive and impart information and ideas without interference by public authority and regardless of frontiers”, and art.13 “The arts and scientific research shall be free of constraint. Academic freedom shall be respected” (Chapter II “Freedoms”). Also, protection of personal data (art.8) is under “Freedoms”: “Everyone has the right to the protection of personal data concerning him or her”. Freedom of movement and residence within the European Union is part of Citizen’s Rights (art.45): “Every citizen of the Union has the right to move and reside freely within the territory of the Member States”. Non discrimination and equality before the law is ensured by art. 20 of Chapter III on “Equality”:“Everyone is equal before the law” and art.21 “Any discrimination based on any ground […]shall be prohibited”
Having in mind these principles, three main points should be discussed: 1) risk analysis; 2) resource allocation; and 3) disease control practices. 
 
1) Risk analysis
Risk Analysis is a scientific discipline that consists of risk assessment, management and communication. All risk components are important elements of an ethical evaluation of the bioterrorist threat. It is beyond the purposes of this paper to discuss these elements in depth. There is, however, a crucial issue that must be addressed: is there a substantial risk that biological weapons are used by terrorists? The answer is vital because there is the frightening possibility that security experts, by focusing too much on bioterrorism, are generating a “self-fulfilling prophecy” - the expression introduced by the American sociologist W.I. Thomas to describe the fundamental idea that if people define certain situations as real, then they are real in their consequences. Moreover only by weighing attack risks against prevention costs is possible to make an ethical assessment. The well known case of the small pox vaccine may illustrate this issue.
Research on vaccinations done decades ago suggests that at least three people may die for every million inoculated by the small pox vaccine. Now the number may be higher because more people have suppressed immune systems thanks to AIDS and to the rise of sophisticated new medical procedures such as organ transplants and cancer treatments. Moreover, the vaccine may not work against many of the nastiest strains of smallpox now being developed. Ken Alibek, a scientist who ran the Soviet Union's biological-weapons laboratories before defecting to America a decade ago, says that Russia has developed 2,000 strains of smallpox. Many are impossible to treat or defend against with existing drugs; some cannot be detected with existing diagnostic tests. With such a highly uncertain evaluation of potential risks, are we entitled to administer a small pox vaccine, which entails some definite risks, against a supposed biological attack?
After 9/11, security experts and political analysts have told us that a biological attack is not matter of “if” but “when and where”. As a matter of fact, this attack has not yet happened (the anthrax affair is a complex incident that is still unclear). Historical experience indicates that in most cases terrorists are more likely to continue to use conventional techniques that are technically undemanding and not dangerous for them to handle. But this point does not apply to individuals and groups that are willing to risk or give their lives when carrying out terrorist attacks. So, why do post-modern terrorists still rely on “traditional” means of mass destruction?
There are two possible answers: 1) Terrorists do not possess the necessary background to produce and handle bioweapons; 2) Bioweapons are not the right instrument to terrorise people, they cannot provoke the same terror provoked by traditional means such as bombs;
The first answer is likely to be wrong. The magnitude of effects of biological agents have been perhaps overestimated. Simulations that speak of hundred thousands or even millions of casualties are probably unrealistic (P.S.Wrightson, The Science and Security Dilemma, Brussels 3-4 Feb, 2004) because they would require the weaponization and use of large quantities of biological agents. This is unlikely because of the sophisticated scientific and technological requirements for their production. Yet a small-scale operation using crude bioweapons is definitely within many terrorists’ reach. It could cause societal disruption and have severe economic consequences, in addition to the human cost and psychological effects.


The second question is whether terrorists consider bioweapons to be too 'dry' in comparison to traditional bombings, in the sense that biological attacks do not produce immediate, visible effects. The impact of a biological attack, while significant, is delayed, lacking a single point for the media to focus on. Biological attacks do not break the TV screen. As such, the fact that biological terrorism has not emerged as more of a problem is understandable. Terrorism is a form of warfare based on the systematic use of means tailored for generating fear. One of the key psychological features of an effective terrorist threat is to materialise nightmares, that is to say to evoke internal phantasms (E.Mordini, From Bioterrorism to Bioethics, Brussels 3-4 Feb, 2004).
Post-modern terrorists are sons of globalisation and the population that they are targeting (both as a victim and as a “public”) is made up by other components of the global society: travellers, migrants, international military forces, common citizens who happen to transit in places such as airplanes, airports, train stations, supermarkets, highways, etc. Terrorists address this population specific fear, which is the fear that their “global familiar spaces” – Marc Augé’s “non-lieux” - may suddenly become deadly traps[2]. This is why the idea of using a commercial aircraft on a suicide mission is more frightening than the idea an epidemic. However, it would be wrong to assume that the lack of TV allure and the poor capacity to mobilise unconscious fears preclude the possibility of a terrorists’ switch to biological attacks. But we have to expect future biological attacks furnished with some special features that may turn them easily into media “events”. In other words, my argument is that if terrorists succeed in imagining the right “narrative”[3], we are going to witness biological attacks as devastating as more traditional terrorist actions.
A second group of issues concerns risk management and communication. Bioweapons as such have less fearful potential than other terrorist actions, but they are especially effective at causing long term anxiety and stress. Biological agents are invisible, odourless, and imperceptible to humans. Their effects are not immediate but delayed and often protracted. Ongoing risk of exposure or contracting the illness is difficult to assess, which heightens a sense of vulnerability, loss of control, and thus anxiety (E.McNelly, Bioterrorism, 3-4 Feb, 2004). Identification of an outbreak that may be a terrorist attack, when there are more questions than answers, is a time of heightened vulnerability to inaccurate information, speculation, worst-case scenarios, and hype.


The nature of modern societies amplify the impact of terrorism. Discrepancies between government statements and between scientific experts, can be easily exploited. Access to the media of maverick scientific opinions will reduce confidence. Memories of previous misgovernance will reduce confidence and create societies in which rumours of conspiracy and cover-up can flourish. Rumours, urban legends, and anecdotes can provoke even more destabilisation via the same attack (M.Green, Learning to live with risks, Brussels 3-4 Feb, 2004). Failure to involve the public as a key partner in the medical and public health response could hamper effective management of a biological attack and increase the likelihood of social disruption. Populations are more resilient than experts usually believe, and they may react to assaults with cohesion rather than panic, but it depends on two factors (N.Akkas, Ethics and Policy of Risk Communication, Brussels 3-4 Feb, 2004): 1) trust in communicators and information validators; and 2) the degree of risk that a society is prepared to accept.


Ethics of Risk Analysis and Communication
1. If a biological attack is going to happen, it will be a media event. Low media impact attacks are improbable. Media analysts and communication experts should be involved in foresight exercises and their opinions should be highly evaluated in considering actual risks of biological attacks. Information and journalism ethics is vital to face this aspects of the war on terrorism.
2. “Risk statements are neither purely factual claims nor exclusively value claims. Instead, they are either both at the same time or something in between, a ‘mathematicized morality’ as it were” [4] (U.Beck, 2000, Risk Society Revisited: Theory, Politics, and Research Programmes, in B.Adam, U.Beck, J.Van Loon, eds: The Risk Society and Beyond. Sage:London, p.215). The essence of risk is not that it is happening, but that it might happen. Risk assessment is only in part based on empirical knowledge, and any account of risk involves a hidden politics and ethics. This is particularly true when one has to evaluate the actual risk of bioterrorism threat. Setting the risk agenda is no longer something that can be decided only by experts. In democratic societies, citizens have the right to contribute to setting the risk agenda and to be involved in establishing priorities between different risks that society has to tackle (E.McNelly, Bioterrorism, 3-4 Feb, 2004). The lack of public involvement in debating the implications of biowarfare does not stem from ignorance, but from framing the debate only in terms of scientific expertise of risk perception. Assessing bioterrorism risks is not so much a question of military intelligence but of democracy.
3. Trustfulness, accountability, responsibility are the values on which an effective risk communication can be built. The level of trust by the public, especially in their national governments, is low. Except for honesty in public communication, there are no communication strategies or other technical approaches that can alone solve the problem.. Democratic and responsible communication requires balancing the necessity for security (and thus for secrecy) with the need for the disclosure of information that can allow the public to make informed decisions (E.McNelly, Bioterrorism, 3-4 Feb, 2004).
4. The assumption that people will panic or become irrational following an attack has negative consequences (M.Green, Learning to live with risks, Brussels 3-4 Feb, 2004). Authorities may provide inaccurate information or unfounded reassurances motivated by a wish to calm the public. The panic myth may also lead to the neglect of the public’s role in planning and response, and to missed opportunities to capitalize on the resourcefulness of non professionals and civic organizations.
 
2) Resource Allocation
Risk analysis is strictly interlaced with the issue of resource allocation. Preparedness for a biological attack is very costly and it can be only ethically justified by an actual risk of occurence. On the contrary, it would be unjust to divert scarce resources from public health necessities to unnecessary protection plans against bioterrorism. The economic challenge is not just in terms of huge direct costs that have to be met, but also in deciding what roles should be played by the public sector and by the commercial drug industry. For instance, many new drugs will be required just to tackle smallpox, which is only one of many biological weapons that might be unleashed. Also, a better anthrax vaccine is needed as the existing vaccine has very unpleasant side-effects. There are at least 19 chemical or biological scourges for which there are no reliable counter-measures. Merely preventing, diagnosing or treating these could require 100 new products—and the number could soar if diseases are genetically engineered to resist existing treatments (B.T.Smith, T. V.Inglesby, T.O'Toole , 2003, Biodefense R&D: Anticipating Future Threats, Establishing a Strategic Environment, Biosecurity & Bioterrorism 1(3):193-202). The cost of creating 100 new drugs dwarfs anything yet mentioned. Pfizer and Merck, for instance, each spend around $6 billion annually, to produce two or three new drugs a year (B.T.Smith, T. V.Inglesby, T.O'Toole, 2003).


A major biodefence research and development (R&D) program could, however, also lead to knowledge capable of reducing the global burden of naturally occurring infectious diseases in developing countries. Fundamental discoveries in the science of infectious disease, joined by innovation in drug development and production processes, could substantially diminish not only the threat of bioweapons but also the global burden of infectious disease. It is important that this point is not taken as granted but that it is explicitly mentioned in the political agenda of the war on terrorism.
Resource allocation also concerns micro (local) allocation of resources in case of attack. Availability of medical resources may be limited and medical, public health, and political leaders should assure a fair distribution. Clear principles are needed that allow decision-makers to assign priorities for the use of scarce human, pharmacological, and technical resources and to implement such decisions. It is critical that the capability to efficiently and rapidly distribute antibiotics and other needed resources (e.g., simple face masks) to where they are needed is established. Distribution plans should be able to support additional centres of vaccine and antibiotic distribution, thereby drawing crowds away from hospitals and ensuring the ability to reach all population segments, even the most deprived and isolated.


Ethics of Resource Allocation 
1. Justice in macro allocation of economic resources (E.Noji, Public Health in Emergencies, Brussels 3-4 Feb, 2004): The difficulty to ethically justify the huge amount of resources internationally allocated on the prevention of biowarfare requires that scientific research oriented toward development of drugs to tackle biological agents may also have positive impact on the so called "10/90 gap" (less than 10% of worldwide health research is devoted to diseases that account for 90% of the global burden of disease).
2. Equity in micro allocation of medical resources (E.Noji, Public Health in Emergencies, Brussels 3-4 Feb, 2004):  A biological attack could initially foster social cohesion. Through a common enemy and shared sacrifices, most citizens may develop a sense of fellowship. Yet medical resources could be unevenly and inequitably distributed. This would immediately reduce risk acceptance and would push citizen groups against one another in an effort to assign blame or to protect access to limited resources
3. Ethical Awareness and Community’s involvement (S.Bird Conclusions, Brussels 3-4 Feb, 2004): Clinicians could face complex ethical issues about how resources should be directed toward treatment and how the workforce should be handled. They should be trained in advance to face such dilemmas and priorities should be set accordingly. Community's ethical judgment should be also taken into account in setting priorities for the use of scarce medical resources, such as antibiotics and vaccines
4. Respect for patients who are not directly concerned with the attack (E.Noji, Public Health in Emergencies, Brussels 3-4 Feb, 2004): During a biological attack, hospitals could quickly face unprecedented challenges. They might need to care for overwhelming numbers of patients; manage shortages of personnel, medicines, and equipment; and provide the security needed for crowd control, for the provision of safety for health care workers and patients, and even, perhaps, for the enforcement of mandatory isolation of contagious patients. Attention should be particularly paid to the rights of patients who need urgent medical care for reasons different from the biological attack itself
5. International cooperation in resource allocation: As a result of the growing web of interconnections, germs have an easier ride than ever. A local attack can easily become global. In the case of widespread biological attack, who would be responsible for the triage of priority populations for prevention or treatment? Who would be responsible for international resource allocation, e.g. vaccines, antibiotics ? How should international cooperation work in this case (J.E.Stig Hansen, Bioweapons, Brussels 3-4 Feb, 2004)?


3) Disease control practices
Biological attack is a public health emergency, where potentially thousands of persons are exposed or infected with a contagious disease. Recent epidemics -such as SARS - are good models to study the potential impact on health systems of biological attacks with agents capable of person-to-person transmission. The emergence of these epidemics had forced the medical community to recognize the tension that often occurs between individuals and the protection of public health.


During epidemics of new diseases there is uncertainty about effective treatments and there are concerns that some treatments may be ineffective or dangerous. Sometimes there is no treatment or vaccine and the most effective way to limit infection are social measures such as to isolate people who have been infected and quarantine others who have been exposed. Disease control practices may be required or legislatively mandated. Authorization for the use of coercive powers are the most controversial aspects of public health laws. Nevertheless, their use may be necessary to manage property or protect persons. There are numerous circumstances that might require management of property in the interests of protecting the public’s health, e.g., decontamination of facilities; acquisition of vaccines, medicines, or hospital beds; or use of private facilities for isolation, quarantine, or disposal of human remains. There may also be a need to exercise powers over individuals to avert significant threats to the public’s health. Compulsory powers may be needed for those who will not comply and whose conduct poses risks to others or the public health. These people may be required to yield some of their autonomy or liberty to protect the health and security of the community
There is an urgent need to formulate clear, scientifically and politically sound principles for the containment of highly contagious disease outbreaks (both unintentional and provoked) in large urban communities. Decisions regarding patient isolation and regarding travel advisories, home curfews, the closure of airports and highways, and attempts to "quarantine" cities and countries must be balanced against the practical feasibility of such measures and their implications for civil liberties. No social or ethnic group should feel discriminated or unfairly treated. Particular caution should be taken not to unduly stigmatize particular communities (E.Mordini, 2003, Bioethics and ethnicity, in: Dictionary of Race, Ethnicity and Culture, Sage Publication Ltd, London:25-28)


Ethics of disease control practices
 
1. Respect for the person (including respect for autonomy, integrity, and privacy) remains an ethical cornerstone even in health emergencies (S. Bird, Conclusions, Brussels 3-4 Feb, 2004):
- Health policies have generally avoided collective and compulsory measures in favour of individual autonomy and personal choice. With the spread – either intentional or unintentional - of new lethal infections this policy can pose an increasing problem but the principle should be re-affirmed;
- Compulsory physical examination, testing, and vaccination, quarantine and isolation each may help contain the spread of infectious diseases. The tendency to use these draconian means increases as fear and anxiety increase. The demand for these actions as well as the failure to use them may contribute to community conflict and erode the public's confidence in the government;
- Informed consent and respect for individual autonomy are some of the ethical practices that health care workers should struggle to maintain during a public health crisis. Most people will comply with public health programs during emergencies if they are correctly informed and involved in decision making; and
- Other ethical principles that can be challenged are those related to privacy and confidentiality. How can the duty to protect the patient’s confidentiality be balanced with the duty to protect the public good?
2. Some fundamental human rights and freedoms can never be suspended or derogated (E.McNelly, Bioterrorism, 3-4 Feb, 2004), such as the right to life; the right to freedom from torture and all forms of cruel, inhuman, or degrading treatment; and the right to freedom of thought, conscience, and religion. Any restrictions on other rights must be exceptional and temporary in nature; limited to the extent strictly required by the exigencies of the situation; non-discriminatory solely on the ground of race, colour, sex, language, religion or social origin.
 
4. Dual Use Technology and Security Dilemma
“Dual-use items are goods, software and technologies likely to have both civilian and military uses” (definition taken from EC regulation n° 1334/2000 of June 22, 2000).Technology is the practical application of knowledge to perform some actions, to solve some practical problems, or to achieve some practical goals. Technology puts moral intuitions to the test. While knowledge has always a positive value – at least in liberal, open societies – its practical applications often need to be regulated. The enormous growth of modern technology has provided the basis for myriad applications in industry, agriculture, and medicine. Today the time between new discoveries and their applications has grown as short as public opinion and policy makers are often incapable of discerning between scientific discovery and derived technology and to form a clear picture of what (and if) is worth worrying about. The knowledge-technology short circuit is an essential feature of the “dual use technology” problem. 
 

The "dual use" aspect of biotechnology does not only concern a few applications. In principle all biological knowledge can be used both for civil and military purposes. The knowledge needed to weaponise a germ is essentially the same as is needed to understand how that germ causes disease and how to create an effective vaccine against it. In principle the sole guarantee against biotechnology misuse would be a time gap between the new discovery and its technological applications. This time gap would allow for the implementation of self-regulation and internal check mechanisms within the scientific community. But this gap hardly exists any longer. For as an industrial enterprise, biotechnology cannot afford any delay in commercialisation. Biotechnology is invading almost all sectors, chemistry as well as medicine; agriculture as well as stock breeding; informatics as well as telecommunications. Virtually each of these applications may have military uses, and there is no little hope of isolating civilian from military applications. History teaches that excessive worrying about technological revolution rarely stops it: “A successful biodefense R&D&P strategy must accept that the growth and international diffusion of bio-scientific knowledge and technologies will continue at a phenomenal pace and must seek to leverage these powerful forces against the bioterrorist threat ” (B.T.Smith, T.V. Inglesby, T.O'Toole , 2003, Biodefense R&D: Anticipating Future Threats, Establishing a Strategic Environment, Biosecurity & Bioterrorism 1(3):193-202).
 
The dual use nature of biotechnology makes it difficult to really ban biological weapons (J.P.Zanders The coexistence between research policy on certain weapons and disarmament, Brussels 3-4 Feb, 2004). As far as state are concerned, these weapons are as easy to produce; it is virtually impossible that international inspections will be as effective as the those which ensure the non-proliferation of nuclear weapons by signatories to the Non-Proliferation Treaty (NPT). Regular inspections would have to be carried out, covering not only each country’s military facilities but also all its chemical, pharmaceutical and food factories. And even that would not prevent biological agents being produced in nondescript premises that could only be discovered by resorting to old-fashioned cloak-and-dagger methods. Not to mention the fact that some products are easily switched from civilian to military uses. Even biodefence activities are hardly distinguishable from bioweapon production. The defensive value of these activities, whether they are legitimate or are hidden offensive activities, is difficult to assess.
The same holds true for non-state actors and terrorist networks (C.Penn, Human disease and biodefence research: potential benefits but risks of misuse, Brussels 3-4 Feb, 2004). In theory almost any private biotechnology laboratory could produce bioweapons. Commercially available technologies now permit the large-scale production of bioweapon agents in small-scale facilities at relatively low cost. The clandestine manufacture of effective biological weapons can be easily disguised. With simple automated systems, weapons grade material can be manufactured with reduced risk to the people making it while simulating trivial biotechnological productions.
The general legal frame that governs the production of biological weapons is the Biological and Toxic Weapons Convention (BTWC, 1972). Unfortunately the BTWC has no standing organization, no legally binding requirement for declarations, and no provision for investigations. Experts agree that the BTWC does not provide adequate control measures and needs to be substantially amended and extended to non-governmental organisations as well as states(J.P.Zanders The coexistence between research policy on certain weapons and disarmament, Brussels 3-4 Feb, 2004).
Other issues (P.S.Wrightson, The Science and Security Dilemma, Brussels 3-4 Feb, 2004) raised by the dual nature of biotechnology are: i) Free movement of scholars within the scientific community, such as international post-doctoral exchange programs, visiting fellowships, international masters courses, etc.; ii) Freedom of publication in scientific journals; and iii) Restriction of sensitive, but unclassified, information. These are typical liberty issues. At stake is the inherent conflict between science and security. As Patricia Wrightson says “Science played a great role in shaping security policy, but now security threats may restrict the conduct of research. Efforts to strengthen security may end up weakening both the scientific framework and its beneficiaries” (P.S.Wrightson, The Science and Security Dilemma, Brussels 3-4 Feb, 2004).
The free movement of scholars is a very delicate issue. The possibility of differential liberty of people, dependent on their country of origin or on the basis of the countries through which they have passed and the time they have spent there, is ethically arguable. Many of the human-rights documents emanating from international organisations decry the process of discriminating between people of different ethnic, sexual, religious, cultural or racial types. Obviously states have the right to require visas and to establish more or less severe border controls depending on nations of origin of visitors, but in these cases the line between security measures and discriminatory methods is very subtle (P.S.Wrightson, The Science and Security Dilemma, Brussels 3-4 Feb, 2004).

 
Freedom of publication in scientific journals has been a highly debated issue. The problem is how to evaluate the possibility that the content of a paper may result in a possible risk for national security or at least be misused for malevolent purposes. Some have proposed to remove technical information that may allow for the misuse of research results, but this strategy would reduce the editor’s ability to judge the scientific validity of papers. “Peer-reviewed journals play an important role in widely spreading correct, science based, scrutinized information, which may help even to mitigate the damage created by means of other forms of information dissemination” reminds us Philip Campbell, and “the editor of each journal is the one who decides and takes responsibility for what is published” (P.Campbell, Dual-use biomedical research: the roles of journals, Brussels 3-4 Feb, 2004). 
The restriction of sensitive information implies the hard and vain effort to define what “sensitive information” is. Indeed, the dual nature of biotechnology makes almost any piece of information potentially sensitive, and there is a lack of shared values between the security and the scientific communities about what should be considered sensitive (P.S.Wrightson, The Science and Security Dilemma, Brussels 3-4 Feb, 2004). Moreover, it is highly arguable - if even possible – that in a global society, characterised by myriads of information and communication networks, the dissemination of information should be halted.
Security means many things to different people, and there is no broad consensus on its meaning. The rapid movement of people, capital, goods and ideas within and across borders deeply affects the capacity of states to manage security issues. Security is, however, also an individual right. The science and security dilemma can be handled in different ways:


1) From a utilitarian perspective, one must balance risk versus benefit. Freedom in research and cooperation are vital to achieve public health benefits, but also the prevention of misuse of material and knowledge are critical to defending individual and collective interests. These two common goods must be compared and one should find a way to maximise both. The utilitarian perspective gives reasons, beyond simply self-regulation by the scientific community, for harmonisation of international regulations of science and industry, (C.Penn, Human disease and biodefence research: potential benefits but risks of misuse, Brussels 3-4 Feb, 2004)
2) From a Kantian (deontological) perspective, one should consider some absolute values that are not negotiable under any circumstance, such as freedom of research, freedom of information and communication, freedom of association and exchange between peers. The Kantian perspective emphasis the role of ethical codes and self-regulation of the scientific community (P.S.Wrightson, The Science and Security Dilemma, Brussels 3-4 Feb, 2004).
Ethics of dual use technology and security
1. Science and Security Dialogue (P.Campbell, Dual-use biomedical research: the roles of journals, Brussels 3-4 Feb, 2004): The science and security communities have until now suffered from a lack of dialogue. This lack of dialogue is mirrored in a lack shared values. If the science and security communities are to work together, it becomes important to find and identify places and moments in which the two communities can meet and exchange ideas.
2. Scientists’ Responsibility (P.S.Wrightson, The Science and Security Dilemma, Brussels 3-4 Feb, 2004):
- Scientists involved in research programs with dual use nature are the people upon whom to rely on for bioweapons control programs. Bioweapons are the only warfare for which the same agent is important for offensive and for defensive purposes. This implies that science is very unlikely to be easily recognized for its own very final use. The composition and behavior of biological agents for offense are being studied for bioweapons defense program as well putting the scientists in a crucial position;
- There is a need to increase the awareness in the scientific community of the bioweapons-relevant issues and their ethical implications.While there has been a significant increase in the number of regulations governing activities in the fields of biology and biotechnology, these regulations still do not amount to an ethical prescription. Regulations may only constitute the moral minimum. Today there is a moral consensus about the status of the biological weapon, but not about the status of the technologies that may contribute to bioweapons development and production; and
- Professional and scientific organizations must adopt international prohibitions against the misuse of biotechnology in their codes of conduct and ethical norms.
3. Liberty from political control on scientific community (P.S.Wrightson, The Science and Security Dilemma, Brussels 3-4 Feb, 2004):
- The scientific community is by its nature part of the global civil society. Irrespective of whether we rely on self regulation by the scientific community or we set some international regulations to control the dual use nature of biotechnology, in order to protect the scientific community from possible intrusions, it is vital that we establish some rules on liberty which cannot be trespassed by national governments; and
- Dissemination of scientific information cannot be stopped; scientific journals may help to mitigate the damage created by means of other forms of information dissemination (P.Campbell, Dual-use biomedical research: the roles of journals, Brussels 3-4 Feb, 2004)
4. Avoiding the stigma (D.Grondin, BIG Expert Meeting, Rome, Jan 24-26, 2003): A very delicate issue concerns the possibility of differential treatment of scientists dependent on their country of origin, or on the basis of the countries through which they have passed and the time they have spent there. Many of the human rights documents emanating from international organisations decry the process of discriminating between people of different ethnic, sexual, religious, cultural or racial types. The differential treatment of an individual on the basis of her ethnic, religious, cultural, geographical origins may be ethically problematic.
5. Regulatory and legal frameworks are the true counterweight to asymmetric war (J.P.Zanders The coexistence between research policy on certain weapons and disarmament, Brussels 3-4 Feb, 2004): National implementation remains an undervalued tool in the efforts to counter the use of disease for hostile purposes. The norms in the BTWC also apply to legal and natural persons. Since states parties must ensure that no prohibited activities take place on their territory, they are required to promulgate national legislation. In particular, criminal and penal law based on the conventions can be important tools to prevent and punish biological terrorism and the involvement of companies and individuals in the bioweapons programmes of other states. Internal and external transfer controls will restrict access to relevant technologies to legitimate people, research institutes and companies only.
6. Human security is a class of human rights (Commission on Human Security, 2003, Human Security Now, UN, New York): Human security seeks to complement state security. States have the fundamental responsibility of providing security. But the notion of state security concentrates primarily on safeguarding the integrity of the state and thus has only an indirect connection with the security of those who live in these states. On the contrary, human security should be considered, as in the “The Charter of the Fundamental Rights of the European Union”, intimately connected with liberty (art.6): “Everyone has the right to liberty and security of person”.


5. Ethics of Sensitive Medical Experimentation
The protection of human subjects involved in sensitive biomedical research is one of the problems raised by the war on terrorism. The use of human subjects in clinical trials is regulated through international conventions, which state that participants must give their informed consent, and that the research should be approved through an independent ethical review process, taking into account the risks versus the benefits of performing the trial. In a field such as biodefence, elements or even significant proportions of the research could be considered sensitive, or classified by the government or agency concerned. Given this reality, should biodefence research be subject to the same ethical standards as ordinary clinical trials, and how should these standards be interpreted given the need for secrecy and the difficulty in performing a risk-benefit analysis in a field as full of uncertainty as bioterrorism? There are no specific ethical guidelines or directives to be applied to sensitive or classified biomedical research, nor is there a clear cut definition of what sensitive biomedical research is  (P.S.Wrightson, The Science and Security Dilemma, Brussels 3-4 Feb, 2004). There is thus a need to establish at least some general principles.


The main point, which clearly emerges from all international documents, is that the ethical standards that govern human medical trials should apply under any condition (R.Chadwick, Protection of Human Subjects Involved in Biodefence Research, Brussels 3-4 Feb, 2004). According to the Council of Europe's convention on human rights and biomedicine, even if a country is facing war or conflict, the defence of its economic well being, or a threat to national security, no exceptions are granted to these standards. The Council of Europe's 'Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine states (Chapter II, Article 5): “An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time.”
In the 'Explanatory Report to the Convention on human rights and biomedicine' (drawn up under the responsibility of the Secretary General of the Council of Europe, available at http://conventions.coe.int/treaty/en/Reports/Html/164.htm)

Article 5 is explained as follows: “This article deals with consent and affirms at the international level an already well-established rule, that is that no one may in principle be forced to undergo an intervention without his or her consent. Human beings must therefore be able freely to give or refuse their consent to any intervention involving their person. This rule makes clear patients' autonomy in their relationship with health care professionals and restrains the paternalist approaches which might ignore the wish of the patient.”
The general rule is complemented by the specific articulation in Chapter V, Article 16:
“Research on a person may only be undertaken if all the following conditions are met:
i. there is no alternative of comparable effectiveness to research on humans;
ii. the risks which may be incurred by that person are not disproportionate to the potential benefits of the research;
iii. the research project has been approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of the research, and multidisciplinary review of its ethical acceptability;
iv. the persons undergoing research have been informed of their rights and the safeguards prescribed by law for their protection; and
v. the necessary consent as provided for under Article 5 has been given expressly, specifically and is documented. Such consent may be freely withdrawn at any time.”
The Explanatory Report furthermore notes that “...the Article requires not only the person's free and informed consent, but their express, specific and written consent. The words "specific consent" are to be understood here as meaning consent which is given to one particular intervention carried out in the framework of research.”


A need for secrecy, which makes it difficult to provide full information and to have the clinical trials reviewed by an independent panel, does not rule out military research. ‘(R.Lie Are international ethical codes applicable to classified biomedical research? Brussels 3-4 Feb, 2004). Exceptions are still possible, although under “specific legal measures”, as stated by the Explanatory Report to the Convention on human rights and biomedicine: “War and armed conflict were also ruled out as possible grounds for exceptions. However, this is not meant as preventing the law from taking specific measures in the military aiming at protecting public health in that particular context.” Yet one should always try to respect ethical standards while complying with security needs. This is possible more often than people think, provided that the three groups of people (researchers, military and ethicists) make an effort to speak together and to understand each other.
Ethics of sensitive medical experimentation:
1. Ethical standards must be adopted even in sensitive or classified research (R.Lie Are international ethical codes applicable to classified biomedical research? Brussels 3-4 Feb, 2004): Even in the case of classified biodefence research, the ethical standards that govern human medical trials should still apply. According to the Council of Europe's convention on human rights and biomedicine, even if a country is facing war or conflict, the defence of its economic well being, or a threat to national security, no exceptions are granted to these standards.
2. Ethical review of a protocol that contains classified or sensitive information: (R.Lie Are international ethical codes applicable to classified biomedical research? Brussels 3-4 Feb, 2004): It is not a requirement that a research ethics committee reviews everything there is to know about a study. It is only a requirement that the committee reviews that information that is material to its decision, namely whether the proposed research involves an acceptable risk-benefit ratio, and whether the information provided to the participants will enable the participants to make a valid choice to enter the trial:
 - If the chair of the committee determines that the protocol can be reviewed acceptably without the classified information, then the protocol can be reviewed by a committee whose members to not have security clearance;
 - If, however, this cannot be done, then the only option would be for the protocol to be reviewed by a research ethics committee whose members all have the needed security clearance. If that second option is chosen, one does need to pay attention to the independence of the ethics committee from the research enterprise, but in principle it should be possible to ensure such independence; and
 - If neither of these options is possible, there cannot be an appropriate review of the research and the research cannot be carried out.
3. Informed Consent in a research project that contains classified or sensitive information (R.Lie Are international ethical codes applicable to classified biomedical research? Brussels 3-4 Feb, 2004): There is no requirement that potential participants receive all the information that is available about a research project. It is only a requirement that they receive information that is material to their decision to participate, which means that all information that would make a difference in terms of their decision to participate should be provided. The research ethics committee that reviews the research will have to decide whether the requirement of informed consent can be fulfilled without including any classified information.
- If classified information can be left out, and one can still fulfil the ethical requirement of informed consent, then the research project can go ahead.
- If, on the other hand, the research ethics committee determines that a potential participant will have to obtain classified information in order to make a valid decision, the planned research cannot be carried out in an ethically acceptable manner.

AKNOWLEDGEMENT
Special thanks to Dr Govin Permanand, from the London School of Economics Health and Social Care, who kindly reviewed the manuscript. 
This paper has been prepared in the scope of the EU funded project BIG – Bioethical Implications of Globalisation Processes (QLG6-CT-2002-01796). 

[1] Other well known episodes of deliberate use of biological agents were:
 1) The contamination in 1984 of salad bars in the small town of The Dalles, Oregon, with Salmonella typhimurium, the bacteria were spread by members of a religious cult, who were apparently testing a plan to gain control of local government by keeping other citizens from voting in a coming election. 
2) The Tokyo subway attack by members of the Aum Shinri Kyo sect on 20 March 1995 (7). A week later, the Japanese police found a substantial quantity of botulin in premises belonging to the sect. Had it used that substance instead of sarin in the same circumstances, thousands or tens of thousands might have died.
[2] This is well illustrated by several movies in which public familiar spaces - such as airplanes, airports, trains, supermarkets, etc. - abruptly turn into mortal spaces. Freud wrote some impressive pages on the way in which the experience of something that is familiar may generate horror when it unexpectedly reveals its unfamiliar side (unheimlich).
[3] A logical consequence of this reasoning is that a real prevention of bioterrorism should entail prevention of the narrative in which terrorists can use bioweapons. In principle this is true, but, obviously, practically unfeasible.
[4] Ulrich Beck is the German sociologist who first introduced the notion of risk society. He defines "risk society", or "Risikogesellschaft", as probabilities of physical harm due to given technological processes.

 

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