ARTICLE VII
SCIENTIFIC AND TECHNOLOGICAL EXCHANGE FOR
PEACEFUL
PURPOSES AND TECHNICAL COOPERATION40
(A) GENERAL PROVISIONS
1. Each State Party undertakes to implement specific measures, including those set out in this Article, designed to enhance compliance and ensure effective and full implementation of Article X of the Convention among the States Parties to the Protocol. The implementation of such measures shall be aimed at:
(a) Promoting scientific and technological exchanges and fostering international cooperation, as appropriate, on a multilateral, regional or bilateral basis, directly or through the Organization, in the field of peaceful bacteriological (biological) and toxin activities;
(b) Facilitating free trade and the fullest possible exchange in biological agents, toxins, equipment and materials for peaceful purposes in order to enhance the economic and technological development of States Parties and ensuring the right of States Parties to participate in such exchanges to the fullest extent possible;
(c) Avoiding hampering the economic and technological development of States Parties [or] [imposing and maintaining] [through] any restrictions incompatible with the obligations undertaken under the Convention and/or limitations on the transfer for purposes consistent with the objectives and the provisions of the Convention of scientific knowledge, technology, equipment and materials.
2. The Organization shall provide a forum for consultation and creation of opportunities for cooperation on matters related to the promotion of scientific and technological exchange in the field of peaceful bacteriological (biological) and toxin activities and review of the implementation of Article X assistance41 provisions of the Convention among the States Parties to the Protocol. The Organization shall also develop a framework for activities aimed at promoting scientific and technological cooperation and exchange and providing technical assistance, including protocol implementation assistance, upon request, to States Parties, in particular to developing countries which are States Parties. Such a framework may include activities conducted in collaboration with relevant international organizations and agencies.
(B) MEASURES TO PROMOTE SCIENTIFIC AND TECHNOLOGICAL EXCHANGES
3. Each State Party undertakes 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 and, in its implementation of these measures, to ensure that any transfers or exchanges of materials, equipment, technology, and any information pursuant to this Article shall take place in compliance with the provisions of Articles III and X of the Convention.
4. Each State Party shall promote and support, in furtherance of any current endeavours relevant to and in accordance with the Convention, [where appropriate,] individually, jointly, through arrangements, with relevant international organizations and agencies, including, but not limited to, the FAO, ICGEB, IVI, OIE, OPCW, UNEP, UNIDO, WHO and the Secretariat of the CBD, or the institutional mechanisms provided for under section D of this Article:
(a) The publication, exchange and dissemination of information, including through workshops, training programmes and conferences, on current and recent developments, as well as on research and development on the peaceful uses of microorganisms and toxins, biosafety, [biodefence,] biotechnology, good laboratory practice and current good manufacturing practice, and diagnosis, surveillance, detection, treatment and prevention of diseases caused by biological agents or toxins, in particular infectious diseases;
(b) The work of existing laboratories on the prevention, surveillance, detection and diagnosis of diseases caused by biological agents or toxins, in particular infectious diseases, to improve the capabilities of such laboratories and their effectiveness, through, inter alia, the provision of training and technical advice, equipment and reagents;
(c) The improvement of States Parties' capabilities [, including, where necessary the establishment and operation of new [laboratories] [capabilities] upon the specific request of the State Party concerned,] in the surveillance, prevention, detection, diagnosis and treatment of diseases caused by biological agents or toxins, in particular infectious diseases, as an integral part of a global effort to improve the monitoring of emerging and re-emerging diseases in humans, animals and plants;
(d) The improvement of research capabilities in relevant fields of biosciences and biotechnology for peaceful purposes, through collaborative research programmes and projects [, including, where necessary the establishment and operation of new research [institutes] [capabilities] upon the specific request of the State Party concerned,] in particular in the use of microorganisms and toxins for medical, agricultural, veterinary and industrial purposes;
(e) The establishment, operation and updating of biological data bases including those maintained by the Technical Secretariat on information relevant to the purposes of the Convention as well as accessibility to such data bases;
(f) The monitoring, diagnosis, detection, prevention and control of outbreaks of diseases, and international cooperation on the research, development and production of vaccines;
(g) Transfer among States Parties of technology for the peaceful uses of genetic engineering, the prevention, diagnosis and treatment of diseases caused by biological agents or toxins, in particular infectious diseases, and for other relevant fields of biosciences and biotechnology for peaceful purposes;
(h) Participation [on [a [fair and equitable] [non-discriminatory] basis] [and as wide a geographic basis as possible]] at the bilateral, regional or multilateral levels in the application of biotechnology and scientific research and development, for the prevention, surveillance, detection, diagnosis and treatment of diseases caused by biological agents or toxins, in particular infectious diseases;
(i) The establishment and conduct of training programmes on the diagnosis, surveillance, detection, prevention and treatment of diseases caused by biological agents or toxins, in particular infectious diseases;
[(j) The establishment of a framework of cooperative activities aimed at improving and strengthening the States Parties' capabilities in the field of biodefence, including through the fullest possible exchange of instruments, equipment and technologies, training of personnel as well as collaborative research and development projects amongst States Parties;]42
[(k) Any other specific measure(s) recommended by the Conference of States Parties on the further strengthening of the implementation of Article X of the Convention and this Article in accordance with paragraph ... of Article IX.]
(C) MEASURES TO AVOID HAMPERING THE ECONOMIC AND TECHNOLOGICAL DEVELOPMENT OF STATES PARTIES
5. Nothing in this Protocol shall prejudice the rights of States Parties to, individually or collectively, conduct research with, develop, produce, acquire, retain, transfer and use biological agents and toxins for peaceful purposes.
6. Each State Party shall:
[(a) [In fulfilment of its obligations under Article X,] Not establish or maintain, either individually or collectively, [regimes which conflict with Article X of the Convention] [restrictions, including those in any international agreements, or] any discriminatory measure [, incompatible with the obligations undertaken under the Convention,] which would restrict or impede [trade and the development and promotion of scientific and technological knowledge] [the fullest possible exchange of equipment, materials and scientific and technological information] for the use of bacteriological (biological) agents and toxins for peaceful purposes, [in particular] [including] in the fields of biological research, [including] microbiology, biotechnology, genetic engineering, and their industrial, agricultural, medical, pharmaceutical applications, and other related areas for peaceful purposes;
[(b) Not use any other international agreement or arrangement for pursuing an objective inconsistent with the Convention, nor use the Convention or this Protocol as grounds for applying any measures other than those provided or permitted under the Convention or this Protocol;]
(c) Undertake to review [periodically], and amend [or adopt] as necessary, national regulations governing international exchanges and transfers of bacteriological (biological) agents and toxins, and equipment, materials and scientific and technological information for the use of such agents and toxins in order to ensure their consistency with the objectives and relevant provisions of the Convention and this Protocol [, within ... days of the entry into force of this Protocol for it]. [The first review shall be completed no later than 180 days after the entry into force of this Protocol.] The Director-General shall collate on an annual basis a report containing information on the implementation of this subparagraph.]43 [The Conference of States Parties shall consider the report of the Director-General and may make recommendations to States Parties.] [Those recommendations may include measures to be taken by States Parties participating in any other international agreement or arrangement in order to ensure their consistency with the objectives and provisions of the Convention and this Article.]]
[7. A State Party which considers its peaceful economic and technological development has been hampered by restrictions or measures imposed or maintained by another State Party or States Parties, incompatible with the provisions of Article X of the Convention and this Article and generally applicable principles of international law, shall have the right, in accordance with Article V, to seek measures to redress such a situation and ensure compliance with the provisions of Article X of the Convention and this Article.]
(D) INSTITUTIONAL MECHANISMS FOR INTERNATIONAL COOPERATION AND PROTOCOL IMPLEMENTATION ASSISTANCE
The Cooperation Committee
8. The Cooperation Committee (hereinafter referred to as "the Committee"), established by the Conference of States Parties in accordance with Article IX, paragraph ..., shall be a forum for consultation aimed at promoting the effective and full implementation among the States Parties to the Protocol of the provisions of Article X of the Convention and this Article. To this end, [considering the undertakings of States Parties as envisaged under Article X,] the Committee shall consult on, [monitor] and review activities fostering international cooperation and assistance and [the fullest possible] [transfer and] exchange of equipment, materials and scientific and technological information for the use of bacteriological (biological) agents and toxins for peaceful purposes. [The Committee shall also contribute to efforts by the Organization to develop a framework for activities aimed at promoting scientific and technological exchanges for peaceful purposes and technological cooperation for peaceful purposes.]
9. The Committee shall review the implementation of measures, pursuant to section B of this Article, to promote scientific and technological exchanges and make recommendations thereon to the Conference of States Parties.
10. The Committee shall review and make recommendations to the Executive Council on:
(a) Cooperative relationships of the Organization with other international organizations and agencies, pursuant to section F of this Article;
(b) The programmes and activities of the Technical Secretariat, pursuant to paragraphs 17, 18, 19 and 20 of this section;
(c) The use of [the] voluntary [fund] [contributions] in activities relevant to this Article, as well as the operation of the regular budget where it relates to activities of the Organization in the implementation of this Article.
[11. The Committee shall prepare an annual report on its activities, containing the results of its review of measures agreed upon or taken by the relevant organs of the Organization and its recommendations pursuant to paragraphs 8, 9 and 10 above. The report shall then be forwarded to the Executive Council for any additional recommendations or comments it may wish to annex to the report. The report shall then be submitted to the Conference of States Parties.]
[11 bis The Committee shall submit to the Conference of States Parties, an annual report on its activities, containing the results of its review of measures agreed upon or taken by the relevant organs of the Organization and its recommendations pursuant to paragraphs 8 and 9 above. The Cooperation Committee also submit to the Executive Council, the result of its measures along with the operational recommendations on the routine basis for its timely consideration. The Executive Council should then report its decision to the Conference of States Parties while informing the Cooperation Committee accordingly.]
[12. The Committee [shall] [review] [receive] [may consider] the annual declarations by States Parties in accordance with paragraph(s) ... [on the [specific] measures that they have taken in order to implement the provisions of Article X of the Convention and this Article [, with the aim of identifying best practices in scientific and technical cooperation]].]
[12 bis The Committee shall receive and consider the annual declarations submitted by the States Parties in accordance with paragraph(s) ... of section H and Appendix E.]
[13. [The Committee shall be open to all States Parties] [The members of the Committee shall be elected for a term of two years, on the basis of an equitable geographical distribution, in accordance with Article IX, paragraph ... of this Protocol].]
[13 bis The Committee shall be a pluridisciplinary body open to the participation of all States Parties and shall comprise government representatives competent in the relevant fields of expertise. The Committee may establish working groups on an ad hoc basis.]
[14. The Committee shall elaborate its rules of procedure and submit them [, subject to paragraph ...,] to the [Conference of States Parties] [Executive Council] for approval.]
[14 bis The Committee shall meet at least twice a year, once immediately prior to the Conference of States Parties. Additional meetings may be convened in accordance with the rules of procedure referred to in paragraph 14 above.]
15. The chairmanship of the Committee shall rotate annually between each regional group, as defined in Article IX, paragraph ..., represented in the Committee. [Decisions shall be taken [by consensus] [in the same manner as decisions by the [Conference of State Parties] [Executive Council], in accordance with Article IX, paragraph ...].] [Recommendations shall be agreed by consensus.]
[16. The Committee may establish working groups of scientific experts on an ad hoc basis to review and report to it on specific technical matters, referred to it by the Cooperation Committee, directly relevant to the implementation of the provisions of paragraph ... of this section.]
Role of the Technical Secretariat
17. The Director-General, assisted by the Technical Secretariat, shall promote and facilitate scientific and technical cooperation and exchange among States Parties and shall develop a framework of programmes and activities to implement the decisions of the relevant organs of the Organization, as specified in paragraph ... of Article IX. The Technical Secretariat shall, in accordance with paragraphs ..., where appropriate:
[(a) Promote and finance the establishment of vaccine production facilities, particularly in developing countries [which are States Parties];]
[(a) bis Provide advice and identify possible sources of financial and technical assistance for the establishment and operation of collaborative vaccine research and development programmes, and on the requirements for vaccine production facilities meeting current Good Manufacturing Practice standards;]
[(a) ter Promote collaborative vaccine research and development programmes, which would examine the requirements for vaccine production facilities meeting current Good Manufacturing Practice standards, including through the identification of sources of financial and technical assistance;]
(b) Establish and maintain a network to facilitate contact and communications, using the available electronic systems between States Parties, other relevant international organizations and the Technical Secretariat, for the purposes of enabling and promoting scientific cooperation and exchange among States Parties;
(c) Convene regional or international seminars with a view to optimizing cooperation on the peaceful uses of bacteriological (biological) agents and toxins;
(d) Develop a framework for donor countries, including [through] [a] voluntary [fund] [contributions] to support an international system for the global monitoring of emerging diseases in humans, animals and plants, and to support other specific programmes to improve the effectiveness of national and international efforts on the diagnosis, prevention and treatment of diseases caused by biological agents and toxins, in particular infectious diseases;
(e) Advise and assist States Parties to promote the objective of, employment of personnel on a wide and equitable geographical basis, on the design and conduct of training programmes to help develop and enhance the expertise and skills necessary for their nationals to serve on the staff of the Technical Secretariat;
(f) Conduct internship programmes for appropriately qualified personnel, on the basis of equitable geographical distribution, to optimize cooperation on the peaceful uses of bacteriological (biological) agents and toxins and technical cooperation amongst the States Parties;
(g) Promote the exchange, dissemination and the publication of information on research centres, current research and training programmes and conferences on the diagnosis, treatment and prevention of diseases caused by biological agents and toxins, in particular infectious diseases;
(h) Provide information on the availability of and accessibility to publications and other publicly available forms of information containing the results of recent and current research programmes on the uses of bacteriological (biological) agents and toxins for industrial, pharmaceutical, medical and agricultural purposes [as well as developments in biodefence activities];
[(i) Implement programmes amongst [Inform] States Parties, upon request, on equipment and technology exchanges relevant [on the peaceful uses of bacteriological (biological) agents and toxins] [on the diagnosis, treatment and prevention of diseases caused by biological agents and toxins, in particular infectious diseases];]
(j) Implement at the request of States Parties, programmes of support and assistance for upgrading laboratories nominated for designation and certification pursuant to paragraph 25 of Annex D, section I, part B;
(k) Implement programmes of support and assistance for designation and certification of laboratories pursuant to paragraph 25 of Annex D, section I, part B.
Cooperation and assistance in the context of visits
18. If specifically requested by a State Party in the context of visits pursuant to Article III, paragraphs 14 and 102 (a) and (b), and of paragraph 2 of this Article, the visiting team shall provide information and advice on, and implement, where appropriate, any cooperation and assistance activities contained in programme(s) of the Organization in, inter alia:
(a) Biosafety, including environmental protection and occupational health issues;
(b) The principles of Good Laboratory Practice and current Good Manufacturing Practices;
[(c) [The identification of agents,] diagnostics and the [development of innovative vaccines] [availability of existing vaccines and the possible timetable for the introduction of new vaccines];]
[(c) bis Diagnostic techniques for infectious diseases and the availability of vaccines;]
(d) The principles and requirements of national and international regulatory mechanisms governing the production, validation, marketing and sale of biological products for prophylactic, diagnosis and treatment of diseases caused by biological agents or toxins, in particular infectious diseases, and pharmaceutical products and vaccines;
(e) Training requirements for facility and national regulatory personnel, and sources of such training;
(f) The evaluation of the methodology underpinning the State Party's or facility's declaration process and the formulation of suggestions, if necessary, for methodological improvements to future declarations;
(g) The provision of information, guidance or the identification of any specific training opportunities for facility personnel on efficient biosafety, occupational health and safety practices and environmental protection relevant to the facility. This may include facilitating contact with relevant international bodies;
(h) The provision of information on publications and other publicly available forms of information containing current research programmes in the biosciences and biotechnology, conferences, research centres, information databases and other scientific and technological developments and activities about which the visiting team are cognizant of relevance to the Convention and facility;
(i) The provision of information and guidance as well as the identification of any specific training opportunities for facility personnel to facilitate the development, evaluation or licensing of products;
(j) The identification of national, regional and international sources of information for more detailed follow-up enquiries and specialized assistance on these topics.
Protocol implementation assistance44
19. Upon a specific request by a State Party, the Technical Secretariat shall provide advice and assistance either by itself or in cooperation with other States Parties on:
(a) The establishment and functioning of [national authorities] ;
(b) The preparation of declarations required under Article III of this Protocol;
(c) The drawing up of internal legislation necessary under the provisions of this Protocol;
(d) The content and conduct of training courses and seminars for [National Authority] and declared facility personnel on the compilation of declarations and the planning and hosting of visits.
20. All requests for assistance by States Parties shall be submitted to the Director-General and shall include detailed information and reasons for the assistance sought. Where requests for assistance exceed the available resources of the Technical Secretariat, the Director- General45 shall take into the account one or more of the following factors:
(a) The effective implementation of this Protocol;
(b) The relative capacities and needs of individual States Parties, particularly of developing countries being States Parties;
(c) The specific details of each request;
(d) Whether the State Party seeking assistance has benefitted from technical and assistance programmes established by the Technical Secretariat within the last two years, and, if so, the financial extent of them;
(e) The extent to which the assistance requested would improve the operation and utility of existing national, regional and international efforts in the area of the assistance sought.
(E) [REVIEW OF] [CONSIDERATION OF CONCERNS RELATED TO] THE IMPLEMENTATION OF ARTICLE X OF THE CONVENTION AND THIS ARTICLE
21. The Executive Council shall, in accordance with paragraph ... of Article IX of the Protocol, consider concerns raised by a State Party on the implementation of Article X of the Convention and this Article.
22. The State Party which raises concerns related to the implementation of Article X of the Convention and this Article shall provide the Executive Council with supporting evidence and other information substantiating its concerns. Any other State Party may provide relevant information to support or clarify the concern.
[23. The Executive Council may make recommendations to the States Parties concerned on ways in which they may wish to [resolve] [redress] [address] the situation. [The Executive Council may also bring the issue to the attention of the Conference of States Parties [for further action] [for further necessary action under Article V of this Protocol].]]
[23 bis The Executive Council may make recommendations that would apply collectively to all States Parties concerned on matters of a general nature related to the ways in which they may wish to [resolve] [address] [redress] the situation. The Executive Council may also bring the issue to the attention of the Conference of States Parties.]
[23 ter The Executive Council shall bring the issue to the attention of the Conference of States Parties. The Conference of States Parties may make recommendations to the States Parties concerned on ways in which they may wish to resolve the situation.]
(F) COOPERATIVE RELATIONSHIPS WITH OTHER INTERNATIONAL ORGANIZATIONS AND AMONG STATES PARTIES
24. The Organization may, where appropriate, conclude agreements and arrangements pursuant to paragraphs 22 (j), 32 (k) and 36 (h) of Article IX with relevant international organizations and agencies, including, but not limited to, the FAO, ICGEB, IVI, OIE, OPCW, UNEP, UNIDO, WHO and the Secretariat of the CBD, [taking into account their relevant competences and existing agreements,] [to enhance compliance and ensure effective and full implementation of Article X of the Convention and this Article] in order to, inter alia:
(a) Derive the greatest possible synergy in, and benefits from:
(i) The collection and dissemination of information on the peaceful uses of biological agents and toxins [including developments in biodefence activities];
(ii) Sharing information on environmental release of genetically modified organisms;
(iii) Current Good Manufacturing Practices (GMP), Good Laboratory Practice (GLP), biological containment and other biosafety regulations and practices;
(iv) Facilitation of access to databases containing information on the peaceful uses of bacteriological (biological) agents and toxins, biosafety, and results of scientific research in the life sciences in areas of particular relevance to the Convention;
(v) The collection and dissemination of information on the diagnosis, surveillance, detection, treatment and prevention of diseases caused by biological agents or toxins, in particular infectious diseases;
(vi) Regulations governing the handling, transportation, use and release of bacteriological (biological) agents and toxins;
(b) Coordinate its activities with those of international organizations and agencies on the peaceful uses of bacteriological (biological) agents and toxins, and on the diagnosis, detection, treatment and prevention of diseases caused by biological agents or toxins, in particular infectious diseases, and raise awareness of and facilitate access to those activities by States Parties to the Protocol;
[(c) Support and establish a framework for multilateral cooperation among the States Parties, including exchange of information among scientists and technologists, with the aim of, inter alia:
(i) Utilizing the scientific and technological capabilities, experience and know-how of States Parties;
(ii) Facilitating harmonization of relevant existing national regulatory and administrative procedures;
(iii) Assisting developing countries which are States Parties to strengthen their scientific and technological capabilities in the fields of biosciences, genetic engineering and biotechnology;]
(d) Facilitate the provision of information and advice about relevant existing regulatory procedures on the peaceful uses of bacteriological (biological) agents and toxins.
[25. The Conference of States Parties may consider and decide on possible ad hoc collaborative relationships with relevant non-governmental organizations for the purposes set out in paragraph 24 above.]
26. The Technical Secretariat shall maintain a record of cooperative activities with other relevant international organizations and agencies, pursuant to paragraph 24, and shall make such a record available to States Parties on request, as well as to the Cooperation Committee.
27. The Technical Secretariat, including upon request by the Executive Council, after consultation with relevant international organizations and agencies with which the Organization has cooperative relationships, pursuant to paragraph 24, may make recommendations, as appropriate, to the Cooperation Committee, the Executive Council or the Conference of States Parties for further practical steps with a view to the effective implementation of the cooperative relationships envisaged in this section.
[28. The Organization shall contain a department devoted to the implementation of [Article X of the Convention] [and] [this Article].]
[(G) SAFEGUARDS46
[29. The obligations set out in this Article are subject to, and limited by, the right of each State Party to protect commercial proprietary information and national security. [Such obligations are also subject to the availability of national resources.]]
[30. In implementing the provisions of this Article, the States Parties and the Director- General shall take into account existing agreements and competences of other relevant international organizations and agencies as well as the activities of States Parties in order to avoid duplication as well as to ensure an effective and coordinated use of resources for the effective implementation of the measures identified in this Article.]]47
(H) DECLARATIONS
31. Each State Party shall submit a declaration annually to the Director-General, in accordance with the format set out in Appendix E, with a general description of measures taken, individually or together with other States and international organizations and agencies, in order to implement the provisions of Article X of the Convention and this Article. At the recommendation of the Cooperation Committee, the Director-General shall consider these declarations with the aim of suggesting specific practical steps for the enhanced effectiveness and improved implementation of Article X of the Convention and this Article. The Cooperation Committee shall receive and consider these declarations and any other suggestions, including those from the Director-General, in the preparation of its annual report to the Conference of States Parties, as specified under paragraph 11 of this Article.
[32. Each State Party shall have the right to declare any restrictions, in non-compliance with the obligations under Article X, on the transfer of biological materials, equipment and technology for peaceful purposes.]