Disease by Design

Forward | Table of Contents | Executive Summary | Section 1 | Section 2 | Section 3
  Section 4 | Section 5 | Section 6 | Section 7 | Section 8 | Section 9 | Conclusions
Appendix 1 | Appendix 2 | Appendix 3 | Endnotes.

Part II:
The National and International 
Control Architecture

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Section 6: Attempting to close Pandora’s box: the response by governments to biological weapon proliferation and use 

Analysts believe that no single strategy will be effective against the proliferation and use of biological weapons. Multi-level and interlinked national and international strategies are required if governments are to protect their citizens from the nightmare of biological terrorism or state sanctioned bio-warfare. Graham Pearson (former Director-General and Chief Executive of the UK Chemical and Biological Defence Establishment at Porton Down) has termed such a nexus of action, "a web of re-assurance".[96]  The web needs to be constructed so as to re-assure states and the public that such weapons are effectively prohibited and, if used, will have minimal effect.

Pearson believes that the central elements of this web of re-assurance should be:

• Prohibition: A strong international and national prohibition regime reinforcing the norm that biological weapons are totally prohibited;
  
  

• Control: Broad international and national controls on the handling, storage, use and transfer of dangerous pathogens;
  
  

• Preparedness: Active and passive protective measures and response plans, at the heart of which are good national health care systems and disease detection programmes; and
  
  

• Determination: Determined national and international responses to any use or threat of use of biological weapons ranging from diplomatic sanctions through to armed intervention (within the strict bounds of international law).

If applied systematically these elements are mutually reinforcing and would be expected to deter acquisition and use of biological weapons by making them too costly and of limited effectiveness, increasing the likelihood of detection and raising the severity of punitive measures. The rest of this section assesses how far the international community has gone towards building this web of re-assurance.

6.1 A brief history of prohibition and control (1920-1970)
An important step to eliminate the danger of biological warfare was taken on 17 June 1925 in Geneva when the Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or other Gases, and of Bacteriological Methods of Warfare was signed. [97]  In this protocol to the Geneva Conventions the signatory states declared:

Whereas the use in war of asphyxiating, poisonous or other gases, and of all analogous liquids, materials or devices, has been justly condemned by the general opinion of the civilised world…To the end that this prohibition shall be universally accepted as a part of International Law, binding alike the conscience and the practice of nations... [We] Declare: That the High Contracting Parties, so far as they are not already Parties to Treaties prohibiting such use, accept this prohibition, agree to extend this prohibition to the use of bacteriological methods of warfare and agree to be bound as between themselves according to the terms of this declaration.[98] 

However, while the Geneva Protocol prohibited use of bacteriological (biological) weapons it did not prohibit the research, development and production of such weapons. Furthermore, even the prohibition on use was limited because several states entered reservations at the time of signing or ratifying, which allowed for such use in certain circumstances. Finally, there were no mechanisms for verification and enforcement amongst State Parties.

Concern about the continuing development of biological research and weapons production programmes throughout the 1930-60s led finally to pressure for the negotiation of a treaty that would comprehensively ban all biological weapons.

6.2 The 1972 Biological and Toxin Weapons Convention (BTWC)
The Biological and Toxin Weapons Convention (BTWC) opened for signature in London, Moscow and Washington on 10 April 1972,  and entered into force on 26 March 1975.[99] The Convention now has 143 States Parties.[100]  However, there are 32 countries that have not signed the Convention,[101] and a further 19 that have signed but not yet ratified it.

The BTWC was an important step forward in the control and eventual elimination of biological weapons and was the first worldwide treaty to prohibit an entire class of weapons. It complemented the 1925 Geneva Protocol, which already prohibited the first use of biological (and chemical) weapons.

Under Article I each State Party undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain:

• Microbial or other biological agents or toxins, whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes; and
  
  

• Weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.

It is important to note that the general purpose criterion of Article I is very broad in scope and covers biological weapons encompassing agents against plants, animals, and humans. Furthermore, the significance of the BTWC lies in the legally binding prohibition of the exploitation by states of biological agents and toxins for hostile purposes. It is important to note that its prohibition of biological agents and toxins for all but "peaceful purposes" and its reference not only to "armed conflict", but more generally to "hostile purposes", make the BTWC applicable not only to hostile purposes of a state directed against another state but also to hostile purposes of a state directed against its own citizens or anyone else. Thus, the BTWC strengthens the international norm against biological weapons and provides a legal bulwark against the exploitation of biotechnology by states for hostile purposes, whether in armed conflict or in any other circumstance.[102] 

However, the Convention has a fundamental limitation: it lacks mechanisms for monitoring or verifying compliance. There has been widespread concern among states over this deficiency. China, for example, when it signed the Convention, expressed the following concerns:

China once was one of the victims of biological (bacteriological) weapons. China has not produced or possessed such weapons and will never do so in future. However, the Chinese Government considers that the Convention has its defects. For instance, it fails to provide in explicit terms for the ‘prohibition of the use of’ biological weapons and the concrete and effective measures for supervision and verification; it lacks forceful measures of sanctions in the procedure of complaint against instances of violation of the Convention. It is the hope of the Chinese Government that these defects may be made up or corrected at an appropriate time…[103] 

Unlike the Chemical Weapons Convention (CWC) agreed in 1993, the BTWC has no organisation, budget or inspection provisions to ensure enforcement. The Convention, however, does have some ‘functional substitutes’ for verification. These include provisions for national implementation, consultations, complaints and assistance.104  The recent attempts to negotiate a legally binding Protocol to the BTWC are discussed in section 8 below.

6.3 Australia Group - responsible control or an exporters cartel?
The Australia Group(AG) is an export control regime which aims to discourage and impede biological and chemical weapons proliferation by:

• harmonising national export controls among participant states with regard to materials and technology, including dual-use items, related to chemical and biological weapons (CBW); and
  
  

• sharing information on proliferation programmes.[105} 

The Group was formed in 1984 as a result of chemical weapon use in the Iran-Iraq War. Participant states meet annually in Paris. The Group’s actions are viewed by participant states as complementary measures in support of the 1925 Geneva Protocol, the 1972 Biological and Toxins Weapons Convention and the 1993 Chemical Weapons Convention. There are presently 33 participant states in the AG.[106]  Requests by other states to join the Group are considered on a case-by-case basis.

The Group has established common export controls for technologies and materials for non-proliferation purposes. For chemical weapons, participants in the AG control a list of 54 chemical precursors and agents and a list of chemical weapon-related equipment. For biological weapons, participants have established export controls on certain micro-organisms, toxins and equipment that could be used in a bio-weapon programme.

AG meetings focus on sharing information about national export controls, considering proposals for ‘harmonization’ – the adoption of similar controls by all participants on chemicals, biological agents, equipment and other related materials – and considers other measures to address CBW proliferation.

Each participant state prohibits exports of certain listed items to non-participant states. The export of other items must be notified and may be subject to an end-use certificate. If a state declines an export licence application it must inform all other AG participants of its decision. If a second AG participant then wants to take up this export it must consult with the denier nation and those two states must come to an agreement on this issue before export is allowed.

Whilst participant states assert that the AG is a necessary tool to fulfil their obligation under Article III of the BTWC not to contribute to biological weapons proliferation, many developing countries criticise it as discriminatory. Developing countries argue that such export controls are violating the spirit of Article X of the BTWC to further the exchange of peaceful technology. In their view, the AG prevents the transfer of technology for peaceful purposes and in so doing, helps maintain the global dominance of the developed nations in fields like biotechnology. Supporters of the AG reject this claim, pointing out that the BTWC supports and encourages the transfer of dual-use goods for peaceful purposes.

6.4 International efforts to combat bio-terrorism and attacks by ‘rogue states’
Several efforts towards international cooperation in combating bio-terrorism have been launched, many of them at the instigation of the United States. Following a US initiative with the G7 and the Russian Federation in June 1996, the G7 declared: "Special attention should be paid to the threat of utilization of nuclear, biological and chemical materials, as well as toxic substances, for terrorist purposes".[107] 

On 15 December 1997, the UN General Assembly approved the text of the International Convention for the Suppression of Terrorist Bombings.[108]  Attacks fall within the scope of the Convention if they are carried out with an "explosive or other lethal device." These include not only conventional explosives or other incendiary devices, but also "toxic chemicals, biological agents or toxins or similar substances, or radiation or radioactive material". This is the first time that biological weapons have been explicitly mentioned in an international counter-terrorism agreement. While the CWC and BTWC require parties to criminalize certain conduct by their nationals or people and entities on their territory, the Terrorist Bombing Convention provides for broad international law enforcement cooperation in specified circumstances.[109] 

President Clinton’s address to the UN General Assembly on 21 September 1998 was devoted entirely to the issue of terrorism as a world problem and the vulnerability of any nation to chemical, biological and other kinds of terrorist attacks. Finally, at the ministerial meeting of the North Atlantic Council (NAC) on 8 December 1998, the United States proposed the creation of a new NATO Centre for Weapons of Mass Destruction. The suggestion was that the Centre would be a clearing house for increased intelligence-sharing to produce more unified threat assessments about certain states and non-state actors, including terrorist organisations.[110]  The Centre was subsequently created at NATO’s 50th anniversary summit in April 1999 and inaugurated in May 2000.[111] 

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Section 7:  National programmes for combating bio-weapon attacks

7.1 Programmes in the United States
As well as improving international cooperation, a number of states have developed national ‘preparedness’ programmes to combat bio-terrorism or a full-scale bio-weapons attack by a hostile state. In 1999, for example, the UK government established a special military unit to deal with terrorists or foreign states willing to use chemical, biological or nuclear weapons. The task had previously fallen to the reservist Territorial Army, but with the threat perceived as becoming more serious £240 million was invested in the Joint Nuclear, Biological and Chemical Regiment, made up of Royal Air Force (RAF) and army personnel.[112] 

However, the country that has invested most in defending against potential bio-terrorist attack is the United States. In the US federal budget for the fiscal year 2001, $1.55 billion was requested (pre-11 September) to counter the use of weapons of mass destruction (WMD), including chemical and biological weapons deployed by terrorist groups.[113]  While the Department of State coordinates counter-terrorism policy and operations abroad, US domestic response to a potential or actual terrorist threat or incident involving biological weapons is headed by the Attorney General and is outlined in CONPLAN – the Interagency Domestic Terrorism Concept of Operations Plan. CONPLAN is designed to provide overall guidance to federal, state and local agencies on how to respond to a potential or actual terrorist threat or incident that occurs in the United States, particularly one involving WMD. Six agencies have responsibility for implementing CONPLAN: Department of Justice (DOJ), Federal Emergency Management Agency (FEMA), Department of Defence (DOD), Department of Energy (DOE), Environmental Protection Agency (EPA) and the Department of Health and Human Services (HHS).

Under CONPLAN, the Attorney General is responsible for implementing policies taking direct action against any terrorist threat, as well as prosecuting any terrorist acts that violate US law. DOJ appoints the FBI to manage any federal response to terrorist threats or incidents that take place in the United States. Under the US Domestic Preparedness Programme, headed by the Attorney General, the FBI organises a National Domestic Preparedness Office, Domestic Terrorism/Counter-terrorism Planning, and Domestic Emergency Support Teams. As Lead Federal Agency (LFA), the FBI implements federal crisis management until the Attorney General transfers LFA status to FEMA, which is primarily responsible for response and recovery. In the event of a terrorist attack, FEMA would manage and coordinate any federal response in support of state and local governments.

In terms of combating biological and chemical threats, US policy revolves around reducing the vulnerability to attack, as well as a rapid response to such an attack. These aims are achieved through preparedness planning, detection and surveillance, laboratory analysis, emergency response, and communication systems, as outlined in the Centers for Disease Control and Prevention (CDC) recommendations for reducing the threat of biological and chemical terrorism.[114]

Despite these initiatives, a recent US General Accounting Office (GAO) report states that the "coordination of US federal terrorism research, preparedness, and response programs is fragmented… For bioterrorism, different agencies have developed separate threat lists of biological agents, several agencies have developed programs to provide assistance to state and local governments that are similar and potentially duplicative".[115] 

Since May 2001, US Vice-President Dick Cheney has led an interagency effort to improve coordination. Following the 11 September attacks, President George W Bush announced the creation of the Office of Homeland Security to lead, oversee, and coordinate a comprehensive national strategy to safeguard the US against terrorism. (See appendix 3 for the US government response to the recent anthrax attacks in US cities.)

7.2 Protection programmes for armed forces and civilian populations
Many states, both individually and collectively, have recognised the need to protect their armed forces from biological attack. [116]  In the United States, for example, the 1997 Quadrennial Defence Review stated that: "In particular, the threat or use of chemical or biological weapons (CBW) is a likely condition of future warfare, including the early stages of war to disrupt U.S. operations and logistics". It went on to argue that: "Moreover, given that the United States will most likely conduct future operations in coalition with others, we must encourage our friends and allies to train and equip their forces for effective operations in CBW environments".[117] 

Strategies for the speedy deployment of protective suits, clothing and filters together with the use of biological agent detection systems have been utilised where threat of biological weapons was feared, such as in the Gulf War. Such strategies are normally reinforced with vaccine provision where appropriate. Concerns about the possible possession and/or weaponisation of smallpox by Russia, Iraq and North Korea have led to the US military ordering 300,000 doses of smallpox vaccine from the biotechnology firm Bioreliance through the Joint Vaccine Acquisition Programme.

Similarly, in terms of US domestic preparation, for the 2001 fiscal year, $52 million has been requested for the stockpiling of vaccines and therapeutics against smallpox and toxins, and $91.7 million has been requested for research and development, which includes the search for new smallpox and anthrax vaccines.[118]  As part of this vaccine development, the CDC has awarded an estimated $343 million contract to the biotech company Oravax to produce 40 million doses of smallpox vaccine to augment and replace its aging stockpile for civilian use.[119]  Though originally the vaccine would not be ready until 2004, the latest fears resulting from the 11 September attacks have prompted the government and company to speed up production with first batches planned in 2002.[120] 

7.3 The detection and medical infrastructure [121]  [121] 
For the civilian population an appropriate defence against potential biological attack, whether covert or overt, by state or non-state actors, must be based on improved health surveillance and response. Because some disease agents have lengthy incubation periods, covert biological attack by states or terrorists might well bypass the traditional first responders and quick response teams that could be employed for other terrorist attacks. The ‘first responders’ for a biological attack would most likely be doctors, pathologists and other health care workers, and the speed of a response will depend on their recognition that certain illnesses appear out of the ordinary. Regardless of whether the origin of a disease outbreak is intentional (terrorism), accidental or natural, a public health response will be necessary to detect and contain it. Moreover, such a capability will benefit the host population whether or not a bio-terrorist attack ever occurs.

Preparing for biological terrorism has more in common with confronting the threat of emerging infectious disease than with preparing for chemical or nuclear attacks. Defence against bio-terrorism, like protection against emerging diseases, must rely on disease surveillance.

To be effective, this strategy must have strong domestic and international components. However, the international component is gravely under-funded at present. The World Health Organisation (WHO) is trying to improve the situation with initiatives such as the Global Outbreak Alert and Response Network. Established in April 2000, this network links 72 existing networks around the world, many of which are equipped to diagnose unusual agents and handle dangerous pathogens. It aims to link electronically the expertise and skills needed to keep the international community constantly alert to the threat of outbreaks and provide it with a rapid response when needed.[122] 

Similarly, the domestic component in most nations remains far too weak. Some countries, such as the United States have begun to address this problem. In 1999, for example, the CDC established the Bio-terrorism Preparedness and Response Programme. In fiscal year 2000, the overall budget of this programme was $118 million, including $40 million for improved health surveillance. The latter includes the creation of a network of regional laboratories to provide rapid analysis and identification of selected biological agents.[123]  However, even in the United States, authorities fear that they are still not equipped to deal with a large-scale attack or outbreak. The shortcomings of the US response system were highlighted in June 2001 in a computer simulation exercise at Andrews Air Force base code-named ‘Dark Winter’.[124]  It began with a report of a single case of smallpox in Oklahoma City. By the time the exercise was over, the imaginary epidemic had spread to 25 US states and killed several million people.

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Section 8:  Strengthening international prohibition against biological weapons – development of the Protocol to the BTWC

The energy and resources which some states have devoted to fighting bio-terrorism and developing defensive measures to respond to bio-weapon attacks must now also be mirrored by concerted diplomatic efforts to develop, promote and enforce the national, regional and international regime controlling biotechnology transfers.

Furthermore, the international norm banning the development and use of biological weapons – the cornerstone of which is the BTWC – must be steadfastly protected. The development of a stringent Protocol to the BTWC would do much to combat the dangers of overt or covert biological weapons acquisition and use by states or non-state actors (as regards the latter, see Box 6). In this section, we analyse the current state of the international architecture promoting compliance with the BTWC.

8.1 Strengthening the BWTC: Road to the Protocol
Under the 1972 BTWC signatories pledged never to "develop, produce, stockpile or otherwise acquire or retain" biological weapons.[125]  However, the Convention lacks verification measures and the sort of support structure that reinforces most arms control treaties such as the Nuclear Non Proliferation Treaty (NPT) and Chemical Weapons Convention (CWC). In an attempt to address this shortcoming, the States Parties agreed at the Second Review Conference in 1986 to a politically-binding information exchange that started in 1987 to increase transparency in bio-defense activities and other activities related to the Convention. Unfortunately, these Confidence Building Measures (CBMs) appeared inadequate due both to their inherent weakness and to the failures of a number of states to fully implement their commitments under these agreements.

At the Third Review Conference of the BTWC in September 1991 (following the 1990-91 Gulf War), international concern about the danger of biological weapons proliferation coupled with the end of the Cold War created a window of opportunity to strengthen the Convention. Revelations about the clandestine biological weapons programmes in the Soviet Union and Iraq provided additional impetus for enhancing global security by negotiating a legally-binding regime to strengthen the effectiveness of the BTWC.

At the Conference, States Parties, "determined to strengthen the effectiveness and improve the implementation of the Convention", established an Ad Hoc Group of Governmental Experts to examine possible verification measures from a scientific and technical viewpoint.[126]  This Group (known as VEREX) met twice in 1992 and twice in 1993 and discussed a range of possible verification measures.[127]  Its final report was considered by a Special Conference of BTWC States Parties in September 1994, which then established an Ad Hoc Group (AHG) to consider appropriate measures to strengthen the Convention. The AHG mandate, which is without time limit, calls on the Group to:

consider appropriate measures, including possible verification measures, and draft proposals to strengthen the Convention, to be included, as appropriate, in a legally binding instrument, to be submitted for the consideration of the State Parties.[128] 

At the heart of AHG work, which began in 1995, is the negotiation of a legally binding Protocol to the Convention. States Parties have consistently called for such a Protocol to ensure that the Convention is respected and stringently complied with. The AHG was mandated by the Fourth Review Conference to present a draft Protocol to a Special Conference to be held before the Fifth BTWC Review Conference in November-December 2001.

8.2 The key elements of an effective Protocol
The negotiation of an effective Protocol has proven problematic. By spring 2001, after over six years of AHG talks and 23 negotiating sessions, though much had been agreed there were still important areas where no consensus had formed. The last version of the Rolling Text, which formed the basis of negotiations, contained 1,400 brackets indicating areas of disagreement.

On 30 March 2001, in an attempt to ensure that negotiations would be completed before the target date of the Fifth Review Conference in November, Tibor Toth, the Chair of the Ad Hoc Group, released a 210 page ‘composite text’ to delegates, which proposed compromise wording for areas of difference. The key elements of the draft Protocol are summarised below:

(i) Declarations
Annual declarations by states detailing specific elements of their civil biotechnology and bio-defence activities are the first step in the process of ensuring compliance with the BTWC. The declaration of those facilities, which could in theory be part of biological weapons research or misused for bio-weapons production, is an important confidence building measure and a foundation stone in the process of building greater transparency, understanding and trust between countries.

Agreeing the types of facility, level of technology and scale of activity that would have to be declared proved difficult. The compromise presented in the Chair’s composite text sought to ensure that only those facilities and activities which are of the greatest relevance and concern to the Convention were included. A number of observers have criticised the criteria for leaving too much undeclared.

(ii) Visits
To increase confidence in the accuracy of state declarations and to enhance transparency, the emerging Protocol included provisions for visits to declared facilities.[129]  Such visits fall into two types: randomly-selected transparency visits and voluntary clarification visits.[130]  Voluntary clarification visits, where states invite the Technical Secretariat and/or another State Party to clear up some point of dispute in a declaration were broadly agreed. However, randomly-selected transparency visits proved a major area of contention.

While some states – most EU member states, Argentina, Australia, Canada, New Zealand and South Korea – favoured strong, mandatory transparency visits, seeing them as essential to ensuring honesty and confidence in the declaration process and the Convention itself, other states put forward objections, largely on the grounds of national security and commercial confidentiality. A crucial opponent of a strong visit regime was the United States, which opposed all visits except voluntary ones. The influence of the US pharmaceutical industry is likely to have been crucial in shaping the US government’s stance on this issue (as discussed in Box 7).

The Chair’s composite text attempted to reconcile these positions by limiting the maximum number of randomly-selected transparency visits that a country or a facility would receive.[131] The Chair’s text also attempted to address concerns over the level of intrusiveness of these visits. It declares that the visited State Party should provide access to the visiting team within the facility sufficient to fulfil its mandate whilst leaving the nature and extent of all access inside the facility, and to the information it contains, at the discretion of the visited State Party.[132]  These concessions, however, led to concerns that the right of the visited party to completely control access of the visiting team as well as the right to censor the resulting report would be likely to result in anodyne visits rather than an effective confidence-building and transparency process. In the words of one analyst, the proposals for declaration follow-up procedures outlined in the Chair’s composite text are more like "bio-tourism" than real verification.[133] 

(iii) Investigations
The procedures for initiating and carrying out investigations into suspected breaches ofthe Convention were largely agreed in the emerging Protocol. The means to investigate suspected breaches is vital to the successful strengthening of the BTWC, so agreement in this area was an important achievement.

Under the draft Protocol states "have the right to request an investigation, which shall be carried out for the sole purpose of determining the facts relating to a specific concern about possible non-compliance with the Convention by any other State Party".[135]  Two types of investigations are foreseen:[136] 

• Facility investigations, when a clandestine biological weapons research or production programme is suspected; and
  
  

• Field investigations into unusual outbreaks of disease of humans, animals or plants or the suspected use of biological weapons.

Any State Party can request an investigation if it suspects that another party is violating the Convention. The Executive Council decides about the approval of the request and the timelines for getting the inspectors on the ground are short. [137] 

Once again, however, the effectiveness of such investigations is questionable as the text wording was watered down to protect the rights of states under investigation. The state under investigation will have the right to take measures to protect national security and/or confidential information under so called ‘managed access’ provisions, which are common in multilateral arms control regimes. This may, among other things, mean taking measures such as removing sensitive papers, shrouding sensitive displays and equipment and logging off computer systems. While such provisions will make detection of breaches harder to prove, the onus on proving compliance will be on the party under suspicion.[138] 

(iv) The Organisation for the Prohibition of Bacteriological (Biological) and Toxin Weapons (OPBW)
A crucial element of a future compliance regime is the creation of an international body – the proposed Organisation for the Prohibition of Bacteriological (Biological) and Toxin Weapons (OPBW) – which will monitor and aid adherence of the Protocol and the BTWC itself. The OPBW is modelled on the Organisation for the Prohibition of Chemical Weapons (OPCW), which was created to implement the Chemical Weapons Convention. The proposed OPBW will consist of a Technical Secretariat, an Executive Council and a Conference of States Parties.

Under the current draft, however, the powers of the OPBW are weak. OPBW staff would have very limited freedom of action, they would not be allowed to collect or assess openly available information independently, and there are few provisions for the use of recent advances in verification technologies by the organisation.[139]  Many question whether such a hamstrung OPBW could effectively monitor adherence to the Convention.

(v) Assistance and protection against biological and toxin weapons
A future compliance regime for the BTWC would encourage members to cooperate to strengthen defences against biological weapons.[140]  Measures include an obligation for states to facilitate, and a right to participate in, the fullest possible exchange of equipment, material and scientific and technological information concerning means of protection against biological and toxin weapons. The Technical Secretariat would establish a database of information on protection against biological and toxin weapons, and the Technical Secretariat would provide advice and assistance on protection.

States Parties can seek assistance if they believe biological and toxin weapons have been used against them or if they believe they are threatened by their use. In such instances, the Protocol provides for emergency or humanitarian assistance.

(vi) Non-proliferation versus technological cooperation and exchange for peaceful purposes
There is an inherent tension in the Convention and the proposed Protocol between the goals of controlling the spread of sensitive technology and biological agents on the one hand, and encouraging the exchange of peaceful technologies on the other hand. BTWC Article III on non-proliferation reads: "Each State Party to this Convention undertakes not to transfer to any recipient…any of the agents, toxins, weapons, equipment or means of delivery specified in article I of this Convention", while Article X on technology transfer encourages exchange of biotechnology: "The States Parties to this Convention undertake to facilitate…the fullest possible exchange of equipment, materials and scientific and technological information for the use of bacteriological (biological) agents and toxins for peaceful purposes".

During negotiations this tension manifests itself in the demands of many developing countries for better access to civilian biotechnology, and the determination of many industrialised countries to limit the access of some governments to dual use technology under export control regimes such as the Australia Group.

During the Protocol negotiations a number of non-aligned states called for the Australia Group to be abolished. They also demanded that the Organisation formed to oversee the Protocol should host a mechanism for the settlement of disputes about denials of exports. In an attempt to reconcile these two divergent positions, the Chair’s composite text proposes that States Parties take all measures they deem necessary to ensure that obligations under Article III of the Convention are implemented fully and effectively by: establishing necessary implementation legislation; requiring annual notifications of aggregate data for particular dual-use items; providing for consultations; and requiring the implementation of these provisions to be kept under review.[141]  This was balanced by an agreement on the need for "measures to avoid hampering the economic and technological development of State Parties".[142]  It was also agreed that a Cooperation Committee would be set up under the future organisation as a "forum for consultation" to promote cooperation.[143] 

8.3 Collapse of protocol negotiations and future options
The 24th session of the AHG began on 23 July 2001 with States Parties responding to the Chair’s composite text. Over the next three days over 50 states out of the 55 engaged in the Protocol negotiations spoke, to varying degrees, in favour of the composite text. Whilst many States Parties would have liked to see differences in the compromises adopted, they believed the text would lead to a Protocol that all could agree.

On 25 July, US Ambassador Donald Mahley, special negotiator on chemical and biological weapons, shattered this consensus when he laid out the US government’s position: "After extensive deliberation, the United States has concluded that the current approach to a Protocol to the Biological Weapons Convention...is not, in our view, capable of achieving the mandate set forth for the Ad Hoc Group, strengthening confidence in compliance with the Biological Weapons Convention". He went on to say that: "We believe the objective of the mandate was and is important to international security, we will therefore be unable to support the current text, even with changes, as an appropriate outcome of the Ad Hoc Group efforts".[144] 

Although the position of the United States under the Clinton administration had been rather uncertain, the United States had taken part in the AHG negotiations. Following the election of Bush, the new administration established a policy review to determine the US position on the draft Protocol text. The review was conducted by an inter-agency group including working level officials from the State Department, the Pentagon, the Commerce Department, the Energy Department and intelligence agencies. The review document, which at the time of writing is still confidential, reportedly found 38 problems with the composite Protocol text and concluded that the provisions of the current draft are too weak to enhance confidence in compliance with the Convention.

In conjunction with the US statement of 25 July 2001, a number of statements were made by senior members of the US government which indicate major misunderstandings of the composite Protocol by the administration. The US government’s core concerns were summarised in a State Department briefing of 25 July 2001 by spokesperson Philip Reeker, who stated that:

The protocol, which was proposed, adds nothing new to our verification capabilities. And it was the unanimous view in the United States government that there were significant risks to US national interests and that is why we could not support the protocol. Implementation of such a protocol would have caused problems... for our biological weapons defense programmes, would have risked intellectual property problems for our pharmaceutical and biotech industries and risked the loss of integrity and utility to our very rigorous multilateral export control regimes.[145] 

(i) An assessment of US reasons for rejecting the Protocol
If negotiations on Protocol are to resume in the future, it is important that these US objections be addressed.[146] 

First, the objection that the composite Protocol adds nothing new to global verification capabilities is incorrect. The Protocol requirement for mandatory declarations, its provisions for transparency visits and for field and facility investigations of compliance concerns all add to national means of verification. Though such measures are not as strong as they could have been, one of the main reasons for this was the dilution of text by the US itself. Although weak, they provide something on which to build. At present the Convention has no mechanisms for monitoring or verifying compliance.

Second, the objection that the Protocol would cause problems for the biological weapons defence programmes of the United States is at variance with the assessments of all the other States Parties engaged in the negotiations who also have biological weapons defence programmes. Nor is there anything in the Protocol that requires the provision of any national security ("classified") information in the declarations of biological weapons defence programmes. Indeed, Article XIII explicitly states that: "Nothing in this Protocol shall be interpreted as impeding the right of any State Party to conduct research into, develop, produce, acquire, transfer or use means of protection against bacteriological (biological) and toxin weapons, for purposes not prohibited under the Convention". This is identical language to that used in the Chemical Weapons Convention.

Third, the objection that the Protocol would have risked intellectual property problems for the US pharmaceutical and biotech industries ignores the fact that the Protocol contains stronger provisions for the protection of commercial proprietary information than the Chemical Weapons Convention, which the US government has accepted. Furthermore, there are no requirements for the provision of commercial proprietary information in any of the mandatory declarations. Visits to such facilities in the United States would be at most seven per year. This is a minute fraction of the number of inspections carried out by regulatory agencies in the United States each year. Moreover, it is absolutely not the case, as US Deputy Secretary of Defence Paul Wolfowitz incorrectly asserted, that the compo-site Protocol would expose the US pharmaceutical industry to "Libyan and Iraqi inspectors".[147]  There is no provision in the Protocol for national inspectors from other states to carry out visits and furthermore there are provisions in the composite text for a State Party to exclude international inspectors of a particular nationality if it so wishes, as is also the case in the Chemical Weapons Convention.

Fourth, the objection that the Protocol would have risked the loss of integrity and utility of the multilateral export control regimes is also unsupported by the evidence. Indeed, the Protocol includes provisions in Article XII that require each "State Party…to review and, if necessary, amend or establish any legislation, regulatory or administrative provisions to regulate the transfer of agents, toxins, equipment and technologies relevant to Article III of the Convention". Thus, there are clear benefits for the international community (including the United States) from this requirement for all States Parties to establish the regulation of such transfers, both in countering proliferation and limiting the availability of materials and equipment for bio-terrorism.

Following Ambassador Mahley’s statement, there were initial discussions within the Ad Hoc Group on whether negotiations should continue without the United States via the AHG process or indeed whether a Special Conference should be called to finalise the document. Neither option was felt to be viable without the involvement of the United States. "Quite a number of delegations would be reluctant to engage in continued negotiations among themselves in the absence of a major negotiating partner, that is the United States of America", explained AHG chairman Tibor Toth.148  The AHG subsequently agreed without objection to Tibor Toth’s recommendation that they suspend their negotiating efforts for this year.

Although negotiations were suspended, AHG work continued as they attempted to draft a report for the Fifth Review Conference. Many wished to preserve the language and progress made after six years of negotiations. However, even this foundered in the early hours of 28 July over whether and how to apportion blame for the failure.

(ii) Options facing the international community
Where is the process now and what can the international community do? Does the US rejection mean the end of the AHG and the Protocol? The international community has a number of options:

• Option 1: Abandon the Protocol negotiations entirely and attempt other control measures
During his 25 July announcement, Ambassador Mahley stated that the United States has "new, affirmative ideas for strengthening the Biological Weapons Convention". Although the US government has spoken on the biological weapons issue at the United Nations and has subsequently been engaged in a series of bilateral meetings with allies on how to combat bio-terrorism, no detailed proposals for strengthening the BTWC have been made public thus far. The Review Conference may well be the occasion in which they are publicly expressed. However, it seems unlikely that there are indeed any significantly new ideas that have not been considered during the past decade, either during the VEREX process (in which the national experts from States Parties sought to identify all possible measures) or during the Ad Hoc group negotiations (involving diplomats and experts from over 50 States Parties in seeking to devise an effective Protocol). An assessment of what the US administration might propose is provided in Box 8.

Furthermore, it is doubtful whether any new US proposals, no matter how meritorious, will receive a positive reaction, due to the bad feeling engendered by the US withdrawal from the Protocol negotiations so late in the process. The credibility gap will be exacerbated by the latest disclosures of three US bio-weapon projects that may have violated the BTWC (see box 9 below). These revelations will make it even more difficult for the US government to convince sceptical states that its proposals on developing alternatives to the Protocol are worthy of consideration.

It is very important that the US proposals are not dismissed out of hand, and are given careful consideration by States Parties. However they should not be seen as a replacement for the Protocol. The States Parties should continue with the process of negotiation. If the international community were to decide to walk away from the task of negotiating a Protocol it would send a very dangerous message to would-be proliferators. In short, it would imply that after a decade of effort and a large degree of consensus, the States Parties simply do not care enough about the danger from biological weapons. A group of Leading bio-weapons experts concluded: "even though the United States statement is based on unsound arguments, the other States Parties do not have the political will and conviction to make a significant step forward by adopting the Protocol". [151] 

• Option 2: Suspend the Protocol negotiations for a ‘cooling off’ period
While this proposal has the benefit of allowing states the time to re-group and re-assess their positions and strategies and attempt to bring the United States back into the negotiations, it also has certain dangers. Depending on the length of the dormancy period – which could range from three months to three years – there is a concern that a loss of momentum by active States Parties will occur as other issues arise on their national agendas. There is the further danger, increasing with time, that past text compromises will be revisited with the subsequent unravelling of the composite Protocol text.

• Option 3: Continue negotiations on a lowest common denominator version of the Protocol
The idea of ‘cherry picking’ those elements of the text that have universal or near universal support amongst States Parties does at first sight look appealing and may facilitate speedy conclusion of negotiations. However, it must be remembered that the present composite text has itself evolved from a rolling text (the subject of over six years of negotiations) and has been the result of compromises between States Parties facilitated by the Chair. The composite text is seen by many states as a balanced text. To cherry pick has the danger of unbalancing the text and leading to a Protocol that is incomplete, and incapable of establishing a regime robust and comprehensive enough to enhance compliance.

• Option 4: Continue Protocol negotiations, utilising the Chair’s composite text as the basis for talks
The mandate of the Ad Hoc Group, which it is important to note has not been challenged by any state, is to negotiate a draft Protocol text for presentation to a Special Conference of States. This mandate has not been fulfilled. It should be. The need for such a Protocol, which establishes an effective BTWC verification regime, is great. The Chair’s composite text should be the basis on which future negotiations continue. The text has the support of the vast majority of states involved in the AHG process and is a balanced document. Although the composite text should be strengthened – in areas such as the remit, role and resources of the OPBW and on transparency visits – this is possible during the course of further negotiations. However, negotiations that start with the composite text give the best chance for success.

Every effort must be made to include the United States in this process or allow it join the process later if this is possible. If the United States is not present at the negotiating table there is a danger that a number of key states may not agree to continue the negotiations. Some with developed biotechnological and pharmaceutical industries may be concerned at the lack of a ‘level playing field’, fearing that US industry may gain the advantage by remaining outside the Protocol regime. Other countries who may be distrustful of US biological weapon research and development programmes – especially in the light of the recent revelations (see box 9 below) – may consider a compliance regime which does not include the United States as dangerous to their security. Although this danger exists, and it is very real, this should not be a reason for the international community to refuse to attempt to continue negotiations.

For such talks to be successful they must have a clear timeframe for early completion. BASIC recommends that the AHG reconvene soon after the Fifth Review Conference, early in 2002, and aim to complete negotiations in time to present a draft Protocol to a Special Conference of BTWC States Parties by the end of that year.

(iii) Possible interim work for the AHG and steps to the Protocol
The Harvard Sussex Program has proposed the following areas on which the AHG could work in the interim until there is international consensus to move forward with the Protocol.[152] 

First, the AHG could promote the conduct of voluntary bilateral and multilateral field trials of transparency and compliance measures at bio-defence and industrial facilities, both within and between the three regional groups of nations. The provisions of the AHG Chair’s composite Protocol text could be used as a baseline in joint practice trials not only of declarations, transparency visits and clarification procedures, but, in due course, of facility and field investigations. The objective would be to develop a common base of experience on which to evaluate the utility and acceptability of various modalities and procedures for declaration and on-site measures.

Second, the AHG could develop standards for the design and harmonisation of national measures, including domestic criminal legislation, pursuant to the obligation of each State Party under Article IV of the BTWC to prevent violations of the Convention anywhere on its territory.

Third, the AHG could formulate options for aid and assistance to countries threatened

or attacked with biological weapons, as required under Article VII of the BTWC. This could also include facilitating the acquisition and use of equipment and materials for the diagnosis and treatment of prevalent infectious diseases, an activity that supports Article X of the BTWC.

BASIC commends these ideas to the AHG for consideration, not as replacements to the Protocol but as steps towards it – effective international measures to be incorporated into a legally binding instrument.