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July 2, 2002

Contact: Stephen M. Apatow
Director of Research & Development
Humanitarian Resource Institute Biodefense Reference Library/Legal Resource Center
Eastern USA: (203) 668-0282 Western USA: (775) 884-4680
Biodefense Reference Library: http://www.humanitarian.net/biodefense
Legal Resource Center: http://www.humanitarian.net/law
Email: s.m.apatow@humanitarian.net

BIOLOGICAL AND TOXIC WEAPONS CONVENTION: A CRUCIAL LEGAL INSTRUMENT IN THE GLOBAL WAR AGAINST TERRORISM

According to the World Health Organization, immunization with the smallpox vaccine -- made from a live weakened virus -- would now be fatal for many people whose immune system is impaired by HIV [1].  Therefore, vaccination would be contraindicated for certain groups that  include persons with immune disorders or those experiencing therapeutically-induced immunosuppression, persons with HIV infection, and persons with a history of eczema [2].

According to Anthony S. Fauci, M.D, as the AIDS epidemic enters its third  decade, more than 900 000 individuals are living with HIV infection in the  United States and another 460 000 HIV-infected people in this country have  died. An additional 40 000 Americans will become newly infected with HIV  this year. More than half of these infections will occur in young people  under age 25. Around the world the situation is much worse: 40 million  people are living with HIV/AIDS, and 22 million HIV-infected individuals have already died [3].

HIV and smallpox vaccination present a significant challenge to the statistical equation. Unlike other emerging infectious diseases, there is not a public health mandate for HIV testing combined with contact tracing for known at-risk contacts.  Therefore, the presence of hidden HIV infection in a population base presents a new dimension of issues that would arise from this variable combined with associated contraindications for vaccination in a bioterrorist incident.

1. WHO Infectious Diseases Report, Chapter 7 text. <http://www.who.int/infectious-disease-report/pages/ch7text.html>

2. WHO Fact Sheet on Smallpox, Contraindications, October 2001. <http://www.who.int/emc/diseases/smallpox/factsheet.html>

3. Fauci, Director, National Institute of Allergy and Infectious Diseases,  National Institutes of Health, HIV Vaccine Awareness Day, May 18, 2002. <http://www.niaid.nih.gov/newsroom/mayday/faucimessage.htm>

BACK OF THE ENVELOPE

Kemper et al. did a "Back of the Envelope" presentation of possible risks associated with smallpox vaccination for the Effective Clinical Practice,  March/April 2002 issue for the American College of Physicians (ACP) journal. They concluded: "After excluding high-risk individuals and their contacts, we estimate that a vaccination strategy directed at people aged 1 to 29 years would result in approximately 1600 serious adverse events and 190 deaths. Vaccinating people aged 1 to 65 years would result in approximately 4600 serious adverse events and 285 deaths.   Limitations: While advances in health care over the past 3 decades could mitigate vaccine complications, the increased number of unimmunized high-risk individuals (e.g., those with eczema or immune suppression) could increase complication rates."

They then went on to discuss the limitations and additional dangers to "high-risk" individuals of a mass immunization campaign.  "We assumed that individuals would be screened before vaccination for risk factors, such as eczema, immunodeficiency, or pregnancy, in themselves or in their close contacts. The prevalence of eczema and the number of immunocompromised individuals have increased over the past 3 decades. High-risk populations would be excluded from vaccination, as would their potential contacts,  since recent vaccine recipients are "infectious" and can transmit the virus (vaccinia).

Individuals with eczema are at high risk for developing eczema vaccinatum. The prevalence of eczema is at least 10 percent, or more than 28 million people in the United States. Immunocompromised persons are at high risk for progressive vaccinia. We know of no overall estimate for the number of immunocompromised individuals in the United States. This number would include recipients of organ transplants (184 000 solid-organ transplants in the 1990s), individuals with diagnosed and undiagnosed HIV infection or AIDS (850 000), and patients with cancer (approximately 8.5 million).  We estimate, therefore, that in the entire U.S. population as many as 10 million individuals (3.6 percent) may be at increased risk for developing progressive vaccinia.

Therefore, approximately 15 percent of the population may have increased risk for a direct adverse event after smallpox vaccination. In addition to exclusion of these individuals from vaccination, persons in close contact with them should not be vaccinated to avoid inadvertent transmission and subsequent indirect adverse events. Close contacts would include, at  minimum, household members. Insufficient data are available to estimate precisely the number of close contacts who would be excluded from a vaccination campaign. We estimate that another 10 percent of the population would be excluded. On the basis of the foregoing, we further estimate that 25 percent of the population would be excluded from vaccination because of high risk or the possibility of coming in contact with a high-risk individual." (<http://www.acponline.org/journals/ecp/marapr02/kemper.htm>)

Reference: ProMED: Smallpox Vaccine ACIP Recommendations - USA (02)

BIOLOGICAL AND TOXIC WEAPONS CONVENTION CONSIDERED CRUCIAL LEGAL INSTRUMENT IN THE GLOBAL WAR AGAINST TERRORISM

Recent discussion regarding complications associated with smallpox vaccination and HIV infection has once again drawn international attention to the importance of the Biological and Toxic Weapons Convention as a crucial legal instrument in the global war against terrorism.

Highlights of Issues Discussed during the The Eight Meeting of the ASEAN Regional Forum, Ha Noi, 25, July 2001(US State Department: Bureau of Political-Military Affairs, Washington, DC) included:

24. The Ministers discussed issues relating to proliferation of weapons of mass destruction and their means of delivery as well the implications of missile defence systems. They noted expressions of support for the Nuclear Non-Proliferation Treaty (NPT) as the cornerstone of the global non-proliferation regime. The Ministers also took note the call for all states to sign and ratify the Comprehensive Test Ban Treaty (CTBT) and to accede to the NPT. The Ministers urged all states to maintain existing moratoria on nuclear testing. They also took note of the call made in the NPT Review Conference Final Document on the Conference in Disarmament to agree on a programme  of work which includes the immediate commencement of negotiations on the Fissile Material Cut-Off Treaty. The Ministers further emphasised the importance of systematic and progressive efforts by Nuclear Weapon States on nuclear  disarmament and called on all states to work towards the objective of total elimination of nuclear weapon.

25. The Ministers expressed their hope that the Protocol strengthening the Biological and Toxin Weapons Convention (BTWC) would be finalised before the 5th BTWC Review Conference and urged all countries to speedily conclude their negotiations on the said Protocol.

TEXT OF THE BIOLOGICAL WEAPONS CONVENTION
Source: UN Department for Disarmament Affairs

Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction

Opened for signature at London (L), Moscow (M) and Washington (W): 10 April 1972
Entered into force: 26 March 1975
Depositary Governments: Russian Federation, United Kingdom of Great Britain and Northern Ireland and United States
of America

The States Parties to this Convention, 

Determine to act with a view to achieving effective progress toward general and complete disarmament, including the prohibition and elimination of all types of weapons of mass destruction, and convinced that the prohibition of the development, production and stockpiling of chemical and bacteriological (biological) weapons and their elimination, through effective measures, will facilitate the achievement of general and complete disarmament under strict and effective control, 

Recognizing the important significance of the Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or Other Gases, and of Bacteriological Methods of Warfare, signed at Geneva on June 17, 1925, and conscious also of the contribution which the said Protocol has already made and continues to make, to mitigating the horrors of war, 

Reaffirming their adherence to the principles and objectives of that Protocol and calling upon all States to comply strictly with them, 

Recalling that the General Assembly of the United Nations has repeatedly condemned all actions contrary to the principles and objectives of the Geneva Protocol of June 17, 1925, 

Desiring to contribute to the strengthening of confidence between peoples and the general improvement of the international atmosphere, 

Desiring also to contribute to the realization of the purposes and principles of the Charter of the United Nations, 

Convinced of the importance and urgency of eliminating from the arsenals of States, through effective measures, such dangerous weapons of mass destruction as those using chemical or bacteriological (biological) agents, 

Recognizing that an agreement on the prohibition of bacteriological (biological) and toxin weapons represents a first possible step towards the achievement of agreement on effective measures also for the prohibition of the development, production and stockpiling of chemical weapons, and determined to continue negotiations to that end, 

Determined, for the sake of all mankind, to exclude completely the possibility of bacteriological (biological) agents and toxins being used as weapons, 

Convinced that such use would be repugnant to the conscience of mankind and that no effort should be spared to minimize this risk, 

Have agreed as follows: 

ARTICLE I

Each State Party to this Convention undertakes never in any circumstance 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; 

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

ARTICLE II

Each State Party to this Convention undertakes to destroy, or to divert to peaceful purposes, as soon as possible but not later than nine months after the entry into force of the Convention, all agents, toxins, weapons, equipment and means of delivery specified in article I of the Convention, which are in its possession or under its jurisdiction or control. In
implementing the provisions of this article all necessary safety precautions shall be observed to protect populations and the environment. 

ARTICLE III

Each State Party to this Convention undertakes not to transfer to any recipient whatsoever, directly or indirectly, and not in any way to assist, encourage, or induce any State, group of States or international organizations to manufacture or otherwise acquire any of the agents, toxins, weapons, equipment or means of delivery specified in article I of the Convention. 

ARTICLE IV

Each State Party to this Convention shall, in accordance with its constitutional processes, takes any necessary measures to prohibit and prevent the development, production, stockpiling, acquisition or retention of the agents, toxins, weapons, equipment and means of delivery specified in article I of the Convention, within the territory of such State, under its
jurisdiction or under its control anywhere. 

ARTICLE V

The States Parties to this Convention undertake to consult one another and to cooperate in solving any problems which may arise in relation to the objective of, or in the application of the provisions of, the Convention. Consultation and cooperation pursuant to this article may also be undertaken through appropriate international procedures within the framework of the United Nations and in accordance with its Charter. 

ARTICLE VI

(1) Any State Party to this Convention which finds that any other State Party is acting in breach of obligations deriving from the provisions of the Convention may lodge a complaint with the Security Council of the United Nations. Such a complaint should include all possible evidence confirming its validity, as well as a request for its consideration by the Security Council. 

(2) Each State Party to this Convention undertakes to cooperate in carrying out any investigation which the Security Council may initiate, in accordance with the provisions of the Charter of the United Nations, on the basis of the complaint received by the Council. The Security Council shall inform the States Parties to the Convention of the results of the investigation. 

ARTICLE VII

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. 

ARTICLE VIII

Nothing in this Convention shall be interpreted as in any way limiting or detracting from the obligations assumed by any State under the Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or Other Gases, and of Bacteriological Methods of Warfare, signed at Geneva on June 17, 1925. 

ARTICLE IX

Each State Party to this Convention affirms the recognized objective of effective prohibition of chemical weapons and, to this end, undertakes to continue negotiations in good faith with a view to reaching early agreement on effective measures for the prohibition of their development, production and stockpiling and for their destruction, and on appropriate measures concerning equipment and means of delivery specifically designed for the production or use of chemical agents for weapons purposes. 

ARTICLE X

(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 organizations to the further development and application of scientific discoveries in the field of bacteriology (biology) for 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. 

ARTICLE XI

Any State Party may propose amendments to this Convention. Amendments shall enter into force for each State Party accepting the amendments upon their acceptance by a majority of the States Parties to the Convention and thereafter for each remaining State Party on the date of acceptance by it. 

ARTICLE XII

Five years after the entry into force of this Convention, or earlier if it is requested by a majority of the Parties to the Convention by submitting a proposal to this effect to the Depositary Governments, a conference of States Parties to the Convention shall be held at Geneva, Switzerland, to review the operation of the Convention, with a view to assuring that the purposes of the preamble and the provisions of the Convention, including the provisions concerning negotiations on chemical weapons, are being realized. Such review shall take into account any new scientific and technological developments relevant to the Convention. 

ARTICLE XIII

(1) This Convention shall be of unlimited duration. 

(2) Each State Party to this Convention shall in exercising its natural sovereignty have the right to withdraw from the Convention if it decides that extraordinary events, related to the subject matter of the Convention, have jeopardized the supreme interests of its country. It shall give notice of such withdrawal to all other States Parties to the Convention and to the United Nations Security Council three months in advance. Such notice shall include a statement of the extraordinary events it regards as having jeopardized its supreme interests. 

ARTICLE XIV

(1) This Convention shall be open to all States for signature. Any State which does not sign the Convention before its entry into force in accordance with paragraph (3) of this Article may accede to it at any time.

(2) This Convention shall be subject to ratification by signatory States. Instruments of ratification and instruments of accession shall be deposited with the Governments of the United States of America, the United Kingdom of Great Britain and Northern Ireland and the Union of Soviet Socialist Republics, which are hereby designated the Depositary Governments. 

(3) This Convention shall enter into force after the deposit of instruments of ratification by twenty-two Governments, including the Governments designated as Depositaries of the Convention. 

(4) For States whose instruments of ratification or accession are deposited subsequent to the entry into force of this Convention, it shall enter into force on the date of the deposit of their instrument of ratification or accession. 

(5) The Depositary Governments shall promptly inform all signatory and acceding States of the date of each signature, the date of deposit of each instrument of ratification or of accession and the date of the entry into force of this Convention, and of the receipt of other notices. 

(6) This Convention shall be registered by the Depositary Governments pursuant to Article 102 of the Charter of the United Nations. 

ARTICLE XV

This Convention, the English, Russian, French, Spanish and Chinese texts of which are equally authentic, shall be deposited in the archives of the Depositary Governments. Duly certified copies of the Convention shall be transmitted by the Depositary Governments of the signatory and acceding States. 
 

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