The Biological and Toxin Weapons Convention (BTWC) Database
Strengthening the Biological Weapons Convention
Briefing Paper No. 17: The Strengthened BTWC Protocol: Implications for the Biotechnology and Pharmaceutical Industry
Executive Summary
Malcolm R. Dando
Series Editors, Graham S. Pearson and Malcolm R. Dando
Department of Peace Studies, University of Bradford
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The mandate for the Ad Hoc Group (AHG) is "to consider appropriate measures, including possible verification measures, and draft proposals to strengthen the Convention". The mandate includes also the requirement that:
"Measures should be formulated and implemented in a manner designed to protect sensitive commercial proprietary information and legitimate national security needs."
Although some States have kept their national biotechnology and pharmaceutical industries informed of the developments in the negotiations, it is evident that in some countries the potential implications for industry are less well understood. This Briefing Paper examines the likely implications of the central elements of the Protocol for industry and considers the extent to which the negotiators have successfully met the objective of their mandate to devise measures designed to protect sensitive commercial proprietary information and to avoid any negative impact on industrial development. It is concluded that the draft Protocol will not impose a significant additional burden upon an industry that is already tightly regulated and controlled in most parts of the world.
The central and essential elements of the Protocol to strengthen the BTWC are widely recognised as comprising:
Declarations of a range of facilities and activities of potential relevance under the Convention so as to enhance transparency;
Provisions for visits to facilities in order to promote accurate and complete declarations and thus further enhance transparency and confidence;
Provision for rapid and effective investigations into concerns over non-compliance, including both facility and field investigations; and
A cost-effective and independent organisation, including a small permanent staff, capable of implementing the Protocol effectively.
The elements of the Protocol of greatest relevance to the biotechnology and pharmaceutical industry are the requirements for declarations, the procedures for visits to facilities, the facility investigations and the provisions for the safeguarding of confidentiality. The likely requirements in the Protocol for each of these is considered in turn.
Declarations
An assessment is given of the number of facilities likely to be declared, and the information likely to be required in declarations. It is concluded that the numbers of facilities that will need to be declared will be of the order of 10s per country, the
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information to be declared will not require any disclosure of commercial proprietary information and the level of detail and amount of information required in the envisaged declarations will not be an undue burden on what is already a highly regulated industry.
Visits
The current rolling text considers four types of visits. An analysis is made of the random and clarification visits, which will not be voluntary. The net impact of visits on the civil pharmaceutical and biotechnology industry would appear to be small. In the first instance visits are directed, with very limited exceptions in extreme circumstances, only at declared facilities, and most industry facilities will simply not be required to be declared. The size of the probable organisation is such that only a very small number of visits by small teams of professional inspectors is likely to take place in any one country. Furthermore, any random or clarification visit will be limited to checking the declaration of the visited facility and carried out under managed access. It is clear from the rolling text that sampling and analysis are not under consideration unless offered by the visited facility.
Investigations
There is little dissent over the need for an effective Protocol to include challenge investigations. However, despite that fact, and the clear indications that very few such investigations are likely to occur, considerable concerns remain in the industrial world about the potential loss of commercial proprietary information during intrusive facility investigations. It is concluded that an industrial facility that is, in fact, in compliance with the BTWC, in a country with strong BTWC legislation and with a strong infrastructure of controls of health and safety as well as of its pharmaceutical industry, will not be the subject of a credible investigation request. Furthermore, it is considered that the provisions in the Protocol for the prevention of frivolous or abusive investigation requests will be effective in preventing such requests in regard to facilities in such a country being implemented.
Confidentiality
The biotechnology and pharmaceutical industry has argued that a loss of confidentiality poses more of a financial risk to them than it does to the chemical industry. However, in considering the risk that a strengthened BTWC might pose to the biotechnology and pharmaceutical industry it has to be asked whether this is of a different order from that posed by the possibility, for example, of challenge inspections to the biotechnology and pharmaceutical industry already accepted under the Chemical Weapons Convention.
Conclusion
It is concluded that the central elements of the Protocol of greatest concern to the biotechnology and pharmaceutical industry - the requirements for declarations, the procedures for visits to facilities, the facility investigations and the provisions for the safeguarding of confidentiality - will not impose a significant additional burden upon industry. Moreover, in view of growing appreciation world-wide of the danger of misuse of biological materials, it is probable that these extra regulations and controls will be quite acceptable to those working in what is already a very highly regulated industry.
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The Biological and Toxin Weapons Convention Database forms part of the Project on Strengthening the Biological and Toxin Weapons Convention and Preventing Biological Warfare, which is based in the Department of Peace Studies, University of Bradford, UK.
Updated 30 September 1998