Information about biological weapons and the BTWC
Implementation of Article X of the BWC
Present Status and Prospects for the Future
Graham S. Pearson
Department of Peace Studies, University of Bradford, UK
Further information about biological weapons and the Biological and Toxin Weapons Convention (BTWC)
Implementation of Article X of the BWC : Present Status and Prospects for the Future
Introduction
1. Article X of the Biological Weapons Convention (BWC)1 promotes the peaceful use of biological materials, equipment and information for peaceful purposes as States Parties are committed as follows:
"(1) The States Parties to this Convention undertake to facilitate, and have the right to participate in, the fullest possible exchange of equipment, materials, and scientific and technological information for the use of bacteriological (biological) agents and toxins for peaceful purposes. Parties to the Convention in a position to do so shall also cooperate in contributing individually or together with other States or international organisations to the further development and application of scientific discoveries in the field of bacteriology (biology) for the prevention of disease, or for other peaceful purposes.
(2) This Convention shall be implemented in a manner designed to avoid hampering the economic or technological development of States Parties to the Convention or international cooperation in the field of peaceful bacteriological (biological) activities, including the international exchange of bacteriological (biological) agents and toxins and equipment for the processing, use or production of bacteriological (biological) agents and toxins for peaceful purposes in accordance with the provisions of the Convention."
2. Assistance receives relatively slight mention in Article VII of the BWC which states that:Each State Party to this Convention undertakes to provide or support assistance, in accordance with the United Nations Charter, to any Party to the Convention, which so requests, if the Security Council decides that such Party has been exposed to danger as a result of violation of the Convention.
3. Successive Review Conferences have encouraged States Parties to do more to implement Article X. Thus the Final Declaration of the Fourth Review Conference held in November/December 1996 stated2 that
"This Conference once more emphasizes the increasing importance of the provisions of Article X, especially in the light of recent scientific and technological development in the field of biotechnology, bacteriological (biological) agents and toxins with peaceful applications, which have vastly increased the potential for cooperation between States to help promote economic and social development, and scientific and technological progress, particularly in the developing countries, in conformity with their interests, needs and priorities."
It went on to say that
"The conference urges all States Parties actively to continue to promote international cooperation and exchange with States Parties in the peaceful uses of biotechnology, and urges all States Parties possessing advanced biotechnology to adopt positive measures to promote technology transfer and international cooperation on an equal and non-discriminatory basis, in particular with the developing countries, for the benefit of all mankind. At the same time, the Conference stresses that measures to implement Article X need to be consistent with the objectives and provisions of the Convention."
4. Such language shows the tension that surrounds Article X -- the wish by the developing countries to benefit from the advances in biotechnology and the concern by the developed countries that such technology transfer should not be misused for activities prohibited by the Convention. The consideration of Article X of the BWC and how this might be implemented is particularly timely as the States Parties of the BWC at a Special Conference in September 1994 established3 an Ad Hoc Group which has a mandate "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..." The mandate also specifically states that "the Ad Hoc Group shall, inter alia, consider: .... - Specific measures designed to ensure effective and full implementation of Article X,..."
5. Insofar as assistance is concerned the Fourth Review Conference stated that "pending consideration of a decision by the Security Council, timely emergency assistance could be provided by States Parties if requested." and also noted "the proposal that the Ad Hoc Group might need to discuss the detailed procedure for assistance in order to ensure that timely emergency assistance would be provided by States parties if requested."
6. The Ad Hoc Group (AHG) has now met 10 times. From its outset, it has functioned through Friends of the Chair (FOC) who have led the discussions relating to particular elements of the mandate. The FOC for Article X measures was initially Ambassador Jorge Berguno of Chile and, following his retirement, this FOC has been Carlos Duarte of Brazil. In July 1997, the AHG successfully transitioned to negotiation of the rolling text of a Protocol and subsequent meetings have seen the elaboration of language for the various Articles and Annexes of the Protocol. There is a sense of growing momentum at the AHG negotiations which are engaged in serious negotiation. Earlier this year, several States Parties declared their objective of seeking to complete the substantive negotiation of the Protocol in 1998. Further AHG meetings are scheduled for 3 weeks in June/July and 4 weeks in September/October 1998. It is thus apparent that the end game will come within the next year when it will be important to have addressed all elements of the mandate and to have identified potential measures to implement Article X of the Convention that gain consensus in the final Protocol.
7. Assistance has received relatively little attention at the AHG although in September 1997 Mr Ajit Kumar of India was appointed Friend of the Chair for National Implementation and Assistance and there is some language on Assistance in Article VI 'Assistance and Protection against Biological and Toxin Weapons' of the draft Protocol .
8. This paper takes stock of the AHG negotiations in respect of both assistance and of measures to implement Article X of the Convention. It then identifies a number of areas that are relevant to the BWC and which could both implement Article X and contribute to the strengthening of the BWC through building transparency and enhancing confidence in compliance. References are to Articles in the current draft Protocol4 unless otherwise stated.
Ad Hoc Group (AHG)
9. Assistance. The current rolling text has language in Article VI which addresses 'Assistance and Protection against Biological and Toxin Weapons'. A footnote states that this was largely drawn from the CWC and that some delegations have indicated that the text would need to be modified to take into account the differences between the biological weapons and the chemical weapons context. Article VI, mirroring Article X of the CWC, commences with a definition of assistance:
[For the purposes of this Article, "Assistance" means the coordination and delivery [transfer] to States Parties of protection against biological and toxin weapons, including, inter alia, the following: detection and alarm equipment; protective equipment; decontamination equipment and decontaminants; prophylactic, diagnostic and therapeutic medical measures and materials including immunization; and advice on any of these protective measures.]
10. The rest of Article VI closely reflects the language in Article X of the CWC although, because the draft Protocol elsewhere (Article III D Declarations) has language requiring declarations of biological defence programmes, there is no parallel in Article VII to the CWC requirement (Article X, para 4) that chemical defence programmes be declared:
For the purposes of increasing the transparency of national programmes related to protective purposes, each State Party shall provide annually to the Technical Secretariat information on its programme, in accordance with procedures to be considered and approved by the Conference pursuant to Article VIII, paragraph 21 (i).
Another slight variation from the CWC language reflects the sensitivity in the AHG negotiations to commercial proprietary information. Consequently the Article VI language on the exchange of equipment and information concerning means of protection states:
Each State Party [undertakes to facilitate][shall make available], and shall have the right to participate in, [subject to protection of commercial proprietary information and national security information and under non-discriminatory and equitable commercial terms], the fullest possible exchange of equipment, material and scientific and technological information concerning means of protection against biological and toxin weapons.
The language in square brackets is additional to that in the corresponding paragraph (3) of Article X of the CWC.
11. Article X measures. The rolling text has language in Article VII of the draft Protocol which addresses scientific and technological exchange for peaceful purposes in order to enhance the implementation of Article X of the Convention. At the end of the March 1998 AHG meeting, the title for Article VII had changed to:
ARTICLE VII [SCIENTIFIC AND TECHNOLOGICAL EXCHANGE FOR PEACEFUL PURPOSES][IMPLEMENTATION ASSISTANCE] AND TECHNICAL COOPERATION
The words [Implementation Assistance] had been introduced as an alternative title thereby putting much of the title into square brackets where none had appeared before. This is a retrograde step as it casts doubt on the intention of the AHG to address the element of its mandate requiring it to consider inter alia "Specific measures designed to ensure effective and full implementation of Article X,...". The need to consider measures relating to the implementation of Article X has been generally recognised as an issue that is of particular importance to the developing countries. It is therefore not surprising that the NAM statement5 at the end of the March AHG meeting expressed "their concerns at attempts to reduce the scope and importance of issues related to Article X of the Convention." and went on to say that "Substantive progress in strengthening the application and full operationalisation of Article X is crucial to the conclusion of a universally acceptable and legally binding instrument designed to strengthen the Convention. They reaffirm readiness to work with other delegations in order to achieve an appropriate balance in the Protocol."
12. The language in Article VII contains the following Sections
[(A) [General Provisions]
(B) Measures to promote scientific and technological exchanges
[(C) Measures to avoid hampering the economic and technological development of States Parties
(D) [[Institutional Mechanisms and] International Cooperation] [Protocol Implementation Assistance]
[(E) Cooperative Relationships with other international organizations]
(F) [Safeguards and limitations
In addition, there is language in Article III. D Declarations of the Protocol that requires:
Each State Party shall declare annually the measures taken individually or together with other States and international organizations in implementing Article X of the Convention.
Each State party shall submit a declaration on the implementation of Article X of the Convention according to the format in Annex...
13. Thus far, there has been little consideration by the AHG of specific measures that might be taken to enhance the implementation of Article X as the AHG has understandably concentrated on compliance measures which lie at the heart of the Protocol to strengthen the BWC. As, however, the Protocol text advances it is becoming timely to consider specific measures to enhance the implementation of Article X. In doing this, it is important to consider initiatives being taken in other fora that are separate from yet are relevant to the BWC. The challenge is to identify measures that will enhance the implementation of Article X whilst at the same time contributing to the building of confidence that States Parties are compliant with the Convention and avoiding duplication with activities in other fora.
Strengthening the BWC through implementation of Article X
14. The bacteriological (biological) agents and toxins that are at the heart of the BWC all occur in nature and cause disease and intoxinations in humans, animals or plants. There is consequently an urgent need for public health and environmental safety reasons to study the characteristics of these agents and toxins in order to protect humans, animals and plants from such diseases and intoxinations. Consequently, because these biological agents and toxins can cause outbreaks of disease, there is much global concern to ensure that all work for peaceful purposes with such biological agents and toxins is carried out in such a way that ensures that there is minimum risk to public health and to the environment. This concern extends also to work with living modified organisms, recognising that their hazards are based on those of the parent microorganism. Consequently, increasingly countries are introducing regulations to ensure that such biological agents and toxins and living modified organisms are handled, stored and transferred in controlled ways so as to prevent outbreaks of disease causing harm to trade and prosperity. It is all too clear that outbreaks of disease prevent a real danger and it is widely accepted that work with the causative agents must be supervised and controlled.
15. Other risks to the BWC can arise from those facilities that can produce biological agents and toxins in quantity for peaceful purposes because of the potential dual purpose nature of the pharmaceutical and biotechnological industry. However, because much of that industry is engaged in the production of licensed medicinal products for humans or for animals, there are increasingly international standards for such facilities along with regular inspections by national regulatory authorities to ensure that the facilities are operated in such a way that the licensed products are produced consistently and are free from cross contamination and hence present no danger to the patient.
16. These frameworks of national, regional and international controls of the handling and transfer of biological agents and toxins and of living modified organisms for peaceful purposes and of the facilities manufacturing licensed medicinal products provide public reassurance that such biological agents and toxins will not cause outbreaks of disease or be misused for prohibited purposes. It will be recognised that there is a closely similar goal in the negotiations of a protocol to strengthen the BWC which aims to increase transparency and build confidence that States Parties are not using biological agents and toxins for purposes prohibited by the Convention. Consequently, measures designed to facilitate the use of such agents and toxins for peaceful purposes through the regional and international harmonization of the regulatory frameworks for the handling, storage and transfer of biological agents and toxins and through the promotion of internationally accepted standards and regulatory inspections of facilities producing licensed medicinal products for humans and animals will both implement Article X of the Convention and contribute to strengthening the BWC through increasing transparency and building confidence in compliance.
17. An outline is provided below of the current status of moves to harmonise these regulatory frameworks for the handling, storage and transfer of biological agents and toxins and of living modified organisms6 and of the moves to develop international standards and inspections of facilities producing licensed medicinal products.
Health and Environment Initiatives
18. The past decade has seen considerable progress through several health and environment initiatives which received considerable encouragement at the UN Conference on Environment and Development held in Rio de Janeiro in June 1992, known as the Earth Summit. This agreed Agenda 21, a set of principles, intended to address the global objective of achieving sustainable development whilst protecting the environment. Chapter 16 of Agenda 21 addresses the environmentally sound management of biotechnology and has five Sections:
* Increasing the availability of food, feed and renewable raw materials;
* Improving human health;
* Enhancing protection of the environment;
* Enhancing safety and developing international mechanisms for cooperation; and,
* Establishing enabling mechanisms for the development and the environmentally sound application of biotechnology.
The penultimate of these Sections specifically states that there is a need for further development of internationally agreed principles on risk assessment and management of all aspects of biotechnology. These have subsequently been developed as the UNEP International Technical Guidelines on Biosafety. In addition, Chapter 16 says that "only when adequate and transparent safety and border-control procedures are in place will the community at large be able to derive maximum benefit from, and be in a much better position to accept the potential benefits and risks of, biotechnology." This has led under the Convention on Biological Diversity (CBD)7 to negotiations which are nearing completion of a Biosafety Protocol which includes the principle of advance informed agreement for transfers of living modified organisms. The various activities over the last five or so years relating to the UNEP biosafety guidelines and to the Biosafety Protocol are outlined schematically below.
19. Article 19 of the CBD8 which is entitled 'Handling of Biotechnology and Distribution of its Benefits' addresses the distribution of the benefits of biotechnology and includes consideration of safety and transfer aspects. It states that "The Parties shall consider the need for and the modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology which may have adverse effect on the conservation and sustainable use of biological diversity." The implementation of the CBD and negotiation of such a Protocol has been taken forward by the Conferences of the Parties.
20. The first Conference of the Parties in Nassau, Bahamas from 28 November to 9 December 1994 decided to establish an Open-ended Ad Hoc Group of Experts on Biosafety (BSWG) with a mandate to consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of safe transfer, handling and use of any living modified organism resulting from biotechnology that may have an adverse effect on the conservation and sustainable user of biological diversity. The second Conference of the Parties to the CBD in Jakarta on 6 to 17 November 1995 agreed a two track approach in which an Open-ended Ad Hoc Working Group would begin negotiations on a biosafety protocol with the aim of completing this by 1998 in parallel with the finalisation of the United Nations Environmental Programme (UNEP) International Technical Guidelines on Safety on Biotechnology. These are complementary in that the Protocol will be a binding agreement setting out what States must do and the UNEP Guidelines indicating how to do it.
21. The Open-ended Ad Hoc Working Group on Biosafety met for the first time in Aarhus, Denmark from 22 to 26 July 1996. It has subsequently met again in Montreal, Canada on 12 to 16 May 1997, 13 to 17 October 1997 and 9 to 18 February 1998 at which the draft protocol was further developed. Further meetings are planned in August 1998 and a final meeting in February 1999 to be followed by a two-day extraordinary meeting of the Conference of Parties to adopt the Biosafety Protocol. The UNEP International Guidelines were adopted by a meeting of the Global Consultation of Government-designated Experts held in Cairo, Egypt from 11 to 14 December 1995 and issued by UNEP9. These International Guidelines were developed and have been taken forward by a series of regional consultations on International Technical Guidelines for Safety in Biotechnology and Related Capacity-Building Requirements. These Regional Consultations included meetings in Harare, Zimbabwe (11-14 October 1993), San Jose, Costa Rica (28 February - 3 March 1995), Bangkok, Thailand (6 - 8 March 1995), Keszthely, Hungary (4 - 6 September 1995) and Smolenice, Slovak Republic (16 - 18 October 1996) as well as in Cartagena, Columbia and Budapest, Hungary.
22. Considerable progress has thus been made with extensive international consultation that has led to the agreement of the UNEP International Guidelines for Safety in Biotechnology and the negotiations due to be completed within the next 12 months of the Biosafety Protocol.
Regulatory Frameworks
23. Although the Rio Summit and subsequent action has focussed world attention on protection of human health and the environment, many States have long recognised the potential danger from dangerous diseases to their people and to the livestock and crops on which they depend. Consequently, national regulations have been introduced in many countries to control the handling, use, storage and transfer of hazardous pathogens. More recently, countries have sought to harmonise their national regulations with those used in other countries in the region and internationally thereby facilitating cooperation and trade.
24. In many countries, those wishing to work with or use pathogenic organisms are required to provide information to national authorities who will frequently carry out inspections of the facility in which the pathogens are to be handled. Such notification and inspection can be required prior to any work being carried out on the pathogen. In addition, transfers of pathogens that are perceived to present a particular danger are controlled and monitored in several countries. In many countries, additional regulations control the handling and use of genetically modified organisms. The net effect of all these controls and regulations is to provide a framework within a country aimed at ensuring that the danger to public health and to environmental safety from pathogens is minimized and thereby providing assurance to the public in the country concerned.
25. Increasingly, there are moves to harmonize these controls and regulations both regionally and internationally as it is recognised that an outbreak of human, animal or plant disease in one country can all too easily spread into other countries in the region or even more widely in this era of increasing international trade and travel. There is thus both a regional and international initiative to extend national frameworks for control and regulation of dangerous pathogens into regional and global frameworks thereby increasing public assurance that the dangers from disease outbreaks at home and abroad have been minimized.
Pharmaceutical Regulatory Standards
26. Another area in which there is scope for measures to strengthen Article X whilst at the same time strengthening confidence in compliance with the BWC is that related to the licensing of pharmaceutical and biotechnological production facilities. It is apparent that the guidelines for Good Manufacturing Practice (GMP) for medicinal products issued by the European Community10, by the Pharmaceutical Inspection Cooperation Scheme11 and by the World Health Organization12 have successfully been harmonised. These guidelines, or equivalent standards, are required to be met in order for the regulatory authority of one country to accept the reports of inspections of manufacturers carried out by the inspectorate of another country. Such international acceptance of inspection reports is already accepted within the European Community and between the members of the Pharmaceutical Inspection Convention. Mutual Recognition Agreements have been and are being negotiated between countries which contain sectoral agreements on good manufacturing practice for pharmaceuticals in order to achieve this goal. The incentives for the harmonization of GMP and for the international acceptance of inspections is the facilitation of trade in licensed medicinal products for both humans and animals which is becoming increasingly more international.
27. The relevance of these harmonised international guidelines for GMP for medicinal products and the international acceptance of inspections is that facilities which meet these standards for GMP for medicinal products are subject to repeated inspections about once every two years by national inspectorates. The GMP requirements are such that it would not be easy for a GMP inspected manufacturing facility to carry out covert manufacture of prohibited products. Consequently, pharmaceutical and biotechnological facilities that meet these harmonised international standards and are subject to regular inspection are unlikely to present a risk to the Convention -- in other words, there are grounds for confidence that such GMP inspected facilities are engaged in activities that are in compliance with the BWC. Consequently, measures to assist developing countries to adopt national standards for GMP of pharmaceutical products that are the same as those that have been internationally harmonised and adopted and to establish national inspectorates to carry out regular inspections of pharmaceutical manufacturers would be a specific measure that would enhance the implementation of Article X whilst at the same time contributing to increased confidence in compliance.
Analysis
28. International security objectives are to ensure that the use of disease as a weapon of war is totally prohibited and to devise a regime to monitor compliance with this prohibition so as to detect and deter cheaters. The pathogens that can be used as a weapon of war are those that present a danger in natural outbreaks of disease. Because of the international initiatives to counter natural outbreaks of disease in humans, animals and plants, there are increasingly moves to ensure that the vital work for peaceful purposes with such pathogens is controlled and supervised to minimize the danger to public health and the environment as well as to ensure the safety and quality of medicinal products for humans and animals. These moves and those to strengthen international security have common goals.
29. The initiatives to harmonise health and safety regulations and controls, for advanced informed agreement for transborder transfers of living modified organisms, and the harmonisation of regulatory requirements for medicinal products all require national oversight and monitoring of the ways in which pathogens and toxins are handled and used -- and thus have a common goal with the national and international objectives to strengthen the BWC through a Protocol which will provide greater transparency and build confidence in compliance. It is evident in that in many countries, for public health and environmental safety reasons, national authorities are already establishing regulations, collecting relevant information about facilities and activities and inspecting these facilities and activities. As the BWC Protocol is likely to contain declarations and inspections of facilities and activities together with national implementation measures, as well as measures to improve implementation of Articles III and X of the Convention, there is potential for a two way synergy between the strengthening of the BWC and the strengthening of national procedures for the handling, use and transfer of harmful pathogens for public health and environmental safety. Consequently, in regard to the strengthening of the implementation of Article X of the BWC, there appears to be scope for measures to facilitate the harmonization of national, regional and international safety rules for pathogens and toxins and for the production of medicinal products involving both the collection of data and the inspection of facilities thereby enhancing both national public confidence as well as regional and international security. There are synergistic benefits to be gained, both for public health and environmental safety and for international security, through the regime to strengthen the BWC building upon the controls and regulations for public health and environmental safety and seeking to harmonise and strengthen these. This would help capacity building and also, by building upon existing national authorities and reporting requirements, reduce the administrative burden and avoid duplication of effort.
30. It is therefore considered that the Protocol being negotiated to strengthen the BWC should contain specific measures to strengthen the implementation of Article X including:
a. Measures to facilitate the harmonization of national, regional and international safety rules for the handling, storage and transfer of pathogens and toxins. Such rules should involve both the collection of data and the inspection of facilities.
b. Measures to assist countries to adopt internationally harmonised standards for GMP of pharmaceutical products and to establish national inspectorates to carry out regular inspections of pharmaceutical manufacturers.
Both of these measures will bring significant benefits to the States Parties that do not already have such national health and safety or GMP standards and inspectorates. These measures would be additional to the proposals already in the draft Protocol for the BWC Organization to establish cooperative arrangements with relevant organizations such as the OPCW, WHO, FAO, OIE, UNIDO, ICGEB, and UNEP and for the promotion of scientific and technological exchanges.
31. A study13 of the likely size of the BTWC Organization concluded that it was likely to number about 200, well under half the size of the OPCW. Nevertheless, provision was made in that study for an International Cooperation and Assistance section in the BTWC Organization with a similar strength (10 posts) to the number of posts (11) actually in the OPCW in its Cooperation and Assistance section as it was anticipated that the measures to implement Article X of the BTWC would require a small dedicated staff. It is envisaged that the staff in the proposed International Cooperation and Assistance section of the BTWC Organization would keep track of the progress being made by States Parties to introduce safety regulations covering
the handling, storage and transfer of pathogens and toxins as well as their adoption of internationally harmonised standards for GMP of pharmaceutical products and establishment of national inspectorates to carry out regular inspections of pharmaceutical manufacturers. They could report on such progress in the reports that the BTWC Organization is expected to make on the implementation of the Convention to the States Parties in a similar way to the OPCW reports.14 These progress reports could identify where action is needed to provide help to the States Parties in their implementation of these Article X measures. Such aid could then be provided by other States Parties.
Conclusions
32. It is concluded that specific measures to implement Article X of the Convention, such as
a. The harmonization of national, regional and international safety rules for the handling, storage and transfer of pathogens and toxins,
b. The adoption of internationally harmonised standards for GMP of pharmaceutical products and establishment of national inspectorates to carry out regular inspections of pharmaceutical manufacturers,
would also contribute to the strengthening of the BWC through building transparency and enhancing confidence in compliance. The resources needed to do this could be easily accommodated in a small and efficient BTWC Organization of about 200 people well under half the size of the OPCW.
Further information about biological weapons and the Biological and Toxin Weapons Convention (BTWC)
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Footnotes
1. United Nations General Assembly, Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Resolution 2826(XXVI), 16 December 1971.
2. United Nations, Fourth Review Conference of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Final Document, Geneva, 1996.
3. United Nations, Special Conference of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Final Report, Geneva, 1992.
4. The current rolling text is that produced following the January 1998 meeting together with the further changes issued following the March 1998 meeting. United Nations, Procedural Report of the Ad Hoc Group of the States Parties to the Convention on the prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, BWC/AD HOC GROUP/39, 2 February 1998 and United Nations, Procedural Report of the Ad Hoc Group of the States Parties to the Convention on the prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, BWC/AD HOC GROUP/40, 17 March 1998.
5. Mision Permanente de Colombia, Statement by the Non-Aligned Movement and other countries, Geneva, 13 March 1998.
6. Further detail is available in two Briefing Papers: University of Bradford, Article X: Some Building Blocks, Briefing Paper No 6, March 1998 and University of Bradford, Article X: Further Building Blocks, Briefing Paper No 7, March 1998. These are available on the web at http://www.brad.ac.uk/acad/sbtwc
7. The Convention on Biological Diversity (CBD) opened for signature at the Rio summit; it entered into force in December 1993 and it currently has 171 States Parties; two notable exceptions are the USA and North Korea.
8. United Nations, Convention on Biological Diversity, opened for signature at Rio de Janeiro 5 June 1992, UNEP/CBD/94/1, Geneva, November 1994. Also available as HMSO, Cm 2127, January 1993.
9. United Nations Environment Programme, UNEP International Technical Guidelines for Safety in Biotechnology, UNEP Nairobi, Kenya.
10. European Community, Guide to Good Manufacturing Practice for medicinal products, reproduced in Medicines Control Agency, Rules and Guidance for Pharmaceutical Manufacturers and Distributors 1997, The Stationery Office. London, 1997.
11. Pharmaceutical Inspection Convention - Pharmaceutical Inspection Cooperation Scheme (PIC - PIC/S), Guide to Good Manufacturing Practice for medicinal products, Document PH 1/97, February 1997, EFTA Secretariat, Geneva.
12. World Health Organization, Good manufacturing practices for pharmaceutical products, Annex 2 of WHO Expert Committee on Specifications for Pharmaceutical Preparations, Thirty-second report, WHO Technical Report Series 823, Geneva, 1992.
13. Graham S Pearson, An Optimum Organization, Briefing Paper No 5, University of Bradford, January 1998. Available on the web at http://www.brad.ac.uk/acad/sbtwc Graham S. Pearson, A Lean Organization to Strengthen the Biological Weapons Convention, CBW Conventions Bulletin, Issue No 39, March 1998.
14. Organization for the Prohibition of Chemical Weapons, Conference of States Parties, Report of the Organisation on the Implementation of the Convention (29 April - 28 October 1997), C-II/2/Rev. 2, 5 December 1997.
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The Project on Strengthening the Biological and Toxin Weapons Convention and Preventing Biological Warfare is based in the Department of Peace Studies, University of Bradford, UK.
Updated 21 August 1998.